nctId: NCT06390072 id: 23-X-71 briefTitle: Project Hypnos: The Impact of a Brief Hypnosis Intervention on Single-limb Dynamic Balance in People With Chronic Ankle Instability overallStatus: COMPLETED date: 2023-09-25 date: 2023-11-27 date: 2023-11-27 date: 2024-04-29 date: 2024-04-29 name: Ohio University class: OTHER briefSummary: This study will determine the relationship of one's self-reported awareness of their body and their ankle motor control for people with chronic ankle instability. This study will further identify the correlates between certain psychological characteristics (i.e., fear and anxiety) and autonomic nervous system arousal (i.e., heart rate variability). Furthermore, this study will elucidate the potential impact of a brief hypnosis practice on balance performance. conditions: Ankle Sprains conditions: Motor Coordination or Function; Developmental Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This basic experimental pilot study involved a randomized cross-over design of two brief interventions with a 1:1 allocation ratio primaryPurpose: TREATMENT masking: NONE count: 24 type: ACTUAL name: Self-Hypnosis name: Ankle Education measure: Balance test 1 measure: Balance test 2 measure: Heart rate variability measure: Ankle disability measure 1 measure: Ankle disability measure 2 measure: Interoceptive awareness measure 1 measure: Interoceptive awareness measure 2 measure: Emotional Distress-Anxiety measure: Kinesiophobia measure: Pain self-efficacy 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: NCT06390059 id: EF-39 id: EF-39 type: OTHER domain: Sponsor id: 2022-003157-55 type: EUDRACT_NUMBER briefTitle: EF-39 PANOVA-4: Study of Tumor Treating Fields Concomitant With Atezolizumab, Gemcitabine and Nab-Paclitaxel as First-LineTreatment for Metastatic Pancreatic Ductal Adenocarcinoma overallStatus: RECRUITING date: 2023-08-28 date: 2026-08 date: 2026-08 date: 2024-04-29 date: 2024-04-29 name: NovoCure GmbH class: INDUSTRY briefSummary: The PANOVA-4 study is designed to evaluate the safety and efficacy of Tumor Treating Fields (TTFields) therapy together with atezolizumab, gemcitabine and nab-paclitaxel, for the treatment of metastatic pancreatic cancer. The study is intended for patients who have been diagnosed with metastatic pancreatic cancer and have not received prior systemic therapy. conditions: Metastatic Pancreatic Ductal Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, open-label, single arm, multi-center, historical control pilot study. primaryPurpose: TREATMENT masking: NONE count: 76 type: ESTIMATED name: Tumor Treating Fields name: Atezolizumab name: Gemcitabine name: nab-paclitaxel measure: Disease control rate (DCR) measure: Overall survival (OS) measure: Progression-free survival (PFS) measure: 1-Year survival rate measure: Objective response rate (ORR) measure: Progression free survival at 6 months (PFS6) measure: Duration of response (DOR) measure: Rate of of patients with treatment emergent adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Vall d'Hebron status: RECRUITING city: Barcelona zip: 08035 country: Spain name: Teresa Macarulla Mercade role: CONTACT phone: 34 (93) 274 6085 email: tmacarulla@vhebron.net lat: 41.38879 lon: 2.15899 facility: University Hospital Foundation Jimenez Diaz status: RECRUITING city: Madrid zip: 28040 country: Spain name: Angela Lamarca Lete role: CONTACT phone: 34 951 504800 email: angela.lamarca@quironsalud.es name: 1 role: CONTACT lat: 40.4165 lon: -3.70256 facility: Clara Campal Comprehensive Cancer Center (CIOCC) status: RECRUITING city: Madrid zip: 28050 country: Spain name: Antonio Cubillo Gracian role: CONTACT phone: 34 91 756 7800 email: acubillo@hmhospitales.com lat: 40.4165 lon: -3.70256 facility: Regional University Hospital of Malaga status: RECRUITING city: Málaga zip: 29010 country: Spain name: Inmaculada Ales role: CONTACT phone: 34 951308129 email: inales@hotmail.com lat: 36.72016 lon: -4.42034 facility: University Clinic of Navarra - Pamplona status: RECRUITING city: Pamplona zip: 31008 country: Spain name: Mariano Ponz-Sarvise role: CONTACT phone: 34 948 255 400 email: mponz@unav.es lat: 42.81687 lon: -1.64323 hasResults: False

 nctId: NCT06390046 id: 1072.6120.135.2023 briefTitle: Opioid-free Anesthesia, Optimization of Anesthesia After Bariatric Surgery overallStatus: RECRUITING date: 2024-03-14 date: 2025-12-31 date: 2025-12-31 date: 2024-04-29 date: 2024-04-29 name: Jagiellonian University class: OTHER briefSummary: Total intravenous general anesthesia and combined general anesthesia are recognized methods used during anesthesia. They allow you to effectively control pain and reduce the number of complications associated with taking large doses of opioid drugs. It should be emphasized that both methods of anesthesia are currently approved for use in routine anesthetic practice, and only the experience, knowledge and preferences of the anesthesiologist determine which technique will be used in a given patient. Both techniques are used in everyday anesthetic practice, but there is no conclusive scientific data confirming the superiority of either method in patients undergoing bariatric surgery, therefore currently only the individual experience, knowledge and preferences of the anesthesiologist determines which technique will be used in a given patient. conditions: Analgesics, Opioid conditions: Anesthesia; Adverse Effect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study group will be male and female patients, ASA II or III, over 18 years of age and under 75 years of age. Each patient will undergo abdominal (bariatric) surgery. primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 200 type: ESTIMATED name: Intubation name: TIVA versus Inhalation measure: compare the effectiveness of analgesia measure: determine whether modern technologies such as videolaryngoscopy shorten intubation time. measure: incidence of postoperative nausea and vomiting sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jagiellonian University status: RECRUITING city: Kraków state: Malopolskie zip: 31501 country: Poland name: Tomasz Skladzien, phd md role: CONTACT phone: 506602250 phoneExt: 48 email: t.skladzien@interia.pl lat: 50.06143 lon: 19.93658 hasResults: False

 nctId: NCT06390033 id: ITS/133/21 briefTitle: Biomechanical Study of Different Prostheses for Unilateral Transtibial Amputees During Indoor and Outdoor Activities overallStatus: ENROLLING_BY_INVITATION date: 2023-06-30 date: 2024-04-30 date: 2024-06-30 date: 2024-04-29 date: 2024-04-29 name: The Hong Kong Polytechnic University class: OTHER briefSummary: The goal of this observational study is to evaluate and compare the performance of two prosthetic feet for unilateral transtibial amputees during both indoor and outdoor activities. The main research questions aim to answer are:

1. Can a low-cost prosthetic foot enhance gait mechanics and physical performance in individuals who have undergone traumatic unilateral transtibial amputation, as compared to the traditional K2 - K3 prosthetic feet currently available on the market, during both indoor and outdoor activities?
2. Can the low-cost prosthetic foot meet user satisfaction levels after traumatic unilateral transtibial amputation, when compared to the traditional K2 - K3 prosthetic foot on the market?

Participants will be asked to do

1. Prior to the commencement of the experiment, a professional prosthetist and orthotist will conduct all fitting and alignment procedures for the transtibial amputees. Participants will then be given a two to three-week period to train and acclimate to the individual socket alignment and prosthetic foot.
2. Participants are asked to refrain from consuming caffeine or any stimulants for 24 hours before the tests.
3. Participants will be required to perform the Berg Balance Test.
4. Participants will undergo a series of clinical tests, including: 1) Time to Go Up (measured in seconds), 2) Four Square Step Test (measured in seconds), 3) 10-Meter Walk Test (measured in seconds), 4) Eye Close Standing, 5) Tandem Test, and 6) Functional Reach Test. Each test will be conducted three times. The test items of 4) and 5) will be performed on a force plate (Bertect, Ohio, USA) with dimensions of 400 x 600 mm and a capturing frequency of 1,000 Hz.
5. Participants will be asked to walk on a force plate (AMTI, Advanced Mechanical Technology, Inc., Watertown, USA) at a fixed walking speed of 1.11 ± 0.11m/s, allowing the foot to land naturally on the force plate. Five trials of the gait cycle with a clean foot will be used for analysis.
6. Participants will perform the Counter Movement Jump Test three times with maximum effort on the force plate (Bertect, Ohio, USA), which will be performed without a hand swing.
7. Participants will be asked to perform a 2-minute walking test on flat concrete ground, stairs, and a ramp, respectively.
8. Finally, participants will be asked to complete the Locomotion Capabilities Index questionnaire. conditions: Amputation conditions: Prosthesis User studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 6 type: ESTIMATED name: Prosthetic foot measure: Basic mobility function with two prostheses by Berg Balance Test measure: Basic mobility function with two prostheses by Time to Go Up measure: Basic mobility function with two prostheses by Four Square Step Test measure: Basic mobility function with two prostheses by 10-meter Walk Test measure: Stability index with two prostheses by Eye Close Standing measure: Stability index with two prostheses by Tandem Test measure: Functional Reach Test measure: Gait symmetry analysis of lower limb joint angle measure: Gait symmetry analysis of lower limb joint power measure: Gait symmetry analysis of lower limb joint moment measure: Walking feasibility with two prostheses measure: Jump feasibility with two prostheses measure: Subjective evaluation by Locomotion Capabilities Index questionnaire sex: ALL minimumAge: 36 Years maximumAge: 64 Years stdAges: ADULT facility: The Hong Kong Polytechnic University city: Kowloon zip: 999077 country: Hong Kong lat: 22.31667 lon: 114.18333 hasResults: False

 nctId: NCT06390020 id: NL84880.091.23 briefTitle: Mindfulness-Based Stress Reduction (MBSR) for People High on the Personality Trait Sensory Processing Sensitivity: A Mixed Methods Study acronym: MindSens overallStatus: RECRUITING date: 2024-01-15 date: 2024-12 date: 2024-12 date: 2024-04-29 date: 2024-04-29 name: Radboud University Medical Center class: OTHER briefSummary: This study investigates the efficacy of MBSR training in alleviating stress-related symptoms among individuals with high sensory processing sensitivity. Participants will be randomly allocated to either the MBSR group or the control group.

The primary hypothesis is that participants in the MBSR group, relative to control group, will have lower depression-anxiety-stress scores post-intervention, after controlling for baseline scores. The secondary hypothesis is that in the MBSR group, relative to control group, other mental health, physical health and well-being outcomes, as well as potential mindfulness mechanisms will also improve, after controlling for baseline scores. conditions: Sensory Processing Sensitivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 52 type: ESTIMATED name: MBSR measure: Change from Baseline to Post-intervention in self-reported depression, anxiety, and stress measure: Change from Baseline to Post-intervention in self-reported well-being measure: Change from Baseline to Post-intervention in self-reported burnout symptoms measure: Change from Baseline to Post-intervention in self-reported physical symptoms measure: Change from Baseline to Post-intervention in self-reported overstimulation measure: Change from Baseline to Post-intervention in self-reported mindfulness measure: Change from Baseline to Post-intervention in self-reported attention regulation measure: Change from Baseline to Post-intervention in self-reported strategies for cognitive emotion regulation measure: Change from Baseline to Post-intervention in self-reported body awareness measure: Change from Baseline to Post-intervention in self-reported self-compassion measure: Change from Baseline to Post-intervention in self-reported sensory processing sensitivity measure: Perceived facilitators, barriers, effects, and mechanisms of participating in the MBSR training sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Radboudumc Center for Mindfulness status: RECRUITING city: Nijmegen state: Gelderland zip: 6525 GC country: Netherlands name: Anne Speckens, prof. dr. role: CONTACT phone: (024) 36 68 456 email: mindfulness@radboudumc.nl lat: 51.8425 lon: 5.85278 hasResults: False

 nctId: NCT06390007 id: 24916 briefTitle: The Efficacy of Acupuncture in the Management of Postoperative Pain in the Pediatric Intensive Care Unit at Cipto Mangunkusumo Hospital overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-11 date: 2024-12 date: 2024-04-29 date: 2024-04-29 name: Indonesia University class: OTHER briefSummary: Pain is an unpleasant sensory and emotional experience resulting from tissue damage. Pain management is typically conducted according to the World Health Organization (WHO) pain management ladder. Analgesics administered to pediatric patients vary in dosage and type, but these analgesics often have significant side effects. The acupuncture technique using press needles is a non-pharmacological pain therapy modality that has been studied for its ability to reduce the use of analgesic drugs, thereby potentially decreasing side effects associated with analgesic use.

The study was conducted using a randomized controlled trial (RCT) design involving 70 pediatric postoperative patients aged 1-18 years who were admitted to the Pediatric Intensive Care Unit at Cipto Mangunkusumo Hospital. Subjects were divided into two groups: a control group and an experimental group. The control group received standard analgesic therapy and sham press needle application (a patch resembling a press needle without a needle), while the experimental group received standard analgesic therapy and press needle application at acupuncture points after the patient had been in the Pediatric Intensive Care Unit for 24 hours. Pain scale monitoring was conducted at 1, 6, 24, 48, and 72 hours using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale for children aged 1-8 years, and the Numeric Rating Scale (NRS) for children over 8 years old.

This study hypothesizes that the acupuncture technique using press needles can reduce the pain scale in pediatric postoperative patients, leading to a decrease in the use of analgesics and a reduction in side effects associated with analgesic use. conditions: Pain, Postoperative conditions: Pediatric Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 70 type: ESTIMATED name: Sham press needle name: Press needle acupuncture measure: Face, Legs, Activity, Cry, and Consolability (FLACC) pain scale measure: Numeric Rating Scale (NRS) pain scale sex: ALL minimumAge: 1 Year maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: RSUPN Dr. Cipto Mangunkusumo city: Jakarta Pusat state: DKI Jakarta zip: 10430 country: Indonesia name: Irene Yuniar role: CONTACT phone: +6281380327808 email: irene.tambunan@yahoo.co.id lat: -6.1818 lon: 106.8223 hasResults: False

 nctId: NCT06389994 id: 23-021041 briefTitle: Esophageal String Test Monitoring to Monitor Eosinophilic Esophagitis During Oral Immunotherapy overallStatus: RECRUITING date: 2024-04-01 date: 2026-04-02 date: 2026-10-01 date: 2024-04-29 date: 2024-04-29 name: Children's Hospital of Philadelphia class: OTHER briefSummary: Patients with IgE mediated food Allergy have elevated risk of eosinophilic esophagitis, and new therapies like oral immunotherapy (OIT) carry additional risk of Eosinophilic Esophagitis (EoE). The goal of this study is to investigate the Esophageal String Test (EST) as a screening tool for Eosinophilic Esophagitis (EoE) during OIT therapy. Investigators will compare the efficacy of the Esophageal String Test to symptom assessment using a validated patient reported symptom questionnaire, the Pediatric Eosinophilic Esophagitis Symptom Score (PEESS) v2.0. Investigators will utilize these tools to screen patients at their baseline visit prior to the start of OIT, then at the 3- and 6-month OIT follow-up visits. conditions: Eosinophilic Esophagitis (EoE) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 75 type: ESTIMATED name: Esophageal String Test measure: Esophageal String Test measure: Prevalence of Eosinophilic Esophagitis measure: Eosinophilic Esophagitis Symptoms sex: ALL minimumAge: 7 Years maximumAge: 17 Years stdAges: CHILD facility: The Children's Hospital of Philadelphia status: RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Sharon A Carbonara, MS, BSN, RN role: CONTACT phone: 267-426-8603 email: carbonara@chop.edu lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06389981 id: 1692052 briefTitle: Co-Design and Pilot Testing of Peer-led Community Outreach to Improve Equity, Veteran-Centeredness and Uptake of Lung Cancer Screening acronym: VPC overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-02-28 date: 2025-06-30 date: 2024-04-29 date: 2024-04-29 name: VA Boston Healthcare System class: FED briefSummary: Co-design will be implemented to develop an innovative, Veteran-centered intervention (Vet Peer Connects program) that meets the needs of Black Veterans.

Next, a feasibility pilot test of the Vet Peer Connects program will be conducted. The Peer will lead up to 4 group lung cancer screening orientations in community partner sites to reach around 40 lung cancer screening eligible Black Veterans. The Peer will provide one-to-one tailored support to up to 15 Veterans (coaching, goal-setting, navigation to access Veterans Affairs lung cancer screening). Then, the study team will evaluate program delivery through ethnographic observation and field notes, Peer activity logs, and weekly check-ins between the study team and Peer. Investigators will interview Veteran participants, community partners, and lung cancer screening clinical staff to explore feasibility and acceptability of the Vet Peer Connects program and solicit suggestions for improvement. Preliminary data on the outcomes of the Vet Peer Connects program will be collected by study team through administering surveys to assess change in Social Cognitive Theory constructs, and extracting lung cancer screening uptake and tobacco treatment 3 months post enrollment from VA's Corporate Data Warehouse. This work will inform a subsequent multi-site stepped-wedge trial to assess effectiveness, implementation, and cost of the Vet Peer Connects program in VA lung cancer screening sites and neighboring branches of the National Association for Black Veterans conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 40 type: ESTIMATED name: Veterans peer connect Program measure: Lung Cancer Screening Uptake measure: Tobacco cessation Treatment measure: Stigma Related to Smoking measure: Perceived support from peer measure: Lung Cancer Screening Knowledge measure: Lung Cancer Screening Fatalism measure: Trust in VA measure: Lung Cancer Self-efficacy measure: General Cancer Self-efficacy measure: Intention to engage in shared decision making measure: Motivation to quit smoking measure: Intention to undergo lung cancer screening sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06389968 id: 2023-491-S-KH briefTitle: Light Stimulation to Improve Visual Function After Optic Neuritis in Persons With Multiple Sclerosis acronym: ONSTIM overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2025-12-31 date: 2025-12-31 date: 2024-04-29 date: 2024-04-29 name: Technical University of Munich class: OTHER briefSummary: The aim of this monocentric randomized controlled intervention study is to improve visual function in persons with multiple sclerosis (pwMS) following optic neuritis (neuritis nervi optici, NNO) by means of a light stimulation.

In the treatment arm, two 80-second light stimulations are to be administered daily for 12 days in 25 pwMS following recent NNO (1-3 months). For the standardized application of light stimulation in the sense of standardized training, the light stimulation is to be carried out by watching a generated flicker video on a mobile phone. In a sham-intervened control group (n=25), the spontaneous course after NNO will be recorded in parallel. Intensive neuronal stimulation of the visual pathway will be used to stimulate regenerative processes, which will be recorded by means of changes in high-contrast visual acuity (primary endpoint). Secondary endpoints are changes in a colored-contrast test, in 2.5% low contrast visual acuity (LCVA), the P100 conduction latency of visual evoked potentials, and retinal layer thicknesses and vessel densities measured in optical coherence tomography (OCT) and OCT angiography (OCTA). These physiological parameters should help to understand the underlying processes of a potentially altered visual performance. conditions: Multiple Sclerosis, Relapsing-Remitting conditions: Optic Neuritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: sham-controlled primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: Light stimulation name: Sham light stimulation measure: High contrast visual sensitivity measure: Low contrast visual sensitivity measure: VEP measure: OCT measure: OCT Angiography measure: Color contrast sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06389955 id: TP-3654-103 briefTitle: Assessment of Relative Bioavailability and Effect of Food on Capsule and Tablet Formulations of TP-3654 overallStatus: COMPLETED date: 2023-05-22 date: 2023-08-01 date: 2023-08-24 date: 2024-04-29 date: 2024-04-29 name: Sumitomo Pharma America, Inc. class: INDUSTRY briefSummary: This study comprised of 2 parts, Part A and Part B. Part B will only be conducted if the relative bioavailability of the tablet formulation was at least 70% of the capsule formulation. conditions: Effect of Drug studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 12 type: ACTUAL name: TP 3654 measure: Part A - The maximum concentration (Cmax) of TP-3654 in a capsule formulation measure: Part A - The area under the curve (AUC) of TP-3654 in a capsule formulation measure: Part A - Ratio of Peak Plasma Concentration (Cmax) of TP-3654 tablet versus TP-3654 capsule under fasted conditions measure: Part B - The maximum concentration (Cmax) of TP-3654 in a tablet formulation measure: Number of participants with Treatment Emergent Adverse Events (TEAE) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Frontage Investigative Site city: Secaucus state: New Jersey zip: 07094 country: United States lat: 40.78955 lon: -74.05653 hasResults: False

 nctId: NCT06389942 id: 9MW3011-2022-CP101 briefTitle: Single Ascending Dose Study of 9MW3011 in Chinese Healthy Subject overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-10 date: 2024-04 date: 2024-04 date: 2024-04-29 date: 2024-04-29 name: Mabwell (Shanghai) Bioscience Co., Ltd. class: INDUSTRY briefSummary: The objectives of the study are to evaluate the safety , tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single ascending intravenous (IV) doses of 9MW3011 in Chinese healthy volunteers. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 48 type: ACTUAL name: 9MW3011 name: 9MW3011 placebo measure: Adverse Event(including serious adverse event) measure: Number of subjects with abnormal vital signs measure: Number of subjects with abnormal clinically significant results from physical examination measure: Number of subjects with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters measure: Number of subjects with abnormal clinically significant clinical laboratory results measure: Cmax measure: AUC0-t measure: AUC0-∞ measure: Tmax measure: λz measure: t1/2z measure: Vz measure: CL measure: MRT measure: Pharmacodynamic(PD)parameters-hepcidin measure: PD parameters-serum iron measure: PD parameters-TSAT measure: Anti-drug antibodies(ADA) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PKUcare Luzhong Hospital city: Zibo state: Shandong country: China lat: 36.79056 lon: 118.06333 hasResults: False

 nctId: NCT06389929 id: IU-HB-RK-02 briefTitle: Do the Health Education Materials Developed in the Gynecology and Diseases Nursing Course Affect Students' Teaching Material Motivation and Material Design Self-Efficacy Beliefs? overallStatus: COMPLETED date: 2023-10-30 date: 2024-01-20 date: 2024-01-28 date: 2024-04-29 date: 2024-04-29 name: Inonu University class: OTHER briefSummary: Purpose: This study aimed to examine the effect of health education material developed by nursing students in gynecological health and disease nursing on students' teaching material motivation and material design self-efficacy belief.

Method: The study was conducted as a prospective randomized controlled study. n=86 (43=control, 43=intervention) students who took the Women's Health and Diseases Nursing course at Bartın University Faculty of Health Sciences Nursing Department between 30.10.2023-20.01.2024 and volunteered to participate in the study were randomized. It was conducted in two groups: intervention and control.In the research, data will be collected with the Data Collection Form prepared by reviewing the literature, Instructional Material Motivation Scale and Material Design Self-Efficacy Belief Scale. Descriptive statistics, Student t-test, Mann-Whitney U Test, Wilcoxon Signed Rank Test and Pearson correlation tests will be used to evaluate the data. conditions: Nursing Caries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective randomized controlled n = 86 (43 = control, 43 = intervention) students who took the Women's Health and Diseases Nursing course at Bartın University, Faculty of Health Sciences, Department of Nursing and volunteered to participate in the study were randomly assigned to two groups: intervention and control. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 92 type: ACTUAL name: Education measure: Instructional Material Motivation Scale measure: Material Design Self-Efficacy Belief Scale sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Simge OZTURK city: Bartin state: None Selected zip: 74100 country: Turkey lat: 41.63583 lon: 32.3375 hasResults: False

 nctId: NCT06389916 id: EU-PHX-RCT-001 briefTitle: Euclid Phoenix Lens Design Trial overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-01 date: 2024-04 date: 2024-04 date: 2024-04-29 date: 2024-04-29 name: Euclid Systems Corporation class: INDUSTRY briefSummary: The "first fit" success rate of the current Euclid orthokeratology "MAX" lens design will be compared to that of the new Euclid orthokeratology MAX "Phoenix" lens design in 30 children. conditions: Myopia conditions: Cornea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Euclid orthokeratology MAX (current design) name: Euclid orthokeratology MAX Phoenix (new design) measure: First fit success rate sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Insight Vision Center Optometry city: Costa Mesa state: California zip: 92626 country: United States lat: 33.64113 lon: -117.91867 facility: Dau Family Eye Care city: Saint Johns state: Florida zip: 32259 country: United States lat: 30.0815 lon: -81.54774 facility: Cornea and Contact Lens Institute of Minnesota city: Edina state: Minnesota zip: 55436 country: United States lat: 44.88969 lon: -93.34995 facility: Somerset Eye Care city: North Brunswick state: New Jersey zip: 08902 country: United States lat: 40.454 lon: -74.482 facility: Treehouse Eyes city: Tysons Corner state: Virginia zip: 22182 country: United States lat: 38.91872 lon: -77.23109 hasResults: False

 nctId: NCT06389903 id: 2018-A00185-50 briefTitle: Subthalamic Nucleus Stimulation Electrode and Psychiatric Lesion Effects in Parkinson's Disease acronym: PSYLES-STIM overallStatus: COMPLETED date: 2019-06-04 date: 2020-07-03 date: 2021-10-05 date: 2024-04-29 date: 2024-04-29 name: Centre Hospitalier du Rouvray class: OTHER_GOV briefSummary: This is a pilot, prospective, monocentric study concerning 15 Parkinson's disease patients requiring deep brain stimulation implantation.

The primary objective is to evaluate the psychiatric lesion effects of deep brain stimulation in patients with Parkinson's disease, using the Young Mania Rating Scale (YMRS), Big Five Inventory and the Hamilton Depression Rating Scale (HAMD 21). conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ACTUAL name: assessment measure: Assessment of change of mania symptoms measure: Assessment of change of depressive symptoms measure: Assessment of change of Behavior measure: Assessment of change of Impulsivity measure: Assessment of change of Apathy measure: Assessment of personality measure: Assessment of executive functions measure: Assessment of confusion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marie Desbordes, MD city: Sotteville Les Rouen zip: 76300 country: France lat: 49.40972 lon: 1.09005 hasResults: False

 nctId: NCT06389890 id: PaSuTE briefTitle: Pancreatic Surgery - Optimal Caseload Thresholds and Predictive Accuracy acronym: PaSuT overallStatus: COMPLETED date: 2010-01-01 date: 2019-12-31 date: 2019-12-31 date: 2024-04-29 date: 2024-04-29 name: Richard Hunger class: OTHER name: Medizinische Hochschule Brandenburg Theodor Fontane briefSummary: The main objective of the study is to identify the optimal annual number of cases in a hospital with regard to minimising hospital mortality in pancreatic surgery. In particular, the prognostic value of such case numbers will be analysed. conditions: Volume-Outcome Relationship in Pancreatic Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 80000 type: ACTUAL name: Pancreatic resection procedure measure: In-hospital mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06389877 id: BTX-302-001 briefTitle: A Study to Evaluate the Safety and Efficacy of BEAM-302 in Adult Patients With Alpha-1 Antitrypsin Deficiency (AATD) overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-06 date: 2027-08 date: 2024-04-29 date: 2024-04-29 name: Beam Therapeutics Inc. class: INDUSTRY briefSummary: This is a Phase 1/2, multicenter, open-label, dose-exploration (Phase 1) and dose-expansion (Phase 2) study to evaluate the safety, tolerability, PK/PD, and efficacy of BEAM-302 in adult patients with AATD-associated lung disease and/or liver disease and to determine the optimal biological dose (OBD). conditions: Alpha 1-Antitrypsin Deficiency studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 106 type: ESTIMATED name: BEAM-302 measure: Phase 1 Dose Exploration: Rates of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) measure: Phase 2 Dose Expansion: Absolute blood levels of total AAT measure: Phase 1 Dose Exploration: Absolute blood levels of total AAT measure: Phase 2 Dose Expansion: Rates of TEAEs and SAEs sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Study Center city: London country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06389864 id: rTMS in ADHD briefTitle: rTMS in Children and Adolescents With ADHD: overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-10 date: 2024-04-29 date: 2024-04-29 name: Assiut University class: OTHER briefSummary: Assess the effect of RTMS on ADHD symptoms and assessment of this effect clinically and objectively. conditions: ADHD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: rTMS (repetitive transcranial magnetic stimulation) measure: The resting motor threshold (RMT) measure: Arabic version Conners' Parent Rating Scale - Revised Long form measure: Clinical Global Impression CGI sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06389851 id: NAFLD-LYCOPENE briefTitle: Effects of Tomato Consumption on Steatosis, Intestinal Function and Glucose and Lipid Metabolism in Subjects With NAFLD overallStatus: NOT_YET_RECRUITING date: 2024-05-20 date: 2025-05-20 date: 2025-05-20 date: 2024-04-29 date: 2024-04-29 name: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis class: OTHER name: Dr. Di Stasi Vincenza name: Dr. Donvito Rosanna name: Dr. Cozzolongo Raffaele name: Dr. Giannuzzi Vito name: Dr. Zappimbulso Marianna name: Dr. Shahini Endrit name: Dr. Notarnicola Maria name: Dr. Russo Francesco name: Dr. Riezzo Giuseppe name: Dr. Donghia Rossella name: Dr. Cesternino Anna Maria name: Dr. Cici Rosalisa name: Dr. Cerabino Nicole name: Dr. Martina Di Chito name: Dr. Pesole Pasqua Letizia name: Dr. Coletta Sergio name: Dr. Stabile Dolores name: Dr. Ancona Anna name: Dr. D'Attoma Benedetta name: Dr. Ignazzi Antonia name: Dr. De Nunzio Valentina name: Dr. Tatoli Rossella name: Dr. Pinto Giuliano briefSummary: The study in question is an interventional study with nutritional intervention. the aim of the study is to evaluate whether a diet enriched with tomatoes can have favorable effects on:

* specific aspects associated with NAFLD, such as the degree of hepatic steatosis and fibrosis;
* circulating levels of molecules correlated with the degree of generalized and hepatic inflammation and the blood concentrations of metabolic and cardiovascular risk factors associated with abdominal obesity;
* intestinal barrier;
* body composition;
* intestinal microbiota;
* symptoms of IBS (irritable bowel syndrome) in patients with NAFLD. conditions: NAFLD conditions: IBS studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study evaluates the effects on NAFLD, Intestinal Integrity and Microbiota of a diet enriched with tomatoes compared to a diet without tomatoes primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Experimental: Case Group - Tomato-free diet name: Experimental: Case group - Diet enriched with tomatoes measure: The effect of intervention on CAP value (Controlled Attenuation Parameter) measure: The effect of intervention on FLI value (fatty liver index) measure: The effect of intervention on routine blood chemistry parameters, relating to NAFLD and fibrosis measure: The effect of the intervention on the integrity of the intestinal barrier measure: The effect of the intervention on the microbiota sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Irccs Saverio de Bellis city: Castellana Grotte state: Bari zip: 70013 country: Italy lat: 40.88643 lon: 17.16549 hasResults: False

 nctId: NCT06389838 id: DINKS01 id: DRKS00033704 type: REGISTRY domain: DRKS id: 2024-512094-27 type: EUDRACT_NUMBER briefTitle: RCT on Multimodal Self-treatment for Women With Incontinence Using a Digital Health Application acronym: DINKS overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2024-09-30 date: 2024-12-01 date: 2024-04-29 date: 2024-04-29 name: Kranus Health GmbH class: INDUSTRY name: Johannes Gutenberg University Mainz briefSummary: This study, titled "Prospective Randomized Study on Multimodal Self-Treatment for Women with Incontinence Symptoms Using a Digital Health Application," abbreviated as DINKS, aims to investigate the efficacy of a digital health application in treating incontinence in women. The study involves a single-center, single blinded, randomized, controlled trial with two arms: one receiving digital therapy intervention and the other serving as a control group with standard of care. The primary objective is to reduce the frequency of incontinence episodes over a 12-week intervention period, with secondary goals including improvements in disease symptoms, quality of life, and patient activation. The study plans to recruit 198 female participants and assess various endpoints related to incontinence severity, quality of life, and treatment outcomes. conditions: Urinary Incontinence,Stress conditions: Urinary Incontinence, Urge conditions: Urinary Incontinence conditions: Overactive Bladder Syndrome conditions: Female Urinary Stress Incontinence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, randomized, controlled, single-blinded, 2-arm design primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants know which group they are assigned to, but the investigators are blinded. whoMasked: INVESTIGATOR count: 198 type: ESTIMATED name: Kranus Mictera measure: Incontinence episodes measure: ICIQ-SF measure: I-QoL measure: PAM-13 measure: PGI-I measure: Cured patients measure: Urinary frequency day measure: Urinary frequency night measure: Pad use measure: Urge incontinence measure: Functional bladder capacity measure: Body weight measure: Treatment Failure sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kranus Health Gmbh city: München zip: 80331 country: Germany name: Laura E Wiemer, MD role: CONTACT phone: +4989 124 146 79 email: lwiemer@kranushelath.com lat: 48.13743 lon: 11.57549 hasResults: False

 nctId: NCT06389825 id: FH-Diet-RX briefTitle: Unravelling the Impact of Diet on Cardiovascular Health in Treated Heterozygous Familial Hypercholesterolemia. overallStatus: RECRUITING date: 2024-04-01 date: 2024-06-30 date: 2024-06-30 date: 2024-04-29 date: 2024-04-29 name: Laval University class: OTHER briefSummary: The investigators will conduct a fully controlled dietary randomized crossover trial (RCT) including 10 adults with HeFH using lipid-lowering medication to investigate the impact of a diet low in red and processed meats and high in plant foods, reflecting Canada's Food Guide, in place of a standard North-American diet on LDL-cholesterol (LDL-C) levels and the plasma metabolome. conditions: Familial Hypercholesterolemia conditions: Nutrition, Healthy conditions: Cholesterol, Elevated studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 10 type: ESTIMATED name: Healthy diet measure: Post-diet differences in LDL-C levels. measure: Post-diet differences in plasma metabolomics profiles sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: INAF-NUTRISS Université Laval status: RECRUITING city: Québec zip: G1V0a6 country: Canada name: Valérie Guay role: CONTACT phone: 418-656-2131 email: valerie.guay@fsaa.ulaval.ca lat: 46.81228 lon: -71.21454 hasResults: False

 nctId: NCT06389812 id: LoughboroughUni briefTitle: Dual-task Exercise in People With Cognitive Impairment overallStatus: ACTIVE_NOT_RECRUITING date: 2023-08-30 date: 2024-04-30 date: 2024-09-30 date: 2024-04-29 date: 2024-04-29 name: Loughborough University class: OTHER briefSummary: The purpose of this study is to explore how performing two exercise-based tasks simultaneously (dual-task exercise) affects the neurovascular and cognitive responses of people with cognitive impairment, which is a growing concern globally. Specifically, the study will examine how motor-cognitive dual-task exercises, such as using elastic resistance bands combined with visual perception training, including eye movement exercises, can immediately improve outcomes such as Brain-derived neurotrophic factor (BDNF) levels, cerebral blood flow, cognitive function, and mobility. BDNF is a special chemical in our brain that helps with the connections between brain cells. Participants will be asked to complete a single 30-minute exercise session and undergo assessments before and after the intervention. Participants with cognitive impairment will be initially assessed using Mini-Mental State Examination (MMSE) which is a 30-point questionnaire used extensively in clinical and research settings to measure cognitive impairment. Any score of 24 or more (out of 30) indicates normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points), or mild (19-23 points) cognitive impairment. Participants with lower MMSE scores (\&lt;10) will be removed from the study. conditions: Dementia conditions: Mild Cognitive Impairment conditions: Older Adults studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Dual-task exercise traning measure: BDNF serum level measure: Visual screening sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Loughborough University city: Loughborough state: Leicestershire zip: LE11 3TU country: United Kingdom lat: 52.76667 lon: -1.2 hasResults: False

 nctId: NCT06389799 id: PERELI id: 2022-501993-21-00 type: CTIS briefTitle: A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma (PERELI) acronym: PERELI overallStatus: NOT_YET_RECRUITING date: 2024-05-07 date: 2027-12-31 date: 2028-12-31 date: 2024-04-29 date: 2024-04-29 name: Lund University Hospital class: OTHER briefSummary: Dedifferentiated liposarcomas (DDLPS) are aggressive soft tissue sarcomas with no effective medical treatment options.

Immunotherapy with checkpoint inhibitors, so-called PD-1 inhibitors, have shown some effect in DDLPS in previous studies. Effect of immunotherapy can be improved by combining it with other types of tumor drugs. Medicines that inhibit signaling via the FGF receptor, so-called FGFR inhibitors, have shown a tumor-slowing effect in DDLPS in early studies. FGFR inhibitors can also induce changes that make the tumor more available to treatment with immunotherapy.

The study aims to investigate whether the combination of an FGFR inhibitor, pemigatinib, with a PD-1 inhibitor, retifanlimab can provide a tumor-slowing effect in patients with advanced DDLPS who have progressed on first-line treatment. conditions: Dedifferentiated Liposarcoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: Pemigatinib name: Retifanlimab measure: To evaluate clinical benefit of retifanlimab and pemigatinib in patients with advanced DDLPS measure: To further evaluate clinical efficacy of retifanlimab and pemigatinib in DDLPS measure: To evaluate the safety and tolerability of pemigatinib and retifanlimab measure: To evaluate impact of treatment and disease status on quality of life measure: To evaluate the relationship between baseline and on-treatment biomarkers and clinical activity sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Oslo University Hospital HF city: Oslo country: Norway name: Kjetil Boye, MD role: CONTACT phone: 4722934000 email: kjetil.boye@rr-research.no lat: 59.91273 lon: 10.74609 facility: Sahlgrenska University Hospital city: Göteborg country: Sweden name: Lina Hansson, MD role: CONTACT phone: 46313427950 email: lina.hansson@vgregion.se lat: 57.70716 lon: 11.96679 facility: Lund University Hospital city: Lund country: Sweden name: Helena Nyström, MD role: CONTACT role: CONTACT phone: +4646177520 email: helena.nystrom@skane.se lat: 55.70584 lon: 13.19321 hasResults: False

 nctId: NCT06389786 id: MC230504 id: NCI-2024-03306 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-009377 type: OTHER domain: Mayo Clinic Institutional Review Board id: MC230504 type: OTHER domain: Mayo Clinic briefTitle: Accuracy of 18F-rhPSMA-7.3 PET/ MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2026-05 date: 2026-05 date: 2024-04-29 date: 2024-04-29 name: Mayo Clinic class: OTHER briefSummary: This clinical trial evaluates the use of an imaging scan (18F-rhPSMA-7.3 positron emission tomography \[PET\]/magnetic resonance imaging \[MRI\]) for identifying patients who are at risk of having their disease spread to the lymph nodes in those undergoing radical prostatectomy for prostate cancer that has not spread to other parts of the body (localized). Prostate specific membrane antigen (PSMA) PET/computed tomography (CT) has emerged as an option to stage newly diagnosed high risk prostate cancer patients. PSMA PET/CT has demonstrated improved diagnostic accuracy for identifying metastasis. PET is procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is used. Because cancer cells often use more glucose than normal cells, the pictures can be used to find cancer cells in the body. MRI is procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. This study may help researchers learn whether 18F-rhPSMA-7.3 PET/ MRI may improve predicting which patients are at risk of lymph node metastases and who are suitable candidates for pelvic lymph node dissection in patients with localized high-risk prostate cancer undergoing radical prostatectomy. conditions: Localized Prostate Carcinoma conditions: Oligometastatic Prostate Carcinoma conditions: Stage I Prostate Cancer AJCC v8 conditions: Stage II Prostate Cancer AJCC v8 conditions: Stage III Prostate Cancer AJCC v8 conditions: Stage IVA Prostate Cancer AJCC v8 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 50 type: ESTIMATED name: Bilateral Pelvic Lymph Node Dissection name: Biospecimen Collection name: Bone Scan name: Computed Tomography name: Electronic Health Record Review name: Flotufolastat F-18 Gallium name: Laparoscopic Radical Prostatectomy with Robotics name: Magnetic Resonance Imaging name: Positron Emission Tomography measure: Sensitivity of flotufolastat F-18 gallium (18F-rhPSMA-7.3) positron emission tomography (PET)/magnetic resonance (MRI) for the detection of lymph node metastasis measure: Specificity measure: Positive/negative predictive value measure: Prostate specific antigen (PSA): < 5, 5-10, 10-20, > 20 measure: Gleason score measure: Digital rectal examination measure: Number of patients where management has changed measure: Rates of biochemical recurrent disease (BCR) sex: MALE minimumAge: 30 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Florida 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: Ram A. Pathak, M.D. role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 hasResults: False

 nctId: NCT06389773 id: 302958 briefTitle: Teamwork for Resilient Staff and Safe Care in ICU acronym: FEARLESS_ICU overallStatus: NOT_YET_RECRUITING date: 2024-09-02 date: 2025-09-30 date: 2025-09-30 date: 2024-04-29 date: 2024-04-29 name: King's College London class: OTHER briefSummary: The goal of this ethnographic study is to observe how healthcare professionals work together in an intensive care unit (ICU). The main questions it aims to answer are

* How do healthcare staff work together in everyday ICU settings?
* What helps people work together in ICUs?
* What challenges do staff face in working together in ICUs?
* How have teamwork practices changed since the COVID-19 pandemic?

Researchers will shadow staff during their day-to-day work. Key staff members will also be interviewed about their perceptions and experiences of teamwork. conditions: Teamwork studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 75 type: ESTIMATED measure: Examine the changing nature of teamwork in ICUs in the post-pandemic context sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06389760 id: IST-Nim-PC-16 briefTitle: Single-arm Study of Nimotuzumab Combined With mFOLFIRNIOX as Postoperative Adjuvant Therapy in Pancreatic Cancer overallStatus: RECRUITING date: 2023-10-18 date: 2026-09-30 date: 2026-09-30 date: 2024-04-29 date: 2024-04-29 name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School class: OTHER briefSummary: This is a prospective, multicenter, single-arm, phase II trial. The main purpose of the study is to evaluate the efficacy and safety of Nimotuzumab combined with mFOLFIRINOX for postoperative adjuvant treatment of pancreatic cancer. conditions: Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Nimotuzumab name: mFOLFIRINOX measure: disease-free survival (DFS) measure: distant metastasis-free survival (DMFS) measure: overall survival (OS) measure: European Organization 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 pancreatic cancer 29 (EORTC-QLQ-PAN26) measure: tumor-related markers measure: adverse events sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School status: RECRUITING city: Nanjing state: Jiangsu zip: 210008 country: China name: Juan Du, M.D. Ph.D role: CONTACT phone: +86-025-83106666 email: dujunglyy@163.com name: Juan Du, M.D. Ph.D role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06389747 id: OU briefTitle: Effect of Blood Flow Restriction Technique on Delayed Onset Muscle Soreness overallStatus: RECRUITING date: 2024-04-24 date: 2024-05-28 date: 2024-06-15 date: 2024-04-29 date: 2024-04-29 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: The aim of our study is to determine and evaluate the effects of blood flow restriction technique on pain, biomechanical properties and strength of the muscle in delayed onset muscle pain in healthy individuals. A Double Blind, Randomized Controlled, prospective study was planned. conditions: Pain Intensity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: participants and assessors will be blind to different intensity BFR groups. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 15 type: ESTIMATED name: BFR technique measure: Visual analog scale measure: myoton measure: dynamometer measure: dolorimeter sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Gamze Aydın status: RECRUITING city: Istanbul zip: 34940 country: Turkey name: Gamze Aydın role: CONTACT email: gmzetsn@gmail.com lat: 41.01384 lon: 28.94966 facility: Istanbul Okan University status: RECRUITING city: Istanbul zip: 34944 country: Turkey name: Gamze Aydın, PhD role: CONTACT phone: +905377600256 email: gmzetsn@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06389734 id: B-ER-111-470 briefTitle: Combining Manual Soft Tissue Release and Exercise Training in COPD: the Effect on LF, EC, and CAF overallStatus: COMPLETED date: 2023-03-02 date: 2024-02-02 date: 2024-02-02 date: 2024-04-29 date: 2024-04-29 name: National Cheng Kung University class: OTHER briefSummary: The potential effects of combining manual soft tissue release and physical exercise training on lung function, exercise capacity, and cardiac autonomic function in patients with moderate and severe chronic obstructive pulmonary disease were investigated. conditions: Chronic Obstructive Pulmonary Disease conditions: Manual Soft Tissue Release conditions: Exercise Training conditions: Lung Function conditions: Exercise Capacity conditions: Cardiac Autonomic Function studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study population will be randomized and separated in two groups, experimental and control group. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 70 type: ACTUAL name: Manual soft tissue release name: Myofascial release name: Exercise training measure: Forced expiratory volume in 1 s (FEV1) measure: forced vital capacity (FVC) measure: FEV1/FVC ratio measure: expiratory reserve volume (ERV) measure: functional residual capacity (FRC) measure: inspiratory capacity (IC) measure: inspiratory reserve volume (IRV), measure: residual volume (RV) measure: total lung capacity (TLC) measure: tidal volume (TV) measure: vital capacity (VC) measure: Rate of perceived exertion (RPE) measure: Oxygen consumption (VO2) measure: oxygen saturation measure: heart rate (HR) measure: blood pressure (BP) measure: Diaphragmatic mobility measure: Cardiac Autonomic Function measure: six minute walk test (6-MWT) measure: maximal expiratory pressure (MEP) measure: maximal inspiratory pressure (MIP) measure: St. George's Respiratory Questionnaire (SGRQ) measure: fatigue severity scale (FSS) measure: Modified Medical Research Council (mMRC) measure: 36-Item Short Form Health Survey (SF-36) sex: ALL minimumAge: 30 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cheng Kung University city: Tainan zip: 701 country: Taiwan lat: 22.99083 lon: 120.21333 hasResults: False

 nctId: NCT06389721 id: 2024-0145 id: NCI-2024-03672 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy overallStatus: NOT_YET_RECRUITING date: 2024-10-31 date: 2025-01-31 date: 2027-01-31 date: 2024-04-29 date: 2024-04-29 name: M.D. Anderson Cancer Center class: OTHER briefSummary: Cohort 1: To track the onset and progression of a condition called chemotherapy-induced peripheral neuropathy (CIPN).

Cohort 2: To track the onset and progression of a condition called chemotherapy-induced peripheral neuropathy (CIPN) and to test a certain type of experimental neuromodulation (stimulation of the brain) with a device called a closed-loop brain-computer interface (clBCI) to see if can help to prevent pain due to CIPN. conditions: Chemotherapy-induced Peripheral Neuropathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 45 type: ESTIMATED name: Electroencephalogram (EEG) 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: Sarah Prinsloo, PHD role: CONTACT phone: 713-563-9627 email: sprinsloo@mdanderson.org name: Sarah Prinsloo, PHD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06389708 id: VEVUS-HF briefTitle: Evaluation of VEXUS Score of Patients With Heart Failure in the Intensive Care Unit. overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-12-15 date: 2025-01-15 date: 2024-04-29 date: 2024-04-29 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: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: VEXUS measure: MORTALİTY measure: AKI sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06389695 id: CP-2023-03 id: NYM032D01 type: OTHER domain: National Medical Products Administration briefTitle: Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of 68Ga-NYM032 in Patients overallStatus: RECRUITING date: 2024-05 date: 2024-12 date: 2024-12 date: 2024-04-29 date: 2024-04-29 name: Norroy Bioscience Co., LTD class: INDUSTRY briefSummary: 68Ga-NYM032 is a PSMA-targeting small-molecular radiotracer for PET/CT imaging of prostate cancer, which is needed for clinical trial to be conducted conditions: Prostate Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 10 type: ESTIMATED name: 68Ga-NYM032 injection measure: Incidence of Adverse Events sex: MALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affliated Hospital of Jiangnan University status: RECRUITING city: Wuxi state: Jiangsu zip: 214000 country: China name: Chunjing Yu role: CONTACT phone: 15312238622 email: ycj_wxd1978@163.com lat: 31.56887 lon: 120.28857 hasResults: False

 nctId: NCT06389682 id: CP-2023-02 briefTitle: Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of 68Ga-NYM005 in Patients overallStatus: RECRUITING date: 2024-05 date: 2024-12 date: 2024-12 date: 2024-04-29 date: 2024-04-29 name: Norroy Bioscience Co., LTD class: INDUSTRY briefSummary: 68Ga-NYM005 is a CAIX-targeting small-molecular radiotracer for PET/CT imaging of clear cell renal cell carcinoma conditions: Clear Cell Renal Cell Carcinoma Metastatic studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 12 type: ESTIMATED name: 68Ga-NYM005 injection measure: Incidence of Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affliated Hospital of Jiangnan University status: RECRUITING city: Wuxi state: Jiangsu zip: 214000 country: China name: Chunjing Yu role: CONTACT phone: 15312238622 email: ycj_wxd1978@163.com lat: 31.56887 lon: 120.28857 hasResults: False

 nctId: NCT06389669 id: Inonu LTI briefTitle: Is Low Flow Anaesthesia Feasible? overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-08-15 date: 2024-09-15 date: 2024-04-29 date: 2024-04-29 name: Inonu University class: OTHER briefSummary: Although low-flow anaesthesia (LFA) has been described for many years and its benefits are known, its clinical use has been limited. Concerns about the risk of hypoxia contributed to this situation. Although the risk of hypoxia is almost prevented with advanced anaesthesia machines, the use of LFA has not reached the desired levels. However, in recent years, as adverse developments related to climate change have started to affect us all, LFA has started to be on the agenda of anaesthetists again. In this study, our aim is to examine the feasibility of its clinical use in order to popularise the use of LFA. conditions: Feasibility of Low Flow Anaesthesia in Clinical Use conditions: Factors Affecting Oxygen Consumption studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED measure: Feasibility of Low Flow Anaesthesia measure: Factors affecting oxygen consumption sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Inonu Univercity city: Malatya zip: 44280 country: Turkey lat: 38.35018 lon: 38.31667 hasResults: False

 nctId: NCT06389656 id: 1K23DK135791-01 type: NIH link: https://reporter.nih.gov/quickSearch/1K23DK135791-01 briefTitle: Addressing Weight Bias Internalization to Improve Adolescent Weight Management Outcomes acronym: SWIFT overallStatus: RECRUITING date: 2024-04-08 date: 2025-02 date: 2025-02 date: 2024-04-29 date: 2024-04-29 name: The Miriam Hospital class: OTHER briefSummary: Weight stigma and weight bias internalization (WBI) are common among adolescents at higher weight statuses. WBI is associated with negative physical and mental health outcomes. The current study aims to test intervention for weight stigma and WBI in conjunction with an evidence-based adolescent weight management program. Adolescents (ages 13-17) will participate in a 20-week program tailored to improve WBI and weight-related health behaviors in tandem. Primary outcomes are feasibility and acceptability of the developed intervention, assessed following the 20-week intervention. conditions: Body Weight conditions: Weight Bias conditions: Weight Stigma conditions: Weight studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open trial primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Behavioral Weight Management name: Weight Bias Internalization measure: Total score on an adapted version of the Acceptability of Intervention Measure (AIM) measure: In depth qualitative feedback from teens regarding intervention acceptability and feasibility measure: Attendance rates at intervention sessions measure: Retention rate for intervention sessions measure: Total score on the Modified Weight Bias Internalization Scale (WBIS-M) measure: Total score on the Weight Self-Stigma Questionnaire (WSSQ) measure: Total score on the weight-related teasing sub-scale of the Perception of Teasing Scale (POTS) measure: Total score on the competency-related teasing subscale of the Perception of Teasing Scale (POTS) measure: Anthropometrics sex: ALL minimumAge: 13 Years maximumAge: 17 Years stdAges: CHILD facility: The Miriam Hospital status: RECRUITING city: Providence state: Rhode Island zip: 02903 country: United States name: Katherine Darling, PhD role: CONTACT phone: 401-793-8688 email: katherine_darling@brown.edu name: Andrea M Grenga, BA role: CONTACT phone: 401-793-8997 email: agrenga@lifespan.org lat: 41.82399 lon: -71.41283 hasResults: False

 nctId: NCT06389643 id: 11/WIM/2021 briefTitle: Comparison of Safety and Efficacy of Four-Point Scleral Intraocular Lens Fixation and Yamane Techniques overallStatus: COMPLETED date: 2021-03-19 date: 2022-09-14 date: 2023-09-19 date: 2024-04-29 date: 2024-04-29 name: Military Institute od Medicine National Research Institute class: OTHER briefSummary: Comparison of safety and efficacy of two scleral fixation intraocular lens (IOL) methods of four-point scleral fixation ( Akreos AO60) and the Yamane technique (AcrySof MA60AC) conditions: Aphakia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 50 type: ACTUAL name: Four-point scleral fixation of Akreos AO60 IOL name: Sutureless scleral fixation of AcrySof MA60AC IOL with Yamane technique measure: BCVA measure: RE measure: ECC measure: Number of complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Military Institute of Medicine - National Research Institute city: Warsaw zip: 04-141 country: Poland lat: 52.22977 lon: 21.01178 hasResults: False

 nctId: NCT06389630 id: 0012 briefTitle: Evaluation of the Efficiency of Two Different Teaching Methods in Safe Subcutaneous Injection Skills acronym: EETDTMSSİS overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2024-11-20 date: 2025-01-20 date: 2024-04-29 date: 2024-04-29 name: Kocaeli Sağlık ve Teknoloji Üniversitesi class: OTHER briefSummary: Subject: Subcutaneous (SC) insulin injection is frequently used in the treatment of Type 2 Diabetes patients. Complications such as pain, ecchymosis, hematoma, lipoatrophy and lipohypertrophy are frequently observed after SC injections. These complications that develop due to incorrect injection application negatively affect the use of injection application areas, change body image and negatively affect drug absorption. In order to reduce and prevent complications related to SC insulin injection, it is very important to gain the skill of safe SC insulin injection. It is stated that there are a limited number of studies on which of the teaching methods used in sick individuals are effective. In the national and international literature, no study has been found evaluating the effect of SC injection skill teaching based on video-supported training and low-fidelity simulation model applications on disease management in individuals diagnosed with Type 2 Diabetes Mellitus. In this regard, the research was planned as an experimental design in order to examine the effectiveness of video-supported training and low-fidelity simulation model-based teaching in gaining safe insulin injection skills via SC. For this purpose; It is aimed to evaluate the effect of two different skill teaching methods on the patient's SC injection ability, complication management and blood glucose level.

Purpose: This research was planned as an experimental design to examine the effectiveness of two different teaching methods (video-supported training and low-fidelity simulation model) in gaining safe insulin injection skills via the Subcutaneous (SC) route.

Design: A pretest-posttest two-group, quasi-experimental design will be used in the study. conditions: Complication of Injection studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 82 type: ESTIMATED name: video-assisted training group name: low fidelity simulation model group measure: subcutaneous injection skills measure: ecchymosis measure: hematoma measure: lipoarthrrophy measure: lipohypertrophy measure: pain measure: blood glucose level sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06389617 id: USM/JEPeM/KK/24010061 briefTitle: Different Doses of Intravenous Administered Dexamethasone Effecting Brachial Plexus Supraclavicular Block overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-11-30 date: 2024-12-30 date: 2024-04-29 date: 2024-04-29 name: Hospital Universiti Sains Malaysia class: OTHER briefSummary: To compare the analgesic properties of ultrasound guided supraclavicular block using ropivacaine 0.5% in arteriovenous fistula creation when used in combination with intravenous administered dexamethasone at 4mg and 8 mg as an adjuvant conditions: End Stage Renal Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 50 type: ESTIMATED name: supraclavicular block with 20mls of Ropivacaine 0.5% and Intravenous administered dexamethasone measure: To compare the difference of onset time between sensory and motor block of supraclavicular block between ropivacaine with IV dexamethasone 4mg and ropivacaine with IV dexamethasone 8mg measure: To compare the difference in duration of analgesia between supraclavicular block with ropivacaine and IV dexamethasone 4mg with ropivacaine and IV dexamethasone 8mg measure: To compare the duration difference of the return of motor block between supraclavicular block using ropivacaine with IV dexamethasone 4mg and ropivacaine with IV dexamethasone 8mg sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06389604 id: NL86367.068.24 briefTitle: Preparing for Heat Waves - Enhancing Human Thermophysiological Resilience acronym: Prep4heat overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2024-12 date: 2024-04-29 date: 2024-04-29 name: Maastricht University Medical Center class: OTHER briefSummary: As the ongoing progression of climate change exposes individuals to elevated temperatures and an escalating frequency of extreme heat events, the risk of more intense and prolonged heat waves raises significant concerns for public health, particularly among vulnerable populations. The physiological response to acute heat stress involves involuntary thermolytic reactions that may strain the cardiovascular system, especially in individuals with pre-existing vulnerabilities. Heat acclimation has been identified as a potential strategy to enhance thermoregulation and mitigate the adverse effects of heat stress. While existing research primarily focuses on athletes and military, this study aims to investigate the impact of a practical heat acclimation strategy, combining passive and active heat exposure, on thermophysiological, cardiovascular and metabolic parameters in healthy overweight adults. The study targets a population at increased risk for heat-related complications, seeking to provide realistic guidelines for broader application when a heat wave appears on the weather forecast. conditions: Body Temperature Changes conditions: Heat Exposure conditions: Heat Stress conditions: Hyperthermia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Non-randomized, within subject experiemental trial primaryPurpose: PREVENTION masking: NONE maskingDescription: No blinding due to nature of intervention count: 12 type: ESTIMATED name: Heat acclimation measure: Core temperature measure: Skin temperature measure: Sweat rate measure: Heart rate measure: Blood pressure measure: Skin blood flow measure: Energy expenditure measure: Substrate oxidation measure: Plasma metabolites measure: Brain blood flow measure: Flow-mediated dilation sex: ALL minimumAge: 60 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06389591 id: OCR44973 briefTitle: RNA-Lipid Particle (RNA-LP) Vaccines for Recurrent Adult Glioblastoma (GBM) overallStatus: NOT_YET_RECRUITING date: 2024-12 date: 2027-12 date: 2028-12 date: 2024-04-29 date: 2024-04-29 name: University of Florida class: OTHER briefSummary: This is a Phase I study to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in adult patients with recurrent glioblastoma. conditions: Recurrent Glioblastoma studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: pp65 RNA loaded lipid particles, pp65 RNA-LPs (Drug Product 1 or DP1) name: RNA loaded lipid particles, RNA-LPs (Drug Product 2 or DP2) measure: Percentage of vaccines meeting release criteria in the DLT window during the first three vaccines measure: Incidence of investigational treatment related toxicities sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UF Health city: Gainesville state: Florida zip: 32608 country: United States name: Marcia Hodik role: CONTACT phone: 352-273-9000 email: marcia.hodik@neurosurgery.ufl.edu name: Ashley Ghiaseddin, MD role: PRINCIPAL_INVESTIGATOR lat: 29.65163 lon: -82.32483 hasResults: False

 nctId: NCT06389578 id: HZNP-TEP-103 briefTitle: A Study of TEPEZZA® Treatment in Participants With Thyroid Eye Disease overallStatus: COMPLETED date: 2022-07-14 date: 2023-02-28 date: 2023-09-12 date: 2024-04-29 date: 2024-04-29 name: Horizon Therapeutics USA, Inc. class: INDUSTRY briefSummary: The main goal of this study is to learn how teprotumumab will be processed in the body (Pharmacokinetics) subcutaneously and whether it is safe and tolerable after administration into adult patients with thyroid eye disease. conditions: Thyroid Eye Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 16 type: ACTUAL name: Teprotumumab measure: Pharmacokinetics (PK): Area Under the Curve (AUC) of Teprotumumab measure: PK: Maximum Serum Concentration (Cmax) of Teprotumumab measure: Number of Participants With Adverse Events (AE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bascom Palmer Eye Institute - University of Miami city: Miami state: Florida zip: 33136 country: United States lat: 25.77427 lon: -80.19366 facility: Barnes Jewish Hospital Washington University city: Saint Louis state: Missouri zip: 63108 country: United States lat: 38.62727 lon: -90.19789 facility: Neuro-Eye Clinical Trials city: Bellaire state: Texas zip: 77401 country: United States lat: 29.70579 lon: -95.45883 hasResults: False

 nctId: NCT06389565 id: 2024p000857 briefTitle: Pilot Randomized Clinical Trial of Change My Story overallStatus: NOT_YET_RECRUITING date: 2025-01-01 date: 2025-12-31 date: 2026-06-30 date: 2024-04-29 date: 2024-04-29 name: Massachusetts General Hospital class: OTHER name: University of Ibadan briefSummary: Psychological distress and depression are common among young people living with HIV (Y-PLWH) and negatively impact medication adherence and disease control. In low- and middle-income countries, this problem is compounded by the lack of trained mental health professionals on the provider side and the requirement of frequent clinic-based visits imposing greater cost, inconvenience, and stigma for patients. Change My Story, is a theory-grounded, interactive narrative game designed to address the key drivers of depression and psychological distress among Y-PLWH in Nigeria. This pilot hybrid implementation-effectiveness randomized controlled trial (RCT) will compare Change My Story combined with PST to PST alone among 80 Y-PLWH with depression or psychological distress. conditions: Hiv conditions: Depression conditions: Psychological Distress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: Problem Solving Therapy name: Change My Story measure: Engagement measure: Satisfaction measure: Feasibility 1 measure: Feasibility 2 measure: Feasibility 3 measure: Feasibility 4 measure: Feasibility 5 measure: Feasibility 6 measure: Feasibility 7 measure: Acceptability 1 measure: Acceptability 2 measure: Acceptability 3 measure: Acceptability 4 measure: Acceptability 5 measure: Remission of depression. measure: Remission of psychological distress. measure: ART adherence measure: Viral suppression sex: ALL minimumAge: 16 Years maximumAge: 24 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06389552 id: IN_CTP_N01 briefTitle: Long-term Observational Study to Evaluate the DFS and OS of Adjuvant FOLFIRINOX Regimen in Pancreatic Cancer Patients overallStatus: RECRUITING date: 2023-09-25 date: 2026-12 date: 2027-12 date: 2024-04-29 date: 2024-04-29 name: HK inno.N Corporation class: INDUSTRY briefSummary: This study is designed to evaluate the safety and efficacy of adjuvant FOLFIRINOX regimen in pancreatic cancer patients after curative surgery. conditions: Adjuvant Chemotherapy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 36 type: ESTIMATED measure: Disease-free survival measure: Overall survival sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul ST. Mary's Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Myung-Ah Lee role: CONTACT name: Myung-Ah Lee role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06389539 id: Pro00070958 briefTitle: Synbiotic to Attenuate Resorption of the Skeleton acronym: STARS overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-04 date: 2028-04 date: 2024-04-29 date: 2024-04-29 name: Hebrew SeniorLife class: OTHER name: Solarea Bio, Inc name: Beth Israel Deaconess Medical Center name: Tufts University name: MaineHealth briefSummary: This randomized, double blind, placebo controlled clinical trial will test the efficacy of a probiotic/prebiotic combination ("synbiotic") on the skeleton in older women. conditions: Osteoporosis conditions: Inflammation conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to either SBD111 medical food or placebo capsules for a period of 18 months. primaryPurpose: OTHER masking: QUADRUPLE maskingDescription: Study staff involved in participants' outcome assessments will be masked to the intervention assignment. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 220 type: ESTIMATED name: SBD111 medical food name: Placebo measure: Lumbar spine BMD (g/cm2) measure: Vertebral compressive strength (N) measure: volumetric BMD measure: C-terminal cross-linked telopeptide of type I collagen (β-CTX) measure: Procollagen Type I Intact N-terminal Propeptide (P1NP) sex: FEMALE minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hebrew SeniorLife city: Roslindale state: Massachusetts zip: 02131 country: United States name: Kathryn Tasker role: CONTACT phone: 617-971-5351 email: KathyTasker@hsl.harvard.edu lat: 42.29121 lon: -71.1245 hasResults: False

 nctId: NCT06389526 id: CHS-1000-01 briefTitle: A Study of CHS-1000 in Participants With Advanced or Metastatic Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2028-01-30 date: 2028-01-30 date: 2024-04-29 date: 2024-04-29 name: Coherus Biosciences, Inc. class: INDUSTRY briefSummary: The primary purpose of this trial is to assess the tolerability and safety of CHS-1000 alone and in combination with toripalimab-tpzi in participants with advanced solid tumors. conditions: Advanced or Metastatic Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: CHS-1000 name: Toripalimab measure: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) measure: Maximum Observed Concentration (Cmax) measure: Area Under the Concentration-time Curve (AUC) measure: Terminal Half-life (t1/2) measure: Number of Participants with Antidrug Antibodies measure: Investigator-assessed Objective Response Rate (ORR) measure: Duration of Response (DoR) measure: Disease Control Rate (DCR) measure: Time to Response (TTP) measure: Progression-free Survival (PFS) measure: Landmark PFS Rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06389513 id: CTP-MCVF-005 briefTitle: Clinical Study of the Safety of Menhycia® in 3-Month-Old Infants overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-04 date: 2025-04 date: 2024-04-29 date: 2024-04-29 name: CanSino Biologics Inc. class: INDUSTRY briefSummary: This study is an open, multicenter Phase IV clinical study to evaluate the safety of vaccination with Menhycia®. The study plan is to enroll approximately 3,000 infants at 3 months of age who have not been vaccinated with any epidemic encephalitis vaccine, and to administer a total of 3 doses of Menhycia®, with a minimum of 1 month between doses, and a booster dose of 1 dose of immunization is allowed at 12 months of age. conditions: Epidemic Meningitis studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 3000 type: ESTIMATED name: MCV4 measure: Incidence of localized adverse reactions in subjects measure: Incidence of systemic adverse reactions in subjects measure: Incidence of adverse reactions in subjects measure: Incidence of adverse events in subjects measure: Incidence of severe adverse events sex: ALL minimumAge: 3 Months maximumAge: 3 Months stdAges: CHILD hasResults: False

 nctId: NCT06389500 id: SHR-1316-HLJ-006 briefTitle: HAIC+Adebrelimab+Lenvatinib for Conversion Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2028-05-01 date: 2024-04-29 date: 2024-04-29 name: Harbin Medical University class: OTHER briefSummary: This is a single-arm, exploratory, phase II trial to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib for borderline resectable, locally advanced biliary tract cancer. conditions: Biliary Tract Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Adebrelimab name: Lenvatinib name: Hepatic Arterial Infusion Chemotherapy measure: R0 resection rate measure: Surgery conversion rate measure: Objective response rate measure: pathological complete response rate measure: Major pathological response rate measure: Recurrence-free survival measure: Overall survival measure: AEs sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06389487 id: 222253 id: 2023-510190-34-00 type: OTHER domain: EU CTR Number briefTitle: A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2024-08-12 date: 2025-04-28 date: 2024-04-29 date: 2024-04-29 name: GlaxoSmithKline class: INDUSTRY briefSummary: The aim of this study is to demonstrate the immune response and to evaluate safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised adults 18-49 years of age (YOA), who are at increased risk (AIR) for respiratory syncytial virus (RSV) disease, compared to older adults (OA) (\>=) 60 YOA and above conditions: Respiratory Syncytial Virus Infections studyType: INTERVENTIONAL phases: PHASE3 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 850 type: ESTIMATED name: RSVPreF3 OA investigational vaccine measure: RSV-A neutralizing titers expressed as Geometric Mean Titers (GMTs) ratio (RSV-OA over RSV-A-AIR) measure: Seroresponse rate (SRR) in RSV-A neutralizing titers measure: RSV-B neutralizing titers expressed as GMT ratio (RSV-OA over RSV-A-AIR) measure: SRR in RSV-B neutralizing titers measure: Percentage of participants reporting solicited administration site events measure: Percentage of participants reporting solicited systemic events measure: Percentage of participants reporting unsolicited adverse events (AEs) measure: Percentage of participants reporting any serious adverse events (SAEs), related SAEs and fatal SAEs measure: Percentage of participants reporting any adverse events of special interest (AESIs), including potential immune-mediated diseases (pIMDs) and atrial fibrillation (AF) measure: RSV-A neutralizing titers expressed as GMTs measure: RSV-B neutralizing titers expressed as GMTs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GSK Investigational Site city: Phoenix state: Arizona zip: 85023 country: United States 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: Abram Burgher role: PRINCIPAL_INVESTIGATOR lat: 33.44838 lon: -112.07404 facility: GSK Investigational Site city: Tempe state: Arizona zip: 85284 country: United States 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: Joseph Daniel Davis role: PRINCIPAL_INVESTIGATOR lat: 33.41477 lon: -111.90931 facility: GSK Investigational Site city: North Hollywood state: California zip: 91606-3287 country: United States 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: Aaron Weinberg role: PRINCIPAL_INVESTIGATOR lat: 34.17223 lon: -118.37897 facility: GSK Investigational Site city: Oakland state: California zip: 94610 country: United States 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: Allison Boyd role: PRINCIPAL_INVESTIGATOR lat: 37.80437 lon: -122.2708 facility: GSK Investigational Site city: Walnut Creek state: California zip: 94598 country: United States 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: Helen L Stacey role: PRINCIPAL_INVESTIGATOR lat: 37.90631 lon: -122.06496 facility: GSK Investigational Site city: Hialeah state: Florida zip: 33012 country: United States 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: Jose Cardona role: PRINCIPAL_INVESTIGATOR lat: 25.8576 lon: -80.27811 facility: GSK Investigational Site city: Miami state: Florida zip: 33173 country: United States 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: Jorge Caso role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: GSK Investigational Site city: Orlando state: Florida zip: 32806 country: United States 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: Felipe Suplicy role: PRINCIPAL_INVESTIGATOR lat: 28.53834 lon: -81.37924 facility: GSK Investigational Site city: Lexington state: Kentucky zip: 40509 country: United States 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: Mark S Adams role: PRINCIPAL_INVESTIGATOR lat: 37.98869 lon: -84.47772 facility: GSK Investigational Site city: Silver Spring state: Maryland zip: 20904 country: United States 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: Jonathan Cohen role: PRINCIPAL_INVESTIGATOR lat: 38.99067 lon: -77.02609 facility: GSK Investigational Site city: Rochester state: New York zip: 14609 country: United States 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: Matthew G Davis role: PRINCIPAL_INVESTIGATOR lat: 43.15478 lon: -77.61556 facility: GSK Investigational Site city: Oklahoma City state: Oklahoma zip: 73111 country: United States 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: Charles Lunn role: PRINCIPAL_INVESTIGATOR lat: 35.46756 lon: -97.51643 facility: GSK Investigational Site city: Knoxville state: Tennessee zip: 37909 country: United States 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: William Smith role: PRINCIPAL_INVESTIGATOR lat: 35.96064 lon: -83.92074 facility: GSK Investigational Site city: DeSoto state: Texas zip: 75115 country: United States 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: Haresh Boghara role: PRINCIPAL_INVESTIGATOR lat: 32.58986 lon: -96.85695 facility: GSK Investigational Site city: Charlottesville state: Virginia zip: 22911 country: United States 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: James R Clark role: PRINCIPAL_INVESTIGATOR lat: 38.02931 lon: -78.47668 facility: GSK Investigational Site city: Wenatchee state: Washington zip: 98801 country: United States 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: Anton Grasch role: PRINCIPAL_INVESTIGATOR lat: 47.42346 lon: -120.31035 facility: GSK Investigational Site city: St Leonards state: New South Wales zip: 2065 country: Australia 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: Munro Neville role: PRINCIPAL_INVESTIGATOR lat: -33.82344 lon: 151.19836 facility: GSK Investigational Site city: Tarragindi state: Queensland zip: 4121 country: Australia 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: Ferdinandus de Looze role: PRINCIPAL_INVESTIGATOR lat: -27.53333 lon: 153.03333 facility: GSK Investigational Site city: North Melbourne state: Victoria zip: 3051 country: Australia 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: Michelle Giles role: PRINCIPAL_INVESTIGATOR lat: -37.80132 lon: 144.95822 facility: GSK Investigational Site city: St Albans state: Victoria zip: 3021 country: Australia 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: Roy Rasalam role: PRINCIPAL_INVESTIGATOR lat: -37.73901 lon: 144.80024 facility: GSK Investigational Site city: New Westminster state: British Columbia zip: V3L 3W4 country: Canada 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: David Shu role: PRINCIPAL_INVESTIGATOR lat: 49.20678 lon: -122.91092 facility: GSK Investigational Site city: Victoria state: British Columbia zip: V8V 4A1 country: Canada 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: Michael B Jones role: PRINCIPAL_INVESTIGATOR lat: 48.43294 lon: -123.3693 facility: GSK Investigational Site city: Truro state: Nova Scotia zip: B2N 1L2 country: Canada 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: Murdo Ferguson role: PRINCIPAL_INVESTIGATOR lat: 45.36685 lon: -63.26538 facility: GSK Investigational Site city: Guelph state: Ontario zip: N1G 0B4 country: Canada 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: Anthony Bier role: PRINCIPAL_INVESTIGATOR lat: 43.54594 lon: -80.25599 facility: GSK Investigational Site city: London state: Ontario zip: N5W 6A2 country: Canada 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: Peter Dzongowski role: PRINCIPAL_INVESTIGATOR lat: 42.98339 lon: -81.23304 facility: GSK Investigational Site city: Sherbrooke state: Quebec zip: J1J 2G2 country: Canada 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: Jean-Sebastien Gauthier role: PRINCIPAL_INVESTIGATOR lat: 45.40008 lon: -71.89908 facility: GSK Investigational Site city: St-Charles-Borromée state: Quebec zip: J6E 2B4 country: Canada 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: Bonavuth Pek role: PRINCIPAL_INVESTIGATOR lat: 46.05007 lon: -73.46586 facility: GSK Investigational Site city: Quebec zip: G1N 4V3 country: Canada 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: Jean-Francois Roussy role: PRINCIPAL_INVESTIGATOR lat: 46.81228 lon: -71.21454 facility: GSK Investigational Site city: Québec zip: G1V 4G2 country: Canada 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: Marie-Louise Vachon role: PRINCIPAL_INVESTIGATOR lat: 46.81228 lon: -71.21454 facility: GSK Investigational Site city: Weinheim state: Baden-Wuerttemberg zip: 69469 country: Germany 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: Beate Moeckesch role: PRINCIPAL_INVESTIGATOR lat: 49.54887 lon: 8.66697 facility: GSK Investigational Site city: Wallerfing state: Bayern zip: 94574 country: Germany 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: Josef Grosskopf role: PRINCIPAL_INVESTIGATOR lat: 48.68416 lon: 12.88035 facility: GSK Investigational Site city: Wuerzburg state: Bayern zip: 97074 country: Germany 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: Tino F Schwarz role: PRINCIPAL_INVESTIGATOR lat: 49.79391 lon: 9.95121 facility: GSK Investigational Site city: Essen state: Nordrhein-Westfalen zip: 45355 country: Germany 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: Axel Schaefer role: PRINCIPAL_INVESTIGATOR lat: 51.45657 lon: 7.01228 facility: GSK Investigational Site city: Witten state: Nordrhein-Westfalen zip: 58455 country: Germany 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: Thomas Horacek role: PRINCIPAL_INVESTIGATOR lat: 51.44362 lon: 7.35258 facility: GSK Investigational Site city: Mainz state: Rheinland-Pfalz zip: 55116 country: Germany 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: Bernhard Schmitt role: PRINCIPAL_INVESTIGATOR lat: 49.98419 lon: 8.2791 facility: GSK Investigational Site city: Berlin zip: 10117 country: Germany 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: Sameer Kulkarni role: PRINCIPAL_INVESTIGATOR lat: 52.52437 lon: 13.41053 facility: GSK Investigational Site city: Berlin zip: 10787 country: Germany 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: Keikawus Arasteh role: PRINCIPAL_INVESTIGATOR lat: 52.52437 lon: 13.41053 facility: GSK Investigational Site city: Berlin zip: 13347 country: Germany 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: Nicole Toursarkissian role: PRINCIPAL_INVESTIGATOR lat: 52.52437 lon: 13.41053 facility: GSK Investigational Site city: Ibaraki zip: 300-0062 country: Japan 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: Kota Yamada role: PRINCIPAL_INVESTIGATOR lat: 34.81641 lon: 135.56828 facility: GSK Investigational Site city: Kanagawa zip: 211-0041 country: Japan 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: Masamitsu Takahashi role: PRINCIPAL_INVESTIGATOR lat: 37.58333 lon: 139.91667 facility: GSK Investigational Site city: Tokyo zip: 155-0031 country: Japan 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: Tomofumi Murakami role: PRINCIPAL_INVESTIGATOR lat: 35.6895 lon: 139.69171 facility: GSK Investigational Site city: Tokyo zip: 180-0022 country: Japan 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: Minoru Nozaki role: PRINCIPAL_INVESTIGATOR lat: 35.6895 lon: 139.69171 facility: GSK Investigational Site city: Boksburg state: Gauteng zip: 1459 country: South Africa 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: Agatha C Wilhase role: PRINCIPAL_INVESTIGATOR lat: -26.21197 lon: 28.25958 facility: GSK Investigational Site city: Bellville zip: 7530 country: South Africa 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: Maria M Pretorius role: PRINCIPAL_INVESTIGATOR lat: -33.90022 lon: 18.62847 facility: GSK Investigational Site city: Mowbray zip: 7700 country: South Africa 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: Jonathan Peter role: PRINCIPAL_INVESTIGATOR lat: -33.94802 lon: 18.47333 facility: GSK Investigational Site city: Newton zip: 2113 country: South Africa 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: Essack Aziz Mitha role: PRINCIPAL_INVESTIGATOR hasResults: False

 nctId: NCT06389474 id: CT-INM004-04 briefTitle: A Phase III Study to Evaluate the Efficacy of INM004 in Children With STEC-HUS overallStatus: NOT_YET_RECRUITING date: 2024-05-16 date: 2025-07-28 date: 2025-09-28 date: 2024-04-29 date: 2024-04-29 name: Inmunova S.A. class: OTHER name: KLIXAR name: Chemo Research name: Linical name: Crovelis briefSummary: The objectives of this study are to evaluate the efficacy, safety, and pharmacokinetics of INM004 in pediatric patients with Hemolytic Uremic Syndrome associated to infection by Shiga toxin-producing Escherichia coli (STEC-HUS). conditions: Hemolytic-Uremic Syndrome studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Adaptive design. IA will be done when approximately 50% of the enrollment is reached and the participants have completed 28 days of follow-up. This analysis will not be blinded and will be carried out to declare futility or re-estimate the sample size. The re-estimation of the sample size will allow a maximum of 300 randomized subjects in total, but a reduction in the initial item size of 220 subjects is not expected. In case of re-estimating the sample size, the smallest sample size under 300 will be selected, which allows a power of ≥ 80%. %. If with 300 subjects, a power of 80% is not reached, but it is ≥ 50%, then the sample size is re-estimated to 300 subjects, as long as the conditional power of the IA is ≥ 50% (promising results) primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 220 type: ESTIMATED name: INM004 name: Placebo measure: Time to recovery of renal function during the acute phase measure: Short-term recovery of renal function measure: MAKE 90 measure: Dialysis longer than 10 days measure: Dialysis requirement measure: Mortality measure: CKD Risk Assessment According to Kidney Disease Improving Global Outcomes (KDIGO) Categories measure: Evolution of renal function at 7 days (GFR_AUC1-7) measure: Evolution of renal function at 28 days (GFR_AUC1-28) measure: Evolution of renal function at 90 days (GFR_AUC1-90) measure: Incidence of anuria measure: Extrarenal composite endpoint measure: Recovery of the thrombotic microangiopathy (TMA), thrombocytopenia measure: Recovery of the thrombotic microangiopathy (TMA), hemolytic anemia measure: Duration of hospitalization measure: Incidence of adverse events of special interest measure: Incidence of adverse events measure: Pharmacokinetic - AUC0-t measure: Pharmacokinetic - AUC0-inf measure: Pharmacokinetic - Cmax measure: Pharmacokinetic - Tmax measure: Pharmacokinetic - λz measure: Pharmacokinetic - t1/2 measure: Pharmacokinetic - Vz measure: Pharmacokinetic - Cl measure: Pharmacokinetic - AUC/dose measure: Pharmacokinetic - Cmax/dose measure: Baseline Shiga toxin serum levels measure: Kinetics of Shiga toxin in serum sex: ALL minimumAge: 9 Months maximumAge: 17 Years stdAges: CHILD facility: Hospital El Cruce - Néstor Kirchner city: Florencio Varela state: Buenos Aires country: Argentina lat: -34.82722 lon: -58.39556 facility: Hospital Interzonal Especializado Materno Infantil Don Victorio Tetamanti city: Mar Del Plata state: Buenos Aires country: Argentina lat: -38.00228 lon: -57.55754 facility: Sanatorio de Niños city: Rosario state: Santa Fe country: Argentina lat: -32.94682 lon: -60.63932 facility: Clínica Zabala city: Ciudad Autonoma de Buenos Aire country: Argentina lat: -34.61315 lon: -58.37723 facility: Hospital de Niños Dr. Ricardo Gutierrez city: Ciudad Autonoma de Buenos Aire country: Argentina lat: -34.61315 lon: -58.37723 facility: Hospital de Niños de la Santísima Trinidad city: Córdoba country: Argentina lat: -31.4135 lon: -64.18105 facility: Sanatorio Allende city: Córdoba country: Argentina lat: -31.4135 lon: -64.18105 facility: Hospital Pediátrico Dr. Humberto Notti city: Mendoza country: Argentina lat: -32.89084 lon: -68.82717 hasResults: False

 nctId: NCT06389461 id: OST1_012 briefTitle: 4th Ventricular Compression Technique on Anxiety overallStatus: NOT_YET_RECRUITING date: 2024-09-16 date: 2024-12-31 date: 2024-12-31 date: 2024-04-29 date: 2024-04-29 name: Escola Superior de Tecnologia da Saúde do Porto class: OTHER briefSummary: Determinate the effects of the technique of 4th ventricle in college students with anxiety, applying the technique one time per week during three weeks. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: 4th Ventricular Compression Technique name: "Sham" Therapy measure: Change from baseline in anxiety levels through the STAI (The State-Trait Anxiety Inventory) questionnaire score on the 1st and last intervention. measure: Change from baseline in thoraco-abdominal perimetry on the 1st and last intervention sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Escola Superior da Saúde do Porto city: Porto zip: 4200-072 country: Portugal lat: 41.14961 lon: -8.61099 hasResults: False

 nctId: NCT06389448 id: pCLE vs EB 2024tj briefTitle: Comparison of pCLE and EB in Gastric Lesion Diagnosis overallStatus: RECRUITING date: 2024-04-11 date: 2026-04 date: 2026-10 date: 2024-04-29 date: 2024-04-29 name: Huazhong University of Science and Technology class: OTHER briefSummary: This is a prospective multicenter comparative study, aiming to compare probe-based confocal laser endomicroscopy (pCLE) and endoscopic biopsies in the diagnosis of the whole specific gastric lesion especially for distinguishing low grade intraepithelial neoplasia (LGIN) from high grade intraepithelial neoplasia (HGIN) and create an endoscopic image database for the follow-up research. conditions: Low Grade Intraepithelial Neoplasia conditions: High Grade Intraepithelial Neoplasia conditions: Early Gastric Cancer conditions: Gastric Intraepithelial Neoplasia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Participants undergo pCLE after pre-ESD assessment and before ESD resection. primaryPurpose: DIAGNOSTIC masking: NONE count: 366 type: ESTIMATED name: pCLE-gastr measure: Diagnostic accuracy of pCLE and endoscopic biopsy in diagnosing the whole gastric lesion measure: The histological upstaging rate of pCLE and endoscopic biopsy in diagnosing the whole gastric lesion sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji hospital, Tongji Medical College, Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei zip: 430030 country: China name: Bin Cheng, Professor role: CONTACT phone: 86-027-8366-3333 email: bcheng@tjh.tjmu.edu.cn name: Yilin Gu role: CONTACT phone: 86-19884836004 email: yilingu2019@163.com lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06389435 id: 2024DS id: Knee type: OTHER domain: Danderyds sjukhus briefTitle: RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques acronym: ROCKETS overallStatus: RECRUITING date: 2024-03-04 date: 2027-01 date: 2028-01 date: 2024-04-29 date: 2024-04-29 name: Danderyd Hospital class: OTHER name: Karolinska Institutet name: Stockholm South General Hospital briefSummary: Rationale for conducting the study:

The study aims to systematically evaluate the clinical and economic impacts of Robotic-Assisted Total Knee Replacement (RTKR) compared to conventional Total Knee Replacement (TKR). It focuses on the potential benefits of RTKR, including improved precision in surgery, potentially leading to better patient outcomes and reduced healthcare costs. Our primary endpoint is the Forgotten Joint Score (FJS), aimed at measuring patients awareness of their knee joint in everyday life, indicating the success of the knee replacement surgery in restoring natural joint function. Secondary endpoints include patient-reported outcome measures (PROMs), patient activity levels, the accuracy of implant positioning on x-ray, and the incidence of adverse events.

Study design:

Multicentre,, preference-tolerant, randomized, controlled, superiority trial with two treatment arms that compares the outcomes of RTKR with traditional TKR techniques.

Study population:

Adult patients aged 18 years and older who are eligible for TKR as per local guidelines and who have given informed consent to participate in the study.

Number of patients:

400

Inclusion criteria:

Patients must be adults aged 18 years and older, eligible for TKR according to local guidelines, and willing to participate in the study.

Exclusion criteria:

Patients with extreme malalignment requiring special implants or techniques, patients unfit for surgery due to medical reasons, and those deemed unsuitable to participate in the study for other reasons.

Primary outcome variables:

The Forgotten Joint Score (FJS) at 2 years after surgery conditions: Knee Arthroplasty, Total conditions: Robotic-assisted conditions: Osteoarthritis of the Knee studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: Patients will be randomized to undergo TKR or RTKR measure: The Forgotten Joint Score (FJS) measure: KOOS measure: ADLS knee instability measure: The Forgotten Joint Score (FJS) measure: EQ-5D measure: Knee alignment measure: Adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Danderyds Sjukhus status: RECRUITING city: Stockholm zip: 18288 country: Sweden name: Olof Skoldenberg, Md, PhD role: CONTACT phone: 800-555-5555 email: olof.skoldenberg@ki.se name: Olof Skoldenberg, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Karl Erikson, MD, PhD role: SUB_INVESTIGATOR lat: 59.33258 lon: 18.0649 hasResults: False

 nctId: NCT06389422 id: NCC4620 briefTitle: Phase II Study of Moderate-dose Hypofractionated RT Combined With Pembrolizumab for HCC With Diffuse Tumor Thrombosis overallStatus: RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2027-04-30 date: 2024-04-29 date: 2024-04-29 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER briefSummary: This is a single-center, single-arm, open-label study that includes patients meeting the inclusion criteria (liver-GTV volume \< 700ml or estimated liver-GTV V5 \< 300ml) with hepatocellular carcinoma with diffuse tumor thrombosis involving both left and right lobes. All lesions receive moderate-dose hypofractionated intensity-modulated radiotherapy, with a gross tumor dose of 25Gy/5f, and a maximum dose of 35Gy/5f at the tumor center. One week before or during the radiotherapy, patients receive concurrent Pembrolizumab at a dose of 200mg. Subsequently, Pembrolizumab is administered intravenously every 3 weeks. Follow-up examinations are conducted 1-3 months post-radiotherapy. Lenvatinib 4mg may be used for maintenance therapy with Pembrolizumab if there are no contraindications. Maintenance therapy is continued until disease progression or intolerance. The primary endpoint is median overall survival (mOS), and secondary endpoints include objective response rate (ORR), progression-free survival (PFS), and toxicity. conditions: Hepatocellular Carcinoma conditions: Radiotherapy conditions: Pembrolizumab conditions: Tumor Thrombosis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Moderate-dose Hypofractionated Intensity-modulated Radiotherapy name: Pembrolizumab measure: Median Overall Survival measure: Objective Response Rate measure: Progression-free Survival measure: Toxicity sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciecnces and Peking Union Medical College status: RECRUITING city: Beijing state: Beijing country: China name: Bo Chen, MD role: CONTACT phone: 0086-13240000876 email: chenboo@outlook.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06389409 id: Protocollo N.2009 Testicolo briefTitle: Study on the Quality of Life and Functional/Oncological Outcome of Testicular Cancer Patients overallStatus: RECRUITING date: 2010-08-24 date: 2030-09-01 date: 2040-08-31 date: 2024-04-29 date: 2024-04-29 name: IRCCS San Raffaele class: OTHER briefSummary: The research aims to collect data in order to report the main problems related to the testicular cancer; To reach this aim, this study proposes to create a database of the testicular cancer condition.

From this perspective, the aim of this project is the improving of scientific knowledge of the disease and develop appropriate and effective procedures for the diagnosis and treatment of the patient. conditions: Testicular Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED name: Observation of testicular cancer patients measure: Clinical data measure: Adjuvant therapy measure: lactate dehydrogenase measure: Testicular objective examination measure: Testicular objective examination - cysts measure: Testicular objective examination - nodules measure: Testicular objective examination - varicocele measure: Testicular objective examination - hydrocele measure: α-feto protein measure: β human Chorionic Gonadotropin measure: carcinoembryonic antigen sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Ospedale San Raffaele status: RECRUITING city: Milan state: Lombardy zip: 20132 country: Italy name: Alessia d'Arma, PhD role: CONTACT phone: 02 2643 5506 email: darma.alessia@hsr.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06389396 id: CP362 briefTitle: Investigation of a New Rectal Catheter for Users of Transanal Irrigation overallStatus: RECRUITING date: 2024-04-08 date: 2024-06-30 date: 2024-06-30 date: 2024-04-29 date: 2024-04-29 name: Coloplast A/S class: INDUSTRY briefSummary: The clinical investigation is an exploratory, randomised controlled, open-labelled, crossover investigation.

The clinical investigation will be conducted as a multi-centre clinical investigation in two different clinical investigation sites in Denmark. conditions: Bowel Management studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: NONE count: 20 type: ESTIMATED name: CP362 Test Catheter measure: The primary endpoint is: Was it possible to perform transanal irrigation (assessed after irrigation at V1 and V2) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Århus Universitetshospital status: RECRUITING city: Århus state: Jutland zip: 8200 country: Denmark name: Peter Christensen role: CONTACT lat: 56.15674 lon: 10.21076 facility: Amager Hvidovre Hospital status: RECRUITING city: Hvidovre state: Zealand zip: 2650 country: Denmark name: Michael Sørensen role: CONTACT lat: 55.65719 lon: 12.47364 hasResults: False

 nctId: NCT06389383 id: 22-0182 briefTitle: Pilot Study - Monitoring the Nasal Microbiome and Viral Respiratory Infections in Newborn Hospitalized in Neonatalogy. acronym: NEONATMICROBIO overallStatus: ACTIVE_NOT_RECRUITING date: 2022-12-21 date: 2023-06-30 date: 2024-12 date: 2024-04-29 date: 2024-04-29 name: University Hospital, Caen class: OTHER briefSummary: The objective of our study is therefore to study the evolution of the respiratory microbiome of hospitalized newborns, its interaction with viral infections and their impacts on the evolution of newborns. conditions: Newborn; Infection studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 38 type: ACTUAL name: Nasal Swab measure: rate of viral infections sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: CAEN University Hospital city: Caen country: France lat: 49.18585 lon: -0.35912 hasResults: False

 nctId: NCT06389370 id: knowledge, Attitude, Behaviour briefTitle: ASSESSMENT OF ORAL HEALTH KNOWLEDGE, ATTITUDE AND BEHAVIOUR AND ITS ASSOCIATION WITH SOCIODEMOGRAPHIC FACTORS OF PRECLINICAL AND CLINICAL DENTAL STUDENTS IN CAIRO UNIVERSITY: A CROSS-SECTIONAL STUDY overallStatus: NOT_YET_RECRUITING date: 2024-11-04 date: 2024-11-18 date: 2024-12-03 date: 2024-04-29 date: 2024-04-29 name: Cairo University class: OTHER briefSummary: The knowledge, behaviour and attitude of oral health professionals reflects their awareness and understanding of oral preventive measures, which will have significant impact on their delivery of public oral health promotion in the future. They are expected to set an example for positive oral health behaviour among other college students, family members and their patients. Various external factors like sociodemographic factors like age, gender, marital state, occupation, and number of family members play a major role in oral hygiene. The relationships between various modifiable factors needs to be assesses in a vast manner.

There were some researches about oral health knowledge, behaviour and attitude in correlation to socio-demographic data, of dental students in other countries, but little was known in Egypt. Dental students are expected to play a critical role in instructing public oral health for improving their patient's, families, and friends. In addition, it may pave the way to develop new programs to encourage needful oral health practices. conditions: Oral Health Knowledge, Attitude and Behaviour of Dental Students studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 535 type: ESTIMATED name: HU-DBI questionnaire measure: Increase of dental students KAB by preceding through higher academic levels sex: ALL minimumAge: 17 Years maximumAge: 27 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06389357 id: 1305G2024 briefTitle: Return to School Adaptation Programme for Children With Cancer acronym: web-based overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2024-09-06 date: 2024-11-30 date: 2024-04-29 date: 2024-04-29 name: Gazi University class: OTHER briefSummary: This study is planned to evaluate the effect of back-to-school adaptation programme on social anxiety score, coping score and back-to-school readiness score in children aged 8-17 years who are followed up with a diagnosis of cancer.

H1: Is there a significant difference in children's social anxiety scores before and after the back-to-school adaptation programme? H2: Is there a significant difference in children's coping scores before and after the back-to-school adaptation programme? H3: Is there a significant difference in children's readiness to return to school scores before and after the back-to-school adaptation programme? conditions: Childhood Cancer conditions: ALL, Childhood conditions: AML, Childhood conditions: Lymphoma conditions: Solid Tumor, Childhood studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The research is a technical/scientific/collaborative action research design. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 35 type: ESTIMATED name: training and counselling measure: social anxiety measure: coping measure: back to school readiness measure: process evaluation sex: ALL minimumAge: 8 Years maximumAge: 17 Years stdAges: CHILD facility: Gizem Cakir city: Ankara state: Cankaya zip: 06490 country: Turkey name: Gizem Cakir, PhD(c) role: CONTACT phone: +905300858879 email: cakirgzem@gmail.com lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06389344 id: lk20240401 briefTitle: Effect of Esketamine on Conscious State in Patients With pDoC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2026-06-30 date: 2024-04-29 date: 2024-04-29 name: Beijing Tiantan Hospital class: OTHER briefSummary: The goal of this clinical trial is to learn about the effect of intraoperative infusion of subanesthetic dose of esketamine on conscious status in patients with prolonged disorders of consciousness under sevoflurane anesthesia.

Participants will be patients with prolonged disorders of consciousness undergoing surgery with general anesthesia at Beijing Tiantan Hospital. 0.3mg/kg esketamine or saline will be infused will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation. Coma recovery scale-revised, Glasgow coma scale, Full Outline of UnResponsiveness scores, SedLine multi-channel electroencephalogram and perioperative adverse events after surgery will be investigated. conditions: Esketamine conditions: Consciousness Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 116 type: ESTIMATED name: Esketamine name: normal saline measure: Coma recovery scale-revised(CRS-R) measure: Coma recovery scale-revised(CRS-R) measure: Full Outline of UnResponsiveness(FOUR) measure: Glasgow coma scale(GCS) measure: Original EEG measure: Patient state index(PSI) measure: Power spectral density measure: Burst-suppression ratio measure: Spectral edge frequency measure: The incidence of perioperative adverse events sex: ALL minimumAge: 16 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06389331 id: IRC/1971/020 briefTitle: Study on Effects of Defect Closure in Laparoscopic Repair of Direct Inguinal Hernia overallStatus: COMPLETED date: 2020-09-01 date: 2021-06-30 date: 2021-08-31 date: 2024-04-29 date: 2024-04-29 name: B.P. Koirala Institute of Health Sciences class: OTHER briefSummary: The defect closure was found to have higher pain and less seroma formation at various intervals of time following TEP for moderate-large direct inguinal hernia. Although these findings were statistically insignificant, they may be clinically significant, and further studies with a larger sample size are suggested. conditions: Hernia conditions: Direct Inguinal Hernia conditions: Seroma Following Procedure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 88 type: ACTUAL name: closed the defect with barbed suture measure: seroma sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vijay Pratap Sah city: Malangwa state: Madhesh Pradesh country: Nepal lat: 26.85679 lon: 85.55811 typeAbbrev: Prot_ICF hasProtocol: True hasSap: False hasIcf: True label: Study Protocol and Informed Consent Form date: 2020-09-01 uploadDate: 2024-04-24T12:06 filename: Prot_ICF_000.pdf size: 190465 hasResults: False

 nctId: NCT06389318 id: RC 29-11-2023 briefTitle: Buccal Midazolam Versus Intranasal Dexmedetomidine Plus Oral Chloral Hydrate in Inguinal Hernia Repair overallStatus: COMPLETED date: 2023-03-26 date: 2024-03-26 date: 2024-04-24 date: 2024-04-29 date: 2024-04-29 name: Benha University class: OTHER briefSummary: Inguinal hernia surgery is one of the most common surgical procedures in early infancy. Preoperative anxiety remains a vexing issue, and it exists in nearly 50% of pediatric patients conditions: Inguinal Hernia Repair studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Group A (40 patients): Children received oral placebo syrup, Group B (40 patients): Children received oral chloral hydrate (Chloral Hydrate mixture) primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Both participant and the care-provider in this trial were blinded. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 80 type: ACTUAL name: buccal midazolam +oral placebo syrup name: oral chloral hydrate,intranasal dexmedetomidine and buccal normal saline measure: Ramsay sedation score measure: Parental separation anxiety scale sex: ALL minimumAge: 2 Years maximumAge: 7 Years stdAges: CHILD facility: Benha University city: Banha zip: 13511 country: Egypt lat: 30.45906 lon: 31.17858 hasResults: False

 nctId: NCT06389305 id: BJGBYY-IIT-LCYJ-2024-012 briefTitle: CIK Cell Therapy for Relapsed or Refractory Acute B-Lymphoblastic Leukemia: Prognostic Impact on Patients With Early CAR-T Cell Dysfunction overallStatus: RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2026-04-30 date: 2024-04-29 date: 2024-04-29 name: Beijing GoBroad Hospital class: OTHER briefSummary: This is a single-center, double-blind, randomized trial. Patients with r/r B-ALL experiencing early functional exhaustion of CAR-T cells will be randomly allocated into three groups: the control cell group, the CIK treatment group, and the mRNA-CIK treatment group. The primary objective of the study is to evaluate the prognostic impact of CIK cell therapy on the early functional exhaustion of CAR-T cells in children and adolescent and young adult (AYA) with r/r B-ALL. The primary endpoint of the study is the event-free survival rate of these patient in the CIK cell therapy group.A total number of 213 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: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: a prospective cohort study primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 213 type: ESTIMATED name: peripheral blood lymphocytes name: CIK cell measure: EFS in CIK infusion group measure: PFS in CIK infusion group measure: DOR in CIK infusion group measure: OS in CIK infusion group measure: EFS in mRNA-CIK infusion 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: NCT06389292 id: APG2575AG301 briefTitle: A Pivotal Phase 3 Study of APG-2575 (Lisaftoclax) Combined With Azacytidine in the Treatment of Acute Myeloid Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-05-25 date: 2029-03-26 date: 2024-04-29 date: 2024-04-29 name: Ascentage Pharma Group Inc. class: INDUSTRY briefSummary: An international multicenter, randomized, double-blind, placebo-controlled, phase III pivotal registration study, to evaluate the efficacy of APG-2575 (Lisaftoclax) combined with azacitidine (AZA) versus placebo combined with azacitidine in newly diagnosed acute myeloid leukemia who are not eligible for standard induction chemotherapy. conditions: Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 486 type: ESTIMATED name: Lisaftoclax (APG-2575) name: Placebo name: Azacitidine Injection measure: Overall Survival（OS） measure: Percentage of Participants with Objective Response Rate (ORR) measure: Safety evaluation based on the adverse event concurrence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hematology Hospital of the Chinese Academy of Medical Sciences city: Tianjin state: Tianjin zip: 300020 country: China name: Hui Wei, M.D. role: CONTACT phone: 022-23909120 email: weihui@ihcams.ac.cn name: Hui Wei, M.D. role: PRINCIPAL_INVESTIGATOR lat: 39.14222 lon: 117.17667 facility: The First Affiliated Hospital of Zhejiang University School of Medicine city: Hangzhou state: Zhejiang zip: 310003 country: China name: Jie Jin, M.D. role: CONTACT email: jiej0503@163.com role: CONTACT phone: 0571-87236896 name: Jie Jin, M.D. role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06389279 id: 2023-18/11 briefTitle: The Effect of Facial Plane Blocks on Postoperative Recovery Quality in Hip Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04-24 date: 2024-09-24 date: 2024-10-24 date: 2024-04-29 date: 2024-04-29 name: Antalya Training and Research Hospital class: OTHER_GOV briefSummary: The aim of this study was to evaluate the effect of ultrasound-guided pericapsular nerve block, fascia iliaca compartment block, and femoral block on the quality of recovery as part of multimodal analgesia before hip surgery under spinal anesthesia. conditions: Hip Fracture studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: PENG block group name: FIC block group name: Femoral block group name: Control group measure: recovery quality measure: postoperative Numeric Rating Scale (NRS) pain score measure: postoperative opioid consumption sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Health Sciences, Antalya Training and Researh Hospital city: Antalya country: Turkey name: Antalya Training and Research Hospital role: CONTACT lat: 36.90812 lon: 30.69556 hasResults: False

 nctId: NCT06389266 id: 221550 briefTitle: Network-Targeted Neuromodulation for Nicotine Dependence in Schizophrenia overallStatus: RECRUITING date: 2023-06-15 date: 2029-01-10 date: 2029-01-10 date: 2024-04-29 date: 2024-04-29 name: Vanderbilt University Medical Center class: OTHER briefSummary: The goal of this clinical trial is to compare two active types of transcranial magnetic stimulation in two nicotine-using populations: nicotine-using people with psychosis and nicotine-using people without a diagnosis of a psychotic disorder. The main questions it aims to answer are:

1. Can rTMS change functional connectivity in brain circuits associated with nicotine use?
2. Are those rTMS-induced changes in functional connectivity related to craving?

Participants will complete tasks assessing their cognitive performance and craving before and after each week of TMS. Researchers will compare the effect of each TMS intervention on participants with and without psychosis to see if one type of TMS has an effect on nicotine craving. conditions: Schizophrenia conditions: Nicotine Dependence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: All participants receive five days of DMN-targeted cTBS and five days of L DLPFC-targeted iTBS. The order in which participants receive the two types of TMS is randomized. primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: The study is not sham-controlled, as both arms are active TMS treatments. The type of TMS is not masked from the participant or the investigator. Statistician will be blinded to intervention. count: 100 type: ESTIMATED name: Repetitive Transcranial Magnetic Stimulation (rTMS) measure: Resting-state functional connectivity measure: Cue-induced craving measure: Tiffany Brief Questionnaire of Smoking Urges (QSU) measure: Self-reported craving measure: Wisconsin Smoking Withdrawal Scale (WSWS) measure: Fagerstrom Test for Nicotine Dependence (FTND) measure: Self-reported nicotine use sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vanderbilt University Medical Center status: RECRUITING city: Nashville state: Tennessee zip: 37232 country: United States name: Heather B Ward, MD role: CONTACT phone: 615-327-7000 email: heather.b.ward@vumc.org name: Sophia H Blyth, BA role: CONTACT phone: 6154345891 email: sophia.h.blyth@vumc.org name: Stephan Heckers, MD, MSc role: SUB_INVESTIGATOR name: Hilary A Tindle, MD, MPH role: SUB_INVESTIGATOR lat: 36.16589 lon: -86.78444 hasResults: False

 nctId: NCT06389253 id: HTSW1 briefTitle: Subtalar Extra-articular Screw Arthroereisis overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-29 date: 2024-04-29 name: Università Vita-Salute San Raffaele class: OTHER briefSummary: The aim of the study is to investigate the effect of subtalar extra-articular calcaneo-stop screw on the proprioceptive and nociceptive pathways of the ankle before and after implantation. The hypothesis of the study is that an increased number of receptors related to proprioception will be detected in the sinus tarsi. conditions: Flatfoot, Flexible conditions: Ankle Proprioception studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED name: Histological Analysis measure: Primary Endpoint (%) measure: Secondary Endpoint sex: ALL minimumAge: 10 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ircss Ospedale San Raffaele city: Milan state: Lombardy zip: 20149 country: Italy lat: 45.46427 lon: 9.18951 facility: Università Vita-Salute San Raffaele city: Milan zip: 20132 country: Italy name: Francesco Pezone role: CONTACT role: CONTACT email: f.pezone@studenti.unisr.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06389240 id: 160848 briefTitle: Early Weight Bearing in Unicondylar Tibial Plateau Fractures overallStatus: ACTIVE_NOT_RECRUITING date: 2022-12-21 date: 2025-12 date: 2025-12 date: 2024-04-29 date: 2024-04-29 name: University of Utah class: OTHER briefSummary: The investigators aim of the study is to assess the effects of early mobilization after surgically treated unicondylar tibia plateau fractures (6 weeks without weight bearing) on gait, patient satisfaction, return to work/sports and complication rate. The data will be compared to a 10-12 week non-weight bearing group (standard of care).

It is assumed that earlier mobilization does not lead to an increase in the complications - in particular osteosynthesis failure and infections -, but leads to improved patient satisfaction, reduced return to work/sports times, and has a positive impact on the overall outcome conditions: Early Mobilization studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: 6 weeks post-operatively early weight bearing name: 10 weeks post-operatively weight bearing (standard of care) measure: Average peak load (Newtons (N)) measure: Average peak load (Newtons (N)) measure: Average peak load (Newtons (N)) measure: Average peak load (Newtons (N)) measure: Average peak load (Newtons (N)) measure: Average peak load (Newtons (N)) measure: Average peak load (Newtons (N)) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Utah Orthopedics city: Salt Lake City state: Utah zip: 84108 country: United States lat: 40.76078 lon: -111.89105 hasResults: False

 nctId: NCT06389227 id: 0433611 briefTitle: Developing the Physical Performance in Youth Soccer: Short-term Effect of Dynamic-Ecological Versus Traditional Training Approach for Sub-élite U13 Players: An Ecological Exploratory Cluster Randomised Trial overallStatus: COMPLETED date: 2023-10-15 date: 2023-10-30 date: 2024-02-15 date: 2024-04-29 date: 2024-04-29 name: University of Turin, Italy class: OTHER briefSummary: Therefore, this study aims to verify the effects of a soccer training program based on the dynamic-ecological approach on U13 sub-elité players' physical efficiency by analysing explosive strength, speed, resistance to speed and muscle flexibility. This study hypothe-sises that the dynamic-ecological approach can consistently help players develop adequate physical efficiency and motor coordination. conditions: Verify the Effects of a Soccer Training Program Based on the Dynamic-ecological Approach on U13 Sub-elité Players' Physical Efficiency studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 35 type: ACTUAL name: dynamic ecological approach (DEA) name: traditional training group measure: Number of participants evaluated on physical efficiency sex: MALE minimumAge: 12 Years maximumAge: 13 Years stdAges: CHILD facility: Cit Turin LDE city: Turin zip: 10100 country: Italy lat: 45.07049 lon: 7.68682 hasResults: False

 nctId: NCT06389214 id: ADX-102-DED-030 briefTitle: A Phase 3 Clinical Trial to Assess the Efficacy and Safety of Subjects With Dry Eye Disease overallStatus: RECRUITING date: 2024-04-09 date: 2024-12-31 date: 2024-12-31 date: 2024-04-29 date: 2024-04-29 name: Aldeyra Therapeutics, Inc. class: INDUSTRY briefSummary: A Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease conditions: Dry Eye Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 110 type: ESTIMATED name: Reproxalap Ophthalmic Solution (0.25%) name: Vehicle Ophthalmic Solution measure: Ocular discomfort symptom score over 100 minutes in the dry eye chamber at Visit 2 and Visit 4 sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cliantha Research status: RECRUITING city: Mississauga state: Ontario country: Canada name: Patricia Couroux, MD role: CONTACT phone: (888) 989-1808 email: pcouroux@cliantha.com lat: 43.5789 lon: -79.6583 hasResults: False

 nctId: NCT06389201 id: 2024HCQ briefTitle: Pretreatment With HCQ Before Radiotherapy and Chemotherapy in Advanced NPC Patients overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2026-12-31 date: 2024-04-29 date: 2024-04-29 name: Affiliated Hospital of Nantong University class: OTHER briefSummary: Dormant cancer cells that survive anti-cancer therapy can lead to cancer recurrence and disseminated metastases that prove fatal in most cases. Recently, specific dormant polyploid giant cancer cells (PGCC) have drawn our attention because of their association with the clinical risk of nasopharyngeal carcinoma (NPC) recurrence, as demonstrated by previous clinical data. In study, we report the biological properties of PGCC, and reveal that autophagy is a critical mechanism of PGCC induction. Moreover, pharmacological inhibition of autophagy greatly impaired PGCC formation, significantly suppressing metastasis and improving survival in a mouse model. Mechanistically, chemotherapeutic drugs partly damaged mitochondria, and activated autophagy to promote PGCC formation. High numbers of PGCCs correlated with shorter recurrence time and worse survival outcomes in NPC patients. Collectively, these findings suggest a therapeutic approach of targeting dormant PGCCs in cancer.

Pretreatment with an autophagy inhibitor (HCQ) before chemotherapy and radiotherapy could prevent formation of therapy-induced dormant polyploid giant cancer cells, thereby reducing recurrence and metastasis of nasopharyngeal carcinoma. conditions: Nasopharyngeal Carcinoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: HCQ name: Placebo measure: Recurrence and metastasis sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bo You city: Nantong state: Jiangsu zip: 226000 country: China lat: 32.03028 lon: 120.87472 hasResults: False

 nctId: NCT06389188 id: JVT003 briefTitle: Effectiveness of Cervical Osteopathic Manipulation in Patients With Whiplash overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-09-01 date: 2024-10-01 date: 2024-04-29 date: 2024-04-29 name: Universidad Miguel Hernandez de Elche class: OTHER name: Consorci Sanitari de Terrassa briefSummary: To determine the mid- and long-term efficiency (15, 30 and 120 days after starting sessions) of the SAT technique in patients with grade II acute WL, comparing it with a conventional rehabilitation program. conditions: Whiplash studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: RHB Group measure: Subjective pain intensity measure: Neck specific disability measure: Cervical range of motion (CROM) measure: Cervical lordosis Cobb angle measure: Hospital anxiety and depression scale sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Consorci Sanitari de Terrassa. city: Terrassa state: Barcelona zip: 08227 country: Spain name: Joan Parera-Turull, PhD role: CONTACT phone: 937310007 phoneExt: 0007 email: joanparera@osteopatiaterrassa.com lat: 41.56667 lon: 2.01667 hasResults: False

 nctId: NCT06389175 id: BON001 id: KR 4555/10-1 type: OTHER_GRANT domain: Deutsche Forschungsgemeinschaft (DFG) briefTitle: Non-invasive Vagus Nerve Stimulation as a Tool to Modulate Stomach-Brain Coupling in Depression overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-12 date: 2026-12 date: 2024-04-29 date: 2024-04-29 name: University of Bonn class: OTHER name: University Hospital Tuebingen briefSummary: The overarching goal of the project is to determine whether differences in stomach-brain coupling contribute to key symptoms of major depressive disorder (MDD) and whether transcutaneous non-invasive vagus nerve stimulation (tVNS) may serve as a non-invasive intervention to improve aberrant interoceptive signaling in participants suffering from MDD. conditions: Depressive Disorder, Major studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: Transcutaneous non-invasive vagus nerve stimulation (tVNS) name: Sham stimulation measure: Stimulation-induced acute changes in stomach-brain coupling measure: Stimulation-induced acute changes in gastric motility measure: Stimulation-induced mid-term changes in gastric motility measure: Stimulation-induced mid-term changes in self-reported interoception measure: Stimulation-induced mid-term changes in somatic symptoms measure: Stimulation-induced mid-term changes in depressive symptoms measure: Stimulation-induced acute neural changes in food cue reactivity measure: Stimulation-induced acute behavioral changes in invigoration measure: Stimulation-induced acute neural changes during foraging measure: Stimulation-induced acute behavioral changes in foraging decisions measure: Stimulation-induced mid-term changes in positive and negative affect measure: Stimulation-induced mid-term changes in self-reported interoception measure: Stimulation-induced mid-term changes in motivation measure: Stimulation-induced mid-term changes in physical activity measure: Stimulation-induced mid-term changes in heart rate measure: Stimulation-induced acute changes in blood parameters measure: Stimulation-induced mid-term changes in blood parameters measure: Stimulation-induced mid-term changes in composition of microbiome measure: Stimulation-induced mid-term changes in discounting-related decision-making measure: Stimulation-induced mid-term changes in reward learning measure: Stimulation-induced mid-term changes in loneliness sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06389162 id: UNLV-2024-115 briefTitle: Dorsolateral Prefrontal Cortex Transcranial Direct Current and Muscle Fatigue Stimulation on Muscle Fatigue overallStatus: ENROLLING_BY_INVITATION date: 2024-04-04 date: 2024-08-31 date: 2024-09-30 date: 2024-04-29 date: 2024-04-29 name: University of Nevada, Las Vegas class: OTHER briefSummary: The goal of this clinical trial is to learn if transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) can impact muscle fatigue. The main questions it aims to answer are:

1. Does tDCS of the left DLPFC increase the time that a fatiguing contraction can be maintained?
2. Does tDCS of the left DLPFC decrease the rate of increase of muscle activity, force error, and standard deviation of force during a fatiguing contraction.

Researchers will compare tDCS of the left DLPFC to a SHAM stimulation (a type of stimulation that feels like real tDCS but does not elicit physiological effects) to see if tDCS of the left DLPFC works to reduce the progression of muscle fatigue.

Participants will:

Performing two experimental sessions held 3-10 days apart (usually 7 days) Perform a 9 hole pegboard test, maximum voluntary contractions, and a fatiguing contraction. conditions: Fatigue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Double-blind whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: transcranial direct current stimulation measure: Time to Task Failure measure: Fatigue Index measure: Average EMG activity measure: Force error measure: Standard deviation of force measure: 9 Hole Pegboard Test sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University of Nevada Las Vegas city: Las Vegas state: Nevada zip: 89154 country: United States lat: 36.17497 lon: -115.13722 hasResults: False

 nctId: NCT06389149 id: 0165-24-FB briefTitle: Leg Exercise Assistive Paddling (LEAP) Therapy for Peripheral Artery Disease overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-08 date: 2025-08 date: 2024-04-29 date: 2024-04-29 name: University of Nebraska class: OTHER briefSummary: 1) The purpose of this study is to test the effects of leg exercise assistive paddling (LEAP) therapy during prolonged sitting (PS) on vascular and functional performance in those with peripheral artery disease (PAD) and age-matched controls. LEAP therapy is a novel application of passive limb movement to enhance blood flow through the legs without muscular contractions. Specifically, LEAP therapy is the rotational passive movement of the lower leg about the knee from 90 to 180 degrees of rotation at a cadence of 1Hz. Previous literature has indicated that this movement pattern can produce robust increases in blood flow in the passively moved limb in healthy individuals, and passive limb movement may protect vascular function during PS. However, the impact of LEAP therapy to improve blood flow in the legs of those with PAD during PS is unknown. 2) To be eligible for this study, those with PAD must be between the ages of 50-85 years, women must be postmenopausal, must have a history of exercise-limiting claudication, have an ankle brachial index (ABI) 0.9. 3) Subjects will participate in a randomized cross-over design study with 2 visits (LEAP therapy and no LEAP therapy). For the first visit, subjects will be randomly allocated to receive LEAP therapy during 2.5 hours of PS or not. For the second visit, subjects will sit for 2.5 hours and will receive the condition that they did not previously receive. Before and after PS, the following measurements will be made: flow-mediated dilation of the popliteal and brachial arteries, arterial stiffness with tonometry techniques, microvascular vasodilatory capacity and skeletal muscle metabolic rate with near-infrared spectroscopy, autonomic nervous system function, and there will be blood drawn from the antecubital vein. After PS, subjects will participate in a graded exercise test to assess functional walking capacity. Finally, during PS, near-infrared spectroscopy on the calf muscles and electrocardiogram will be collected continuously to monitor muscle oxygen availability and autonomic activity, respectively. 4) There will be no follow-up. conditions: Peripheral Arterial Disease conditions: Peripheral Vascular Disease conditions: Peripheral Artery Occlusive Disease conditions: Peripheral Artery Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: There will be a peripheral artery disease (PAD) group and an age-matched healthy control group. Within each of these groups will be a 1:1 randomized, crossover study design. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: LEAP therapy name: no LEAP therapy measure: Macrovascular Endothelial Function measure: Microvascular Vasodilatory Capacity measure: Femoral and Popliteal Artery Blood Flow measure: Walking capacity measure: Autonomic Function measure: Autonomic Activity measure: Arterial Stiffness measure: Muscle Oxygenation measure: Peripheral blood mononuclear cell mitochondrial function sex: ALL minimumAge: 55 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Nebraska - Omaha city: Omaha state: Nebraska zip: 68182 country: United States lat: 41.25626 lon: -95.94043 hasResults: False

 nctId: NCT06389136 id: M24-601 briefTitle: A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab acronym: Switch-Up overallStatus: NOT_YET_RECRUITING date: 2024-05-24 date: 2025-08-22 date: 2026-03-09 date: 2024-04-29 date: 2024-04-29 name: AbbVie class: INDUSTRY briefSummary: Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study aims to provide data on the efficacy and safety of upadacitinib at different doses in adult participants with moderate to severe AD.

Upadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis (AD). This study is conducted in 2 periods. During Period 1, participants are randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib Dose A or dupilumab Dose A. Based on the participants response to upadacitinib Dose A, they may have their dose increased to upadacitinib Dose B after 2 weeks. In Period 2, participants that completed Period 1 will either remain on their assigned dose or be reassigned to a different dose based on their Eczema Area and Severity Index (EASI) response. Approximately 300 adult participants ages 18 to 64 with moderate to severe AD who are current users of dupilumab and had a history of inadequate response to dupilumab will be enrolled at up to 94 sites worldwide.

The study is comprised of a 35-day Screening Period, an 8-week Open-Label Period 1 and a 24-week Open-Label Period 2 for participants that completed Period 1. Participants will receive upadacitinib oral tablets once daily or dupilumab subcutaneous (SC) injection every other week for 32 weeks and followed for 30 days.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular 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: Atopic Dermatitis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Upadacitinib Dose A name: Dupilumab Dose A name: Upadacitinib Dose B measure: Participants who achieve a composite endpoint of both a 90% reduction in Eczema Area and Severity Index from Baseline (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) measure: Percentage of participants who achieve EASI 90 measure: Percentage of participants achieving worst pruritus numerical rating scale (WP-NRS) 0/1 measure: Percentage of participants achieving worst pruritus numerical rating scale (WP-NRS) 0/1 sex: ALL minimumAge: 18 Years maximumAge: 63 Years stdAges: ADULT hasResults: False

 nctId: NCT06389123 id: 1788760 briefTitle: Molecularly Targeted Theranostic Approach for the Detection and Treatment of Metastatic Carcinomas overallStatus: RECRUITING date: 2024-04-01 date: 2027-03-31 date: 2028-03-31 date: 2024-04-29 date: 2024-04-29 name: University of California, Davis class: OTHER name: National Institutes of Health (NIH) briefSummary: This is a Phase I study to evaluate the safety and efficacy of the \[68Ga\]Ga DOTA-5G and \[177Lu\]Lu DOTA-ABM-5G theranostics pair in patients with metastatic cancer. conditions: Metastatic Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single treatment primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G. measure: [68Ga]Ga DOTA-5G PET/CT imaging measure: [177Lu]Lu DOTA-ABM-5G treatment measure: [177Lu]Lu DOTA-ABM-5G treatment efficacy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of California Davis Comprehensive Cancer Center status: RECRUITING city: Sacramento state: California zip: 95817 country: United States name: Julie L Sutcliffe, PhD role: CONTACT phone: 916-734-5536 email: jlsutcliffe@ucdavis.edu lat: 38.58157 lon: -121.4944 hasResults: False

 nctId: NCT06389110 id: SOPH201-1023/III briefTitle: Study to Evaluate the Efficacy of Alleance® (Atropine Sulfate 0.01%) as a Treatment to Delay Myopia and Axial Ocular Elongation in Children. overallStatus: NOT_YET_RECRUITING date: 2024-12-30 date: 2027-06-30 date: 2027-06-30 date: 2024-04-29 date: 2024-04-29 name: Laboratorios Sophia S.A de C.V. class: INDUSTRY briefSummary: Phase III clinical study to evaluate the efficacy of Alleance® (atropine sulfate 0.01%) ophthalmic solution through the incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), changes in intraocular pressure, changes in the amplitude of accommodation, compared to placebo, as a treatment to delay the progression of myopia and axial ocular elongation in children. conditions: Myopia conditions: Myopia, Progressive studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a study to demonstrate superiority, double-blind, randomized, controlled, comparative, and multicenter phase III clinical trial. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 123 type: ESTIMATED name: Alleance® name: Placebo measure: Changes in the spherical equivalent measure: Changes in axial eye length measure: Incidence of unexpected adverse events related to the interventions measure: Incidence of photophobia between interventions measure: Changes in pupillary diameter between the interventions measure: Changes in Best Corrected Visual Acuity (BCVA) measure: Changes in near best-corrected visual acuity measure: Changes in the amplitude of accommodation (AA) between interventions measure: Changes in intraocular pressure (IOP) sex: ALL minimumAge: 3 Years maximumAge: 12 Years stdAges: CHILD hasResults: False

 nctId: NCT06389097 id: J23152 id: IRB00411454 type: OTHER domain: JHM IRB id: P01CA272222 type: NIH link: https://reporter.nih.gov/quickSearch/P01CA272222 briefTitle: SPECT Imaging for Pharmacokinetics and dosimEtry Towards TREATment Optimization acronym: (SEEtoTREAT) overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-05 date: 2029-05 date: 2024-04-29 date: 2024-04-29 name: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins class: OTHER name: National Cancer Institute (NCI) briefSummary: The investigators will study SPECT imaging of radiopharmaceutical therapies given as standard of care or as part of other compatible research protocols. The goal is to validate the quantitative SPECT image reconstruction methods developed in this proposal, and to investigate the relation between dosimetry calculated from SPECT images and the outcomes. Patients will be recruited for SPECT/CT imaging during treatment. This is an observational study no additional new drugs or activities will be administrated. The investigators will perform SPECT imaging on a total of 80 patients (\~20 each from year 2 to year 5). Each participant will be imaged 3 times after the first and last cycles of planned radiopharmaceutical therapy. conditions: Prostate Cancer conditions: Advanced Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 80 type: ESTIMATED name: Radium-223 name: 177Lu-DOTATATE name: 177Lu-PSMA-617 measure: Mean absorbed dose to normal organs compared using different quantitative methods measure: Variability of intra-patient and inter-patient mean absorbed dose to normal organs compared using SPECT images measure: Mean absorbed dose to normal organs correlated with toxicity sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06389084 id: 179939 briefTitle: Parents Together: Supporting Parents to Promote Healthy Behaviours in Children overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-03-31 date: 2025-12-31 date: 2024-04-29 date: 2024-04-29 name: The Hospital for Sick Children class: OTHER briefSummary: The Parents Together trial aims to determine if the Parents Together program consisting of virtual parent group sessions and coaching calls, will result in better health outcomes for children. The program which is facilitated by a Public Health Nurse seeks to encourage healthy lifestyle behaviours, help build strong family relationships, and promote child development and mental health. conditions: Child Eating Behaviours conditions: Child Nutrition conditions: Early Child Development conditions: Parenting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized control trial primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 128 type: ESTIMATED name: Parents Together parenting course measure: Child eating behaviours measure: Dietary intake and food environment measure: Nutritional risk measure: Physical Activity, Sedentary Time, Sleep Duration measure: Physical activity measure: Social and emotional development measure: Child development measure: Family psychosocial health measure: Parenting measure: Parenting sense of competence measure: sociodemographic, maternal and child characteristics measure: zBMI measure: Waist circumference measure: Blood pressure sex: ALL minimumAge: 2 Years maximumAge: 5 Years stdAges: CHILD facility: The Hospital for Sick Children city: Toronto state: Ontario country: Canada lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06389071 id: PLS001 briefTitle: Laser Treatment for Lichen Sclerosus overallStatus: RECRUITING date: 2024-03-01 date: 2025-12-20 date: 2025-12-30 date: 2024-04-29 date: 2024-04-29 name: Sciton class: INDUSTRY briefSummary: Fractional ablative laser treatment for Lichen Sclerosus lesion conditions: Lichen Sclerosus Lesion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: Fractional 2940 nm Laser measure: Histological clearance sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinique Medicale Uro-Gyneco de l'Abitibi status: RECRUITING city: Val-d'Or state: Quebec zip: J9P1W1 country: Canada name: Josee Parent, MD role: CONTACT phone: 819-825-3800 lat: 48.0974 lon: -77.79737 hasResults: False

 nctId: NCT06389058 id: G00014538 briefTitle: Using NLP and Neural Networks to Autonomously Identify Severe Asthma and Determine Study Eligibility in a Large Healthcare System overallStatus: ACTIVE_NOT_RECRUITING date: 2023-05-01 date: 2024-07-01 date: 2026-11 date: 2024-04-29 date: 2024-04-29 name: San Diego State University class: OTHER name: GlaxoSmithKline name: Scripps Health name: Modena Allergy + Asthma, La Jolla, CA name: University of California, San Diego briefSummary: The study aims to to use new technologies (ML, AI, NLP), to autonomously identify moderate to severe asthma populations within an EHR system, describe differences in treatment patterns across different populations, and determine trial eligibility.

Primary Objectives Please ensure you detail primary objectives Aim 1. Determine and validate a diagnosis of severe asthma (SA) using predictive features obtained from the Scripps Health EHR.

* Aim 1a: Use ML applied to structured EHR data to predict SA. Use the opinion of 2 specialty-trained physicians and ATS guidelines to determine model accuracy.
* Aim 1b: Use NLP applied to unstructured text to predict SA. Determine model accuracy as above in Aim 1a.
* Aim 1c: Use a combination of ML applied to structured data to predict SA. Determine model accuracy as above in Aim 1a. conditions: Severe Asthma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 31795 type: ACTUAL name: Recommendation for the diagnoses and treatment of Severe Athma measure: Identification of Patients with Severe Asthma sex: ALL minimumAge: 6 Years maximumAge: 85 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: San Diego State University city: San Diego state: California zip: 92182-1309 country: United States lat: 32.71533 lon: -117.15726 hasResults: False

 nctId: NCT06389045 id: EUS briefTitle: Profopol and Remifentanil Sedation in Endoscopic Ultrasonography overallStatus: RECRUITING date: 2024-04-24 date: 2024-06-24 date: 2024-07-01 date: 2024-04-29 date: 2024-04-29 name: Samsun University class: OTHER briefSummary: Endoscopic ultrasonography (EUS) is an endoscopic procedure performed to investigate conditions affecting the stomach, liver, and bile ducts, as well as for therapeutic interventions. The complexity of EUS can vary significantly, with increased complexity affecting procedure duration, technical success, and the occurrence of adverse events. For the comfort of patients and the success of the procedure, these interventions are typically performed under anesthesia with procedural sedation. To enhance the success rate of the procedure, reduce the risk of side effects, and maximize patient comfort, EUS is generally performed under sedation according to the recommendations of the American Society of Anesthesiologists (ASA). During sedation, the aim is for the patient to be more relaxed and comfortable while maintaining spontaneous respiratory function. Preserving spontaneous respiratory parameters is crucial for procedural safety. conditions: Sedation Complication conditions: Endoscopic Ultrasonography conditions: Procedural Sedation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 70 type: ESTIMATED name: Procedural Sedation measure: Anesthesia related major complications measure: The prevalence of symptoms of inadequate sedation sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsun University Faculty of Medicine status: RECRUITING city: Samsun country: Turkey name: Caner Genc, M.D. role: CONTACT phone: 5444846865 phoneExt: +90 email: dr.canergenc@gmail.com lat: 41.27976 lon: 36.3361 hasResults: False

 nctId: NCT06389032 id: 21041503 id: 1R01AG079128-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R01AG079128-01A1 briefTitle: PERSEVERE in Lewy Body Dementia: A Randomized, Controlled Trial of Peer Mentor Support and Caregiver Education overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-10-15 date: 2028-06-30 date: 2024-04-29 date: 2024-04-29 name: Rush University Medical Center class: OTHER name: National Institute on Aging (NIA) briefSummary: Lewy Body Dementia (LBD) is the second most common form of degenerative dementia, affecting at least 2.4 million US adults, and the overwhelming majority of persons living with LBD (PLBD) are cared for by family caregivers. LBD caregiver strain: 1) exceeds that of non-LBD dementia caregivers; 2) worsens caregiver physical and mental health; and 3) increases the risk of PLBD hospitalization and institutionalization. LBD progression is complicated by combined motor, cognitive, and neuropsychiatric decline, and is punctuated by falls, infections, dehydration, and neuropsychiatric symptoms leading to acute healthcare utilization. Although family caregivers are uniquely positioned to identify and manage these challenges, which may avert emergency department visits and reduce morbidity, many caregivers lack the knowledge, skills, confidence, resources, and support to do so.

We aim to 1) quantify the impact of PERSEVERE on caregiver knowledge, attitudes, mastery, and strain; 2) identify the intervention and mentor factors determining implementation fidelity; and 3) test the effects of PERSEVERE on PLBD quality of life and healthcare utilization. This will be accomplished in an NIH Behavioral Model Stage II national, randomized, attention-controlled, 12-week trial of PERSEVERE in 502 LBD caregivers in partnership with the Lewy Body Dementia Association, Parkinson's Foundation, and LBD Caregiver Advisors. We will match intervention arm caregivers with a trained peer mentor who will coach them through a modular, theory-based curriculum on LBD knowledge and social support. Attention-control participants will receive weekly, curated links to educational materials. We will identify immediate and delayed intervention effects, including mediators of strain at 12 weeks, and caregiver strain and PLBD outcomes at nine months. Implementation fidelity and PLBD healthcare utilization will be tracked biweekly. Qualitative methods will explore the intervention- and mentor-specific factors predicting fidelity, mentee outcomes, and retention. Remote recruitment, mentoring, and community engagement strategies will maximize accessibility and inclusion of underrepresented caregiver groups. Results will illuminate the extent to which leveraging prior LBD caregivers as expert interventionists can improve current caregiver outcomes, and in turn, PLBD outcomes. These results will inform future adaptation and dissemination of this model for other conditions. conditions: Lewy Body Dementia conditions: Parkinson Disease Dementia conditions: Dementia With Lewy Bodies conditions: Lewy Body Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 622 type: ESTIMATED name: Peer Mentor Support and Caregiver Education name: Caregiver Education measure: Multidimensional Caregiver Strain Index (MCSI) measure: Quality of Life in Alzheimer's Disease ( QoL-AD) measure: Dementia Attitudes Scale (DAS) measure: LBD Knowledge Test ( LBDK) measure: Baseline PLBD Fall Frequency and Healthcare Utilization Questionnaire measure: Fortinsky Caregiver Self-Efficacy Score measure: Multidimensional Scale of Perceived Social Support (MSPSS) measure: Pearlin Mastery Scale measure: Frequency and Duration of Mentoring Calls measure: Study adherence of Mentors and Mentees measure: Coverage of target topics; additional topics discussed sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rush University Medical Center city: Chicago state: Illinois zip: 60612 country: United States name: Persevere Study Team role: CONTACT phone: 312-563-3300 email: persevere@rush.edu name: Dr. Jori Fleisher, MD MSCE role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06389019 id: BLCA_CMUFH id: K2024-187-01 type: OTHER domain: The First Affiliated Hospital of Chongqing Medical University briefTitle: Whole-slide Image and CT Radiomics Based Deep Learning System for Prognostication Prediction in Bladder Cancer overallStatus: RECRUITING date: 2024-01-01 date: 2024-06-01 date: 2024-10-01 date: 2024-04-29 date: 2024-04-29 name: Mingzhao Xiao class: OTHER briefSummary: Bladder cancer (BLCA), with its diverse histopathological features and varying patient outcomes, poses significant challenges in diagnosis and prognosis. Postoperative survival stratification based on radiomics feature and whole slide image feature may be useful for treatment decisions to improve prognosis. In this research, we aim to develop a deep learning-based prognostic-stratification system for automatic prediction of overall and cancer-specific survival in patients with BLCA. conditions: Bladder Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED name: Deep learning system for prognostication prediction in bladder cancer measure: Overall survival measure: Recurrence free survival sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Urology, The First Affiliated Hospital of Chongqing Medical University status: RECRUITING city: Chongqing state: Chongqing zip: 400016 country: China name: QuanHao He, PHD role: CONTACT phone: 800-555-5555 email: 2020120460@stu.cqmu.edu.cn name: Mingzhao Xiao, PHD role: CONTACT phone: 023-89012557 email: 2023140134@stu.cqmu.edu.cn lat: 29.56278 lon: 106.55278 hasResults: False

 nctId: NCT06389006 id: RC48-C025 briefTitle: To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-06-01 date: 2026-12-31 date: 2024-04-29 date: 2024-04-29 name: RemeGen Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Toripalimab sequential chemotherapy as in patients with HR-positive, HER2-low breast cancer conditions: HR-positive, HER2-low Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 79 type: ESTIMATED name: Disitamab Vedotin for Injection name: Toripalimab name: Epirubicin name: Cyclophosphamide measure: Total pathological complete response (tpCR) rate measure: Breast pathological complete response（bpCR） measure: Event free survival (EFS) measure: Disease-free survival (DFS) measure: Objective Response Rate (ORR) measure: Adverse events (AEs) measure: Change in cluster of differentiation 8 (CD8) measure: Health-related quality of life - EORTC-QLQ-C30 measure: Residual cancer burden score measure: Change in tumor-infiltrating lymphocytes (TILs) measure: Change in programmed cell death protein L1 (PD-L1) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jiong Wu city: Shanghai state: Fudan University Shanghai Cancer Center zip: 200032 country: China name: Jiong Wu, Ph.D role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06388993 id: 2023H0351 briefTitle: Marrow Cellution™ vs. Traditional BMA Harvest Project overallStatus: RECRUITING date: 2024-03-25 date: 2024-12-31 date: 2025-03-31 date: 2024-04-29 date: 2024-04-29 name: Ohio State University class: OTHER briefSummary: Six patients with diagnosed bone loss of the hip who have consented to minimally invasive repair will be approached to participate in the study. Participants will have the liquid portion of bone marrow collected using the Zimmer Biomet Biocue system, which is the standard system used by physicians at The Ohio State University, and the novel Marrow Cellutions system™. Bone marrow liquid will be collected from the surgical hip using the Zimmer Biomet Biocue system, and the Marrow Cellutions system™ will be used to collect bone marrow liquid from the non-surgical hip. Following collection, the bone marrow liquid will be processed using the respective systems to concentrate the cells and molecules found in the bone marrow liquid. As part of the standard of care for this arthroscopic procedure, concentrated bone marrow liquid processed using the Zimmer Biomet Biocue system will be delivered to the surgical site as an adjunct to promote healing. Concentrated bone marrow liquid prepared with the Zimmer Biomet Biocue system is given as part of the standard of care for patients undergoing minimally invasive treatment for bone loss of the hip; therefore, the target population for this study are individuals between the ages of 18-50 years with confirmed bone loss of the hip who have consented to minimally invasive repair. In addition to the concentrated bone marrow liquid prepared using the Zimmer Biomet Biocue system, patients will also have bone marrow liquid collected from the non-surgical hip using the Marrow Cellutions™ system. Only concentrated bone marrow liquid produced with the Zimmer Biomet Biocue system will be given to the patient. All concentrated bone marrow liquid produced with the Marrow Cellutions™ system will be sent to the laboratory for analysis. Additionally, white blood cells will be concentrated into an autologous protein solution (APS) using the Zimmer Biomet Plasmax system from blood collected using a routine blood draw. All protein solution produced will be sent to the laboratory for analysis. No protein solution will be given to the patient. As the bone marrow liquid collection using the Marrow Cellutions™ system and the blood draw to produce protein solution using the Zimmer Biomet Plasmax system are being performed for research, conditions: Hip Arthropathy conditions: Avascular Necrosis of Bone conditions: Subchondral Cysts studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: Bone Marrow Collection measure: Assess overall number of stem cells collected from each aspiration method measure: Assess overall number of cytokines collected from each aspiration method measure: Assess overall number of growth factors collected from each aspiration method sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Jameson Crane Sports Medicine Institute status: RECRUITING city: Columbus state: Ohio zip: 43202 country: United States name: Michael Keller role: CONTACT phone: 614-293-2410 email: michael.keller@osumc.edu name: Karen Persons role: CONTACT email: andrea.persons@osumc.edu name: William K Vasileff, MD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06388980 id: UFCIN1_2022 briefTitle: Knowledge and Needs of Nursing in Relation to the Treatment Complex Wounds overallStatus: ACTIVE_NOT_RECRUITING date: 2023-05-01 date: 2023-06-01 date: 2024-06-01 date: 2024-04-29 date: 2024-04-29 name: Corporacion Parc Tauli class: OTHER briefSummary: Study with cross-sectional and descriptive mixed methodology. With questionnaires with likert-type questions (0-10) being the 10 with the highest score, and open questions in relation to knowledge in wound care; include all Corporaciló Sanitària Parc Taulí (CCSPT) nurses who voluntarily want to participate in a pseudo-anonymized surv conditions: Nurse's Role conditions: Knowledge, Attitudes, Practice conditions: Wound studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Validated questionnaires and ad hoc questions measure: "What not to do in chronic wounds?" measure: ReAc-PUKT (Renobato-Acosta Pressure Ulcer Knowledge Test) measure: Ad hoc open questions sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Corporació Sanitària Parc Taulí city: Sabadell state: Barcelona zip: 08208 country: Spain lat: 41.54329 lon: 2.10942 hasResults: False

 nctId: NCT06388967 id: 19288/PCDC briefTitle: Pancreatic Cancer Detection Consortium acronym: PCDC overallStatus: RECRUITING date: 2023-03-15 date: 2025-11-21 date: 2025-11-21 date: 2024-04-29 date: 2024-04-29 name: City of Hope Medical Center class: OTHER briefSummary: This study aims to prospective validate an exosome-based miRNA signature for noninvasive and early detection of pancreatic ductal adenocarcinoma. conditions: Pancreatic Cancer conditions: Pancreatic Carcinoma conditions: Pancreatic Adenocarcinoma conditions: Pancreatic Ductal Adenocarcinoma conditions: Pancreatic Neoplasms conditions: Pancreatic Cancer Stage I conditions: Pancreatic Cancer Stage conditions: Pancreatic Cancer Resectable conditions: Pancreatic Cancer Stage 0 conditions: Pancreatic Cancer Stage II conditions: Pancreatic Cancer Stage III conditions: Pancreatic Cancer, Adult conditions: Pancreatic Cancer Non-resectable studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED name: PANcreatic cancer Exosome Early detectiON (PANXEON) measure: Sensitivity measure: Specificity measure: Accuracy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Translational Genomics Research Institute status: RECRUITING city: Phoenix state: Arizona zip: 85004 country: United States name: Daniel Von Hoff role: CONTACT email: dvh@tgen.org name: Daniel Von Hoff role: PRINCIPAL_INVESTIGATOR name: Haiyong Han role: SUB_INVESTIGATOR name: Derek Cridebring role: SUB_INVESTIGATOR lat: 33.44838 lon: -112.07404 facility: Honorhealth status: RECRUITING city: Scottsdale state: Arizona zip: 85258 country: United States name: Erkut Borazanci role: CONTACT email: erkut.borazanci@honorhealth.com name: Erkut Borazanci role: SUB_INVESTIGATOR lat: 33.50921 lon: -111.89903 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 role: PRINCIPAL_INVESTIGATOR name: Stanley Hamilton role: SUB_INVESTIGATOR name: Vincent Chung role: SUB_INVESTIGATOR name: Caiming Xu role: SUB_INVESTIGATOR name: Alessandro Mannucci role: SUB_INVESTIGATOR lat: 34.14806 lon: -117.99895 facility: Hoag Center status: RECRUITING city: Newport Beach state: California zip: 92663 country: United States name: Michael Demeure role: CONTACT email: michael.demeure@hoag.org name: Michael Demeure role: SUB_INVESTIGATOR lat: 33.61891 lon: -117.92895 facility: OSF HealthCare status: RECRUITING city: Peoria state: Illinois zip: 61637 country: United States name: Chandler Wilfong role: CONTACT email: chandler.d.wilfong@osfhealthcare.org name: Chandler Wilfong role: SUB_INVESTIGATOR lat: 40.69365 lon: -89.58899 facility: Ochsner Medical Center status: RECRUITING city: Jefferson state: Louisiana zip: 70121 country: United States name: John Bolton role: CONTACT email: jbolton@ochsner.org name: John Bolton role: SUB_INVESTIGATOR lat: 29.96604 lon: -90.15313 facility: Atlantic Health System status: RECRUITING city: Morristown state: New Jersey zip: 07960 country: United States name: Angela Alistar role: CONTACT email: angela.alistar@atlantichealth.org name: Angela Alistar role: SUB_INVESTIGATOR name: Eric Whitman role: SUB_INVESTIGATOR lat: 40.79677 lon: -74.48154 facility: Piedmont Medical Center status: RECRUITING city: Rock Hill state: South Carolina zip: 29732 country: United States name: Andrew Page role: CONTACT email: Andrew.Page@piedmont.org name: Andrew Page role: SUB_INVESTIGATOR name: Eyal Meiri role: SUB_INVESTIGATOR lat: 34.92487 lon: -81.02508 facility: Medical College of Wisconsin status: RECRUITING city: Milwaukee state: Wisconsin zip: 53226 country: United States name: Douglas Evans role: CONTACT email: devans@mcw.edu name: Douglas Evans role: SUB_INVESTIGATOR lat: 43.0389 lon: -87.90647 facility: Nagoya University status: RECRUITING city: Nagoya country: Japan name: Yasuhiro Kodera role: CONTACT email: ykodera@med.nagoya-u.ac.jp name: Yasuhiro Kodera role: SUB_INVESTIGATOR name: Masamichi Hayashi role: SUB_INVESTIGATOR lat: 35.18147 lon: 136.90641 facility: Asan Medical Center status: RECRUITING city: Seoul country: Korea, Republic of name: Song Cheol Kim role: CONTACT email: drksc@amc.seoul.kr name: Song Cheol Kim role: SUB_INVESTIGATOR lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06388954 id: P.T.REC/012/005107 briefTitle: Plasticity Biomarkers,Interleukin-6 and Motor Performance in Response to Vagus Nerve Stimulation After Stroke overallStatus: RECRUITING date: 2024-02-21 date: 2024-04-23 date: 2024-05-09 date: 2024-04-29 date: 2024-04-29 name: Cairo University class: OTHER briefSummary: Forty-eight clinically verified Egyptian patients from both sexes with ischemic stroke that occurred at least 6 months to 2 years before inclusion will be randomly assigned into 2 groups, control group (GA) and the experimental group (GB). Patients will be randomly assigned into two equal groups: the control group (GA) and the experimental group (GB). Patients in the control group (GA) will be treated with sham Vagus nerve stimulation (taVNS) immediately before a selected physical therapy program, while in the experimental group (GB), patients will receive real transcutaneous auricular Vagus nerve stimulation (taVNS) followed by the same selected physical therapy program as (GA). Plasma level of Brain-Derived Neurotrophic Factors (BDNF) and Interleukin-6 (IL-6), Box and Blocks Test (BBT), and modified Ashworth scale (MAS) will be assessed at baseline and immediately post-treatment. conditions: Stroke conditions: Motor Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Single-blind, randomized controlled study. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Patients participated will be masked about the type of intervention, where (GA) patients will receive physical therapy program + sham transcutaneous auricular Vagus nerve stimulation, while patients in (GB) will receive true transcutaneous auricular Vagus nerve stimulation in addition to the same physical therapy program as (GA). whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: True Transcutaneous auricular Vagus Nerve Stimulation (TaVNS) name: Sham Trancutaneous auricular Vagus Nerve Stimulation measure: Muscle tone of the upper limb measure: Gross hand dexterity measure: Level of Plasma brain-derived Derived factor (BDNF) measure: Level of Serum Interleukin IL-6 sex: ALL minimumAge: 55 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Physical Therapy, Cairo University status: RECRUITING city: Giza state: Ad Doqi, Giza District, Giza Governorate zip: 11432 country: Egypt name: Engy BadrEldin S Moustafa, PhD role: CONTACT phone: 00201099445112 email: engybm.saleh@cu.edu.eg name: Moshera H. Darwish, PhD role: CONTACT phone: 00201015163617 email: dr.moshera11@yahoo.com lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06388941 id: CLNP023R12201 briefTitle: Iptacopan in Patients With ANCA Associated Vasculitis overallStatus: NOT_YET_RECRUITING date: 2024-08-28 date: 2027-08-27 date: 2027-09-22 date: 2024-04-29 date: 2024-04-29 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of iptacopan compared to standard of care (SOC) to induce and maintain remission in study participants with active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), when used in combination with rituximab (RTX) induction. The trial will also assess the impact of iptacopan on disease relapses, evolution of renal function and proteinuria, GC side effects, patients' immune status, and QoL. conditions: Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 78 type: ESTIMATED name: Iptacopan name: Placebo name: Rituximab measure: Sustained remission through Week 48 defined as complete remission at Week 24 without major relapse up to Week 48. measure: B cell counts measure: Total IgG levels measure: Complete remission at week 24 measure: Time to reach BVAS=0 measure: Time to major relapse measure: Estimated glomerular filtration rate (eGFR) using the CKD-EPI formula, urinary protein excretion and hematuria over 48 weeks measure: Cumulative dose of glucocorticoid (GC) measure: Glucocorticoid toxicity index over 48 weeks measure: 36-Item short form survey (SF-36) measure: Patient's Global Assessment (PtGA) measure: Physician's global assessment (PhGA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06388928 id: P.T.REC/012/004596 briefTitle: Effect of Menstrual Cycle on the Manual Dexterity of Female Dentists overallStatus: COMPLETED date: 2023-07-09 date: 2023-12-26 date: 2023-12-26 date: 2024-04-29 date: 2024-04-29 name: Cairo University class: OTHER briefSummary: The aim of this observational study was to investigate the effect of the menstrual cycle on the manual dexterity of female dentists.

This study was conducted to answer the following question:

- Is there any effect of the menstrual cycle on the manual dexterity of female dentists? conditions: Menstrual Cycle conditions: Manual Dexterity studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 45 type: ACTUAL measure: Manual dexterity assessment sex: FEMALE minimumAge: 25 Years maximumAge: 35 Years stdAges: ADULT facility: Horus University city: Damietta country: Egypt lat: 31.41648 lon: 31.81332 hasResults: False

 nctId: NCT06388915 id: K2202403004 briefTitle: A Retrospective Cohort Study of 15 Cases of Pelvic Fractures Complicated by Morel-Lavallee Lesion overallStatus: COMPLETED date: 2024-03-12 date: 2024-03-20 date: 2024-03-23 date: 2024-04-29 date: 2024-04-29 name: Weikang Chen class: OTHER briefSummary: Some related factors of pelvic fracture and Morel-Lavallee injury (MLL) are preliminarily discussed, which provides some preliminary references for early clinical detection and research of such injuries. conditions: Pelvic Fracture conditions: Morel-Lavallee Lesion studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 15 type: ACTUAL measure: Site of MLL measure: Site of injury and Classification of pelvic fracture measure: Time to treatment measure: Drainage volume sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian Provincial Hospital city: Fuzhou state: Fujian zip: 350000 country: China lat: 26.06139 lon: 119.30611 hasResults: False

 nctId: NCT06388902 id: BR115-101 briefTitle: A Phase I Study of BR115 for Injection Alone in Subjects With Advanced Solid Malignancies overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-08 date: 2028-12 date: 2024-04-29 date: 2024-04-29 name: BioRay Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: This is a Phase I, multicenter, open-label, single-arm and first-in-human clinical study of BR115 for injection. The study objectives are to evaluate the safety, tolerability, pharmacokinetic profile, anti-tumor activity and immunogenicity of BR115 for injection in patients with advanced solid malignancies.

Patients will receive two doses at the first week of treatment, followed by once per week until intolerable toxicity, disease progression, pregnancy, withdrawal of informed consent, death, study discontinuation, or withdrawal from the study. conditions: Advanced Solid Malignancies studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: BR115 for injection measure: Treatment-emergent Adverse Events Following Treatment With BR115 measure: Objective Response Rate measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Disease control rate (DCR) measure: Duration of response (DOR). measure: Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) measure: Pharmacokinetic Parameter Area Under the Concentration-time Curve (AUC) measure: The anti-drug antibody (ADA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center city: Guangzhou state: Guangdong zip: 510060 country: China name: Rui Xu, MD role: CONTACT phone: 86-20-87343468 email: ruihxu@163.com lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06388889 id: AR-DEX-22-04 briefTitle: Phase III Long-Term Extension Study With Dexpramipexole acronym: EXHALE-5 overallStatus: ENROLLING_BY_INVITATION date: 2024-05-08 date: 2027-06-01 date: 2027-06-01 date: 2024-04-29 date: 2024-04-29 name: Areteia Therapeutics class: INDUSTRY briefSummary: The goal of this clinical trial\] is to evaluate the long term safety of dexpramipexole treatment in participants with severe asthma, aged ≥12 years, on Global Initiative for Asthma (GINA) 2021 \[GINA, 2021\] Step 4 or 5 therapy and who completed either of the Phase III studies EXHALE-2 or EXHALE-3. conditions: Eosinophilic Asthma studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 1600 type: ESTIMATED name: Dexpramipexole Dihydrochloride measure: Number and Percentage of Participants with a Treatment Emergent Adverse Event measure: Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Clinical Laboratory Evaluations measure: Number and Percentage of Participants with Potentially Clinically Significant Postbaseline Changes in Vital Signs and Body Weight measure: Number and Percentage of Participants with Potentially Significant Postbaseline Changes in Electrocardiogram Parameters measure: Severe Asthma Exacerbations measure: Change in Asthma Control Questionnaire-6 (ACQ-6) measure: Change in absolute eosinophil counts (AEC) sex: ALL minimumAge: 12 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site 20001-004 city: Tampa state: Florida zip: 33607 country: United States lat: 27.94752 lon: -82.45843 hasResults: False

 nctId: NCT06388876 id: AnkaraYBUbk briefTitle: The Effect of Exercise on Post-traumatic Stress Disorder and Sleep Quality in Individuals Affected by the 2023 Kahramanmaraş Earthquakes overallStatus: COMPLETED date: 2023-04-01 date: 2023-06-15 date: 2023-07-30 date: 2024-04-29 date: 2024-04-29 name: Ankara Yildirim Beyazıt University class: OTHER name: TÜBİTAK briefSummary: Natural disasters can have adverse impacts on both physical and mental health. Post-traumatic stress disorder (PTSD) and sleep disorders are among the most common problems seen after natural disasters. Exercise may represent a safe, cost-effective, accessible, non-pharmacological method for treating PTSD and sleep problems. The aim of this study was to investigate the effect of exercise interventions on PTSD and sleep quality in young individuals affected by the 2023 Kahramanmaraş earthquakes in Türkiye. conditions: Earthquake conditions: Stress Disorders, Post-Traumatic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: there are 2 groups; exercise and control primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 38 type: ACTUAL name: Exercise name: lifestyle advice measure: Post-traumatic Stress Disorder Short Scale measure: Pittsburgh Sleep Quality Index sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Ankara Yildirim Beyazıt University city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06388863 id: B2024-002 briefTitle: Evaluation of the Efficacy and Safety of FMT for Constipation in Parkinson's Disease overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-05-31 date: 2026-05-31 date: 2024-04-29 date: 2024-04-29 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: Participants will be allocated to FMT group or placebo group at a 1:1 ratio. For interventional group, patients will be given six FMT capsules twice a week for 24 weeks. Placebo capsules are identical in appearance and smell but contain milk powder. During visitpoints, participants complete specific scales to assess improvement in constipation, emotion and quality of life. Besides, fecal samples are collected for metagenomics and metabolomics sequencing and blood samples are tested peripheral concentration of levodopa. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 76 type: ESTIMATED name: Healthy donor-derived FMT capsule name: Placebo capsule measure: Response rate of constipation in Parkinson's Disease (PD) measure: Change from baseline PD symptoms at week 5, week 13 and week 24 measure: Change from baseline anxiety at week 5, week 13 and week 24 measure: Change from baseline depression at week 5, week 13 and week 24 measure: Change from baseline quality of life at week 5, week 13 and week 24 measure: Change from baseline drug concentration of levodopa in peripheral blood at week 13 and week 24 measure: Change from baseline fecal microbiota at week 5, week 13 and week 24 measure: Change from baseline fecal metabolites at week 5, week 13 and week 24 sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 180 Fenglin Road city: Shanghai state: Shanghai zip: 200032 country: China name: Shengdi Wu role: CONTACT phone: (86)13817923359 email: wu.shengdi@zs-hospital.sh.cn name: Shengdi Wu role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06388850 id: 5U01CE003393-03 type: NIH link: https://reporter.nih.gov/quickSearch/5U01CE003393-03 briefTitle: Evaluation of HRP Among Pre-K Through 5th Grade overallStatus: ENROLLING_BY_INVITATION date: 2023-03-23 date: 2025-09-30 date: 2025-09-30 date: 2024-04-29 date: 2024-04-29 name: Northeastern University class: OTHER briefSummary: This study is a rigorous experimental evaluation of an existing manualized universal child sexual abuse primary prevention program with a history of 30+ years of implementation across 30 states and robust pilot data. conditions: Child Sexual Abuse studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: A stepped wedge cluster randomized clinical trial design will be used to assess the efficacy of two linked curricula of the Healthy Relationships Project (HRP): Care for Kids (Pre-K through 2nd Grade) and We Care Elementary (3rd through 5th Grade). The HRP includes a 1.5 hour training for school staff prior to implementation, six 30-minute classroom lessons delivered to students once per week for 6 weeks, and 3 caregiver workshops. primaryPurpose: PREVENTION masking: NONE count: 16 type: ESTIMATED name: Healthy Relationships Project measure: Reports of child sexual abuse measure: The Parental Knowledge Scale (PKS) measure: The Parental Discussions about Sex Abuse Scale (PDSAS) measure: The adapted Parenting Self Agency (PSAM) measure: The Parent Knowledge Questionnaire (PKQ) measure: HRP evaluation measure: The CSA Myths Scale measure: The Teachers' Reporting Attitudes Scale for Child Sexual Abuse (TRAS-CSA) sex: ALL minimumAge: 3 Years maximumAge: 11 Years stdAges: CHILD facility: Safe Shores city: Washington state: District of Columbia zip: 20001 country: United States lat: 38.89511 lon: -77.03637 hasResults: False

 nctId: NCT06388837 id: RECO6U/20- 2021 briefTitle: Effect of Symphysis Onlay Bone Graft, Injectable Platelet Rich Fibrin (I-PRF) and Xenograft on Horizontal Alveolar Ridge Augmentation in Esthetic Zone overallStatus: COMPLETED date: 2021-02-20 date: 2023-03-01 date: 2023-03-01 date: 2024-04-29 date: 2024-04-29 name: October 6 University class: OTHER briefSummary: The aim of the study: was to evaluate whether mandibular symphysis Onlay autogenous bone graft mixed with Injectable PRF could offer any advantages for patients undergoing horizontal alveolar ridge widening regarding increase alveolar ridge width compared to mandibular symphysis Onlay autogenous bone graft mixed with Xenograft conditions: Symphysis Onlay Bone Graft conditions: Platelet Rich Fibrin conditions: Xenograft conditions: Horizontal Alveolar Ridge Augmentation conditions: Esthetic Zone studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 12 type: ACTUAL name: Injectable Platelet Rich Fibrin name: Xenograft measure: Alveolar ridge width measure: Bone density sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: October 6 University city: Giza zip: 12511 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06388824 id: GWang028 briefTitle: The Effect of Esketamine on Sleep Disturbance overallStatus: NOT_YET_RECRUITING date: 2024-05-20 date: 2024-09-30 date: 2024-10-10 date: 2024-04-29 date: 2024-04-29 name: Tianjin Medical University General Hospital class: OTHER briefSummary: To explore the efficacy of a single low dose of esketamine during surgical abortion in patients with sleep disturbance conditions: Sleep Disturbance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: normal saline name: Esketamine measure: The incidence of sleep disturbance on the first night after surgery measure: The incidence of sleep disturbance on the second and third postoperative nights measure: The incidence of sleep disturbance on the seventh postoperative nights measure: Postoperative anxiety measure: Postoperative depression measure: Pain intensity measure: Adverse event measure: preoperative hemoglobin concentration measure: Human Chorionic Gonadotropin level measure: The incidence of sleep disturbance on the day before surgery measure: The incidence of sleep disturbance before surgery sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Medical University General Hospital city: Tianjin zip: 300052 country: China lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06388811 id: 2023/1162 briefTitle: Validity and Reliability Study of the Turkish Version of the Early Osteoarthritis Questionnaire overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-11-15 date: 2024-12-15 date: 2024-04-29 date: 2024-04-29 name: Istanbul University class: OTHER briefSummary: The symptoms of early osteoarthritis (OA) are quite similar to established knee OA, they differ, particularly in frequency, intensity, and severity. For this reason, in 2023, the International Symposium of intra-articular treatment (ISIAT) technical experts panel (TEP-technical experts panel) published for the first time a questionnaire designed to assess and monitor the follow-up and clinical progression of patients affected by early knee OA. Early management of knee OA is recommended by various guidelines because this approach may alter the course and clinical features of the disease, especially when considering disease-modifying agents that may delay disease progression.

Therefore, the assessment of early knee OA with a questionnaire may facilitate the follow-up of OA in the early stages of the disease when treatment is likely to be more effective. This approach will allow to reduce disability and improve patients' quality of life. While creating the Early Osteoarthritis Questionnaire (EOAQ), it was aimed to have a complete, short and easy-to-understand questionnaire and to ensure that the respondents could complete the questionnaire easily and in a short time. The EOAQ consists of 11 questions. The questions were divided into two different groups. While the first two questions were related with clinical characteristics, the other nine questions aimed to investigate the results reported by the patient. For each question, there are three responses depending on the number of episodes: Never, rarely (between one and three episodes) and frequently (more than three episodes) within a 6-month period. Turkish validity and reliability study of the EOAQ has not been conducted yet.

For the translation of the questionnaire, the guide recommended by Beaton et al. for the cultural adaptation of questionnaires will be used. According to this guideline the original EOAQ will be translated into Turkish by two experts independently of each other, and then a single Turkish version will be created by two experts working together. This Turkish version will then be translated back into English by an expert who can speak both languages at an advanced level. The experts will then evaluate the translation and adapt the questionnaire accordingly. After the completion of the translated form, 110 patients and 110 control group participants who applied to Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation and met the inclusion criteria will be included. The participants will be informed verbally and in writing about the purpose, duration and method of the study and will be asked to sign an "Informed Voluntary Consent Form" after their consent is obtained. Participants will fill in the Turkish version of the questionnaire. Along with the questionnaire, knee pain will be questioned with the Numeric Rating Scale (0=no pain, 10=the most severe pain you experience) and disability will be questioned with the WOMAC Questionnaire, whose Turkish validity and reliability study has been conducted. Test-retest method will be applied for reliability analyses; therefore, at least 30 patients among the patients included in the study will complete the questionnaire twice (the second evaluation will be 2 weeks after the first evaluation). conditions: Early Knee Osteoarthritis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 220 type: ESTIMATED name: Early Osteoarthritis Questionnaire measure: Numeric Rating Scale measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06388798 id: Ankara Etlik city hospital briefTitle: Evaluation of the Effectiveness of Psychoeducational Training Given to Nurses Working in a Psychiatric Clinic overallStatus: COMPLETED date: 2023-05-30 date: 2023-07-30 date: 2023-07-30 date: 2024-04-29 date: 2024-04-29 name: Ankara Etlik City Hospital class: OTHER_GOV briefSummary: Summary:

Background One of the most important roles of psychiatric nurses, who help individuals, families and society in promoting health, preventing diseases and coping with problems, is their educational role. With its educational role, the nurse can help the patient and their family function at the best level in biopsychosocial integrity in preventing and coping with diseases through psychoeducation.

Goals This research was conducted to evaluate the effectiveness of psychoeducational training given to nurses working in a psychiatric clinic.

Design This research is a randomized controlled experimental study. Participants Participants were determined using simple randomization. The sample of the study consisted of 78 nurses (intervention = 39; control = 39) working in a psychiatric clinic in a city hospital in Turkey.

Methods Groups were determined using the simple randomization method. Psychoeducational training was given to the intervention group, nurses working in the Psychiatry clinic, for a total of 4 sessions, with two sessions of 50 minutes each. The data of the research were collected with the ;Personal Information Form; Form for evaluating the knowledge level of nurses working in the psychiatry clinic regarding psychoeducation and Perception of Adequacy Scale in Psychoeducation Program Development and Implementation. Data were analyzed using independent samples t test and two-way repeated measures analysis of variance (ANOVA). conditions: Nursing Education conditions: Psychoeducation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: INVESTIGATOR count: 78 type: ACTUAL name: Education measure: Psychoeducation program development and implementation competence perception scale. Data will be collected before and after the training program in the intervention group, and at parallel times to the intervention group in the control group. measure: Form for evaluating the knowledge level of nurses working in a psychiatric clinic regarding psychoeducation sex: ALL minimumAge: 23 Years maximumAge: 45 Years stdAges: ADULT facility: Ankara Etlik City Hospital city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2023-05-05 uploadDate: 2024-03-04T06:15 filename: Prot_SAP_ICF_000.pdf size: 163176 hasResults: False

 nctId: NCT06388785 id: TAK-003-5001 briefTitle: A Study to Monitor the Adverse Events of QDENGA Vaccine in Participants in Malaysia acronym: PRIME-Q overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-09-01 date: 2027-09-01 date: 2024-04-29 date: 2024-04-29 name: Takeda class: INDUSTRY briefSummary: The main aim of this study is to collect the number and type of medical problems (adverse events) after vaccination with QDENGA in Malaysia and to learn more about such medical problems after vaccination. Another aim of this study is to collect the number of persons vaccinated with QDENGA who need to stay in the hospital because of severe dengue fever.

No vaccination will be given as part of this study. The study will only collect data of persons already vaccinated with QDENGA who agree to participate. conditions: Dengue Fever studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10000 type: ESTIMATED name: No Intervention measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Number of Participants who Require Hospitalization for Severe Dengue Diagnosed by Healthcare Provider (HCP) sex: ALL minimumAge: 4 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Universiti Putra Malaysia city: Serdang state: Selangor zip: 43400 country: Malaysia name: Study Contact role: CONTACT phone: +603-9769 1000 email: zamberi@upm.edu.my name: Zamberi Sekawi, Dr role: PRINCIPAL_INVESTIGATOR facility: Universiti Malaya city: Kuala Lumpur state: Wilayah Persekutuan Kuala Lumpur zip: 50603 country: Malaysia name: Study Contact role: CONTACT phone: +60379493641 email: sfaridah@ummc.edu.my name: Sharifah Faridah binti Syed Omar, Dr role: PRINCIPAL_INVESTIGATOR lat: 3.1412 lon: 101.68653 hasResults: False

 nctId: NCT06388772 id: HJG-CZQH-QHRD106 briefTitle: Study to Assess PK, Safety and Tolerability Early in Healthy Subjects overallStatus: COMPLETED date: 2021-07-05 date: 2022-07-22 date: 2023-01-06 date: 2024-04-29 date: 2024-04-29 name: Changzhou Qianhong Bio-pharma Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of QHRD106 early in Chinese healthy subjects with single doses. conditions: Acute Ischemic Stroke studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 74 type: ACTUAL name: QHRD106 Injection name: placebo measure: Safety as assessed by incidence, severity, and causality of adverse events measure: Plasma measurements of QHRD106 sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Nanjing Drum Tower Hospital city: Nanjing state: Jiangsu zip: 210008 country: China lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06388759 id: TQ05105-Ib-03 briefTitle: TQ05105 Tablet for Myelofibrosis Treatment in Ruxolitinib-Resistant or Intolerant Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2022-08-01 date: 2024-12 date: 2024-12 date: 2024-04-29 date: 2024-04-29 name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. class: INDUSTRY briefSummary: This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy of TQ05105 Tablets in patients with intermediate-risk and high-risk myelofibrosis. conditions: Myelofibrosis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 9 type: ACTUAL name: TQ05105 Tablets measure: Spleen volume reduction (SVR35)≥35% from baseline measure: Optimum effective rate measure: Onset time of splenic response measure: Duration of maintenance of spleen response (DoMSR) ≥35% reduction measure: Myeloproliferative neoplasm- Symptom Assessment Form- Total Symptom Score (MPN-SAF TSS) : ≥ 50% Reduction from Baseline measure: The total symptom score of MPN-SAF TSS decreased compared with baseline measure: Progression-free survival (PFS) measure: Leukemia free survival (LFS) measure: Overall Survival (OS) measure: Incidence of adverse events (AEs) measure: Severity of AEs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui Provincial Hospital city: Hefei state: Anhui zip: 230001 country: China lat: 31.86389 lon: 117.28083 facility: The First Affiliated Hospital of Wannan Medical College city: Wuhu state: Anhui zip: 241001 country: China lat: 31.33728 lon: 118.37351 facility: Union Hospital Tongji College Huazhong University of Science And Technology city: Wuhan state: Hubei zip: 430071 country: China lat: 30.58333 lon: 114.26667 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 Hospital of Jilin University city: Changchun state: Jilin zip: 130021 country: China lat: 43.88 lon: 125.32278 facility: Shanghai Sixth People's Hospital city: Shanghai state: Shanghai zip: 200233 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06388746 id: NKUA briefTitle: Arresting Carious Lesions With Minimal Intervention Techniques overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2025-12 date: 2024-04-29 date: 2024-04-29 name: National and Kapodistrian University of Athens class: OTHER briefSummary: A single-blinded randomized clinical trial with a split-mouth design that will assess the 12-month clinical and radiographic success of two minimally invasive treatment techniques, one using a chemo-mechanical caries removal agent and one using a caries arresting agent, for the treatment of deep caries in primary molars. conditions: Caries,Dental studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: BRIX3000® name: Riva Star Aqua, SDI Limited, Australia measure: clinical success measure: radiographic success measure: Longevity and the quality of the final restoration measure: Patient's acceptance sex: ALL minimumAge: 4 Years maximumAge: 8 Years stdAges: CHILD hasResults: False

 nctId: NCT06388733 id: IVY P3-24-021 briefTitle: A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-12 date: 2028-03 date: 2024-04-29 date: 2024-04-29 name: Ivy Brain Tumor Center class: OTHER name: GlaxoSmithKline briefSummary: The goal of this Phase 3 clinical trial is to compare the efficacy of niraparib versus temozolomide (TMZ) in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma multiforme (GBM). The main questions it aims to answer are:

Does niraparib improve progression-free survival (PFS) compared to TMZ?

Does niraparib improve overall survival (OS) compared to TMZ?

Participants will be randomly assigned to one of two treatment arms: niraparib or TMZ.

* study drug (Niraparib) or
* comparator drug (Temozolomide - which is the standard approved treatment for MGMT unmethylated glioblastoma).

The study medication will be taken daily while receiving standard of care radiation therapy (RT) for 6-7 weeks.

Participants may continue to take the niraparib or TMZ adjuvantly as long as the cancer does not get worse or completion of 6 cycles of treatment (TMZ). A total of 450 participants will be enrolled in the study.

Participants' tasks will include:

* Complete study visits as scheduled
* Complete a diary to record study medication conditions: Glioblastoma conditions: GBM conditions: Brain Neoplasms, Adult, Malignant conditions: Brain Tumor studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE maskingDescription: Blinded Independent Central Review is composed of independent radiologists and will be utilized to assess progression of disease count: 450 type: ESTIMATED name: Niraparib name: Temozolomide measure: Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) measure: Overall survival measure: Overall response rate measure: Compare symptoms, function, and Health-related quality of life (HRQoL) and symptoms by EORTC QLQ-C30-item Core module (EORTC QLQ-C30) (Scores on a scale) measure: Compare symptoms, function, and Health-related quality of life (HRQoL) and symptoms by EORTC QLQ-BN20-item Core module (EORTC QLQ-BN20) (Scores on a scale) measure: Changes from baseline in neurocognitive function assessed by Hopkins Verbal Learning Test measure: Changes from baseline in neurocognitive function assessed by Controlled Oral Word Association measure: Changes from baseline in neurocognitive function assessed by Trail Making Test Parts A and B measure: Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) measure: Number of treatment discontinuations, dose interruptions, and dose reductions due to AEs, SAEs, or AESIs, changes in Karnofsky performance status, changes in clinical laboratory results, and vital sign measurements measure: Frequency and severity of symptomatic AEs based on PRO-CTCAE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06388720 id: NCC2024-0026 briefTitle: The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy acronym: IMGeS overallStatus: RECRUITING date: 2024-04-30 date: 2025-06-30 date: 2027-12-31 date: 2024-04-29 date: 2024-04-29 name: National Cancer Center, Korea class: OTHER_GOV briefSummary: The aim of this study is to evaluate the effectiveness and safety of mitomycin-c and gemcitabine sequential instillation in BCG unresponsive high risk non-muscle invasive bladder cancer patients. conditions: Bladder Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 82 type: ESTIMATED name: Mitomycin-c 40mg/20ml and Gemcitabine 2000mg/50ml measure: Recurrent free survival in sequential treatment group. measure: Progression free survival in sequential treatment group. measure: Cystectomy free survival in sequential treatment group. measure: cancer specific survival in sequential treatment group. measure: Overall survival in sequential treatment group. measure: Safety of sequential treatment. sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center status: RECRUITING city: Goyang-si country: Korea, Republic of name: Ho Kyung Seo role: CONTACT phone: 82-31-920-1678 email: seohk@ncc.re.kr name: Ho Kyung Seo, MD role: PRINCIPAL_INVESTIGATOR name: Eui Hyun Jung, Ph.D role: SUB_INVESTIGATOR lat: 37.65639 lon: 126.835 hasResults: False

 nctId: NCT06388707 id: NF-2022-01 briefTitle: A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2025-07-31 date: 2025-12-31 date: 2024-04-29 date: 2024-04-29 name: NaviFUS Corporation class: INDUSTRY name: NaviFUS US LLC briefSummary: This will be a prospective, open-label, single-arm, multi-center, pilot study to evaluate the safety, tolerability, and preliminary efficacy of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant unilateral or bilateral temporal lobe epilepsy (DR-TLE). conditions: Drug Resistant Epilepsy conditions: Epilepsy studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: NaviFUS System measure: Adverse events (AEs) measure: Change from baseline in seizure frequency measure: Change from baseline in electroencephalography (EEG) epileptiform discharges measure: Days of seizure-free measure: Changes from baseline in Beck Anxiety Inventory (BAI) measure: Changes from baseline in Beck Depression Inventory (BDI-II) measure: Changes from baseline in Personal Impact of Epilepsy Scale (PIES) measure: Change from baseline in subjective seizure strength sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford University School of Medicine city: Palo Alto state: California zip: 94305 country: United States name: Robert Fisher, M.D., Ph.D. role: CONTACT lat: 37.44188 lon: -122.14302 facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02115 country: United States name: Ellen Bubrick, M.D. role: CONTACT lat: 42.35843 lon: -71.05977 facility: University of Virginia School of Medicine city: Charlottesville state: Virginia zip: 22903 country: United States name: Nathan Fountain, M.D. role: CONTACT lat: 38.02931 lon: -78.47668 hasResults: False

 nctId: NCT06388694 id: RDO KPNC 24-056 briefTitle: Pharmacist Management of Attention Deficit Hyperactivity Disorder Medication Refill Requests overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2024-06-28 date: 2024-07-31 date: 2024-04-29 date: 2024-04-29 name: Kaiser Permanente class: OTHER briefSummary: This cluster randomized trial will compare pharmacist management of secure message requests for refills of attention deficit hyperactivity medications with primary care physician management regarding quality of care, timeliness of service, and parent care experience. conditions: Attention-deficit Hyperactivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: INVESTIGATOR count: 315 type: ESTIMATED name: Pharmacist Care name: Primary Care Physician Care measure: Percentage of participants appropriately referred for a follow-up weight check measure: Timeliness of care measure: Parent perception of effectiveness of care sex: ALL minimumAge: 2 Years maximumAge: 17 Years stdAges: CHILD facility: Kaiser Permanente Northern California city: Oakland state: California zip: 94612 country: United States lat: 37.80437 lon: -122.2708 hasResults: False

 nctId: NCT06388681 id: HMKU-KMY-SA-02 briefTitle: Stress Ball Use in Patients Undergoing Coronary Angiography overallStatus: RECRUITING date: 2024-04-24 date: 2024-04-26 date: 2024-06-26 date: 2024-04-29 date: 2024-04-29 name: Mustafa Kemal University class: OTHER briefSummary: One of the nonpharmacologic interventions included in the NIC-Nursing Interventions Classification is the use of stress balls. Stress balls are one of the cognitive distraction methods used especially in reducing pain and increasing the comfort level of patients. On the other hand, there are studies showing that stress balls have a positive effect not only on pain but also on vital signs, anxiety and comfort level of the patient. conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 72 type: ESTIMATED name: The Effect of Stress Ball Use on Immobilization Comfort, Pain Level and Vital Signs in Patients Undergoing Coronary Angiography measure: Patient Identifying Information Form measure: Immobilization Comfort Scale measure: Visual Benchmarking Scale measure: Vital Signs Monitoring Form sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hatay Mustafa Kemal University status: RECRUITING city: Hatay country: Turkey name: SÜMEYYE AKÇOBAN role: CONTACT lat: 38.40227 lon: 27.10486 hasResults: False

 nctId: NCT06388668 id: ICM 2025-3428 briefTitle: Lipid Testing After Myocardial Infarction at the Montreal Heart Institute overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-07 date: 2025-09 date: 2024-04-29 date: 2024-04-29 name: Montreal Heart Institute class: OTHER name: Novartis Pharmaceuticals briefSummary: Because treatment decisions are usually based on a single measurement of the lipid panel at the time of an admission for an MI, the overarching objective of this project is to evaluate whether the measurement of LDL, non-HDL, and apoB values are reliable through all the duration of the hospitalization.

It will be a single-center, prospective, observational study will be conducted, including consecutive patients hospitalized for myocardial infarction at the Montreal Heart Institute.

Every patient at the Cardiac Care Unit will undergo non-fasting lipid panel testing at day 0 of their admission for Myocardial Infarction during the study period. Patients who consent to participate will have a 2nd non-fasting lipid panel drawn at day 2 of their admission.

Thereafter, the levels of the different lipid values from the panel will be compared between day 0, day 2, and 4-6 weeks after discharge. conditions: Dyslipidemias conditions: Lipid Testing conditions: Myocardial Infarction studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Lipid panel measure: Variation in LDL measure: Variation in non-HDL and apoB measure: Evaluation of intensification threshold measure: Repeat lipid panel after discharge measure: Evaluation of intensification threshold after discharge sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Montreal Heart Institute city: Montréal state: Quebec zip: H1T 1C8 country: Canada name: Guillaume Marquis-Gravel, MD, MSc role: CONTACT phone: (514) 376-3330 email: guillaume.marquis.gravel@umontreal.ca name: Guillaume Marquis-Gravel, MD, MSc role: PRINCIPAL_INVESTIGATOR name: Jean Grégoire, MD role: SUB_INVESTIGATOR name: François Simard, MD role: SUB_INVESTIGATOR name: Rafaël Monet-Alarcia, MD role: SUB_INVESTIGATOR lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06388655 id: MDCR-19-007 briefTitle: The Effect of the Mobile EEG-Neurofeedback in Healthy Child and Adolescent overallStatus: COMPLETED date: 2019-06-10 date: 2022-06-30 date: 2022-06-30 date: 2024-04-29 date: 2024-04-29 name: Daegu Catholic University Medical Center class: OTHER briefSummary: The objective of this study was to ascertain the therapeutic impact of mobile neurofeedback (MNF) in neurotypical children when compared to sham MNF. Clinical assessments were conducted both before and after the MNF intervention, and the effectiveness of the intervention was to be validated through these evaluations. conditions: Internet Addiction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 61 type: ACTUAL name: mobile neurofeedback name: sham mobile neurofeedback measure: Comparisons of the means of children's self-scale variables measure: Comparisons of the means of parents' self-scale variables : Beck Depression Inventory-II (BDI-II) measure: Comparisons of the means of parents' self-scale variables : Beck Anxiety Inventory (BAI) measure: Comparisons of the means of children's K-WISC-IV(Korean Wechsler Intelligence Scale for Children-IV) measure: Comparisons of the means of children's Stroop measure: Comparisons of the means of children's ATA(Advanced Test of Attention) measure: Comparisons of the means of children's CCTT(Children's Color Trails Test) sex: ALL minimumAge: 8 Years maximumAge: 15 Years stdAges: CHILD facility: Daegu Catholic University Medical Center city: Daegu state: Nam-gu zip: 42471 country: Korea, Republic of lat: 35.87028 lon: 128.59111 hasResults: False

 nctId: NCT06388642 id: CUV052 briefTitle: Pharmacokinetics of Afamelanotide in EPP Patients overallStatus: RECRUITING date: 2024-03-07 date: 2024-07-01 date: 2024-10-01 date: 2024-04-29 date: 2024-04-29 name: Clinuvel Europe Limited class: INDUSTRY briefSummary: The purpose of this study is to evaluate the concentration of afamelanotide in serum after the administration of afamelanotide in adolescent and adult EPP patients. conditions: Erythropoietic Protoporphyria studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 28 type: ESTIMATED name: Afamelanotide 16mg implant measure: Cmax (maximum Plasma Concentration) measure: AUC(0-t) (area under the curve from administration to last observed concentration at time t) measure: AUC(0-∞) (area under the curve extrapolated to infinite time) sex: ALL minimumAge: 12 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus Medical Center status: RECRUITING city: Rotterdam country: Netherlands name: Erasmus Medical Centre role: CONTACT lat: 51.9225 lon: 4.47917 hasResults: False

 nctId: NCT06388629 id: M064-066 Rev 00 briefTitle: Epicardial Access Study With Rook acronym: EASY-R overallStatus: RECRUITING date: 2023-12-17 date: 2024-05 date: 2024-05 date: 2024-04-29 date: 2024-04-29 name: Circa Scientific, Inc. class: INDUSTRY briefSummary: The goal of this clinical trial is to test how how effective the Circa Scientific Rook® Epicardial Access Kit is at gaining guidewire access to the outside surface of the heart (epicardium). In addition the safety of the device will be compared to the available data for alternative methods of epicardial access.

Participants will receive treatment with the subject device during the course of a typical epicardial electrophysiology procedure. conditions: Arrythmia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, non-randomized primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: Rook Epicardial Access Kit measure: Successful Epicardial Access measure: Speed of Access measure: Rate of Use Errors measure: Rate of Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Na Homolce Hospital status: RECRUITING city: Prague zip: 15030 country: Czechia name: Petr Neuzil, MD, PhD role: CONTACT phone: +420257272211 lat: 50.08804 lon: 14.42076 hasResults: False

 nctId: NCT06388616 id: D6402C00013 briefTitle: Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2024-11-15 date: 2024-11-15 date: 2024-04-29 date: 2024-04-29 name: AstraZeneca class: INDUSTRY briefSummary: This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of balcinrenone in patients with mild and moderate hepatic impairment in comparison to a matched healthy control group. conditions: Hepatic Impairment studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Three cohorts (two hepatic impairment cohorts and controls with normal hepatic function) will be enrolled into this study.

All subjects will receive the study intervention:

* Cohort 1 will enroll 8 participants with mild hepatic impairment
* Cohort 2 will enroll 8 participants with moderate hepatic impairment
* Cohort 3 will enroll 8-12 healthy participants matched on a group level regarding age, BMI and sex primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: Balcinrenone measure: Area under plasma concentration-time curve from time zero to the last measurable concentration (AUClast) measure: Area under plasma concentration-time curve from zero to infinity (AUCinf) measure: Maximum observed plasma concentration (Cmax) measure: AEs and SAEs up to the follow-up telephone call (Day 10 [± 3 days]) measure: Number of participants with abnormal Vital signs, abnormal ECGs, and abnormal physical examination findings measure: Number of participants with abnormal laboratory tests results sex: ALL minimumAge: 18 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site city: Hialeah state: Florida zip: 33014 country: United States lat: 25.8576 lon: -80.27811 facility: Research Site city: Orlando state: Florida zip: 32809 country: United States lat: 28.53834 lon: -81.37924 facility: Research Site city: San Antonio state: Texas zip: 78215 country: United States lat: 29.42412 lon: -98.49363 hasResults: False

 nctId: NCT06388603 id: DFORCT012023 briefTitle: RCT on Bioactive Glass S53P4 in Diabetic Foot Osteomyelitis in the Forefoot (DFORCT) acronym: DFORCT overallStatus: RECRUITING date: 2024-03-21 date: 2026-09-30 date: 2026-12-30 date: 2024-04-29 date: 2024-04-29 name: ASST Ovest Milanese class: OTHER name: Hippocrates Research name: Bonalive Biomaterials Ltd briefSummary: The Study will be a prospective multicenter randomized trial, focused on the management of acute and chronic Osteomilytis in Diabetic Foot patients. The aim of this Study will be to compare the effectiveness and safety of S53P4 bioactive glass, medical device class III used as per its CE mark indication and Instruction For Use, in the surgical management of OM in the forefoot performed as per local surgical standard of care, in the same indications in a group of Diabetic Foot patients admitted in highly specialized dedicated centers.

Participants will randomized into two groups:

* Patients in Group A will be treated with surgical removal of the affected bone, debridement of infected soft tissues and systemic antibiotic therapy targeted on the sampling on the bone during the surgical procedure, with or without use of bone substitutes (with the only exception of Bioactive glasses) according to the judgement of the operator as per normal practice.
* Patients in Group B will be debrided as well and the infected bone will be debrided without eliminating completely the structure of the bone, but instead preserving the cortex, while all the soft bone visibly infected will be removed and then replaced with Bioactive glass, as per IFU, (S53P4 - Bonalive® granules and putty, Bonalive Biomaterials Ltd. Finland) and then closed for primary intention whenever possible. conditions: Osteomyelitis - Foot studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 140 type: ESTIMATED name: Bioactive Glass name: Standard of Care measure: healing rate measure: Duration of antibiotic therapy measure: Rate of recurrences measure: Number of re-interventions because of the same lesion measure: Timing of re-interventions because of the same lesion measure: Proportion of patients undergoing amputations measure: Patients' Quality of Life measure: Patients' Quality of Life measure: Time back to walk measure: Characteristics of surgery measure: Length of surgery sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ASUGI Azienda Sanitaria Universitaria Giuliano Isontina - Ospedale Monfalcone status: NOT_YET_RECRUITING city: Monfalcone state: Gorizia zip: 34074 country: Italy name: Dr. Roberto Da Ros, Med Doctor role: CONTACT phone: +39 3470606008 email: roberto.daros@aas2.sanita.fvg.it name: Dr. Roberto Da Ros, Med Doctor role: PRINCIPAL_INVESTIGATOR lat: 45.80463 lon: 13.53292 facility: ASST Ovest Milanese - Ospedale di Abbiategrasso status: RECRUITING city: Abbiategrasso state: Milano zip: 20081 country: Italy name: Dr. Roberto De Giglio, Med Doctor role: CONTACT phone: +39 331 6989775 email: roberto.degiglio@asst-ovestmi.it name: Dr. Roberto De Giglio, Med Doctor role: PRINCIPAL_INVESTIGATOR name: Dr. Ilaria Formenti, Med Doctor role: SUB_INVESTIGATOR name: Dr. Vincenzo Curci, Med Doctor role: SUB_INVESTIGATOR lat: 45.39821 lon: 8.91678 facility: Casa di Cura Abano Terme - POLICLINICO ABANO TERME status: NOT_YET_RECRUITING city: Abano Terme state: Padova zip: 35031 country: Italy name: Dr. Christine Whisstock, Med Doctor role: CONTACT phone: +39 338 8924624 email: cwhisstock@casacura.it name: Dr. Christine Whisstock, Med Doctor role: PRINCIPAL_INVESTIGATOR lat: 45.35753 lon: 11.78725 facility: USL Sud Est Toscana - Ospedale San Donato status: NOT_YET_RECRUITING city: Arezzo zip: 52100 country: Italy name: Dr. Alessia Scatena, Med Doctor role: CONTACT phone: +39 328 3281501 email: alessia.scatena@uslsudest.toscana.it name: Dr. Alessia Scatena, Med Doctor role: PRINCIPAL_INVESTIGATOR name: Dr. Matteo Apicella, Med Doctor role: SUB_INVESTIGATOR lat: 43.46276 lon: 11.88068 facility: AUSL Romagna - Ospedale Morgagni Pierantoni status: NOT_YET_RECRUITING city: Forlì zip: 47121 country: Italy name: Dr. Silvia Acquati, Med Doctor role: CONTACT phone: +39 335 1239344 email: silvia.acquati@auslromagna.it name: Dr. Silvia Acquati, Med Doctor role: PRINCIPAL_INVESTIGATOR lat: 44.22177 lon: 12.04144 facility: Azienda USL Toscana Nord Ovest - Ospedale Campo di Marte status: NOT_YET_RECRUITING city: Lucca zip: 55100 country: Italy name: Dr. Ilaria Casadidio, Med. Doctor role: CONTACT phone: +39 3284882078 email: ilaria.casadidio@uslnordovest.toscana.it name: Dr. Ilaria Casadidio, Med Doctor role: PRINCIPAL_INVESTIGATOR lat: 43.84369 lon: 10.50447 facility: AOU Pisana - Ospedale di Cisanello status: NOT_YET_RECRUITING city: Pisa zip: 5612 country: Italy name: Prof. Alberto Piaggesi, Med Doctor role: CONTACT phone: +39 3473331949 email: alberto.piaggesi@med.unipi.it name: Dr. Chiara Goretti, Med Doctor role: CONTACT phone: +39 3294125791 email: chiara.goretti@gmail.com name: Prof. Alberto Piaggesi, Med Doctor role: PRINCIPAL_INVESTIGATOR name: Dr. Chiara Goretti, Med Doctor role: SUB_INVESTIGATOR lat: 43.70853 lon: 10.4036 hasResults: False

 nctId: NCT06388590 id: MOMMC.2024.0029 briefTitle: Acupuncture for Chronic Pelvic Pain overallStatus: RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-29 date: 2024-04-29 name: David Moss class: FED briefSummary: The objective of this study is to determine if alternative pain management strategies, namely acupuncture, may help reduce intensity of female pelvic pain compared to other pain control modalities. This research study will focus specifically on the Dragon's protocol of acupuncture which will seek to alleviate chronic non-endometriosis pelvic pain for women both with and without a history of sexual assault.

This study may support evidence for an inexpensive alternative means of treatment for patients with or without traumatic sexual history and chronic pelvic pain. conditions: Pelvic Pain conditions: Acupuncture conditions: Gynecology studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Patient sample will be both control and treatment groups. Individuals will not be divided into distinct groups. Patients will serve as their own controls. Control patients will be participating in standard of care therapies including physical therapy, psychotherapy, behavioral health, typical primary care management, etc. as deemed appropriate by the primary care provider for 4 weeks prior to study intervention. The same patients will then be re-evaluated and will be offered Acupuncture with Dragon technique (see attachment Protocol for Needle Insertion) as a means of pain control once per week for 4 weeks. primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: Dragons name: Standard of Care measure: Defense and Veterans Pain Rating Scale (DVPRS) measure: Defense and Veterans Pain Rating Scale (DVPRS) measure: Defense and Veterans Pain Rating Scale (DVPRS) measure: Defense and Veterans Pain Rating Scale (DVPRS) measure: Defense and Veterans Pain Rating Scale (DVPRS) measure: Defense and Veterans Pain Rating Scale (DVPRS) measure: Female Genitourinary Pain Index (GUPI) measure: Female Genitourinary Pain Index (GUPI) measure: Female Genitourinary Pain Index (GUPI) measure: Female Genitourinary Pain Index (GUPI) measure: Female Genitourinary Pain Index (GUPI) measure: Female Genitourinary Pain Index (GUPI) measure: PTSD Checklist for DSM-5 (PCL-5) measure: PTSD Checklist for DSM-5 (PCL-5) measure: PTSD Checklist for DSM-5 (PCL-5) measure: PTSD Checklist for DSM-5 (PCL-5) measure: PTSD Checklist for DSM-5 (PCL-5) measure: PTSD Checklist for DSM-5 (PCL-5) sex: FEMALE minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mike O'Callaghan Military Medical Center status: RECRUITING city: Nellis Air Force Base state: Nevada zip: 89191 country: United States name: Amanda J Crawford, MSHS role: CONTACT phone: 702-653-3583 email: amanda.j.crawford.ctr@health.mil lat: 36.24607 lon: -115.05721 hasResults: False

 nctId: NCT06388577 id: MEU-HEM-SY-189 briefTitle: The Effect of the Training Programme Based on the Health Promotion Model Given to Parents overallStatus: NOT_YET_RECRUITING date: 2024-05-13 date: 2024-06-13 date: 2024-09-13 date: 2024-04-29 date: 2024-04-29 name: Mersin University class: OTHER briefSummary: This randomised controlled study evaluates the effect of a training programme based on the Health Promotion Model developed for parents of children diagnosed with epilepsy on parents' level of knowledge about epilepsy, parents' general self-efficacy level, parents' health promoting and protective behaviours and the number of hospital admissions of their children. The hypothesis of this study is that education has an effect on these. conditions: Parents conditions: Epilepsy in Children conditions: Disease Management studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, single-centre, randomised controlled, single-blind interventional study in parallel groups primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Participants and the person who will perform the statistical analysis will be blinded. Participants will be assigned to intervention and control groups coded as A and B. Afterwards, it will be determined which of the A and B groups belong to the control and intervention groups by drawing lots.It will not be explained to the parents which group they are in, and it will be stated that education about epilepsy will be given. While entering the data, the researcher will enter the data encrypted as A and B in order to prevent measurement bias, the statistical analysis of the data will be carried out according to this encryption and the report of the study will be written in encrypted form. After the statistical analyses of the research are carried out and the research report is written as a result of the data found, it will be explained which of the groups the individuals are included in. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 76 type: ESTIMATED name: Education measure: Parents' level of knowledge about epilepsy evaluated using the Form for the Evaluation of Parents' Level of Knowledge about Epilepsy measure: Self-efficacy evaluated using the General Self-Efficacy Scale measure: Health Promoting and Protective Behaviors evaluated using the Health Promoting and Protective Behaviors Scale measure: Number of Hospital Admissions for Children evaluated using the Evaluation Form for the Number of Hospital Admissions sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Turkey, Mersin University city: Mersin country: Turkey name: Sümerya YASTI, MASTER role: CONTACT email: 2204160171012@mersin.edu.tr name: Hacer ÇETİN, PROFESSOR role: PRINCIPAL_INVESTIGATOR lat: 36.79526 lon: 34.61792 hasResults: False

 nctId: NCT06388564 id: INCA34176-254 id: 2022-502168-19-00 type: REGISTRY domain: EU CT Number briefTitle: A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease overallStatus: NOT_YET_RECRUITING date: 2024-07-08 date: 2027-03-05 date: 2028-09-05 date: 2024-04-29 date: 2024-04-29 name: Incyte Corporation class: INDUSTRY briefSummary: This study will be conducted to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD. conditions: Chronic Graft-versus-host-disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Axatilimab name: Ruxolitinib name: Corticosteroids measure: Objective Response Rate measure: Number of participants with Treatment-emergent Adverse Events (TEAEs) measure: Duration of Response measure: Proportion of participants with a ≥ 7-point improvement in modified Lee symptom scale (mLSS) score measure: Best overall response in the first 6 months measure: OR at 12 months, defined as CR or PR at 12 months (C14D1) in the absence of new systemic therapy for cGVHD. measure: Proportion of participants who remain corticosteroid-free measure: Organ-specific response in the first 6 cycles and on study, based on the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD. measure: Failure-free Survival (FFS) measure: Axatilimab pharmacokinetic (PK) in Plasma measure: Ruxolitinib PK in Plasma sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06388551 id: LY03017/CT-CHN-101 briefTitle: A Phase 1, SAD Study to Evaluate the Safety and Tolerability of LY03017 overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2025-03-30 date: 2025-03-30 date: 2024-04-29 date: 2024-04-29 name: Luye Pharma Group Ltd. class: INDUSTRY briefSummary: This is a phase 1，randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and pharmacokinetics of oral LPM526000133 Fumarate Capsules (LY03017) in healthy adult subjects. conditions: Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis conditions: Hallucinations and Delusions Associated With Parkinson Disease Psychosis conditions: Negative Symptoms of Schizophrenia studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: LY03017 name: LY03017-Placebo measure: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) measure: Maximum observed concentration (Cmax) of LPM526000133 in plasma measure: Time to maximum observed concentration (Tmax) of LPM526000133 in plasma measure: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM526000133 in plasma measure: Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of LPM526000133 in plasma measure: Apparent terminal elimination half-life (t1/2) of LPM526000133 in plasma sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Shanghai Mental Health Center city: Shanghai country: China name: Huafang Li role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06388538 id: Carlo Bergamini briefTitle: The COLD2B Multicenter, Two-arm Prospective Cohort Study acronym: COLD2B overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-05-01 date: 2025-06-01 date: 2024-04-29 date: 2024-04-29 name: Azienda Sanitaria di Firenze class: OTHER briefSummary: Since it is still debated whether 2b acute diverticulitis (AD), according to the World Society of Emergency Surgery (WSES) classification, should be initially treated surgically or conservatively, we launched the COLD2B study to compare the clinical results of both therapeutic regimens in a multi-institutional cohort of prospectively enrolled patients.

The primary aim of the COLD2B (Conservative vs surgical (either Open or Laparoscopic) approach in the emergency management of acute Diverticulitis WSES 2B) study is to develop a model able to predict the length of hospitalization, comparing the management of WSES 2b AD in the emergency setting (conservative versus surgical approach) (primary endpoint of the first arm of the study).

Moreover, the two groups will be compared regarding mortality and morbidity (secondary end-point).

The second arm of the study will consider the population undergoing surgery, develop a model able to predict the length of hospitalization, and compare the open vs laparoscopic approach (primary end-point), and mortality, morbidity, and surgical outcome indices (secondary end-point). conditions: Acute Diverticulitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Conservative treatment (non-operative treatment) name: Surgical treatment (operative treatment) measure: Length of hospital stay in the overall population measure: Morbidity rate for both arms measure: Mortality rate for both arms measure: Surgical complications rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dipartimento di Medicina di Precisione e Rigenerativa e Area Jonica (DiMePRe-J), Universita' di Bari city: Bari country: Italy name: Francesco Paolo Prete role: CONTACT lat: 41.11148 lon: 16.8554 facility: Department of Emergency and Acceptance, Emergency Surgery Unit, Azienda Ospedaliero-Universitaria Careggi, Firenze, Italy city: Florence zip: 50134 country: Italy name: Carlo Bergamini, MD role: CONTACT phone: +39(0)557949173 email: drcarlobergamini@gmail.com name: Carlo Bergamini role: PRINCIPAL_INVESTIGATOR name: Alessio Giordano role: PRINCIPAL_INVESTIGATOR lat: 43.77925 lon: 11.24626 facility: Department of Medicine, Surgery and Health Sciences, University of Trieste city: Trieste country: Italy name: Manuela Mastronardi role: CONTACT lat: 45.64953 lon: 13.77679 facility: Department of General Surgery, PO di Vittorio Veneto (TV), ULSS2 Marca Trevigiana city: Vittorio Veneto country: Italy name: Giulia Montori role: CONTACT lat: 45.98026 lon: 12.30065 hasResults: False

 nctId: NCT06388525 id: PostERCPLC briefTitle: Post-ERCP Cholecystectomy. How ERCP and ERCP-related Variables Effect the Outcomes? overallStatus: COMPLETED date: 2016-01-01 date: 2020-01-01 date: 2020-01-01 date: 2024-04-29 date: 2024-04-29 name: Kanuni Sultan Suleyman Training and Research Hospital class: OTHER briefSummary: In this retrospective study, we aimed to detect of effects of ERCP on outcomes of Laparoscopic Cholecystectomy. Patients underwent elective cholecystectomy surgery with a diagnosis of symptomatic cholelithiasis were identified and divided into two main groups regarding to have a ERCP procedure prior to surgery or not. To eliminate possible differences in baseline characteristics, patients in ERCP and non-ERCP groups were propensity score-matched 1:1 using nearest-neighbor matching without replacement based on age, sex and ASA score. Following propensity score matching (PSM), the ERCP and non-ERCP groups were first compared to detect effects of the ERCP procedure itself. After comparison of two main groups, subgroup analyzes performed for the ERCP group to detect effect of ERCP-related variables (indication for ERCP procedure, time between last ERCP procedure and surgery, number of preoperative ERCPs, stone extractions, and biliary stent use) conditions: Endoscopic Retrograde Cholangiopancreatography conditions: ERCP-Laparoscopic Cholecystectomy Interval conditions: Number of Preoperative ERCPs conditions: Stone Extraction Status in ERCP Procedures conditions: Biliary Stents conditions: Mechanical Lithotripsy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 426 type: ACTUAL name: Endoscopic Retrograde Cholangiopancreatography measure: Conversion to open measure: Subtotal Cholecystectomy measure: Postoperative Complications measure: Adhesion levels measure: Operative time measure: Length of hospital stay sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bakirkoy Dr. Sadi Konuk Training and Research Hospital city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06388512 id: STUDY00160044 briefTitle: iMRI Prone Positioning Frame Design Feasibility Study overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-29 date: 2024-04-29 name: University of Kansas Medical Center class: OTHER name: Continuum Educational Technologies briefSummary: The goal of this study is to learn if the prototype adjustable prone positioning frame is a feasible design for use during neurosurgical procedures which utilize intraoperative magnetic resonance imaging (iMRI). The main questions it aims to answer are:

* Is the prototype prone positioning device design feasible for use during neurosurgical procedures which utilize intraoperative MRI?
* Does use of the prototype device place the patient at increased risk of complications compared to the standard positioning pads? Researchers will place patients in the prone position on the prototype device during neurosurgical procedures that utilize intraoperative MRI and observe for any problems with the positioning device or complications attributable to the positioning device. conditions: Epilepsy conditions: Pulmonary Embolism studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 5 type: ESTIMATED name: prototype prone positioning device measure: Number of devices that meet functional requirements measure: Number of devices that are damaged during use measure: Number of patients with skin complications measure: Number of patients with thromboembolic complications 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 name: Andrew Guillotte, MD role: CONTACT phone: 309-648-7036 email: aguillotte@kumc.edu name: Anand Dharia, MD role: SUB_INVESTIGATOR name: Jennifer Cheng, MD role: SUB_INVESTIGATOR name: Michael Kinsman, MD role: PRINCIPAL_INVESTIGATOR name: Christopher Miller, MD role: SUB_INVESTIGATOR lat: 39.11417 lon: -94.62746 hasResults: False

 nctId: NCT06388499 id: GOIPG/2022/1854 briefTitle: A Physiotherapy-led Disease-agnostic Telerehabilitation Programme for People With Chronic Health Conditions overallStatus: RECRUITING date: 2024-04-16 date: 2024-07-22 date: 2024-07-31 date: 2024-04-29 date: 2024-04-29 name: University of Limerick class: OTHER briefSummary: This protocol outlines a planned mixed methods feasibility trial which will be conducted to examine the feasibility and acceptability of a physiotherapy-led exercise-based telerehabilitation programme for groups of people with mixed chronic health conditions. conditions: Chronic Conditions, Multiple studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: TECC (Telerehabilitation and Exercise for Chronic Conditions) measure: Recruitment rate assessed by number of participants recruited during recruitment period. measure: Retention rate assessed by the proportion of enrolled participants who complete post-intervention assessments. measure: Adherence rate assessed by the attendance at synchronous group exercise sessions measure: Satisfaction with the intervention as assessed by the Client-Satisfaction Questionnaire 8 (CSQ-8) measure: Satisfaction with individual intervention components assessed by Numerical Rating Scales (NRS) measure: Adverse events assessed via self-report questionnaire measure: Intervention acceptability as assessed by qualitative feedback from participants via focus groups measure: Physical function assessed by the 30-second chair stand test (30CST). measure: Quality of life assessed by the Euro-QoL 5 Dimension 5 Level (Euro-QoL-5D-5L). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: South Tipperary Chronic Disease Management Hub, St. Brigid's Hospital, Carrick-on-Suir status: RECRUITING city: Tipperary country: Ireland name: Niamh Julian, BSc role: CONTACT lat: 52.47333 lon: -8.15583 hasResults: False

 nctId: NCT06388486 id: UMCGoettingen9/9/16 briefTitle: Cytokine-Induced Transcription in Depressed Inpatients Undergoing Psychotherapy acronym: CitDip overallStatus: COMPLETED date: 2017-01-01 date: 2022-03-09 date: 2024-01-01 date: 2024-04-29 date: 2024-04-29 name: University Medical Center Goettingen class: OTHER briefSummary: The goal of this observational study is to measure the levels of cytokine-induced transcription factor activation in a cohort of depressed inpatients undergoing psychotherapy. The study aims to answer the following main questions:

* Do psychological traits (i.e.: social inhibition, negative affectivity, ...) affect the activation of immunomodulatory transcription factors (STAT3, NFkB) in depressed patients?
* Are subjects with these psychological traits affected differently by psychotherapeutic intervention?

Study subjects are assessed for their psychological and behavioral traits and receive psychotherapeutic care over several weeks during hospital treatment. Peripheral blood mononuclear cells are isolated from the study subjects, and activation of transcription factors is measured by flow cytometry. conditions: Depression studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 63 type: ACTUAL name: Psychotherapy measure: Change in depression sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06388473 id: NMRR-20-2188-56086 IIR briefTitle: Implementation of a Web-based App for Screening in Men in a Malaysian Primary Care Setting acronym: iScreenMen overallStatus: COMPLETED date: 2021-01-14 date: 2021-06-06 date: 2021-06-06 date: 2024-04-29 date: 2024-04-29 name: University of Malaya class: OTHER briefSummary: The purpose of this study is to determine how to successfully implement ScreenMen in the primary care setting. ScreenMen is a mobile web-based app that has been developed to increase the uptake of screening in men. ScreenMen undertook a vigorous and systematic approach in its development. It was developed based on theories, evidence and needs of men. ScreenMen particularly target men in the age group of 20 to 50 years as this group of men usually do not attend any health screening. This research is necessary because ScreenMen has yet to be implemented in the primary care setting. The study will last about five months and your participation will be about five months. conditions: Men's Health Screening conditions: Implementation conditions: Web-based Application studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 101 type: ACTUAL name: Tailored implementation intervention measure: Reach measure: Reach measure: Adoption of ScreenMen using qualitative methods measure: Implementation of ScreenMen using qualitative methods measure: Maintenance of ScreenMen using qualitative methods measure: Impact of COVID-19 on the clinic using qualitative methods sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Klinik Kesihatan Cheras Baru city: Kuala Lumpur zip: 56100 country: Malaysia lat: 3.1412 lon: 101.68653 hasResults: False

 nctId: NCT06388460 id: STUDY00001015 id: R01HL169229 type: NIH link: https://reporter.nih.gov/quickSearch/R01HL169229 briefTitle: Asthma Link Effectiveness Trial: Cluster Randomized Controlled Trial overallStatus: RECRUITING date: 2024-04-04 date: 2028-01 date: 2028-04 date: 2024-04-29 date: 2024-04-29 name: University of Massachusetts, Worcester class: OTHER name: National Institutes of Health (NIH) name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The goal of this cluster RCT is to determine the effectiveness of Asthma Link, a school supervised asthma therapy program, compared with an educational asthma workbook, in improving asthma symptoms for children with poorly controlled asthma aged 5-14. conditions: Childhood Asthma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 350 type: ESTIMATED name: Asthma Link name: Enhanced Usual Care measure: Improving Asthma Symptoms measure: Improving Medication Adherence measure: Improving Healthcare Utilization measure: Reducing Parental Lost Workdays measure: Reducing School Absences measure: Improving Quality of Life sex: ALL minimumAge: 5 Years maximumAge: 14 Years stdAges: CHILD facility: University of Massachusetts Chan Medical School status: RECRUITING city: Worcester state: Massachusetts zip: 01655 country: United States name: Michelle Spano role: CONTACT phone: 508-856-2990 email: michelle.spano@umassmed.edu name: MIchelle Trivedi, MD MPH role: PRINCIPAL_INVESTIGATOR lat: 42.26259 lon: -71.80229 hasResults: False

 nctId: NCT06388447 id: UCMSC1 briefTitle: Reconstruction of Deficient Interdental Papilla Using Stem Cells vs Physiological Saline: a RCT overallStatus: ENROLLING_BY_INVITATION date: 2023-12-01 date: 2024-12-31 date: 2025-03-30 date: 2024-04-29 date: 2024-04-29 name: University of Malaya class: OTHER briefSummary: The goal of this study is to assess the reconstruction of interdental papilla following the injection of UC-MSCs or physiological saline in patients with interdental papilla deficiency. Participants will be randomised into 2 groups (intervention vs placebo) to receive the treatment. conditions: Gingival Recession, Localized studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Umbilical cord-mesenchymal stem cells measure: Reconstruction of the deficient interdental papilla with soft tissue measure: Reconstruction of the deficient interdental papilla with bone measure: Reconstruction of the deficient interdental papilla with bone sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Orthodontic Postgraduate Clinic city: Kuala Lumpur state: Wilayah Persekutuan Kuala Lumpur zip: 50603 country: Malaysia lat: 3.1412 lon: 101.68653 hasResults: False

 nctId: NCT06388434 id: HP-00100309 briefTitle: Protective Arm Balance Responses acronym: PAT overallStatus: RECRUITING date: 2023-10-01 date: 2024-07 date: 2024-08 date: 2024-04-29 date: 2024-04-29 name: University of Maryland, Baltimore class: OTHER briefSummary: The overall objective of this study is to investigate the effect of attention control training on reach-grasp stabilizing responses during fall-induced perturbations. The central hypothesis is that training attention control during reach to grasp balance perturbations will lead to increased grasp accuracies and reduced in-task falls. This research will mark the first explore the effects of training attention control on protective arm responses and fall rate during a balance perturbation paradigm and the first feasibility testing of a fully integrated cognitive and physical rehabilitation paradigm, moving beyond correlative designs and parallel treatments. The overall public health significance of the proposed research is that with improved protective arm responses and grasp accuracies, a larger randomized control study may be designed to mitigate falls among community dwelling older adults.

Participants will be involved in 6 sessions. Session 1 will include the assessment, questionnaires, and training. Session 2 will include just the training. Session 3 will include the assessment and training. Sessions 4-5 will include just the training. Session 6 will include the assessment, questionnaires, and training. conditions: Old Age; Debility conditions: Peripheral Neuropathy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: The study will include two groups (older adults and people with peripheral neuropathy) which will be assessed pre- and post-intervention primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: Protective Arm Balance Response Training measure: Grasp Accuracy measure: In-task falls incidence measure: Electromyography (EMG) of the shoulder muscles measure: Physiological responses (heart rate variability) measure: Physiological responses (electrodermal activity) measure: Activity specific balance confidence scale measure: Stait Trait Anxiety Inventory measure: Subjective Units of Distress Scale measure: Mini Mental State Examination (MMSE) measure: Beck Anxiety Inventory measure: Somatosensation sex: ALL minimumAge: 45 Years maximumAge: 88 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Allied Health Research Building status: RECRUITING city: Baltimore state: Maryland zip: 21201 country: United States name: Kelly P Westlake, PhD role: CONTACT phone: 410-706-5919 email: kwestlake@som.umaryland.edu lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06388421 id: GMS-PH-401 briefTitle: DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2030-08-01 date: 2030-11-30 date: 2024-04-29 date: 2024-04-29 name: United Therapeutics class: INDUSTRY briefSummary: This is a prospective, non-interventional, multicenter, registry of patients with pulmonary associated with interstitial lung disease (PH-ILD). conditions: Pulmonary Hypertension Due to Lung Diseases and Hypoxia conditions: Pulmonary Hypertension conditions: Interstitial Lung Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Prospective study assessments measure: Baseline characteristics as described by demographics, medical history, ILD history, PH history, family history (comorbidities), and diagnostic right heart catheterization values measure: Changes in clinical features relating to patients' interstitial lung disease and pulmonary hypertension sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06388408 id: SufMAST briefTitle: Effects of Sufentanil Target Controlled Infusion on Patient State Index Values and Electroencephalographic Spectrum During Total Intravenous Anesthesia With Propofol overallStatus: NOT_YET_RECRUITING date: 2024-05-05 date: 2024-09-15 date: 2024-09-30 date: 2024-04-29 date: 2024-04-29 name: University of Padova class: OTHER briefSummary: Sufentanil Target Controlled infusion (TCI, Gepts model) effects on Neuromonitoring during Total Intravenous Anesthesia (TIVA) with Propofol TCI (Eleveld model) has not been investigate yet.

Authors aim to investigate its effect on Patient State index (PSi), the power spectrum EEG, the Analgesia Nociception Index (ANI) nad pupillometry values during maintenance durin TIVA-TCI with Propofol and Sufentanil. conditions: Anesthesia Brain Monitor conditions: Sufentanil conditions: Target Controlled Infusion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: Effects of Sufentanil on Patient State index (PSi) during stable Propofol general anesthesia measure: Effects of Sufentanil on Electroencephalogram (EEG) power spectrum during stable Propofol general anesthesia measure: Effects of Sufentanil on Analgesia Nociception Index (ANI) during stable Propofol general anesthesia measure: Analgesia Nociception Index (ANI) values and postoperative pain measure: Patient State Index (PSi) values and postoperative delirium measure: Analgesia Nociception Index (ANi) values and postoperative delirium sex: FEMALE minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Treviso Regional Hospital city: Treviso state: TV zip: 31100 country: Italy lat: 45.66673 lon: 12.2416 hasResults: False

 nctId: NCT06388395 id: REC-23-05-12-02-F briefTitle: Clinical Performance of All-on-4 PEEK and Conventional Prostheses overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-06-30 date: 2027-08-30 date: 2024-04-29 date: 2024-04-29 name: University of Sharjah class: OTHER briefSummary: The all-on-4 treatment approach for completely edentulous mandible is a proven concept. However, there are still issues regarding the use of metal substructure to support the prostheses such as allergy, metallic taste, and aesthetic. Therefore, other materials such as polyetheretherketone (PEEK) are being tested for its suitability and is showing good potential. However, available evidence is limited regarding its clinical performance. Thus, the aim of this study is to compare clinical performance of all-on-4 treatment concept utilizing PEEK versus conventional metal framework as substructure in fully edentulous mandible. Thirty suitable patients will receive either PEEK or conventional all-on-4 prostheses for fully edentulous mandible. The prostheses will be retained by four implants utilizing the all-on-4 principle. Clinical performance will be assessed during the follow up period of up 3 years concerning screw loosening, material chipping or fracture, wear or staining, prosthesis survival and success, implant survival and success. conditions: Failure, Prosthesis conditions: Dental Prosthesis, Implant-Supported conditions: Survival, Prosthesis conditions: Complete Edentulism conditions: Complication;Prostheses studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups will be provided with two types of implant-supported prostheses primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Block randomization will be used to randomly assign participants. The sequences will be concealed in opaque, consecutively numbered envelopes for each block. One envelope will be obtained for each participant, corresponding to the assignment of the protocol (conventional versus PEEK). The outcome assessor will be independent and not involved in any treatment procedure whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Accuracy of full-arch surgical guides name: Survival and complications of the prostheses name: Survival and complications of the implants name: Conventional (metal-resin) implant-supported prosthesis name: PEEK implant-supported prosthesis measure: Accuracy of full-arch surgical guides measure: Survival rate of implants measure: Success rates of the Prostheses measure: Pain level measure: Marginal bone loss measure: Plaque index measure: Pocket depth measure: Bleeding index sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Sharjah city: Sharjah zip: 7724 country: United Arab Emirates lat: 25.33737 lon: 55.41206 hasResults: False

 nctId: NCT06388382 id: UKKx2024 briefTitle: Investigation of the Audible ICD Alert Tone overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-05-15 date: 2025-05-30 date: 2024-04-29 date: 2024-04-29 name: Universitätsklinikum Köln class: OTHER briefSummary: Ability of ICD patients to hear the audible ICD alert is being assessed. conditions: Implantable Defibrillator User studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Alert tone demonstration measure: Alert tone audible sex: ALL minimumAge: 15 Years maximumAge: 100 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Cologne city: Cologne zip: 50937 country: Germany lat: 50.93333 lon: 6.95 hasResults: False

 nctId: NCT06388369 id: CA184-608 briefTitle: Neoadjuvant Lu-PSMA Radioligand Therapy and Ipilimumab in Men With Very High-risk Prostate Cancer acronym: NEPI overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-03 date: 2028-09 date: 2024-04-29 date: 2024-04-29 name: University Hospital, Essen class: OTHER name: Advanced Accelerator Applications name: Bristol-Myers Squibb briefSummary: A randomized, open-label Phase I/II study of neoadjuvant treatment with \[177Lu\]Lu-PSMA-617 radioligandtherapy (LuPSMA) with or without Ipilimumab in participants with very high-risk prostate cancer who are candidates for Radical Prostatectomy. conditions: Very High Risk Prostate Carcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The first patients are enrolled - without randomization - into the Safety Cohort to assess whether the treatment regime under investigation, i.e. Ipilimumab (3mg/kg) + \[177Lu\]Lu-PSMA-617 RLT (7,4 GBq), is appropriately tolerated as per dose escalation algorithm.

If it is established that Ipilimumab (3mg/kg) + \[177Lu\]Lu-PSMA-617 RLT (7,4 GBq) is appropriately tolerated, patients will be randomized into the two arms of the Analysis Cohort:

* Arm A: Ipilimumab + \[177Lu\]Lu-PSMA-617 RLT
* Arm B: \[177Lu\]Lu-PSMA-617 RLT primaryPurpose: TREATMENT masking: NONE count: 58 type: ESTIMATED name: [177Lu]Lu-PSMA-617 name: Ipilimumab measure: Feasibility to perform prostatectomy on time measure: Clinical activity: Proportion of participants in the full analysis set who achieve a pCR measure: Safety Profile of neoadjuvant treatment before radical prostatectomy measure: Safety Profile of neoadjuvant treatment before radical prostatectomy sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Essen, Clinic of Urology city: Essen zip: 45147 country: Germany name: PD Dr. med. Ulrich Krafft role: CONTACT email: ulrich.krafft@uk-essen.de lat: 51.45657 lon: 7.01228 hasResults: False

 nctId: NCT06388356 id: 042024 briefTitle: Patient's Informational Privacy in Prehospital Emergency Care - Educational Intervention Study for the Paramedics overallStatus: ENROLLING_BY_INVITATION date: 2024-03-25 date: 2024-05-19 date: 2024-06-16 date: 2024-04-29 date: 2024-04-29 name: Eini Koskimies class: OTHER briefSummary: The main goal of this educational intervention study about patient's informational privacy (IP) is to evaluate the effect of the educational intervention into the paramedics' knowledge and attitude regarding patient's IP. The study also investigates the usability and the feasibility of the educational intervention.

The main questions it aims to answer are:

1. What is the effect of the educational intervention on the

   1. theoretical knowledge of paramedics' regarding IP?
   2. the paramedics' attitude towards patient's IP?
2. What is the usability and feasibility of the intervention being evaluated according to the respondents? conditions: Knowledge conditions: Attitude of Health Personnel studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups, intervention and control group. Only intervention group is receiveing the intervention. primaryPurpose: BASIC_SCIENCE masking: NONE count: 50 type: ESTIMATED name: Educational intervention - Yksityisyyttä ensihoitoon / Informational privacy for preospital emergency care measure: Paramedics' knowledge about patient's informational privacy measure: paramedics' attitude towards patient's informational privacy. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Turku city: Turku zip: 20520 country: Finland lat: 60.45148 lon: 22.26869 hasResults: False

 nctId: NCT06388343 id: S68485 briefTitle: Causes of Listening Difficulties in Children acronym: CLINIC overallStatus: NOT_YET_RECRUITING date: 2025-01 date: 2027-12 date: 2027-12 date: 2024-04-29 date: 2024-04-29 name: Universitaire Ziekenhuizen KU Leuven class: OTHER name: Universitair Ziekenhuis Brussel briefSummary: Many children experience listening and processing difficulties (LiD), especially in background noise, despite normal hearing sensitivity. The prevalence of these problems is estimated at 0.5-1% in the general population. Listening difficulties are associated with developmental disorders (DD) such as specific language disorders, autism spectrum disorder (ASD), ADHD and learning disabilities. Many children with developmental problems are easily distracted by sounds, have difficulty concentrating for long periods, processing language, remembering and summarizing oral information, and can experience academic difficulties (reading, writing). Early identification, differential diagnosis and intervention are important to help children overcome these difficulties and reach their full potential. Some concerns about these listening and processing problems, such as the lack of a gold standard to diagnose LiD and age-appropriate reference data, led to the initiation of this study.

CLINIC aims to develop a new approach to diagnose the causes of listening difficulties in children. This is accomplished through (1) a validated parent questionnaire and (2) a multidisciplinary behavioral assessment tool. Data from these combined measures will lead to evidence-based profiles of children with LiD, which in turn will help streamline their referral pathways and care pathways. conditions: Listening Difficulties studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: PARTICIPANT count: 280 type: ESTIMATED name: Evaluation of Children's Listening and Processing Skills name: Multidisciplinary behavioral assessment measure: ECLiPS questionnaire measure: Behavioral measures sex: ALL minimumAge: 6 Years maximumAge: 14 Years stdAges: CHILD hasResults: False

 nctId: NCT06388330 id: s61692 briefTitle: The Effect of a Low FODMAP Diet in Functional Dyspepsia Patients With Meal Related Symptoms acronym: FFD overallStatus: COMPLETED date: 2019-04-26 date: 2022-03-08 date: 2022-03-08 date: 2024-04-29 date: 2024-04-29 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: In this study, the investigators will evaluate the FODMAP diet as an alternative treatment for functional dyspepsia and explore its effect on different aspects of the pathophysiology of FD. conditions: Functional Dyspepsia conditions: FODMAP Diet studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE maskingDescription: open label strict diet phase blinded participant during reintroduction count: 32 type: ACTUAL name: low FODMAP diet measure: Improvement on gastrointestinal symptoms measure: Reintroduction period measure: Evaluation of the low FODMAP diet on IBS related symptoms measure: Evaluation of the low FODMAP diet on symptom response and quality of life measure: Evaluation of the low FODMAP diet on depression, somatization measure: Evaluation of the low FODMAP diet on duodenal barrier function measure: Evaluation of the low FODMAP diet on gastric emptying measure: Evaluation of the low FODMAP diet on gastric accommodation sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: KU Leuven city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium lat: 50.87959 lon: 4.70093 hasResults: False

 nctId: NCT06388317 id: 123632 briefTitle: Machine-based Algorithm for Increased Physical Activity and Sustained User Engagement overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-01 date: 2025-01-01 date: 2025-02-01 date: 2024-04-29 date: 2024-04-29 name: Western University, Canada class: OTHER briefSummary: This 12-week study compares the effectiveness of personalized daily step goals generated by a machine learning algorithm in the Sprout app versus fixed daily step goals of 10,000 steps among adults. Participants will be recruited through the Sprout app, and after a 1-week run-in period, they will be assigned to either the intervention or control group. The intervention group will receive adaptive goals based on their historical step data, while the control group will have a fixed goal. Both groups will receive financial incentives. This study aims to inform future interventions measuring changes in daily steps and app engagement levels (i.e., time spent on app, number of app opens) by studying how using financial incentives and an adaptive goal-setting design can improve physical activity levels of app users, informed by a machine learning algorithm. conditions: Health Behavior studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Retrospective, quasi-experimental study. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants are unaware of the other intervention arm (i.e., adaptive step goals versus static step goals). whoMasked: PARTICIPANT count: 500 type: ESTIMATED name: Adaptive Step Goal (Intervention) name: Static Step Goal (Control) measure: Step count measure: Number of app opens, total time spent on app, number of pages opened sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Western University city: London state: Ontario country: Canada lat: 42.98339 lon: -81.23304 hasResults: False

 nctId: NCT06388304 id: 23-0556 briefTitle: THRIVE Study: Positive Affect Training for Endocrine Therapy Medication Adherence acronym: THRIVE overallStatus: RECRUITING date: 2024-03-12 date: 2024-10-12 date: 2024-12-12 date: 2024-04-29 date: 2024-04-29 name: Joanna Arch class: OTHER briefSummary: The purpose of this study is to pilot and refine an online behavioral intervention based on Positive Affect Training (PAT) that aims to increase positive emotional attitudes and decrease negative emotional attitudes toward endocrine therapy (ET, i.e., anti-hormonal medication) and to increase positive affect and decrease negative affect more generally, among post-treatment breast cancer survivors who are prescribed ET to prevent recurrence of breast cancer. conditions: Breast Cancer conditions: DCIS studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: THRIVE Online PAT Program measure: Acceptability of THRIVE intervention (AIM) measure: Feasibility of THRIVE intervention measure: Client Satisfaction Survey sex: FEMALE minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado Boulder status: RECRUITING city: Boulder state: Colorado zip: 80309 country: United States name: Sienna Russel role: CONTACT phone: 720-897-1850 email: archlab@colorado.edu name: Madeline Nealis, MPH role: CONTACT phone: 720-897-1850 email: archlab@colorado.edu name: Joanna Arch, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.01499 lon: -105.27055 hasResults: False

 nctId: NCT06388291 id: CTU/2018/321 briefTitle: Deep Brain Stimulation in Tourette Syndrome acronym: Op-TICS overallStatus: RECRUITING date: 2022-08-02 date: 2025-01 date: 2025-06-30 date: 2024-04-29 date: 2024-04-29 name: University College, London class: OTHER name: National Institute for Health Research, United Kingdom name: University College London Hospitals name: Northern Care Alliance NHS Foundation Trust name: St George's University Hospitals NHS Foundation Trust name: Royal Devon and Exeter NHS Foundation Trust name: University of Bristol name: University of Dundee name: London School of Hygiene and Tropical Medicine name: King's College London name: University Hospital, Rouen name: Imperial College London briefSummary: Op-TICS is a clinical investigation of the use of Deep Brain Stimulation (DBS), with a CE marked implantable device, to reduce severe motor and vocal tics in patients who suffer from Tourette Syndrome (TS).

It is a randomised, double-blind, crossover clinical investigation for 20 patients. Op-TICS will be performed at the National Hospital for Neurology \& Neurosurgery.

Following DBS surgery, participants will first enter an open adjustment phase, of 6 months, where the electrical stimulation settings of the device are optimised. Participants will then enter the double-blind phase that will include successively up to 2 weeks with stimulation on and up to 2 weeks with the stimulation off in a randomised order.

The primary outcome measure is the tic severity score measured by the Yale Global Tic Severity Scale -Total Tic Score after two weeks OFF-stimulation versus two weeks ON-stimulation in the double-blind randomised crossover phase conditions: Tourette Syndrome conditions: Deep Brain Stimulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: All participants will have electrodes implanted in the globus pallidus interna and connected to a subcutaneous pulse generator.

This will be followed by a 6 months open-phase period of stimulation for electrical parameter adjustment.

Following these 6 months, participants will be randomised into two groups by the order of treatment condition (ON/OFF-stimulation vs OFF/ON-stimulation): one group will be kept with the stimulation on ("ON-stimulation") and the other switched off ("OFF-stimulation") for up to two weeks. Tic severity will be assessed and all participants will enter a 2-day interval, in the ON state, before switching to the other treatment condition for another two weeks. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Double Blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Deep Brain Stimulation measure: Tic severity score measured by the YGTSS-TTS (total tic) after two weeks OFF-stimulation versus two weeks ON-stimulation in the double-blind randomised crossover phase measure: MRVRS at the end of the OFF-stimulation state versus the end of the ON-stimulation state in the blinded, randomised crossover phase. measure: Change in the MRVRS between baseline 0 and the end of the open-phase (Baseline 1) measure: Change in the YGTSS (global) between baseline 0 and the end of the open-phase (Baseline 1) measure: Change in the GTS-QOL questionnaire measures at baseline 0 and the end of the open-phase (Baseline 1) measure: Change in the YBOCS between baseline 0 and the end of the open-phase (Baseline 1) measure: Change in the BDI scale between baseline 0 and the end of the open-phase (Baseline 1) measure: Change in the BAI scale between baseline 0 and the end of the open-phase (Baseline 1) measure: Change in the BAARS-IV between baseline 0 and the end of the open-phase (Baseline 1) measure: Safety of DBS as indicated by the number of participants with any adverse events and number with any serious adverse events measure: A mechanistic part of the study will look at possible explanations of differing responses in both the open and randomised phase. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Hospital of Neurology & Neurosurgery status: RECRUITING city: London country: United Kingdom name: Patricia Limousin role: CONTACT lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06388278 id: NET-2018-12366982-4/ASP_LOMB briefTitle: Cost-effectiveness Analysis of an Antimicrobial Stewardship Program in Regione Lombardia (RF-net2018) acronym: RF-net2018 overallStatus: RECRUITING date: 2023-03-01 date: 2024-11-01 date: 2025-04-15 date: 2024-04-29 date: 2024-04-29 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER name: Regione Lombardia name: Ministero della Salute, Italy briefSummary: Cost-effectiveness analysis of an Antimicrobial Stewardship program in Regione Lombardia: "RF-net2018" is a prospective, experimental, multicenter, pre-post study, whose objectives are the evaluation of the efficiency of economic resources allocated to the antimicrobial stewardship program (AMS) in patients with infection and in patients with infections caused by carbapenem-resistant gram-negative (CR-GN) bacteria, identified in a network of 18 hospital facilities participating in our study. Moreover, this study aims to compare hospital mortality among patients admitted to the facilities participating in the study before and during the implementation of the AMS project. The study will include two main phases of analysis: the pre-intervention-phase and the intervention phase, both of 6 months duration. The pre-intervention phase will serve as a control for the intervention phase. The intervention phase is represented by antimicrobial stewardship activities which have been implemented in the network of 18 hospital facilities and that include a group of activities listed above (Hospital commitment, Tracking and reporting, Action and Education). Data source and analysis for the cost-effectiveness analysis, using month-department as statistical unit, are regional data: Discharge record ICD-9 codes (identification of target population 1, 2, 3, average days of hospitalization and mortality), R file (for antibiotic drug consumption month-ward) and Microbio (identification of target population 2, CR-GN and MRSA bacteremia and Cases of C. difficile infection). For what concerns healthcare costs data, each Management control office of the 18 facilities has to provide: AVERAGE HOSPITALISATION DAYS, NUMBER OF HOSPITALIZED AND TRANSFERRED PATIENTS and HEALTHCARE COSTS (healthcare personnel, diagnostic services, surgical interventions and consumption of operating rooms). conditions: Antimicrobial Stewardship conditions: Cost-effectiveness Analysis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 50000 type: ESTIMATED measure: evaluate the efficiency of the economic resources allocated to the antimicrobial stewardship program (AMS) through a cost-effectiveness analysis in patients with infection measure: evaluate the efficiency of the economic resources allocated to the AMS program through a cost-effectiveness analysis in patients with infections caused by carbapenem-resistant gram-negative (CR-GN) bacteria. measure: compare hospital mortality among patients admitted to the facilities participating in the study before and during the implementation of the AMS project sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Fondazione Policlinico of Milan status: RECRUITING city: Milan zip: 20135 country: Italy name: GIULIA dr RENISI, Doctor role: CONTACT phone: 3887429609 email: giulia.renisi@policlinico.mi.it name: Alessandra dr Bandera, Doctor role: CONTACT phone: 0255034770 email: alessandra.bandera@unimi.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06388265 id: 18/2018, Acta 26-6-2018 briefTitle: Emotional and Oral Characteristics of Patients That Attend a Dental Consultation for the Extraction of Third Molars overallStatus: COMPLETED date: 2022-01-09 date: 2023-07-31 date: 2023-07-31 date: 2024-04-29 date: 2024-04-29 name: University of Barcelona class: OTHER briefSummary: Analyze the level of anxiety, hemodynamic parameters, oral status, and satisfaction among patients undergoing third molar extraction, we will assess those who attend the Master of Oral Medicine, Surgery, and Implantology program at the University of Barcelona. conditions: Anxiety and Fear studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 75 type: ACTUAL name: Trifold information measure: Changes in STAI-S measure: Changes in MDAS measure: Changes in blood pressure measure: Changes in Heart rate measure: Changes in Oxygen saturation measure: Patient Satisfaction of procedure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Odontològic Universitat de Barcelona city: L'Hospitalet De Llobregat state: Barcelona zip: 08907 country: Spain lat: 41.35967 lon: 2.10028 hasResults: False

 nctId: NCT06388252 id: ERID-KSOPR-0049/2023 id: 0120-297/2023/3 type: OTHER domain: National Medical Ethics Committee of the Republic of Slovenia briefTitle: Electrochemotherapy Induces Changes in the Tumor Microenvironment of Cutaneous and Subcutaneous Metastases in Patients With Cutaneous Melanoma overallStatus: ENROLLING_BY_INVITATION date: 2023-11-10 date: 2025-09-30 date: 2025-11-30 date: 2024-04-29 date: 2024-04-29 name: Institute of Oncology Ljubljana class: OTHER name: Slovenian Research and Innovation Agency briefSummary: In the last 10 years, the treatment of metastatic cutaneous melanoma has changed dramatically. The new systemic treatment with immunotherapy has led to a dramatic improvement in quality of life and overall survival. Systemic treatment means that the patient receives the drug as an infusion into a vein. Unfortunately, we know that immunotherapy is not equally successful in all patients. Recent studies have shown that the success of the treatment is not only influenced by the cellular composition of the metastasis, but also by its surroundings. This is called tumor microenvironment. Depending on the differences in the composition of this microenvironment, some metastases can be described as immunologically hot and others as immunologically cold. Immunologically hot metastases respond better to immunotherapy than immunologically cold metastases.

Studies have shown that with some interventions we can change the tumor microenvironment from being immune-cold to being immune-hot. Electrochemotherapy is one of the interventions that might improve the efficacy of immunotherapy in cutaneous melanoma. Electrochemotherapy is an established method for the local treatment of tumors, in which only a certain tumor is treated with special electrodes, to which a weak electric current is applied. We hypothesize that electrochemotherapy stimulates the body's own immune response and enables more effective treatment. Since immunotherapy also stimulates the body's own immune response to cutaneous melanoma cells, the interaction of the two drugs could be even more successful. Recent research results support this assumption.

The primary objective is to evaluate the changes in the tumor microenvironment of cutaneous and subcutaneous melanoma metastases induced by electrochemotherapy, based on the histologic analysis of treated and untreated metastases before and after treatment. The secondary aim is to determine whether the changes in the tumor microenvironment differ depending on the chemotherapeutic agent used.

The results will help us to better understand the synergistic effects of electrochemotherapy and immunotherapy on cutaneous melanoma metastases. The combination of systemic immunotherapy and electrochemotherapy could become an important treatment method for patients with metastatic melanoma. conditions: Cutaneous Malignant Melanoma studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: Electrochemotherapy with intratumoural cysplatin is recommended for smaller (less than 3 cm) and fewer tumours (up to 10 lesions), while electrochemotherapy with intravenous bleomycin is preferable for multiple and larger tumours. primaryPurpose: BASIC_SCIENCE masking: NONE count: 10 type: ESTIMATED name: Electrochemotherapy with Intratumoral Cysplatin name: Electrochemotherapy with Intravenous Bleomycin measure: Changes in the tumor microenvironment of cutaneoys and subcutaneousm melanoma metastases induced by electrochemotherapy measure: Diferrent changes in the tumor microenvironment induced by electrochemotherapy with bleomycin or cysplatin sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Oncology Ljubljana city: Ljubljana zip: 1000 country: Slovenia lat: 46.05108 lon: 14.50513 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-11-10 uploadDate: 2024-03-20T00:20 filename: ICF_000.pdf size: 356929 hasResults: False

 nctId: NCT06388239 id: BE24-006 briefTitle: Bioequivalence Study of Apixaban 5 mg Film-coated Tablets in Healthy Thai Volunteers overallStatus: NOT_YET_RECRUITING date: 2024-08-26 date: 2024-09-14 date: 2024-09-23 date: 2024-04-29 date: 2024-04-29 name: International Bio service class: NETWORK briefSummary: The goal of this bioequivalence of two formulations of generic apixaban 5 mg film-coated tablets. Single-dose under fasting conditions and pharmacokinetics will be characterized for a total of 28 healthy adult human subjects. Twenty-eight (28) subjects will be randomly assigned to receive either generic apixaban 5 mg film-coated tablets (1 x 5 mg; Test) or ELIQUISTM (1 x 5 mg; Reference) in Period 1 and after the washout period they will receive the other formulation as a crossover fashion in Period 2. conditions: Healthy Volunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: Apixaban 5MG name: ELIQUIS measure: Plasma Area Under the Curve (AUC(0 to 36hr)) for Apixaban measure: Peak Plasma Concentration (Cmax) of Apixaban sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06388226 id: IRB # 16143 briefTitle: Leg Heat Therapy in Heart Failure With Preserved Ejection Fraction overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2026-07-31 date: 2026-07-31 date: 2024-04-29 date: 2024-04-29 name: Indiana University class: OTHER name: Purdue University briefSummary: The objective of this pilot study is to establish evidence to support the validity of HT in improving skeletal muscle function and physical capacity of patients with HFpEF. Our central hypothesis is that HT treatment will lead to improvements in skeletal muscle and microvascular function compared to a control intervention. As a result, we anticipate that patients treated with HT will demonstrate improved skeletal muscle microvascular blood flow and oxygenation resulting in enhanced exercise tolerance. To explore this hypothesis, we propose the following specific aim: Explore the effects of home-based HT on exercise tolerance in patients with HFpEF. conditions: Heart Failure With Preserved Ejection Fraction studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Leg heat therapy name: Leg sham therapy measure: Change in time to exhaustion during treadmill exercise measure: Change in maximal pulmonary oxygen uptake during treadmill exercise measure: Change in triceps surae microvascular oxygenation during treadmill exercise measure: Change in systolic blood pressure measure: Change in diastolic blood pressure measure: Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score measure: Change in triceps surae microvascular oxygenation during reactive hyperemia measure: Change in triceps surae volume measure: Change in triceps surae intramuscular fat content measure: Change in the time constant for phosphocreatine recovery after dynamic exercise measure: Change in maximal plantar flexor strength sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06388213 id: GLP-1 RA patients GE by GUS briefTitle: Investigation of the Evolution of Gastric Emptying by Gastric Ultra Sonography in Patients Treated With GLP-1 Receptor Agonists on a 7 Days Pausing Period. overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2026-05 date: 2024-04-29 date: 2024-04-29 name: University Hospital, Geneva class: OTHER briefSummary: Glucagon-like-peptide-1 is a hormone released by the gut enteroendocrine cells. Its secretion occurs after each meal to enable production of insulin and inhibits the production of glucagon to lower after meal glycemia. It also inhibits gastric emptying and food intake. GLP-1 RA plays a role on GLP-1 receptors present on islet beta cells and delta cells of the pancreas to control insulin. GLP-1 receptors are also present in multiple region of the central nervous system such as the hypothalamus and hindbrain where it results in reducing food intake. For anesthesiologist it is important to understand how GLP-1 RA influence gastric emptying. Indeed, respecting a fasting period (6 hours for solid and 2 hours for liquid) before each surgery is one of the cornerstones of anesthesiology to significantly reduce the risk of pulmonary aspiration. One of the side effects of GLP-1 RA is slowing gastric emptying and increasing the risk of regurgitation in patient that observed a recommended fasting period. During 2023 a lot of cases reports have emerged of pulmonary aspiration or the presence of a full stomach in patient treated by GLP-1 RA for a type 2 diabetes. Despite recommendations made by the American Society of Anesthesiology, it is still unkown what is the best fasting period and how long patients should pause a long acting GLP-1 RA before surgery. In this observational study, we would like to determine the effect of GLP-1 RA on gastric emptying in patient scheduled for general anesthesia. We will measure and compare residual gastric content with gastric ultrasonography in patients treated by GLP-1 RA and in those who are not. We will also do these comparisons in a group of patients with type 2 diabetes treated by weekly GLP-1 RA at different days after the injection of the medication. Our hypothesis is that we will observe a reduction in gastric residue in patients who stopped weekly GLP-1 RA 7 days prior the examination compared to those who have stopped less days considering the same fasting period. This would lead us to propose an optimal duration of stopping time for GLP-1 inhibitors in the preoperative period. conditions: Diabetes Mellitus, Type 2 conditions: Anesthesia conditions: Pulmonary Aspiration of Gastric Contents studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Gastric Ultrasonography measure: Reduction of 5.5 cm2 of the CSA in patients pausing 7 days their GLP-1 RA treatment. measure: Correlation between a full stomach evaluated on gastric ultrasonography and gastric symptoms such as nausea and bloating. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06388200 id: OCU400-301 briefTitle: A Phase 3 Study Of OCU400 Gene Therapy for the Treatment Of Retinitis Pigmentosa acronym: liMeliGhT overallStatus: RECRUITING date: 2024-04-26 date: 2025-06-30 date: 2026-10-30 date: 2024-04-29 date: 2024-04-29 name: Ocugen class: INDUSTRY briefSummary: This is a Phase 3 study to Assess the Efficacy, Safety and Tolerability of OCU400 in patients with retinitis pigmentosa (RP) associated with RHO mutations and patients with any other RP associated mutation with a clinical phenotype of RP.

This is a multicenter, assessor blinded and randomized study which will enroll 150 subjects. conditions: Retinitis Pigmentosa studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: This is outcome assessor blinded study whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Sub-Retinal Administration of OCU400-301 measure: Number of participants with change in functional vision in the study eye of RP subjects as assessed by LDNA measure: Number of participants with change in functional vision in the study eye in Gene Agnostic group as assessed by LDNA measure: Number of participants with change in functional vision in the all treated eyes of RP subjects as assessed by LDNA measure: Number of participants with change in functional vision in the all treated eyes of subjects in Gene Agnostic Arm as assessed by LDNA measure: Number of participants with change in visual function in subjects with RHO mutation as assessed by LLVA letter score measure: Number of participants with change in visual function in Gene Agnostic Arm as assessed by LLVA letter scores measure: Ocular and non-ocular Events measure: Patients Global Impression of Change (PGIC) score sex: ALL minimumAge: 8 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Associated Retina Consultants status: RECRUITING city: Phoenix state: Arizona zip: 85020 country: United States name: Mallory Mintert, MS role: CONTACT phone: 480-999-5458 email: Mallory.mintert@doctrials.com name: Jillian Bollinger, BS role: CONTACT phone: 480-999-5458 email: Jillian.bollinger@doctrials.com name: Benjamin Bakall role: PRINCIPAL_INVESTIGATOR lat: 33.44838 lon: -112.07404 facility: Retina Consultants of Texas status: NOT_YET_RECRUITING city: Bellaire state: Texas zip: 77401 country: United States name: Rebbeca C Taing role: CONTACT phone: 713-524-3434 email: rebbecca.taing@retinaconsultantstexas.com name: Kenneth C Fan, M.D, MBA role: PRINCIPAL_INVESTIGATOR lat: 29.70579 lon: -95.45883 hasResults: False

 nctId: NCT06388187 id: NN9838-7749 id: U1111-1298-3451 type: OTHER domain: World Health Organization (WHO) id: 2023-509273-24 type: OTHER domain: European Medical Agency (EMA) briefTitle: A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight overallStatus: NOT_YET_RECRUITING date: 2024-06-24 date: 2026-02-27 date: 2026-04-10 date: 2024-04-29 date: 2024-04-29 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This study will look at how well CagriSema helps people with excess body weight lose weight. CagriSema is a new medicine developed by Novo Nordisk that combines cagrilintide and semaglutide. CagriSema cannot yet be prescribed by doctors. In the study, participant will either get CagriSema or dummy medicine and which treatment participant get is decided by chance. The study will last for about 1½ years for each participant. conditions: Obesity 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: Cagrilintide name: Semaglutide name: Placebo measure: Relative change in body weight measure: Achievement of ≥5% weight reduction measure: Achievement of ≥10% weight reduction measure: Achievement of ≥15% weight reduction measure: Achievement of ≥20% weight reduction measure: Change in waist circumference measure: Change in systolic blood pressure measure: Ratio to baseline in lipids: Total cholesterol measure: Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol measure: Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol measure: Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol measure: Ratio to baseline in lipids: Triglycerides measure: Ratio to baseline in lipids: Free fatty acids sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aurora FDRC Inc. city: Costa Mesa state: California zip: 92627 country: United States lat: 33.64113 lon: -117.91867 facility: Clinical Trial Res Assoc,Inc city: Plantation state: Florida zip: 33324 country: United States lat: 26.13421 lon: -80.23184 facility: Midwest Inst For Clin Res city: Indianapolis state: Indiana zip: 46260 country: United States lat: 39.76838 lon: -86.15804 facility: Accellacare city: Wilmington state: North Carolina zip: 28401 country: United States lat: 34.22573 lon: -77.94471 facility: Velocity Clinical Res-Dallas city: Dallas state: Texas zip: 75230 country: United States lat: 32.78306 lon: -96.80667 facility: Washington Cntr Weight Mgmt city: Arlington state: Virginia zip: 22206 country: United States lat: 38.88101 lon: -77.10428 facility: Capital Clin Res Ctr,LLC city: Olympia state: Washington zip: 98502 country: United States lat: 47.03787 lon: -122.9007 facility: Ocean West Research Clinic city: Surrey state: British Columbia zip: V3Z 2N6 country: Canada lat: 49.10635 lon: -122.82509 facility: Nova Scotia Health Authority city: Halifax state: Nova Scotia zip: B3H 1V7 country: Canada lat: 44.64533 lon: -63.57239 facility: Wharton Med Clin Trials city: Hamilton state: Ontario zip: L8L 5G8 country: Canada lat: 43.25011 lon: -79.84963 facility: Hospices Civils de Lyon-Hopital Lyon Sud-1 city: Pierre-Benite zip: 69310 country: France lat: 45.7009 lon: 4.82511 facility: Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1 city: Saint Herblain zip: 44800 country: France lat: 47.21765 lon: -1.64841 facility: Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1 city: Toulouse Cedex 9 zip: 31059 country: France lat: 43.60426 lon: 1.44367 facility: InnoDiab Forschung GmbH city: Essen zip: 45136 country: Germany lat: 51.45657 lon: 7.01228 facility: Wendisch/Dahl Hamburg city: Hamburg zip: 22607 country: Germany lat: 53.57532 lon: 10.01534 facility: AmBeNet GmbH city: Leipzig zip: 04107 country: Germany lat: 51.33962 lon: 12.37129 facility: Institut für Diabetesforschung GmbH Münster - Dr. med. Rose city: Münster zip: 48145 country: Germany lat: 51.96236 lon: 7.62571 facility: Forschungszentrum Ruhr KliFoCenter GmbH, Dr. med. Kahrmann city: Witten zip: 58455 country: Germany lat: 51.44362 lon: 7.35258 facility: The Health Centre city: Bradford-on-Avon zip: BA15 1DQ country: United Kingdom lat: 51.34772 lon: -2.25065 facility: Southmead Hospital city: Bristol zip: BS10 5NB country: United Kingdom lat: 51.45523 lon: -2.59665 facility: Addenbrooke's Hospital_Cambridge city: Cambridge zip: CB2 0QQ country: United Kingdom lat: 52.2 lon: 0.11667 facility: WISDEM Centre city: Coventry zip: CV2 2DX country: United Kingdom lat: 52.40656 lon: -1.51217 facility: The Staploe Medical Centre city: Soham zip: CB7 5JD country: United Kingdom lat: 52.33543 lon: 0.33654 facility: Joint Clinical Research Facility - Swansea city: Swansea zip: SA2 8PP country: United Kingdom lat: 51.62079 lon: -3.94323 hasResults: False

 nctId: NCT06388174 id: S2022-0336 briefTitle: Idiopathic Generalized Epilepsy Syndromes overallStatus: RECRUITING date: 2023-01-01 date: 2026-12-31 date: 2033-12-31 date: 2024-04-29 date: 2024-04-29 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: The idiopathic generalized epilepsies (IGEs) have historically included the syndromes childhood absence epilepsy (CAE), juvenile absence epilepsy (JAE), juvenile myoclonic epilepsy (JME), and epilepsy with generalized tonic-clonic seizures alone (GTCA). Recognition of the IGEs is important for clinical care, as it informs diagnosis, prevents unnecessary investigation, allows optimal selection of anti-seizure medications (ASMs), and provides prognostic guidance.

According to the new ILAE definition in 2022, the study aims to describe the clinical features, electroencephalographic, imaging findings and long-term prognosis. conditions: Epilepsy conditions: Epilepsy, Idiopathic Generalized studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: The proportion of drug-resistent epilepsy measure: The proportion of seizure freedom measure: The proportion of psychiatric comorbidity measure: The proportion of psychosocial outcome measure: The proportion of seizure relapse after antiseizure medication withdrawn sex: ALL minimumAge: 4 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China status: RECRUITING city: Hangzhou state: Zhejiang zip: 310000 country: China name: Chunhong Shen role: CONTACT phone: +86 0571 87783872 email: shen_neurology@zju.edu.cn lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06388161 id: Yan2022-0336 briefTitle: Neural Autoantibody Prevalence in New-onset Focal Seizures of Unknown Etiology overallStatus: RECRUITING date: 2023-08-01 date: 2025-12-31 date: 2030-12-31 date: 2024-04-29 date: 2024-04-29 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER name: Sir Run Run Shaw Hospital name: Ningbo Medical Center Lihuili Hospital name: Shaoxing People's Hospital briefSummary: Seizure is one of the most common symptoms in autoimmune encephalitis with neuronal surface-mediated antibodies. Interestingly, some patients may exhibit new-onset seizures as the initial manifestation without fulminant sign of encephalitis, particularly in the early stage.

It is essential to recognize these patients early and to perform antibody testing, as studies have reported early immunotherapy can improve their clinical outcomes. At the same time, it is important to limit the number of patients who require testing, for the sake of specificity and cost effectiveness. Thus, this prospective, multicenter study aims to identify neural antibodies in patients with focal seizures of unknown etiology, and to create a score to preselect patients requiring autoantibody testing. conditions: Epilepsy conditions: Encephalitis Autoimmune studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: Detectable serum neural autoantibodies measure: Neuronal surface antibodies-mediated autoimmune- encephalitis measure: The proportion of seizure freedom measure: The proportion of drug-resistent epilepsy measure: Clinical severity and recovery sex: ALL minimumAge: 14 Years maximumAge: 100 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China status: RECRUITING city: Hangzhou state: Zhejiang country: China name: Chun-Hong Shen role: CONTACT phone: +86 0571 87783872 email: shen_neurology@zju.edu.cn lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06388148 id: XL STROKE-2 briefTitle: Endovascular Treatment for eXtra-Large Ischemic Stroke acronym: XL STROKE-2 overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-10-31 date: 2027-01-31 date: 2024-04-29 date: 2024-04-29 name: Zhongming Qiu class: OTHER name: The First Affiliated Hospital, University of South China name: Xiangtan Central Hospital name: Zhejiang University name: Longyan First Affiliated Hospital of Fujian Medical University briefSummary: The role of endovascular thrombectomy in patients with extra-large ischemic burden is still unclear. The XL STROKE-2 randomized trial is aiming to investigate the efficacy and safety of mechanical thrombectomy in acute extra-large ischemic stroke patients with large vessel occlusion. conditions: Stroke, Acute Ischemic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 286 type: ESTIMATED name: Medical management name: Endovascular thrombectomy measure: Modified Rankin Scale score measure: Rate of successful reperfusion measure: Rate of excellent outcome measure: Rate of functional independence measure: Rate of independent ambulation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xiangtan Central Hospital city: Xiangtan state: Hunan zip: 421001 country: China lat: 27.85 lon: 112.9 facility: Xingguo County People's Hospital city: Ganzhou state: Jiangxi country: China hasResults: False

 nctId: NCT06388135 id: SNC-01 briefTitle: Serplulimab Combined With Nab-paclitaxel and Cisplatin in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05 date: 2027-05 date: 2024-04-29 date: 2024-04-29 name: Yang Jianjun, PhD class: OTHER briefSummary: Abstract Objective: This study aims to investigate the potential clinical impact of neoadjuvant immunotherapy in resectable esophageal squamous cell carcinoma (ESCC).

The efficacy and safety of combining the programmed death 1 (PD-1) inhibitor serplulimab with nab-paclitaxel and cisplatin as neoadjuvant therapy in patients with resectable ESCC will be evaluated. Methods and analysis: A prospective, single-center, open-label cohort study will enroll 80 patients, with 40 patients allocated to the experimental group and 40 patients to the control group. Patients in the experimental arm will undergo 3 cycles of neoadjuvant therapy comprising serplulimab, cisplatin, and nab-paclitaxel, while those in the control arm will receive 3 cycles of neoadjuvant therapy with cisplatin and nab-paclitaxel. The primary efficacy endpoint will be the assessment of pathological complete response (pCR) following neoadjuvant therapy. Secondary efficacy endpoints will include major pathological response (MPR), disease-free survival, objective response rate (ORR), and monitoring of adverse events (AEs).

Ethics: Ethics approval has been obtained from the Ethics Committee at the First Affiliated Hospital (Xijing Hospital) of Air force Military Medical University (KY20242052-C-1). conditions: Esophageal Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Serplulimab Combined With Nab-paclitaxel and Cisplatin name: nab-paclitaxel，Cisplatin measure: pCR measure: MPR measure: DFS measure: ORR measure: AEs sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06388122 id: 23-009689 id: NCI-2024-03405 type: REGISTRY domain: CTRP (Clinical Trials Reporting Program) id: MC240301 type: OTHER domain: Mayo Clinic briefTitle: DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Metastatic Breast Cancer Patients overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2026-06-15 date: 2026-06-15 date: 2024-04-29 date: 2024-04-29 name: Mayo Clinic class: OTHER briefSummary: The purpose of this study is to explore the clinical utility of routinely measuring thymidine kinase activity (TKa) in HR+ metastatic breast cancer patients receiving treatment with any approved endocrine therapy either alone or in combination with any approved CDK4/6 inhibitor. conditions: HER2-negative Breast Cancer conditions: Hormone-receptor-positive Breast Cancer conditions: Metastatic Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Biospecimen Collection measure: DiviTum®TKa assay as an early predictor of primary treatment resistance sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Florida city: Jacksonville state: Florida zip: 32224-9980 country: United States name: Clinical Trials role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Pooja Advani, MBBS, MD role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 hasResults: False

 nctId: NCT06388109 id: IRB15-00741 briefTitle: Positive Peers Intervention Clinical Trial acronym: PoPIT overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-05 date: 2027-11 date: 2024-04-29 date: 2024-04-29 name: MetroHealth Medical Center class: OTHER name: Kent State University briefSummary: The goal of this clinical trial is to learn if the Positive Peers mobile app intervention increases rates of viral suppression in young (13-34 y/o) persons with HIV.

Does use of the Positive Peers app improve viral suppression among young minority persons with HIV? What user characteristics are associated with a) viral suppression, b) retention in care, and c) perceived HIV-related stigma?

Participants will:

* download the mobile app onto their personal smartphone
* Use the mobile app as they find useful
* complete online surveys at enrollment, 3 mo, 6, mo, 9 mo and 12 months. conditions: HIV Infections studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized control trial with observational cohort for eligible patients who decline participation primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 250 type: ESTIMATED name: Positive Peers mobile app measure: Viral suppression measure: Correlates of app use and viral suppression measure: Correlates of app use and retention in care measure: Correlates of app use and HIV related perceived stigma sex: ALL minimumAge: 13 Years maximumAge: 34 Years stdAges: CHILD stdAges: ADULT facility: Northeast Valley Health Corporation city: Van Nuys state: California zip: 91405 country: United States name: Edgar Banuelos role: CONTACT email: edgarbanuelos@nevhc.org name: Herberth Osorio, MPH role: PRINCIPAL_INVESTIGATOR lat: 34.18667 lon: -118.44897 facility: Infectious Disease Practice- Rutgers University city: Newark state: New Jersey zip: 07103 country: United States name: Jared Khan role: CONTACT email: khanjj@njms.rutgers.edu name: Shoba Swaminathan, MD role: PRINCIPAL_INVESTIGATOR lat: 40.73566 lon: -74.17237 facility: Equitas Health city: Cincinnati state: Ohio zip: 45206 country: United States name: Tania Slack-Peterson role: CONTACT email: TaniaSlack@equitashealth.com name: Kelly Wesp, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.12713 lon: -84.51435 facility: Equitas Health city: Columbus state: Ohio zip: 43203 country: United States name: Tania Slack-Peterson role: CONTACT email: TaniaSlack@equitashealth.com name: Kelly Wesp, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 facility: Thomas Street Clinic city: Houston state: Texas zip: 77004-8004 country: United States name: Ernesto Linares Pineda role: CONTACT email: Ernesto.LinaresPineda@bcm.edu name: Shital Patel, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 facility: UW Madison Clinic at Harborview city: Seattle state: Washington zip: 98104 country: United States name: Tala Mahmoud role: CONTACT email: talam2@uw.edu name: H Nina Kim, MD, MPH role: PRINCIPAL_INVESTIGATOR name: Raaka Kumbhakar, MD role: SUB_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06388096 id: PERGCLAD001 briefTitle: CLAD Deconvolved PERG Responses in Glaucoma Patients overallStatus: RECRUITING date: 2023-06-01 date: 2025-06-01 date: 2025-06-01 date: 2024-04-29 date: 2024-04-29 name: Jorvec Corp. class: INDUSTRY name: University of Miami briefSummary: Glaucoma is a progressive disease resulting in blindness. Determining the onset of the disease is critical so patients may obtain treatment to preserve useful vision. This study will collect data from a population of glaucoma suspects (with positive factors for the disease but with normal vision) along with a population of age matched controls using the pattern electroretinogram (PERG) and other standard eye tests for glaucoma. The PERG measures the function of retinal ganglion cells (RGCs) which come together to form the optic nerve. RGCs may become dysfunctional before dying. The Continuous loop deconvolution technique (CLAD) will be used to extract transient PERG responses in both glaucoma suspects and age matched controls. All patients will be monitored with PERG, Optic Coherence Tomography (OCT) and other ancillary tests over 2 years. CLAD will be compared with conventional techniques of monitoring glaucoma (standard PERG, OCT, visual field etc) to see if the CLAD is better at distinguishing between glaucoma suspects and controls. conditions: Glaucoma, Suspect studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 120 type: ESTIMATED name: No Intervention Provided measure: PERG Amplitude measure: PERG Latency sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Miami, Bascom Palmer Eye Institute 900 NW 17th Street status: RECRUITING city: Miami state: Florida zip: 33136 country: United States name: Vittorio Porciatti, MD/PhD role: CONTACT email: vporciatti@med.miami.edu lat: 25.77427 lon: -80.19366 hasResults: False

 nctId: NCT06388083 id: LBS-008-CT07 briefTitle: A Phase 2/3 Study to Evaluate the Efficacy and Safety of Tinlarebant in Subjects With Stargardt Disease acronym: DRAGON II overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-06 date: 2027-07 date: 2024-04-29 date: 2024-04-29 name: Belite Bio, Inc class: INDUSTRY briefSummary: The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of tinlarebant in subjects with Stargardt Disease conditions: STGD1 conditions: Stargardt Disease 1 studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Tinlarebant name: Placebo measure: To measure the annualized rate of change from baseline lesion size in aggregate area of atrophy measure: To measure the annualized rate of change in total area of atrophy measure: Change in BCVA measured by the ETDRS method sex: ALL minimumAge: 12 Years maximumAge: 20 Years stdAges: CHILD stdAges: ADULT facility: Belite Study Site city: Dallas state: Texas zip: 75231 country: United States lat: 32.78306 lon: -96.80667 hasResults: False

 nctId: NCT06388070 id: HUC3-053 briefTitle: To Evaluate the Efficacy and Safety of HUC3-053 in Patients With Dry Eye Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03 date: 2025-04 date: 2024-04-29 date: 2024-04-29 name: Huons Co., Ltd. class: INDUSTRY briefSummary: This is a multi-center, randomized, double-blinded, non-inferiority study to evluate the efficacy and safety of HUC3-053 in patients with dry eye syndrome.

After a 2-week run-in period, patients will be randomized equally to the HUC3-053 or Hyalein Mini Drops administered bilaterally five to six times a day for 12 weeks. conditions: Dry Eye Syndromes studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 280 type: ESTIMATED name: HUC3-053 name: Hyalein Mini Drops measure: Change from Baseline in Corneal staining score measure: Change from Baseline in Corneal staining score measure: Change from Baseline in Conjunctival staining score measure: Change from Baseline in Schirmer test measure: Change from Baseline in Tear film break-up time measure: Change from Baseline in Ocular surface disease index measure: Change from Baseline in Soreness after eye drop assessed by NRS sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06388057 id: 5836 briefTitle: Intraoperative Ultrasound in Crohn's Disease overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-06-30 date: 2025-09-01 date: 2024-04-29 date: 2024-04-29 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: To study the role of intraoperative ultrasound of small bowel as a possible tool that can reduce the rate of histologically involved resection margins from Crohn's Disease. conditions: Crohn Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients with Crohn's disease with an indication for surgery primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: Intraoperative Small Bowel Ultrasonography measure: Specificity and sensibility of intraoperative ultrasound of small bowel in identifying resection margins histologically involved by Crohn's disease sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06388044 id: PRO00115010 briefTitle: ACT for Infertility: Case Series overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-29 date: 2024-04-29 name: Duke University class: OTHER briefSummary: In the United States, around 19% of reproductive-aged couples suffer from infertility. The psychological distress associated with infertility is well-established; those diagnosed commonly experience depression and anxiety symptoms, diminished quality of life, and relationship dissatisfaction. In the current study, the investigators report on a case series, in which up to 10 infertility patients will receive 12 sessions of Acceptance and Commitment Therapy (ACT). The overarching goal for the current case series is to determine whether ACT might be well-suited for infertility patients experiencing distress. The specific aims are: 1) to describe the components of the intervention that was delivered; 2) to determine the extent to which infertility patients perceive a 12-session ACT intervention beneficial and acceptable; 3) to describe change in mood, stress, and ACT processes across 12 sessions of ACT; and 4) to highlight potential processes through which ACT might promote benefits to the patient by describing how change in mood, stress, and ACT processes relate to each other over the course of 12 sessions of ACT. conditions: Infertility conditions: Psychological Distress conditions: Acceptance and Commitment Therapy conditions: Psychological Flexibility studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Acceptance and Commitment Therapy measure: Acceptability of the Intervention measure: Change in Fertility Problem Inventory (FPI) measure: Change in Patient Health Questionnaire 9 (PHQ-9) measure: Change in Patient Health Questionnaire 2 (PHQ-2) measure: Change in Generalized Anxiety Disorder Questionnaire 7 (GAD-7) measure: Change in Generalized Anxiety Disorder Questionnaire 2 (GAD-2) measure: Change in Modified Differential Emotions Scale (mDES) measure: Change in Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT-15) measure: Change in Intolerance of Uncertainty (IUS) measure: Change in Valuing Questionnaire (VQ) measure: Change in Values-Based Behavior sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Duke North Pavilion city: Durham state: North Carolina zip: 27705 country: United States name: Francesca Scheiber, PhD role: CONTACT phone: 919-668-8696 email: fs158@duke.edu name: Julia Woodward, PhD role: SUB_INVESTIGATOR name: Ashley Moskovich, PhD role: SUB_INVESTIGATOR lat: 35.99403 lon: -78.89862 hasResults: False

 nctId: NCT06388031 id: CAPTRAL2024v1 briefTitle: ICI Rechallenge for Advanced NSCLC With Long-Term Response to First-Line ICI overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2027-01-10 date: 2027-12-10 date: 2024-04-29 date: 2024-04-29 name: Peking Union Medical College Hospital class: OTHER briefSummary: An exploratory phase II trial of immune checkpoint inhibitors (ICIs, anti-PD-1/anti-PD-L1) as second-line treatment with advanced non-small cell lung cancer (NSCLC) who had long-term response to first-line immunotherapy (with or without chemotherapy).

This study aims to evaluate efficacy and safety of ICI rechallenge in long-term responders to prior ICI. Furthermore, it seeks to identify biomarkers capable of predicting the efficacy of immunotherapy and prognosis. conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: Immune checkpoint inhibitor measure: Progression Free Survival (PFS) measure: Overall Survival (OS) measure: Objective Response Rate (ORR) measure: Progression Free Survival 2 (PFS 2) measure: Safety profile sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital city: Beijing zip: 100730 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06388018 id: NRG-GY032 id: NCI-2023-09355 type: REGISTRY domain: CTRP id: CCTG EN.10 type: OTHER domain: CCTG id: U10CA180868 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180868 briefTitle: Tailoring Therapy in Post-surgical Patients With Low-risk Endometrial Cancer overallStatus: SUSPENDED date: 2024-04-16 date: 2025-01-09 date: 2025-01-09 date: 2024-04-29 date: 2024-04-29 name: NRG Oncology class: OTHER name: National Cancer Institute (NCI) name: Canadian Cancer Trials Group briefSummary: This phase II trial tests how well tailoring therapy in post-surgery works in patients with low-risk endometrial cancer. The usual approach for patients with low-risk endometrial cancer is treatment with surgery. In this study, tissue that is removed as part of the surgical procedure is analyzed in the pathology laboratory to help guide the doctor to decide whether or not additional treatment such as radiation and or chemotherapy should be recommended. conditions: Stage I Uterine Corpus Endometrial Stromal Sarcoma AJCC V8 conditions: Stage II Uterine Corpus Endometrial Stromal Sarcoma AJCC V8 conditions: Stage III Uterine Corpus Endometrial Stromal Sarcoma AJCC V8 studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 325 type: ESTIMATED name: Clinical Observation name: External Beam Radiation Therapy name: High-Dose-Rate Vaginal Brachytherapy name: Computed Tomography name: Positron Emission Tomography name: X-Ray Imaging name: Magnetic Resonance Imaging name: Questionnaire Administration measure: Time to pelvic recurrence measure: Time to isolated vaginal recurrence measure: Recurrence-free survival measure: Endometrial cancer-specific survival measure: Fear of recurrence sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Washington University School of Medicine city: Saint Louis state: Missouri zip: 63110 country: United States lat: 38.62727 lon: -90.19789 hasResults: False

 nctId: NCT06388005 id: 2021-060 briefTitle: The Application of Emotion Release Technology in Anxiety Patients Before Daytime Thyroid Surgery overallStatus: COMPLETED date: 2022-03-01 date: 2022-07-31 date: 2022-07-31 date: 2024-04-29 date: 2024-04-29 name: Yantai Yuhuangding Hospital class: OTHER briefSummary: Research methods

1 Data collection and evaluation tools

1. The general data record sheet was self-designed by the research team, and the collected content included age, gender, BMI, occupation, general family status, economic situation, history of hypertension and cardiovascular diseases, history of anxiety and depression, self-rating anxiety scale (SAS) score, blood pressure and heart rate before and after intervention, disease diagnosis and severity, etc.
2. The anxiety was self-scored using the VAS-A (0-10 points), with 0 point as no anxiety and 10 as severe anxiety.
3. Negative emotional intensity was scored using the subjective unit of disturbance scale (SUDS, 0-10 points), with 0 point as no and 10 points as severe.
4. Nursing satisfaction was scored by the self-designed questionnaire (1-5 points): 5 points, very satisfied; 4 points, relatively satisfied; 3 points, satisfied; 2 points, medium; 1 point, dissatisfied.

2 Intervention method of the control group The control group was given routine nursing. After entering the pre-anesthesia room, the patients were scored using the VAS-A, and those with VAS-A score ≥ 5 were considered to meet the inclusion criteria. After identity authentication, the preoperative precautions and reasons for waiting in the pre-anesthesia room were explained to the patients, and answers were provided to the questions raised by the patients. After routine nursing, VAS-A score was recorded, blood pressure and heart rate were monitored, and nursing satisfaction was inquired. The survey of patient satisfaction with nursing was completed before entering the operating room.

3 Intervention method of the experimental group 3.1 Researcher training Before intervention, 4 nurses were trained for 5 d by a nurse with EFT qualification certificate, 1 h per day. The training content included: theoretical knowledge of EFT, tapping techniques, etc. After training, two assessments were conducted. Only those who scored above 90 points in both assessments could participate in the study.

3.2 Operating instructions The acupoint diagram was distributed to the experimental group by nurses, and the essentials and precautions of acupoint tapping were explained. The nurses demonstrated and tapped the acupoints on the patients while explaining, and then instructed them to tap on their own until they were able to complete the task independently and proficiently. For patients with upper limb vein puncture, proper fixation and close observation were needed, and the flexible nature of the puncture needle that would not affect operations was explained to the patients to eliminate their concerns.

3.3 Intervention content After routine nursing, the patients received EFT intervention. In addition, subjective anxiety was scored, blood pressure and heart rate were monitored, and nursing satisfaction was surveyed after admission and intervention. The specific methods are as follows.

1. Preparation stage The patients with VAS-A score ≥ 5 meeting the inclusion criteria were in a comfortable position with eyes closed, and adopted breathing exercise to relax their whole body. The patients were guided to summarize the main current distresses, such as fear, tension, pain, surgical prognosis, economic burden, etc., name the caused negative emotions, and use the SUDS to evaluate the intensity of negative emotions. The patients were asked to recite silently the prompt "Although I am very \*\* (a negative emotional word) now, I still deeply and completely love and accept myself" while tapping.
2. Tapping stage The patients were guided to gently massage the sore points on both sides of the body (2-3 fingers below the midpoint of the clavicle) with their five fingers together in a clockwise direction, while silently reciting the prompt 3 times. Then, the patients were guided to close their index and middle fingers together and gently tap the Zanzhu, Tongziliao, Chengqi, Renzhong, Chengjiang, Shufu, Dabao and Baihui acupoints successively with their fingertips at 2-3 times/s and the force they can bear. The prompt was recited silently when tapping each acupoint. After 3-5 rounds of tapping, 3 deep breaths were taken to re-evaluate the intensity of negative emotions.
3. Feedback stage After tapping, the patients communicated with the nurses at least once about their evaluated negative emotional intensity score and whether the score was accepted. If the tapping effect was not obvious, the evaluation was conducted by nurses, and the patients were guided to massage the sore points while silently reciting the prompt 3 times. To relieve reverse psychological drive, tapping was continued until the intensity of negative emotions reduced. conditions: Anxiety conditions: Day Surgery conditions: Preoperative Nursing Care conditions: Emotional Freedom Technique studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 237 type: ACTUAL name: emotional freedom technique (EFT) measure: VAS-A score measure: hemodynamic and endocrine indicators measure: nursing satisfaction sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: Yantai Yuhuangding Hospital city: Yantai state: Shandong zip: 264000 country: China lat: 37.47649 lon: 121.44081 hasResults: False

 nctId: NCT06387992 id: PP24023 briefTitle: Evaluation of the Agreement Between a Consultation With a Nurse Acquiring Three-dimensional Intraoral Images Made With a 3D Intraoral Camera and the Standard Consultation With a Dental Surgeon, in Institutionalized Elderly Subjects acronym: GEROdonto3D overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-06-01 date: 2027-06 date: 2024-04-29 date: 2024-04-29 name: CHU de Reims class: OTHER briefSummary: The primary objective of this study will be to assess the agreement between a dental consultation with a nurse acquiring intraoral images, using a 3D intraoral camera, and a standard consultation with a dental surgeon, in institutionalized elderly subjects Institutionalized subjects planned to have a dental consultation and eligible will be included once written informed consent is signed. Their dental consultation will start with a consultation with a nurse to record 3D intraoral images, then a consultation with a dental surgeon for standard dental care, blinded from the nurse consultation will be performed. Thereafter, 3D images will be analyzed by another dental surgeon blinded from the results of both consultations. Agreement on different outcomes between the analysis of the images acquired by the nurse and the standard dental evaluation by a dental surgeon will be assessed.

Agreement on the results between the interpretation of the 3D images acquired by a nurse and the standard consultation by a dental surgeon could lead, in the long term, to a significant step forward in dental care of institutionalized patients.

Indeed, training nursing home nurses to acquire 3D dental images would enable the identification of patients in need of immediate dental care and thus extend the possibilities of access to consultations with a dentist for these patients. This would increase the efficiency of care. conditions: Dental Care for Institutionalized Elderly Persons studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 50 type: ESTIMATED name: Three-dimensional dental acquisition measure: DMFT index measure: Plaque control record measure: General Oral Health Assessment Index (GOHAI) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Damien JOLLY city: Reims country: France name: Carole ETIENNOT role: CONTACT phone: 03 10 73 66 79 phoneExt: 0033 email: cetiennot@chu-reims.fr lat: 49.25 lon: 4.03333 hasResults: False

 nctId: NCT06387979 id: 19-010725 id: NCI-2024-01000 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 19-010725 type: OTHER domain: Mayo Clinic in Florida id: P30CA015083 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA015083 id: R33CA240181 type: NIH link: https://reporter.nih.gov/quickSearch/R33CA240181 briefTitle: Advanced Development of Desorption Electrospray Ionization Mass Spectrometry for Intraoperative Molecular Diagnosis of Brain Cancer Using Pathology Biopsies overallStatus: RECRUITING date: 2020-10-26 date: 2025-10-15 date: 2025-10-15 date: 2024-04-29 date: 2024-04-29 name: Mayo Clinic class: OTHER name: National Cancer Institute (NCI) briefSummary: This study explores whether DESI-MS can be used to identify cancerous vs. noncancerous tissue during brain tumor surgery. conditions: Glioma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 185 type: ESTIMATED name: Non-Interventional Study measure: Pathological state of the tissue measure: Percentage of tumor infiltration measure: Presence of IDH mutations sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT 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: Alfredo Quinones-Hinojosa, M.D. role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 hasResults: False

 nctId: NCT06387966 id: H-FNTN-PI-Ia briefTitle: A Randomized, Double-blind,Dose-escalating, Single-dose, Oral Phase I Clinical Study of Flunotinib Healthy People overallStatus: RECRUITING date: 2024-02-29 date: 2024-08-29 date: 2024-12-30 date: 2024-04-29 date: 2024-04-29 name: Chengdu Zenitar Biomedical Technology Co., Ltd class: INDUSTRY briefSummary: Evaluate the safety and tolerability of a single increasing dose of Flibanserin Maleate tablets administered orally to healthy adult Chinese subjects; preliminarily assess the pharmacokinetic characteristics of a single dose of oral Flibanserin Maleate tablets conditions: Healthy Person studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: flunotinib name: flunotinib placebo measure: Prilinostat Mesylate Pharmacokinetics (PK)：Cmax measure: Prilinostat Mesylate Pharmacokinetics (PK)：Tmax measure: The statistical parameters of fecal pharmacokinetics are the cumulative excretion of prototype drugs and major metabolites in feces (Ae0-144h) and excretion rate (Ae%); measure: Prilinostat Mesylate Pharmacokinetics (PK)：AUC0-∞ measure: Prilinostat Mesylate Pharmacokinetics (PK)：MRT measure: Prilinostat Mesylate Pharmacokinetics (PK)：Vd measure: Prilinostat Mesylate Pharmacokinetics (PK)：t1/2 measure: Prilinostat Mesylate Pharmacokinetics (PK)：CLz/F measure: Prilinostat Mesylate Pharmacokinetics (PK)：Vz/F measure: Prilinostat Mesylate Pharmacokinetics (PK)：Ke sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Chengdu Xinhua Hospital status: RECRUITING city: Chengdu state: Sichuan zip: 610000 country: China name: Xiaolan Yong, bachelor role: CONTACT phone: 13568843829 email: yongxlan@126.com lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06387953 id: STUDY00019480 briefTitle: Mitigation of Emergence Agitation Through Implementation of Masimo Bridge Therapy overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-06 date: 2025-06 date: 2024-04-29 date: 2024-04-29 name: University of Washington class: OTHER briefSummary: This is a randomized, prospective, double-blinded (patient and outcome-assessor) trial. Our goal is to assess efficacy of Bridge Therapy (versus sham bridge therapy) to prevent emergence agitation following general anesthesia.

Primary Objective: Activation of Bridge Therapy from the time of the pre incision "time out" until 24 hours after admission to the PACU (Post Anesthesia Care Unit) is associated with reduced frequency and intensity of emergence agitation.

Secondary Objective: Bridge Therapy activation will also result in a lower incidence of rescue pharmacologic treatment of agitation.

Tertiary Objective: Activation of Bridge Therapy during a stable anesthetic state is associated with a reduced Patient State Index as measured on Sedline conditions: Emergence Delirium conditions: Agitation, Emergence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Bridge Therapy name: Sham Therapy measure: Emergence agitation measure: Emergence agitation measure: Rescue pharmacologic treatment of agitation measure: Patient State Index sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06387940 id: UEC 2019 008 FHMS briefTitle: Acute Metabolic Effects of Carbohydrate Restriction at Varying Energy Levels overallStatus: COMPLETED date: 2019-11-05 date: 2020-04-01 date: 2022-11-20 date: 2024-04-29 date: 2024-04-29 name: University of Surrey class: OTHER briefSummary: This study investigates how different low-carbohydrate diets affect metabolism and hunger in overweight adults. We will measure metabolic rates and blood metabolites. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 12 type: ACTUAL name: nEB Diet, followed for 36 hours name: LC25 Diet, followed for 36 hours name: LCEB Diet, followed for 36 hours measure: Biomarkers in blood Measured measure: Resting metabolic rate measure: Perceived Appetite Scores measure: Food intake sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Surrey city: Guildford zip: GU2 7XH country: United Kingdom lat: 51.23536 lon: -0.57427 hasResults: False

 nctId: NCT06387927 id: PT-NEUR-10/2023-520 briefTitle: Effect of Home-exercise Programs Versus Supervised Core Stability Exercises on Hypertensive Patient With Low Back Pain overallStatus: COMPLETED date: 2023-09-02 date: 2024-02-02 date: 2024-02-20 date: 2024-04-29 date: 2024-04-29 name: Ahram Canadian University class: OTHER briefSummary: Thirty male and female hypertension patients with chronic mechanical non-specific low back pain were included in this randomized controlled study conducted at the Ababa Private Physical Therapy Center in Beni-Seuf, Egypt. They were randomly assigned into two equal groups; the study group A control (n = 15) had a supervised conventional core stability, while the study group B (n = 15) received a home exercise program. In both groups' patients had evaluations before and after their six-week course of therapy. Modified-modified Schober test was used to assess the active back range of motion (ROM), Arabic version of Oswestry disability index (ODI) was utilized to evaluate functional disability, and visual analog scale (VAS) was used to measure pain. conditions: Hypertension conditions: Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 30 type: ACTUAL name: home exercise program name: the core stability exercise measure: Assessment of pain measure: Assessment of lumbar flexion range of motion measure: Assessment of functional disability sex: ALL minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of physical therapy city: Giza zip: 3387722 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06387914 id: PID 16707 id: 23/WM/0219 type: OTHER domain: Ethics Committee (South Birmingham REC) UK briefTitle: Efficacy of Pain Intervention With Deep Brain Stimulation Neuromodulation acronym: EPIONE overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2026-05-02 date: 2027-05-02 date: 2024-04-29 date: 2024-04-29 name: University of Oxford class: OTHER name: Jon MoultonTrust name: Placito Bequest name: Bioinduction briefSummary: The goal of this clinical trial is to learn if deep brain stimulation (DBS) works to treat severe pain following a stroke in adults. It will also learn about the safety of deep brain stimulation. The main questions it aims to answer are:

* Does DBS lower the pain score in these participants.
* What medical problems do participants have when having DBS? Researchers will compare different settings, to see if DBS works to treat severe post stroke pain.

Participants will:

* Undergo baseline screening procedures and have an MRI scan.
* Have neurosurgery to put the DBS system in
* Have follow up for 10 months
* Visit the clinic at least 5 times in the study for check-ups and tests
* Fill in questionnaires about pain and mood and have check ups remotely conditions: Central Post Stroke Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Double-blind trial, within subject randomisation and cross-over. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Blinding maintained using the hand held controller (shows ON at all times) and programs which ensure equivalent battery drain at all stimulation settings.

Pseudo-ON =high frequency, low amplitude stimulation. Frequency up to 250 Hertz(Hz), Amplitude less than 0.5 milliamps(mA), Pulse Width 500 microseconds(uS). whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Stimulation ON name: Stimulation Pseudo-ON measure: McGill Pain Questionnaire V2.0 -Short Form - Present Pain Intensity (MQ-SF-PPI) score measure: Numerical Rating Scale (NRS) measure: McGill Pain Questionnaire V2.0 short form (MPQ-SF) McGill Pain Questionnaire V2.0 short form) MPQ-SF (McGill Pain Questionnaire V2.0 short form) measure: Brief Pain Inventory (BPI) - Short Form measure: Beck Depression Inventory (BDI II) measure: Patients' Global Impression of Change (PGIC) measure: EuroQol Quality of life (EQ5D-5L) measure: Healthy Days Measures (HDM) measure: Adverse Events (AEs) measure: Heart rate variability (HRV) measure: Client Service Receipt Inventory (CSRI) measure: MRI sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06387901 id: PABTOX - part 1 briefTitle: Investigating Paclitaxel Toxicity in Breast Cancer: The Roles of Physical Activity and Body Composition. acronym: PABTOX overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2025-05-06 date: 2025-10-31 date: 2024-04-29 date: 2024-04-29 name: Universitair Ziekenhuis Brussel class: OTHER name: Vrije Universiteit Brussel name: University Ghent briefSummary: This study looks into how a common breast cancer treatment, paclitaxel, can sometimes cause severe side effects that make it hard for patients to continue treatment. These side effects can significantly affect a patient's quality of life and even impact their recovery and overall health costs. What's interesting about this research is that it considers how a patient's lifestyle, specifically their physical activity levels and body makeup (like how much muscle and fat they have), might influence these side effects.

The researchers are doing a detailed study with 40 women receiving paclitaxel treatment, tracking how the drug is processed in their bodies and how their body composition and physical activity might play a role in the side effects they experience. They are using a special method to monitor drug levels in the blood and are also keeping tabs on the patients' health and physical activity through questionnaires and modern tracking devices.

The goal here is twofold: first, to better understand why these side effects happen to some people and not others, and second, to develop a model that can predict who might be at higher risk for these side effects based on their body composition, lifestyle, and how their body handles the drug. This could lead to more personalized treatment plans that could help reduce the risk of severe side effects and improve the overall treatment experience for patients with breast cancer.

In simpler terms, this research is trying to find a way to make breast cancer treatment with paclitaxel safer and more comfortable by considering how a person's lifestyle and body type might affect their reaction to the drug. This could make a big difference in helping patients complete their treatment successfully and with a better quality of life. conditions: Breast Cancer conditions: Paclitaxel Adverse Reaction conditions: Chemotherapeutic Toxicity conditions: Chemotherapeutic Agent Toxicity conditions: Body Weight conditions: Physical Inactivity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Paclitaxel Chemotherapy measure: Identification of Body Composition Parameter (Muscle mass) Related to Dose-Limiting Toxicities (DLTs) measure: Identification of Body Composition Parameters (Fat %) Related to Dose-Limiting Toxicities (DLTs) measure: Identification of Physical Activity Parameters Related to Dose-Limiting Toxicities (DLTs) measure: Paclitaxel Exposure Analysis (Cmax) measure: Paclitaxel Exposure Analysis (AUC) measure: Number and Type of Dose-Limiting Toxicities measure: Treatment-Related Adverse Events measure: Body Composition Measurement via Bioelectrical Impedance Analysis (BIA) (muscle mass) measure: Body Composition Measurement via Bioelectrical Impedance Analysis (BIA) (fat %) measure: Body Composition Measurement via Dual X-ray Absorptiometry (DEXA) (muscle mass) measure: Body Composition Measurement via Dual X-ray Absorptiometry (DEXA) (fat mass) measure: Body Composition Measurement via Dual X-ray Absorptiometry (DEXA) (extracellular fluid) measure: The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) measure: EORTC QLQ-BR45 Breast (BR) Cancer Module measure: EORTC QLQ- Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20 measure: European Health Interview Survey Physical Activity Questionnaire (EHIS PAQ) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vrije Universiteit Brussel city: Brussel state: Jette zip: 1090 country: Belgium name: Nele Adriaenssens role: CONTACT phone: +32 2 476 36 23 email: Nele.Adriaenssens@vub.be name: Len De Nys role: CONTACT phone: +32 472 99 49 48 email: Len.de.nys@vub.be lat: 50.85045 lon: 4.34878 hasResults: False

 nctId: NCT06387888 id: E-31034136-302.08.01-4221 briefTitle: The Effect of Mother's Voice on the Levels of Pain and Comfort in Newborns acronym: Newborn overallStatus: COMPLETED date: 2021-07-01 date: 2021-09-01 date: 2022-04-30 date: 2024-04-29 date: 2024-04-29 name: Istanbul Medipol University Hospital class: OTHER briefSummary: This study was conducted in a randomized controlled experimental type to determine the effect of maternal voice during care on pain and comfort level in term newborns receiving mechanical ventilation. The sample of the study was consisted of 60 term newborns receiving mechanical ventilation who were hospitalized in the 7-bed Neonatal Intensive Care Unit of a private hospital in Istanbul in accordance with the selection criteria. Introductory Information Form, Vital Signs Follow-up Form, Neonatal Comfort Behavior Scale and Neonatal Pain Scale (NPASS) forms prepared by the researchers were used as data collection tools. conditions: Newborns studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: INVESTIGATOR count: 60 type: ACTUAL name: Listening to mother's voice measure: Neonatal Comfort Behavior Scale measure: Neonatal Comfort Behavior Scale (COMFORTneo): sex: ALL minimumAge: 3 Weeks maximumAge: 41 Weeks stdAges: CHILD facility: Istanbul Medipol University Hospital city: Istanbul state: Beykoz country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06387875 id: Hangzhou Bay Cohort briefTitle: Cohort in Qianwan New District, Ningbo overallStatus: RECRUITING date: 2023-11-01 date: 2027-06-30 date: 2027-06-30 date: 2024-04-29 date: 2024-04-29 name: RenJi Hospital class: OTHER name: Ningbo Hangzhou Bay Hospital briefSummary: Our objective is to carry out research on prevention and control of noncommunicable chronic diseases, and establish a risk prediction mechanism for chronic diseases to promote early detection, early diagnosis and early treatment of chronic diseases in natural population in Qianwan District of Ningbo, significantly reduce medical costs and extend population life span. conditions: Cardiovascular Diseases conditions: Stroke conditions: Non-Communicable Chronic Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30000 type: ESTIMATED measure: death measure: incidence of cardio-cerebrovascular diseases measure: incidence of other non-communicable chronic diseases sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University status: RECRUITING city: Shanghai country: China name: Jun Pu, MD,PHD role: CONTACT phone: 86-21-68383477 email: pujun310@hotmail.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06387862 id: 2022SIMBIOV briefTitle: Pharmacokinetics of Inhaled Levosimendan acronym: Symbiov overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-11 date: 2025-01 date: 2024-04-29 date: 2024-04-29 name: Universitair Ziekenhuis Brussel class: OTHER briefSummary: Determination of biological availability, time-to-peak and elimination half-life of inhaled levosimendan by administration of an inhaled- and intravenous dose of levosimendan. conditions: Left Ventricular Dysfunction studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: BASIC_SCIENCE masking: NONE count: 6 type: ESTIMATED name: Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Inhaled name: Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Intravenous measure: Bioavailability of inhaled levosimendan measure: Time-to-peak of inhaled levosimendan measure: Elimination half-life of inhaled levosimenan measure: Effect of inhaled levosimendan on MAP measure: Effect of inhaled levosimendan on TVR measure: Effect of inhaled levosimendan on CO measure: Effect of inhaled levosimendan on LVOT VTI measure: Effect of inhaled levosimendan on FAC of the right vetricle measure: Effect of inhaled levosimendan on S' measure: Effect of inhaled levosimendan on SPAP sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZ Brussel city: Brussel zip: 1090 country: Belgium name: Matthias Raes, MD role: CONTACT phone: 024749872 email: matthias.raes@uzbrussel.be name: Marie-Claire Van Malderen, SC role: CONTACT phone: 024763110 email: marieclaire.vanmalderen@uzbrussel.be lat: 50.85045 lon: 4.34878 hasResults: False

 nctId: NCT06387849 id: 03/2023 briefTitle: Aromatherapy Effect on Pain and Anxiety After C-section overallStatus: COMPLETED date: 2023-04-21 date: 2023-08-31 date: 2023-08-31 date: 2024-04-29 date: 2024-04-29 name: University Tunis El Manar class: OTHER briefSummary: A prospective randomized triple blinded study conducted in the obstetrics gynecology department of Ben Arous hospital over a period of four months and 10 days between April 2023 and August 2023.

The aim of this study was to evaluate the effectiveness of lavender aromatherapy on postoperative pain and anxiety after cesarean section under spinal anesthesia in Tunisian women. conditions: Post-operative Pain conditions: Post-operative Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ACTUAL name: Aromatherapy name: Placebo measure: Post-operative pain level measure: Post-operative anxiety level measure: Heart Rate (HR) measure: Systolic Blood Pressure (SBP) measure: Diastolic Blood Pressure (DBP) measure: Respiratory Rate (RR) measure: Pulsatile Oxygen Saturation sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Ben Arous Regional Hospital city: Ben Arous country: Tunisia lat: 36.75306 lon: 10.21889 hasResults: False

 nctId: NCT06387836 id: B2024-063 briefTitle: LINC01844 as a Diagnostic Biomarker for POCD in Elderly Patients overallStatus: RECRUITING date: 2024-02-21 date: 2025-02-21 date: 2025-06-30 date: 2024-04-29 date: 2024-04-29 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: Postoperative cognitive dysfunction (POCD) is a common complication after surgery that is associated with more adverse events and death. The goal of this observational study is to learn about the diagnosis performance of long intergenic non-coding RNA(LINC01844) level in blood of older people for POCD. The main question it aims to answer is:

Does the relative level of LINC01844 in blood help diagnose POCD of older people after surgery? Participants undergoing elective lumbar decompression and fusion will finish neuropsychological evaluations one day before and 1st, 3rd and 5th day after surgery. At the same timepoint, the relative level of LINC01844 in blood will also be tested. conditions: Postoperative Cognitive Dysfunction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 63 type: ESTIMATED measure: relative level of LINC01844 measure: serum reactive protein-C measure: serum interleukin-6 sex: ALL minimumAge: 65 Years maximumAge: 85 Years stdAges: OLDER_ADULT facility: Zhongshan Hospital Fudan University status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Danfeng Jin, M.D. role: CONTACT phone: +8613795306154 email: jindanfeng0506@163.com name: Shengjin Ge, Ph.D. role: CONTACT phone: +8613601926171 email: ge.shengjin@zs-hospital.sh.cn name: Shengjin Ge, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06387823 id: K5321 briefTitle: Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS acronym: STAR overallStatus: NOT_YET_RECRUITING date: 2024-04-27 date: 2025-06-01 date: 2025-09-01 date: 2024-04-29 date: 2024-04-29 name: Peking Union Medical College Hospital class: OTHER name: Peking University name: Shanghai Huilun Pharmaceutical Co., Ltd. briefSummary: The goal of this clinical trial is to evaluate the efficacy and safety of Sivelestat sodium and dexamethasone in the treatment of patients with moderate to severe ARDS. The main questions it aims to answer are:

* Is Sivelestat sodium more effective in the treatment of patients with moderate to severe ARDS compared with placebo?
* Is dexamethasone more effective in the treatment of patients with moderate to severe ARDS compared with placebo? Participants will receive Sivelestat sodium, dexamethasone or placebo. Researchers will compare the efficacy and safety of Sivelestat sodium, dexamethasone and placebo. conditions: Acute Respiratory Distress Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Sivelestat sodium name: Dexamethasone name: Sivelestat sodium placebo name: Dexamethasone placebo measure: 28-day ventilator-free days measure: Informed consent rate measure: Recruitment rate measure: Recruitment compliance rate measure: Protocol adherence rate measure: Completion of follow-up visits measure: 28-day mortality measure: 90-day mortality measure: 28-day length of stay measure: 28-day organ support free day measure: Sequential organ failure assessment (SOFA) measure: Murray's acute lung injury score measure: C-reactive protein (CRP) measure: Interleukin-6 (IL-6) measure: Interleukin-8 (IL-8) measure: Procalcitonin (PCT) measure: Neutrophil-to-lymphocyte Ratio (NLR) measure: Neutrophil elastase measure: New-onset infection rate measure: Re-intubation rate measure: Adverse event sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06387810 id: MA-PC-II-010 briefTitle: Irinotecan Liposome II in Combination With 5-FU/LV and Oxaliplatin in Perioperative Treatment of Borderline Resectable Pancreatic Cancer acronym: undetermined overallStatus: NOT_YET_RECRUITING date: 2024-04-17 date: 2026-04-30 date: 2026-06-30 date: 2024-04-29 date: 2024-04-29 name: Peking Union Medical College Hospital class: OTHER briefSummary: This is a prospective, single-arm, phase II study to evaluate the efficacy and safety of irinotecan liposome II in combination with oxaliplatin and 5-FU/LV in perioperative treatment of borderline resectable pancreatic cancer in 45 patients. conditions: Borderline Resectable Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: irinotecan liposome II combined with 5-FU/LV and oxaliplatin measure: event free survival measure: overall survival measure: R0 resection rate measure: R1 excision rate measure: adverse event sex: ALL minimumAge: 18 Years maximumAge: 110 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06387797 id: UNLV-2023-321 briefTitle: Primary and Secondary Prevention of Type 2 Diabetes Mellitus in Clark County overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-05-30 date: 2025-05-31 date: 2024-04-29 date: 2024-04-29 name: University of Nevada, Las Vegas class: OTHER name: University of Nevada, Reno briefSummary: This pilot and feasibility study aims to assess the effectiveness of a nutrition education intervention using the Cooking Matters for Adults Curriculum (SNAP-Ed). The study compares this standard curriculum with an enhanced version that includes the same curriculum but has additional components, incorporating specific information related to type 2 diabetes. Additionally, participants in the enhanced group will receive continuous glucose monitors to wear during the study for 10 days. The primary outcomes of the study include evaluating the acceptability of the intervention, and the feasibility of conducting the intervention at the UNLV Nutrition Center. The investigators will also assess participants' Knowledge, Attitudes, and Intentions regarding produce consumption. Alongside feasibility and acceptability, the study aims to explore the preliminary effectiveness of the intervention in increasing fruit and vegetable consumption, reducing HbA1c, managing cardiometabolic risk, and improving gut microbiome composition and diversity among participants in the program. The investigators will also assess changes in other lifestyle behaviors from baseline to post-intervention (6 weeks) (sleep, stress, physical activity, and sedentary behavior). conditions: At Risk for Type 2 Diabetes Mellitus conditions: Pre Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to one of two parallel study arms.

1. Cooking Matters for Adults (CMA) Curriculum Delivery over 6 weeks
2. CMA + Enhanced cooking classes with added components comprising cooking practices specific to diabetes prevention, online information as well as short assignments and activities regarding sleep, stress, physical activity, and sedentary behaviors. The CMA+ arm will also have the opportunity to use a continuous glucose monitor (CGM) for 10 days immediately following the baseline assessment visit. This will be an optional component and participants will not be excluded if they do not wish to use the CGM. (6 weeks) primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Because of the parallel arm differences, it would not be possible to mask the arm assignment for the participant or investigator. However, we will mask the arm assignment for the outcomes assessor, in particular for the HbA1c% assessment. whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Cooking Matters for Adults (CMA+) name: Cooking Matters for Adults (CMA) measure: Feasibility of conducting the intervention measure: Acceptability of the intervention measure: Acceptability of each cooking class measure: Knowledge about the importance of produce consumption measure: Attitudes toward produce consumption measure: Intentions to consume recommended amounts of produce during and after intervention measure: Changes in fruit and vegetable consumption in servings per day measure: HbA1c% measure: Body weight in kg measure: Gut Microbiota composition measure: waist circumference in cm measure: body fat percentage (%) measure: non fat mass in kg measure: blood pressure in mmHg measure: fasting blood glucose in mg/dL measure: fasting total cholesterol in mg/dL measure: fasting LDL cholesterol in mg/dL measure: fasting HDL cholesterol in mg/dL measure: fasting triglyceride level in mg/dL measure: Usual dietary quality measure: Week 6 dietary quality measure: physical activity energy expenditure average kcals per day measure: Time spent in sedentary behavior in minutes per day measure: physical activity intensity distribution as minutes per day and average percentage of day measure: sleep quantity in hours per day measure: sleep quality measure: stress levels measure: Nutrition Security sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Nevada, Las Vegas city: Las Vegas state: Nevada zip: 89154 country: United States name: Sara K Rosenkranz, PhD role: CONTACT phone: 702-895-0938 email: Sara.Rosenkranz@unlv.edu name: Richard Rosenkranz, PhD role: CONTACT phone: 702-895-5198 email: Richard.Rosenkranz@unlv.edu name: Keren Morales, B.S., RD role: SUB_INVESTIGATOR name: Donya Shahamati, B.S. role: SUB_INVESTIGATOR name: Laura Kruskall, PhD, RD role: SUB_INVESTIGATOR name: Elika Nematian, M.S. role: SUB_INVESTIGATOR lat: 36.17497 lon: -115.13722 hasResults: False

 nctId: NCT06387784 id: 2024/823 briefTitle: Acute Beetroot Juice Supplementation in Pre-eclampsia Pregnancies acronym: BEET_PE overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-12 date: 2025-06 date: 2024-04-29 date: 2024-04-29 name: University of Sao Paulo class: OTHER name: Hospital das Clínicas de Ribeirão Preto name: Universidade Estadual Paulista Júlio de Mesquita Filho briefSummary: Pre-eclampsia is a serious condition that typically affects pregnant women after the 20th week of pregnancy, characterized by high blood pressure and damage to organs such as the kidneys and liver. Currently, treatment options are limited, which has prompted researchers to explore alternative approaches. One such promising alternative is dietary nitrate found in vegetables like beetroot, as nitrate can be converted into nitric oxide in the body, which helps lower blood pressure. This study aims to determine the acute effects of nitrate-rich beetroot juice on blood pressure, several blood and salivary markers in pregnant women with pre-eclampsia. Furthermore, the study will assess fetal blood flow using Doppler ultrasound. The investigators want to understand the kinetics of nitrate and nitric oxide metabolites and assess the temporal dependency of the hypotensive response. Through this investigation, the investigators seek evidence of nitrate-enriched beetroot juice as an adjunct therapy in managing pre-eclampsia. conditions: Pre-Eclampsia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, placebo-controlled, single-blind, parallel-group study assessing acute rich-nitrate juice on pregnant women diagnosed with early and late-onset pre-eclampsia. Participants will be divided into four distinct groups: two groups for each onset category. Within each group, participants will be further divided into a control group and a treated group. The assignment of participants to these groups will be randomized using an online program. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 96 type: ESTIMATED name: Beetroot juice name: Placebo juice measure: Acute Effect of Beetroot Juice Supplementation on Blood Pressure measure: Plasma Concentrations of Nitric Oxide Metabolites measure: Concentration of Salivary Nitrate Reductase Enzyme measure: Plasma Lipid Peroxidation Levels measure: Concentration of Total Antioxidant Capacity in Plasma measure: Maternal Blood Flow Velocity measure: Fetal Heart Rate measure: Umbilical Arterial Pulsatility Index sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06387771 id: rs4680-tolcapona briefTitle: Evaluation of Tolcapone as a Cognitive Enhancer in Schizophrenia overallStatus: RECRUITING date: 2014-09-22 date: 2025-08 date: 2024-04-29 date: 2024-04-29 name: Clinica Universidad de Navarra, Universidad de Navarra class: OTHER briefSummary: Objective: To assess the efficacy of tolcapone to improve cognition in schizophrenia, as a genotype-based targeted treatment of cognitive and negative symptoms of schizophrenia considering the polymorphism rs4680.

Methodology: 20 patients with chronic and stabilized schizophrenia (10 patients with genotype Val/Val and 10 patients with genotype Met/Met according to polymorphism rs4680) will receive treatment with tolcapone during 7 days. The cognitive function and clinical status will be evaluated with a neuropsychological battery and appropriate clinical scales before and after treatment. The efficiency of the activation of the prefrontal cortex will be measured using functional magnetic resonance imaging (fMRI) before and after treatment.

Hypothesis: Only patients with genotype Val/Val treated with tolcapone would show a cognitive improvement, a higher efficiency of the activation of the prefrontal cortex and an amelioration of some negative symptoms. conditions: Schizophrenia studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Tolcapone measure: Efficacy: Change from baseline in cognitive test scores at day 8 measure: Efficacy: Change from baseline in the brain blood-oxygen-level-dependent (BOLD) response at day 8 measure: Efficacy: change from baseline in psychotic symptoms intensity measured by the PANSS scores at day 8 measure: Efficacy: negative symptoms intensity: change from baseline in the 16-item Negative Symptom Assessment (NSA-16) scale scores at day 8 measure: Efficacy: change from baseline in the intensity of psychotic symptoms measured by the Brief Psychiatric Rating Scale (BPRS) scores at day 8 measure: Efficacy: change from baseline in the clinical global impression measured by the Clinical Global Impression (CGI) scale scores at day 8 measure: Efficacy: change from baseline in the global assessment of functioning measured by the Global Assessment of Functioning (GAF) scale scores at day 8 measure: Efficacy: change from baseline in the anxiety symptoms measured by the Hamilton Anxiety Rating Scale (HAM-A) scale scores at day 8 measure: Efficacy: change from baseline in the depressive symptoms measured by the Hamilton Depression Rating Scale (HAM-D) scale scores at day 8 measure: Efficacy: change from baseline in the Clinician-Rated Dimensions of Psychosis Symptom Severity (CRDPSS) scale scores at day 8 measure: Change from baseline in plasmatic homocysteine (umol/L) measure: Patient Reported Outcome: change from baseline in the Profile of Mood States (POMS) scores at day 8 measure: Patient Reported Outcome: change from baseline in the mood state Visual Analogue Scale (VAS) scores at day 8 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinica Universidad de Navarra status: RECRUITING city: Pamplona state: Navarra zip: 31008 country: Spain name: Jose Maria Galindo role: CONTACT phone: 34 948 255400 phoneExt: 2725 email: ucicec@unav.es lat: 42.81687 lon: -1.64323 hasResults: False

 nctId: NCT06387758 id: UMMC-IRB-2022-473 briefTitle: Low Systemic/High Local Exercise Load in Peds SCD overallStatus: RECRUITING date: 2023-09-19 date: 2025-06-30 date: 2025-06-30 date: 2024-04-29 date: 2024-04-29 name: University of Mississippi Medical Center class: OTHER name: University of Alabama at Birmingham briefSummary: This research study wants to learn about what kind of exercise is best for kids with sickle cell disease. Participating children will have a small amount of blood drawn one time at the beginning of the study. Children will then complete some questionnaires that measure pain, physical function, and emotions (depression, anxiety) and complete some tests that measure physical fitness at the beginning and end of the study. Children will be randomized to either a home-based telehealth (1) walking or (2) strengthening exercise program that lasts for 8-weeks, 3-x week, for 45 minutes each session. Children's participation will last up to 10 weeks. conditions: Sickle Cell Anemia in Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Low systemic strength training name: Moderate systemic exercise measure: Demographics and medical history (parents) measure: Pediatric Pain Questionnaire measure: Functional Disability Inventory measure: NIH PROMIS 2582 measure: Heart Rate Variability measure: Heart Rate measure: Blood Pressure measure: Bruininks-Oseretsky Test of Motor Proficiency measure: American Thoracic Society 6-minute walk test measure: Actigraphy measure: Daily diaries measure: Biomarkers measure: Medical Chart Review sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD facility: University of Mississippi Medical Center status: RECRUITING city: Jackson state: Mississippi zip: 39216 country: United States name: Cynthia Karlson, PhD role: CONTACT phone: 601-984-2723 email: ckarlson@umc.edu lat: 32.29876 lon: -90.18481 hasResults: False

 nctId: NCT06387745 id: US-REFERRAL briefTitle: Referral of Patients to Hepatology With Hepatoscope acronym: US-REFERRAL overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2025-12 date: 2024-04-29 date: 2024-04-29 name: University Hospital, Antwerp class: OTHER name: E-Scopics briefSummary: Patients identified as being at risk of liver fibrosis because of a positive Fibrosis-4 (FIB-4) test in the primary care setting will be offered be enrolled in the trial and to undergo an Hepatoscope exam (external non-invasive ultrasound imaging exam) to screen for liver fibrosis (with stiffness measurements) and/or steatosis (with ultrasound parameters related to fatty liver). All patients presenting with a liver stiffness value of at least 6.5 kilopascal (kPa) will be referred to the tertiary hepatology consultations for further assessment. Hepatoscope measurements will be compared to the standard of care for these patients, as defined at the tertiary hepatology center. conditions: Chronic Liver Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 200 type: ESTIMATED name: Hepatoscope measure: Positive Predictive Value for significant fibrosis measure: Correlation of stiffness measurements measure: Concordance of stiffness measurements measure: Diagnostic performance of liver stiffness measurements sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06387732 id: 161223 briefTitle: Mechanisms Underlying Antidepressant Effects of Physical Activity acronym: LIFE overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-08 date: 2028-01 date: 2024-04-29 date: 2024-04-29 name: University College, London class: OTHER name: King's College London name: Queen Mary University of London name: University of Dublin, Trinity College briefSummary: It is well established that any level of physical activity can help prevent and treat depression, with more strenuous activity having a greater effect. Understanding the mechanisms driving this antidepressant effect is important because it could allow exercise programmes to be made more effective, accessible, and targeted. Such knowledge could contribute to social prescribing, increasingly a priority for mental healthcare. Importantly, physical activity is highly scalable, low cost, well suited to early intervention, and has beneficial impacts on physical health co-morbidities. This trial may provide initial indications of whether there are sub-groups of depressed individuals who are particularly likely to benefit from physical activity, lead to strategies to personalise physical activity prescription based on motivational factors, and pave the way for augmentative approaches, for example combining physical activity with psychological interventions.

To date the mechanisms driving the antidepressant effects of physical activity in humans are poorly understood. Building on links between depressive symptoms, reward processing and dopamine, plus evidence from animal studies that physical activity is anti-inflammatory and boosts both dopamine and reward processing, the overarching aim of this trial is to understand the mechanisms underlying the effects of physical activity in depression, focusing on the concept of motivation.

The key objective is to conduct a randomised controlled trial (RCT) in N=250 depressed participants comparing aerobic exercise to a stretching/relaxation control condition, examining a range of mechanistic factors. The proposed trial will examine the impact of physical activity at multiple, linked potential levels of explanation: (1) immune-metabolic markers; (2) dopamine synthesis capacity; (3) activation in the brain's reward and effort processing circuitry;(4) effort-based decision making incorporating computational analysis; and (5) symptom networks based on fine-grained, daily measurements. conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The trial will use a single-site parallel group design with depressed participants randomised to eight weeks of either 45 minutes of aerobic exercise of moderate-to-vigorous activity (experimental group: three times per week, N=125) or 45 minutes of non-aerobic stretching/guided relaxation (control group: three times per week, N=125). primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The control arm is stretching and relaxation. Prior research indicates that participants have similar efficacy expectations regarding mild stretching and aerobic exercise, which will help to improve masking. Due to the nature of the interventions, it is not possible for the participants to be masked as to the intervention they are undergoing, but all study information will be agnostic about which intervention we expect to be more effective, and all analysis will be performed by blinded staff. The trial will assess expectations and preferences about the intervention conditions, allowing for sensitivity analyses. whoMasked: PARTICIPANT count: 250 type: ESTIMATED name: Aerobic exercise name: Stretching and relaxation measure: Patient Health Questionnaire-9 score measure: Physical activity measure: Aerobic capacity: CPET measure: Ecological Momentary Assessment measure: Inflammatory response (cytokines) measure: Inflammatory response (genetic markers) measure: Inflammatory response (flow cytometry immunophenotype) measure: Neuroendocrine system measure: Metabolic function measure: Dopamine synthesis capacity measure: Functional magnetic resonance imaging (fMRI) during cognitive tasks measure: Online cognitive tasks measure: Depression symptoms measure: Anxiety (GAD7 score) measure: Anxiety (STAI score) measure: Anhedonia (SHAPS score) measure: Anhedonia (DARS score) measure: Apathy measure: Fatigue measure: Cognitive impairment measure: Self-efficacy measure: Self-esteem measure: Sleep quality sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06387719 id: PREC-BED Study briefTitle: Precursors of Binge Eating Disorder in a Clinical Sample of Adolescents With Obesity acronym: PREC-BED overallStatus: RECRUITING date: 2023-07-21 date: 2025-03 date: 2026-05 date: 2024-04-29 date: 2024-04-29 name: Fundació Sant Joan de Déu class: OTHER name: Instituto de Salud Carlos III briefSummary: BACKGROUND: Binge eating disorder (BED) is the worldwide most-prevalent eating disorder. It is associated with psychiatric comorbidities and obesity, a high impact in life functioning, and high morbidity and mortality. First symptoms appear frequently in youths, who most commonly present incomplete (subthreshold) criteria for BED (precursor forms, PREC-BED). While some subjects will evolve from PREC-BED to BED, there is no gold standard to identify the clinical evolution. Information from prior studies suggest early alterations in reward and inhibitory brain circuits in PREC-BED may predict increased vulnerability or resilience to develop BED. Tools based on MRI brain connectivity analyses (MRI-BC), built on robust and interpretable connectivity whole-brain models, have proven successful in diagnostic classification and predicting certain clinical outcomes. OBJECTIVES: To study MRI-BC diagnostic markers of PREC-BED and to explore prognosis at 1 year of follow-up in a sample of adolescents with obesity (12-17 years old). METHODS: A) Transversal analytical design: 3-group (n=34 per group) comparison of neuroimaging (MRI-BC), neurocognitive and clinical markers in adolescents with obesity and i) BED, ii) PREC-BED, iii) no BED nor PREC-BED (Healthy group, HC). B) Longitudinal analytical design, pilot, exploratory: adolescents with PREC-BED will be evaluated in clinical and neurocognitive variables at 1 year. Baseline brain neuroimaging variables (alone and in combination with clinical and neurocognitive variables) will be analyzed as predictors of clinical prognosis, including conversion to BED. conditions: Binge-Eating Disorder conditions: Obesity conditions: Eating Disorders conditions: BED conditions: Other Specified Feeding or Eating Disorder conditions: Eating Disorder Nos conditions: Emotion Regulation conditions: Food Addiction studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 102 type: ESTIMATED name: Magnetic resonance imaging measure: Neuroimaging assessment measure: Neuroimaging assessment measure: Height measure: Weight measure: Waist perimeter measure: BMI measure: Blood pressure measure: Fasting glucose measure: Triglycerides measure: HDL cholesterol measure: Developmental Tanner stage measure: Adherence to Mediterranean diet measure: Diagnosis of BED, and PREC-BED or exclusion of other DMS-5 diagnosis. measure: Functioning measure: Depression measure: Anxiety measure: Emotion Regulation measure: Eating symptomatology measure: Eating symptomatology measure: Temperamental tendencies for sensitivity to punishment and sensitivity to reward. measure: Food Addiction measure: Food intake measure: General Intelligence measure: Attention ability measure: Visuo-constructional ability and visual memory measure: Executive function: cognitive flexibility, alternating attention, sequencing, visual search, and motor speed. measure: Executive function: working memory ability measure: Executive function: decision-making abilities reward based measure: Executive function: ability to inhibit cognitive interference measure: Executive function: planning and strategic organisation sex: ALL minimumAge: 12 Years maximumAge: 16 Years stdAges: CHILD facility: Hospital Sant Joan de Déu status: RECRUITING city: Esplugues De Llobregat state: Barcelona zip: 08950 country: Spain name: ESTHER VIA VIRGILI role: CONTACT phone: 34 + 673342094 email: esther.via@sjd.es name: ESTHER VIA VIRGILI role: PRINCIPAL_INVESTIGATOR name: EDUARDO SERRANO role: SUB_INVESTIGATOR name: RAQUEL CECILIA role: SUB_INVESTIGATOR name: SILVIA MARÍN role: SUB_INVESTIGATOR name: MARINA LLOBET role: SUB_INVESTIGATOR name: LAURA MARITZA ASTIASUAINZARRA VILLA role: SUB_INVESTIGATOR name: LILIANA SZEGHALMI role: SUB_INVESTIGATOR name: ANTONIO PÉREZ role: SUB_INVESTIGATOR name: MATTHIEU GILSON role: SUB_INVESTIGATOR name: MANEL VILA-VIDAL role: SUB_INVESTIGATOR name: GUIDO FRANK role: SUB_INVESTIGATOR name: CHRISTIAN STEPHAN OTTO role: SUB_INVESTIGATOR lat: 41.37732 lon: 2.08809 hasResults: False

 nctId: NCT06387706 id: GAP briefTitle: The Development of a Gamified Web-based Pain Management Program (GAP) for Community-dwelling Older Adults With Chronic Pain overallStatus: RECRUITING date: 2023-12-01 date: 2024-07-30 date: 2024-11-30 date: 2024-04-29 date: 2024-04-29 name: The Hong Kong Polytechnic University class: OTHER briefSummary: Pain Management in Older Adults: Pain significantly impacts the well-being of older adults, often leading to diminished physical abilities and a reduced quality of life. Despite this, pain management remains suboptimal, with concerns about medication side effects and a tendency to view pain as a natural aspect of aging. Consequently, many seniors are hesitant to use painkillers. As an alternative, non-pharmacological strategies such as educational programs, physical activity, massage, relaxation techniques, and music therapy are gaining traction.

Innovative Non-Drug Solutions: To improve participation in non-medication pain relief methods, we suggest incorporating gaming elements into these programs (GAP). Originating in digital media in 2008, gamification has since spread across various industries. It involves adding game-like elements to activities to boost engagement, experience, and motivation.

Project Goals: The aims of this initiative include creating a web-based Gamified Pain Management Program (GAP), engaging older adults with chronic pain in the development of GAP, and gathering their feedback on the program's effectiveness. conditions: Chronic Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 4 type: ESTIMATED name: Gamified web-based pain management Program measure: Pain Relief sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hong Kong Metropolitan University status: RECRUITING city: Hong Kong country: Hong Kong name: Mimi Mun Yee Tse, PhD. role: CONTACT phone: (852)39708764 email: mmytse@hkmu.edu.hk name: Mimi Mun Yee Mimi Mun Yee, PhD. role: PRINCIPAL_INVESTIGATOR name: Tyrone Tai On Kwok, PhD. role: SUB_INVESTIGATOR name: Timothy Chung Ming Wu, Master role: SUB_INVESTIGATOR lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06387693 id: 24U-1359 briefTitle: Artificial Intelligence in ANOCA acronym: (AI)NOCA overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2028-08 date: 2028-12 date: 2024-04-29 date: 2024-04-29 name: UMC Utrecht class: OTHER briefSummary: Angina pectoris is diagnosed in \>180.000 people in the Netherlands each year. Diagnosis in angina pectoris focuses on epicardial coronary stenosis, the identification of which may lead to guideline-directed medical therapy or revascularization. However, no such stenosis is identified in 40-70% of patients. This condition, angina with no obstructed coronary artery (ANOCA), is more prevalent in women and is related to poor quality of life, high medical expenses, and a higher incidence of adverse events.

The origin of ANOCA can be evaluated during invasive coronary angiography by coronary function testing (CFT) to identify coronary vasomotor disorders. This relates to vasospasm of the coronary artery and microcirculation, or to impaired microvascular vasodilation. For the diagnosis of vasospasm, CFT needs to result in electrocardiographic signs of myocardial ischemia as part of the diagnostic criteria. This is a critical point in the diagnosis of vasospasm, as these signs can be subtle and can vary, and are therefore prone to misinterpretation. Apart from this caveat, the diagnosis approach therefore currently requires an invasive procedure for the diagnosis. This limits the broad application and hampers early identification and treatment of ANOCA.

During CFT, a coronary guide wire is routinely advanced in the coronary artery which also allows obtaining an intracoronary ECG by attaching a sterile alligator clamp to a standard electrocardiogram lead. This allows continuous recording of intracoronary ECG throughout CFT on the same monitor as the routine ECG. This technique can increase sensitivity for myocardial ischemia during CFT. Further, Holter ECG monitoring allows the identification of ischemic changes in the ECG in the outpatient setting. Evidence is lacking on the patterns of myocardial ischemia that occur during spontaneous angina pectoris symptoms in ANOCA patients, and on the sensitivity of Holter ECG for this purpose. Finally, the interpretation of ischemic patterns on ECG tracings can be cumbersome, especially when changes are subtle or change from beat to beat. The use of deep learning techniques allows to automate the interpretation of ECG traces and may improve the standardized diagnosis in ANOCA. conditions: Angina, Stable studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 250 type: ESTIMATED name: Holter monitoring, intracoronary ECG measure: Prevalence of myocardial ischemia in patients with equivocal coronary function test results measure: Diagnostic accuracy of perprocedural Holter ECG monitoring to diagnose coronary vasomotor disorders measure: Diagnostic ccuracy of outpatient Holter monitoring for coronary vasomotor disorders sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06387680 id: 2022/187 briefTitle: The Peanut Ball Use on Labor overallStatus: COMPLETED date: 2023-01-01 date: 2024-03-01 date: 2024-04-01 date: 2024-04-29 date: 2024-04-29 name: Selcuk University class: OTHER briefSummary: The purpose of this study was to evaluate the effect of using peanut balls during labor on labor memory, labor satisfaction, labor length, and neonatal APGAR scores. conditions: Birth Outcome, Adverse conditions: Birth, First conditions: Labor Long conditions: Apgar; 4-7 at 1 Minute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 140 type: ACTUAL name: The Effect of Peanut Ball Use on Labor Memory, Labor Satisfaction, Delivery Length, and Neonatal APGAR Score: A Randomized Controlled Trial measure: Comparison of sociodemographic of pregnant women. measure: Comparison of obstetric characteristics of pregnant women measure: Comparison of postpartum characteristics of pregnant women measure: Comparison of duration of 1st and 2nd stage of labor by group measure: Comparison of 1st and 5th minute APGAR scores of newborns by group measure: Comparison of the mean scores of the Pregnant Women's Birth Memory and Recall Questionnaire (BirthMARQ) and its subscales by groups measure: Comparison of pregnant women's Birth Satisfaction Scale (BSS) mean scores by groups sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Selcuk University city: Konya zip: 42250 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06387667 id: FIRTI briefTitle: Characterizing Diversity and Antifungal Resistance in Immunocompromised ICU Patients With Respiratory Tract Infections overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-12-01 date: 2026-06-01 date: 2024-04-29 date: 2024-04-29 name: New Valley University class: OTHER briefSummary: Immunocompromised individuals face a heightened risk of life-threatening fungal infections, which arise from a multitude of environmental and commensal fungi. Surveillance data from ICUs worldwide identifies Candida spp. as the dominant foe, responsible for 80% of such infections, earning it the dubious distinction of being the third most prevalent pathogen. While C. albicans holds the dubious crown as the most common Candida offender, recent years have witnessed a concerning trend toward non-Albicans candida, raising concerns about potential antifungal resistance. conditions: Immunocompromised ICU Patients With Respiratory Tract Infections studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Immunocompromised ICU Patients with Respiratory tract infections primaryPurpose: DIAGNOSTIC masking: NONE count: 250 type: ESTIMATED name: Complete blood count name: C-reactive protein, urea, creatinine, Random blood glucose (RBG), aspartate aminotransferase (AST), alanine aminotransferase (ALT) name: CT chest name: Microscopic examination name: culture and sensitivity measure: Number of fungal species causing pneumonia in immunocompromised ICU patients measure: Determine the antifungal susceptibility profiles of the identified fungal isolates. measure: Number of associated specific patient factors with the type or antifungal resistance of fungal infections sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06387654 id: RC31/23/0361 briefTitle: Clinico-biological Collection of Autoimmune, Dysimmune or Auto-inflammatory Dermatological Diseases acronym: TekAPo overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2029-04 date: 2034-04 date: 2024-04-29 date: 2024-04-29 name: University Hospital, Toulouse class: OTHER briefSummary: The aim of this project is to start a biological and clinical collection of patients presenting autoimmune, dysimmune or auto-inflammatory dermatological diseases. This collection will provide appropriate biological samples to identify new biomarkers and to be accessible to the medical, scientific and industrial communities for the identification of new therapeutic strategies. conditions: Autoimmune Bullous Dermatosis conditions: Systemic Autoimmune Diseases With Dermatological Presentation conditions: Dysimmune Dermatological Diseases conditions: Auto-inflammatory Dermatological Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 800 type: ESTIMATED name: Blood sampling name: Remainders of samples taken as part of the treatment measure: Building a collection of biological samples and clinical-biological data from patients with autoimmune, dysimmune or auto-inflammatory dermatological disease measure: Identification of new autoantibodies measure: Identification of biomarkers regarding the severity (such as cytokines, survival factors) in order to help the therapeutic decisions measure: Exploration of the pathophysiological mechanisms of rare autoimmune dermatological pathologies measure: Comparison of blood cells populations determinants with flow cytometry, before and after cell therapy and in patients responder or not responder to cell therapy sex: ALL minimumAge: 6 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Purpan University Hospital city: Toulouse zip: 31059 country: France name: Chloé BOST, MD, PhD role: CONTACT phone: 5 61 77 61 44 phoneExt: 0033 email: bost.c@chu-toulouse.fr lat: 43.60426 lon: 1.44367 hasResults: False

 nctId: NCT06387641 id: 2024004 briefTitle: Effects of Life Review Intervention on Meaning in Life Among Older Adults With Disabilities overallStatus: ENROLLING_BY_INVITATION date: 2024-03-25 date: 2025-01-01 date: 2025-01-01 date: 2024-04-29 date: 2024-04-29 name: Bao Huimin class: OTHER briefSummary: The goal of this interventional study is to learn if life review works to improve the sense of meaning in life in older adults with disabilities who live at home. The main questions it aims to answer are:

Does life review enhance the sense of meaning in life of participants? Dose life reviews enhance the life satisfaction of participants. Dose life reviews enhance the quality of life of participants?

Researchers will compare the life review program to routine community health services to see if the life review intervention program is effective in enhancing the sense of meaning in life of older adults with disabilities who live at home.

Participants will:

Take face-to-face life review interview or routine community health service every week for 6 weeks.

Take the the questionnaire survey before and after the six-week life review intervention. conditions: Disabilities, Psychological studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 68 type: ESTIMATED name: Life review name: Routine community health services measure: Change from Baseline in Meaning in life on the Meaning in Life Questionnaire (MLQ) at Week6 measure: Change from Baseline in Life satisfaction on the Life Satisfaction In-dex A (LSIA) at Week6 measure: Change from Baseline in Quality of life on the 12-Item Short Form Survey (SF-12) at Week6 sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xixi Street Community Health Service Center city: Hanzhou state: Zhejiang zip: 310012 country: China lat: 26.4965 lon: 99.437 facility: Gongchenqiao Street Community Health Service Centre city: Hanzhou state: Zhejiang zip: 310015 country: China lat: 26.4965 lon: 99.437 facility: Baiyang Street Wenchao Community Health Centre city: Hanzhou state: Zhejiang zip: 310018 country: China lat: 26.4965 lon: 99.437 facility: School of Nursing, Hangzhou Normal University city: Hanzhou state: Zhejiang zip: 311121 country: China lat: 26.4965 lon: 99.437 hasResults: False

 nctId: NCT06387628 id: LM108-IIT-202 briefTitle: LM-108 in Combination With PD-1 Based Treatment for Patients With Recurrent or Metastatic Triple - Negative Breast Cancer overallStatus: RECRUITING date: 2024-06-01 date: 2026-04-01 date: 2027-04-01 date: 2024-04-29 date: 2024-04-29 name: Fudan University class: OTHER briefSummary: To evaluate the efficacy and safety of LM108 plus toripalimab plusnab-paclitaxel or eribulin as first-line or post-line treatment in patients with metastatic triple-negative breast cancer. conditions: TNBC - Triple-Negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 74 type: ESTIMATED name: LM-108 name: Toripalimab name: Eribulin name: Nab paclitaxel measure: ORR measure: DoR measure: DCR measure: PFS measure: OS measure: Adverse events 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: Biyun Wang role: CONTACT phone: 18017312387 email: pro_wangbiyun@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06387615 id: H22086 id: 1R21HD108576-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R21HD108576-01A1 briefTitle: Impact of Non-invasive Brain Stimulation on Learning Novel Spoken Words overallStatus: RECRUITING date: 2024-01-01 date: 2024-10-31 date: 2025-12-31 date: 2024-04-29 date: 2024-04-29 name: Georgia State University class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) briefSummary: The purpose of the proposed study is to use transcranial magnetic stimulation (TMS) to evaluate a neurobiological model of spoken word learning in older youth. Specifically, it is hypothesized that: (1) inhibition of the left dorsal stream will impact subsequent learning, processing, and retention of phonologically similar pseudowords; (2) the impact of dorsal stream inhibition on word learning will be associated with baseline levels of variability in neural activity, indicative of underlying differences in cortical excitability. conditions: Dyslexia conditions: Dyslexia, Developmental conditions: Learning; Developmental Disorder, Reading studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Active cTBS name: Sham measure: Novel Word Learning Task measure: Pseudoword Discrimination Task measure: MRI Scan sex: ALL minimumAge: 16 Years maximumAge: 24 Years stdAges: CHILD stdAges: ADULT facility: Georgia State University/Georgia Tech Center for Advanced Brain Imaging (CABI) status: RECRUITING city: Atlanta state: Georgia zip: 30318 country: United States name: C.Nikki Arrington, PhD role: CONTACT phone: 404-385-8621 lat: 33.749 lon: -84.38798 hasResults: False

 nctId: NCT06387602 id: FUI/CTR/2024/6 briefTitle: Comparison Between Effects of Active Release Technique and Post Isometric Relaxation on Adductor Strain in Mixed Martial Arts Fighters overallStatus: RECRUITING date: 2023-07-15 date: 2023-11-20 date: 2024-11-20 date: 2024-04-29 date: 2024-04-29 name: Foundation University Islamabad class: OTHER briefSummary: This study is a randomized controlled trial and the purpose of this study is to compare the effects between active release technique and post-isometric relaxation on adductor strain in mixed martial arts fighters. conditions: Adductor Strain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Cryotherapy name: Strengthening of adductors name: Active release technique name: Post-Isometric Relaxation measure: Pain Intensity measure: Range of motion measure: Functionality measure: Flexibility sex: ALL minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: Foundation University College of Physical Therapy status: RECRUITING city: Rawalpindi state: Punjab zip: 46000 country: Pakistan name: Furqan Yaqoob, MS-OMPT,PHD* role: CONTACT phone: 03465333101 email: furqan.yaqoob@fui.edu.pk lat: 33.6007 lon: 73.0679 hasResults: False

 nctId: NCT06387589 id: FUI/CTR/2024/5 briefTitle: Effects of Static Stretching Versus Post Facilitation Stretch of Iliopsoas in Non-Specific Low Back Pain overallStatus: RECRUITING date: 2023-07-15 date: 2023-11-20 date: 2024-06-20 date: 2024-04-29 date: 2024-04-29 name: Foundation University Islamabad class: OTHER briefSummary: This study is a randomized controlled trial and the purpose of this study is to determine the effects of Static Stretching Versus Post Facilitation Stretch of Iliopsoas combined with core stability exercises in Non-Specific Low Back Pain" conditions: Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Core stability exercises name: Static Stretching of Iliopsoas name: Post Facilitation Stretch of Iliopsoas measure: Pain intensity measure: Level of disability measure: Lumbar Range of motion measure: Hip Range of motion sex: ALL minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: Foundation University College of Physical Therapy status: RECRUITING city: Rawalpindi state: Punjab zip: 46000 country: Pakistan name: Sana Khalid, MSNMPT,PHD role: CONTACT phone: 03315050460 email: sana.khalid@fui.edu.pk lat: 33.6007 lon: 73.0679 hasResults: False

 nctId: NCT06387576 id: Post-discharge Appointments briefTitle: Post-Discharge Follow-up Appointment Scheduling overallStatus: RECRUITING date: 2024-04-08 date: 2024-05 date: 2024-06 date: 2024-04-29 date: 2024-04-29 name: University of California, Los Angeles class: OTHER briefSummary: This is a prospective clinical trial evaluating whether a behaviorally informed intervention (pre-discharge iPad video scheduling) increases post-discharge primary care physician (PCP) appointment completion compared to the status-quo scheduling process (post-discharge via phone), with the ultimate goal of improving patient health outcomes. conditions: Appointments and Schedules studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel-arm control trial primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: PARTICIPANT count: 300 type: ESTIMATED name: Behaviorally informed pre-discharge iPad video scheduling measure: Post-discharge follow-up PCP appointment completion rate within 7 days measure: Post-discharge follow-up PCP appointment completion rate within 14 days measure: Post-discharge follow-up PCP appointment scheduling rate within 7 days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UCLA Santa Monica Medical Center status: RECRUITING city: Santa Monica state: California zip: 90404 country: United States name: Rich Leuchter, MD role: CONTACT phone: 310-825-9111 email: rleuchter@mednet.ucla.edu lat: 34.01945 lon: -118.49119 hasResults: False

 nctId: NCT06387563 id: FUI/CTR/2024/4 briefTitle: Effects of Abdominal Muscle Activation Training, Using Pressure Biofeedback in Comparison With Surface Electromyography overallStatus: RECRUITING date: 2023-11-06 date: 2024-05-01 date: 2024-05-30 date: 2024-04-29 date: 2024-04-29 name: Foundation University Islamabad class: OTHER briefSummary: This study is a randomized control trial and the purpose of this study to determine the effects of abdominal muscle activation training on non-specific low back pain; using pressure biofeedback in comparison with surface electromyography biofeedback: a randomized control trial. conditions: Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized control trial primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Abdominal activation using pressure biofeedback name: Abdominal activation using SEMG biofeedback measure: Pain Intensity measure: Level of Disability sex: ALL minimumAge: 18 Years maximumAge: 44 Years stdAges: ADULT facility: Foundation University College of Physical Therapy status: RECRUITING city: Rawalpindi state: Punjab zip: 46000 country: Pakistan name: Anam Rehman, MS-OMPT role: CONTACT phone: 03355082299 email: anam.rehman@fui.edu.pk lat: 33.6007 lon: 73.0679 hasResults: False

 nctId: NCT06387550 id: FUI/CTR/2024/3 briefTitle: Effects of Eccentric Training on Glycemic Control and Quality of Life in Patients With Type II Diabetes Mellitus overallStatus: RECRUITING date: 2024-03-20 date: 2024-07-01 date: 2024-07-15 date: 2024-04-29 date: 2024-04-29 name: Foundation University Islamabad class: OTHER briefSummary: Diabetes is defined by the level of hyperglycemia its a metabolic chronic disorder that furthur lead to life threatning medical conditions however, the prevalence of diabetes is rapidly increasing day by day in both developed and developing countries making it global pandemic and type II is more prevalent. Life dependency is increased due to long term effects of diabetes in specifically older individuals. Physical activity and exercise improves glucose tolerance and also reduces other life threatening diabetic complications, improving the quality of life in diabetic population. conditions: Type II Diabetes Mellitus studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a pre-post quasi experimental study having one group analysis.Participants will be selected through inclusion and exclusion criteria then pre assessment would be done that include HBA1C and EQ5DL QOL tool, followed by intervention and post assessment. primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Eccentric Training measure: Glycemic control measure: Patient's quality of life sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Foundation University College of Physical Therapy status: RECRUITING city: Rawalpindi state: Punjab zip: 46000 country: Pakistan name: Zara Khalid, PhD* role: CONTACT phone: +923335415822 email: zara.khalid@fui.edu.pk lat: 33.6007 lon: 73.0679 hasResults: False

 nctId: NCT06387537 id: FUI/CTR/2024/2 briefTitle: Effects of Scapular Mobilization on Shoulder Proprioception and Pain in Patients With Adhesive Capsulitis overallStatus: RECRUITING date: 2024-03-01 date: 2024-07-01 date: 2024-07-15 date: 2024-04-29 date: 2024-04-29 name: Foundation University Islamabad class: OTHER briefSummary: Adhesive capsulitis is a common musculoskeletal condition. Painful gradual loss of both active and passive gleno-humeral motion resulting from progressive fibrosis and ultimate contracture of the gleno-humeral joint capsule.Scapular position and movement perception both effected by shoulder adhesive capsulitis, change in the scapular kinematics in the form of an increase in scapular lateral rotation, and reduced joint sense for shoulder movements in adhesive capsulitis. Physiotherapists have a wide range of options in managing Adhesive capsulitis including Electrotherapeutic modalities, kaltenborn mobilization, Maitland's mobilization,Mulligan's mobilization and Manipulation. So far studies have shown the efficacy of different treatments in combination or in isolation.Few studies on proprioception in rotator cuff tear, sub acromial impingment syndrome, but no obseved effects of scapular mobilization on shoulder proprioception in patients with adhesive capsulitis.Physical therapist focus on lowering pain and ROM limitations in the shoulder,but often neglect to evaluate proprioception/joint position sense as well as the roleof scapula in adhesive capsulitis during treatment.If found effective,this study can help in probviding treatment protocols for improving proprioception in patients with adhesive capsulits. conditions: Adhesive Capsulitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a randomized controlled trial having two groups. One group will receive conventional physical therapy and the second will receive conventional physical therapy along with scapular mobilization. Both groups will be recruited concurrently. primaryPurpose: PREVENTION masking: NONE count: 30 type: ESTIMATED name: Conventional physical therapy name: Scapular mobilization. measure: Shoulder Proprioception measure: Pain Intensity measure: Shoulder Range of motion measure: Shoulder Disability sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Foundation University College of Physical Therapy status: RECRUITING city: Rawalpindi state: Punjab zip: 460000 country: Pakistan name: Zara Khalid, DPT, MS-CPPT,PHD* role: CONTACT phone: +923335415822 email: zara.khalid@fui.edu.pk lat: 33.6007 lon: 73.0679 hasResults: False

 nctId: NCT06387524 id: FUI/CTR/2024/1 briefTitle: Effects of Eccentric Exercises on Gait Parameters in Patellofemoral Pain Syndrome: A Quasi-Experimental Study overallStatus: RECRUITING date: 2023-07-15 date: 2024-11-20 date: 2024-11-20 date: 2024-04-29 date: 2024-04-29 name: Foundation University Islamabad class: OTHER briefSummary: This study is a quasi experimental and the purpose of this study is to determine the effects of eccentric exercises on gait parameters in patellofemoral pain syndrome: a quasi - experimental study conditions: Patellofemoral Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Quasi experimental study primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: McConnell Taping name: ECCENTRIC EXERCISES: measure: Dynamic knee valgus angle measure: Hip Range of Motion measure: Knee Range of Motion measure: Pain intensity measure: Gait Speed measure: Cadence measure: Stride length measure: Step length measure: Cycle length sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Foundation University College of Physical Therapy status: RECRUITING city: Rawalpindi state: Punjab zip: 46000 country: Pakistan name: Qurat ul Ain Saeed, MS-OMPT,PHD* role: CONTACT phone: 03315562889 email: quratulain.saeed@fui.edu.pk lat: 33.6007 lon: 73.0679 hasResults: False

 nctId: NCT06387511 id: NutriVax-Measles briefTitle: Increasing Measles Vaccination Coverage Through Supplementation With an SQ-LNS Incentive in Children Aged 6-23 Months overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-06-15 date: 2025-06-15 date: 2024-04-29 date: 2024-04-29 name: Alliance for International Medical Action class: OTHER name: Institut National de la Santé Et de la Recherche Médicale, France name: Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire name: Yobe State Ministry of Health, Nigeria name: Eleanor Crook Foundation name: Gavi, The Vaccine Alliance briefSummary: Provision of SQ-LNS also holds promise in incentivizing vaccination as well as other health services.

We will estimate 1) the effectiveness of a SQ-LNS mass supplementation program added to routine immunization program compared to routine immunization program alone in terms of measles vaccine coverage, after 12 months of program implementation, 1) in children aged 12-23 months in the endline cross-sectional household survey, 2) in children aged 6-12 months at inclusion in a longitudinal 12 months follow-up survey.

Secondary objectives are to assess the barriers and facilitators from the perspectives of parents/legal guardian of children, health care providers and community health workers and to assess the cost-efficiency of the

This study will implrmented in 20 wards covering the Karasuwa and Nguru Local Government Areas (LGAs) in Yobe state, Northeast Nigeria.

This is a pragmatic parallel cluster randomized trial (PCT) with baseline measure with different populations and data collection modes: 1) baseline and endline cross-sectional household surveys of children aged 12-23 months, 2) a longitudinal follow-up survey (LS) of children aged 6-12 months at inclusion, 3) a qualitative feasibility and acceptability survey of parents of children aged 6-23 months, of health providers, of community health workers and community representatives and 4) a cost survey of parents/legal guardian of children from the longitudinal follow-up cohort, and 5) a health facility cost survey of a randomized sub-sample of health facilities.

Clusters will be randomly allocated at a ratio of 1:1 either to the standard arm or to the NutriVax arm:

* The standard Expanded Program on Immunization (EPI) in children aged 6-23 months delivered according to the Ministry of Health's routine plans in the community and at health centres and health posts, named the standard EPI arm;
* The NutriVax program combining the EPI in children aged 6-23 months according to the Ministry of Health's routine plans in the community and at health centres (i.e. PHCCs) and health posts associated with SQ-LNS mass supplementation integrated into pre-existing services delivered at health centres (i.e. PHCCs) for children 6-23 months of age, named the NutriVax arm. conditions: Immunization Coverage Improvment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A two arms opened pragmatic parallel cluster-randomized controlled trial with baseline measure primaryPurpose: PREVENTION masking: NONE maskingDescription: No possible to mask intervention due to the specifity of the intervention tested count: 3720 type: ESTIMATED name: Small-quantity lipid-based nutrition supplements (SQ-LNS) NutriVax measure: Measles vaccine coverage in children aged 12-23 months measure: Measles vaccine coverage in children 6-12 months at inclusion measure: Measles vaccine coverage: at least one dose measure: Measles vaccine coverage : two doses measure: Timeliness of measles 1 vaccination measure: Other infant vaccines coverage measure: Zero-dose measure: Fully immunization measure: Acceptability measure: Cost-efficiency sex: ALL minimumAge: 6 Months maximumAge: 23 Months stdAges: CHILD hasResults: False

 nctId: NCT06387498 id: 20-2286 briefTitle: Testicular Tissue Cryopreservation (TTC) acronym: TTC overallStatus: RECRUITING date: 2020-09-28 date: 2027-12-30 date: 2027-12-30 date: 2024-04-29 date: 2024-04-29 name: University of Colorado, Denver class: OTHER briefSummary: The "Testicular Tissue Cryopreservation" study is open to a subset of patients facing disease or treatment regimens that could lead to infertility (gonadotoxic therapies). For some of these patients, experimental testicular tissue cryopreservation is the only fertility preservation option available. The overall objective of this study is to determine the feasibility and acceptability of testicular tissue cryopreservation in male patients of all ages who have a condition or will undergo a treatment that can cause infertility. conditions: Fertility Issues studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: Testicular tissue biopsy and cryopreservation measure: Feasibility, as Assessed via the Percentage of Eligible Patients who do a Procedure measure: Feasibility, as Assessed via Percentage of Patients who Attempted a Procedure who were able to Cryopreserve measure: Safety, as Assessed via the Number of Participants with At Least One Pre-specified Adverse Event measure: Safety, as Assessed via the Number of Participants with At Least One Pre-specified Adverse Event measure: Safety, as Assessed via the Number of Participants with At Least One Pre-specified measure: Safety, as Assessed via the Number of Participants with At Least One Pre-specified measure: Acceptability, as Assessed via Annual Survey Regret Score sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Jocelyn Phipers, RN role: CONTACT phone: 303-724-7807 email: jocelyn.phipers@cuanschutz.edu name: Leslie Appiah, MD role: CONTACT email: LESLIE.APPIAH@CUANSCHUTZ.EDU name: Leslie Appiah, MD role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 hasResults: False

 nctId: NCT06387485 id: SR-001 briefTitle: A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-04-01 date: 2024-04-29 date: 2024-04-29 name: Ricoh USA, Inc. class: INDUSTRY briefSummary: This prospective, multi-center, randomized controlled study aims to assess the efficacy of utilizing 3D printed models in preoperative planning for the excision of tumors involving bony structures within the body. The study is expected to last approximately 12 months and involve up to 150 subjects across 3 sites. Subjects will be randomized in a 1:1 ratio into either the experimental arm, utilizing 3D printed models and imaging, or the active comparator arm, using only imaging.

Primary endpoint: Operative time of surgical procedure.

Secondary endpoints: Reduction of blood loss, proportion of postoperative adverse events, and negative tumor margins.

Exploratory endpoints: Surgical planning ease, changes in surgical plan, and surgeon satisfaction. conditions: Sarcoma, Ewing conditions: Chondrosarcoma conditions: Osteosarcoma conditions: Fibrous Histiocytoma conditions: Fibrosarcoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: 3D Printed Anatomic Model name: CT/MRI measure: Operative time measure: Blood loss measure: Adverse Events measure: Tumor margin status sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: William Beaumont University Hospital status: RECRUITING city: Royal Oak state: Michigan zip: 48073 country: United States name: Pamela Sloan, RN, CCRP role: CONTACT phone: 248-551-6059 email: Pamela.Sloan@corewellheath.org lat: 42.48948 lon: -83.14465 facility: The Ohio State University Wexner Medical Center status: RECRUITING city: Columbus state: Ohio zip: 43212 country: United States name: Rachel Herster, BS role: CONTACT phone: 248-514-4490 email: rachel.herster@osumc.edu lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06387472 id: 23-007636 briefTitle: DermAI to Evaluate Human Factor of Testing overallStatus: RECRUITING date: 2024-04-29 date: 2024-08-01 date: 2024-12-31 date: 2024-04-29 date: 2024-04-29 name: Mayo Clinic class: OTHER briefSummary: The purpose of this research is to improve how well remote patch allergy testing works and make sure they are easy and practical for people to use from home. conditions: Contact Dermatitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 150 type: ESTIMATED name: AI algorithm to evaluate photographs of skin test patch regions name: Allergen Patch measure: Classification of test site region reaction measure: Classification of test site region using a 5-point scale measure: False Positive Rate measure: False Negative Rate measure: Early termination of testing measure: Participants that removed patches early measure: Adverse events related to allergen exposure 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: Laura Pacheco-Spann role: CONTACT phone: 904-953-0408 email: FLAQHSCS@mayo.edu name: Matthew Hall, MD role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 hasResults: False

 nctId: NCT06387459 id: 2022M3C1A3090827 briefTitle: Feasibility of Fabric Orthosis for Knee Support in Elderly Gait Improvement overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-05-14 date: 2026-05-14 date: 2024-04-29 date: 2024-04-29 name: Seoul National University Hospital class: OTHER name: Ministry of Science and ICT briefSummary: This pilot clinical trial assesses the safety and feasibility of a novel fabric-type orthosis designed to mimic the knee extensor muscles and improve gait in elderly patients with mobility impairments due to conditions like sarcopenia, diabetes, or knee osteoarthritis. The study aims to test this orthosis in a real- world setting to see if it can enhance mobility and stability for elderly individuals, potentially reducing falls and improving quality of life. A total of 30 participants aged 65 and older will be recruited to use this orthosis across multiple sessions, where their gait will be analyzed under various conditions to measure the device's impact on walking speed, stability, and muscle activation. conditions: Gait conditions: Fall conditions: Orthotic Devices studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: Fabric-Type Knee Extensor Muscle-Mimicking Orthosis measure: Completion Rate measure: Dropout Rate measure: User Feedback measure: 6-Minute Walk Test measure: 10-Meter Walk Test measure: Surface Electromyography measure: Gait Analysis sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06387446 id: RB-P00044611 briefTitle: Allogeneic Valve Transplantation overallStatus: RECRUITING date: 2024-05-01 date: 2027-06-01 date: 2027-06-01 date: 2024-04-29 date: 2024-04-29 name: Boston Children's Hospital class: OTHER briefSummary: Valves will be taken from hearts donated by organ donors, and implanted into patients who need a new heart valve. conditions: Valve Heart Disease conditions: Valve Disease, Heart conditions: Valve Disease, Aortic studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 4 type: ESTIMATED name: Valve transplant measure: Valve Regurgitation measure: Valve Annulus Growth measure: Leaflet Growth measure: Ventricular Function measure: Survival sex: ALL minimumAge: 30 Days maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Boston Children's Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States name: Sitaram Emani, MD role: CONTACT lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06387433 id: mHealth id: SG-222/R3-05/RDC/DUHS/1478 type: OTHER_GRANT domain: National Institutes of Health Pakistan briefTitle: Effectiveness of an mHealth Mobile App acronym: mHealth overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-20 date: 2025-08 date: 2025-08 date: 2024-04-29 date: 2024-04-29 name: Dow University of Health Sciences class: OTHER name: National Institutes of Health (NIH) briefSummary: Type II diabetes is a serious challenge for Pakistan. Not using medications properly increases healthcare costs and diabetes-related deaths. A mobile app in local language can improve medication adherence and self-management among diabetics. Therefore, in this 18 months long study we will develop a diabetes-related mobile application in Urdu, and will conduct a trial to assess whether it improves medication compliance and self-management, and how much economical this app would be compared to the usual standard of care for type II diabetics in Pakistan. This trial will be conducted at the National Institute of Diabetes and Endocrinology Karachi. The study participants will be divided in two groups. Only one group will use this application. We will measure medication compliance and self-management through diabetes-specific blood test and self-reporting questionnaires between two groups. We will also determine how much economic costs would be saved by using this app to improve medication compliance conditions: Type II Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 160 type: ESTIMATED name: mobile app use measure: adherence to medication measure: self-management among diabetics measure: Intervention usability measure: economic effectiveness of the app sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institute of Diabetes and Endocrinology city: Karachi state: Sindh country: Pakistan lat: 24.8608 lon: 67.0104 hasResults: False

 nctId: NCT06387420 id: AK117-206 briefTitle: A Study of AK117 in Combination With Azactidine Plus Venetoclax in Patients With Acute Myeloid Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2026-04 date: 2027-04 date: 2024-04-29 date: 2024-04-29 name: Akeso class: INDUSTRY briefSummary: This is a phase 1b/2 study. All patients are diagnosed with Acute Myeloid Leukemia (AML), Eastern Cooperative Oncology Group (ECOG) performance status 0-3. The purpose of this study is to evaluate the safety and efficacy of AK117 + azacitidine + venetoclax in subjects with AML. conditions: ACUTE MYELOID LEUKEMIA; AML studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: AK117 name: Azacitidine name: Venetoclax name: Placebo measure: Phase 1b: Number of participants with dose limiting toxicity (DLT) measure: Phase 1b/2: Number of participants with adverse events (AEs) measure: Phase 1b/2: Composite complete remission rate (CCR) measure: Overall response rate (ORR) measure: Time to response (TTR) measure: Time to CCR (TTCCR) measure: Duration of response (DoR) measure: Duration of CCR (DoCCR) measure: Rate of CCR Without Minimal Residual Disease (CCR MRD-) measure: Event-free survival (EFS) measure: Overall survival (OS) measure: Peak of Serum Concentration (Cmax) measure: Anti-drug antibody (ADA) measure: Receptor occupancy (RO) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College city: Tianjin country: China name: Jianxiang Wang role: CONTACT lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06387407 id: 2024037K briefTitle: Population Pharmacokinetic Study of the Effect of Polymorphisms in the ABCB1 and CES1 Genes on the Pharmacokinetics of Dabigatran overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-06-10 date: 2025-11-25 date: 2024-04-29 date: 2024-04-29 name: The Affiliated Hospital Of Guizhou Medical University class: OTHER briefSummary: According to published studies, the effects of genetic polymorphisms in the ABCB1 and CES1 genes on the blood concentration of dabigatran are controversial, and it is not clear whether dabigatran dosage and dosing intervals need to be adjusted according to genotype or other covariates in Chinese subjects. For these purposes, we will include patient demographics, genetic polymorphisms, and PK data based on a population pharmacokinetic study of dabigatran ester in healthy Chinese subjects to analyze the effect on dabigatran pharmacokinetics.

The aim of this study was to develop a population pharmacokinetic model to understand the relationship between dabigatran-related genes and dabigatran plasma levels after a single oral dose in healthy Chinese subjects and patients, and to analyze the effects of genetic variation on the efficacy and safety of dabigatran etexilate. conditions: Combined Analysis of Polymorphisms and Dabigatran Pharmacokinetic Parameters studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 30 type: ESTIMATED name: Dabigatran Etexilate 150mg measure: Plasma drug concentration sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06387394 id: M21-416 briefTitle: A Study to Assess BOTOX Injections in Adult Participants for the Change of Masseter Muscle Prominence overallStatus: RECRUITING date: 2024-04-22 date: 2025-12-27 date: 2026-01-26 date: 2024-04-29 date: 2024-04-29 name: AbbVie class: INDUSTRY briefSummary: The masseter muscle is one of the muscles in the lower face used for chewing. The prominence of the masseter muscle can appear as a widened lower face which some individuals deem as aesthetically undesirable and can be treated by selectively weakening the masseter muscles with small quantities of botulinum toxin. The purpose of this study is to assess how safe and effective injection of onabotulinumtoxinA (BOTOX) is in adult participants with Masseter Muscle Prominence (MMP).

BOTOX is being investigated for the treatment of Muscle Masseter Prominence. In Period 1, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment, placebo or BOTOX. There is a 1 in 4 chance that participants will be assigned to placebo. In Period 2, eligible participants can receive an optional open-label retreatment of BOTOX. Approximately 200 adult participants with MMP will be enrolled in the study at approximately 20 sites in the United States.

Participants will receive intramuscular injections across both the right and left masseter muscle of either BOTOX or placebo on Day 1. Participants who are eligible for re-treatment will be given BOTOX injections on either the Day 180, 210, 240, or 270 visit and will be followed up for up to 6 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, and completing questionnaires. conditions: Masseter Muscle Prominence studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: BOTOX name: Placebo measure: Composite Achievement of MMP Severity Improvement and at Least a 2-Grade Improvement from Baseline by Both Investigator-Rated MMPS and Participant-Rated MMPS-P measure: Number of Participants with Adverse Events (AEs) measure: Percentage of Participants Achieving Investigator-Rated MMPS Improvement Over Time measure: Percentage of Participants Achieving Participant-Rated MMPS-P Improvement Over Time measure: Percentage of Participants who Responded as "Very satisfied" or "Satisfied" on the Lower Facial Shape Questionnaire - Treatment Satisfaction Assessment (LFSQ-TXSAT) measure: Percentage of Participants who Responded as "Much improved" or "Moderately improved" on the MMP Participant Self-Assessment of Change (MMP-PSAC) measure: Percentage of Participants who Responded as "Not at all bothered" or "A little bothered" on the Bother Impact Assessment for Masseter Muscle Prominence (BIA-MMP) measure: Change from Baseline in Lower Facial Shape Questionnaire-Impact Assessment (LFSQ-IA) Summary Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Delricht Research /ID# 249825 status: RECRUITING city: New Orleans state: Louisiana zip: 70115 country: United States lat: 29.95465 lon: -90.07507 facility: Clarkston Dermatology /ID# 248888 status: RECRUITING city: Clarkston state: Michigan zip: 48346 country: United States lat: 42.73586 lon: -83.41883 hasResults: False

 nctId: NCT06387381 id: CYYY-KY-2024-048-01 briefTitle: 68Ga-PSFA PET Imaging in Patients With PSMA/FAP Positive Disease overallStatus: RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2026-12-31 date: 2024-04-29 date: 2024-04-29 name: First Affiliated Hospital of Chongqing Medical University class: OTHER briefSummary: As a new dual receptor (PSMA and FAP) targeting PET radiotracer, 68Ga-PSFA is promising as an excellent imaging agent applicable to PSMA/FAP positive diseases. In this research, we investigate the safety, biodistribution and potential usefulness of 68Ga-PSFA positron emission tomography (PET) for the diagnosis of lesions in PSMA/FAP positive diseases. conditions: PSMA conditions: FAP conditions: Positron-Emission Tomography studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ESTIMATED name: 68Ga-PSFA measure: Diagnostic efficacy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Chongqing Medical University status: RECRUITING city: Chongqing state: Chongqing zip: 400016 country: China name: Xiaoyang Zhang, PhD role: CONTACT phone: 023-89011755 email: zhangxy@mail.bnu.edu.cn lat: 29.56278 lon: 106.55278 hasResults: False

 nctId: NCT06387368 id: HE-202303 briefTitle: Clinical Study of Huaier Granule in the Treatment of Unresectable Pancreatic Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-03 date: 2028-08 date: 2024-04-29 date: 2024-04-29 name: Health Science Center of Xi'an Jiaotong University class: OTHER name: LinkDoc Technology (Beijing) Co. Ltd. name: Huazhong University of Science and Technology briefSummary: This is a prospective, multicenter, randomized, open, parallel controlled clinical study to evaluate the efficacy and safety of Huaier Granules combined with capecitabine in the treatment of unresectable pancreatic cancer. conditions: Pancreatic Cancer Non-resectable studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 488 type: ESTIMATED name: Huaier Granule name: Capecitabine measure: Overall survival measure: Objective response rate measure: Progression free survival measure: Conversion surgery rate measure: The incidence and severity of adverse events (AE) and severe adverse events (SAE) measure: The incidence and severity of ADR, severe adverse reactions (SADR), suspicious and unexpected severe adverse reactions (SUSAR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06387355 id: SURG-006-23S briefTitle: Diagnosis and Treatment of CAD in Severe PAD After Lower Extremity Revascularization acronym: CAD in sPAD overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2027-08-01 date: 2029-08-01 date: 2024-04-29 date: 2024-04-29 name: VA Office of Research and Development class: FED briefSummary: Peripheral artery disease, lack or blood flow to the legs, has a high prevalence in the Veteran population. In patients with severe peripheral artery disease that requires an endovascular or surgical intervention for lower leg revascularization, the long-term mortality of approximately 50% is worse that most cancers. The goal of this study is to develop a management strategy to improve cardiovascular outcomes in this high-risk peripheral artery disease population after lower extremity revascularization. conditions: Peripheral Artery Disease conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This will be a parallel interventional model to assign participants to a treatment strategy in a clinical study primaryPurpose: TREATMENT masking: NONE count: 450 type: ESTIMATED name: Coronary computed topography (CT) angiography with FFR-CT measure: Major adverse cardiovascular events (MACE) measure: Cardiovascular-related death measure: Myocardioal infarction measure: All-cause mortality measure: Amputation-free survival sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rocky Mountain Regional VA Medical Center, Aurora, CO city: Aurora state: Colorado zip: 80045 country: United States name: Clay Quint, MD PhD role: CONTACT phone: 210-606-2940 email: clay.quint@va.gov name: Clay Quint, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 facility: North Florida/South Georgia Veterans Health System, Gainesville, FL city: Gainesville state: Florida zip: 32608-1135 country: United States name: Salvatore Scali, MD role: CONTACT phone: 352-376-1611 lat: 29.65163 lon: -82.32483 facility: Louis Stokes VA Medical Center, Cleveland, OH city: Cleveland state: Ohio zip: 44106-1702 country: United States name: Michael Rosenbaum, MD role: CONTACT phone: 216-791-3800 lat: 41.4995 lon: -81.69541 facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA city: Pittsburgh state: Pennsylvania zip: 15240 country: United States name: Edith Tzeng, MD role: CONTACT phone: 866-482-7488 lat: 40.44062 lon: -79.99589 facility: Tennessee Valley Healthcare System Nashville Campus, Nashville, TN city: Nashville state: Tennessee zip: 37212-2637 country: United States name: John Curci, MD role: CONTACT phone: 615-327-4751 lat: 36.16589 lon: -86.78444 facility: VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX city: Dallas state: Texas zip: 75216-7167 country: United States name: Shirling Tsai, MD role: CONTACT phone: 469-797-2100 lat: 32.78306 lon: -96.80667 facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA city: Seattle state: Washington zip: 98108-1532 country: United States name: Gale Tang, MD role: CONTACT phone: 800-329-8387 lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06387342 id: CF102-222PC briefTitle: Namodenoson Treatment of Advanced Pancreatic Cancer overallStatus: NOT_YET_RECRUITING date: 2024-07-15 date: 2026-07-15 date: 2026-12-15 date: 2024-04-29 date: 2024-04-29 name: Can-Fite BioPharma class: INDUSTRY briefSummary: This is an open-label trial in patients with advanced pancreatic cancer. The trial will evaluate the safety, clinical activity, and pharmacokinetics of the study drug, namodenoson, in this group of patients. conditions: Pancreatic Adenocarcinoma conditions: Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open-label study primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Namodenoson 25mg measure: Adverse Events measure: Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Change from baseline measure: Objective response rate measure: Progression free survival measure: Disease control rate measure: Duration of response measure: Overall survival measure: Quality of Life evaluation with EORTC QLQ-C30 measure: Quality of Life evaluation with EORTC QLQ-PAN26 measure: Pharmacokinetics of namodenoson: Cmax measure: Pharmacokinetics of namodenoson: Cmin measure: Pharmacokinetics of namodenoson: AUC(0-12) measure: Cancer antigen 19-9 (CA 19-9) measure: Carcinoembryonic Antigen (CEA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rabin Medical Center Institute of Oncology city: Petach Tikva zip: 49100 country: Israel name: Salomon M Stemmer, MD role: CONTACT lat: 32.08707 lon: 34.88747 hasResults: False

 nctId: NCT06387329 id: WRNMMC-2023-0438 briefTitle: Bladder Botox UTI Antibiotic Prophylaxis overallStatus: RECRUITING date: 2024-04-04 date: 2025-06-30 date: 2025-06-30 date: 2024-04-29 date: 2024-04-29 name: Walter Reed National Military Medical Center class: FED briefSummary: Overactive bladder (OAB) is a common condition with a prevalence of 17% in the general population that significantly affects quality of life. Intradetrusor onabotulinumtoxinA injections are an advanced therapy for OAB as well as interstitial cystitis/bladder pain syndrome (IC/BPS). The most common adverse event following intradetrusor injection of onabotulinumtoxinA in urinary tract infection (UTI), which occurs in 8.6-48.1% of patients. To prevent UTIs, patients are given a course of antibiotics, however the ideal prophylactic regimen has not been determined for the timing, duration, and type of antibiotic. Four retrospective studies in the literature address this question with variable conclusions, and there are no prospective studies. Identifying the ideal regimen is important for preventing UTIs as well as minimizing antibiotic use to prevent adverse effects and development of antibiotic resistance.

The population to be studied will be female patients 18 years and older who are patients of the urogynecology and urology clinics at Walter Reed National Military Medical Center with a diagnosis of OAB or IC/BPS and have chosen to be treated with intradetrusor onabotulinumtoxinA injections. It will be a non-blinded randomized controlled noninferiority trial in which the patients are randomly placed into 2 groups. The first group will receive a 3 day course of twice daily oral nitrofurantoin 100mg starting at the time of the procedure, and the second group will receive a single dose of 100mg oral nitrofurantoin at the time of the procedure.

The patients will be screened at the clinic at the time that they schedule their intradetrusor onabotulinumtoxinA injection appointment or by phone 1-2 weeks prior to their procedure. If the patient agrees to participate in the study then they will be instructed to give a urine sample for urinalysis and culture 1 week prior to the procedure appointment to exclude existing UTI. If a UTI is diagnosed at this time they must complete treatment prior to the procedure or will need to reschedule their procedure. On the day of the procedure patients will receive the clinic standard 10ml of 2% viscous lidocaine through the urethra 10-20 minutes prior to the procedure, and may be offered 5-10mg oral diazepam at the discretion of the treating physician. All patients will be given 200mg of phenazopyridine and 100mg of nitrofurantoin prior to the initiation of the procedure. The procedure will take place as directed by the treating physician per standard operating procedure.

A urinalysis and urine culture will be placed for all study participants at time of their procedure appointment in case they have symptoms of UTI, and they will be instructed to follow up with the research team by phone if they have concerns for a UTI. Patients will be contacted 30-45 days after the procedure by phone, email, or message through genesis and asked about any UTI symptoms, UTI diagnoses and secondary outcomes during the 30 days following the procedure. Data will be analyzed for the primary outcome of UTI rates in the 30 days following intradetrusor onabotulinumtoxinA injection. conditions: Overactive Bladder conditions: Bladder Pain Syndrome studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Nonblinded, randomized, noninferiority trial of single dose nitrofurantoin vs 3 day twice daily course of nitrofurantoin for prevention of post-procedure urinary tract infections after intradetrusor onabotulinumtoxinA injections for OAB and IC/BPS. primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: Nitrofurantoin 100 MG measure: Urinary tract infection measure: Urinary tract infection symptoms measure: Urinary retention measure: Adverse effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Walter Reed National Military Medical Center status: RECRUITING city: Bethesda state: Maryland zip: 20899 country: United States name: Jordan Gisseman, MD role: CONTACT phone: 301-400-2468 email: jordan.gisseman.mil@health.mil lat: 38.98067 lon: -77.10026 hasResults: False

 nctId: NCT06387316 id: 2023-1526 briefTitle: Cephalic Phase Responses to Nutritive and Non-Nutritive Sweeteners overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-26 date: 2024-04-17 date: 2025-03-30 date: 2024-04-29 date: 2024-04-29 name: Purdue University class: OTHER briefSummary: This study will focus on changes in blood sugar in response to tasting different types of sweeteners using continuous glucose monitoring (CGM) technology. conditions: Pre Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: solutions are coded whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: No Oral Stimulation name: Oral water stimulation name: Oral Salt Stimulation name: Oral Sucralose Stimulation name: Oral Sucrose stimulation measure: Blood glucose concentration sex: ALL minimumAge: 18 Years maximumAge: 70 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: NCT06387303 id: HSR230492 briefTitle: Pain Control and Quality of Recovery After Intravenous Methadone Versus Intrathecal Morphine in Major Abdominal Surgery overallStatus: NOT_YET_RECRUITING date: 2024-05-12 date: 2026-05-11 date: 2026-05-11 date: 2024-04-29 date: 2024-04-29 name: University of Virginia class: OTHER briefSummary: Moderate to severe postoperative pain is relatively common after major abdominal surgery and is associated with less than optimal surgical experience, poor quality of recovery, and development of persistent postsurgical pain. Opioids remain a major component of postoperative pain management. Side effects of opioids used for treatment of postoperative pain include constipation, pruritus, nausea, and vomiting.1,2 Enhanced recovery after surgery (ERAS) protocols involve utilization of multimodal analgesia. Analgesic techniques used include epidural analgesia, nerve blocks, and Intrathecal (IT) administration of morphine. IT morphine reduces postoperative opioid requirement for 18-24 hours after major abdominal surgery and reduces hospital length of stay (LOS) compared with epidural analgesia.3,4 Significant number of patients that receive IT morphine still experience moderate to severe postoperative pain.5 Additionally, many patients refuse the invasive procedure or cannot receive IT morphine due to procedure contraindications; thrombocytopenia and/or coagulopathy.6

Intravenous (IV) methadone has a long analgesic half-life and has N-methyl-D-aspartate (NMDA) receptor antagonist and serotonin and norepinephrine reuptake inhibitor (SNRI) properties.7-9 It has previously been shown to reduce postoperative opioid requirements, postoperative nausea and vomiting (PONV), and postoperative pain scores in patients that underwent orthopedic, abdominal, complex spine, and cardiac surgery.10-13 Similar findings have been shown in obstetric patients that underwent caesarean delivery under general anesthesia as well as patients that underwent gynecologic surgery.14,15 IV methadone has, however, never been compared with IT morphine as a postoperative analgesic.

Our hypothesis is that intravenous (IV) methadone is non-inferior to IT morphine in patients who undergo major abdominal surgery. It offers the advantage of being a noninvasive analgesic, modality that may contribute to decreasing opioid consumption during the first 72 hours postoperatively, controlling postoperative pain, and improving quality of recovery after surgery. conditions: Pain, Postoperative studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: a single blind study primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: PARTICIPANT count: 218 type: ESTIMATED name: Methadone name: Morphine measure: Quality of Recovery 15 score measure: Overall Benefits of Analgesic Score (OBAS) measure: morphine milligram equivalent measure: Verbal Rating Scale (VRS) pain scores measure: McGill Pain questionnaire score measure: Verbal Rating Scale (VRS) pain scores sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Virginia city: Charlottesville state: Virginia zip: 22908-0710 country: United States lat: 38.02931 lon: -78.47668 hasResults: False

 nctId: NCT06387290 id: 00172836 briefTitle: Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2030-05-01 date: 2030-05-01 date: 2024-04-29 date: 2024-04-29 name: University of Utah class: OTHER name: Rutgers University briefSummary: The primary aim of this implementation-effectiveness trial is to examine the effectiveness of Mindfulness-Oriented Recovery Enhancement (MORE) and patient-centered chronic pain management visits in primary care as interventions to reduce chronic pain, improve quality of life, and reduce opioid-related harms among chronic pain patients on long-term opioid therapy. conditions: Chronic Pain conditions: Prescription Opioid Misuse conditions: Substance-Related Disorders conditions: Pain conditions: Narcotic-Related Disorders conditions: Chemically-Induced Disorders conditions: Mental Disorders conditions: Opioid-Related Disorders conditions: Neurologic Manifestations studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Hybrid implementation-effectiveness trial primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Investigators, study staff, and statistician will be blinded to treatment condition. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Mindfulness Oriented Recovery Enhancement name: Patient-Centered Chronic Pain Management Visits measure: Opioid Misuse measure: Chronic Pain measure: Change in Quality of Life measure: Opioid Dosing measure: Opioid Craving measure: PTSD Symptoms measure: Depression measure: Generalized Anxiety measure: Decentering measure: Mindful Reappraisal of Pain Sensations measure: Savoring measure: Reappraisal sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rutgers University Primary Care Clinics city: New Brunswick state: New Jersey zip: 08901 country: United States name: Thanusha Puvananayagam, MPH role: CONTACT phone: 732-235-4341 email: puvanath@rwjms.rutgers.edu name: Taylor Scott, MSW role: CONTACT phone: 732-235-7453 email: taylor.m.scott@rutgers.edu name: Nina Cooperman, PsyD role: PRINCIPAL_INVESTIGATOR lat: 40.48622 lon: -74.45182 facility: University of Utah Primary Care Clinics city: Salt Lake City state: Utah zip: 84112 country: United States name: Kelly A Hendrickson, MS role: CONTACT phone: 801-585-6354 email: kelly.hendrickson@utah.edu name: Layla Lincoln, BA role: CONTACT phone: 801-581-7508 email: layla.lincoln@utah.edu name: Eric L Garland, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.76078 lon: -111.89105 hasResults: False

 nctId: NCT06387277 id: RV1551P20220376 briefTitle: Re-epithelialization Efficacy Evaluation of Cosmetic Product RV1551P vs Non-treated Forearm of Healthy Adult Women overallStatus: COMPLETED date: 2022-09-19 date: 2022-12-12 date: 2022-12-12 date: 2024-04-29 date: 2024-04-29 name: Pierre Fabre Dermo Cosmetique class: INDUSTRY briefSummary: The aim of this study was to evaluate the impact of the product RV1551P GB3224 on skin microbiota during wound healing process, based on swab samples collected from lesion areas using an epidermally ablated skin model of erbium YAG laser. conditions: Healthy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 21 type: ACTUAL name: RV1551P GB3224 measure: Time to re-epithelialization as assessed by in vivo examination by the investigator and standardized photographs taken with a C Cube Camera® measure: Skin microbiota diversity from swab samples. measure: Skin microbiota composition from swab samples. measure: Metabolomic analysis from swab samples sex: FEMALE minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT facility: Skin Research Centre city: Toulouse state: Haute-Garonne zip: 31300 country: France lat: 43.60426 lon: 1.44367 hasResults: False

 nctId: NCT06387264 id: 2022PHC032 briefTitle: Compont - Varicose Veins of the Lower Extremities overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-11 date: 2024-04 date: 2024-12 date: 2024-04-29 date: 2024-04-29 name: Peking University People's Hospital class: OTHER name: Peking University First Hospital name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine name: First Affiliated Hospital Xi'an Jiaotong University name: Liaocheng People's Hospital name: The Second Affiliated Hospital of Chongqing Medical University briefSummary: The purpose of this clinical trial is to evaluate the effectiveness and safety of Medical Adhesive produced by Beijing Compont Medical Devices Co., Ltd. in the treatment of varicose veins in the lower extremities.

The main questions it aims to answer is: What medical problems do participants have when using tissue glue? Researchers will compare Medical Adhesive to ClosureFast Endovenous Radiofrequency Ablation (RFA) Catheter (produced by Medtronic Inc. to see if Medical Adhesive works to treat varicose veins in the lower extremities.

Participants will:

Treated with closed varicose veins of the lower extremity by Medical Adhesive or ClosureFast.

Return to the hospital at 1, 12, and 24 weeks postoperatively for Doppler ultrasound, and at 4, 12, 24 weeks postoperatively for venous scoring. conditions: Varicose Veins of Lower Limb studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 188 type: ACTUAL name: Medical Adhesive name: ClosureFast Endovenous Radiofrequency Ablation(RFA) Catheter measure: Clinical success rate measure: Technical success rate measure: Target vascular closure rate at 12 weeks after operation. measure: Clinical signs measure: Venous Clinical Severity Score (VCSS) measure: Aberdeen Varicose Vein Questionnaire (AVVQ) measure: Operation duration measure: Evaluation of product performance sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University People's Hospital city: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06387251 id: 2023-11-437-0003 briefTitle: Assess the Effects of a 30 Day-wellness Program on Digestive Health, Weight and Overall Well-being overallStatus: COMPLETED date: 2024-01-29 date: 2024-02-29 date: 2024-02-29 date: 2024-04-29 date: 2024-04-29 name: Peryam & Kroll Research Corporation class: OTHER name: Alticor Inc. briefSummary: The digestive system is a pivotal component of human health, playing a crucial role in the absorption of nutrients, elimination of waste, and even influencing mental well-being. Poor digestive health can significantly impact one's quality of life and overall well-being. Issues such as bloating, constipation, or imbalanced gut microbiome can affect one's overall well-being. Moreover, the gut-brain connection underscores how digestive health can affect mental well-being. The gut can contribute to serotonin and energy production thus influencing one's mood, energy levels and cognitive functions, affecting one's emotional stability. Additionally, inadequate nutrient absorption from an imbalanced digestive system may lead to suboptimal health, weakening the body and causing fatigue. Overall, maintaining good digestive health is crucial not only for physical comfort but also for normal metabolism, immune function, cognitive abilities, sleep and skin health, ultimately enhancing the overall quality of life. Products designed by the sponsor contains a blend of ingredients recognized for their potential benefits in promoting digestive health (including prebiotics, probiotics, postbiotics, plant-based extracts and plant-based protein). Furthermore, it is well established in the literature that diet, exercise, hydration and mindfulness all impact our gut health and overall well-being. Therefore, this scientific study seeks to validate the efficacy of the combination of products and life-style changes by assessing its impact on gut health and related health aspects like weight, metabolic health, fitness level, energy/fatigue levels, satiety/hunger, food cravings, cognitive abilities and overall well-being. conditions: Digestive Health studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 150 type: ACTUAL name: 30 day wellness program measure: Bristol Stool Scale measure: Digestive symptom frequency questionnaire measure: Waist Circumference measure: Improvements in sleep measure: Improvements in stress measure: Fitness Level measure: Satiety Responsiveness and Hunger measure: Craving Intensity measure: Cognitive Abilities measure: Fatigue measure: Skin Appearance measure: General Health measure: Program Feedback sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wilkins Research city: Chattanooga state: Tennessee zip: 37421 country: United States lat: 35.04563 lon: -85.30968 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-11 uploadDate: 2024-03-07T13:19 filename: ICF_000.pdf size: 144142 hasResults: False

 nctId: NCT06387238 id: PSMA-mHSPC briefTitle: Exploration of the Value of PSMA PET/CT in Dynamic Monitoring of the Efficacy of Novel Endocrine Therapy in Patients With Metastatic Hormone Sensitive Prostate Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2026-06-30 date: 2024-04-29 date: 2024-04-29 name: Peking University First Hospital class: OTHER briefSummary: 1. Based on the treatment response and prognosis of mHSPC patients with novel endocrine therapy, a PSMA PET whole-body tumor burden classification was constructed to guide treatment and evaluate prognosis.
2. Based on the treatment response and prognosis of mHSPC patients with novel endocrine therapy, a multivariable model will be constructed using quantitative parameters of PSMA PET/CT imaging, pre-treatment gene status, PSA, GS/ISUP and other clinical pathological parameters to further achieve accurate patient classification, guide treatment, and evaluate prognosis. conditions: Prostate Adenocarcinoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients With Metastatic Hormone Sensitive Prostate Cancer, will receive pre-therapeutic PSMA PET/CT and post-therapeutic PSMA PET/CT after three-month novel endocrine therapy. primaryPurpose: DIAGNOSTIC masking: NONE count: 150 type: ESTIMATED name: PSMA PET/CT measure: rPFS measure: PSA-PFS measure: OS sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06387225 id: RC23_0248 briefTitle: Early and Objective Assessment of Neurological Prognosis in Cardiac Arrest Patients acronym: HYPERION-2 overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-12-01 date: 2026-12-01 date: 2024-04-26 date: 2024-04-29 name: Nantes University Hospital class: OTHER briefSummary: Cerebral lesions are responsible for two thirds of deaths in patients admitted to intensive care following cardiac arrest. Patients with neurological lesions should be the priority target for neuroprotective interventions, which are the cornerstone of post-cardiac arrest care (allowing a reduction in the burden of care for patients without this type of lesion). Furthermore, these interventions must be based on a precise assessment of the severity of these brain lesions: carrying out neuro-protective interventions in patients without brain lesions exposes these patients to unnecessary treatment potentially associated with adverse effects without any possible benefit. However, the early assessment of neurological prognosis, particularly on admission to intensive care, is an area where there is little research and where it is not possible to obtain a precise and reproducible assessment. Several tools can be used to assess this prognosis at an early stage: anamnesis and characteristics of the cardiac arrest and the patient's comorbidities, imaging, electrophysiology and biomarkers.

To assess the predictive value of early biomarker testing in patients resuscitated after cardiac arrest, whatever the cause, the investigators plan to conduct a prospective observational multicentre trial.

It is important to bear in mind that the aim of this study is not to assess the long-term prognosis of patients suffering cardiac arrest in order to take measures to limit or discontinue active therapies, but simply to provide a reliable tool, simple and quick to use, in order to be able to identify a sub-population of patients who should be the subject of preferential neuro-protection measures, and conversely to simplify management (moderate temperature control, early cessation of sedation, early extubation) for patients with no neurological lesions. conditions: Cardiac Arrest conditions: Neurologic Symptoms conditions: Intensive Care Neurological Disorder studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 608 type: ESTIMATED measure: Dosage of biomarker UCHL-1 (Ubiquitin carboxy-terminal hydrolase L1) at the time of admission to intensive care measure: Dosage of biomarker GFAP (Glial fibrillary acidic protein) at the time of admission to intensive care measure: Neurological outcome at D90 assessed by modified Rankin scale (mRS) measure: Dosage of biomarkers UCHL-1 ((Ubiquitin carboxy-terminal hydrolase L1) and GFAP (Glial fibrillary acidic protein) at the time of admission to intensive care measure: Dosage of biomarkers UCHL-1 ((Ubiquitin carboxy-terminal hydrolase L1) and GFAP( Glial fibrillary acidic protein) at 4 hours for recovery of effective cardiac activity (RACS) measure: Neurological outcome at D90 assessed by modified Rankin scale (mRS) ranging from 0 to 6 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHD Vendée city: La Roche-sur-Yon zip: 85025 country: France name: Gwenael COLIN role: CONTACT lat: 46.66667 lon: -1.43333 facility: APHP - Hôpital Cochin city: Paris zip: 75679 country: France name: Sarah BENGHANEM role: CONTACT lat: 48.85341 lon: 2.3488 facility: CH Saint-Nazaire city: Saint-Nazaire zip: 44600 country: France name: Julien LORBER role: CONTACT lat: 47.28333 lon: -2.2 hasResults: False

 nctId: NCT06387212 id: HUI0001 briefTitle: Clinical Efficacy and Safety of 35 kDa Hyaluronan Fragment (HA35) Injection in the Treatment of Skin Problems. overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-05 date: 2024-05 date: 2024-04-26 date: 2024-04-26 name: Nakhia Impex LLC class: INDUSTRY briefSummary: To explore the clinical effect and safety of 35 kDa hyaluronic acid fragment ( HA35 ) combined with negative pressure microneedle technology in improving skin problems. conditions: Skin Inflammation conditions: Cosmetic Skin studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: 35 kDa hyaluronan fragment HA35 injection measure: A skin dryness scale measure: A fair or smooth skin scale measure: A skin pore size scale measure: A inflammatory skin thick hardness scale measure: An erythema color and area scale measure: Self-satisfaction evaluation sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nahia Impex LLC city: Ulaanbaatar country: Mongolia name: Mizhou Hui role: CONTACT phone: 13484005199 email: mizhou.hui@alumni.utoronto.ca lat: 47.90771 lon: 106.88324 hasResults: False

 nctId: NCT06387199 id: 2024-10227 briefTitle: Alleviating Carbohydrate Counting for Patients With Type-1 Diabetes Using a Closed Loop System With Weekly Subcutaneous Semaglutide acronym: SEMA SMA overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-07 date: 2026-07 date: 2024-04-26 date: 2024-04-26 name: McGill University Health Centre/Research Institute of the McGill University Health Centre class: OTHER briefSummary: A closed-loop insulin system, often labelled the "artificial pancreas" (AP), consists of an insulin pump, a continuous glucose monitor, and an interface coordinating between them to regulate insulin dosage based on glucose levels. Primarily designed for managing type 1 diabetes, this system has demonstrated significant benefits in previous studies. Yet, despite these advantages, certain challenges persist.

Semaglutide, utilized in treating type 2 diabetes and obesity, is a once-weekly injectable medication that elevates levels of a gastrointestinal hormone known as Glucagon-Like Peptide-1 (GLP-1). This hormone alters gastric emptying, inhibits glucagon release, and reduces appetite. While not officially sanctioned for type 1 diabetes treatment in North America, studies have explored its efficacy as an adjunctive therapy alongside insulin, yielding favorable outcomes in blood glucose regulation. Comparable drugs like liraglutide and exenatide have been employed in type 1 diabetes treatment as well, albeit with less pronounced glucose-regulating effects compared to semaglutide, even in type 2 diabetes.

The goal of this 50-week randomized placebo-controlled crossover 2x4 factorial designed trial is to assess whether commercial automated insulin delivery (AID) systems using rapid-acting insulin with adjunct weekly injections of semaglutide (at the maximally tolerated dose) can replace carbohydrate counting with simple meal announcements (SMA) without degrading glucose control. conditions: Type 1 Diabetes conditions: Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: randomized placebo-controlled crossover 2x3 factorial designed trial primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 26 type: ESTIMATED name: Semaglutide with 4 meal strategies name: Placebo with 4 meal strategies measure: Percentage of daytime plasma glucose levels spent in target range (semaglutide vs. placebo) measure: Percentage of time spent in the range of glucose levels between 3.9 and 7.8 mmol/L measure: Percentage of time spent in glucose levels below 3.9 and 3.0 mmol/L measure: Percentage of time spent in glucose levels above 7.8, 10 and 13.9 mmol/L measure: Mean glucose level measure: Standard deviation of glucose levels as a measure of glucose variability measure: Percentage coefficient of variation of glucose levels measure: Proportions of participants with time in range between 3.9 - 10.0 mmol/L≥ 70% measure: Glycated hemoglobin (HbA1c) measure: Area under the curve 0-2h post meal, 0-3h post peal measure: Average scores between interventions on the Type 1 Diabetes Distress Scale questionnaire measure: Average scores between interventions on the Diabetes Treatment Satisfaction questionnaire measure: Average scores between interventions based on the Hypoglycemic Fear Survey - II measure: Heart rate measure: Blood pressure measure: Measure of body weight measure: Measure of body mass index measure: Measure of waist circumference and hip circumference measure: Measure of waist-to-hip ratio measure: Lipid profile, specifically: LDL-cholesterol, HDL-cholesterol, triglycerides measure: Urine albumin-creatinine ratio sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Research Institute of the McGill University Health Centre city: Montreal state: Quebec zip: H4A 3J1 country: Canada name: Nicholas Sabelli, BSc role: CONTACT phone: (514) 377-9455 email: nicholas.sabelli@mail.mcgill.ca name: Michael Tsoukas, MD role: PRINCIPAL_INVESTIGATOR name: Ahmad Haidar, Ph.D role: SUB_INVESTIGATOR name: Vanessa Tardio, MD role: SUB_INVESTIGATOR lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06387186 id: 2023P003233 briefTitle: Leucine Enriched Essential Amino Acid Powder as an Add-on to a Classic Ketogenic Diet in Refractory Epilepsy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03-31 date: 2025-03-31 date: 2024-04-26 date: 2024-04-26 name: Elizabeth Anne Thiele class: OTHER name: Ajinomoto USA, INC. name: Ajinomoto Co., Inc. briefSummary: The main purpose of this study is to evaluate the safety and tolerability of a Leucine-Enriched Essential Amino Acid (LEAA) Powder as an add-on to a classic ketogenic diet (KD) in pediatric and adult patients with refractory epilepsy. conditions: Refractory Epilepsy conditions: Drug Resistant Epilepsy studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Leucine-Enriched Essential Amino Acid powder measure: Number of participants with treatment-related adverse events measure: Number of participants with improved nutritional status as assessed by weight. measure: Number of participants with improved nutritional status as assessed by body mass index (BMI). measure: Number of participants with improved nutritional status as assessed by serum ketone and glucose level. measure: Changes in seizure frequency as assessed by seizure diary. measure: Changes in behavior and cognitive function as assessed by a questionnaire. measure: Changes in seizure severity and overall health as assessed by a questionnaire. sex: ALL minimumAge: 2 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02114 country: United States name: Lydia Tsega, MD, MPH role: CONTACT phone: 617-726-6524 email: ltsega@mgh.harvard.edu name: Carolyn Wilson role: CONTACT email: cwilson41@mgh.harvard.edu lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06387173 id: 23-001743 id: NCI-2024-01240 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) briefTitle: Registry of Patients Undergoing Cryoablation for Early Stage Breast Cancer overallStatus: RECRUITING date: 2024-01-04 date: 2025-01-03 date: 2099-01-03 date: 2024-04-26 date: 2024-04-26 name: Jonsson Comprehensive Cancer Center class: OTHER briefSummary: This study evaluates the side effects and outcomes of patients who undergo cryoablation for early stage breast cancer. conditions: Early Stage Breast Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Non-Interventional Study measure: Prospectively track patients who undergo cryoablation for breast cancer and record post-treatment related events. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UCLA / Jonsson Comprehensive Cancer Center status: RECRUITING city: Los Angeles state: California zip: 90095 country: United States name: Aletta Deranteriassian role: CONTACT phone: 310-206-6114 email: ADeranteriassian@mednet.ucla.edu name: Nimmi S. Kapoor, MD role: CONTACT phone: 818-995-8044 email: nskapoor@mednet.ucla.edu name: Nimmi S. Kapoor, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06387160 id: ILBS-ACLF-18 briefTitle: To Determine the Predictors of Reversibility for Acute-on-Chronic Liver Failure at 6-months. overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2026-02-27 date: 2026-02-27 date: 2024-04-26 date: 2024-04-26 name: Institute of Liver and Biliary Sciences, India class: OTHER briefSummary: ACLF is defined differently in APASL,EASL and AASLD.APASL talks of reversibility in ACLF as per its definition and constitution of Homogenous population with ACLF.The definition of ACLF as per APASL is an acute hepatic insult manifesting as jaundice (serum bilirubin ≥ 5 mg/dL (85 micromol/L) and coagulopathy (INR ≥ 1.5 or prothrombin activity \<40%) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis, and is associated with a high 28-day mortality .From the point of view of intensivists, events in form of organ dysfunction , failure or mortality would cumulatively effect the outcome.Reversibility of ACLF syndrome is a feature of the ACLF defined by the AARC criteria, as nearly all the patients included are after the index presentation.With mitigation of the acute insult and over time, the hepatic reserve improves ,fibrosis regresses and the portal pressure decreases. Further, unlike patients with decompensated cirrhosis and similar to patients with ALF, the reversal of coagulopathy preceded the reversal of jaundice,that is ,median time to reversal of syndrome, i.e jaundice and coagulopathy was 7 (4-30)days versus 19 (7-60)days for jaundice, respectively. The median time for reversal of syndrome, i.e, jaundice and coagulopathy ,was 30 days. Baseline albumin, AARC score and Transient elastography predicted long term reversibility .The disease severity assessment is needed for prognostication and to guide the therapy. Furthermore,the available prediction scores have been validated at baseline,but none has been evaluated in a dynamic manner for prognostication in ACLF patients.A DYNAMIC Model that could predict the reversibility in ACLF is urgently required. conditions: Acute-On-Chronic Liver Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 480 type: ESTIMATED name: as per institutional protocol measure: To determine predictors of Reversibility[ Serum Bilirubin < 5mg/dl and PTINR <1.5] at 6 months in Patients of Acute on chronic liver failure as defined by Asian pacific association of study of liver disease[APASL] measure: Change in Asian Pacific Association of Research consortium [AARC] Score from baseline to 90 days and 6 month follow up measure: Change in liver stiffness measurement [LSM] by Velocity controlled transient elastography[VCTE] at Baseline and 28 Days with values at 90 Days and 6 months. measure: Change in Spleen stiffness measurement [SSM] by Velocity controlled transient elastography[VCTE] at Baseline and 28 Days with values at 90 Days and 6 months measure: Change in Grade of fibrosis at Baseline [Day 0 to 28 Day of presentation] measured by Magnetic resonance elastography with 90 Days and 6months values measure: Proportion of Acute on Chronic Liver failure patients achieving reversibility [Sr Bilirubin <5mg/dl and INR <1.5] as per Asian pacific association of study of liver disease[APASL] at 90 Days. measure: Proportion of Acute on Chronic Liver failure patients achieving reversibility [Sr Bilirubin <5mg/dl and INR <1.5] as per Asian pacific association of study of liver disease[APASL] at 6months. measure: Proportion of Acute on Chronic Liver failure patients maintaining reversibility [Sr Bilirubin <5mg/dl and INR <1.5] as per Asian pacific association of study of liver disease[APASL] at 1year. measure: Proportion of Cirrhotic patients of Acute on Chronic Liver failure patients achieving re compensation at 1year. measure: Proportion of Cirrhotic patients of Acute on Chronic Liver failure patients achieving survival at 1year. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of liver and Biliary Sciences city: New Delhi state: Delhi zip: 110070 country: India name: Dr Shreyas Sarvesh, MD role: CONTACT phone: 01146300000 email: shreyassarvesh@gmail.com lat: 28.63576 lon: 77.22445 hasResults: False

 nctId: NCT06387147 id: APHP220818 briefTitle: ORal Antibiotics In Acute Mesenteric Ischemia acronym: ORIAMI overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2027-10-01 date: 2027-10-01 date: 2024-04-26 date: 2024-04-26 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Acute mesenteric ischemia (AMI) is a life-threatening condition with an increasing incidence (7-13/100000 PY). The mortality of AMI is associated with the development and extent of transmural intestinal necrosis (IN), ranging from 25% without IN to 75% with IN. Given its potential reversibility, preventing the progression of AMI towards IN is now considered a primary therapeutic goal. Early management of AMI can thus avoid fatal outcomes and prevent lifelong complications such as short bowel syndrome. Following the results of a pilot study showing an improvement in survival and lower resection rates, our team created a first-of-its-kind intestinal stroke center (SURVI unit, Beaujon Hospital, Clichy, France) that provides 24/7 standardized multimodal and multidisciplinary care to AMI patients referred from all hospitals in the Paris region. As no randomized clinical trial has ever been conducted, the treatment offered by SURVI is based on pathophysiological knowledge and observational clinical data. AMI naturally progresses to sepsis, surgical complications, and multi-organ failure, direct consequences of IN. Features of sepsis are reported in up to 90% of AMI patients compared with 3-22% of patients with brain or myocardial ischemia, supporting a specific septic component in AMI. Experimental studies demonstrated reduced translocation and mortality in germ-free animals or after administration of oral antibiotics targeting Gram-negative and anaerobic early bacterial overgrowth and translocation. In a prospective observational study, the investigators recently suggested a protective effect of systematic oral antibiotics in terms of intestinal preservation, yielding a reduced occurrence of IN (HR: 0.16, 95% confidence interval 0.03-0.62). However, the systematic use of oral antibiotics in AMI remains controversial due to the individual and collective risk of increasing the carriage of multi-drug resistant bacterias. conditions: Acute Mesenteric Ischemia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: double-blind Gentamicin + Metronidazole versus placebo primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 196 type: ESTIMATED name: Gentamicin name: Placebo name: Metronidazole measure: The primary objective is to assess the efficacy of oral antibiotics compared to placebo on reducing the rate of intestinal necrosis or death (composite primary outcome) in AMI patients within 30 days following the randomisation. measure: the rate of intestinal necrosis in the 30 days following the randomisation measure: the rate of short bowel syndrome (<200cm of remnant small bowel) at day-30 following the randomisation measure: the length of intestinal resection at day-30 following the randomisation measure: the occurrence of organ failures within the 30 days following the randomisation measure: the length of ICU stay measure: the length of hospital stay measure: expected minor side effects during the 14 days of treatment measure: hypersensitivity reactions during the 14 days of treatment measure: unexpected or serious adverse event throughout the duration of the study measure: the occurrence of healthcare-associated infection measure: the gentamicin during the 14 days of treatment measure: the metronidazole during the 14 days of treatment sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gastroentérologie-Hépatologie Beaujon city: Clichy zip: 92110 country: France name: Alexandre NUZZO, Dr role: CONTACT phone: (0)1 40 87 56 57 email: alexandre.nuzzo@aphp.fr lat: 48.90018 lon: 2.30952 facility: Réanimation - Beaujon city: Clichy zip: 92110 country: France name: Emmanuel WEISS, Dr role: CONTACT email: emmanuel.weiss@aphp.fr lat: 48.90018 lon: 2.30952 facility: Chirurgie vasculaire city: Paris zip: 75018 country: France name: Yves Hervé CASTIER role: CONTACT email: yves.castier@aphp.fr lat: 48.85341 lon: 2.3488 facility: Réanimation Bichat city: Paris zip: 75018 country: France lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06387134 id: TCM for early-stage LUAD briefTitle: Lifei Xiaoji Wan Treatment's of Early-stage NSCLC and Its Impact on the Tumor Microenvironment overallStatus: RECRUITING date: 2022-12-01 date: 2025-01-01 date: 2025-05-31 date: 2024-04-26 date: 2024-04-26 name: Henan University of Traditional Chinese Medicine class: OTHER briefSummary: This study evaluated the relationship between the clinical efficacy, histopathological changes and tumor microenvironment of the pharmacopharmacologic Lifei Xiaoji Wan in the treatment of early stage lung adenocarcinoma, and improved high-level clinical evidence and action targets for the prevention and treatment of early stage lung cancer by traditional Chinese medicine conditions: Early Stage Lung Adenocarcinoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Lifei Xiaoji Wan name: Conventional treatment with Western medicine measure: Lung Cancer Quality of Life Scale (FACT-L) measure: TCM symptoms and syndromes measure: Evaluation of tumor efficacy using RECIST criteria to measure changes in tumor body measure: Tumor markers：CEA measure: Tumor markers：CA211 measure: Tumor markers：squamous cell carcinoma antigen measure: Complete blood count: white blood cells measure: Complete blood count: haemoglobin measure: Complete blood count: Platelet measure: Liver function tests: ALT measure: Liver function tests: AST measure: Renal function tests: BUN measure: Renal function tests: Cr sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mingli Zhao status: RECRUITING city: Zhengzhou country: China name: Mingli Zhao, MD role: CONTACT phone: 0371-66246152 email: 13937159120@163.com lat: 34.75778 lon: 113.64861 hasResults: False

 nctId: NCT06387121 id: IIT2023060-EC-1 briefTitle: Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Elderly/Unfit Ph- B-ALL overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-12-01 date: 2028-12-31 date: 2024-04-26 date: 2024-04-26 name: Institute of Hematology & Blood Diseases Hospital, China class: OTHER briefSummary: In the treatment of Ph-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL), despite the achievements of chemotherapy and immunotherapy, the therapeutic outcomes are unsatisfactory in elderly or unfit patients. In recent years, tumor immunotherapy has demonstrated a high safety and efficacy profile in refractory Ph- B-ALL patients. These findings suggest that the advancement of immunotherapy application may be an important approach to improve patient survival. In this study, we propose a treatment approach that combines immuno-targeted drugs with low-dose chemotherapy for newly diagnosed elderly or unfit patients with Ph- B-ALL, aiming to enhance the measurable residual disease (MRD)-negative complete remission (CR) rate measured through flow cytometry following induction therapy, reduce the risk of relapse, and ultimately improve patients' overall survival. conditions: Precursor Cell Lymphoblastic Leukemia-Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 53 type: ESTIMATED name: Vincristine name: Cyclophosphamide name: Dexamethasone name: Venetoclax name: Inotuzumab ozogamicin name: Blinatumomab name: 6-mercaptopurine name: Methotrexate name: Cytarabine name: Prednisone measure: MRD-negative complete remission rate measured by flow cytometry. measure: Complete remission (CR) rate measure: Overall survival (OS) measure: Relapse free survival (RFS) measure: Disease-free Survival (DFS) measure: Mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06387108 id: 24-0045 briefTitle: Evaluation of a Training Course for Educational Professionals overallStatus: RECRUITING date: 2024-04 date: 2025-01 date: 2025-01 date: 2024-04-26 date: 2024-04-26 name: Ludwig-Maximilians - University of Munich class: OTHER name: Prof. OTTO Beisheim Stiftung (Germany) briefSummary: The aim of this study is to evaluate the efficacy of a two-hour online training course on depression and mental health in childhood and adolescence in educational professionals to improve depression and mental health literacy. It will further be investigated whether the course leads to changes in attitudes towards the illness (reduction of stigma) and to an increased behavioural confidence and behavioral change in dealing with pupils with symptoms and illnesses. conditions: Depression conditions: Depression in Children conditions: Depression in Adolescence studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 42 type: ESTIMATED name: training course measure: increase in Knowledge measure: decrease in depression stigma measure: Change in helping behaviour towards pupil measure: Change in conficende in dealing with pupils with mental health issues measure: Evaluation of the training sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: LMU University Hospital (recruitment is conducted online) status: RECRUITING city: Munich country: Germany name: Lisa Feldmann, PhD role: CONTACT email: lisa.feldmann@med.uni-muenchen.de lat: 48.13743 lon: 11.57549 hasResults: False

 nctId: NCT06387095 id: 2024/01/756 briefTitle: Efficacy of Parasternal Blocks in Cardiovascular Surgery Patients Undergoing Median Sternotomy overallStatus: RECRUITING date: 2024-02-01 date: 2024-04-16 date: 2025-08-01 date: 2024-04-26 date: 2024-04-26 name: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital class: OTHER_GOV briefSummary: Acute and chronic pain after cardiac surgery is a common problem that negatively affects quality of life. Postoperative pain after cardiac surgery is most intense in the first two days and decreases in the following period. However, postoperative pain with incomplete management in the acute period may become chronic. This may negatively affect the patient's quality of life. Although central blocks such as thoracic epidural and paravertebral blocks are considered the gold standard in analgesia control, the advantages of thoracic plan blocks, which are more superficial due to peroperative heparinisation; coagulation disorders; and procedural difficulties, are undeniable. Thoracic plane blocks, which can also be used in patients receiving anticoagulant and/or antiplatelet therapy, have recently been used for acute pain. The aim of this study was to evaluate the effect of thoracic plane blocks on extubation time, pain scores, intensive care unit (ICU) and hospital stays in patients undergoing median sternotomy. conditions: Postoperative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: randomized controlled primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: INVESTIGATOR count: 300 type: ESTIMATED name: 1. no block name: 2. superficial parasternal block name: 3. deep parasternal block measure: postoperative chronic pain measure: postoperative 24 hours acute pain measure: extubation time measure: icu time sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kosuyolu High Education and Training Hospital status: RECRUITING city: Istanbul state: Kartal country: Turkey name: münire deniz role: CONTACT phone: +905556461015 email: muniredeniz.md@gmail.com name: ömer savluk role: CONTACT phone: +905056877440 email: dromersavluk@hotmail.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06387082 id: 2023-506-00CH1 briefTitle: A Clinical Study of HMPL-506 in Patients With Hematological Malignancies overallStatus: NOT_YET_RECRUITING date: 2024-05-09 date: 2027-10-08 date: 2027-12-08 date: 2024-04-26 date: 2024-04-26 name: Hutchmed class: INDUSTRY briefSummary: This is a Phase 1, multicenter, open-label clinical study of HMPL-506 administered orally in the treatment of hematological malignancies. Only eligible patients who provide the signed informed consent form (ICF) can be enrolled in this study. The study consists of two phases, i.e., a dose escalation phase and a dose expansion phase. The study is expected to enroll approximately 60 to 98 patients, including approximately 30 to 38 patients in the dose escalation phase and approximately 30 to 60 patients in the dose expansion phase. conditions: Hematological Malignancies studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 98 type: ESTIMATED name: HMPL-506 measure: Safety evaluation: Safety Incidence of Dose-limiting Toxicity (DLTs) measure: Safety evaluation: Incidence of serious adverse events (SAEs) and Relationship to Study Drug measure: Efficacy evaluation: Anti-tumor efficacy evaluation. measure: Incidence of adverse events (AEs) and Relationship to Study Drug measure: Adverse Events Associated with Dose Modifications measure: Evaluate electrocardiogram (ECG) assessments. measure: Complete response rate (CR rate) measure: Complete response (CR)+ Complete response with partial recovery of hematology (CRh) rate measure: Composite complete response (CRc) rate measure: Objective response rate (ORR) measure: Time to Complete response (CR)+Complete response with partial recovery of hematology (CRh) measure: Time to Complete response (CR)+Complete response with partial recovery of hematology (CRh) +incomplete hematological recovery (CRi) measure: Time to disease response (TTR) measure: Duration of Complete response (CR)+Complete response with partial recovery of hematology (CRh) measure: Duration of response (DOR) measure: Event-free survival (EFS) measure: Relapse-free survival (RFS) measure: Overall survival (OS) measure: Pharmacokinetic analysis-Maximum concentration (Cmax) measure: Pharmacokinetic analysis: Peak time (Tmax) measure: Pharmacokinetic analysis: Clearance half-life (T1/2) measure: Pharmacokinetic analysis: area under the plasma concentration-time curve (AUC0-t) measure: Evaluate the changes of the Pharmacodynamic Biomarker sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06387069 id: 2023-306-00CH1 briefTitle: A Study to Evaluate HMPL-306 in Patients With IDH1- and IDH2-mutated Acute Myeloid Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2027-06-03 date: 2028-06-29 date: 2024-04-26 date: 2024-04-26 name: Hutchmed class: INDUSTRY briefSummary: An open-label design is adopted in this study. All patients will first undergo pre-screening to determine the mutation status of IDH, and all patients will be assigned to the registry study of the corresponding cohorts of IDH1 and IDH2 based on the pre-screening results. Patients with both IDH1 and IDH2 mutations will be enrolled in the IDH2 cohort. This study is divided into two cohorts. Cohort 1 includes R/R AML patients with IDH1-R132 mutations; Cohort 2 includes R/R AML patients with IDH2-R140 and R172 mutations. The two cohorts are designed independently and will be analyzed separately for statistical hypothesis testing. Patients in both cohorts will be randomized in a 1:1 ratio according to the central Interactive Web Response System (IWRS) into the test or control group, patients in the test group will receive HMPL-306 monotherapy at a dose of 250 mg once daily (QD) (Cycle 1, C1) + 150 mg QD \[starting from Cycle 2 (C2)\]. Patients in the control group will receive salvage chemotherapy (one of four options) consisting of two intensive chemotherapy regimens (MEC regimen and FLAG ± Ida regimen) and two non-intensive chemotherapy regimens (azacitidine and LoDAC) conditions: Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 316 type: ESTIMATED name: HMPL-306 Regimen name: Salvage Chemotherapy Regimen measure: OS measure: CR rate measure: CR + CRh rate measure: CR + CRi + CRh rate measure: Assessments for PK (pharmacokinetics) measure: Assessments for PK (pharmacokinetics) measure: Duration of response (DOR) measure: Transfusion-dependence conversion ratio measure: HSCT(hematopoietic stem cell transplantation) ratio measure: Safety measure: Quality of life (QoL) measure: Time to response (TTR) measure: EFS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06387056 id: XMYY-2024KY040 briefTitle: Genomic Biomarker-guided Neoadjuvant Therapy for Prostate Cancer (SEGNO) acronym: SEGNO overallStatus: RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2029-04-01 date: 2024-04-26 date: 2024-04-26 name: The First Affiliated Hospital of Xiamen University class: OTHER briefSummary: To evaluated the safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer. conditions: Locally Advanced Prostate Cancer conditions: Oligometastatic Prostate Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Rezvilutamide name: Goserelin Microspheres for Injection name: Docetaxel name: Pamiparib name: Cisplatin name: Tislelizumab measure: Rate of clinical complete response (cCR) measure: Rate of pathological minimal residual disease (pMRD) measure: Rate of complete pathologic response (pCR) measure: Progression-free survival measure: Overall survival sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Xiamen University status: RECRUITING city: Xiamen state: Fujian zip: 361000 country: China name: Kaiyan Zhang, M.D. role: CONTACT phone: +865922139714 email: zkyken@163.com name: Haichao Huang, M.D. role: CONTACT phone: +865922139493 email: hhc_pku@163.com lat: 24.47979 lon: 118.08187 hasResults: False

 nctId: NCT06387043 id: MS and Balance briefTitle: Effects of Balance Exercises Performed With Different Visual Stimuli overallStatus: NOT_YET_RECRUITING date: 2024-12-01 date: 2025-03-01 date: 2026-12-01 date: 2024-04-26 date: 2024-04-26 name: Halic University class: OTHER name: Fenerbahce University name: Biruni University name: Istanbul University - Cerrahpasa (IUC) briefSummary: The study aims to examine the effects of balance exercises applied with different visual stimuli on individuals with MS. conditions: Multiple Sclerosis 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: ESTIMATED name: Balance exercises with Virtual Reality Glasses name: Balance Exercises with Stroboscopic Glasses name: Balance Exercises with Visual-Based Metaphor Training name: Traditional Balance Exercises measure: Functional Near Infrared Ray Spectroscopy (fNIRS) measure: Timed Up and Go Test measure: Functional Reach Test measure: Berg Balance Scale measure: Timed 25 Step Walking Test measure: Lower Extremity Motor Coordination Test measure: Fatigue Severity Scale measure: Quality of Life in Multiple Sclerosis Patients sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Haliç University city: Istanbul state: Eyüpsultan country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06387030 id: APHP231662 briefTitle: EDN and Eosinophilic Esophagitis acronym: OesEDN overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-26 date: 2024-04-26 name: Assistance Publique - Hôpitaux de Paris class: OTHER name: INRAe - Micalis Institute - Jouy en Josas briefSummary: Eosinophilic esophagitis is a recent and emerging chronic disease, secondary to eosinophilic infiltration of the esophageal mucosa leading to esophageal dysfunction. The diagnosis of this pathology, and monitoring of the efficacy of therapies, relies on the assessment of eosinophilic density on esophageal biopsies: follow-up requires numerous digestive endoscopies under general anesthesia, at each therapeutic change, to assess remission. The search for non-invasive biomarkers of active eosinophilic esophagitis is therefore a subject of major interest.

The first step is to study EDN (Eosinophil-Derived Neurotoxin), a protein secreted when eosinophils are activated. Several studies have investigated the association between serum EDN, EDN on esophageal brushing or esophageal biopsies with eosinophilic esophagitis activity, and the results look promising. Urinary EDN is associated with atopy but has not been studied in eosinophilic esophagitis. EDN is a biomarker of interest because it is stable over time and, above all, can be measured routinely, making it applicable to routine patient management and care. Our main objective is to evaluate the correlation of EDN in urine, blood and esophageal brushings with the eosinophilic infiltrate counted on esophageal biopsies in patients undergoing upper GI endoscopy at Trousseau Hospital for suspected eosinophilic esophagitis, or as part of the re-evaluation of known eosinophilic esophagitis under treatment.

Finally, esophageal and salivary dysbiosis has been described in eosinophilic esophagitis without direct evidence of its influence on esophageal inflammation and disease. Our secondary objective is to study the esophageal, salivary and fecal microbiota in these same patients in order to describe the composition, alpha and beta-diversity of bacterial and mycological flora between patients and controls, as well as their association with pathology, and to propose possible alternative therapies aimed at modulating the esophageal and/or salivary microbiota in the management of eosinophilic esophagitis.

This study will be carried out on a cohort of pediatric patients followed up in the pediatric nutrition and gastroenterology department of the Trousseau-APHP hospital and hospitalized for upper GI endoscopy, either as part of a suspected case of eosinophilic esophagitis, or during follow-up of a previously known case of eosinophilic esophagitis. Blood, urine, stool, saliva, 4 additional esophageal biopsies and esophageal brushings were collected on the day of the digestive endoscopy. Depending on the eosinophilic densitý on the biopsies, subjects will be classified into either the "patient with active eosinophilic esophagitis" group, the "patient with eosinophilic esophagitis in remission" group, or the "control without eosinophilic esophagitis" group. The investigator aim to include 60 patients undergoing upper GI endoscopy, at least half of whoḿ will have active or remitting eosinophilic esophagitis.

Furthermore, the study of the immunological, allergological and metabolomic signature of this disease is essential to enable the identification of new biomarkers to guide the creation of models combining several biomarkers predictive of eosinophilic density on esophageal biopsies. In a second step, the concentration of a panel of cytokines in blood and esophageal biopsies, the allergic sensitization profile in blood and esophageal biopsies, and an untargeted description of esophageal metabolomics will be compared between groups. In terms of clinical prospects, the investigator plan to develop a patient follow-up strategy based on the biomarkers studied, which is better adapted to clinical practice, better tolerated by patients and less costly than repeated endoscopies with esophageal biopsies. conditions: Eosinophilic Esophagitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 60 type: ESTIMATED name: Blood sampling name: Esophageal biopsies name: Unstimulated saliva sampling name: Urine sampling name: Stool sampling measure: Urinary EDN measure: Serum EDN measure: Endoluminal EDN measure: Eosinophilic infiltrate of esophagus measure: Blood eosinophilia measure: Concentrations of a panel of serum cytokines measure: Concentrations of a panel of cytokines on esophageal biopsies measure: Esophagus metabolomic profile measure: Total IgE and tryptase measure: Food or respiratory allergens sensitivity measure: Serum specific-IgE measure: Specific-IgE on esophageal biopsies measure: Composition of esophageal, salivary and fecal microbiota measure: Quality of life scale measure: Symptom score sex: ALL minimumAge: 2 Years maximumAge: 17 Years stdAges: CHILD facility: Nutrition et gastro-entérologie pédiatrique-Trousseau Hospital city: Paris zip: 75012 country: France name: Anaïs LEMOINE, Doctor role: CONTACT phone: 00 33 1 44 73 60 69 email: anais.lemoine@aphp.fr name: Patrick TOUNIAN, Professor of University role: CONTACT phone: 00 33 1 44 73 60 69 email: p.tounian@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06387017 id: RCAPHM22_0411 briefTitle: Prospective Multicenter Cohort Study to Validate Four Groups of Biomarkers for Assessing Lung Cancer Risk Among Patients With Atheromatous Cardiovascular Disease in a Screening Pathway acronym: BIOCEPTION overallStatus: RECRUITING date: 2024-04-02 date: 2028-07 date: 2029-07 date: 2024-04-26 date: 2024-04-26 name: Assistance Publique Hopitaux De Marseille class: OTHER briefSummary: Interventional study with minimal risks and constraints, with evaluation of the incidence of lung cancers by low-dose thoracic CT scan without injection of contrast medium, of the immunological, inflammatory and metabolic blood profile and of the microbiota; systematic proposal of smoking cessation for active smokers or assistance in maintaining cessation. conditions: Smoking-related Pathology conditions: Atheroma conditions: Non-progressive Cancer > 5 Years conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 750 type: ESTIMATED name: blood sampling name: stool collection name: low dose CT scan measure: biomarker group validation measure: Describe changes in biomarkers over time measure: Describe and compare biomarkers according to clinical characteristics of participants measure: Describe changes in quality of life over time measure: Describe changes in smoking habits over time measure: Describe changes in anxiety over time measure: Describe and compare biomarkers according to medical characteristics of participants measure: Describe and compare biomarkers according to geographic characteristics of participants measure: Describe and compare biomarkers according to socioeconomic characteristics of participants sex: ALL minimumAge: 45 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Assistance Publique Hopitaux de Marseille status: RECRUITING city: Marseille country: France name: David Boulate role: CONTACT email: david.boulate@ap-hm.fr lat: 43.29551 lon: 5.38958 hasResults: False

 nctId: NCT06387004 id: 2023-A01971-44 briefTitle: Radiation-Related Dysphagia Development Prediction Using a Two-Step Ultrasonographic Model (R-2D-2) acronym: R-2D-2 overallStatus: RECRUITING date: 2024-01-18 date: 2026-02-18 date: 2026-02-18 date: 2024-04-26 date: 2024-04-26 name: Hopital Forcilles class: OTHER briefSummary: Radiotherapy for head and neck cancers (H\&NC) heightens the risk of swallowing disorders (SD), impacting nutrition, quality of life, and overall health, leading to increased hospitalization and mortality. Dietary plans hinge on patients' nutritional status, swallowing ability, and prognosis. Early interventions are crucial, emphasizing the need for precise assessments guiding prognosis, specifying structures for intervention, and facilitating targeted rehabilitation.

Clinical examinations lack precision, while existing complementary methods like videofluoroscopy or Fiberoptic Endoscopic Evaluation of Swallowing are invasive, irradiating, resource-intensive, and challenging to access, with uncertain prognostic values.

Ultrasound imaging emerges as a non-invasive alternative, offering morphological and dynamic evaluation of swallowing-related structures. It enables qualitative and quantitative analyses, improving precision in targeting structures for rehabilitation. Researchers propose an ultrasound predictive model to anticipate SD risk during H\&NC radiotherapy, assessing its reliability and accuracy.

Over eighteen months, 124 outpatients beginning H\&NC radiotherapy at Forcilles's Hospital will undergo weekly clinical and water-swallow tests by a speech language therapist, with videofluoroscopy when SD is suspected. Ultrasound evaluations pre-treatment and at seven and fourteen days will be conducted by blinded ultrasonographers. Cox models will test ultrasound measurement thresholds for SD prediction, estimating sensitivity, specificity, and prediction values. A global ultrasound predictive model will be developed via logistic multivariable regression.

The study aims to establish an association between ultrasound markers and SD, improving early detection for tailored management. This non-invasive alternative to videofluoroscopy offers potential for enhancing patient outcomes in H\&NC radiotherapy. conditions: Swallowing Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 112 type: ESTIMATED measure: The primary endpoint is the predictive ability of morphology and/or movement of the tongue, hyoid bone and suprahyoid muscles measured by ultrasound on the occurrence of TDs during radiotherapy. measure: Inter and intra-rater evaluation measure: Predictive capacity of observed changes in ultrasound to anticipate swallowing disorders development measure: Predictive capacity of ultrasound markers measured at inclusion on the incidence of undernutrition during radiotherapy. measure: Predictive capacity of observed changes in ultrasound to anticipate incidence of undernutrition or nutritional status evolution during radiotherapy. measure: Predictive capacity of ultrasound markers for anticipating quality of life assessed by the MD Anderson Dysphagia Inventory questionnaire at 30 days of radiotherapy treatment measure: Ratio of ultrasound measurements of tongue, hyoid bone, and suprahyoid muscle morphology and/or movement successfully conducted sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Forcilles status: RECRUITING city: Férolles-Attilly zip: 77150 country: France name: Aymeric Le Neindre, PhD role: CONTACT phone: +33160646093 email: aleneindre@cognacq-jay.fr name: Carlos DIAZ LOPEZ, MSc role: PRINCIPAL_INVESTIGATOR lat: 48.73184 lon: 2.63088 hasResults: False

 nctId: NCT06386991 id: 2024/206 briefTitle: Effect of Different Irrigation Solutions on Postoperative Pain and Lesion Healing overallStatus: RECRUITING date: 2024-01-01 date: 2024-08-01 date: 2026-01-01 date: 2024-04-26 date: 2024-04-26 name: TC Erciyes University class: OTHER briefSummary: In this study researchers plan to conduct, three different irrigation solutions that are responsible for the release of growth factors necessary for the success of regenerative endodontic treatments will be used. These solutions; Ethylene Diamine Tetra Acetic Acid (EDTA), Etidronic Acid and Citric Acid. The aim of this study is to evaluate the effect of different irrigation solutions used in regenerative endodontic treatment of necrotic open apex molar teeth on postoperative pain. Additionally, the healing of these teeth will be monitored for 1 year. conditions: Endodontic Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 39 type: ESTIMATED name: Using ethylenediaminetetraacetic acid (EDTA), citric acid ((MONO/ANH) and etidronic acid (HEBP) to clean root canals during regenerative endodontic treatments measure: Determining and recording pain levels on the pain scale between treatment sessions measure: In the follow-up sessions after the treatment, the size of the lesion in the bone (mm2) is measured by radiography. sex: ALL minimumAge: 8 Years maximumAge: 15 Years stdAges: CHILD facility: Erciyes Üniversitesi Diş Hekimliği Fakültesi status: RECRUITING city: Kayseri zip: 38039 country: Turkey name: ERASLAN AKYÜZ role: CONTACT phone: 4447138 phoneExt: 0352 email: ipekemamak@hotmail.com name: ÜSTÜN role: CONTACT phone: 4447138 phoneExt: 0352 email: yustun@erciyes.edu.tr lat: 38.73222 lon: 35.48528 hasResults: False

 nctId: NCT06386978 id: 2024/209 briefTitle: Analgesic Efficacy of Transvers Abdominis Plane Block and Transversalis Fascia Plane Block in Cesarean Section overallStatus: RECRUITING date: 2024-05-30 date: 2025-05-30 date: 2026-05-30 date: 2024-04-26 date: 2024-04-26 name: TC Erciyes University class: OTHER briefSummary: This study was designed as a prospective, randomized observational clinical trial.

A total of 90 adult women were included in the study performed elective cesarean section.

After excluding patients, the care of 90 was included and 3 of these amounts were reserved.

TAP Block Group (n=30,Group 1): Spinal Anesthesia + TAP block ; TFP Block group (n=30,Group 2): Spinal Anesthesia + TFP block ; Control group (n=30,Group 3); Spinal Anesthesia + No block; conditions: Obstetric studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 90 type: ESTIMATED name: Transverse Facia Plane Block (TAP Block) name: Transversalis Facia Plane Block (TFP Block) name: Control measure: VAS score evaluation measure: time until the first analgesic request measure: Satisfaction/Dissatisfaction sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Erciyes University status: RECRUITING city: Kayseri zip: 38039 country: Turkey name: Kudret Dogru, Prof role: CONTACT phone: +905334735112 email: kdogru@erciyes.edu.tr name: Sibel Pehlivan, Asssoc Prof. role: CONTACT phone: +905052532919 email: sibelpehlivan@erciyes.edu.tr lat: 38.73222 lon: 35.48528 hasResults: False

 nctId: NCT06386965 id: 010.99/15 briefTitle: Sevoflurane Versus Propofol: Effect on Stress Response overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-05 date: 2024-06-05 date: 2024-06-05 date: 2024-04-26 date: 2024-04-26 name: Dr. Lutfi Kirdar Kartal Training and Research Hospital class: OTHER_GOV briefSummary: Stress is defined as hormonal and metabolic changes in the biological system that follow any injury. The stress response occurs as a general systemic response to injury and includes a wide range of endocrinological, immunological and hematological effects. The level of stress in the surgical process can affect not only the patients outcome but also the overall health system.

The two main agents used in maintenance for general anesthesia are inhalation and intravenous anesthetics. Both inhalation anesthesia and TIVA (Total Intravenous Anesthesia) approaches provide general anesthesia suitable for surgical operations. However, the mechanisms of action of these two methods differ and are not fully understood.

The aim of investigators' for this study was to investigate the effect of different anesthetic agents on stress inflammatory response in the preoperative, peroperative and postoperative periods. conditions: Propofol conditions: Sevoflurane conditions: Inflammatory Response studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: taking blood sample measure: compare inflammatory markers with sevolurane and propofol : glucose, WBC, procalcitonin, CRP, erytrocyte sedimentation rate, ferritin, pre albumin, albumin,tranferrin sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Health Science, Kartal Dr Lutfi Kırdar Training and Researh Hospital city: İstanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06386952 id: 02/2024-2025 briefTitle: To Compare People With T2DM Who Have Double Hump Versus Who do Not Have Double Hump overallStatus: RECRUITING date: 2024-05-01 date: 2025-05-31 date: 2025-06-30 date: 2024-04-26 date: 2024-04-26 name: Diabetes Foundation, India class: OTHER name: National Diabetes Obesity and Cholesterol Foundation briefSummary: Hypothesis: Double Hump in people with T2D is associated with higher magnitude of complication than people with single hump or no hump

Objectives: To correlate single and double hump with diabetes complication T2DM patient will be recruited from endocrine OPD

1. Clinical History and Examination:

1. General Physical Examination: Height, weight, waist circumference, hip circumference, BMI, Blood Pressure, Hand grip. Buffalo Hump.
2. Complications Assessment: Patient will be analyzed for:

Micro Vascular

(a) Diabetic retinopathy (i) Mild NPDR (ii) Mod NPDR (iii) Macular Edema / CSME (b) Neuropathy (Mild/Mod/Severe) (c) Chronic Kidney Disease (i) Micro/Macro albumin urea (ii) Increased Creatinine (iii) Decreased eGFR

Macro Vascular

1. Low ABI/PAD
2. CVD-MI/PTCA/CABG/Heart Failure
3. CVS-Stroke/ TIA/Carotid Blockage \>50% conditions: Type 2 Diabetes Mellitus With Complication studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Double Hump increases diabetes complications sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anoop misra status: RECRUITING city: New Delhi state: Delhi zip: 110048 country: India name: Anoop Misra, MD role: CONTACT phone: 01149101222 email: anoopmisra@gmail.com name: Koel Dutta, M.Sc role: CONTACT phone: 01149101222 email: koelduttac@gmail.com name: Anoop Misra, MD role: PRINCIPAL_INVESTIGATOR name: Koel Dutta, M.Sc role: SUB_INVESTIGATOR lat: 28.63576 lon: 77.22445 hasResults: False

 nctId: NCT06386939 id: 01/2024-2025 briefTitle: Comparison of Micro- and Macrovascular Disease(s) in People With T2D, Who Have Moderate to Severe Acanthosis Nigricans vs. Those Who do Not Have Acanthosis Nigricans overallStatus: RECRUITING date: 2024-05-01 date: 2025-10-30 date: 2025-11-30 date: 2024-04-26 date: 2024-04-26 name: Diabetes Foundation, India class: OTHER name: National Diabetes Obesity and Cholesterol Foundation briefSummary: Hypothesis: Moderate to severe acanthosis nigricans in people with T2D is associated with higher magnitude of complication than people who do not have acanthosis nigricans.

Objectives: To correlate moderate to severe acanthosis nigricans with diabetes complication

Methodology:

T2DM patient will be recruited from endocrine OPD

1. Clinical History and Examination:

1. General Physical Examination: Height, weight, waist circumference, hip circumference, BMI, Blood Pressure, Hand grip. Acanthosis Nigricans.
2. Complications Assessment: Patient will be analysed for:

Micro Vascular

(a) Diabetic retinopathy (i) Mild NPDR (ii) Mod NPDR (iii) Macular Edema / CSME (b) Neuropathy (Mild/Mod/Severe) (c) Chronic Kidney Disease (i) Micro/Macro albumin urea (ii) Increased Creatinine (iii) Decreased eGFR

Macro Vascular

1. Low ABI/PAD
2. CVD-MI/PTCA/CABG/Heart Failure
3. CVS-Stroke/ TIA/Carotid Blockage \>50% conditions: Type 2 Diabetes Mellitus With Complication studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 300 type: ESTIMATED measure: Moderate to Severe Acanthosis Nigricans increases diabetes complications sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anoop misra status: RECRUITING city: New Delhi state: Delhi zip: 110048 country: India name: Anoop Misra, MD role: CONTACT phone: 01149101222 email: anoopmisra@gmail.com name: Koel Dutta, M.Sc role: CONTACT phone: 01149101222 email: koelduttac@gmail.com name: Anoop Misra, MD role: PRINCIPAL_INVESTIGATOR name: Koel Dutta, M.Sc role: SUB_INVESTIGATOR lat: 28.63576 lon: 77.22445 hasResults: False

 nctId: NCT06386926 id: P.T.REC/012/005075 briefTitle: Radial Shockwave Versus Ultrasound Phonophoresis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07 date: 2024-09 date: 2024-04-26 date: 2024-04-26 name: Cairo University class: OTHER briefSummary: Comparative study to compare the effect of radial shockwave versus ultrasound phonophoresis in management of chronic supraspinatus tendinitis consists of 3 groups exp1(shockwave treatment + conventional physical therapy) , exp2( ultrasound phonophoresis+ conventional physical therapy) and control group ( conventional physical therapy) conditions: Supraspinatus Tendinitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 69 type: ESTIMATED name: Electro Therapy measure: change in the thickness of supraspinatus tendon measure: change in pain intesity measure: Change in shoulder range of motion measure: Function of the Upper Limb measure: measure weight in kg and height in cm sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Cairo university city: Giza country: Egypt name: Shady Alkadry role: CONTACT lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06386913 id: IRB-20-1065 briefTitle: Implementation and Evaluation of Measurement-Based Care (MBC) Training overallStatus: ACTIVE_NOT_RECRUITING date: 2021-02-09 date: 2024-06-30 date: 2024-12-31 date: 2024-04-26 date: 2024-04-26 name: Carilion Clinic class: OTHER name: Virginia Polytechnic Institute and State University briefSummary: The purpose of this study is to get feedback on a new standardized Measurement-Based Care (MBC) provider training program. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Clinicians completed pre- and post-training surveys. Patient satisfaction was assessed prior to and after clinician training. primaryPurpose: OTHER masking: NONE count: 56 type: ACTUAL name: Training measure: Digital MBC training rate measure: Assessing feasibility of a novel digital MBC training in mental health providers (FIM) measure: Assessing acceptability of a novel digital MBC training program in mental health providers (AIM) measure: Assessing appropriateness of a novel digital MBC training program in mental health providers (IAM) measure: Monitoring and Feedback Attitudes Scale (MFA) measure: Attitudes Towards Standardized Assessment Scales: Monitoring and Feedback (ASA-MF) measure: Clinician Attitude and Satisfaction Survey (CASS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Carilion Clinic city: Roanoke state: Virginia zip: 24014 country: United States lat: 37.27097 lon: -79.94143 hasResults: False

 nctId: NCT06386900 id: S67595 briefTitle: The Impact of Grand Tour Cycling on Sleep and the Hematological and Metabolomic Profile in World-class Cyclists overallStatus: ENROLLING_BY_INVITATION date: 2023-07-01 date: 2024-09-15 date: 2024-12-01 date: 2024-04-26 date: 2024-04-26 name: KU Leuven class: OTHER briefSummary: This project aims to identify the effect of a 3-week Grand Tour (e.g. Tour de France, Giro d'Italia, and Vuelta a España) on sleep, hematological parameters and the serum metabolome in world-class cyclists. conditions: Overreaching studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 16 type: ESTIMATED name: Cyclist measure: Serum metabolome abundance of cyclists participating in a Grand Tour measure: Sleep efficiency during the Grand Tour measure: Total sleep time during the Grand Tour measure: Blood haemoglobin concentration measure: Wakefulness after sleep onset measure: Light sleep measure: Deep sleep measure: REM sleep measure: Red blood cell concentration measure: Subjective fatigue sex: MALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: KU Leuven city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium lat: 50.87959 lon: 4.70093 hasResults: False

 nctId: NCT06386887 id: CASE1824 briefTitle: Fasting During Neoadjuvant Chemotherapy in Patient With Epithelial Ovarian Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-12-01 date: 2026-01-01 date: 2024-04-26 date: 2024-04-26 name: Case Comprehensive Cancer Center class: OTHER briefSummary: The goal of this clinical trial is to see if timed fasting (periods of time that you don't eat) in participants who are receiving chemotherapy prior to surgery is achievable, safe and can improve quality of life, symptoms and outcomes (results) compared to participants who receive standard dietary recommendations in individuals being treated for epithelial ovarian cancer . The main questions it aims to answer are:

* Is it feasible to use intermittent fasting during neoadjuvant chemotherapy?
* Is it safe to use intermittent fasting during neoadjuvant chemotherapy?
* Do participants find it acceptable to use intermittent fasting during neoadjuvant chemotherapy?

Researchers will compare participants who receive standard dietary recommendations to see which method is more achievable, safe, and able to improve quality of life, symptoms and outcomes.

Participants will:

* Receive either the fasting intervention (schedule of times when you do not eat) or standard diet recommendations for 6-9 weeks prior to your surgery starting with the second cycle of chemotherapy.
* All participants will be asked to complete chemotherapy and surgery, cancer imaging, baseline screening tests, nutritional assessments, food diaries, blood tests, and surveys about wellbeing.
* Participants in the intervention group will be asked to follow a fasting schedule that consists of not eating for 16 hours a day followed by normal eating for the remaining 8 hours of the day for 5 days in a row followed by 2 days of regular eating each week. conditions: Epithelial Ovarian Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two arm, randomized, controlled study. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Participants' cross-sectional skeletal muscle areas will be measured. Measurements will be performed on CT scans obtained within 4-6 weeks of treatment initiation (with a 7-day screening window) by a fellowship-trained, experienced radiologist and imaging specialist in consensus who will be blinded to participant clinical variables and treatment. whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Intermittent Fasting name: Neoadjuvant chemotherapy measure: Intermittent fasting compliance as measured by serum glucose laboratory testing measure: Intermittent fasting compliance as measured by ketone laboratory testing measure: Intermittent fasting compliance as measured by IGF-1 laboratory testing measure: Intermittent fasting compliance as measured by insulin laboratory testing measure: Intermittent fasting compliance as measured by serum glucose laboratory testing measure: Intermittent fasting compliance as measured by ketone laboratory testing measure: Intermittent fasting compliance as measured by IGF-1 laboratory testing measure: Intermittent fasting compliance as measured by insulin laboratory testing measure: Intermittent fasting compliance as measured by serum glucose laboratory testing measure: Intermittent fasting compliance as measured by ketone laboratory testing measure: Intermittent fasting compliance as measured by IGF-1 laboratory testing measure: Intermittent fasting compliance as measured by insulin laboratory testing measure: Intermittent fasting compliance as measured by self-reported assessment measure: Intermittent fasting compliance as measured by self-reported assessment measure: Intermittent fasting compliance as measured by food diary measure: Intermittent fasting compliance as measured by food diary measure: Intermittent fasting compliance as measured by food diary measure: Pre body composition measure: Post body composition measure: Chemotherapy related toxicity at Cycle 2 measure: Chemotherapy related toxicity at Cycle 3 measure: Chemotherapy related toxicity at Cycle 4 measure: Chemotherapy related toxicity at post treatment measure: ESAS Score at Enrollment measure: ESAS Score at Cycle 2 measure: ESAS Score at Cycle 3 measure: ESAS Score at Post Treatment measure: SF-125 Score at Baseline measure: SF-125 Score at Cycle 2 measure: SF-125 Score at Cycle 3 measure: SF-125 Score at Post Treatment measure: Pre Quality of Life (QLQ-C30) Score at Baseline measure: Post Quality of Life (QLQ-C30) Score Post Treatment measure: Pre Functional Assessment (FACT-O) Score at Baseline measure: Post Functional Assessment (FACT-O) Score Post Treatment measure: AIM Survey Score at Cycle 2 measure: AIM Survey Score at Cycle 3 measure: AIM Survey Score at Post Treatment sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06386874 id: BQ7 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-26 date: 2024-04-26 name: [Redacted] hasResults: False

 nctId: NCT06386861 id: 24.210.01e briefTitle: Validating the Spanish "Attitudes Toward Genomics and Precision Medicine" (AGPM). overallStatus: RECRUITING date: 2024-04-14 date: 2024-05-31 date: 2024-12-31 date: 2024-04-26 date: 2024-04-26 name: Boston College class: OTHER briefSummary: the investigators aim to evaluate English and Spanish versions of the "Attitudes toward genomics and precision medicine" instrument (AGPM). This study will help validating a Spanish version of the AGPM among people identifying as Hispanic, Latino/a, or Latinx. Having a valid instrument is important for developing tailored interventions to decrease disparities in genomic healthcare for this population. conditions: Adult ALL studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 500 English-speaking Latinx individuals 500 Spanish-speaking Latinx individuals primaryPurpose: OTHER masking: NONE count: 1000 type: ESTIMATED name: Attitudes Toward Genomics and Precision Medicine (English) name: Attitudes Toward Genomics and Precision Medicine (Spanish) measure: Psychometric properties measure: Health literacy/numeracy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Boston College status: RECRUITING city: Chestnut Hill state: Massachusetts zip: 02467 country: United States name: Andrew A Dwyer, FNP-BC, PhD role: CONTACT phone: 617-552-1711 email: andrew.dwyer@bc.edu name: Maria Pineros-Leano, PhD role: SUB_INVESTIGATOR lat: 42.33065 lon: -71.16616 hasResults: False

 nctId: NCT06386848 id: 2023PI187 briefTitle: Strategy to Adapt Botulinum Toxin Doses in Dystonia overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-05-01 date: 2024-06-01 date: 2024-04-26 date: 2024-04-26 name: Central Hospital, Nancy, France class: OTHER briefSummary: The study is designed to observ and collect the doses of botulinum toxin injected in dystonia in different centres to compare the initial dose and the dose recommended.

We we ll study the increase of the dose injected over the time, the side effects...

The hypothesis is that we inject smaller doses than we could regarding the recommandations conditions: Dystonia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: Botulinum toxin measure: First dose of botulinum toxin injected, U measure: Effective dose of botulinum toxin measure: Side effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06386835 id: CREC2021.724-T briefTitle: Collagen Paste vs Mucosal Advancement Flap for FIA overallStatus: RECRUITING date: 2024-01-26 date: 2026-03-31 date: 2027-03-31 date: 2024-04-26 date: 2024-04-26 name: Chinese University of Hong Kong class: OTHER briefSummary: The treatment for fistula-in-ano (FIA) remains a challenge to General and Colorectal Surgeons Worldwide. A variety of surgical treatments have been described for high anal fistulas, but none offers the panacea of fistula eradication with guaranteed preservation of continence. This study compares Collagen paste injection to mucosal advancement flap for the treatment of fistula-in-ano. conditions: Fistula-in-ano studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 118 type: ESTIMATED name: Collagen Paste name: Mucosal advancement measure: Clinical healing of Fistula-in-ano measure: 30-day morbidity measure: Quality of life score measure: Postoperative pain score measure: Faecal incontinence rate measure: Hospital readmission rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Surgery, Chinese University of Hong Kong status: RECRUITING city: Shatin state: New Territories country: Hong Kong name: Kaori Futaba role: CONTACT email: kfutaba@surgery.cuhk.edu.hk lat: 22.38333 lon: 114.18333 facility: Prince of Wlaes Hospital status: RECRUITING city: Sha Tin country: Hong Kong name: Kaori Futaba role: CONTACT phone: 35051495 email: kfutaba@surgery.cuhk.edu.hk lat: 22.38333 lon: 114.18333 hasResults: False

 nctId: NCT06386822 id: 23-1562H briefTitle: The Development of a System for the Measurement of Tremor overallStatus: RECRUITING date: 2023-08-01 date: 2024-12 date: 2024-12 date: 2024-04-26 date: 2024-04-26 name: The Bionics Institute of Australia class: OTHER briefSummary: The goal of this clinical trial is to develop a system which can be used to measure movements in people with Essential Tremor (with or without dystonia). The main questions it aims to answer are:

* Can individuals with Essential Tremor be distingushed from individuals without tremor using Virtual Reality (VR)
* Can the current Essential Tremor Assessment Scale (the TETRAS) be reproduced in VR
* Can Essential Tremor be quantified using a measurement system
* Can Dystonia be quantified using a measurement system.

Participants will don the equipment used to measure their tremor and replicate a series of standardised movements to measure their tremor, in and out of the VR platform. The assessment will take no longer than an hour. conditions: Tremor studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single group assignment. Up to 90 participants with Essential Tremor and up to 30 Control participants will be recruited to the study. Both groups will undergo the same intervention. primaryPurpose: OTHER masking: NONE count: 120 type: ESTIMATED name: HTC Vive Pro Eye name: HTC Vive Tracker name: Valve Index Controllers name: Biokin measure: To quantify Essential Tremor and dystonia using a measurement system sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Royal Victorian Eye and Ear Hospital status: RECRUITING city: East Melbourne state: Victoria zip: 3002 country: Australia name: Sarah Osborn, BSc role: CONTACT phone: 061396677500 email: sosborn@bionicsinstitute.org lat: -37.81667 lon: 144.9879 hasResults: False

 nctId: NCT06386809 id: 2024 -25 briefTitle: Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation in Bruxism overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-01 date: 2024-11-01 date: 2024-04-26 date: 2024-04-26 name: Bandırma Onyedi Eylül University class: OTHER briefSummary: Our study aimed to investigate the effects of transcutaneous auricular vagus nerve stimulation (TAVNS) application on treatment efficacy in bruxism in terms of masseter muscle activity, pain, stress level, sleep and life quality, and autonomic functions. conditions: Bruxism studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: TAVNS name: Exercise program measure: Pain Severity measure: Oral Health Quality of Life measure: Stress Level measure: Sleep Quality measure: Pressure Pain Threshold measure: Muscle Activation Measurement measure: Measurement of heart rate variability/ Autonomic nervous system evaluation sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bandırma Onyedi Eylül University city: Balıkesir country: Turkey lat: 39.64917 lon: 27.88611 hasResults: False

 nctId: NCT06386796 id: Asw.U./867/11/23 briefTitle: Renal Resistive Index as a Predictor of Acute Renal Impairment in High-risk Patients overallStatus: RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2026-04-01 date: 2024-04-26 date: 2024-04-26 name: Aswan University class: OTHER briefSummary: To study the ability of RRI, measured by bedside Doppler ultrasound, in detecting acute kidney injury in high-risk patients admitted to surgical intensive care unit, Aswan university hospital, compared with renal biomarkers and conventional assessment using urine output and serum creatinine levels. conditions: Acute Kidney Injury conditions: Critical Illness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Early detection of acute kidney injury. measure: Diagnosis of acute kidney injury. measure: To grade the severity of AKI. measure: To predict clinical outcome (clinical improvement) measure: To predict clinical outcome (necessity for renal replacement therapy) measure: To predict clinical outcome (death) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aswan University status: RECRUITING city: Aswan zip: 81528 country: Egypt name: Soudy S Hammad role: CONTACT phone: +201014761523 email: soudi.salah@aswu.edu.eg name: Tarek S Hemaida role: CONTACT phone: 01007363190 email: dr.tarek@aswu.edu.eg name: mohamed H Abolwafa, MSc role: PRINCIPAL_INVESTIGATOR lat: 24.09082 lon: 32.89942 hasResults: False

 nctId: NCT06386783 id: Asw.U./823 /7/23 briefTitle: Fentanyl Versus Dexmedetomidine as an Adjuvant to Bupivacaine in Spinal Anesthesia ; Peritoneal Symptomatic Effects overallStatus: RECRUITING date: 2023-07-01 date: 2024-12-31 date: 2025-07-01 date: 2024-04-26 date: 2024-04-26 name: Aswan University class: OTHER briefSummary: To compare whether 5 μg dexmedetomidine with 25 μg fentanyl added to 0.5% hyperbaric bupivacaine as adjuvants in spinal anaesthesia in patients undergoing appendectomy could reduce intraoperative peritoneal related symptoms. conditions: Dexmedetomidine conditions: Fentanyl studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This randomized double blinded study will be conducted at Aswan university hospitals at patients scheduled for emergency appendectomy primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: concealed based on study drugs assigned to each group \& to conduct this double -blinded clinical trials, our study drugs will be prepared by the senior anesthesiologist who won't be involved in further observations of the patients and neither patients nor outcome assessor will be aware of which drugs they will receive. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 148 type: ESTIMATED name: Dexmedetomidine Injection [Precedex] name: Fentanyl HCl measure: intraoperative peritoneal symptoms during appendectomy. measure: Assessment of motor block with Modified Bromage scale measure: Degree of post-operative analgesia measure: Assessment of sensory block by using pin prick method sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Aswan University status: RECRUITING city: Aswan zip: 81528 country: Egypt name: Soudy S Hammad, MD role: CONTACT phone: +201014761523 email: soudi.salah@aswu.edu.eg name: Ahmed M Hagag, MSc role: CONTACT phone: 01141097536 name: Ayman M Eldemrdash, MD role: PRINCIPAL_INVESTIGATOR name: Ahmed A Mahmoud, MD role: SUB_INVESTIGATOR lat: 24.09082 lon: 32.89942 hasResults: False

 nctId: NCT06386770 id: Asw.U./742 /2/23 briefTitle: Systemic Versus Local Dexmedetomidine as An Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Block overallStatus: RECRUITING date: 2023-02-01 date: 2024-06-01 date: 2025-12-31 date: 2024-04-26 date: 2024-04-26 name: Aswan University class: OTHER briefSummary: The aim of this study is to investigate the analgesic effect of local versus systemic dexamedetomedine as adjuvant to bupivacaine in erector spinae block in kidney exploration surgeries. conditions: Erector Spinae Block conditions: Dexmedetomidine studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: These prospective, randomized, controlled clinical trials will be performed in Aswan University Hospital on 75 patients who are scheduled for kidney exploration surgeries primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: In our randomized controlled trial, we employed masking (also called blinding) to reduce bias. Participants were unaware of whether they were receiving the intervention or control. Caregivers were instructed not to reveal this information, and outcome assessors who evaluated results were kept separate from intervention delivery. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: Dexmedetomidine Injection [Precedex] name: Bupivacaine Hydrochloride name: Dexmedetomidine in 0.9 % NaCl 200 Mcg/50 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML) measure: The duration of analgesia, this was defined as the time in minutes to the first request for postoperative analgesics. measure: 2. Total postoperative opioid consumption (Nalbuphine consumption (mg) within the 48-hour period . measure: Ramsay Sedation Scale (RSS) (1: anxious; 2: cooperative and tranquil; 3: responding to command; 4: brisk response to stimuli; 5: sluggish response to stimuli; and 6: no response to stimuli) will be all assessed measure: Intraoperative hemodynamic parameters blood pressure measure: Minimum alveolar concentration (MAC) requirements sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aswan University status: RECRUITING city: Aswan zip: 81511 country: Egypt name: soudy S hammad role: CONTACT phone: +201014761523 email: soudi.salah@aswu.edu.eg name: tarek S hemaida role: CONTACT phone: 01007363190 email: dr.tarek@aswu.edu.eg name: Rehab A Mahmoud, MSc role: SUB_INVESTIGATOR lat: 24.09082 lon: 32.89942 hasResults: False

 nctId: NCT06386757 id: Asw.U. 911/3/24 briefTitle: Incidence Of Nasal and Oropharyngeal Bleeding: Video Laryngoscopy Versus Direct Laryngoscopy overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-31 date: 2025-12-31 date: 2024-04-26 date: 2024-04-26 name: Aswan University class: OTHER briefSummary: The objective of this study is to compare the effectiveness and safety of video laryngoscopy versus direct laryngoscopy for nasal intubation in patients with maxillofacial fractures regarding less bleeding to oral and nasal structures, quicker intubation times, increased success rates for first intubation attempts, fewer uses of the Magill forceps and the less need for cervical spine extension conditions: Maxillofacial Injuries conditions: Nasal Bleeding conditions: Intubation Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: These prospective, randomized, controlled clinical trials will be conducted at Aswan University Hospital on 62 patients who are scheduled for maxillofacial surgeries requiring nasal intubation. primaryPurpose: PREVENTION masking: NONE count: 64 type: ESTIMATED name: Combined Video Laryngoscopy (VL) and Bougie name: Combined Direct Laryngoscopy (DL) and Bougie measure: Incidence of nasal and oropharyngeal bleeding measure: Time of successful intubation, defined as the time from removal of mask ventilation and beginning of bougie insertion until inflation of tube cuff measure: Overall rate of first trial success. measure: The use of magill forceps sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aswan University status: RECRUITING city: Aswan zip: 81528 country: Egypt name: Soudy S Hammad, MD role: CONTACT phone: +201014761523 email: soudi.salah@aswu.edu.eg name: Mohammed E Yahia, MSc role: CONTACT phone: 01125257916 name: Mohammed A Alazhary, MD role: SUB_INVESTIGATOR lat: 24.09082 lon: 32.89942 hasResults: False

 nctId: NCT06386744 id: DUS-AUBD-01 briefTitle: Dusquetide for the Treatment of Behcet's Disease overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-02 date: 2025-03 date: 2024-04-26 date: 2024-04-26 name: Soligenix class: INDUSTRY briefSummary: This is a clinical study to see if dusquetide can treat flares of oral and genital ulcers caused by Behcet's Disease. Study participants will receive an infusion of dusquetide twice a week for 4 weeks (8 treatments total), with weekly follow-up visits for an additional 4 weeks. conditions: Behçet Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Dusquetide measure: Number of Oral Ulcers measure: Number of Genital Ulcers measure: Pain of Oral Ulcers measure: Pain of Genital Ulcers sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul University - Cerrahpasa, Cerrahpasa School of Medicine city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06386731 id: SYNEO-01 briefTitle: Continuous Versus Intermittent Phototherapy in Treatment of Neonatal Jaundice overallStatus: COMPLETED date: 2022-07-05 date: 2022-11-25 date: 2023-04-28 date: 2024-04-26 date: 2024-04-26 name: Goztepe Prof Dr Suleyman Yalcın City Hospital class: OTHER briefSummary: One of the most common diseases in the neonatal period is indirect hyperbilirubinemia (IHB). After phototherapy was discovered accidentally in 1958, it has been used as the most effective treatment method for IHD for more than 60 years. Sources that provide phototherapy are developing rapidly technologically. However, there is no clearly defined usage table in the literature for applying phototherapy with faster effects and fewer side effects. In recent years, the use of intermittent phototherapy has been recommended with similar effectiveness. Phototherapy has significant side effects such as dehydration, diarrhea, chromosome breaks, retinal damage, skin rashes, hypocalcemia, thrombocytopenia. As phototherapy exposure decreases, its side effects decrease.In our study; We plan to find the most ideal method in the treatment of IHB by comparing intermittent PT with continuous phototherapy in terms of effectiveness. We aim to achieve the best bilirubin reduction and minimal side effects with less exposure to phototherapy. conditions: Neonatal Jaundice conditions: Phototherapy Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This was a single-center, with block randomisation \[1:1\], open-label, parallel group study. primaryPurpose: TREATMENT masking: NONE count: 225 type: ACTUAL name: Intermittent Phototherapy measure: Comparison of the effectiveness of CPT and IPT measure: Comparison of side effect frequency of CPT and IPT sex: ALL minimumAge: 1 Day maximumAge: 15 Days stdAges: CHILD facility: Göztepe Prof. Dr. Suleyman Yalcin City Hopital city: Kadıköy state: İstanbul zip: 34730 country: Turkey lat: 40.62015 lon: 29.22536 hasResults: False

 nctId: NCT06386718 id: USG for ped art can briefTitle: Ultrasonographic Evaluation of Arteries of the Hand in Pediatric Patients overallStatus: RECRUITING date: 2023-05-15 date: 2024-06-01 date: 2025-05-01 date: 2024-04-26 date: 2024-04-26 name: Ankara University class: OTHER briefSummary: Ultrasound measurements of the ulnar artery and radial artery at different angles are obtained and compared to determine the optimal diameters for possible arterial cannulation in pediatric patients. conditions: Ulnar and Radial Artery studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 184 type: ESTIMATED measure: Determining the Diameter and Depth at different angles measure: Comparing Ulnar and Radial Artery Diameters Across Age Groups sex: ALL maximumAge: 10 Years stdAges: CHILD facility: Ankara University School Of Medicine status: RECRUITING city: Ankara zip: 06100 country: Turkey name: Zeynep Altinbas, MD role: CONTACT phone: +905356082156 email: szpostalcioglu@gmail.com name: Ozlem S Can, MD role: PRINCIPAL_INVESTIGATOR name: Zeynep S Altinbas, MD role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06386705 id: TSN084-101CH briefTitle: A Study of TSN084 in Patients With Advanced Malignant Tumors overallStatus: RECRUITING date: 2022-07-20 date: 2025-09-30 date: 2026-03-30 date: 2024-04-26 date: 2024-04-26 name: Tyligand Bioscience (Shanghai) Limited class: INDUSTRY briefSummary: TSN084 is a novel type II kinase inhibitor with demonstrated anti-tumor effects in vitro and in vivo and targets multiple tyrosine kinases, such as c-MET, FLT3, TRK and serine/threonine kinase CDK8/19. This phase 1a/1b study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of TSN084 in advanced or metastatic malignancies in China. conditions: Malignant Neoplasm studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 114 type: ESTIMATED name: TSN084 measure: Dose limiting toxicity (DLT) measure: Incidence of Treatment-Emergent Adverse Events (TEAE) measure: Maximum plasma concentration (Cmax) measure: Time to Cmax (Tmax) measure: Area under the concentration versus time curve from time 0 to the last measurable concentration (AUC 0-t) 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: Cancer Hospital Chinese Academy of Medical Sciences status: RECRUITING city: Beijing state: Beijing zip: 100021 country: China name: Jie Wang, MD, PhD role: CONTACT lat: 39.9075 lon: 116.39723 facility: Peking university cancer hospital status: RECRUITING city: Beijing state: Beijing zip: 100142 country: China name: Minglei Zhuo, MD role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06386692 id: Aarhus111 briefTitle: Community Based Promotion of Physical Activity in Nepal (COBIN-PA) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-30 date: 2024-12-30 date: 2024-04-26 date: 2024-04-26 name: University of Aarhus class: OTHER briefSummary: Globally, one in four adults does not meet the WHO-recommended level of physical activity. Insufficient physical activity is the fourth leading risk factor, contributing to 9% of global premature mortality. PA is effective in weight management, cardiorespiratory fitness, and increasing quality of life. However, there is lack of evidence on effectiveness on promoting physical activity in community level. The aim of the study is to test the effectiveness of Female Community Health Volunteers (FCHVs)-led community-based educational program on physical activity promotion in community level. This is an open label cluster-randomized controlled trial with 1:1 allocation where FCHVs will deliver a family-based education for the promotion of physical activity at community level in Nepal. The intervention package will be guided by Theory of planned behavior and will contain home-based interactive health education sessions focused on increasing PA in a household setting. FCHVs will use resource materials for health education. The mixed-effect linear regression model will determine the adjusted interaction between time and intervention. The results of this study will show the changes in the mean moderate to vigorous physical activity minutes per day due to time intervention interaction. The evidence generated from this study will help to provide new knowledge on the community-based promotion of Physical Activity and its effectiveness for policymakers and researchers. It will hopefully support the attainment of the national and global target of reducing insufficient physical activity. conditions: Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 264 type: ESTIMATED name: FCHVs-led community based educational physical activity intervention measure: Mean moderate to vigorous physical activity sex: ALL minimumAge: 19 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06386679 id: R016634005 briefTitle: Amniotic Fluid Mesenchymal Stem Cells Developed for Chondrogenic Treatment (AFCC) Injection in Elderly Knee Osteoarthritis Patients overallStatus: ENROLLING_BY_INVITATION date: 2023-08-17 date: 2023-11-23 date: 2025-03 date: 2024-04-26 date: 2024-04-26 name: Siriraj Hospital class: OTHER briefSummary: Amniotic fluid mesenchymal stem cells developed for chondrogenic treatment (AFCC) are used to treat elderly patients suffering from knee osteoarthritis (OA). The injection reduces inflammation and promotes the recovery of knee function, leading to an improved quality of life. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Ten elderly patients from both gender diagnosed with knee osteoarthritis, will be enrolled according to specific inclusion and exclusion criteria. These patients will be injected with amniotic fluid mesenchymal stem cells developed for chondrogenic treatment. Then, they are followed by clinical assessment, laboratory investigations as well as magnetic resonance imaging (MRI) of the injected knee. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: allogenic amniotic fluid mesenchymal stem cell measure: Incidence of abnormal physical examination measure: Incidence of abnormal vital sign measure: Incidence of abnormal laboratory test results measure: Incidence of abnormal ECG parameters measure: The type of Adverse event (AE), numbers of AE and proportion of patients with AE. measure: Pain score measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) measure: Degree of cartilage change sex: ALL minimumAge: 60 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Siriraj Hospital city: Bangkok Noi state: Bangkok zip: 10700 country: Thailand lat: 13.76266 lon: 100.47798 hasResults: False

 nctId: NCT06386666 id: RLRL-CTP briefTitle: A Clinical Trial to Evaluate the Safety and Efficacy of Single-use Fibrous Ring Sutures for the Suture of Fibrous Ring Incision After Nucleus Pulposus Removal overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-04-29 date: 2025-07-15 date: 2024-04-26 date: 2024-04-26 name: Suzhou Kerui Medical Technology Co., Ltd class: OTHER briefSummary: The objective of this clinical trial was to evaluate the safety and effectiveness of single-use annular sutures for the closure of annular incisions after nucleus pulposus removal. Participants used single-use annular sutures to close the annular fibers. The success rate of suture, reduction value of annulus, proportion of annulus reduction, intraoperative blood loss, suture time, VAS pain score (low back, bilateral lower extremities), Oswestry index (ODI index), and Short were evaluated The effectiveness evaluation results of Form-12 health survey (SF-12 score), treatment success rate, device defects, product operation satisfaction, and safety evaluation results of recurrence rate, adverse events, and serious adverse events were used to verify the safety and effectiveness of disposable fibrillar suture for annular incision suture after nucleus pulposus removal. conditions: Intervertebral Disc Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 135 type: ESTIMATED name: Disposable fibrous ring sutures measure: Success rate of suture measure: Annulus fibril cleft decreased in value measure: Reduced proportion of annular fibril cleft measure: Intraoperative blood loss measure: Suture time measure: Treatment success rate measure: VAS pain score (lower back, bilateral lower limbs) measure: SF-12 rating measure: ODI index measure: Recurrence rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06386653 id: [123I]I-DARPIN-Ec1 briefTitle: Molecular Imaging of EpCAM Receptors Using [123I]I-DARPIN-Ec1 overallStatus: ENROLLING_BY_INVITATION date: 2024-05-14 date: 2024-12-31 date: 2024-12-31 date: 2024-04-26 date: 2024-04-26 name: Tomsk National Research Medical Center of the Russian Academy of Sciences class: OTHER name: Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry of the Russian Academy of Sciences name: Uppsala University briefSummary: The study should evaluate the biological distribution of \[123I\]I-DARPIN-Ec1 in patients with lung and ovarian cancer

The primary objective are:

1. To assess the distribution of \[123I\]I-DARPIN-Ec1 in normal tissues and tumors at different time intervals.
2. To evaluate dosimetry of \[123I\]I-DARPIN-Ec1 .
3. To study the safety and tolerability of the drug \[123I\]I-DARPIN-Ec1 after a single injection in a diagnostic dosage.

The secondary objective are:

1. To compare the obtained \[123I\]I-DARPIN-Ec1 SPECT imaging results with the data of CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) studies in lung and ovarian cancer patients. conditions: Lung Cancer conditions: Ovarian Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: PARTICIPANT count: 10 type: ESTIMATED name: Diagnostic Test: whole body study and SPECT with [123I]I-DARPIN-Ec1 measure: Gamma camera-based whole-body [123I]I-DARPIN-Ec1 uptake value (%) measure: SPECT-based [123I]I-DARPIN-Ec1 value in tumor lesions (counts) measure: SPECT-based [123I]I-DARPIN-Ec1 uptake value (counts) measure: Tumor-to-background ratio (SPECT) measure: Percent of cases with abnormal findings in physical examination, vital signs and ECG associated with [123I]I-DARPIN-Ec1 injections. measure: Percent of cases with abnormal laboratory test results associated with [123I]I-DARPIN-Ec1 injections associated with [123I]I-DARPIN-Ec1 injections. measure: Incidence and severity of adverse events associated with [123I]I-DARPIN-Ec1 injections measure: Percent of cases requiring administration of concomitant medication due to [123I]I-DARPIN-Ec1 injections sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: TomskNRMC city: Tomsk country: Russian Federation lat: 56.49771 lon: 84.97437 hasResults: False

 nctId: NCT06386640 id: 0784 briefTitle: A Holistic Patient-centred Intervention to Improve Outcomes of Older People Living With Frailty and Chronic Heart Failure acronym: FIT-HF overallStatus: RECRUITING date: 2023-01-27 date: 2025-04-30 date: 2025-04-30 date: 2024-04-26 date: 2024-04-26 name: University of Leicester class: OTHER briefSummary: Two-centre complex intervention development and feasibility trial using mixed qualitative and quantitative approach conditions: Chronic Heart Failure conditions: Frailty studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Intervention Development measure: Phase I: Qualitative evaluation with stakeholders to identify gaps in current HF care pathway leading to unmet healthcare needs in older people living with frailty and CHF measure: Phase II: Co-design and production of a holistic, patient-centered intervention addressing various healthcare needs of older people living with frailty and CHF measure: Phase IIa: Time spent in sedentary, light, moderate and vigorous activity over monitoring duration measure: Phase III: Change in physical function as assessed by the SPPB upon completion of 12-week intervention and at 6 month follow up (this may alter depending on findings from Phase II) sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Glenfield Hospital status: RECRUITING city: Leicester country: United Kingdom name: Shirley Sze role: CONTACT email: kyss1@leicester.ac.uk lat: 52.6386 lon: -1.13169 hasResults: False

 nctId: NCT06386627 id: Skoltech-CNBR3 id: 21-75-30024 type: OTHER_GRANT domain: Russian Science Foundation briefTitle: Study of Neurophysiological Markers of Motor Recovery in Post-stroke Patients. overallStatus: COMPLETED date: 2023-07-01 date: 2024-03-15 date: 2024-03-15 date: 2024-04-26 date: 2024-04-26 name: Skolkovo Institute of Science and Technology class: OTHER name: Federal center of brain research and neurotechnologies, FMBA, Moscow, Russia briefSummary: The aim of the study was to explore potential pathways for recovery and adaptation of neural pathways after stroke by examining electrical activity of the brain cortex and cortico-spinal excitability using transcranial magnetic stimulation in people with motor impairment after stroke. Participants in the study performed a simple stimulus-response task with a healthy and a paralysed limb several times at different stages of basic rehabilitation. To compare the data, a group of healthy volunteers took part in a similar experiment. We recorded cortical activity using electroencephalography and muscle activity using electromyography. After the stimulus-response task, we also carried out a study using transcranial magnetic stimulation to assess the integrity of corticospinal connections. conditions: Stroke studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 40 type: ACTUAL name: Stimulus response task name: Transcranial magnetic stimulation measure: Atypical shape of lateralized readiness potential measure: Absent of ipsilateral muscles contraction in response to primary motor cortex stimulation in both hemispheres sex: ALL minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Skolkovo Institute of Science and Technology (Skoltech) city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 hasResults: False

 nctId: NCT06386614 id: BDNF briefTitle: Effects of TDCS of the Frontal Lobe on Cognitive Function and BDNF in PSCI overallStatus: RECRUITING date: 2023-01-01 date: 2024-06-01 date: 2024-06-01 date: 2024-04-26 date: 2024-04-26 name: The Second Affiliated Hospital of Dalian Medical University class: OTHER briefSummary: The purpose of the clinical trial is to find a treatment for stroke patients with cognitive impairment, and the main questions it aims to answer are:

* \[Search for effective treatments of cognitive impairment after stroke\]
* \[explore the relationship between BDNF level and cognitive function\] Participants will receive conventional treatment, tDCS treatment, .And then compare cognitive function and BDNF level conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Routine treatment name: Transcranial Direct Current Stimulation measure: BDNF measure: Cognitive function level measure: Executive function level measure: Memory function level sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Rehabilitation Medicine, the Second Hospital of Dalian Medical University status: COMPLETED city: DaLian state: Liaoning zip: 116021 country: China lat: 38.91222 lon: 121.60222 facility: Lily status: RECRUITING city: Dalian state: Liaoning zip: 116021 country: China name: Yang Tu role: CONTACT phone: 18875214238 email: 715700399@qq.com lat: 38.91222 lon: 121.60222 hasResults: False

 nctId: NCT06386601 id: 2024-15804 briefTitle: Surgical Ergonomics Education During Minimally Invasive Gynecologic Skills Training acronym: SEE MIGS overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2024-10 date: 2024-10 date: 2024-04-26 date: 2024-04-26 name: Montefiore Medical Center class: OTHER briefSummary: The goal of this pilot study is to learn if a class and hands-on-practice of ergonomic body positions - or specific ways to move the body while working to prevent injury - is valuable to training obstetrics and gynecology doctors. The main questions the study team aims to answer are:

* Will these lessons successfully teach the participants how to move bodies at work in a way that will prevent injury?
* Will the participants feel that learning and practicing such lessons helps to avoid injury while at work?

Researchers will compare training obstetrics and gynecology doctors that attend a class on ergonomics and have guided hands-on-practice of ergonomic body positions with training obstetrics and gynecology doctors that attend the class only to see if the first group learns and remembers how to move their bodies safely while working. All participants will attend a class that teaches basic ergonomic lessons before they are divided into two groups. Group 1 will practice common surgery skills on a model while being videotaped by an artificial intelligence application. The application will make a report on unsafe positions a participant does while practicing surgical skills. The Group 1 participant will then go over the report with one of the study supervisors to talk about ways that the participant can move safely while practicing the skills. The participant will then practice the skills one more time while being videotaped. The study supervisors will then compare the two reports to see if the participant improved.

Group 2 will also practice common surgery skills on a model while being videotaped. Group 2 participants will not get to see the report that the application generates or speak with the study supervisors about ways to move safely while practicing the skills.

There will be a follow up after two months to see if participants remembered what was learned during the class and during the hands-on practice lesson. All participants will again be videotaped. The study supervisors will compare the videos and reports from the last class to the most recent ones to see if the participants learned and remember how to move safely while working.

Participants in both groups will take a quiz about the lessons learned in the class before and after the class to determine what had been learned from the lesson. A survey about how useful and helpful the class was and hands-on practice sessions were will also be completed. conditions: Work-related Injury conditions: Work Related Upper Limb Disorder conditions: Surgery conditions: Educational Problems studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be stratified into junior residents (1st and 2nd year) and senior residents (3rd and 4th year) and then randomized to the intervention group or control group. primaryPurpose: OTHER masking: NONE count: 24 type: ESTIMATED name: Ergonomics Knowledge name: Ergonomics Feedback/Guided Practice measure: Number of participants that would recommend incorporating surgical ergonomics lecture/module as a permanent part of the didactic curriculum. measure: Number of participants that would recommend incorporating surgical ergonomics hands-on skills session with feedback and guided practice on surgical ergonomics as a permanent part of the didactic curriculum. measure: Change from baseline in surgical ergonomic knowledge score over two sessions measure: Change from baseline in surgical ergonomic practice based on rapid upper limb assessment (RULA) score over two sessions measure: Change from baseline in surgical ergonomic practice based on rapid entire body assessment (REBA) score over two sessions measure: Change from baseline in surgical ergonomic practice based on revised hand strain index (RHSI) score over two sessions measure: Number of participants that reported an increase in knowledge following surgical ergonomics lecture/module and/or skills practice. measure: Number of participants that reported an increase in practice following surgical ergonomics lecture/module and/or skills practice. measure: Number of participants that reported that surgical ergonomics education is valuable following surgical ergonomics lecture/module and/or skills practice measure: Number of participants with a change in pain scores following surgical ergonomics lecture/module and skills practice sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Montefiore Medical Center city: Bronx state: New York zip: 10467 country: United States name: Alexandria Connor, MD role: CONTACT phone: 859-512-4053 email: alconnor@montefiore.org lat: 40.84985 lon: -73.86641 hasResults: False

 nctId: NCT06386588 id: 2024P000610 briefTitle: The Effects of Auditory Stimulation During Sleep on Brain Networks in Schizophrenia overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-06-30 date: 2027-12-31 date: 2024-04-26 date: 2024-04-26 name: Massachusetts General Hospital class: OTHER briefSummary: In this research study the investigators will use sleep headbands to measure brain rhythms and to improve their coordination across brain regions. The headbands will be worn at home for multiple nights. On some nights the headbands will play soft sounds at specific times during sleep. The investigators are interested in learning whether this timed auditory stimulation may be a strategy to improve the coordination of sleep rhythms across brain regions, improve network communication, and as a result, improve memory. The investigators will study 30 adults aged 18-45 with schizophrenia and 30 demographically matched healthy controls. Participants will first have a daytime MRI scan, during which they will complete a finger tapping motor sequence task (MST), followed by a week of sleep at home with a sleep headband. They will also do the MST at home on two of the nights. On the final day of the study, participants will return for a second MRI scan. conditions: Schizophrenia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 60 type: ESTIMATED name: Closed loop auditory stimulation during sleep measure: Changes in sleep physiology measure: Changes in functional connectivity of the hippocampus and thalamus measure: Changes in hippocampal activation during motor sequence task (MST) measure: Changes in hippocampal microstructural integrity measure: Greater gains in typing speed over rest breaks during MST training (micro-offline gains) measure: Sleep dependent memory consolidation (SDMC) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Massachusetts General Hospital city: Charlestown state: Massachusetts zip: 02129 country: United States name: Dara Manoach, PhD role: CONTACT phone: 617-724-6148 email: manoachlab@gmail.com name: Lindsey Jones, MS role: CONTACT phone: 617-702-2368 email: manoachlab@gmail.com name: Dara Manoach, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.37787 lon: -71.062 hasResults: False

 nctId: NCT06386575 id: suprainguinal briefTitle: Suprainguinal Fascia Iliaca Block in Knee Arthroplasty overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-01 date: 2024-09-01 date: 2024-04-26 date: 2024-04-29 name: Konya City Hospital class: OTHER briefSummary: Total knee arthroplasty is the most commonly performed orthopedic surgery, especially in patients with advanced gonarthrosis and limited joint movement. After total knee arthroplasty, patients experience unbearably severe pain. Pain that is not adequately treated in the postoperative period increases the stress response in patients, increases the risk of embolism, causes bleeding in the surgical area, and causes undesirable conditions such as agitation and delirium in patients. This postoperative pain is successfully treated with various variants of multimodal analgesia. conditions: Analgesia conditions: Anesthesia, Local studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Suprainguinal fascia iliaca block will be applied to the patients at the end of the surgery. primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: control group; Patients who received physiological saline name: suprainguinal fascia block; Patients receiving local anesthetic measure: quality of recovery-15T sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06386562 id: 2023-07489-01 briefTitle: Pilot Study of an Internet-based Parenting Program for Child Disruptive Behavior overallStatus: NOT_YET_RECRUITING date: 2024-04-24 date: 2024-06-30 date: 2024-06-30 date: 2024-04-26 date: 2024-04-26 name: Karolinska Institutet class: OTHER briefSummary: The goal of this pilot randomized controlled trial is to learn about effects and experiences of an internet-based parenting program for parents of children and adolescents with behavioral problems (e.g., aggressive or defiant behavior).

The main questions the study aims to answer are:

* What are the preliminary effects of the internet-based parenting program?
* What is the level of parents' engagement in the parenting program?
* How do parents perceive the program?

Families will be randomized to a version of an internet-based parenting program with support provided from family guides (psychologists) through chat messages in the program, or to the same internet-based parenting program with additional phone/digital support-meetings. Parents will answer quantitative measurements questions before, during, and after treatment. Parents will also be asked to participate in a qualitative interview after the program. Both within and between group comparisons will be conducted to see if there are trends within each arm and differences between the two types of support. conditions: Child Behavior Problem conditions: Disruptive Behavior conditions: Oppositional Defiant Disorder conditions: Conduct Problems conditions: Parent-Child Relations studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 20 type: ESTIMATED name: Family Check-up and Cognitive behavior therapy online: a Swedish internet-based parenting program name: Family Check-up and Cognitive behavior therapy online: a Swedish internet-based parenting program with additional parental support measure: Mean change from baseline in behavior problems on the Disruptive Behavior Disorder scale (oppositional defiant disorder subscale). measure: Mean change from baseline in parenting on the Parenting Children and Adolescents Scale measure: Mean change from baseline in parenting on the Parenting Children and Adolescents Scale: Impact scale measure: Mean change from baseline in child wellbeing on the KIDSCREEN-10 measure: Mean change from baseline in child wellbeing on the Strengths and Difficulties Questionnaire measure: Mean change from baseline in emotion regulation on the Difficulties in Emotion Regulation Scale measure: Mean change from baseline in parental emotion regulation on the Parent Emotion Regulation Scale measure: Mean change in family warmth measure: Mean change in family conflicts measure: Mean change in parental satisfaction with the week measure: Parental experiences of the internet-based parenting program explored through qualitative interviews measure: Parental experiences of each module in the internet-based parenting program measure: Parental experiences of the whole internet-based parenting program measure: Parental use of the internet-based parenting program: homework tasks, exercises measure: Parental use of the internet-based parenting program: time spent working with the program measure: Parental use of the internet-based parenting program: drop out rate measure: Background information measure: Working alone or with partner in the parenting program sex: ALL minimumAge: 8 Years maximumAge: 16 Years stdAges: CHILD hasResults: False

 nctId: NCT06386549 id: HSEARS20220424001 briefTitle: Effect of a Tele-rehabilitation Programme in Children With Burns: a Randomized Controlled Trial overallStatus: RECRUITING date: 2022-11-14 date: 2024-10-31 date: 2024-12-31 date: 2024-04-26 date: 2024-04-26 name: LIAO Peng class: OTHER briefSummary: The goal of this clinical trial is to compare tele-rehabilitation and routine post-discharge rehabilitation in children with burn injuries. The main questions it aims to answer are:

* Is tele-rehabilitation better for improving the quality and outcomes of care for burn children?
* Is tele-rehabilitation more effective in improving scar management in children with burns injuries?
* Is tele-rehabilitation more effective in improving perceived stress in parents of children with burns injuries? conditions: Burns conditions: Tele-rehabilitation conditions: Scar conditions: Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: tele-rehabilitation measure: The scars of children with burns measure: The quality and outcomes of care for burn children measure: psychological stress of caregvers sex: ALL minimumAge: 3 Years maximumAge: 6 Years stdAges: CHILD facility: Hongkong Poly Uiniversity status: RECRUITING city: Hong Kong country: China name: Fu Jinfeng role: CONTACT phone: +8613987695500 email: fujinfeng@etyy.cn lat: 22.39407 lon: 114.13737 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2022-05-31 uploadDate: 2024-04-17T21:22 filename: ICF_000.pdf size: 59989 hasResults: False

 nctId: NCT06386536 id: 2023-1796 briefTitle: Development and Evaluation of TRIVEL Smart Bike Training Prescription Programs. overallStatus: RECRUITING date: 2024-01-15 date: 2024-05 date: 2024-05 date: 2024-04-26 date: 2024-04-26 name: Sylvie Nadeau class: OTHER briefSummary: This pilot A-B study aims to develop and validate personalized training programs for older adults with decreased mobility on a Semi-Reclining Intelligent Stationary Bike prototype.

The study also aims to assess the feasibility and acceptability of the training programs and to document their preliminary effects on physical health, perceived well-being, and quality of life. Ten participants will take part in five personalized training sessions with the intelligent bike and five standard training sessions with a traditional stationary bike. conditions: Aging conditions: Mobility Limitation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: A single-subject reversal study design (A-B) will be used. During the A and B phases, the participants will undergo training with either the VI-TRIVEL or a conventional stationary bike. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 10 type: ESTIMATED name: Intelligent stationary bike name: Conventional stationary bilke measure: Walking ability and functional capacity measure: Leg strength and endurance measure: Well-being measure: Quality of life sex: ALL minimumAge: 50 Years maximumAge: 95 Years stdAges: ADULT stdAges: OLDER_ADULT facility: L'Institut de réadaptation Gingras-Lindsay-de-Montréal status: RECRUITING city: Montréal state: Quebec zip: H3S 2J4 country: Canada name: Sylvie Nadeau, PhD role: CONTACT phone: 5143436111 phoneExt: 12253 email: sylvie.nadeau@umontreal.ca name: Roua Walha, PhD role: CONTACT phone: 8199195095 email: roua.walha@umontreal.ca name: Sylvie Nadeau, PhD role: PRINCIPAL_INVESTIGATOR name: Roua Walha, PhD role: SUB_INVESTIGATOR name: Julie Soulard, PhD role: SUB_INVESTIGATOR name: Cyril Duclos, PhD role: SUB_INVESTIGATOR name: Nicolas Berryman, PhD role: SUB_INVESTIGATOR name: Elaine Deguise, PhD role: SUB_INVESTIGATOR name: Claudine Auger, PhD role: SUB_INVESTIGATOR name: Dahlia Kairy, PhD role: SUB_INVESTIGATOR name: David Labbé, PhD role: SUB_INVESTIGATOR name: Rachid Aissaoui, PhD role: SUB_INVESTIGATOR name: Gabriel Moisan, PhD role: SUB_INVESTIGATOR lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06386523 id: 23-AOI-03 briefTitle: Standardization of a New Psychophysical Olfactory Test, TODA2 acronym: TODA-STAR overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-05-23 date: 2025-11-15 date: 2024-04-26 date: 2024-04-26 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: Recruitment of patients consulting the IUFC for another pathology unrelated to an olfactory disorder:

Interview and clinical examination and Passing the 2 olfactory tests for 30 voluntary's patients, a second consultation of 15 minutes including the time of the test within 7 days after the 1st conditions: Patients Without an Olfactory Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 112 type: ESTIMATED name: Passage of olfactory tests measure: Passage of olfactory tests: measure: Passage of olfactory tests: measure: Passage of olfactory tests: measure: Identify confounding factors, i.e. factors that can influence the results of the olfactory test measure: Identify confounding factors, i.e. factors that can influence the results of the olfactory test sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06386510 id: 2025-5517 briefTitle: Cranial Nerve Neuromodulation to Improve Arm Function and Brain Plasticity in Stroke acronym: CN-NINM overallStatus: NOT_YET_RECRUITING date: 2024-11-01 date: 2027-05-01 date: 2027-07-01 date: 2024-04-26 date: 2024-04-29 name: Université de Sherbrooke class: OTHER briefSummary: Following a stroke, persistent residual muscle weakness in the upper limb (UL) drastically impacts the individuals' quality of life and level of independence. Training interventions are recommended to promote UL motor recovery, and recent studies have shown that training must be tailored to each individual's recovery potential to maximise training gains. Complementary to training interventions, non-invasive brain stimulation devices (NIBS) can help support the provision of post-stroke care by modulating brain excitability and enhancing recovery. Among NIBS, cranial nerve non-invasive neuromodulation (CN-NINM) is gaining increasing attention in rehabilitation since it can directly and non-invasively stimulate the tongue's cranial nerves. The impulses generated can then reach the motor cortex, induce neuroplastic changes and support recovery. Promising results in various neurological populations have been observed, but in stroke, the efficacy of CN-NINM at improving arm motor recovery and brain plasticity is yet to be determined. This is what the present project intends to address, using a stratified randomized controlled trial, where participants in the chronic phase of a stroke will take part in a 4-week individualized training program of their affected UL in combination with real or sham CN-NINM. Before and after the intervention, participants will undergo clinical and neurophysiological evaluations to thoroughly evaluate CN-NINM-induced changes in UL motor function and associated neuroplastic changes. The proposed study will allow an in-depth evaluation of the effects of CN-NINM for an eventual implementation in clinics and at home to support optimal post-stroke recovery. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: multicentered stratified randomized controlled trial primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 74 type: ESTIMATED name: Strength training name: Cranial nerve non-invasive neuromodulation measure: Change in UL motor function on the Fugl-Meyer Stroke Assessment Scale measure: Change in UL functional performance on the Wolf Motor Function Test measure: Change in motor cortex excitability by means of resting MEP amplitudes elicited by TMS over both hemispheres. measure: Change in participants' subjective real life functional UL performance on the Motor Activity Log measure: Change in active and passive range of motion at both UL in shoulder flexion, elbow flexion and wrist extension measure: Change in resting motor threshold of the affected and unaffected FDI sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CRIR/Feil/Oberfeld Research Center; Centre intégré de santé et de services sociaux de Laval; Jewish Rehabilitation Hospital city: Laval state: Quebec zip: H7V 1R2 country: Canada name: Marie-Helene Boudrias, PhD role: CONTACT phone: 514-398-5457 email: mh.boudrias@mcgill.ca name: Marie-Helene Boudrias, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.56995 lon: -73.692 facility: Centre de recherche sur le vieillissement city: Sherbrooke state: Quebec zip: J1H 4C4 country: Canada name: Marie-Helene Milot, PhD role: CONTACT phone: 819-780-2220 phoneExt: 45277 email: marie-helene.milot@usherbrooke.ca name: Maureen Ahiatsi, MsC role: CONTACT phone: 819-780-2220 phoneExt: 45691 email: maureen.rudy.sandra.ahiatsi@usherbrooke.ca lat: 45.40008 lon: -71.89908 facility: CIRRIS city: Québec zip: G1M2S8 country: Canada name: Andréanne Blanchette, PhD role: CONTACT phone: 418-529-9141 phoneExt: 46896 email: andreanne.blanchette@fmed.ulaval.ca name: Andréanne Blanchette, PhD role: PRINCIPAL_INVESTIGATOR lat: 46.81228 lon: -71.21454 hasResults: False

 nctId: NCT06386497 id: 2023-D0100 briefTitle: Acceptability of the Somnomat Casa for the Treatment of Parkinson's Disease acronym: Somnomat Casa overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-09-30 date: 2025-12-31 date: 2024-04-26 date: 2024-04-26 name: Insel Gruppe AG, University Hospital Bern class: OTHER name: ETH Zurich briefSummary: This pilot study aims to evaluate the feasibility and acceptability of nocturnal translational vestibular stimulations (VS) applied by a rocking bed (Somnomat Casa) for two months in patients with Parkinson's Disease. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 15 type: ESTIMATED name: Nocturnal translational vestibular stimulation measure: Evaluation of acceptability and feasibility measure: Evaluation of acceptability and feasibility measure: Pittsburgh Sleep Quality Index (PSQI) measure: Pittsburgh Sleep Quality Index (PSQI) measure: Pittsburgh Sleep Quality Index (PSQI) measure: Pittsburgh Sleep Quality Index (PSQI) measure: Epworth Sleepiness Scale (ESS) measure: Epworth Sleepiness Scale (ESS) measure: Epworth Sleepiness Scale (ESS) measure: Epworth Sleepiness Scale (ESS) measure: Parkinson's Disease Sleep Scale version 2 (PDSS-2) measure: Parkinson's Disease Sleep Scale version 2 (PDSS-2) measure: Parkinson's Disease Sleep Scale version 2 (PDSS-2) measure: Parkinson's Disease Sleep Scale version 2 (PDSS-2) measure: Restless Legs Syndrome Rating Scale (IRLS) measure: Restless Legs Syndrome Rating Scale (IRLS) measure: Restless Legs Syndrome Rating Scale (IRLS) measure: Restless Legs Syndrome Rating Scale (IRLS) measure: Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) measure: Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) measure: Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) measure: Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) measure: Parkinson's disease quality of life questionnaire (PDQ-39) measure: Parkinson's disease quality of life questionnaire (PDQ-39) measure: Parkinson's disease quality of life questionnaire (PDQ-39) measure: Parkinson's disease quality of life questionnaire (PDQ-39) measure: Patients' Global Impression of Severity Scale (PGIS) measure: Patients' Global Impression of Change Scale (PGICS) measure: Patients' Global Impression of Change Scale (PGICS) measure: Patients' Global Impression of Change Scale (PGICS) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Insel Gruppe AG, University Hospital Bern city: Bern zip: 3010 country: Switzerland lat: 46.94809 lon: 7.44744 facility: ETH Zurich, Sensory-Motor Systems Lab, IRIS city: Zürich zip: 8092 country: Switzerland name: Robert Riener, Prof. role: CONTACT phone: 44 632 66 79 phoneExt: +41 email: robert.riener@hest.ethz.ch lat: 47.36667 lon: 8.54999 hasResults: False

 nctId: NCT06386484 id: 2019-05463 briefTitle: Selective Head-and-neck Cooling on Biomarker Levels and Symptom Rating Following a Boxing Bout overallStatus: RECRUITING date: 2021-11-02 date: 2025-01-01 date: 2025-01-30 date: 2024-04-26 date: 2024-04-26 name: Region Skane class: OTHER briefSummary: Young, healthy elite boxers ≥ 18 years old are recruited. Prior to, and immediately after a competitive boxing bout over 3x2 or 3x3 minutes, blood samples are drawn. Boxers are randomized to intervention or control management by 1:1 allocation prior to baseline testing. After the initial post-fight blood sample is drawn and symptom rating using the sports concussion assessment tool-5 (SCAT-5) has been collected, the boxers receive either acute selective head-and-neck cooling for 45 min, or routine post-fight management. The number of head impacts are counted in all boxers on match video recordings. In both groups, blood samples are drawn 45 minutes after the initial post-bout blood sample, as well as 3 and 6 days post-fight. conditions: Repetitive Head Impact conditions: Selective Head and Neck Cooling studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The PolarCap System consists of a high-powered portable cooling system, designed to reduce brain temperature by controlled cooling of the scalp and neck with a circulating coolant (PolarCap Coolant, PolarCool AB, Lund, Sweden). The coolant is maintained at 0°C and flows through a silicone-based head cap. An insulating neoprene cover is put on top of the cap for isolation. primaryPurpose: PREVENTION masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: PolarCap System measure: Selective head-and-neck cooling in boxing attenuates the release of brain injury biomarkers such as NFL and GFAP post fight. measure: Selective head-and-neck cooling improves symptom rating post fight in boxing, using the Sports Concussion Assessment tool- 5 (SCAT-5). sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Department of Clinical Sciences Lund, Department of Neurosurgery, Sweden status: RECRUITING city: Lund state: Skane zip: 22100 country: Sweden name: Ali Al-husseini, MD, Medical doctor, PhD stud role: CONTACT phone: +46707267261 email: Ali.al-husseini@med.lu.se name: Ali Al-husseini role: SUB_INVESTIGATOR lat: 55.70584 lon: 13.19321 hasResults: False

 nctId: NCT06386471 id: 24093 briefTitle: Personalized GI Motility Responses to Diet overallStatus: RECRUITING date: 2024-03-07 date: 2024-06-12 date: 2025-06-02 date: 2024-04-26 date: 2024-04-26 name: University of Illinois at Urbana-Champaign class: OTHER briefSummary: The goal of this randomized, crossover, clinical trial is to link: 1) gastrointestinal motility patterns induced by acute consumption of whole and refined grains, 2) enteric microbial production of bioactive metabolites, and 3) circulating postprandial appearance of metabolites important to cardiometabolic health including glucose, triglycerides, and cholesterol.

Participants will be asked to consume a Smartpill monitoring device that records metrics of gastrointestinal motility in response to whole or refined grains, monitor cardiometabolic metabolties over an 8 hour postprandial window, and provide a fecal sample for microbiome-related analyses. conditions: Nutritional and Metabolic Diseases conditions: Gastrointestinal Dysfunction conditions: Cardiovascular Diseases conditions: Dysbiosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized, controlled, crossover primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: Appearance, flavor, and texture of whole grain vs refined bread could not be masked count: 50 type: ESTIMATED name: Whole grain rye bread name: Refined grain rye bread measure: Gastrointestinal Pressure (mmHg) measure: Luminal pH (pH units) measure: Temperature (degrees celcius) measure: Gastrointestinal Transit Time (hours:minutes) measure: Blood Glucose measure: Triglycerides measure: Total Cholesterol measure: HDL cholesterol measure: LDL cholesterol measure: Lipopolysaccharide Binding Protein measure: Microbiome measure: Metabolomics sex: ALL minimumAge: 21 Years maximumAge: 63 Years stdAges: ADULT facility: University of Illinois at Urbana-Champaign status: RECRUITING city: Urbana state: Illinois zip: 61801 country: United States name: Brett R Loman, PhD, RD role: CONTACT name: Brett R Loman, PhD, RD role: PRINCIPAL_INVESTIGATOR lat: 40.11059 lon: -88.20727 hasResults: False

 nctId: NCT06386458 id: AT-01 briefTitle: Assessing AThrough Radiofrequency Transseptal Puncture System for Left Atrial Access overallStatus: COMPLETED date: 2022-07-08 date: 2023-05-09 date: 2023-05-11 date: 2024-04-26 date: 2024-04-26 name: Hangzhou NOYA MedTech Co. Ltm. class: INDUSTRY briefSummary: This study is a prospective, multicenter, randomized controlled trial with a non-inferiority design. Participants are patients scheduled for atrial septal puncture. After signing informed consent, subjects will be randomly assigned to either the radiofrequency transseptal puncture system group (referred to as the trial group) or the traditional mechanical transseptal puncture system group (referred to as the control group). All participants will undergo immediate postoperative and discharge clinical follow-ups. conditions: Heart Diseases conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 177 type: ACTUAL name: AThrough radiofrequency transseptal puncture system name: Traditional mechanical transseptal puncture needle measure: Transseptal puncture success rate. measure: Initial transseptal puncture success rate. measure: Time required to successfully complete the transseptal puncture. measure: Number of attempts needed to successfully complete the transseptal puncture. measure: Ratio of atrial septal puncture failures that cross over to the opposite group. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The 7th People's Hospital of Zhengzhou city: Zhengzhou state: Henan zip: 450000 country: China lat: 34.75778 lon: 113.64861 facility: The First Affiliated Hospital with Nanjing Medical University city: Nanjing state: Jiangsu zip: 210000 country: China lat: 32.06167 lon: 118.77778 facility: Tianjin Chest Hospital city: Tianjin state: Tianjin country: China lat: 39.14222 lon: 117.17667 facility: The First Affiliated Hospital of Ningbo University city: Ningbo state: Zhejiang zip: 315000 country: China lat: 29.87819 lon: 121.54945 hasResults: False

 nctId: NCT06386445 id: XJTU1AF-CRF-2023-XK013 briefTitle: Study on the Serum Metabolic Markers and Early Complications After Allo-HSCT： Cohort Study overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-31 date: 2026-12-31 date: 2024-04-26 date: 2024-04-26 name: First Affiliated Hospital Xi'an Jiaotong University class: OTHER briefSummary: This study aims to establish a cohort of 500 patients with hematological disease who undergoing allogeneic hematopoietic stem cell transplantation in the northwest region. All patients will be followed up at the outpatient clinic once a week after transplantation until 100 days after transplantation to observe the presence of acute graft versus host disease, acute kidney damage, and major cardiovascular adverse events. Serum samples from the day before pre-treatment, day after pre-treatment, 2 weeks，4 weeks，8 weeks and 12 weeks after transplantation will be detected by metabolomics sequencing.The primary objective is to explore the serum metabolic markers of acute graft versus host disease，acute kidney injury, and major adverse cardiac events within 100 days after transplantation，the secondary objective is to observe the high-risk factors for early complications. conditions: Stem Cell Transplant Complications conditions: Acute Graft Versus Host Disease conditions: Acute Kidney Injury conditions: Major Adverse Cardiac Events studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Serum metabolomics sequencing measure: acute graft versus host disease measure: acute kidney injury measure: major adverse cardiac events sex: ALL minimumAge: 0 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06386432 id: RG1124189 id: NCI-2024-02453 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: RG1124189 type: OTHER domain: Fred Hutch/University of Washington Cancer Consortium id: U54CA132381 type: NIH link: https://reporter.nih.gov/quickSearch/U54CA132381 briefTitle: EQQUAL-NM for the Promotion of Smoking Cessation in Sexual and Gender Minority Young Adults in New Mexico overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2025-12-01 date: 2025-12-01 date: 2024-04-26 date: 2024-04-26 name: Fred Hutchinson Cancer Center class: OTHER name: National Cancer Institute (NCI) name: National Cancer Institute Center to Reduce Cancer Health Disparities name: New Mexico State University briefSummary: This clinical trial assesses the acceptability and efficacy of Empowered, Queer, Quitting, and Living--New Mexico (EQQUAL-NM), a smoking cessation intervention for sexual and gender minority young adults in New Mexico. Smoking prevalence among sexual and gender minority (SGM) adults in New Mexico is more than twice as high as non-SGM adults. Helping young adult tobacco users to quit is critical, yet there have been few efforts to develop tailored treatments specifically for this population. EQQUAL-NM is a digital smoking cessation intervention designed specifically for SGM young adult smokers in New Mexico and may help them quit smoking. conditions: Cigarette Smoking-Related Carcinoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Any outcome evaluator who has contact with participants will remain blinded to treatment group assignment until the final set of questions regarding acceptability of specific program components is asked. whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Smartphone App-delivered Smoking Cessation Intervention name: Smartphone App-delivered Smoking Cessation Intervention name: Health Promotion and Education name: Health Promotion and Education name: Biospecimen Collection name: Questionnaire Administration measure: Participant satisfaction measure: Number of logins to the assigned application measure: Self-reported 7-day point prevalence abstinence (PPA) from all nicotine and tobacco products measure: Biochemically confirmed 7-day point prevalence abstinence (PPA) from all nicotine/tobacco products measure: Self-reported 30-day PPA from all nicotine/tobacco products measure: Biochemically confirmed 30-day PPA from all nicotine/tobacco products measure: Self-reported 7-day PPA from cigarette smoking measure: Self-reported 30-day PPA from cigarette smoking measure: Change in Contemplation Ladder scores measure: Change in acceptance of tobacco-use triggers measure: Change in values-guided action sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Fred Hutch/University of Washington Cancer Consortium city: Seattle state: Washington zip: 98109 country: United States name: Jaimee Heffner role: CONTACT phone: 206-667-7314 email: jheffner@fredhutch.org name: Jaimee Heffner role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06386419 id: CKJX839A1IN03 briefTitle: A Clinical Study to Evaluate the Safety and Effectiveness of Inclisiran Sodium in Indian Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-08-08 date: 2025-08-30 date: 2024-04-26 date: 2024-04-26 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: This study is to generate post-marketing safety and effectiveness data of inclisiran sodium in Indian patients as per approved indication i.e., primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia that more closely resembles the real-world population intended to be treated with inclisiran sodium. conditions: Primary Hypercholesterolemia conditions: Mixed Dyslipidemia studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: open label assignment primaryPurpose: TREATMENT masking: NONE count: 65 type: ESTIMATED name: inclisiran measure: Incidence and type of treatment-emergent adverse events (TEAEs) measure: Mean change in LDL-C from baseline to Day 300. measure: Proportion of the participants with ≥50% LDL-C reduction on Day 300 measure: Proportion of the participants who attain global lipid targets for their level of atherosclerotic cardiovascular disorders (ASCVD) risk measure: Percentage change in TC, HDL-C, non-HDL-C, VLDL-C and TG sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06386406 id: ORL-ORT-040 briefTitle: This is a Study to Evaluate a Pre-confectioned Plantar Insole for the Treatment of Plantar Heel Pain acronym: TAP overallStatus: RECRUITING date: 2024-04-23 date: 2026-03-31 date: 2026-03-31 date: 2024-04-26 date: 2024-04-26 name: Ente Ospedaliero Cantonale, Bellinzona class: OTHER briefSummary: Patients affected by plantar heel pain will be asked to use a pre-confectioned plantar insole for one year.

The aim of the study is to assess if the insole under study allows the patient to reach a better mobility and a faster return to the normal everyday life. conditions: Plantar Fascitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: TAP insole measure: Change in pain severity according to visual analog scale measure: Change in pain severity according to visual analog scale measure: Subjective functional recovery based on the Foot Function Index (FFI) score [ measure: Quality of life and foot general health through the assessment of the Foot Health Status Questionnaire (FHSQ) measure: Patient satisfaction on a 0-10 numeric rating scale (NRS) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: EOC status: RECRUITING city: Lugano zip: 6900 country: Switzerland name: Martin Riegger, Dr.med role: CONTACT phone: +41 (0) 91 811 70 29 email: RicercaOrtopedia.ORL@eoc.ch lat: 46.01008 lon: 8.96004 hasResults: False

 nctId: NCT06386393 id: HHSP233201500048I-75P00120F370 briefTitle: Survey on Where Parents Look for and Find Information and How They Use Information When Selecting Child Care overallStatus: ENROLLING_BY_INVITATION date: 2024-03-28 date: 2024-06-30 date: 2024-06-30 date: 2024-04-26 date: 2024-04-29 name: National Opinion Research Center class: OTHER name: Office of Planning, Research & Evaluation name: Urban Institute briefSummary: The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) is contracting with NORC at the University of Chicago to collect nationally representative survey data to learn more about where parents look for and find information about Child Care and Early Education (CCEE); how parents assess the people, places, or things that may offer CCEE information; what types of CCEE information parents look for; and how parents use information to make CCEE selections. The study aims to gather information that may be used by Child Care Lead Agencies to inform their consumer education efforts. This study is part of the Consumer Education and Parental Choice in Early Care and Education (CEPC) project.

The study will select a nationally representative sample from NORC's probability-based AmeriSpeak panel. The AmeriSpeak panel provides sample coverage of approximately 97 percent of the U.S. population. It currently contains 48,900 panel members age 13 and over residing in over 40,000 households. U.S. households are randomly selected with a known, non-zero probability from the NORC National Frame, and then recruited by mail, telephone, and by field interviewers face-to-face. NORC's in-person recruitment enhances representativeness for young adults, lower socio-economic households, non-internet households, and other households that are typically hard to reach for statistical surveys of the population.

The survey respondents are AmeriSpeak panelists of at least 18 years of age who have indicated that they have a young child in the household (under the age of 6 years, but not in kindergarten). If a household has two or more panel members who reside in a household with a young child, one will be selected at random to complete the survey, with preference given to parents/legal guardians. Selected panelists will be asked questions to confirm eligibility for the survey, including that the household has at least one child under the age of 6 but not in kindergarten. The study is designed to include parents and legal guardians across race/ethnicity, education level, and gender from the full spectrum of geographic locations. To include families who may not have English as a preferred language, a Spanish version of the survey will be provided. The survey will include parents and legal guardians using many kinds of CCEE and those who use parental care only to see if there are differences in how information is used depending on care type. In addition, the study will include understudied subgroups, such as parents who speak a language other than English, to help inform consumer education efforts. The survey is intended to produce findings that are generalizable to the larger population of parents with children under the age of 6, but not in kindergarten. conditions: Searching for and Selecting Child Care in the US studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 2196 type: ESTIMATED measure: Primary sources of information about child care measure: How parents assess the people, places, or things that may offer CCEE information measure: What types of CCEE related information parents look for measure: Information about the last time parents made a decision about CCEE and what information they tried to learn about at that time measure: Characteristics and experiences of the household and types of CCEE being used sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NORC at the University of Chicago city: Chicago state: Illinois zip: 60603 country: United States lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06386380 id: IRE-4906 briefTitle: Adversity and Its Association With the Development and Expression of Rheumatic Diseases acronym: RD overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-01-01 date: 2026-02-01 date: 2024-04-26 date: 2024-04-26 name: National Institute of Medical Sciences and Nutrition, Salvador Zubiran class: OTHER briefSummary: Epidemiological evidence shows that adverse experiences, particularly, but not exclusively in childhood, are predictors of poor long-term health outcomes and certain social domains. In the field of rheumatic diseases, traumatic events, not only in childhood, have been associated with hospitalization, chronic pain, inflammation, worse outcomes, severity of the disease, and mortality. Some mechanisms proposed to explain the association between the experience of adversity and the development of chronic diseases include an impact on the physiology of immune system cells, gene expression due to DNA modification, and cellular senescence.

With this background, we wonder if, for patients with rheumatoid arthritis, the presence of adversity understood as a history of violence in childhood and abuse due to suffering from rheumatoid arthritis is associated with markers of cellular senescence and with the severity of illness. conditions: RhA - Rheumatoid Arthritis studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 110 type: ESTIMATED name: Rheumatic diseases Mistreatment Scale (RDMS) name: Routine assessment of patient index data 3 (RAPID-3) name: Health Assessment Questionnaire (HAQ) name: WHOQOL-BREF name: Depression, Anxiety and Stress Scale (DASS-21) name: Brief Resilient Coping Scale name: Expression of CDKN2A /p16INK4a name: Immunophenotype of leukocyte subpopulations name: Telomere length name: Cellular senescence measure: Adversity and senescence in patients with rheumatoid arthritis measure: Eexpression of the p16INK4a gene in CD3+ measure: Telomere length sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06386367 id: MHNO-001 briefTitle: Health Education by Buddhist Monks to Promote Malaria Knowledge and Preventive Practices in Rural Myanmar overallStatus: COMPLETED date: 2022-07-01 date: 2023-03-31 date: 2024-03-30 date: 2024-04-26 date: 2024-04-29 name: Myanmar Health Network Organization class: OTHER name: Chulalongkorn University name: Ministry of Health and Sports, Myanmar briefSummary: Malaria is still a leading public health concern in Myanmar. However, people living in rural areas usually showed poor prevention practice despite residing in malaria hotspots. The majority in Myanmar are Buddhists who frequently visit the monastery and receive the speech delivered by the monks. In a malaria high burden township of the Sagaing Region from northern Myanmar, current study will first explore the difference in malaria preventive practices among people residing in different malaria-endemic villages through a mixed-methods approach. Next, this research will address the knowledge gaps by a monastery-based health education delivered by trained Buddhist monks using standardized health messages instruction for six consecutive months between August 2022 to January 2023. To test whether the intervention could balance those gaps among different groups, quantitative data of baseline, 3-month, and 6-month will be compared using descriptive statistics, chi-square test, T-test or repeated ANOVA, and the Difference-In-Differences (DID) analysis, as applicable. conditions: Buddhist Monks conditions: Health Education conditions: Malaria conditions: Monastery-based conditions: Myanmar conditions: Preventive Practice studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 501 type: ACTUAL name: Monastery-based health education by Buddhist monks measure: Malaria knowledge and preventive practices sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Myanmar Health Network Organization city: Yangon zip: 11091 country: Myanmar lat: 16.80528 lon: 96.15611 hasResults: False

 nctId: NCT06386354 id: 2023-464-1 briefTitle: Residual Neuromuscular Block in the Post-Anesthetic Unit and Postoperative Complications acronym: Porcerito overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-06-30 date: 2024-06-30 date: 2024-04-26 date: 2024-04-26 name: Dr. Negrin University Hospital class: OTHER briefSummary: The use of neuromuscular blockers (NMB) is essential to optimize surgical conditions, ensure patient immobility during the intervention and prevent complications derived from involuntary movements. Intraoperative monitoring of neuromuscular relaxation allows the depth of neuromuscular blockade to be accurately evaluated, guaranteeing ideal conditions for the surgical team. Residual neuromuscular blockade (RNMB) is the persistence of muscle paralysis after the administration of NMB during a surgical intervention. The appearance of RNMB poses substantial challenges in the postoperative period, as it has negative repercussions for the safety and well-being of the patient. conditions: Postoperative Neuromuscular Block conditions: Postoperative Complications studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Train-of-four measure: Residual Neuromuscular Block measure: Residual Neuromuscular Block measure: Postoperative complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ángel Becerra city: Las Palmas De Gran Canaria state: Las Palmas zip: 35019 country: Spain lat: 28.09973 lon: -15.41343 hasResults: False

 nctId: NCT06386341 id: W23.154 briefTitle: QoL in OSA patiënts Treated With MMA Surgery. acronym: QOMAS overallStatus: RECRUITING date: 2023-08-02 date: 2026-08-02 date: 2026-08-02 date: 2024-04-26 date: 2024-04-26 name: Diakonessenhuis, Utrecht class: OTHER briefSummary: The aim of this observational study is to evaluate the impact of maxillomandibular advancement surgery on the quality of life in patients treated with obstructive sleep apnea.

The main question it aims to answer is:

Does MMA surgery in OSA patiënts improve their quality of life?

Patients will answer online surverys about their QoL and there will be data collected like length, weight and blood pressure. conditions: Sleep Apnea, Obstructive conditions: Quality of Life studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Maxillomandibular Advancement Surgery measure: SF-36 measure: OHIP-14 measure: ESS measure: FOSQ measure: EQ-5D-3L measure: OQLQ sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Diakonessenhuis status: RECRUITING city: Utrecht zip: 3582KE country: Netherlands name: Susanne Leij role: CONTACT phone: 088-250 6172 email: sleij@diakhuis.nl name: Maurits de Ruiter, MD, DDS, PHD role: PRINCIPAL_INVESTIGATOR name: Haya Al-Bayyati role: SUB_INVESTIGATOR lat: 52.09083 lon: 5.12222 hasResults: False

 nctId: NCT06386328 id: A129_03FDI2317 briefTitle: A Clinical Trial to Evaluate the Food Effect of CKD-378 overallStatus: NOT_YET_RECRUITING date: 2024-05-03 date: 2024-06-03 date: 2024-06-11 date: 2024-04-26 date: 2024-04-26 name: Chong Kun Dang Pharmaceutical class: INDUSTRY briefSummary: A clinical trial to evaluate the food effect of CKD-378 conditions: Type II Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: CKD-378, QD, PO measure: AUCt of CKD-378 measure: Cmax of CKD-378 sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06386315 id: MC230808 id: NCI-2024-03242 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-010273 type: OTHER domain: Mayo Clinic Institutional Review Board id: MC230808 type: OTHER domain: Mayo Clinic briefTitle: Reduced Dose Radiotherapy for the Treatment of Indolent Non-Hodgkin Lymphoma overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-05-30 date: 2024-05-30 date: 2024-04-26 date: 2024-04-29 name: Mayo Clinic class: OTHER briefSummary: This phase II trial compares the safety, side effects and effectiveness of reduced dose radiation therapy to standard of care dose radiation in treating patients with indolent non-Hodgkin lymphoma. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Standard of care radiation treatment for indolent non-Hodgkin lymphoma is usually delivered in 12 treatments. Studies have shown indolent lymphoma to be sensitive to radiation treatment, however, larger doses have higher rates of toxicities. A reduced radiation dose may be safe, tolerable and/or effective compared to standard of care radiation dose in treating patients with indolent non-Hodgkin lymphoma. conditions: Indolent B-Cell Non-Hodgkin Lymphoma conditions: Recurrent Indolent B-Cell Non-Hodgkin Lymphoma conditions: Refractory Indolent B-Cell Non-Hodgkin Lymphoma conditions: Recurrent Indolent Non-Hodgkin Lymphoma conditions: Refractory Indolent Non-Hodgkin Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 112 type: ESTIMATED name: Computed Tomography name: Endoscopic Procedure name: Involved-site Radiation Therapy (3 Fractions) name: Involved-site Radiation Therapy (12 Fractions) name: Positron Emission Tomography name: Questionnaire Administration measure: Incidence of grade 2 or higher acute adverse events (AEs) measure: Response rate measure: Time to progression rate measure: Patient reported quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Arizona 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: William G. Rule, MD role: PRINCIPAL_INVESTIGATOR lat: 33.50921 lon: -111.89903 facility: Mayo Clinic in Florida 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: Bradford S. Hoppe, MD, MPH role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 facility: Mayo Clinic in Rochester 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: Scott C. Lester, MD role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06386302 id: CSIIT-A36 briefTitle: Chidamide, Venetoclax, and Azacitidine for Newly Diagnosed Acute Myeloid Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2027-12-30 date: 2027-12-30 date: 2024-04-26 date: 2024-04-26 name: Institute of Hematology & Blood Diseases Hospital, China class: OTHER briefSummary: To evaluate the feasibility, effectiveness and safety of chidamide combined with venetoclax and azacitidine in the treatment of newly diagnosed acute myeloid leukemia (AML) who are not suitable for intensive chemotherapy. conditions: AML conditions: Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 184 type: ESTIMATED name: Chidamide name: Venetoclax name: azacitidine measure: Composite complete remission rate measure: Overall response rate (ORR) measure: Overall survival (OS) measure: MRD response rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06386289 id: CNV202202 briefTitle: Safety, Performance of CEREGLIDE 92 Intermediate Catheter in Treatment of Acute Ischemic Stroke acronym: SPLENDID overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-02-28 date: 2026-06-30 date: 2024-04-26 date: 2024-04-26 name: Cerenovus, Part of DePuy Synthes Products, Inc. class: INDUSTRY briefSummary: The device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease conditions: Acute Ischemic Stroke studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 172 type: ESTIMATED name: Cereglide 92 measure: First pass reperfusion sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Iowa Hospital & Clinics city: Iowa City state: Iowa zip: 52242 country: United States lat: 41.66113 lon: -91.53017 facility: JFK Medical Center city: Edison state: New Jersey zip: 08820 country: United States lat: 40.51872 lon: -74.4121 facility: Westchester Medical Center city: Valhalla state: New York zip: 10595 country: United States lat: 41.07482 lon: -73.77513 facility: Vanderbilt University Medical Center city: Nashville state: Tennessee zip: 37232 country: United States lat: 36.16589 lon: -86.78444 facility: University of Utah city: Salt Lake City state: Utah zip: 84132 country: United States lat: 40.76078 lon: -111.89105 facility: West Virginia University city: Morgantown state: West Virginia zip: 26506 country: United States lat: 39.62953 lon: -79.9559 hasResults: False

 nctId: NCT06386276 id: 00025986 briefTitle: Surgical TReatment of Women With Deep ENDometriosis acronym: TrEnd overallStatus: RECRUITING date: 2023-10-11 date: 2028-06-30 date: 2029-06-30 date: 2024-04-26 date: 2024-04-26 name: Casa di Cura Privata 'Malzoni - Villa dei Platani' S.P.A. class: OTHER briefSummary: TrEnd trial is aimed to collect data from consecutive patients undergoing segmental sigmoid colon/rectal resection for deep endometriosis. The main purpose of this project is to gather a large series of cases treated using standardized surgical procedures, allowing a precise evaluation of complications and long-term outcomes. conditions: Deep Endometriosis conditions: Surgery studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 250 type: ESTIMATED name: Colorectal bowel resection measure: To document the surgical strategies adopted for treating patients with deep endometriosis undergoing to sigmoid colon/rectal resection measure: To assess the rate of complications measure: To assess the rate of conversion to open surgery measure: To assess the rate of endometriosis-free bowel resection margins measure: To assess the rate of recurrence measure: To assess the intraoperative blood loss measure: To assess the operating time measure: To assess the gastrointestinal function recovery measure: To assess the duration of hospital stay measure: To assess the reproductive outcomes sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Casa Di Cura Malzoni Villa Platani Spa status: RECRUITING city: Avellino state: Campania zip: 83100 country: Italy name: Francesca Falcone, MD role: CONTACT email: francesca.falcone3@icloud.com name: Mario Malzoni, MD role: PRINCIPAL_INVESTIGATOR name: Francesca Falcone, MD role: PRINCIPAL_INVESTIGATOR lat: 40.91494 lon: 14.79103 hasResults: False

 nctId: NCT06386263 id: D9673R00032 briefTitle: HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada acronym: HER-TEMPO overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2025-04-04 date: 2025-04-04 date: 2024-04-26 date: 2024-04-26 name: AstraZeneca class: INDUSTRY name: Daiichi Sankyo briefSummary: Trastuzumab deruxtecan (T-DXd) has been studied in multiple global prospective DESTINY-Breast trials and has a marketing authorization from Health Canada for patients with HER2-positive metastatic breast cancer (mBC) and HER2-low mBC, respectively.

Multiple stakeholders, including clinicians, patients, regulators, and healthcare decision makers, are interested in real-world treatment-related outcomes in order to better represent the effectiveness of therapies in routine care settings. conditions: Unresectable Breast Cancer conditions: Metastatic Breast Cancer conditions: HER2-low Expressing Breast Cancer conditions: HER2-positive Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 75 type: ESTIMATED name: Trastuzumab deruxtecan measure: Early treatment discontinuation rates measure: Dose modifications measure: Real world time to treatment discontinuation (rwTTD) measure: Reasons for treatment discontinuations measure: Median treatment duration and dose intensity sex: ALL minimumAge: 18 Years maximumAge: 130 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NavieGo Patient ProgramsLtd & Affiliate city: Oakville state: Ontario zip: L6H 1A7 country: Canada lat: 43.45011 lon: -79.68292 hasResults: False

 nctId: NCT06386250 id: 0005 briefTitle: Comparison of Regional Block, Caudal Block and Wound Infiltration in Inguinal Hernitomy acronym: Painseverity overallStatus: COMPLETED date: 2019-01-05 date: 2020-01-06 date: 2020-01-06 date: 2024-04-26 date: 2024-04-26 name: King Edward Medical University class: OTHER briefSummary: Background: Although Inguinal herniotomy in children is taken as a day care procedure, post-operative pain management still remain controversial in these cases and superiority of wound infiltration, caudal block or regional block over each isn't known.

Objective: The objective of the study was compare regional block, caudal block and wound infiltration for post-operative pain management in children undergoing inguinal herniotomy conditions: Postoperative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Regional block group (Group A), wound infiltration group (Group B), caudal block group (Group C) primaryPurpose: PREVENTION masking: NONE count: 300 type: ACTUAL name: regional block name: Caudal block name: Epidural measure: Postoperative pain intensity measure: postoperative pain intesity sex: ALL minimumAge: 3 Years 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: NCT06386237 id: UVienna_NDNL_1 briefTitle: Nutritional Modulation of Cognition and Brain Activity overallStatus: RECRUITING date: 2024-04-08 date: 2025-02-28 date: 2025-02-28 date: 2024-04-26 date: 2024-04-26 name: University of Vienna class: OTHER name: Medical University of Vienna briefSummary: The aim of the present study is to investigate the effects of different meal interventions on cognition (i.e., learning and decision making) and brain activity in healthy participants. conditions: Nutrition, Healthy conditions: Cognitive Change conditions: Brain Activity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE count: 40 type: ESTIMATED name: Dietary intervention: Standardized breakfast with varying amounts of macronutrients (in particular carbohydrate/protein ratios) measure: Changes in cognition/behavior I measure: Changes in cognition/behavior II measure: Changes in brain activity measure: Changes in metabolic parameters I measure: Changes in metabolic parameters II measure: Changes in metabolic parameters III measure: Changes in metabolic parameters IV measure: Changes in subjective affective state measure: Changes in experienced hunger sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University of Vienna status: RECRUITING city: Vienna zip: 1090 country: Austria name: Stefan Schulreich, Prof. Dr. role: CONTACT phone: +4314277 phoneExt: 54960 email: stefan.schulreich@univie.ac.at lat: 48.20849 lon: 16.37208 hasResults: False

 nctId: NCT06386224 id: 1R01DK137520-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01DK137520-01 briefTitle: Internet-Delivered Pain Self-Management for Persons With Acute Recurrent and Chronic Pancreatitis Pain acronym: IMPACT-2 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-03-31 date: 2026-09-30 date: 2024-04-26 date: 2024-04-26 name: Seattle Children's Hospital class: OTHER name: University of Kentucky briefSummary: Severe and disabling abdominal pain is common in individuals with chronic pancreatitis. Although pain is associated with reduced quality of life and high economic and societal costs, there are limited effective options for pain management in this population. This study proposes an evidence-based psychological intervention approach using an internet-delivered pain self-management program to minimize the impact of pain and improve quality of life. The ultimate goal is to maximize the public health impact of the intervention with successful implementation and dissemination to pancreas clinics and to the community. conditions: Pancreatitis conditions: Chronic Pancreatitis conditions: Acute Recurrent Pancreatitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants randomized to the active intervention arm will receive access to the Pancreatitis Pain Course to learn cognitive-behavioral (CBT) pain self-management skills (e.g., changing negative thoughts, relaxation, activity pacing, goal setting). Participants randomized to the control arm will receive access to an education website. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: Participants are not informed of their condition assignment and both receive online programs for chronic pancreatitis. Investigators are blinded \& masked to study condition, and all outcomes are assessed via self-reported REDCap surveys. Care providers are not involved in the study (N/A). whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 280 type: ESTIMATED name: Internet-delivered pain self-management (CBT Condition) name: Education Program measure: Change in pain severity and pain interference measure: Change in disease-specific pain measure: Change in physical functioning measure: Change in psychological functioning measure: Change in pain catastrophizing measure: Change in sleep disturbance measure: Change in disease specific health-related quality of life measure: Change in patient global impression of change measure: Change in opioid use measure: Treatment acceptability measure: Change in substance use sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seattle Children's Hospital city: Seattle state: Washington zip: 98105 country: United States name: Tonya Palermo, PhD role: CONTACT phone: 206-884-4208 email: tonya.palermo@seattlechildrens.org name: Tonya M Palermo, PhD role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06386211 id: BDR17228 id: BDR17228 type: OTHER domain: Sanofi Identifier briefTitle: Bioavailability Study of Magne-B6 New Formulation overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2024-06-15 date: 2024-06-15 date: 2024-04-26 date: 2024-04-26 name: Opella Healthcare Group SAS, a Sanofi Company class: INDUSTRY briefSummary: The purpose of the study is to assess the relative bioavailability of two Magne-B6 preparations, in fasting conditions. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: MAGNE-B6 Oral Solution name: MAGNE-B6 New Formulation Tablet measure: Maximal Observed Concentration (Cmax) of Magnesium in Plasma measure: Area Under the Concentration-time Curve from Time Zero Until time 12 hour (h) (AUC0-12) of Magnesium in Plasma measure: Area Under the Concentration-time Curve from Time Zero Until time 24 h (AUC0-24) of Magnesium in Plasma measure: Maximal Observed Concentration (Cmax) of Pyridoxine in Plasma measure: Area Under the Concentration-time Curve from Time Zero Until the Last Observed Concentration (AUClast) of Pyridoxine in Plasma measure: Area Under the Concentration-time Curve from Time Zero to Infinity (extrapolated) (AUC0-infinity) of Pyridoxine in Plasma measure: Time When the Maximal Concentration is Observed (Tmax) of Magnesium in Plasma measure: Time When the Maximal Concentration is Observed (Tmax) of Pyridoxine in Plasma measure: Cumulative Amount of Unchanged Drug Excreted into the Urine From Time Zero to the Time Point 24 hours (Ae0-24) of Magnesium in Urine measure: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06386198 id: 23-40699 briefTitle: HEalth Advocate for Liver Transplantation: Improving Transition of Care for Adolescent Liver Transplant Recipients acronym: HEAL-Tx:ToC overallStatus: RECRUITING date: 2024-03-03 date: 2026-06-30 date: 2026-06-30 date: 2024-04-26 date: 2024-04-26 name: University of California, San Francisco class: OTHER name: American Society of Transplantation briefSummary: The Health Advocate for Liver Transplant (HEAL-Tx) Transition of Care Pilot is a nonrandomized, open-label intervention pilot of a health advocate intervention aimed to assess feasibility and acceptability of integrating a Health Advocate onto the transplant team to help adolescents transition their care to adult transplant teams. Across studies, health advocate roles vary, and can include coordinating medical care treatment, facilitating financial assistance (e.g., taxi vouchers), and connecting patients to community resources, which can improve self-management, mitigate social risks, and lead to better communication between the healthcare system and the family. In this pilot, the investigators will adapt this intervention for adolescent/young adult liver transplant patients and measure acceptability and feasibility according to RE-AIM. conditions: Liver Transplant; Complications conditions: Pediatric ALL studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 20 type: ESTIMATED name: Health Advocate measure: Changes in patient experience measure: Change in medication adherence using MLVI measure: The quality of health advocate interactions with the participants, healthcare team, and community-based resources. measure: A qualitative assessment of patient and healthcare provider satisfaction with the Health Advocate intervention. sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: University of California San Francisco status: RECRUITING city: San Francisco state: California zip: 94158 country: United States name: Emily Stekol role: CONTACT phone: 415-502-3190 email: emily.stekol@ucsf.edu name: Sharad Wadhwani, MD, MPH role: PRINCIPAL_INVESTIGATOR lat: 37.77493 lon: -122.41942 facility: Children's Healthcare of Atlanta status: NOT_YET_RECRUITING city: Atlanta state: Georgia zip: 30345 country: United States name: Nitika Gupta role: CONTACT name: Nitika Gupta role: PRINCIPAL_INVESTIGATOR lat: 33.749 lon: -84.38798 hasResults: False

 nctId: NCT06386185 id: DRAPE briefTitle: Developing the Probability Algorithm for Pulmonary Hypertension Echocardiography acronym: DRAPE overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-07-01 date: 2026-11-01 date: 2024-04-26 date: 2024-04-26 name: Royal United Hospitals Bath NHS Foundation Trust class: OTHER name: Sheffield Teaching Hospitals NHS Foundation Trust name: Royal Free Hospital NHS Foundation Trust name: Golden Jubilee National Hospital name: Papworth Hospital NHS Foundation Trust name: University of Bath briefSummary: The goal of this observational study is to assess the efficacy that the addition of novel markers cardiac function, particularly of right ventricular (RV) function in echocardiography, and ECG have in detecting pulmonary hypertension.

The main questions it aims to answer are:

Can novel markers in ECG and echocardiography suggest the presence of PH? Can existing screening guidelines be improved with the addition of these markers? conditions: Pulmonary Hypertension studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 2500 type: ESTIMATED name: Electrocardiogram name: Transthoracic echocardiogram name: Right heart catheter measure: Distinguish between patients with and without pulmonary hypertension measure: Distinguish between patients with pre-capillary hypertension and post-capillary hypertension measure: Assess the impact of the severity of pulmonary hypertension measure: Assess the impact of additional ECG markers on existing PH probability stratification sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Royal United Hospital NHS Foundation Trust city: Bath state: Banes zip: BA1 3NG country: United Kingdom lat: 51.3751 lon: -2.36172 facility: Golden Jubilee Hospital city: Glasgow state: Lanarkshire zip: G81 4DY country: United Kingdom lat: 55.86515 lon: -4.25763 facility: Sheffield Teaching Hospitals NHS Foundation Trust city: Sheffield state: South Yorkshire zip: S10 2JF country: United Kingdom lat: 53.38297 lon: -1.4659 facility: Royal Papworth Hospital city: Cambridge zip: CB2 0AY country: United Kingdom lat: 52.2 lon: 0.11667 facility: Royal Free NHS Foundation Trust city: London zip: NW3 2QG country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06386172 id: 2023-03537-01 id: FoUI-986028 type: OTHER_GRANT domain: ALF Medicin, Region Stockholm briefTitle: Electronic Decision-support System to Improve Detection and Care of Patients With Chronic Kidney Disease in Stockholm acronym: ALMA-CKD overallStatus: RECRUITING date: 2023-09-09 date: 2025-04 date: 2026-12 date: 2024-04-26 date: 2024-04-26 name: Karolinska Institutet class: OTHER name: Danderyd Hospital name: Region Stockholm briefSummary: One in 10 adults in Region Stockholm have chronic kidney disease (CKD), which dramatically increases healthcare costs and the risk of medication errors or adverse health outcomes, including cardiovascular disease and death. Identification and early management of these patients is done in primary care settings. However, most adults with CKD in our region are under detected, undiagnosed and undertreated, with low rates of referral to nephrology-specialist care.

This is a pragmatic cluster randomized controlled trial (RCT) involving 66 primary healthcare centers in Region Stockholm, and testing the effect of an electronic clinical decision support (CDS) triggering system to assist general practitioners through the guideline-recommended processes of CKD care.

The centers, providing healthcare to approximately 780.000 citizens, will be randomized 50:50 to this CDS trigger (vs basic advice) for 18 months. Study outcomes will consider the improvement in the indicators of CKD care.

As a pragmatic trial there is no active recruitment or active data collection. The trial is embedded into the ongoing Stockholm CREAtinine Measurements (SCREAM) project, a database collection of healthcare use for the complete population of Stockholm. Using this real-world healthcare data collection, the investigators will be able to measure with precision the impact of our CDS trigger and its potential to improve clinical care. conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The primary healthcare network system of the region of Stockholm coordinates 66 public primary healthcare centers. Collectively, these centers offer care to an estimated population of 780.000. Since November 2022, a new platform for CDS (clinical decision support) triggers called ALMA has been implemented in these centers. ALMA is connected to patient records and uses CDS triggers to identify medical problems, issue alerts and propose solutions.

Using the ALMA platform, this project has the following objectives:

Objective 1: to develop a CDS trigger connected with the electronic healthcare records specific to the processes of screening, diagnosis, and nephrologist referral of patients with CKD, including individualized CKD management optimization, in primary care.

Objective 2: to evaluate the effectiveness of this CDS trigger (versus current basic advice) through a 2-arm pragmatic cluster RCT. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 780000 type: ESTIMATED name: Clinical decision support trigger measure: Number of participants screened for creatinine and albuminuria measure: Number of screened participants with retesting for creatinine and albuminuria measure: Number of participants with laboratory-determined CKD receiving a clinical diagnosis measure: Number of participants receiving CKD-modifying agents measure: Number of participants referred to nephrologist care sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Karolinska Institutet status: RECRUITING city: Stockholm country: Sweden name: Juan J Carrero, Prof role: CONTACT phone: 0046739636948 email: juan.jesus.carrero@ki.se lat: 59.33258 lon: 18.0649 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-04-01 uploadDate: 2024-04-23T02:35 filename: SAP_000.pdf size: 292236 hasResults: False

 nctId: NCT06386159 id: 2023-1178 briefTitle: Clinical Application of Comprehensive Intervention for PED Based on Neuroregulatory Mechanism overallStatus: RECRUITING date: 2024-03-15 date: 2025-04-30 date: 2025-07-30 date: 2024-04-26 date: 2024-04-26 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: This study aims to establish a practical comprehensive intervention program for dysphagia after extubation in adult ICU patients based on the best evidence of its assessment and intervention, through expert panel discussion and Delphi method. In addition, combining the preliminary experimental results of vagus nerve stimulation applied to PED patients, we further develop a comprehensive intervention program for dysphagia after extubation based on neural regulation mechanism. Finally, the implementation effect of this PED comprehensive intervention program based on neural regulation mechanism will be verified through clinical application. conditions: Post-extubation Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 69 type: ESTIMATED name: Electrical vagus nerve stimulation measure: functional oral intake scale（FOIS） measure: standardized Swallowing Assessment（SSA） measure: Rate of total oral feeding after the intervention measure: Duration of Enteral Nutrition Tube Indwelling measure: Rate of Re-intubation after Endotracheal Intubation measure: Incidence of aspiration within one week after extubation measure: The incidence of aspiration pneumonia within one week after extubation measure: Inflammation-related indicators: serum C-reactive protein (CRP) measure: Inflammation-related indicators: serum interleukin-6 (IL-6) measure: Inflammation-related indicators: serum procalcitonin, acetylcholine (ACh) measure: Inflammation-related indicators: high mobility group box-1 protein (HMGB1) measure: Days of ICU hospitalization measure: Total days of hospitalization measure: In-hospital survival rate sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Feng Xiuqin status: RECRUITING city: Hangzhou zip: 310000 country: China name: Feng Feng, Xiuqin role: CONTACT phone: 13757119151 email: fengxiuqin@zju.edu.cn lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06386146 id: JAB-30355-1001 briefTitle: JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-01 date: 2027-07 date: 2024-04-26 date: 2024-04-26 name: Jacobio Pharmaceuticals Co., Ltd. class: INDUSTRY briefSummary: This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation. conditions: Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 144 type: ESTIMATED name: JAB-30355 name: JAB-30355 measure: Dose limiting toxicity (DLT) measure: Number of participants with adverse events measure: Peak Plasma Concentration (Cmax) measure: Time to reach the observed maximum (peak) concentration (Tmax) measure: Terminal half-life (t1/2) measure: Objective response rate (ORR) measure: Duration of response (DOR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06386133 id: MS Boost briefTitle: Chronic Fatigue in Multiple Sclerosis: MS Copilot Boost Solution Compared to Standard Care acronym: MSBoost overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2025-07-01 date: 2026-04-01 date: 2024-04-26 date: 2024-04-26 name: Ad scientiam class: OTHER name: Assistance Publique - Hôpitaux de Paris briefSummary: The main objective of the MS Boost study is to demonstrate the superiority of MSCopilot Boost over standard practice in reducing the impact of fatigue on Patients with Multiple Sclerosis (MS).

The secondary objectives include validating MSCopilot Boost clinical performance in reducing fatigue and its impact as well as evaluating its functional tests performance and its safety of use. The investigation team will also investigate the effects of MSCopilot Boost on patient symptoms, functional parameters and physical activity levels. The investigation team will evaluate patients and healthcare professionals' perceived clinical benefit as well as adherence, satisfaction and user experience related to the mobile application and the web portal. Ultimately, the investigation team will define the medico-economic and organizational impact of the MSCopilot Boost solution.

Patients' expected benefits are the access to additional clinical tests not routinely performed, covering dimensions not addressed by standard tests like the EDSS for example; a remote monitoring of functional tests similar to those of the modified MSFC with the possibility of adding an evaluation of fatigue through digital questionnaires; improvement of symptoms related to MS fatigue through access to a personalised tele-rehabilitation program.

Healthcare professionals' expected benefits are to track objective measures of key functional symptoms of the disease between consultations, supporting MS patients' management and to gain time by providing a "big picture" of the patient's condition over time. conditions: Multiple Sclerosis conditions: Fatigue Syndrome, Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Boost group: Use of MSCopilot Boost and wear of an actimeter during the whole study participation duration.

Control group: Standard practice and wear of an actimeter during the whole study participation duration. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 208 type: ESTIMATED name: MS Boost name: Standard of care measure: To demonstrate that MSCopilot Boost is superior to standard practice in reducing the impact of fatigue on Patients with Multiple Sclerosis measure: To evaluate the impact of fatigue in both groups. measure: To compare the effect of MSCopilot Boost in reducing fatigue impact compared to standard practice (Short term and Medium term) measure: To compare the fatigue impact between the two groups. measure: To compare the effect of MSCopilot Boost in reducing perceived fatigue compared to standard practice. measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital. measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterparts performed under supervised conditions at the hospital. measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital. measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital. measure: Correlation of MSCopilot Boost functional test performed autonomously at home with its standard counterpart performed under supervised conditions at the hospital. measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital measure: Correlation of the answers of MSCopilot Boost questionnaire performed autonomously with its standard counterpart performed under supervised conditions at the hospital measure: Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home. measure: Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home. measure: Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home. measure: Correlation of the reproductibility of MSCopilot Boost functional test from the hospital to home. measure: To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home. measure: To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home. measure: To evaluate the test-retest reliability of MSCopilot Boost functional test performed at home. measure: To evaluate the test-retest reliability of MSCopilot Boost functional tests performed at home. measure: To evaluate the test-retest reliability of MSCopilot Boost functional tests performed at home. measure: To assess the number of adverse events of using MSCopilot Boost. measure: To compare the effect of MSCopilot Boost on walking compared to standard practice: -Assessed by the functional standard test performed at the hospital -Assessed at home measure: To compare the proportion of patients whose symptoms improved in both groups on Fatigue impact. measure: To compare the proportion of patients whose symptoms improved in both groups on anxiety and depression. measure: To compare the proportion of patients whose symptoms improved in both groups on Depression. measure: To compare the proportion of patients whose symptoms improved in both groups on Fatigue. measure: To compare the proportion of patients whose symptoms improved in both groups on Walking. measure: To compare the proportion of patients whose symptoms improved in both groups on Dexterity. measure: To compare the proportion of patients whose symptoms improved in both groups on Cognition. measure: To compare the proportion of patients whose symptoms improved in both groups on the Low-contrast Vision. measure: To compare the effect of MSCopilot Boost on quality of life compared to standard practice. measure: To compare the effect of MSCopilot Boost on the mean overall physical activity compared to standard practice. measure: To evaluate the satisfaction and user experience of both patients and healthcare professionals regarding MSCopilot Boost. measure: To assess the clinical benefit of MSCopilot Boost reported by patients and healthcare professionals. measure: To assess the organizational impact of MSCopilot Boost as reported by healthcare professionals. measure: To assess user compliance with MSCopilot Boost throughout the follow-up period. measure: To evaluate the link between MSCopilot Boost use compliance and fatigue improvement. measure: To assess the relationship between self-reported and objectively measured physical activity. measure: To explore the factors that might influence the effect of MSCopilot Boost on fatigue and its impact. measure: To assess the changes in sleep patterns and areas of life impacted by fatigue, as measured with MSCopilot Boost at home. measure: To assess the evolution of overall physical activity reported by patients. measure: To explore the correlation between overall physical activity and the change in : -Fatigue impact -Fatigue measure: Calculation of cost-effectiveness in reducing fatigue at 1, 3, 6 and 9 months using MSCopilot Boost as an intervention, compared to standard care. measure: To assess the impact of MSCopilot Boost on work-related factors (duration without working, absenteeism from work, return-to-work time, presenteeism) at 3, 6 and 9 months, compared to baseline (Day 0), in both groups. measure: To evaluate behavioral changes in terms of physical activity and energy management. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06386120 id: 2024-z033 briefTitle: Respiratory Function Monitoring of Mechanical Ventilation in Patients With Chest Blunt Injury overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-07 date: 2024-04-26 date: 2024-04-26 name: Peking University People's Hospital class: OTHER briefSummary: The goal of this observational study is to learn about EIT in observing the application of lung protective ventilation strategies in patients with pulmonary contusion, particularly the impact on pulmonary ventilation blood flow ratio, oxygen, and condition. The main question it aims to answer is:

Can lung protective ventilation strategies improve respiratory function in patients with severe chest contusion? We will collect clinical data of participants who already taking lung protective ventilation strategies as part of their regular medical care. conditions: Lung Contusion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: PEEP setting strategy measure: ventilation blood flow ratio measure: oxygenation index measure: 28-day mortality measure: Mechanical ventilation-free from day 1 to 28 measure: Length of ICU stay measure: Length of hospital stay measure: The rate of successful weaning sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06386107 id: 23PH188 id: 2023-A02175-40 type: OTHER domain: ANSM briefTitle: Thrombin Generation Parameters and Bleeding in Patients Treated With Anticoagulants for Cancer Associated Thrombosis acronym: CATforCAT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-01 date: 2026-08 date: 2024-04-26 date: 2024-04-26 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER name: Diagnostica Stago name: LEO Pharma name: Ligue contre le cancer, France briefSummary: Pulmonary embolism, the second leading cause of death in cancer patients, is effectively treated with anticoagulants. In patients with cancer-associated thrombosis (CAT), the use of anticoagulants is associated with 10 to 15% of bleeding in the first 6 months. Most of the guidelines propose to integrate the bleeding risk in the choice of therapies. Thrombin generation assay (TGA) reflects an overall hemostatic response and could be a useful biomarker. Proven on the thrombotic side in the CAT population, useful in the assessment of the bleeding risk of hemophiliac patients, the TGA is emerging as a tool. The investigators to measure TGA in cancer patients included prospectively, having recently developed a CAT and to evaluate the association between the measurement and the risk of hemorrhagic complication under anticoagulant during the first 6 month of treatment. conditions: Cancer conditions: Pulmonary Embolism conditions: Thrombosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective cohort of consecutive patients initiating full-dose anticoagulant therapy for an episode of CAT, followed up until the 6th month of treatment to assess the risk of clinically relevant adjunctive bleeding events and any other adverse event during anticoagulant therapy (recurrence of CAT, death).

TGT measurement is fully automated and calibrated with quality control. primaryPurpose: OTHER masking: NONE count: 212 type: ESTIMATED name: Thrombin Generation Assay (TGA) measure: The measurement of the area under the curve ( endogenious thrombin potential) nMxmin measure: the measurement of the lag time unit = seconds measure: the measurement of the peak height unit = nm measure: the measurement of the time to peak unit = seconds measure: Effect of adding TGT results on the performance of bleeding risk prediction scores measure: Occurrence of clinically relevant bleeding between m1 and m6, based on the change in TGT measure: Occurrence of an event of interest under treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Clermont-Ferrand city: Clermont-Ferrand zip: 63003 country: France name: Jeannot SCHMIDT, MD PHD role: CONTACT name: Jeannot SCHMIDT, MD PHD role: PRINCIPAL_INVESTIGATOR name: Aurélien LEBRETON, MD PHD role: SUB_INVESTIGATOR name: Fares MOUSTAFA, MD PHD role: SUB_INVESTIGATOR name: Nicolas DUBLANCHET, MD role: SUB_INVESTIGATOR name: Dorian TEISSANDIER, MD role: SUB_INVESTIGATOR lat: 45.77966 lon: 3.08628 facility: CHU de Grenoble city: Grenoble zip: 38043 country: France name: Gilles PERNOD, MD PHD role: CONTACT phone: 04 76 76 57 17 phoneExt: +33 email: gpernod@chu-grenoble.fr name: Gilles PERNOD, MD PHD role: PRINCIPAL_INVESTIGATOR name: Raphaël MARLU, MD PHD role: SUB_INVESTIGATOR lat: 45.16667 lon: 5.71667 facility: HCL city: Lyon country: France name: Yesim DARGAUD, MD PHD role: CONTACT name: Judith CATELLA, MD role: PRINCIPAL_INVESTIGATOR name: Claire GRANGE, MD role: SUB_INVESTIGATOR name: Yesim DARGAUD, MD PHD role: SUB_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: Chu St-Etienne city: Saint-Étienne zip: 42055 country: France name: Géraldine POENOU, MD PHD role: CONTACT email: geraldine.poenou@chu-st-etienne.fr name: Laurent BERTOLETTI, MD PHD role: SUB_INVESTIGATOR name: Xavier DELAVENNE, MD PHD role: SUB_INVESTIGATOR name: Coline LEGENDRE, MD role: SUB_INVESTIGATOR name: Pauline NOYEL, MD role: SUB_INVESTIGATOR name: Brigitte TARDY, MD PHD role: SUB_INVESTIGATOR name: Géraldine POENOU, MD PHD role: PRINCIPAL_INVESTIGATOR lat: 45.43389 lon: 4.39 hasResults: False

 nctId: NCT06386094 id: INT/IEC/2023/SPL-902 briefTitle: Cardiac Dysfunction in Patients With Non-alcoholic Fatty Liver Disease overallStatus: RECRUITING date: 2023-07-15 date: 2025-08-15 date: 2025-11-15 date: 2024-04-26 date: 2024-04-26 name: Post Graduate Institute of Medical Education and Research, Chandigarh class: OTHER briefSummary: Cirrhotic cardiomyopathy is seen as a blunted contractile responsiveness to stress, and/or altered diastolic relaxation with electrophysiological abnormalities, in absence of known cardiac disease. Left ventricular diastolic dysfunction (LVDD) is associated with risk of hepatorenal syndrome (HRS) , septic shock. , heart failure in the perioperative period following liver transplantation, and after trans-jugular intrahepatic portosystemic shunt (TIPS) insertion . The echocardiographic E/e' ratio is a predictor of survival in LVDD, with multiple studies, including prospective data from our Centre. The inability of the heart to cope with stress or sepsis induced circulatory failure is a key concept of the increased mortality risk due to LVDD. In view of the metabolic syndrome and diabetes epidemic and an increasing number of patients being diagnosed with non-alcoholic fatty liver disease, there is increased risk of developing cardiac dysfunction due to multiple comorbidities including coronary artery disease, hypertensive heart disease, cirrhotic cardiomyopathy, which are contributors to overall cardiovascular risk of mortality. conditions: NAFLD conditions: Cardiac Disease conditions: Fatty Liver studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Echocardiographic assessment measure: To determine the prevalence of cardiac dysfunction in patients with non-alcoholic fatty liver disease measure: Presence of myocardial abnormalities in CCM dysfunction measure: Presence of perfusion abnormalities in CCM dysfunction measure: All cause mortality in NAFLD measure: Cardiac event related mortality in NAFLD measure: To determine the severity of cardiac dysfunction in patients with non-alcoholic fatty liver disease sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dr. Madhumita Premkumar status: RECRUITING city: Chandigarh zip: 160012 country: India name: Dr. Madhumita Premkumar, MD role: CONTACT phone: +9101722754777 email: drmadhumitap@gmail.com lat: 30.73629 lon: 76.7884 hasResults: False

 nctId: NCT06386081 id: AC18/00031 briefTitle: Dietary Intervention in Food Allergy acronym: AC18/00031 overallStatus: COMPLETED date: 2021-01-01 date: 2023-01-31 date: 2023-06-30 date: 2024-04-26 date: 2024-04-26 name: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud class: OTHER briefSummary: The goal of this randomized double-blind placebo-controlled clinical study is to determine whether the dietary intervention with pectins leads to food immunomodulation in non-specific lipid transfer proteins (nsLTP) allergic patients. The main question it aims to answer is if the microbiome is a target of intervention against food allergy through the use of prebiotics such as pectins.

Participants will be enrolled to receive a two-month dietary intervention with either two different pectins (citrus or apple pectin) or placebo. Increase in oral tolerance to the peach nsLTP will be measured through a double-blind placebo-controlled food challenge (DBPCFC). Microbiome, proteomic and metabolomic studies will also be performed in blood and stool samples. conditions: Food Allergy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Treatment will be blinded to the participants and research team. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 51 type: ACTUAL name: Citrus pectin with low DE name: Apple pectin with high DE name: Placebo measure: Clinical efficacy of pectin dietary intervention in nsLTP allergic patients measure: Changes in Pru p 3 (nsLTP of peach) specific IgE production induced by pectin intervention measure: Pru p 3-specific maturational changes of dendritics cells induced by pectin intervention measure: Pru p 3-specific proliferative response of different lymphocytes cell subpopulations after pectin intervention measure: Changes in Pru p 3-specific basophil activation induced by pectin intervention measure: Changes induced in the taxonomic diversity of gut microbiota measure: Changes in feaces metabolome induced by pectin dietary intervention measure: Changes in serum metabolome induced by the pectin dietary intervention measure: Epigenomic changes induced by the pectin dietary intervention measure: Pectin safety profile sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Hospital Regional Universitario de Málaga city: Malaga country: Spain lat: 36.72016 lon: -4.42034 hasResults: False

 nctId: NCT06386068 id: 2110041 briefTitle: Interdisciplinary Value-based Cognitive Behavioral Treatment for People With Persistent Whiplash Associated Disorders. acronym: VALIANT overallStatus: RECRUITING date: 2024-01-23 date: 2024-06 date: 2024-06 date: 2024-04-26 date: 2024-04-26 name: University of Southern Denmark class: OTHER briefSummary: The goal of this clinical trial is to address the critical need for effective interventions by developing and testing an interdisciplinary values-based cognitive behavioral therapy (V-CBT) program for individuals with persistent whiplash. The main question it aims to answer are:

* What is the treatment effect of the interdisciplinary values-based cognitive behavioral therapy (V-CBT) program on individuals with persistent whiplash?
* What are the temporal relationships between primary and secondary outcome measures in the context of the V-CBT program?

Participants will undergo a replicated multiple baselines single-case experimental design (SCED). Twelve participants who meet specific eligibility criteria will be block-randomized to a 1, 2, or 3-week baseline phase, serving as their own controls. The intervention involves an interdisciplinary team delivering a manualized adapted V-CBT program over ten sessions, focusing on psychological and physical rehabilitation. Participants will be required to attend these sessions as part of the treatment protocol. Data collection includes daily online self-reports and comprehensive measurements at pre-treatment, post-treatment, and a three-month follow-up. conditions: Whiplash Injuries studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A replicated multiple baselines single-case experimental design with three baseline phases. Baseline randomization into three tiers. primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Values-based Cognitive Behavioral Therapy (V-CBT) measure: Value-based living measure: Pain interference measure: Value-based living measure: Pain interference measure: Pain catastrophizing measure: Positive affect measure: Negative affect measure: Stress measure: Fatigue measure: Pain-related acceptance measure: Pain-related self-efficacy measure: Pain severity measure: Neck Disability measure: Depression measure: Anxiety measure: Stress measure: Health-related quality of life measure: Pain-related acceptance measure: Pain-related self-efficacy measure: Sleep quality measure: Pain severity measure: Self-perceived improvement measure: Satisfaction with treatment measure: Pain Disability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Specialized Hospital for Polio and Accident Victims status: RECRUITING city: Rødovre state: Capital Region Of Denmark zip: 2610 country: Denmark name: Anders O Aaby, PhD role: CONTACT email: aaa@specialhospitalet.dk lat: 55.68062 lon: 12.45373 hasResults: False

 nctId: NCT06386055 id: STUDY00007545 briefTitle: Air Pollution and Physical Activity: A Randomized Controlled Trial acronym: PARC overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2024-10-15 date: 2024-12-01 date: 2024-04-26 date: 2024-04-26 name: State University of New York at Buffalo class: OTHER briefSummary: This is a small pilot intervention trial in which we will collect preliminary data to demonstrate the feasibility of an intervention study. conditions: Physical Inactivity conditions: Pollution; Exposure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 24 type: ESTIMATED name: Active exercise measure: blood pressure measure: Self-report questionnaire sex: ALL minimumAge: 35 Years maximumAge: 55 Years stdAges: ADULT facility: University at Buffalo city: Buffalo state: New York zip: 14214 country: United States lat: 42.88645 lon: -78.87837 hasResults: False

 nctId: NCT06386042 id: MEC-2022-0252 briefTitle: Guideline Implementation and Quality of Care in Patients With Heart Failure: the TITRATE-HF Registry acronym: TITRATE-HF overallStatus: ACTIVE_NOT_RECRUITING date: 2022-06-05 date: 2029-02-14 date: 2029-04 date: 2024-04-26 date: 2024-04-26 name: Erasmus Medical Center class: OTHER name: Netherlands Heart Institute briefSummary: SUMMARY Rationale: Quality of Care registries provide valuable insight in guideline adherence and implementation of guideline recommendations in routine clinical practice.

Objective: The overall aim of the project is to study the titration of guideline directed medical therapy (GDMT) according to the European Society of Cardiology (ESC) HF 2021 guideline recommendations for patients with heart failure (HF) reduced ejection fraction (HFrEF), and mildly reduced ejection fraction (HFmrEF).

Study design: The current study is a prospective multi-center national quality of care registry (longitudinal) of regular HF care (as given).

Study population: The study population consists of patients with heart failure (de novo HF, chronic HF and worsening HF). Study setting is outpatient or inpatient (during admission). Patient sample is set at a minimum of 4000 patients, but can be expanded during the course of the registry project.

Participating sites: all hospitals with dedicated HF outpatient clinic in the Netherlands can participate.

Data: aggregated data

Intervention: none / no

Main study parameters/endpoints: The main parameters of quality of HF care are the adherence to guideline recommendation in terms of percentage (%) drug prescription, percentage (%) target dose (order, speed) and reason not to adhere to the guideline (intolerance, side-effects, maximum tolerated dose). The main endpoints for prognosis are the number of HF related hospitalizations and all-cause mortality during follow-up.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is no risk in participation, no intervention and no active involvement of patients for specific activities in the study. The project is a registration of care as given (standard care) to the participating subject with heart failure. conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 4289 type: ESTIMATED name: no intervention, observational study measure: Prescription level (percentage,%) and target dose (percentage, %) of guideline-directed medical therapy for HF measure: All-cause mortality measure: Hospital admission due to heart failure related event and/or urgent visit with necessity of furosemide iv. measure: Hospital admission due to non heart failure related event sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus MC city: Rotterdam state: Zuid-Holland zip: 3015CE country: Netherlands lat: 51.9225 lon: 4.47917 hasResults: False

 nctId: NCT06386029 id: STUDY24010191 briefTitle: The Power Down Pilot Study: A Novel Bedtime Manipulation Protocol overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-26 date: 2024-04-26 name: University of Pittsburgh class: OTHER briefSummary: The goal of this pilot intervention study is to examine the feasibility and acceptability of a novel bedtime manipulation protocol called "The Power Down" for autistic youth, ages 6-10. The main questions it aims to answer are:

1. Is the Power Down feasible for caregivers to do each night?
2. Do the families find the Power Down an acceptable intervention to address their child's difficulties settling down to fall asleep? conditions: Autism conditions: Sleep Disturbance studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pilot, non-blinded intervention trial primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Power Down bedtime manipulation measure: Recruitment rates of participants through the trial measure: Retention rates of participants through the trial measure: Caregiver reported acceptability measure: Treatment adherence measure: Data collection rates- Questionnaires measure: Data collection rates- Daily diaries measure: Data collection rates- Wearing the actigraphy watch measure: Credibility/Expectancy Questionnaire sex: ALL minimumAge: 6 Years maximumAge: 10 Years stdAges: CHILD facility: University of Pittsburgh city: Pittsburgh state: Pennsylvania zip: 15213 country: United States name: Amy G Hartman, PhD role: CONTACT phone: 614-989-6303 email: agh38@pitt.edu lat: 40.44062 lon: -79.99589 hasResults: False

 nctId: NCT06386016 id: Stethoscope study briefTitle: Detection of Valvular Heart Disease Using Artificial Intelligence-based Stethoscope overallStatus: RECRUITING date: 2024-05-01 date: 2024-08-01 date: 2024-09-01 date: 2024-04-26 date: 2024-04-26 name: Xiao-dong Zhuang class: OTHER briefSummary: The aim of this study is to develop a deep learning-based application of heart sounds in the diagnosis of valvular heart disease, which can be used to screen patients with valvular heart disease and promote earlier clinical monitoring and intervention. conditions: Valvular Heart Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED name: artificial intelligence-based stethoscope measure: valvular heart disease sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital, Sun Yat-Sen University status: RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Xiaodong Zhuang, PhD role: CONTACT phone: +86 13760755035 email: zhuangxd3@mail.sysu.edu.cn lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06386003 id: 23-230 briefTitle: Psilocybin-Assisted Cognitive Processing Therapy for Chronic PTSD overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-03 date: 2025-05 date: 2024-04-26 date: 2024-04-26 name: Unity Health Toronto class: OTHER name: Toronto Metropolitan University name: University of Ottawa briefSummary: This is an open-label trial evaluating feasibility, tolerability, safety and efficacy of psilocybin assisted cognitive processing therapy for chronic Posttraumatic Stress Disorder (PTSD). conditions: Post Traumatic Stress Disorder conditions: PTSD conditions: Chronic PTSD studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Psilocybin measure: Feasibility and tolerability measure: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score measure: Posttraumatic stress disorder Checklist-5 (PCL-5) measure: Patient Health Questionnaire-9 (PHQ-9) measure: Generalized Anxiety Disorder Scale, 7-item (GAD-7) measure: Dissociative Experiences Scale II (DES-II) measure: Pittsburgh Sleep Quality Index (PSQI) measure: World Health Organization Well-Being Index, 5-item (WHO-5) measure: Quality of relationships inventory (QRI) measure: Inventory of psychosocial functioning (IPF) measure: Posttraumatic Maladaptive Beliefs Scale (PMBS) measure: Brief Experiential Avoidance Questionnaire (BEAQ) measure: 24-items Multidimensional Psychological Flexibility Inventory (MPFI-24) measure: Working Alliance Inventory- Short Form (WAI-SF) measure: Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) measure: Self-Compassion Scale-Short Form (SCS-SF) measure: Psychological Insight Questionnaire (PIQ) measure: Emotional Breakthrough Inventory (EBI) measure: Altered States of Consciousness Rating Scale (ASC) measure: Acceptance/Avoidance-Promoting Experiences Questionnaire (APEQ) measure: Effect on digital physiological passive data collected through the use of a wearable device sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St. Michael's Hospital, Unity Health Toronto city: Toronto state: Ontario country: Canada lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06385990 id: 2024ks01 briefTitle: Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy overallStatus: RECRUITING date: 2024-03-29 date: 2025-03-29 date: 2027-03-29 date: 2024-04-26 date: 2024-04-26 name: Hunan Cancer Hospital class: OTHER briefSummary: This trial is a multicenter, single-arm clinical trial to evaluate the efficacy and safety of UTD1 in combination with capecitabine for the adjuvant treatment of TNBC patients who did not achieve pathologic complete remission after neoadjuvant therapy. TNBC patients who did not achieve pathological complete remission or positive lymph node after neoadjuvant chemotherapy received adjuvant treatment with study drug.

Solution: UTD1 30mg / m², once a day on days 1-5; capecitabine: 1000mg / m², days 1-14, oral, twice / day; 21 days a treatment cycle of 6-8 cycles. conditions: Triple Negative Breast Neoplasms studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 53 type: ESTIMATED name: UTD1 measure: 2-year disease-free survival (DFS) measure: Overall Survival (OS) measure: Disease Free Survival (DFS) measure: Invasive Disease free survival (iDFS) measure: Distant Disease-free Survival (DDFS) sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Quchang Ouyang status: RECRUITING city: Changsha state: Hunan zip: 410083 country: China name: Quchang Ouyang role: CONTACT phone: 8673189762161 email: oyqc1969@126.com lat: 28.19874 lon: 112.97087 hasResults: False

 nctId: NCT06385977 id: ShaanxiPPH briefTitle: Risk Factors for Chronic Prostatitis Patients in Northwest China overallStatus: RECRUITING date: 2016-01 date: 2024-05 date: 2024-06 date: 2024-04-26 date: 2024-04-26 name: Shaanxi Provincial People's Hospital class: OTHER briefSummary: The goal of this observational study is to learn about the risk factors of lifestyle, medication and sexual habits in adult chronic prostatitis / chronic pelvic pain syndrome patients. The main questions it aims to answer are:

* Is lifestyle, medication, and sexual habits related to chronic prostatitis / chronic pelvic pain syndrome
* Is there any medication available to protect men from chronic prostatitis / chronic pelvic pain syndrome.

Participants will:

* Independently receive a survey questionnaire on lifestyle, medication, and sexual habits.
* Symptomatic individuals will undergo additional prostate fluid examination for diagnosis.

Researchers will compare healthy adult males to see if there are differences on lifestyle, medication and sexual habits between the two groups. conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED name: lifestyle name: sexual habits name: medication measure: Odds Ratio sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shaanxi Provincial People's Hospital status: RECRUITING city: Xi'an state: Shaanxi zip: 710061 country: China name: Qian Deng, Doctor role: CONTACT phone: 86-029-85251331 phoneExt: 2079 email: dengqian@xiyi.edu.cn lat: 34.25833 lon: 108.92861 hasResults: False

 nctId: NCT06385964 id: SHR-4597-101 briefTitle: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-4597 Inhalation in Healthy Subjects and Asthmatic Patients overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-01 date: 2024-04-26 date: 2024-04-26 name: Guangdong Hengrui Pharmaceutical Co., Ltd class: INDUSTRY briefSummary: The primary objective of this randomized, double-blind, single/multiple ascending dose, placebo-controlled Phase I clinical trial was to evaluate the safety and tolerability of SHR-4597 in healthy subjects and asthmatic patients. The study consists of two parts: Part 1 involves single ascending inhalation dose in healthy subjects; Part 2 involves multiple ascending inhalation dose in asthmatic patients, further divided into Part 2A: multiple ascending inhalation dose in mild to moderate asthmatic patients, and Part 2B: multiple ascending inhalation dose in moderate to severe asthmatic patients. Subsequent lung pharmacokinetic studies of SHR-4597 inhalation will be conducted based on patients' PKPD data. conditions: Healthy Subjects conditions: Asthmatic Patients studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: SHR-4597 name: Placebo measure: Incidence and severity of inhalant adverse events after 4 days of single inhalation of SHR4597 in healthy subjects measure: Incidence and severity of inhalant adverse events after 16 days of multiple inhalation of SHR4597 in asthmatic patients, sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06385951 id: ONZ-2023-0323 briefTitle: Spatial Navigation for the Early Detection of Alzheimer's Disease. acronym: ALLO-task overallStatus: RECRUITING date: 2024-03-05 date: 2028-03-01 date: 2028-10-01 date: 2024-04-26 date: 2024-04-26 name: University Hospital, Ghent class: OTHER briefSummary: Alzheimer's Disease (AD) is the most common form of dementia and may contribute to 60-70 % of all cases. An early, accurate diagnosis of AD will become increasingly important with disease-modifying therapies. Different types of fluid and neuroimaging biomarkers are available for the early detection of AD. However, implementation of routine use of these biomarkers in clinical settings is held back due to the risk of overdiagnosis, increased cost and invasiveness of the assessment method. Therefore, novel biomarkers are needed beyond the amyloid and tau pathologies for the early diagnosis of AD. Neuropsychological paper and pencil tests can detect AD and discriminate between different clinical stages. Since medial temporal lobe structures, including the hippocampus and entorhinal cortex (EC), are involved in spatial navigation and degenerate in the earliest stages of AD, spatial navigation can be considered as an early cognitive biomarker of the disease. Nonetheless, the measurement of spatial navigation needs further improvement since the current paper and pencil tests lack ecological validity. Therefore, the test environment should be set up in immersive Virtual Reality (iVR). Dr. Andrea Castegnaro (Space and Memory Lab of University College of London) developed the Allocentric Spatial Update Task (ALLO task), which is an iVR task measuring egocentric and allocentric spatial abilities.

Therefore, the main objective of this study is to evaluate whether allocentric and egocentric spatial navigation, measured by the ALLO iVR task can be considered a cognitive biomarker for the early detection of AD. In addition, the investigators want to report on the neuronal correlates of both spatial navigation strategies.

Through the Department of Neurology of the University Hospital of Ghent, which has a large cognitive disorders clinic, patients with mild cognitive impairment and mild Alzheimer's dementia will be recruited. Participants will undergo standard clinical assessment, including a neuropsychological examination, Magnetic Resonance Imaging, a 18F-fluorodeoxyglucose PET and a Lumbar Puncture. In addition, participants will also be asked to undergo Tau PET imaging, Amyloid PET imaging and complete the ALLO iVR task. Healthy controls will also be recruited and have to undergo the same investigations, except for the amyloid PET and lumbar puncture. conditions: Mild Cognitive Impairment conditions: Alzheimer Disease conditions: Healthy Aging studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 160 type: ESTIMATED name: Procedure for patients name: Procedure for healthy controls measure: Spatial navigation abilities measure: Medial Temporal Lobe atrophy measure: Amount and spreading of amyloid in the brain measure: Amount and spreading of tau in the brain measure: Decreases in cerebral glucose metabolism in the brain measure: Cognitive functioning measure: amyloidB1-42 / 40 ratio, total tau and phosphorylated tau sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Gent status: RECRUITING city: Ghent state: East-Flanders zip: 9000 country: Belgium name: Tineke Van Vrekhem role: CONTACT phone: 093326483 email: tineke.vanvrekhem@uzgent.be lat: 51.05 lon: 3.71667 hasResults: False

 nctId: NCT06385938 id: 23-012048 briefTitle: Ultrasound Imaging and Quantitative Vibro-Acoustic Assessment of Rickets Under the Age of Ten overallStatus: RECRUITING date: 2024-05 date: 2026-04 date: 2026-04 date: 2024-04-26 date: 2024-04-26 name: Mayo Clinic class: OTHER briefSummary: The goal of this study is to find out if the use of ultrasound pictures of bones can spot changes in the growth areas of children with rickets, a condition that affects how bones harden. Researchers want to see if these ultrasound pictures can help tell the difference between children who have rickets and those who don't. conditions: Rickets studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 45 type: ESTIMATED name: Ultrasound with quantitative vibro-acoustic assessment measure: Relationship of quantitative vibro-acoustic ultrasound and rickets severity score measure: Relationship of ultrasound images with radiographic evidence of rickets measure: Case-control comparison of quantitative vibro-acoustic ultrasound measurements between children with rickets and control subjects measure: Longitudinal changes in vibro-acoustic ultrasound measurements with treatment of rickets sex: ALL maximumAge: 10 Years stdAges: CHILD facility: Mayo Clinic Minnesota status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Mary A Johnson role: CONTACT phone: 507-422-6823 email: johnson.mary15@mayo.edu name: Tom D. Thacher, MD role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06385925 id: TSN1611-2023-101 briefTitle: A Study of TSN1611 Treating Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation overallStatus: RECRUITING date: 2024-04-30 date: 2026-10-30 date: 2027-04-30 date: 2024-04-26 date: 2024-04-26 name: Tyligand Bioscience (Shanghai) Limited class: INDUSTRY briefSummary: The study is a first-in-human (FIH), open-label, multi-center phase 1/2 study of TSN1611 in subjects with KRAS G12D mutant advanced solid tumors. This study will consist of a phase 1 dose escalation part and phase 2 dose expansion part. conditions: Malignant Neoplasm studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: TSN1611 measure: Dose limiting toxicities (DLTs) in phase 1 part measure: Objective response rate (ORR) in phase 2 part measure: Adverse events measure: Area under the plasma concentration-time curve (AUC) measure: Maximum blood concentrations (Cmax) measure: Time to maximum blood concentration (Tmax) measure: Duration of response (DOR) measure: Time to response (TTR) measure: Disease control rate (DCR) measure: Progression free survival (PFS) measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Siqing Fu, MD, PhD role: CONTACT lat: 29.76328 lon: -95.36327 facility: NEXT Oncology status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States name: David Sommerhalder, MD, PhD role: CONTACT lat: 29.42412 lon: -98.49363 facility: NEXT Virginia status: RECRUITING city: Fairfax state: Virginia zip: 22031 country: United States name: Alexander Spira, MD, PhD role: CONTACT lat: 38.84622 lon: -77.30637 hasResults: False

 nctId: NCT06385912 id: 2024-TJ-SLIDS briefTitle: Systematic Lymphadenectomy During Interval Debulking Surgery in Advanced Epithelial Ovarian Cancer overallStatus: COMPLETED date: 2006-07-01 date: 2021-02-10 date: 2021-02-10 date: 2024-04-26 date: 2024-04-26 name: Tongji Hospital class: OTHER briefSummary: The study aims to investigate the prognostic and postoperative complication relevance of lymphadenectomy in advanced epithelial ovarian cancer patients who received neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS). The main question it aims to answer is:

Does systematic lymphadenectomy during interval debulking surgery have a significant impact on survival in patients with advanced epithelial ovarian cancer who have received neoadjuvant chemotherapy?

The progression-free survival (PFS), overall survival (OS), and postoperative complication were compared between the lymphadenectomy and no lymphadenectomy groups to answer the question. conditions: Ovarian Cancer conditions: Postoperative Complications conditions: Neoadjuvant Therapy conditions: Lymph Node Excision studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 1090 type: ACTUAL name: lymphadenectomy measure: Progression free survival (PFS) measure: Overall survival (OS) sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430030 country: China lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06385899 id: : Poorly controlled T2DM-12 briefTitle: Effect of Intensive Monitoring of Patients With Poorly Controlled Type 2 Diabetes With Different Glycemic Background overallStatus: COMPLETED date: 2021-08-01 date: 2023-01-01 date: 2023-03-01 date: 2024-04-26 date: 2024-04-26 name: Goztepe Prof Dr Suleyman Yalcın City Hospital class: OTHER briefSummary: In Turkey, only 55% of patients with type 2 diabetes have been diagnosed, and 91% of these patients have been receiving treatment. The rate of patients reaching the treatment target is 50%. The pandemic has also affected diabetic patients. It is aimed to determine the characteristics of patients with type 2 diabetes (HbA1c \>=10) with poor metabolic control and to evaluate the extent to which metabolic control can be achieved in 12 months. conditions: Type 2 Diabetes conditions: Poor Glycemic Control studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 266 type: ACTUAL measure: Changes in HbA1c levels after 12 months treatment measure: percentage of patients who reached the HbA1c target of equal to or below 7% measure: The effect of education on the HbA1c changes measure: The effect of depression on the HbA1c changes measure: The effect of the level of physical activity on the HbA1c changes measure: The effect of weight loss on the HbA1c changes sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06385886 id: 1R01HL158807-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R01HL158807-01A1 briefTitle: Recruitment and Engagement in Care to Impact Practice Enhancement (RECIPE) for Sickle Cell Disease acronym: RECIPE overallStatus: RECRUITING date: 2023-06-08 date: 2027-10 date: 2027-12 date: 2024-04-26 date: 2024-04-26 name: RTI International class: OTHER briefSummary: The goal of this observational study is to help us understand more about the best ways to help individuals living with Sickle Cell Disease (SCD) get the best care. The main question it aims to answer is: How to find individuals unaffiliated from SCD specialist care use three distinct pathways? Once unaffiliated individuals are found using the pathways, Investigators will employ linkage coordinators (trained staff) to engage these patients in care. Participants will be asked to fill out an assessment survey which will cover areas such as previous and current treatment, clinic and hospital experience, pain, and quality of life. Participants will also be given the option of participation in a 1-hour long interview how they feel about treatment for sickle cell disease including clinic experience, pain, and quality of life? conditions: Sickle Cell Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Linkage Coordinator measure: Identification of unaffiliated patients measure: Affiliation with a Sickle cell disease (SCD)-specific care with SCD specialist measure: Scale Out to Other SCD Centers - Implementation in at least 2 other SCD Center study sites sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama, Birmingham (UAB) status: RECRUITING city: Birmingham state: Alabama zip: 35233 country: United States name: Julie Kanter, MD role: CONTACT phone: 205-934-0435 email: jkanter@uabmc.edu lat: 33.52066 lon: -86.80249 facility: University of California, San Francisco (UCSF) status: RECRUITING city: Oakland state: California zip: 94609 country: United States name: Marsha Treadwell, PhD role: CONTACT phone: 510-428-3356 email: marsha.treadwell@ucsf.edu lat: 37.80437 lon: -122.2708 facility: Augusta University status: RECRUITING city: Augusta state: Georgia zip: 30901 country: United States name: Robert Gibson, PhD role: CONTACT phone: 706-721-1005 email: rogibson@augusta.edu lat: 33.47097 lon: -81.97484 facility: University of Illinois status: RECRUITING city: Chicago state: Illinois zip: 60612 country: United States name: Lewis Hsu, MD, PhD role: CONTACT phone: 312-355-5019 email: lewhsu@uic.edu lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06385873 id: 2024-SR-233 briefTitle: RC48 Combined With Adebrelimab and Apatinib and S-1 of the Neoadjuvant Therapy of Locally Advanced Gastric Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2028-05-01 date: 2024-04-26 date: 2024-04-26 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: This study is a prospective, open-label, phase II clinical trial that aims to enroll patients with locally advanced gastric adenocarcinoma who have not received any prior treatment and are candidates for surgery. The study drugs include RC48, Adebrelimab, Apatinib and S-1. The purpose is to evaluate the effectiveness and safety of the combined coordinated treatment of multi-mechanism drugs for perioperative treatment of locally advanced gastric cancer with HER2 overexpression. conditions: Gastric Cancer/Gastroesophageal Junction Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: RC48 name: Adebrelimab name: Apatinib name: S-1 measure: Pathological Complete Response Rate (pCR) measure: Major Pathological Response rate (MPR) measure: R0 Resection rate measure: Disease-Free Survival (DFS） measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06385860 id: GTMGS0423 briefTitle: Prediction Model for Early Biliary Stasis After Bariatric Surgery acronym: PM-EBS-BS overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2024-09 date: 2025-04 date: 2024-04-26 date: 2024-04-26 name: China-Japan Friendship Hospital class: OTHER briefSummary: Developing and validating a predictive model to estimate the risk of early biliary stasis following bariatric surgery conditions: Obesity conditions: Diabetes conditions: Gallstones conditions: Biliary Stasis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 200 type: ESTIMATED measure: early biliary stasis measure: prediction model sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06385847 id: GOMIMP briefTitle: To Assess The Patient Preference for Goserelin Microsphere Versus Goserelin Implant in Patients With Prostate Cancer overallStatus: RECRUITING date: 2024-05 date: 2025-05 date: 2025-12 date: 2024-04-26 date: 2024-04-26 name: The First Affiliated Hospital of Xiamen University class: OTHER briefSummary: The GOMIMP will be a Prospective, Randomized, Cross-over Trial to Explore the Patient Preference for Goserelin Microsphere (Zoladex®) Versus Goserelin Implant (LY01005) in Patients of Prostate Cancer conditions: Prostate Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Prospective, randomized, open-label, cross-over phase II trial primaryPurpose: OTHER masking: NONE count: 60 type: ESTIMATED name: Zoladex name: LY01005 measure: Patient preference sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Xiamen University status: RECRUITING city: Xiamen state: Fujian zip: 361003 country: China name: Xuegang Wang, doctor role: CONTACT phone: 15960263909 email: stefwxg@163.com lat: 24.47979 lon: 118.08187 hasResults: False

 nctId: NCT06385834 id: LY2014-041-A briefTitle: The Effect of Morning vs Evening Aerobic Exercise Training on Cardiac Remodeling and Function Improvement in Patients After ST Elevation Myocardial Infarction overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2028-04-30 date: 2028-07-30 date: 2024-04-26 date: 2024-04-26 name: RenJi Hospital class: OTHER briefSummary: The aim of the study was to intervene in the Aerobic exercise time of patients with STEMI and to explore the optimal exercise time for STEMI patients conditions: ST-segment Elevation Myocardial Infarction (STEMI) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study was divided into three groups: morning intervention group (8:00-9:00AM), evening intervention group (16:00-17:00AM) and control group primaryPurpose: TREATMENT masking: SINGLE maskingDescription: In this study, outcome measurement personnel and intervention personnel were separated during the whole process of the experiment, outcome measurement personnel did not know the grouping status, intervention personnel and rehabilitation therapists did not participate in the outcome measurement work. whoMasked: OUTCOMES_ASSESSOR count: 201 type: ESTIMATED name: Morning aerobic exercise name: Evening aerobic exercise measure: left ventricle ejection fraction measure: Oxygen consumption measure: Endothelial Function measure: Skeletal muscle and fat mass measure: Cardiac structure measure: One year major Adverse Cardiovascular Events measure: VE/VCO2-SLOPE measure: Flow-mediated dilation measure: glucose measure: Blood lipid measure: N-terminal pro-BNP sex: ALL minimumAge: 17 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06385821 id: GriQv-ch-III-22 briefTitle: A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus overallStatus: COMPLETED date: 2022-09-21 date: 2023-06-15 date: 2023-10-09 date: 2024-04-26 date: 2024-04-26 name: NPO Petrovax class: INDUSTRY briefSummary: The goal of this clinical study is to prove the no less immunogenicity of the Grippol Quadrivalent vaccine compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three identical strains of the compared vaccines in terms of the "proportion of vaccinated with seroconversion in paired sera of the hemagglutination inhibition reaction obtained before and after vaccination". conditions: Influenza conditions: Influenza A conditions: Influenza, Human conditions: Influenza Type B conditions: Flu conditions: Influenza A H3N2 conditions: Influenza A H1N1 conditions: Influenza Epidemic conditions: Flu, Human conditions: Acute Respiratory Infection conditions: Vaccine Reaction studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 824 type: ACTUAL name: Grippol Quadrivalent name: Grippol Plus measure: To prove non-inferior immunogenicity of the Grippol Quadrivalent vaccine when compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three matching strains of the compared vaccines measure: Geometric mean antibody titers measure: Proportion of those vaccinated with seroconversion and geometric mean titer measure: Multiplicity of the increase in the geometric mean titer measure: Seroprotection measure: Incidence of influenza and acute respiratory infections (ARI) measure: The severity and duration of registered cases of influenza and acute respiratory infections (ARI), the presence of complications measure: To assess the reactogenicity of the vaccine Grippol Quadrivalent and the vaccine Grippol plus measure: Frequency and nature of SAEs measure: Frequency and nature of medically attended AEs sex: ALL minimumAge: 6 Months maximumAge: 5 Years stdAges: CHILD facility: State Autonomous Healthcare Institution of the Sverdlovsk Region "Children's City Clinical Hospital No. 11" city: Ekaterinburg zip: 620028 country: Russian Federation lat: 56.8519 lon: 60.6122 facility: Federal State Budgetary Research Institution "Russian research center of surgery named after academician B.V. Petrovsky" city: Moscow zip: 119435 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: State Budgetary Healthcare Institution "Children's City Clinical Hospital No.9 named after G.N. Speransky of Moscow Healthcare Department" city: Moscow zip: 123317 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: State Budgetary Health Institution of the Perm Territory "City Children's Clinical Polyclinic No. 5 city: Perm zip: 614066 country: Russian Federation lat: 58.01046 lon: 56.25017 facility: Limited Liability Company "Clinic USI 4D" city: Pyatigorsk zip: 357502 country: Russian Federation lat: 44.04861 lon: 43.05944 facility: Limited Liability Company Medical technology city: Saint Petersburg zip: 192148 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: St. Petersburg State Budgetary Health Institution "Children's City Polyclinic No. 45 of the Nevsky District" city: Saint Petersburg zip: 193312 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Limited Liability Company " Energiia Zdoroviya" city: Saint Petersburg zip: 194156 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Limited Liability Company PiterClinica city: Saint Petersburg zip: 196158 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Federal State-Financed Institution Pediatric Research and Clinical Center for Infectious Diseases under the Federal Medical Biological Agency city: Saint Petersburg zip: 197022 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: St. Petersburg State Budgetary Healthcare Institution City Polyclinic No.106 Children's Polyclinic Department No. 37 city: Saint Petersburg zip: 198328 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: State Budgetary Healthcare Institution of the Samara region "Samara Regional Children's Clinical Hospital named after N.N. Ivanova" city: Samara zip: 443079 country: Russian Federation lat: 53.20007 lon: 50.15 facility: Limited Liability Company Center DNK-issledovaniy city: Saratov zip: 410005 country: Russian Federation lat: 51.54056 lon: 46.00861 facility: Federal State Budgetary Educational Institution of Higher Education "Tyumen State Medical University" of the Ministry of Healthcare of the Russian Federation city: Tyumen zip: 625023 country: Russian Federation lat: 57.15222 lon: 65.52722 hasResults: False

 nctId: NCT06385808 id: XJTU1AF-CRF-2023-XK014 briefTitle: Efficacy and Safety of MTBF Conditioning Regimen for Salvageable Allo-HSCT in the Treatment of R/R AML overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-31 date: 2026-12-31 date: 2024-04-26 date: 2024-04-26 name: First Affiliated Hospital Xi'an Jiaotong University class: OTHER briefSummary: The primary objective of this study was to evaluate the efficacy of MTBF conditioning regimen of salvageable allo-HSCT in patients with relapsed or refractory acute myeloid leukemia. The secondary purpose of the study was to observe the safety of MTBF regimen in these patients. conditions: Relapse Leukemia conditions: Refractory Acute Myeloid Leukemia conditions: Conditioning conditions: Hematopoietic Stem Cell Transplantation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The relapsed or refractory acute myeloid leukemia patients will pretreated with the MTBF regimen prior to salvageable allogeneic hematopoietic stem cells. The one-year recurrence-free survival after transplantation of these patients and the safty of the MTBF regimen will be studied. primaryPurpose: TREATMENT masking: NONE count: 37 type: ESTIMATED name: MTBF regimen measure: Recurrence rate measure: Incidence and Severity of non-hematological adverse events (NCI CTCAE v5.0) measure: Neutrophil recovery time measure: Platelet recovery time measure: OS measure: PFS measure: aGVHD sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06385795 id: NOE-PMM-201 briefTitle: A Study of NOE-115 in Women With Vasomotor Symptoms Due to Menopause overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-04-30 date: 2025-04-30 date: 2024-04-26 date: 2024-04-26 name: Noema Pharma AG class: INDUSTRY briefSummary: The purpose of this study is to determine the safety, tolerability, and preliminary effectiveness of NOE-115 on moderate to severe vasomotor symptoms (hot flashes) due to menopause in women. conditions: Menopause Syndrome conditions: Menopause conditions: Hot Flashes studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: NOE-115 measure: Withdrawals Due to Adverse Events While on NOE-115 for Any Reason measure: Number of Participants Who Experience at Least One or More Adverse Event and the Severity of the Adverse Events (AEs) measure: Weekly Mean Change in the Severity of Hot Flashes from Baseline to Week 4 measure: Weekly Mean Change in the Frequency (any severity) of Hot Flashes from Baseline to Week 4 measure: Effect of NOE-115 as Assessed by Clinical Global Impression of Severity (CGI-S) from Baseline to Week 4 sex: FEMALE minimumAge: 45 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06385782 id: 20dz1207200 briefTitle: Exploring HRV in Antarctic Overwintering Members of Asia overallStatus: COMPLETED date: 2021-03-01 date: 2022-04-01 date: 2023-09-01 date: 2024-04-26 date: 2024-04-26 name: Ya-Wei Xu class: OTHER briefSummary: Extreme changes in the Antarctic environment can cause emotional and autonomic dysfunction. In this study, volunteers from the Antarctica stations in China provided scale scores and heart rate variability (HRV) data, which were used to assess the autonomic nervous system. Enroll twenty-two members from Zhongshan Station and the Great Wall Station who are overwintering. Using the Generalized Anxiety Disorder (GAD-7) scale, the Patient Health Questionnaire-9 (PHQ-9) scale, and the SF-36 quality of life scale to evaluate the individual's general physical and mental health. Analyze HRV and other associated parameters. conditions: Heart Rate Variability studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 22 type: ACTUAL name: Antarctic environment measure: changes in HRV sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Tenth People's Hospital city: Shanghai state: Shanghai zip: 200079 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06385769 id: PamukkaleU.ftr-NYıldız-3 briefTitle: Transcutaneous Tibial Nerve Stimulation in Patients With Neurogenic Overactive Bladder After Stroke overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2026-01-31 date: 2026-02-28 date: 2024-04-26 date: 2024-04-26 name: Pamukkale University class: OTHER briefSummary: The investigators conducted a prospective, randomized, double-blind, placebo-controlled study based on the placebo technique to evaluate the efficacy of TTNS versus placebo in patients with OAB after stroke.

The main questions aimed to be answered are:

What are the effects of Trans Tibial Nerve Stimulation (TTNS) on incontinence-related clinical parameters and quality of life in patients with overactive bladder (OAB) after stroke compared to the placebo group? Participants (n:22) with post-stroke AAM who meet the exclusion and inclusion criteria will be divided into 2 groups using a randomization table. The first group will receive TTNS (n:11) and the second group will receive placebo TTNS (n:11). Measurements will be performed twice in total, before treatment and at the end of treatment (4th week). conditions: Urinary Bladder, Overactive studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 22 type: ESTIMATED name: Transcutaneous tibial nerve stimulation (TTNS) name: Sham Transcutaneous tibial nerve stimulation (TTNS) measure: Decreased frequency of increased voiding measure: Frequency of voiding measure: The Quality of Life measure: Barthel Index for Activities of Daily Living (ADL) measure: The Overactive Bladder Symptom Score (OABSS) measure: Treatment Satisfaction Level measure: Cystometric value sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pamukkale University city: Denizli country: Turkey lat: 37.77417 lon: 29.0875 hasResults: False

 nctId: NCT06385756 id: TJ-IRB202403020 briefTitle: Effect of Amobarbital Sodium Combined With Low-dose Propofol on Hemodynamics During Induction and Perioperative Adverse Reactions overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-05-01 date: 2024-04-26 date: 2024-04-26 name: Tongji Hospital class: OTHER briefSummary: At present, there are limited data on perioperative efficacy of barbiturates at home and abroad. The purpose of this clinical trial is to observe the effects of amobarbital sodium combined with low-dose propofol on hemodynamics during induction and perioperative adverse reactions in gynecological laparoscopic surgery patients, and to provide a more reasonable, safe and comfortable anesthesia program for female patients who undergoing laparoscopic surgery.

The main questions it aims to answer are:

* whether the combination of the two results on more stable hemodynamics during induction in gynecological laparoscopic surgery patients;
* whether the incidence of perioperative oxidative stress and inflammation and postoperative nausea and vomiting（ponv） improved after the use of the two combinations of anesthesia induction.

Participants will:

* Induction of anesthesia with the experimental drug or placebo；
* 5 ml of venous blood was retained before, after, and 1 day after surgery for follow-up determination of serum associated factor levels；
* To record their vital signs at any point during the anaesthetic process; Serum serological indexes related to oxidative stress and inflammation were determined. The agitation during the recovery period was recorded. The incidence and severity of ponv were recorded at 2h, 2-6h, and 6-24h postoperatively, and the use of palonosetron was also recorded. conditions: Amobarbital Sodium conditions: Hemodynamics Instability studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 96 type: ESTIMATED name: Amobarbital name: Propofol measure: Mean arterial pressure (MAP) during Induction of anesthesia measure: MAP at different time points measure: Incidence of postoperative nausea and vomiting (ponv) sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06385743 id: yeditepe15 briefTitle: The Effectiveness of Neuromuscular Training-Based Exercise Program overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-17 date: 2024-07-14 date: 2024-12-30 date: 2024-04-26 date: 2024-04-26 name: Yeditepe University class: OTHER briefSummary: This randomised controlled study aimed to investigate the effectiveness of a neuromuscular training-based exercise program on pain, function, risk factors specific to shoulder injuries and performance in overhead athletes with shoulder pain.

The main hypothesis is;

H0: There is no difference between the "Thrower's Ten" exercise program and the neuromuscular training-based exercise program applied to overhead athletes with shoulder pain, on pain, function, risk factors specific to shoulder injuries, and performance.

H1: The effects of a neuromuscular training-based exercise program on pain, function, risk factors specific to shoulder injuries and performance in overhead athletes with shoulder pain are superior to the effects of "Thrower's Ten" exercise program conditions: Pain, Shoulder conditions: Sports Physical Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 28 type: ESTIMATED name: Neuromuscular Training-based Exercise Program name: ''Thrower's Ten'' Exercise Program measure: Pain Assessment measure: Disabilities of the Arm, Shoulder and Hand (DASH) measure: Tampa Kinesiophobia Scale measure: Hylyght Injury Prevention and Return to the Sports Screening Program ( measure: Y Balance Test- Upper Quarter measure: Closed Kinetic Chain Extremity Stability Test measure: Single Arm Seated Shot Put Test sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Yeditepe University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06385730 id: SCE2401 briefTitle: Neoadjuvant PD-1 Blockade for Elderly Esophageal Squamous Cell Carcinoma (BLESS) acronym: BLESS overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2027-05 date: 2024-04-26 date: 2024-04-26 name: Shanghai Chest Hospital class: OTHER briefSummary: The investigators will conduct a prospective phase 2 study to evaluate the efficacy and safety of neoadjuvant PD-1 blockade monotherapy with toripalimab in elderly patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC). conditions: Esophageal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: neoadjuvant anti-PD-1 name: neoadjuvant anti-PD-1 with LDRT measure: MPR rate measure: pCR rate measure: Adverse events and treatment-related adverse events measure: R0 resection rate measure: Objective Response rate measure: Event-free survival (EFS) measure: Overall survival (OS) measure: Correlation between potential biomarkers and tumor response sex: ALL minimumAge: 76 Years stdAges: OLDER_ADULT facility: Shanghai Chest Hospital city: Shanghai state: Shanghai zip: 200030 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06385717 id: ZhejiangU briefTitle: Multicenter Cohort Study of ESD and Chemo-radiotherapy for High-risk Early-stage Esophageal Cancer acronym: ESCORT overallStatus: RECRUITING date: 2024-05-01 date: 2026-01-31 date: 2029-01-31 date: 2024-04-26 date: 2024-04-26 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: This multicenter, prospective observational cohort study has the potential to optimize individualized chemoradiotherapy regimen for early-stage esophageal cancer patients who have received endoscopic submucosal dissection. conditions: Esophagus Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: chemo-radiation measure: Incidence of toxic events measure: 3-year overall survival measure: 3-year local-regional recurrence free survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Zhejiang University School of Medicine status: RECRUITING city: Hangzhou state: Zhejiang zip: 310000 country: China name: Jing Xu, MD role: CONTACT phone: 0086-0571-87783521 email: jing_xu@zju.edu.cn lat: 30.29365 lon: 120.16142 facility: The Second Affiliated Hospital of Zhejiang University, School of Medicine status: NOT_YET_RECRUITING city: Hangzhou country: China name: Jing Xu role: CONTACT phone: 0086-0571-87783521 email: jing_xu@zju.edu.cn lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06385704 id: DMRIBFGM0420 briefTitle: Research on Changes in Intestinal Barrier Function and Gut Microbiome in Patients With Type 2 Diabetes After Duodenal Mucosal Resurfacing (DMR) acronym: DMR-IBF-GM overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-12-01 date: 2024-04-26 date: 2024-04-26 name: Wang Siqi class: OTHER name: China-Japan Friendship Hospital briefSummary: The aim of this study is to demonstrate the effects of duodenal mucosal resurfacing (DMR) on intestinal barrier function and gut microbiota when treating uncontrolled type 2 diabetes. Subjects who underwent DMR and those who did not were enrolled, and potential differences were identified by analyzing urine and fecal samples through microbiomic analysis and High Performance Liquid Chromatography（HPLC）, combined with changes in clinical data. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 100 type: ESTIMATED name: DMR Procedure measure: Microbiome Analysis measure: High Performance Liquid Chromatography sex: ALL minimumAge: 25 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06385691 id: ET22-145 briefTitle: Study Evaluating the Efficacy of the myDIET Software Tool in the Nutritional Management of Patients With Localized and Resectable Gastric or Esogastric Junction Cancer. acronym: MyDIET overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2026-06-30 date: 2026-08-31 date: 2024-04-26 date: 2024-04-26 name: Centre Leon Berard class: OTHER briefSummary: This is a prospective, single-center, single-arm Phase II study evaluating the efficacy of the myDIET software tool in the nutritional management of patients with localized and resectable esogastric junction cancer. conditions: Gastric Cancer conditions: Oesogastric Junction Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a prospective, single-center, single-arm Phase II study. primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: myDIET software tool measure: Proportion of patients starting adjuvant chemotherapy within 2 months measure: Adherence to the tool measure: Number of supportive care and emergency consultations initiated by the caregiver measure: Proportion of patients with malnutrition measure: Evolution of body composition in L3 section (volumes) measure: Evolution of body composition in L3 section (indexes) measure: Evolution of resting energy expenditure measure: Proportion of patient covering theoretical nutritional requirement >= 30kcal/kg/day measure: Comparison between theoretical nutritional requirement and measurement of basal metabolic rate using indirect calorimetry measure: Weight changes measure: Brachial circumference changes measure: Triceps skin fold changes measure: Initiation time for post-operative chemotherapy measure: Proportion of patient with incomplete scheme of pre operative chemotherapy measure: Proportion of patient with incomplete scheme of post operative chemotherapy measure: Proportion of patients with severe post operative complication measure: Tolerance to perioperative chemotherapy measure: Changes in food intake measure: Changes in SEFI (Easy Food Intake Score) measure: Measurement of quality of life measure: Average lengh of hospital stay measure: Recurrence free survival (RFS) measure: Overall survival (OS) measure: Adherence to the physical activity program measure: Physical activity levels measure: Assessment of muscular function by the 6-min walk test measure: Assessment of muscular function by muscular strength sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Léon Berard city: Lyon zip: 69008 country: France name: Pamela Funk-Debleds, MD role: CONTACT phone: 0469856020 phoneExt: +33 email: pamela.funk-debleds@lyon.unicancer.fr name: Clélia Coutzac, MD role: CONTACT phone: 0469856020 phoneExt: +33 email: clelia.coutzac@lyon.unicancer.fr lat: 45.74848 lon: 4.84669 hasResults: False

 nctId: NCT06385678 id: HRS-4642-201 briefTitle: A Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-10 date: 2026-08 date: 2024-04-26 date: 2024-04-26 name: Jiangsu HengRui Medicine Co., Ltd. class: INDUSTRY briefSummary: The study is being conducted to evaluate the safety, tolerability, and efficacy of HRS-4642 in combination with antitumor medicine in patients with advanced solid tumors harboring KRAS G12D mutation. conditions: Advanced KRAS G12D Mutant Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: HRS-4642 name: Adebrelimab name: SHR-A1921 name: Pemetrexed Disodium for Injection、Cisplatin Injection、Carboplatin for Injection measure: Phase IB: Safety endpoints: adverse events (AEs). measure: Phase IB： Maximum tolerated dose (MTD) measure: Phase IB：Recommended phase 2 dose (RP2D) measure: Phase II: Overall response rate (ORR). measure: Efficacy endpoints: Overall response rate (ORR). measure: Efficacy endpoints: Duration of response (DoR). measure: Efficacy endpoints: Disease control rate (DCR). measure: Efficacy endpoints: Progression free survival (PFS). measure: Efficacy endpoints: overall survival (OS). sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai East Hospital city: Shanghai state: Shanghai zip: 200120 country: China name: Caicun Zhou, Doctor role: CONTACT phone: 13301825532 email: caicunzhoudr@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06385665 id: Xin Peng briefTitle: The Effect of Appropriate Family Companionship on the Physical and Mental Health of Patients With Advanced Breast Cancer overallStatus: RECRUITING date: 2024-04-22 date: 2024-04-22 date: 2024-12-31 date: 2024-04-26 date: 2024-04-26 name: Xin Peng class: OTHER briefSummary: The goal of this clinical trial is to learn about companionship needs in breast cancer patients who are pathologically or cytologically diagnosed as cancer, are alive with the tumor, and have TNM clinical stage IV. The main questions it aims to answer are:

1. Patients with advanced breast cancer need family companionship
2. Analyze and study the reasons and factors that affect the physical and mental impact of effective family companionship on patients with advanced breast cancer Participants will be divided into a companion group and a non-accompaniment group. Patients in the companion group are given graded companion intervention methods. A comparison group: Researchers will compare a non-accompaniment group to see if the physical and mental impact of companionship on patients. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 304 type: ESTIMATED name: Graded companionship measure: Change from Baseline meatal state on GAD-7 at Week 48. measure: Change from Baseline physical state on kps at Week 48. sex: FEMALE minimumAge: 21 Years maximumAge: 72 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology status: RECRUITING city: Wuhan zip: 430022 country: China name: Peng Xin, postgraduate role: CONTACT lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06385652 id: PekingUFH-MM-NB381 briefTitle: PET Imaging Study of 68Ga-NB381 in Multiple Myeloma overallStatus: RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2026-12-31 date: 2024-04-26 date: 2024-04-26 name: Peking University First Hospital class: OTHER briefSummary: Multiple myeloma (MM) predominantly affects the elderly, often presenting insidiously and with a rising incidence rate. Current diagnostic methods primarily rely on invasive bone marrow biopsies, which can lead to false-negative results if the biopsy site is improperly chosen. CD38 is significantly overexpressed on the surface of malignant plasma cells in MM, making it a characteristic tumor biomarker for this disease.

Addressing the limitations in specificity and sensitivity of traditional PET imaging agents, this project is dedicated to developing a new type of nanobody PET/CT imaging probe, 68Ga-NB381, which possesses high affinity and targets CD38. This probe, which is an intellectual property of our institution, aims to enhance the accuracy and specificity of early MM diagnosis. In terms of clinical evaluation, the project will implement a comprehensive assessment process including case selection, collection of baseline information, high-precision imaging, expert-level image interpretation, and follow-up studies, comparing directly with traditional 18F-FDG imaging to thoroughly verify the specificity and safety of 68Ga-NB381. This lays the groundwork for the clinical translation of this radiopharmaceutical in China. Furthermore, the project contributes to formulating more effective precision treatment plans based on CD38 expression levels and provides evidence for monitoring the therapeutic effects of daratumumab, a drug also targeting CD38. This makes the project of significant academic value and clinical importance, thus promoting the development of personalized treatment strategies. conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: In this sequential assignment clinical trial, we aim to evaluate and compare the diagnostic performance of two PET imaging agents, 68Ga-NB381 and 18F-FDG, in patients diagnosed with multiple myeloma (MM). The study will enroll MM patients who meet the inclusion criteria and are scheduled for routine diagnostic imaging.

Each participant will undergo PET imaging with 18F-FDG first, followed by a second PET scan using 68Ga-NB381 (or reversed). To minimize potential interference between the two imaging sessions and ensure patient safety, a minimum interval of one day will be maintained between the two scans, with all imaging completed within one week. This sequential imaging approach allows for direct comparison of the imaging agents in the same patient, thus controlling for inter-patient variability and providing a more accurate assessment of the relative merits of each imaging agent in the same metabolic and pathological condition. primaryPurpose: DIAGNOSTIC masking: NONE maskingDescription: All PET/CT images are jointly interpreted by at least two imaging and nuclear medicine physicians, each with several years of diagnostic experience and at least at the attending physician level. They compare and record the number of lesions detected and the SUVs (Standard Uptake Values) for both 18F-FDG and 68Ga-NB381 PET/CT scans. After consultation, they provide a unified diagnostic opinion. count: 30 type: ESTIMATED name: 68Ga-NB381 measure: Specificity and Binding Efficiency of 68Ga-NB381 in CD38 Positive Tumors sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University First Hospital status: RECRUITING city: Beijing state: Beijing zip: 100000 country: China name: Ronghui Yu, Master role: CONTACT phone: +8613466379791 email: kyc@bjmu.edu.cn name: Lei Kang, MD role: PRINCIPAL_INVESTIGATOR name: TIANYAO Wang, PhD role: PRINCIPAL_INVESTIGATOR name: Yongkang Qiu, Master role: SUB_INVESTIGATOR name: Zhenghao Tong, MD role: SUB_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06385639 id: WK2024005 briefTitle: Efficacy and Safety of Probiotic Products for Digestive Health overallStatus: RECRUITING date: 2024-04-25 date: 2024-05-25 date: 2024-06-25 date: 2024-04-26 date: 2024-04-26 name: Wecare Probiotics Co., Ltd. class: INDUSTRY briefSummary: The objective of this study is to evaluate the efficacy and safety of the probiotic product as an everyday gut health product in supporting digestive environment and homeostasis of gut microbiota. conditions: Healthy Adult studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Probiotic measure: Intestinal health sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Danang@Equilab-Int.Com status: RECRUITING city: Jakarta state: Pusat zip: 10430 country: Indonesia name: Danang A. Yunaidi, MD role: CONTACT phone: 217515932 phoneExt: +62 email: danang@equilab-int.com lat: -6.21462 lon: 106.84513 hasResults: False

 nctId: NCT06385626 id: UREC: 23_15-Raspberry Leaf Tea briefTitle: The Effects of Raspberry Leaf Tea on Blood Glucose Control acronym: RLT overallStatus: RECRUITING date: 2023-12-18 date: 2024-12-23 date: 2024-12-23 date: 2024-04-26 date: 2024-04-26 name: University of Reading class: OTHER briefSummary: The aim of the present clinical trial is to assess how raspberry leaf polyphenols impact on postprandial glucose and insulin levels in healthy individuals consuming sucrose.

The questions the project will address:

* Do raspberry leaf polyphenols lower sucrose-induced increases in plasma glucose in humans?
* Do these polyphenols mediate these effects by inhibiting digestion of sucrose or the absorption of glucose.

  20 healthy adults will be recruited between the ages of 18-65 years who are non-smokers and not taking certain types of medication (e.g., drugs from a GP for high blood pressure, high blood fats, inflammatory conditions, and depression) or dietary supplements (e.g., cholesterol-lowering spreads, fish oil, probiotics, prebiotics, and natural laxatives), antibiotics in the last three months or if they used any drugs or supplements that could affect their blood glucose or lipid metabolism. No abnormal results for liver function tests, renal function tests, and lipid profile tests. If they have food allergies or consume more than 14 units of alcohol per week (i.e., to help they calculate a alcohol intake, one standard glass of wine (175 ml) or one pint of regular lager is equivalent to just over two units of alcohol), frequently travel for work or are participating in another intervention study, they will not be able to participate. Women who are pregnant or lactating or planning a pregnancy in the next six months will also not be able to take part, not use herbal medicines for at least the previous three months, not be on a weight loss program six months before screening, not involved in clinical trials six months before the screening, and not having severe cardiac, hepatic, or renal function impairment. Not Sufferers of chronic illnesses, not Individuals with food allergies, not people with coeliac disease.

They will be asked to attend a four-study visit after an eight-hour overnight fast. Volunteers will be asked to consume 50 g of carbohydrate powder (sucrose and glucose) with or without 10 g of raspberry leaf tea, which will be dissolved in 300 mL of warm water during four visits (every month). Blood samples will be taken at intervals for a period of two hours after the consumption of raspberry leaf or control. Blood glucose and insulin levels will be tested 15 minutes before, at 15,30,60,90, and 120 minutes after carbohydrate intake. conditions: Type II Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Volunteers will be asked to consume 50 g of carbohydrate powder (sucrose and glucose) with or without 10 g of raspberry leaf tea, which will be dissolved in 300 mL of warm water during four visits (every month). primaryPurpose: PREVENTION masking: NONE count: 20 type: ESTIMATED name: Raspberry leaf tea measure: Blood Glucose sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hugh Sinclair Unit of Human Nutrition, University of Reading status: RECRUITING city: Reading state: Berkshire zip: RG6 5SG country: United Kingdom lat: 51.45625 lon: -0.97113 hasResults: False

 nctId: NCT06385613 id: TDK-2024-13377 briefTitle: The Effect of Mobile-Based Education on Self-Care, Quality of Life and Complications in Patients With Intestinal Stoma overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2025-04-22 date: 2025-08-22 date: 2024-04-26 date: 2024-04-26 name: Ataturk University class: OTHER briefSummary: Stomas are most commonly used in the gastrointestinal tract as ileostomy or colostomy. Although colorectal cancers are the most important factor causing intestinal stoma opening, intestinal ostomies are also used in cases such as congenital anomalies, obstructive or inflammatory bowel diseases, traumas requiring surgery, large defects caused by colorectal injuries as well as sigmoid colon volvulus and ischemic colitis. In stoma surgery performed to increase the duration and quality of life of individuals, the patient's compliance with the stoma and awareness of possible complications are important. Conditions such as peristomal skin problems, noisy bowel movements, stool leakage and pain make it difficult to adapt to the stoma.In addition, despite all the advances in stoma care products and surgical techniques, individuals are faced with stoma complications. Therefore, individuals with stoma should be closely monitored for complications. Inappropriately selected stoma site or bag/adapter system, lack of knowledge and skills related to stoma care can be listed among the possible causes of complications. Complications such as edema, bleeding, ischemia and mucocutaneous separation may develop in the first days after stoma surgery. In studies evaluating patients in terms of stoma compliance and complications in the literature, it has been observed that mobile-based trainings given to patients increase their stoma compliance and reduce the incidence of complications. With the mobile-based training planned to be used in the study, it is thought to contribute to the ability of individuals to perform stoma care independently. With the decrease in peristomal skin lesions and stoma complications, it is predicted that the quality of life of patients with stoma will increase, self-care competence will be formed, and health expenditures and therefore national health expenditures will decrease. It is thought that this mobile training application will not only provide support to patients with stoma but also guide healthcare professionals. It will also contribute to closing the shortage of stoma and wound care nurses in hospitals. conditions: Intestinal Stoma Site Hemorrhage conditions: Intestinal Stoma Leakage conditions: Life Style, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Groups will be divided into control and intervention. People in the group will be randomly assigned in a simple randomized manner. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Individuals assigned to controls and interventions will not know which group they are in. whoMasked: PARTICIPANT count: 62 type: ESTIMATED name: Mobile-based stoma care education group measure: Adaptation of Quality Life Scale measure: Ostomy Self-Care Index measure: Pittman Ostomy Complication Severity Index measure: Peristomal Skin Tool measure: Ostomy Adjustment Inventory-23 measure: Computer System Usability Questionnaire sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ataturk University Faculty of Nursing city: Erzurum country: Turkey name: Nilgün Söylemez, PhD Student role: CONTACT phone: +905439790424 email: nilguntatar@munzur.edu.tr lat: 39.90861 lon: 41.27694 hasResults: False

 nctId: NCT06385600 id: severe preeclampsia briefTitle: Intravenous Labetalol vs Phentolamine for the Management of Severe Preeclampsia. overallStatus: NOT_YET_RECRUITING date: 2024-05-20 date: 2026-01-20 date: 2026-03-20 date: 2024-04-26 date: 2024-04-26 name: Assiut University class: OTHER briefSummary: The only effective treatment of severe preeclampsia is delivery of the fetus but immediate antihypertensive treatment is given to stabilize the patient and prevent further complications. All antihypertensive medication can potentially cross the placenta. At this time, there are no randomized control trials to base a recommendation for the use of one antihypertensive agent over another. However, certain medications are effective in lowering blood pressure with an acceptable safety profile in pregnancy. The choice of therapy depends on the acuity and severity of hypertension conditions: Severe Pre-eclampsia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 200 type: ESTIMATED name: Labetalol name: Phentolamine measure: the effect of Labetalol and Phentolamine on MCA flow velocity by transcranial Doppler monitoring. measure: The effect of labetalol and phentolamine on blood pressure of the patients sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06385587 id: ADH-OL-Study-01-23 briefTitle: Technology-based Symptom Monitoring Intervention for Locally Advanced Head and Neck Cancer Patients acronym: SYMTECH01 overallStatus: NOT_YET_RECRUITING date: 2024-05-03 date: 2024-12-29 date: 2025-09-27 date: 2024-04-26 date: 2024-04-29 name: Aptar Digital Health class: INDUSTRY briefSummary: The goal of this observational study is to assess the satisfaction and usability of an interactive and patient-centered mobile application (app), Oleena™, designed to assist head and neck cancer patients undergoing chemoradiation in managing common and distressing symptoms in real-time, as well as to assess the satisfaction and usability of the related HCP web portal. Additional secondary usage and clinical endpoints that would be used to assess intervention efficacy in future trials will be collected. conditions: Head and Neck Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Oleena measure: Users' satisfaction measure: Feasibility of the technology enabled symptom management solution measure: Usability of the technology enabled symptom management solution measure: Appropriateness of the recommendations measure: Semi-structured exit interviews measure: Symptom burden will be measured using the NIH PRO-CTCAE measurement system, which includes validated scales for individual toxicities measure: Quality of life will be measured using the previously validated FACT-G scale measure: Treatment adherence measure: Health-economic outcome measure: Complaints, alleged deficiencies or malfunctions of the device reported sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06385574 id: 2023-088 briefTitle: Technological Based Rehabilitation on Individuals With Rheumatic Disease overallStatus: RECRUITING date: 2024-03-15 date: 2024-05-15 date: 2024-05-20 date: 2024-04-26 date: 2024-04-26 name: Akdeniz University class: OTHER briefSummary: Affects such as pain, swelling, tenderness, deformities, limitations, strength and function losses, skill and coordination deficiencies in the hand joints, which are frequently seen in rheumatism patients with hand involvement, are included in body structure and function disorders within the framework of International Classification of Function System. Leap Motion Controller is used in hand rehabilitation because it is small in size, low-cost, portable, non-contact, easy to use and provides visual and auditory feedback. The aim of our study is to examine the effect of technology-based rehabilitation on joint range of motion, grip strength, functionality and disease activity in adult individuals with rheumatic disease with hand involvement; and also to compare these effects with the effects of the hand rehabilitation program implemented under the guidance of a physiotherapist and the control group that continues its routine life. conditions: Rheumatic Diseases conditions: Hand Rheumatism conditions: Virtual Reality Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There are three groups in the study. First group is leap motion interventional group, second group is hand exercises group and the third group is waiting list. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Investigator and outcome assessors do not know which patient is in which group. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Virtual reality therapy measure: Hand grip strength measurement measure: Jebsen Hand Function Test (JHFT) measure: Nine Hole Peg Test (NHPT) measure: Duruoz Hand Index (DHI) measure: Michigan Hand Outcome questionnaire (MHQ) measure: Disease Activity Score 28 (DAS 28) measure: Hand fine grip strength measurement sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: Sebahat Yaprak Cetin status: RECRUITING city: Antalya state: Konyaaltı zip: 07100 country: Turkey name: Sebahat Yaprak Cetin, PhD role: CONTACT email: fzt.ycetin@gmail.com lat: 36.90812 lon: 30.69556 hasResults: False

 nctId: NCT06385561 id: Tramadol_OIBD id: 2022-500108-23-00 type: CTIS briefTitle: The Influence of Tramadol on Opioid-induced Bowel Dysfunction overallStatus: COMPLETED date: 2022-08-11 date: 2023-05-15 date: 2023-05-15 date: 2024-04-26 date: 2024-04-26 name: Asbjørn Mohr Drewes class: OTHER briefSummary: Tramadol is a weak opioid and widely used to treat moderate to severe pain. Stronger opioids are known to inhibit gastrointestinal motility and secretion, however the effects of tramadol on gastrointestinal function remains less understood. The aim of this study was to determine to what degree tramadol causes opioid-induced bowel dysfunction by using an objective design to explore gastrointestinal transit, motility pattern, secretion, and colonic volume, in a group of healthy male volunteers. conditions: Opioid-Induced Bowel Dysfunction conditions: Constipation studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ACTUAL name: Tramadol name: Placebo 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: Gastric half emptying time measure: Gastric contraction assessment measure: Gastric contraction assessment measure: Small bowel motility assessment measure: Small bowel water content sex: MALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Aalborg University Hospital city: Aalborg zip: 9000 country: Denmark lat: 57.048 lon: 9.9187 hasResults: False

 nctId: NCT06385548 id: VHIO21001 briefTitle: Efficacy and Safety Study of Lurbinectedin and Dostarlimab in Cancer Patients: Protocol VHIO21001 - LiDer acronym: LiDer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-04 date: 2026-04 date: 2024-04-26 date: 2024-04-26 name: Vall d'Hebron Institute of Oncology class: OTHER briefSummary: Background:

Endometrial cancer is a prevalent gynecological malignancy, with a significant number of cases diagnosed at an advanced stage or recurring following initial treatment. Platinum-based chemotherapy represents a standard treatment option for these patients; however, disease progression often occurs, highlighting the need for novel therapeutic approaches. Lurbinectedin, a synthetic analog of marine alkaloid-derived compounds, and dostarlimab, a monoclonal antibody targeting PD-1, have demonstrated promising antitumor activity in various malignancies. This phase I-II clinical trial seeks to evaluate the safety, tolerability, and efficacy of combining lurbinectedin and dostarlimab in patients with advanced or recurrent endometrial cancer who have experienced disease progression following platinum-based chemotherapy.

Primary Objectives:

To determine the maximum tolerated dose (MTD) and recommended dose for further investigation of lurbinectedin and dostarlimab in combination therapy for advanced or recurrent endometrial cancer.

To assess the antitumor activity of lurbinectedin and dostarlimab combination therapy, measured by objective response rate (ORR), in patients with advanced or recurrent endometrial cancer.

Secondary Objectives:

To evaluate the safety and tolerability of lurbinectedin and dostarlimab combination therapy in patients with advanced or recurrent endometrial cancer.

To characterize the pharmacokinetic profile of lurbinectedin and dostarlimab when administered in combination therapy.

To explore pharmacogenomic biomarkers predictive of response and/or resistance to lurbinectedin and dostarlimab combination therapy in patients with advanced or recurrent endometrial cancer.

To assess progression-free survival (PFS), duration of response (DOR), clinical benefit rate (CBR), and overall survival (OS) in patients receiving lurbinectedin and dostarlimab combination therapy for advanced or recurrent endometrial cancer.

To investigate the impact of lurbinectedin and dostarlimab combination therapy on quality of life and symptom control in patients with advanced or recurrent endometrial cancer. conditions: Endometrial Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Lurbinectedin name: Dostarlimab measure: Maximum Tolerated Dose (MTD) and Recommended Dose (RD) Determination measure: Evaluation of Lurbinectedin and Dostarlimab Combination Therapy in Advanced/Recurrent Cervical Cancer Patients measure: Safety Evaluation of Lurbinectedin in combination with Dostarlimab measure: Evaluate the progression-free survival (PFS) measure: Pharmacokinetic (PK) and Pharmacogenomic Evaluation measure: Overall Response Rate (ORR) measure: Evaluate the Duration of Response (DOR) measure: Evaluate the Clinical Benefit Rate (CBR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06385535 id: IRB_00171031 briefTitle: Clinical Characteristics and Temporal Properties of Individual Tics in Persistent Tic Disorder acronym: PTD overallStatus: RECRUITING date: 2024-04-04 date: 2024-12 date: 2024-12 date: 2024-04-26 date: 2024-04-26 name: University of Utah class: OTHER briefSummary: The goal of this clinical study is to learn more about the timing of tics (sudden, fast movements and sounds that people do and make without meaning to) in people who have multiple tics that have been going on for more than one year. The main questions it aims to answer are:

1. See whether a tic's timing is related to other characteristics of the tic, like how long it has been happening and how well the person can control/stop that tic
2. See whether the timing of a tic can tell us how well the person can control/stop that tic
3. See whether tic treatment changes the timing of tics, and if the timing of a tic has anything to do with how well treatment will work to stop it

Participants will meet with a study researcher to learn more about the study, ask questions, and decide whether or not they would like to be involved. If they decide to do the study, they will meet with the researcher 6 times:

1. During the first visit, the study researcher will ask questions about the participant's life, tics, and other psychological symptoms. The researcher will watch the participant's tics for 10 minutes. The participant will do a computer task where they follow instructions to tic or not tic.
2. During the second visit, the study researcher will treat one of the participant's tics.
3. During the third visit, the study researcher will treat another one of the participant's tics.
4. During the fourth visit, the study researcher will treat another one of the participant's tics.
5. During the fifth visit, the study researcher will treat another one of the participant's tics.
6. During the sixth visit, the study researcher will ask questions about the participant's tics and other psychological symptoms. The participant will do a computer task where they follow instructions to tic or not tic. conditions: Tics conditions: Tic Disorders conditions: Vocal Tic conditions: Motor Tic conditions: Tourette Syndrome conditions: Tourette Syndrome in Children conditions: Tourette Syndrome in Adolescence conditions: Tics/Tremor studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Clinical trial with a single arm (i.e., participants are not assigned to groups). primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: The Principal Investigator and Outcomes Assessors will be blinded to the fractal properties of participants' tics until all study procedures have been completed. count: 12 type: ESTIMATED name: Habit Reversal Training (HRT) measure: Estimates of baseline individual and total tic fractality within free-to-tic (FTT) and differential reinforcement of other behavior (DRO) environmental contingencies measure: Voluntary tic suppression success at baseline measure: Total tic severity at baseline as measured by the Yale Global Tic Severity Scale (YGTSS) measure: Total and individual tic severity at baseline as measured by the Parent Tic Questionnaire (PTQ) measure: Changes in voluntary individual and total tic suppression success pre- and post-intervention measure: Changes in individual and total tic fractality within free-to-tic (FTT) and differential reinforcement of other behavior (DRO) environmental contingencies pre- and post-intervention measure: Changes in individual and total tic severity pre- and post-intervention as measured by the Yale Global Tic Severity Scale (YGTSS) and Parent Tic Questionnaire (PTQ) measure: Individual and total premonitory urge severity at baseline as measured by the Individualized Premonitory Urge for Tics Scale (I-PUTS) measure: Individual and total premonitory urge severity post-intervention as measured by the Individualized Premonitory Urge for Tics Scale (I-PUTS) measure: Changes in individual and total premonitory urge severity pre- and post-intervention as measured by the Individualized Premonitory Urge for Tics Scale (I-PUTS) measure: Total tic severity post-intervention as measured by the Yale Global Tic Severity Scale (YGTSS) measure: Individual and total tic severity post-intervention as measured by the Parent Tic Questionnaire (PTQ) measure: Voluntary tic suppression success post-intervention measure: Estimates of individual and total tic fractality within free-to-tic (FTT) and differential reinforcement of other behavior (DRO) environmental contingencies post-intervention sex: ALL minimumAge: 8 Years maximumAge: 12 Years stdAges: CHILD facility: University of Utah status: RECRUITING city: Salt Lake City state: Utah zip: 84112 country: United States name: Kirsten Bootes, MS role: CONTACT phone: 801-585-7114 email: kirsten.bootes@psych.utah.edu name: Kirsten Bootes, MS role: CONTACT email: theticlab@utah.edu lat: 40.76078 lon: -111.89105 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-11 uploadDate: 2024-01-30T18:49 filename: ICF_000.pdf size: 244576 hasResults: False

 nctId: NCT06385522 id: BITR2101-C-01 briefTitle: A Clinical Trial in Adults With Non-Hodgkin Lymphoma (NHL), With a Particular Emphasis on Cutaneous T Cell Lymphoma (CTCL), Testing the Safety and Activity of a Novel Drug to Inhibit a Protein Called Tumor Necrosis Factor Receptor 2 That Drives Both Lymphoma Growth and Escape of the Immune System overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2027-02 date: 2027-02 date: 2024-04-26 date: 2024-04-26 name: Boston Immune Technologies and Therapeutics class: INDUSTRY briefSummary: The goal of this trial is to learn if a new drug, BITR2101, works to treat non-Hodgkin lymphoma (NHL) in adults, with CTCL patients being sought in particular. The trial also seeks to learn about the safety of this drug. This drug is a protein called an antibody. The drug prevents a molecule called a receptor, named TNFR2, from being made. TNFR2 regulates the immune system and provides important signals to lymphoma cells to grow, make more of themselves and survive. When the drug prevents TNFR2 from being produced in lymphoma cells from CTCL patients, those cells died in the laboratory. Therefore, the trial seeks to enroll CTCL patients in particular, in addition to other subtypes of NHL. When the drug prevents the receptor from being made in certain immune cells, there is increased immune activity. Thus, the trial will test if this drug is a new immune therapy that helps the immune system to keep lymphoma under control. In particular, we want to find out if the amount of lymphoma in the body decreases while taking the drug. Patients with autoimmune diseases are not permitted because of this potential increase in immunity brought on by this drug. Patients should have NHL that has been previously treated, that is getting worse on their current therapy, and their doctors think a new treatment is needed. All patients will receive BITR2101 by a 3 hour infusion into a vein, periodically, initially every 3 weeks. There is no placebo in this trial. Visits to the clinic facility will be required, initially at least every week and later less frequently. Patients will be expected to report changes in their health to the clinic staff including new findings and any change in the status of their lymphoma they may be aware of. Patients can continue to receive BITR2101 for up to a year or until their lymphoma worsens. For patients who are clearly benefiting, they may be able to receive BITR2101 for another year. conditions: NHL conditions: Cutaneous T Cell Lymphoma conditions: Peripheral T-cell Lymphoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 37 type: ESTIMATED name: BITR2101 measure: to assess the safety and tolerability of BITR2101 administered intravenously every 3 weeks in order to determine the MTD, if any, and to inform the RDE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06385509 id: TOL-CLAR-20024 briefTitle: A Phase 4 Study to Evaluate Adrenal Function in Hypogonadal Men Treated With JATENZO® for 12 Months overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-10 date: 2026-02 date: 2024-04-26 date: 2024-04-26 name: Tolmar Inc. class: INDUSTRY name: ICON plc briefSummary: TOL-CLAR-20024 is a Phase 4, multi-center, open-label safety study evaluating the potential effect of JATENZO on adrenal function in hypogonadal men treated with JATENZO for 12 months. conditions: Hypogonadism studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 110 type: ESTIMATED name: Jatenzo measure: CST Test measure: Adrenal Insufficiency measure: Estrogen changes measure: Follicle Stimulating Hormone (FSH) changes. measure: Luteinizing hormone (LH) changes measure: Sperm analysis measure: Sperm analysis measure: Sperm analysis measure: Testis volume analysis sex: MALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06385496 id: NCI-2024-01145 id: NCI-2024-01145 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: EAY131-L id: EAY131-L type: OTHER domain: ECOG-ACRIN Cancer Research Group id: EAY131-L type: OTHER domain: CTEP id: U10CA180820 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180820 briefTitle: Testing MLN0128 (TAK-228) as Potentially Targeted Treatment in Cancers With mTOR Genetic Changes (MATCH - Subprotocol L) overallStatus: ACTIVE_NOT_RECRUITING date: 2017-03-12 date: 2024-12-31 date: 2024-12-31 date: 2024-04-26 date: 2024-04-26 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase II MATCH treatment trial tests how well MLN0128 (TAK-228) works in treating patients with cancer that has certain genetic changes called mTOR mutations. MLN0128 (TAK-228) may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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: Computed Tomography name: Magnetic Resonance Imaging name: Sapanisertib measure: Objective response rate (ORR) measure: Overall survival (OS) measure: 6-month progression free survival (PFS) 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: NCT06385483 id: NCI-2024-01125 id: NCI-2024-01125 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: EAY131-A type: OTHER domain: ECOG-ACRIN Cancer Research Group id: EAY131-A type: OTHER domain: CTEP id: U10CA180820 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180820 briefTitle: Testing Afatinib as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH - Subprotocol A) overallStatus: ACTIVE_NOT_RECRUITING date: 2015-08-11 date: 2024-12-06 date: 2024-12-06 date: 2024-04-26 date: 2024-04-26 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase II MATCH treatment trial tests how well afatinib works in treating patients with cancer that has certain genetic changes. Afatinib is in a class of medications called kinase inhibitors. It is used in patients whose cancer has a certain mutation (change) in the EGFR gene. It works by blocking the action of mutated EGFR that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells. 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: Afatinib name: Biopsy name: Biospecimen Collection name: Computed Tomography name: Echocardiography name: Magnetic Resonance Imaging name: Radionuclide Imaging measure: Objective response rate (ORR) measure: Overall survival (OS) measure: 6-month progression free survival (PFS) 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: NCT06385470 id: HSEARS20231112001 briefTitle: Treatment of Cantonese Speakers With Childhood Apraxia of Speech overallStatus: RECRUITING date: 2024-04-15 date: 2024-08-01 date: 2025-02-01 date: 2024-04-26 date: 2024-04-26 name: The Hong Kong Polytechnic University class: OTHER name: University of Vermont name: The University of Hong Kong briefSummary: The proposed study aims to investigate the efficacy of the Dynamic Temporal and Tactile Cueing treatment in Cantonese-English bilingual speakers with childhood apraxia of speech. conditions: Childhood Apraxia of Speech studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 4 type: ESTIMATED name: Dynamic Temporal and Tactile Cueing treatment measure: Phonemes accuracy measure: Stress accuracy measure: Tone accuracy sex: ALL minimumAge: 3 Years maximumAge: 11 Years stdAges: CHILD facility: The Hong Kong Polytechnic University status: RECRUITING city: Kowloon country: Hong Kong name: Min Ney Wong, PhD role: CONTACT phone: +852 2766 7268 email: min.wong@polyu.edu.hk lat: 22.31667 lon: 114.18333 hasResults: False

 nctId: NCT06385457 id: 24-2933 briefTitle: The Effects of Mindhelper on Young People's Well-being, Psychological Functioning, and Intentions to Help-seeking overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2025-01-31 date: 2025-01-31 date: 2024-04-26 date: 2024-04-26 name: University of Southern Denmark class: OTHER name: TrygFonden, Denmark name: Danske Regioner name: Jascha Fonden name: Centre for Digital Psychiatry, Mental Health Services in the Region of Southern Denmark briefSummary: In this study the investigators will evaluate the effectiveness of Mindhelper.dk, which is the most comprehensive online youth mental health promotion service in Denmark.

A minimum of 9,426 young people aged 15 to 25 will be recruited through social media and invited to participate in the study. When responding to the baseline questionnaire participants will be randomized to either the intervention or control group. The intervention group will receive information about Mindhelper.dk and inspiration on how to use Mindhelper through text-messages during the study period. The control group does not receive information about Mindhelper.dk, until after completion of the last follow-up questionnaire.

Three follow-up questionnaires will then be sent to the participants 2 weeks, 6 weeks and 12 weeks after randomization.

The investigators expect a small, positive effect on participants well-being and psychological functioning in intervention groups as compared to the control group. conditions: Mental Health Issue conditions: Well-Being conditions: Adolescents conditions: Young Adults conditions: Online Intervention conditions: Internet-Based Intervention conditions: Randomized Controlled Trial studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study.

Young people will be recruited through social medias. When responding to the baseline questionnaire participants will be randomized to either the intervention or control group.

The intervention group will receive information about Mindhelper.dk and inspiration on how to use Mindhelper through text-messages during the study period. The control group does not receive information about Mindhelper.dk, until after completion of the last follow-up questionnaire.

Three follow-up questionnaires will then be sent to the participants 2 weeks, 6 weeks and 12 weeks after randomization. primaryPurpose: OTHER masking: SINGLE maskingDescription: The participants are partly masked. The control group will be masked; however, the intervention group will not be masked.

There is no care provider nor outcome assessor as all measures are self-reported and collected through online questionnaires.

Analyses of data and interpretation of results will be done masked. whoMasked: INVESTIGATOR count: 9426 type: ESTIMATED name: Mindhelper- A national youth mental health promotion website measure: General well-being measure by "The Well-Being Index WHO-5" (WHO5) measure: Psychological functioning, measure by "The Short Warwick-Edinburgh Mental Well-Being Scale" (SWEMWBS). measure: Intentions to help-seeking measure: Body Appreciation measured by the "2-items Short forms of the Body Appreciation Scale-2" (2-item BAS-2SF). sex: ALL minimumAge: 15 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: National Institute of Public Health (NIPH), University of Southern Denmark city: Copenhagen state: Copenhagen K zip: 1455 country: Denmark name: Sofie H Hoffmann role: CONTACT phone: 65 50 77 34 phoneExt: +45 email: sohh@sdu.dk name: Lau C Thygesen role: CONTACT phone: 65 50 77 71 phoneExt: +45 email: lct@sdu.dk lat: 55.67594 lon: 12.56553 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-04-22 uploadDate: 2024-04-22T08:21 filename: SAP_000.pdf size: 353976 hasResults: False

 nctId: NCT06385444 id: 2024-HS-020 briefTitle: IVF Failure and Pregnancy Loss on Couples' Psychological Stress overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-06-01 date: 2024-04-26 date: 2024-04-26 name: The First Hospital of Jilin University class: OTHER briefSummary: The goal of this observational study is to learn about The purpose of this study was to compare the psychological differences between couples after IVF transplant failure and IVF pregnancy loss, including the differences in anxiety, depression, stress and post-traumatic stress between women and their spouses. The main question it aims to answer is:

What are the psychological effects of IVF implantation failure and IVF pregnancy loss on women and the psychological differences between couples? Participants already taking IVF as part of their regular medical care will answer online survey questions about their joint pain for 1 years. conditions: Fertilization in Vitro conditions: Pregnancy Loss conditions: Psychological Stress conditions: Post-traumatic Stress studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED measure: As the number of failed IVF implants increases, does it increase the difference in anxiety and depression between couples? measure: As the number of failed IVF implants increases, does it increase the difference in fertility stress between couples? measure: Does pregnancy loss after IVF transplantation have a differential effect on anxiety and depression between couples? measure: Does pregnancy loss after IVF transplantation have a differential effect on post-traumatic stress responses between couples? sex: ALL minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT facility: the first hospital of Jilin University city: Chang chun state: Jilin zip: 130000 country: China name: Qi Xi, doctorate role: CONTACT phone: 15804303801 email: xiqi@jlu.edu.cn lat: 42.74694 lon: 126.24667 hasResults: False

 nctId: NCT06385431 id: Charm briefTitle: Obeservational Cohort for Evaluating Future Cardiovascular Disease With High Metabolic Risks acronym: Charm overallStatus: NOT_YET_RECRUITING date: 2024-04-28 date: 2026-04-30 date: 2026-04-30 date: 2024-04-26 date: 2024-04-26 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: Cardiovascular and metabolic diseases refer to a large category of cardiovascular diseases accompanied by a series of metabolic disorders (including dyslipidemia, obesity, abnormal glucose tolerance, diabetes, hypertension, thyroid dysfunction, etc.), which is the primary cause of death and disease burden of Chinese residents.The number of deaths from atherosclerotic cardiovascular disease (ASCVD) in China is about 2.4 million, accounting for 61% of the total cardiovascular deaths, accounting for more than 40% of the all-cause deaths. In Chinese patients with coronary heart disease, 52.9% are complicated with diabetes.Despite the 1.1 million coronary stents implanted in China, there has been no reduction in cardiovascular mortality, which highlights the importance of threshold advancement and the management of metabolic risk factors.

In recent years, the new concept of cardiovascular and metabolic diseases has been actively promoted at home and abroad, and the focus of prevention and treatment strategy of cardiovascular and metabolic diseases has been called for.The project proposed the concept of co-treatment of metabolic diseases based on disorders of blood pressure regulation, disorders of glucose metabolism and disorders of lipid metabolism. Subjects eligible for cardiovascular and metabolic diseases were screened, their past medical records were registered, education and diagnosis and treatment management were conducted. conditions: Metabolic Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 8000 type: ESTIMATED name: observational study measure: incidence rate of cardiovascular and metabolic diseases measure: treatment rate of cardiovascular and metabolic diseases measure: control rate of cardiovascular and metabolic diseases. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06385418 id: WST-CRC-202404 briefTitle: Fluorouracil Treatment Via Colon for Colorectal Cancer overallStatus: RECRUITING date: 2024-05-01 date: 2028-05-01 date: 2029-05-01 date: 2024-04-26 date: 2024-04-26 name: The Second Hospital of Nanjing Medical University class: OTHER briefSummary: Fluorouracil (5-FU) is a commonly used drug for colorectal cancer (CRC). Thermosensitive hydrogel presents a promising carrier for 5-FU to address challenges encountered with traditional administration methods. We propose an integrated approach utilizing colonic transendoscopic enteral tubing to cover the entire colon flexibly, coupled with a thermo-sensitive gel to enhance the adhesion of 5-FU. This clinical trial aims to assess the feasibility, safety, and efficacy of this approach for treating CRC. conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Colonic local administration of fluorouracil with enhanced adhesion measure: Objective response rate (according to RECIST1.1, investigator assessment) measure: Progression-free survival measure: Overall survival measure: Disease control rate (according to RECIST1.1, investigator assessment) measure: Drop period to ensure operation resection measure: Converted resection rate measure: Actual R0 resection rate measure: The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu zip: 210011 country: China name: Faming Zhang, MD, PhD role: CONTACT lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06385405 id: 2024y0423 briefTitle: Electroencephalography-based Precise Repetitive Transcranial Magnetic Stimulation Treatment overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-05 date: 2024-04-26 date: 2024-04-26 name: Shanghai Mental Health Center class: OTHER name: National Natural Science Foundation of China name: Shanghai Municipal Science and Technology Commission name: Shanghai Jiao Tong University School of Medicine briefSummary: This study will focus on the hypothesis that repetitive transcranial magnetic stimulation (TMS) based on EEG personalized modulation may be more effective in promoting symptomatic relief of major depressive disorder (MDD), and will rely on the platform of neuroimaging and function brain imaging of Shanghai Mental Health Center (SMHC), an authoritative institution in the field of mental health. We will eventually facilitate optimization of physical therapy for major depressive disorder (MDD). conditions: Major Depressive Disorder (MDD) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: To test the hypothesis that repetitive transcranial magnetic stimulation based on individualized EEG modulation may be more effective in promoting symptomatic relief of major depressive disorder (MDD), patients were tested in a parallel controlled trial.During the treatment period, patients will be randomly grouped into the precision group, which will be treated with rTMS based on personalized modulation of EEG data, and the conventional group, which will be treated with TMS at a frequency of 10 Hz to stimulate the left dorsolateral prefrontal cortex (DLPFC). primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Individualized alpha frequency Transcranial Magnetic Stimulation (αTMS) Treatment name: 10Hz-frequency TMS treatment over the left dorsolateral prefrontal cortex (DLPFC) measure: the effective rate measure: complete remission rate measure: alpha band spectral connectivity in electroencephalogram (EEG) parameters measure: Evaluation of therapeutic effect sex: ALL minimumAge: 16 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Mental Health Center city: Shanghai state: Shanghai zip: 200030 country: China name: TianHong Zhang, Doctor role: CONTACT phone: 13127577024 email: zhang_tianhong@126.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06385392 id: A23-354 briefTitle: Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-26 date: 2024-04-26 name: HealthPartners Institute class: OTHER briefSummary: The proposed system (haptic module and insole device) for daily in-community use that detects the occurrence of freezing of gait (FOG) in people with Parkinson's disease (PD). and triggers external cueing stimuli to unfreeze the individual. The purpose of the overall Phase II study is to: (1) Develop a production ready system, (2) Develop a companion mobile app for the proposed system and refine previously developed FOG detection algorithms, and (3) Validate the proper operation of the system and demonstrate its efficacy through lab and in-community testing. This study will focus on validating the system and demonstrating efficacy through in-community testing. conditions: Parkinson Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 36 type: ESTIMATED name: Haptic module and insole device measure: To validate the haptic module and insole device system and evaluate its efficacy with an in-community clinical trial. sex: ALL minimumAge: 45 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Struthers Parkinson's Center city: Golden Valley state: Minnesota zip: 55427 country: United States name: Research Coordinator role: CONTACT phone: 651-495-6363 email: ClinicalTrials@HealthPartners.com lat: 45.00969 lon: -93.34912 facility: HealthPartners Neuroscience Center city: Saint Paul state: Minnesota zip: 55130 country: United States name: Clinical Trial Coordinator role: CONTACT phone: 651-495-6363 email: ClinicalTrials@HealthPartners.com lat: 44.94441 lon: -93.09327 hasResults: False

 nctId: NCT06385379 id: WQ21-2301 briefTitle: Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study) overallStatus: RECRUITING date: 2024-04-30 date: 2025-12-31 date: 2030-12-31 date: 2024-04-26 date: 2024-04-26 name: Hangzhou Endonom Medtech Co., Ltd. class: INDUSTRY briefSummary: A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/pseudo aortic arch aneurysms and ulcers involving aortic arch . (GENIUS Study) conditions: Aortic Arch Aneurysm studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: WeFlow-Tribranch embedded aortic Triple-branch arch Stent Graft system measure: Rate of all-cause mortality and major stroke within 12 months after surgery measure: Rate of immediate technical success following surgery measure: Rate of aortic aneurysm progression under control measure: Incidence of Type I or Type III endoleak measure: Incidence of aortic covered stent graft displacement measure: Postoperative branch vessel patency rate measure: Rate of conversion to thoracotomy or secondary intervention measure: Rate of major adverse events measure: Rate of aortic aneurysm-related mortality measure: Incidence of severe adverse events measure: Incidence of device-related adverse events sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Anzhen Hospital, Capital Medical University status: RECRUITING city: Beijing country: China name: Zhong Chen role: CONTACT lat: 39.9075 lon: 116.39723 facility: Chinese PLA Gencral Hosptial status: RECRUITING city: Beijing country: China name: Wei Guo role: CONTACT phone: 13910758706 lat: 39.9075 lon: 116.39723 facility: The First Hospital of Jilin University status: RECRUITING city: Changchun country: China name: Yongsheng Gao role: CONTACT lat: 43.88 lon: 125.32278 facility: Xiangya Hospital of Central South University status: RECRUITING city: Changsha country: China name: Wei Wang role: CONTACT lat: 28.19874 lon: 112.97087 facility: West China Hospital of Sichuan University status: RECRUITING city: Chengdu country: China name: Jia Hu role: CONTACT lat: 30.66667 lon: 104.06667 facility: Guangdong Provincial Hospital of Traditional Chinese Medicine status: RECRUITING city: Guangzhou country: China name: Xiaoping Fan role: CONTACT lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital ,Sun Yat-sen University status: RECRUITING city: Guangzhou country: China name: Guangqi Chang role: CONTACT lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital of Harbin Medical University status: RECRUITING city: Harbin country: China name: Baodong Xie role: CONTACT lat: 45.75 lon: 126.65 facility: Shandong Provincial Hospital status: RECRUITING city: Jinan country: China name: Xuejun Wu role: CONTACT lat: 36.66833 lon: 116.99722 facility: The First People's Hospital of Yunnan Province status: RECRUITING city: Kunming country: China name: Kunmei Gong role: CONTACT lat: 25.03889 lon: 102.71833 facility: The Second Affiliated Hospital Of Nanchang University status: RECRUITING city: Nanchang country: China name: Weimin Zhou role: CONTACT lat: 28.68396 lon: 115.85306 facility: Nanjing First Hospital status: RECRUITING city: Nanjing country: China name: Xin Chen role: CONTACT lat: 32.06167 lon: 118.77778 facility: The First Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing country: China name: Yongfeng Shao role: CONTACT lat: 32.06167 lon: 118.77778 facility: The Affiliated Hospital Of Qingdao University status: RECRUITING city: Qingdao country: China name: Mingjin Guo role: CONTACT lat: 36.06488 lon: 120.38042 facility: Shanghai Chest Hospital status: RECRUITING city: Shanghai country: China name: Dan Zhu role: CONTACT lat: 31.22222 lon: 121.45806 facility: Zhongshan Hospital, Fudan University status: RECRUITING city: Shanghai country: China name: Weiguo Fu role: CONTACT lat: 31.22222 lon: 121.45806 facility: The First Affiliated Hospital of China Medical University status: RECRUITING city: Shenyang country: China name: Shijie Xin role: CONTACT lat: 41.79222 lon: 123.43278 facility: Xiamen Cardiovascular Hospital status: RECRUITING city: Xiamen country: China name: Xijie Wu role: CONTACT lat: 24.47979 lon: 118.08187 facility: The First Affiliated Hospital of PLA Air Force Military Medical University status: RECRUITING city: Xian country: China name: Jian Zuo role: CONTACT lat: 34.25833 lon: 108.92861 facility: First Affiliated Hospital of Zhengzhou University status: RECRUITING city: Zhengzhou country: China name: Zhen Li role: CONTACT lat: 34.75778 lon: 113.64861 hasResults: False

 nctId: NCT06385366 id: GS_NP1 briefTitle: Developing & Evaluating Models for Early Predicting Obstetrical Diseases in Pregnant Women by Non-invasive Prenatal Test overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-05-06 date: 2025-06-06 date: 2024-04-26 date: 2024-04-26 name: Gene Solutions class: INDUSTRY name: Medical Genetics Institute (MGI) briefSummary: This is Observational study, aiming to investigate the potentiality of cffDNA and cfRNA by a non-invasive test, in combination with clinical characteristics, to establish models for early screening and predicting high-risk pregnancy of PE, SPB, and GDM in Vietnam. conditions: Pregnant With Complication conditions: Preeclampsia conditions: Preterm Birth conditions: Gestational Diabetes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1105 type: ESTIMATED measure: Characteristics of pregnant women at 1st trimester (9-13 weeks 6 days of gestation) measure: Characteristics of pregnant women at recruitment measure: Define the significant differences between cases and controls measure: The development of learning machine models measure: Evaluation of the developed models sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06385353 id: 2022-CHITS-003 id: 2023-A02652-43 type: OTHER domain: ID-RCB number briefTitle: DVT Burden and the Risk of Post-thrombotic Syndrome acronym: DVT-Burden overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-06 date: 2024-04-26 date: 2024-04-26 name: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer class: OTHER name: Assistance Publique Hopitaux De Marseille name: F-CRIN INNOVTE Research Network briefSummary: Post-thrombotic syndrome (PTS) is the most common chronic complication of deep vein thrombosis (DVT), with major consequences for patient quality of life and cost of management. Identifying patients at high risk of developing PTS could be useful for its prevention and may lead to more appropriate therapeutic strategies to reduce its incidence and severity.

Prognostic tools for predicting risk are very useful for choosing the optimum treatment and improving patient management and are a preliminary step before developing predictive models useful for determining sensitivity to treatment. At present, although several prognostic markers and models have been proposed, it is still difficult to predict who will develop a PTS or a moderate to severe PTS. The development of PTS is multifactorial and depends largely on the extent and severity of venous obstruction which supports the theory of thrombosis burden (DVT-Burden) as a potential prognostic marker for PTS. It therefore seems important to study the association between thrombosis burden and the occurrence of PTS.

The Venous Volumetric Index or VVI (Ouriel 1999) will be used for quantifying DVT-Burden. The VVI was constructed by calculating the volume from the diameter and length of 14 venous segments from the calf veins to the inferior vena cava. The VVI has been validated for its ability to discriminate between symptomatic and asymptomatic DVT and has shown superior performance to other methods for quantifying DVT.

This study aim to assess the performance of baseline DVT-burden estimated by the VVI score on ultrasound for predicting the occurrence and the severity of PTS as assessed by the Villalta scale at 6 months. conditions: Postthrombotic Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 400 type: ESTIMATED name: Quantification of deep vein thrombosis burden and assessment of post-thrombotic syndrome measure: Presence of moderate to severe Post-thrombotic Syndrome (PTS) measure: Thrombosis burden measure: Presence of moderate to severe PTS adjusted to other prognostic factors at baseline measure: Thrombosis burden adjusted to other prognostic factors at baseline measure: Presence of moderate to severe PTS adjusted to other prognostic factors at baseline and during follow-up measure: Thrombosis burden adjusted to other prognostic factors at baseline and during follow-up measure: Time to complete resolution of the thrombus as a function of thrombosis burden at baseline measure: Presence of moderate to severe PTS at baseline and at follow-up visits measure: Thrombosis burden at baseline and at follow-up visits measure: Disease specific health related quality of life measure: General health related quality of life measure: Coagulation and fibrinolysis markers measure: Fibrinolytic and pro-coagulant activities of microvesicles/microparticles sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier de Carcassonne city: Carcassonne state: Aude zip: 11010 country: France name: Géraldine PAOLI-CAZANAVE role: CONTACT email: geraldine.paoli-cazanave@ch-carcassonne.fr lat: 43.21667 lon: 2.35 facility: Cabinet libéral city: Martigues state: Bouches-du-Rhône zip: 13500 country: France name: Damien DIAS role: CONTACT email: dam.dias@free.fr lat: 43.40735 lon: 5.05526 facility: Cabinet libéral city: Ajaccio state: Corse-du-sud zip: 20090 country: France name: Jean-François SECONDI role: CONTACT email: dr.jf.secondi@gmail.com lat: 41.91888 lon: 8.73811 facility: Cabinet libéral city: Ajaccio state: Corse-du-sud zip: 20090 country: France name: Céline DE MARI role: CONTACT email: dr.celine.demari@gmail.com lat: 41.91888 lon: 8.73811 facility: Centre Hospitalier Universitaire de Brest city: Brest state: Finistère zip: 29069 country: France name: Benjamin ESPINASSE role: CONTACT email: Benjamin.espinasse@chu-brest.fr lat: 48.3903 lon: -4.48628 facility: Clinique Rive Gauche city: Toulouse state: Haut-Garonne zip: 31076 country: France lat: 43.60426 lon: 1.44367 facility: Hospices Civils de Lyon, Hôpital Edouard Herriot city: Lyon state: Rhône zip: 69003 country: France name: Judith CATELLA role: CONTACT email: judith.catella@chu-lyon.fr lat: 45.74848 lon: 4.84669 facility: Centre Hospitalier Universitaire Amiens Picardie city: Amiens state: Somme zip: 830054 country: France name: Simon SOUDET role: CONTACT email: Soudet.simon@chu-amiens.fr lat: 49.9 lon: 2.3 facility: Centre Hospitalier de Fréjus/Saint-Raphaël city: Fréjus state: Var zip: 83600 country: France name: Hatem BOUGHIDA role: CONTACT email: hatemboughida@yahoo.fr lat: 43.43286 lon: 6.73524 facility: Polyclinique Les Fleurs city: Ollioules state: Var zip: 83190 country: France name: Anaïs CORNE role: CONTACT email: anaiscorne@gmail.com lat: 43.13517 lon: 5.848 facility: Centre cardio-vasculaire Esterel city: Saint-Raphaël state: Var zip: 83700 country: France lat: 43.42332 lon: 6.7735 facility: Cabinet libéral city: Sanary-sur-Mer state: Var zip: 83110 country: France name: Colin RICHARD role: CONTACT email: colin.richard29@gmail.com lat: 43.11783 lon: 5.80007 facility: Cabinet libéral city: Six-Fours-les-Plages state: Var zip: 83140 country: France name: Sophia BENSEDRINE role: CONTACT email: sophia.ange@wanadoo.fr lat: 43.1 lon: 5.85 facility: Centre Hospitalier Intercommunal Toulon La Seyne-sur-Mer city: Toulon state: Var zip: 830054 country: France name: Jean-Noël POGGI role: CONTACT email: jeannoel.poggi@ch-toulon.fr lat: 43.12442 lon: 5.92836 facility: Centre Hospitalier d'Avignon city: Avignon state: Vaucluse zip: 84000 country: France name: Olivier GRAS role: CONTACT email: GRAS.Olivier@ch-avignon.fr lat: 43.94834 lon: 4.80892 hasResults: False

 nctId: NCT06385340 id: CentroDerm_LRP22003 briefTitle: Investigation of the Effect of Lipikar Baume AP+M overallStatus: NOT_YET_RECRUITING date: 2024-04-23 date: 2024-09-30 date: 2024-10-31 date: 2024-04-26 date: 2024-04-26 name: CentroDerm GmbH class: NETWORK briefSummary: Application of Lipikar Baume AP+M at least twice daily for 4 weeks on one of the two arms according to a randomization scheme The purpose of this study is to observe the skin barrier function, transepidermal water loss and microbial changes in study participants with actinic field damage of both arms.

It's a randomized, evaluator blinded, intra-individual controlled study conducted in one center in Germany, in adult subjects having AK (grade I to III) lesions on the forearms and back of hands and meeting specific inclusion/exclusion criteria.

A total of 20 subjects will be enrolled.

The study design consists in 4-week evaluation period, with 2 visits per subject: Screening/Baseline (Day 0, Day 28 (end of Lipikar Baume AP+M application)). conditions: Actinic Keratoses studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: It's a randomized, evaluator blinded, intra-individual controlled study conducted in one center in Germany, in adult subjects having AK (grade I to III) lesions on the forearms and back of hands and meeting specific inclusion/exclusion criteria. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: Lipikar Baume AP+M measure: Skin hydration measured by Corneometrie measure: Transepidermal water loss measured by Tewameter® measure: Aktinic keratosis area and severity index (AKASI) measure: S. aureus colonization and S. epidermidis colonization (application area) measure: Subjects's skin aspect measure: Absolute lesion count by application site measure: Olsen Grade evaluation: percentage of lesion with improvement at least 1 grade at D28 by application site measure: Number of new lesions on application area over the study period by application site measure: Symptom severity score: percentage across individual scores at each visit by application site measure: modified Treatment Satisfaction Questionnaire for Medication-9 (mTSQM-9) measure: Compliance (percentage of subjects using topical agents at all intended days, 90% of days or 75% of days) measure: Pictures at all time points sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06385327 id: ABI-5366-101 briefTitle: A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-5366 in Healthy Participants and Participants Seropositive for HSV-2 With Recurrent Genital Herpes overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-07 date: 2025-07 date: 2024-04-26 date: 2024-04-26 name: Assembly Biosciences class: INDUSTRY briefSummary: This study is designed to assess safety, tolerability, and pharmacokinetics (PK) of single ascending dose (SAD) of ABI-5366 in Part A in healthy participants and multiple-ascending doses (MAD) of ABI-5366 in Part B in participants seropositive for Herpes Simplex Virus Type 2 (HSV-2) with recurrent genital herpes. Effect of food will also be evaluated in Part A. conditions: Recurrent Genital Herpes Simplex Type 2 studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 146 type: ESTIMATED name: ABI-5366 name: ABI-5366 Placebo measure: Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results measure: Area Under the Plasma Concentration Time Curve (AUC) of ABI-5366 measure: Maximum Observed Plasma Concentration (Cmax) of ABI-5366 measure: Time to Cmax (Tmax) of ABI-5366 measure: Apparent Terminal Elimination Half Life (t 1/2) of ABI-5366 measure: Apparent Systemic Clearance (CL/F) of ABI-5366 measure: Apparent Volume of Distribution (Vz/F) of ABI-5366 measure: Dose normalized AUCs and Cmax of ABI-5366 measure: SAD Cohorts: Comparison of plasma AUC and Cmax between fasted and fed treatments measure: MAD Cohorts: If applicable, comparison of plasma PK profiles and parameters with and without loading doses measure: MAD Cohorts: Difference in viral shedding rate (number of anogenital swabs positive for HSV-2 DNA/total number of swabs) across treatments measure: MAD Cohorts: Difference in mean and median HSV-2 DNA copies/mL for swab samples positive for HSV-2 DNA across treatments measure: MAD Cohorts: Difference in the proportion of swab samples with HSV-2 DNA >4 log10 copies/mL across treatments (number of swabbing samples with HSV-2 DNA >4 log10 copies/mL / total number of swabs obtained) measure: MAD Cohorts: Difference in number of shedding episodes during the swabbing period across treatments measure: MAD Cohorts: Difference in duration of shedding episodes during the swabbing period across treatments measure: MAD Cohorts: Difference in subclinical shedding rate (number of swabs positive for HSV-2 DNA in the absence of lesions/total number of swabs in the absence of lesions) across treatments measure: MAD Cohorts: Difference in lesion rate during the swabbing period across treatments measure: MAD Cohorts: Difference in lesion duration during the swabbing period across treatments measure: MAD Cohorts: Difference in recurrence rate (number of reappearances of lesions during the swabbing period/total days assessed) across treatments sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: New Zealand Clinical Research city: Auckland country: New Zealand name: Study Principal Investigator role: CONTACT lat: -36.84853 lon: 174.76349 hasResults: False

 nctId: NCT06385314 id: Degirmenci1499 briefTitle: A Cross Sectional Study on Dental Anxiety and State Anxiety Related to Removal of Fixed Partial Dentures overallStatus: COMPLETED date: 2022-09-05 date: 2023-11-25 date: 2023-12-29 date: 2024-04-26 date: 2024-04-26 name: Abant Izzet Baysal University class: OTHER briefSummary: This study aims to evaluate the effect of the clinical removal of fixed partial dentures (FPDs) on oral health-related quality of life (OHRQoL) and the anxiety values of individuals and to determine the risk factors of high anxiety levels. 300 participants were included in this study. Six different reasons for the clinical removal of FPDs (oral examination, denture renewal, root canal treatment, tooth extraction, periodontal treatment, and composite filling restoration) were defined. Questions pertaining to the United Kingdom Oral Health-Related Quality-of-Life Measure (OHQoL-UK), the Modified Dental Anxiety Scale (MDAS), and the Spielberger State-Trait Anxiety Inventory - State (STAI-S) and Trait (STAI-T) were answered. conditions: Dental Anxiety studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 300 type: ACTUAL name: Collecting data with oral health related quality of life, dental anxiety and state anxiety measure: United Kingdom Oral Health-Related Quality-of-Life Measure measure: Modified Dental Anxiety Scale measure: Spielberger State Anxiety Inventory measure: Spielberger Trait Anxiety Inventory sex: ALL minimumAge: 30 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kubra Degirmenci city: Bolu country: Turkey lat: 40.73583 lon: 31.60611 hasResults: False

 nctId: NCT06385301 id: Lung_disease_6MWD_SOT briefTitle: Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy With Chronic Lung Diseases overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-11 date: 2024-04-26 date: 2024-04-26 name: University of Zurich class: OTHER briefSummary: The investigators aim to study the effect of SOT in subjects with chronic lung disease in submaximal exercise. conditions: Lung Disease Chronic conditions: Lung Diseases, Interstitial conditions: Lung Diseases, Obstructive studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Each participant is its own control primaryPurpose: OTHER masking: NONE count: 14 type: ESTIMATED name: 6-minute walk distance (6MWD) test on ambient air name: 6-minute walk distance test with supplemental oxygen (approximately 3l/min, nasal) measure: 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air measure: SpO2 at rest and peak 6MWD with SOT vs. ambient air measure: Heart rate at rest and peak 6MWD with SOT vs. ambient air measure: Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air measure: Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air measure: Blood pressure at rest and peak 6MWD with SOT vs. ambient air sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Zürich city: Zurich zip: 8091 country: Switzerland name: Silvia Ulrich, Prof. Dr. role: CONTACT phone: 0041 44 255 22 20 email: silvia.ulrich@usz.ch name: Mona Lichtblau, Dr. role: CONTACT phone: +41442552220 email: mona.lichtblau@usz.ch name: Silvia Ulrich, Prof. Dr. role: PRINCIPAL_INVESTIGATOR lat: 47.36667 lon: 8.54999 hasResults: False

 nctId: NCT06385288 id: 268/2021BO2 briefTitle: Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcomas overallStatus: RECRUITING date: 2021-07-21 date: 2026-07-21 date: 2031-07-21 date: 2024-04-26 date: 2024-04-26 name: University Hospital Tuebingen class: OTHER briefSummary: "Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcoma" is a prospective study with additional translational research using preoperative and postoperative tissue, blood sampling and advanced imaging. conditions: Soft Tissue Sarcoma Adult studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE maskingDescription: Open Label count: 30 type: ESTIMATED name: Blood and tissue collection for immunological studies, advanced imaging. name: neoadjuvant Therapy measure: Description of the cellular immune status via flow-cytometrie from collected blood samples measure: Description of the cellular immune status on tissue samples ussing komplex immunohistochemie measure: Measurement of the cellular free DNA from collected blood samples measure: Measurement of HMGB1 from collected blood samples measure: Evaluation of morphological tumor characteristics (size, diffusion) with weekly MRIs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Tuebingen status: RECRUITING city: Tübingen state: Baden-Württemberg zip: 72076 country: Germany name: Vlatko Potkrajcic, MD role: CONTACT phone: +49 7071 29 phoneExt: 82165 email: Vlatko.potkrajcic@med.uni-tuebingen.de name: Cihan Gani, MD role: CONTACT phone: +49 7071 29 phoneExt: 82165 email: cihan.gani@med.uni-tuebingen.de lat: 48.52266 lon: 9.05222 hasResults: False

 nctId: NCT06385275 id: H-44897 briefTitle: The Role of Vitamin K on Knee Osteoarthritis Outcomes overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-12 date: 2026-12 date: 2024-04-26 date: 2024-04-26 name: Boston University class: OTHER name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) briefSummary: The appropriate form and dosing of vitamin K to benefit relevant outcomes in knee osteoarthritis (OA) are not known. In intervention studies for conditions other than knee OA (e.g., prevention of cardiovascular disease), the most commonly used forms and doses include phylloquinone (vitamin K1; 1000µg or 500µg daily) or menaquinone-7 (MK-7 or vitamin K2; 360µg daily). However, whether these doses are adequate to increase vitamin K to levels that ameliorate risk of adverse OA outcomes is not known. Furthermore, although some studies suggest enhanced bioavailability of MK-7 over vitamin K1, as well as extra-hepatic effects, whether this is relevant for an older population with knee OA is not known,

The overall goal of this pilot randomized clinical trial (RCT) is to test different subtypes and doses of vitamin K supplementation in older adults with knee OA and to measure changes in relevant biochemical measures. conditions: Osteo Arthritis Knee studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A stratified permuted block randomization will be used to assign 55 participants in a 1:1:1:1 ratio to each intervention arm. A random allocation sequence will be generated by computer in blocks of 4 or 8, stratified by sex and race. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Use of a placebo from Johnson Compounding Pharmacy (Waltham, MA) of similar appearance and taste to the vitamin K supplements will allow for masking of participants, the study PI, and other study team members to the treatment allocation. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 55 type: ESTIMATED name: Vitamin K1 500 µg name: K1 1000 µg name: Vitamin K2 (MK-7) 360 µg name: Placebo measure: Change in uncarboxylated matrix Gla protein (ucMGP) levels measure: Change in phylloquinone levels measure: Sufficient phylloquinone levels measure: Change in menaquinone-7 (MK-7) levels measure: Study adherence measure: Participant acceptability of intervention sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Boston Medical Center, Rheumatology Clinic city: Boston state: Massachusetts zip: 02118 country: United States name: Jean Liew, MD MS role: CONTACT phone: 617-358-9655 email: jwliew@bu.edu lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06385262 id: Pro00114645 briefTitle: TOP 2301: Neoadjuvant Chemo for NSCLC overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-06-30 date: 2028-06-30 date: 2024-04-26 date: 2024-04-29 name: Duke University class: OTHER name: Regeneron Pharmaceuticals briefSummary: In this open-label, two-arm, randomized phase 2 clinical trial, patients with clinical stage 1B-3A non-small cell lung cancer (NSCLC) will receive neoadjuvant chemotherapy and cemiplimab every 3 weeks for 3 cycles with or without alirocumab every 4 weeks prior to surgery.

Eligible patients will be randomized with equal allocation to two treatment groups. Permuted block randomization algorithm will be used for treatment assignment with stratification factors: stage (1B, 2A, 2B, 3A), and performance status (0 vs. 1).

The study hypothesis is that the addition of alirocumab to neoadjuvant chemoimmunotherapy will make tumor cells more immunogenic to cytotoxic T cells, resulting in an increase in complete pathologic responses in surgically resected tumor. conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 126 type: ESTIMATED name: Alirocumab name: Cemiplimab name: Chemotherapy measure: Compare pathologic complete response (pCR) rate for neoadjuvant chemotherapy plus cemiplimab versus chemotherapy, cemiplimab, and alirocumab. measure: Assess the preliminary efficacy of chemotherapy and cemiplimab with alirocumab as determined by objective response rate (ORR) measure: Assess the preliminary efficacy of chemotherapy and cemiplimab with alirocumab as determined by disease-free survival (DFS) measure: Assess the preliminary efficacy of chemotherapy and cemiplimab with alirocumab as determined by overall survival (OS) measure: Determine the safety of neoadjuvant chemotherapy and cemiplimab with alirocumab in early-stage non-small cell lung cancer (NSCLC) measure: Determine the tolerability of neoadjuvant chemotherapy and cemiplimab with alirocumab in early-stage non-small cell lung cancer (NSCLC) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06385249 id: NAV-0012 briefTitle: An Evaluation of Navina Mini, a New Trans-anal Irrigation (TAI) Device in Children and Adolescents overallStatus: RECRUITING date: 2024-04-03 date: 2024-10 date: 2024-12 date: 2024-04-26 date: 2024-04-26 name: Wellspect HealthCare class: INDUSTRY briefSummary: The study is designed to deliver further information on clinical benefit, patients' satisfaction, and perception of handling and to confirm safety of Navina Mini when used in children and adolescents. conditions: Bowel Dysfunction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: Navina Mini measure: Overall patient satisfaction measure: Incomplete bowel emptying measure: Episodes of fecal incontinence measure: Level of independence measure: Perception of handling of the device measure: Safety outcome sex: ALL minimumAge: 3 Years maximumAge: 17 Years stdAges: CHILD facility: H.K.H. Kronprinsessan Victorias Barn- och ungdomssjukhus Universitetssjukhuset status: RECRUITING city: Linköping country: Sweden name: Peter Wide role: CONTACT phone: +46101031341 email: Peter.Wide@regionostergotland.se name: Jenny Axelsson role: CONTACT phone: +46101032432 email: jenny.axelsson@regionostergotland.se lat: 58.41086 lon: 15.62157 hasResults: False

 nctId: NCT06385236 id: 804913 id: R01HL161362 type: NIH link: https://reporter.nih.gov/quickSearch/R01HL161362 briefTitle: Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping acronym: EPIPHANY overallStatus: RECRUITING date: 2024-02-19 date: 2027-06-30 date: 2028-01-31 date: 2024-04-26 date: 2024-04-26 name: University of California, San Diego class: OTHER name: Mayo Clinic name: Yale University name: University of Arizona name: Harvard University name: Brigham and Women's Hospital name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: In this study, a new method will be used to evaluate response to 2 approved biologic therapies, and assess how well each patient responds to each asthma treatment. This study will measure the response to these treatments using genomic and biologic measurements obtained from participants biosamples.

By evaluating response to 2 different biologic therapies, this study has the potential to provide an in-depth understanding of the mechanisms underlying severe asthma that will inform and change treatment decisions, and may ultimately lead to a change in the way that asthma patients are evaluated for potential personalized therapies and maximize the probability that the subject will respond to treatment. conditions: Moderate to Severe Asthma studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The study is significant in determining molecular disease endotypes in a large group of moderate to severe asthmatics. By evaluating within-person genomic level changes and response to 2 different biologic therapies, this study has the potential to provide an in-depth understanding of the mechanisms underlying severe asthma that will inform and change treatment decisions. primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Dupilumab name: Benralizumab measure: Predicting asthma outcomes and therapeutic responses measure: Responses to the biologic therapies at the single cell level measure: Unique asthma subgroups clinical and molecular endotype approaches measure: Asthma Control Questionnaire (ACQ) measure: CompEx events measure: Asthma Quality of Life Questionnaire (AQLQ) measure: Forced expiratory volume in 1 second (FEV1) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic status: RECRUITING city: Scottsdale state: Arizona zip: 85259 country: United States name: Karalyn Folmes, Ph.D. role: CONTACT phone: 480-301-4298 email: folmes.karalyn@mayo.edu name: Gene R Bleecker, MD role: PRINCIPAL_INVESTIGATOR name: Deborah A Meyers, PhD role: PRINCIPAL_INVESTIGATOR lat: 33.50921 lon: -111.89903 facility: University of California, San Diego status: RECRUITING city: La Jolla state: California zip: 92093 country: United States name: Asthma Research Team role: CONTACT phone: 619-431-0995 email: asthma@health.ucsd.edu name: Kelan Tantisira, MD role: PRINCIPAL_INVESTIGATOR name: Praveen Akuthota, MD role: PRINCIPAL_INVESTIGATOR lat: 32.84727 lon: -117.2742 facility: Yale University status: RECRUITING city: New Haven state: Connecticut zip: 06520 country: United States name: Katherine Spaulding role: CONTACT phone: 203-737-5572 email: katherine.spaulding@yale.edu name: Geoffrey L Chupp, MD role: PRINCIPAL_INVESTIGATOR lat: 41.30815 lon: -72.92816 hasResults: False

 nctId: NCT06385223 id: DSRB 2023/00680 briefTitle: A Novel Individualized Connectome-guided Approach for Precision Intermittent Theta Burst Stimulation for Depression overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-07-01 date: 2026-12-31 date: 2024-04-25 date: 2024-04-25 name: Institute of Mental Health, Singapore class: OTHER name: National University of Singapore briefSummary: The Investigators propose to carry out a randomized, double-blind trial to compare the clinical efficacy of an individualized connectome-guided accelerated iTBS vs an anatomically-guided (Beam F3) accelerated iTBS. The study team will recruit both inpatients and outpatients who had been referred for TMS for the treatment of depression. conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: Beam F3 targeted accelerated iTBS name: Individualized connectome-guided accelerated iTBS measure: Montgomery-Åsberg Depression Rating Scale measure: Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) measure: Montreal Cognitive Assessment (MoCA) measure: EQ-5D (EuroQol) measure: Quality of Life Enjoyment and Satisfaction Questionnaire Short form (Q-LES-QS-SF) measure: TMS induced changes in resting-fMRI functional connectivity sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06385210 id: 22SM7855 briefTitle: Barriers to Routine Surgical Video Recording overallStatus: COMPLETED date: 2024-04-01 date: 2024-04-24 date: 2024-04-24 date: 2024-04-25 date: 2024-04-26 name: Imperial College London class: OTHER briefSummary: In order to improve the implementation of routine surgical video recording, the researchers want to understand what the challenges associated with the uptake of this technology are. The aim of this study is to explore the barriers faced by key stakeholders including the surgical care team, information governance, and patients within the field of surgical video reporting. The data from this qualitative study will allow the researchers to understand better the challenges associated with uptake of surgical video recording. This will allow the researchers to develop strategies to overcome these challenges and subsequently improve uptake of surgical video recording which will promote safer and more transparent surgery. conditions: Minimally Invasive Surgery conditions: Laparoscopic Surgery studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 15 type: ACTUAL name: Semi structured interviews measure: Stakeholder perceived barriers to surgical video recording sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Surgery and Cancer city: London zip: W2 1NY country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06385197 id: 170886-HMO-CTIL briefTitle: Improving the Effect of Multiple Sclerosis Drugs by Chronobiology overallStatus: COMPLETED date: 2022-05-08 date: 2023-06-01 date: 2023-06-02 date: 2024-04-25 date: 2024-04-25 name: Hadassah Medical Organization class: OTHER briefSummary: A trial for evaluating the ability to improve the effect of dimethyl fumarate in patients with Multiple Sclerosis (MS) by chronobiology A controlled-randomization dosing regimen administered to patients with MS and provided by a designated app. The treatment limitations of time interval is pre-defined according to approved therapeutic windows. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A controlled-randomization dosing regimen administered to patients with MS and provided by a designated app. The treatment limitations of time interval is pre-defined according to approved therapeutic windows. primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 8 type: ACTUAL name: App randomizing dosing regimen measure: safety assessment sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Hadassah Medical Center city: Jerusalem country: Israel lat: 31.76904 lon: 35.21633 hasResults: False

 nctId: NCT06385184 id: NCR234859 briefTitle: Social & QoL Behaviors in Parkinson's Disease overallStatus: RECRUITING date: 2024-03-08 date: 2025-12-31 date: 2025-12-31 date: 2024-04-25 date: 2024-04-25 name: Gregory Wallace class: OTHER briefSummary: Adults with Parkinson's Disease experience an array of challenges and changes in daily living, behaviors, and functioning throughout the progression of their condition. The investigators want to learn more about the effects of Parkinson's Disease on individuals' social behavior and quality of life (QoL) compared to people of the same age without Parkinson's Disease. conditions: Parkinson Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 500 type: ESTIMATED name: No Intervention measure: Subjective Quality of Life measure: Social Behavior measure: Activities of Daily Living measure: Mental Health measure: Cognition sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The George Washington University status: RECRUITING city: Washington state: District of Columbia zip: 20052 country: United States name: Gregory Wallace, PhD role: CONTACT phone: 202-994-8285 email: ladn@gwu.edu lat: 38.89511 lon: -77.03637 hasResults: False

 nctId: NCT06385171 id: FFA-BTX-1 briefTitle: Assessing the Impact of Botulinum Toxin Type A on Facial Wrinkles: A Comprehensive Clinical Investigation overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-08-01 date: 2027-01-05 date: 2024-04-25 date: 2024-04-25 name: Global Aesthetics LLC class: OTHER briefSummary: A study conducting to see how well a treatment called Botulinum Toxin Type A works for reducing facial wrinkles. The study will help us understand if this treatment is safe and effective for making wrinkles on the face less noticeable. conditions: Wrinkle studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Botulinum toxin type A measure: Change in facial wrinkles and Lines measure: Facial Appearance measure: Assessment of Wrinkle Severity measure: Assessment of Skin Reaction sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Global Aesthetics LLC city: Cisco state: Texas zip: 76437 country: United States lat: 32.38819 lon: -98.97923 facility: Global Aesthetics LLC city: Lubbock state: Texas zip: 79413 country: United States name: Otis Scroggins, BS, CNA role: CONTACT phone: 806-370-7428 email: fakefaceaesthetics@gmail.com lat: 33.57786 lon: -101.85517 hasResults: False

 nctId: NCT06385158 id: GenSci074-101 briefTitle: A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Dose Escalation of GS1-144 Tablets and the Effects of Food on the Pharmacokinetics of GS1-144 in a Chinese Population overallStatus: RECRUITING date: 2024-04 date: 2024-07 date: 2024-08 date: 2024-04-25 date: 2024-04-25 name: Changchun GeneScience Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: A Phase I clinical study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral dose escalation of GS1-144 tablets and the effects of food on the pharmacokinetics of GS1-144 in a Chinese population conditions: Vasomotor System; Labile conditions: Healthy Volunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 110 type: ESTIMATED name: GS1-144 tablet measure: Part 1:Number of Participants With Treatment -Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) measure: Part 2: Number of Participants With Treatment -Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs). measure: Part 3: Number of Participants With TEAEs and SAEs measure: Part1,Part2 and Part3 AUC0-t- Area Under the Drug Concentration-time Curve From Time 0 to the Last Sample Collection Time t for GS1-144 measure: Part 1 , Part2 and Part 3: AUC0-infinity- Area Under the Drug Concentration-time Curve From 0 to Infinity for GS1-144 measure: Part 1, Part2 and Part 3: Cmax- Maximum Observed Plasma Concentration for GS1-144 measure: Part 1 Part2 and Part 3: Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for GS1-144 measure: Part 1 Part2 and Part 3:: T1/2- Terminal Half-life for GS1-144 measure: Part 1 Part2 and Part 3: CL/F- Apparent Clearance for GS1-144 measure: Part 1 Part2 and Part 3: Vd/F- Apparent Volume of Distribution for GS1-144 measure: Cmax,ss- Observed Maximum Concentration at Steady State for GS1-144 measure: Part 3: Cmin,ss- Observed Minimum Concentration at Steady State for GS1-144 measure: Part 3: Tmax,ss- Time of Cmax at Steady State for GS1-144 measure: Part 3: Cavg,ss- Average Concentration at Steady State for GS1-144 measure: Part 3: AUC0-τ- Area Under the Drug Concentration-time Curve During the Dosing Interval at Steady State for GS1-144 measure: Part 3: CLss/F- CL for Bioavailability at Steady State for GS1-144 measure: Part 3: T1/2,ss- Terminal Half-life at Steady State for GS1-144 measure: Part 3: Accumulation Ratio for GS1-144 measure: Part 1: Baseline and placebo-adjusted changes in ∆∆QTc and other ECG parameters after oral administration of GF1-144 in healthy subjects sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Huashan Hospital, Fudan University status: RECRUITING city: Shanghai state: Shanghai zip: 200040 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06385145 id: GenSci004-107 briefTitle: A Bioavailability Study of Two Different PEG-rhGH Preparations. overallStatus: NOT_YET_RECRUITING date: 2024-05-08 date: 2024-07-13 date: 2024-12-26 date: 2024-04-25 date: 2024-04-25 name: Changchun GeneScience Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to compare the pharmacokinetics of the two different PEG-rhGH preparations. conditions: Pediatric Growth Hormone Deficiency (PGHD) studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 16 type: ESTIMATED name: PEG-rhGH with new preparation (T) name: PEG-rhGH with present preparation (R) measure: Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation measure: Pharmacokinetics (Area under the concentration-time curve from time zero to time infinity (AUC0-inf)) of PEG-rhGH with present and new preparation measure: Pharmacokinetics (Area under the concentration-time curve from time zero to the time of the last quantifiable (AUC0-last)) of PEG-rhGH with present and new preparation measure: Safety and tolerability (Number of participants with treatment-related adverse events) measure: Peak Plasma Concentration (Cmax) of Insulin-like growth factor-1 (IGF-1) with present and new preparation measure: Area under the concentration-time curve from time zero to time infinity (AUC0-inf) of Insulin-like growth factor-1 (IGF-1) with present and new preparation measure: Anti-drug antibody (Number of Participants with positive ADA) sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Chengdu Xinhua Hospital city: Chengdu state: Sichuan zip: 610000 country: China name: Xiaolan Yong, Doctor role: CONTACT phone: +862860212136 email: yongxlan@126.com lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06385132 id: 6447 briefTitle: Psychological and Psychiatric prOfile in Glioblastoma and Head and Neck Cancer acronym: APPOINT overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-30 date: 2025-10-31 date: 2024-04-25 date: 2024-04-25 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Approximately 30% of cancer patients may experience psychopathological disorders. The most common psychopathological disorders in cancer patients are mood disorders, anxiety, depression, adjustment disorders, and suicidal ideation. Among depressive disorders, mixed depression, with the simultaneous presence of symptoms of both depressive and manic polarity, is associated to higher levels of chronicity, functional impairment and suicidality. These disorders can also be worsened by loneliness and demoralization.

Patients with head and neck cancer (H\&N-C) and Glioblastoma multiforme (GBM) have high psychological and sometimes psychiatric comorbidity probably due to the severity, poor prognosis of these cancers and harsh treatment toxicities.

The most important protective factor for psychopathology is psychological resilience, which is "the capacity of a person to protect themselves and their mental health when facing life adversities," such as a GBM or H\&N-C diagnosis. Resilience is influenced by the affective temperament, which refers to basic personality traits related to behavioral and emotional reactivity to environmental stimuli. It is believed to be biologically determined and relatively stable throughout life.

To date, the literature does not clarify the role of resilience and temperament in mediating the psychological profile of cancer patients. Furthermore, extensive profiling of the psychological and psychiatric profile of these patients at such a critical and pivotal moment in their journey is currently lacking in the literature.

Aim of this study is to evaluate global psychological and psychiatric profile of patients affected by GBM and H\&N-C and the eventual fluctuation over time during RT course. Conducting an early and accurate screening for potential psychopathological issues will give the opportunity to avoid factors that could: worsen patient compliance, lead to suicidal risk, and increase hospitalizations.

The results obtained will be utilized for planning precocious psychological or psychiatric take-in-charge aimed at promoting psychological well-being of H\&N-C and GBM patients. conditions: Glioblastoma conditions: Head and Neck Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 207 type: ESTIMATED name: Psychological Tests' administration measure: Distress Thermometer measure: Brief Psychiatric Rating Scale sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario A. Gemelli IRCCS city: Roma zip: 00168 country: Italy name: LOREDANA DINAPOLI role: CONTACT phone: +390630154428 email: loredana.dinapoli@policlinicogemelli.it name: Loredana Dinapoli role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06385119 id: F8394-101 briefTitle: A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Volunteers. overallStatus: NOT_YET_RECRUITING date: 2024-04-24 date: 2024-10-31 date: 2024-11-25 date: 2024-04-25 date: 2024-04-25 name: Fore Biotherapeutics class: INDUSTRY briefSummary: The primary goal of this phase 1 study is to evaluate the effect of food and cobicistat on the pharmacokinetics of plixerafenib in healthy volunteers. Healthy male and female participants between the ages of 18 and 55 will be enrolled into this study. This study is looking to examine:

* The effect of food on the single dose PK of plixorafenib administered with cobicistat.
* The effect of cobicistat administration on the single dose PK of plixorafenib.
* The safety of plixorafenib administered alone and with cobicistat in a single dose regimen in healthy participants. conditions: Healthy Volunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE count: 12 type: ESTIMATED name: Plixorafenib name: Cobicistat measure: Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t). measure: AUC from time 0 extrapolated to infinity (AUC0-inf). measure: Maximum observed plasma concentration (Cmax). measure: Time to maximum observed plasma concentration (Tmax). measure: Terminal elimination rate constant (Kel). measure: Terminal phase half-life (t1/2). measure: Apparent oral clearance (CL/F). measure: Apparent volume of distribution (Vd/F). measure: Terminal rate constant calculated from the terminal slope of the log-linear regression of concentration with time (z). measure: Cumulative amount of plixorafenib excreted in urine, calculated as the sum of the product of urine concentration and urine volume (Ae). measure: Percent of dose excreted in urine in 48 hours calculated as 100*Ae/Dose. sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: PPD - Austin Research Unit city: Austin state: Texas zip: 78744 country: United States name: Kristie Miller, MD role: CONTACT phone: 877-362-2608 lat: 30.26715 lon: -97.74306 hasResults: False

 nctId: NCT06385106 id: rTMS in AD briefTitle: Effects of Repetitive Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-01 date: 2024-04-25 date: 2024-04-25 name: First Affiliated Hospital of Zhejiang University class: OTHER briefSummary: Previous studies have shown that repetitive transcranial magnetic stimulation (rTMS) can improve cognitive function in Alzheimer's disease (AD), but studies on the improvement of sleep disorders in AD are limited. The aim of this study was to evaluate the effects of rTMS on sleep and cognition in patients with mild-to-moderate Alzheimer's disease (AD). conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Real repetitive transcranial magnetic stimulation name: Sham repetitive transcranial magnetic stimulation measure: Cognitive funtion measure: Sleep parameters measure: glymphatic system sex: ALL minimumAge: 55 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06385093 id: EDR-IIS-003 briefTitle: A Study on the Prevention and Treatment of GIOP With Eldecalcitol acronym: ELEGANT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2026-03 date: 2024-04-25 date: 2024-04-25 name: Chinese SLE Treatment And Research Group class: OTHER name: Beijing Life oasis public service center briefSummary: The study will be a multi-center, randomized, open label, parallel trial conducted in rheumatoid arthritis patients treated with glucocorticoids. After signing the informed consent, all patients will be screened as per the inclusion and exclusion criteria. Estimated 314 eligible patients will be enrolled. The enrolled patients will be randomly assigned to either Eldecalcitol group or Alfacalcidol group in a 1:1 ratio and followed up for 12 months. On-site follow up visits will be conducted at Month 6 and 12 after enrollment. The study is designed to evaluate the efficacy and safety of Eldecalcitol in preventing glucocorticoid-induced bone loss in rheumatoid arthritis patients. conditions: Rheumatoid Arthritis conditions: Osteoporosis conditions: Osteopenia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 314 type: ESTIMATED name: Eldecalcitol capsules name: Alfacalcidol tablets name: Calcium carbonate tablets measure: Percent change from baseline to month 12 in lumbar spine (L1-4) bone mineral density (BMD) measure: Percent change from baseline to month 6 in lumbar spine (L1-4) BMD measure: Percent change from baseline in total hip BMD measure: Percent change from baseline in femoral neck BMD measure: Percent change from baseline to month 12 in broadband ultrasound attenuation (BUA) and speed of sound (SOS) measured by quantitative ultrasound (QUS) measure: Percent change from baseline in Procollagen Type 1 N-telopeptide (P1NP) measure: Percent change from baseline in Type 1 Collagen C-telopeptide (CTX) measure: Percentage of patients diagnosed with osteoporosis at month 12 measure: Incidence of new vertebral fracture measure: Change from baseline in Quality of Life assessed using EQ-5D-5L measure: Change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) measure: Change from baseline in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score measure: Percent change from baseline to month 12 in volumetric bone mineral density (vBMD) measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT) measure: Percent change from baseline to month 12 in bone microarchitecture measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT) measure: Percent change from baseline to month 12 in bone geometry measured by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital city: Beijing state: Beijing zip: 100730 country: China name: Ying Jiang, MD role: CONTACT phone: +86-13391701765 email: jiangying@pumch.cn lat: 39.9075 lon: 116.39723 facility: Aerospace Central Hospital city: Beijing state: Beijing country: China name: Jian Liu role: CONTACT lat: 39.9075 lon: 116.39723 facility: Beijing Luhe hospital, Capital Medical University city: Beijing state: Beijing country: China name: Baoyu Zhang role: CONTACT lat: 39.9075 lon: 116.39723 facility: Beijing Shijingshan Hospital city: Beijing state: Beijing country: China name: Lian'na Xu role: CONTACT lat: 39.9075 lon: 116.39723 facility: Beijing Shijitan Hospital city: Beijing state: Beijing country: China name: Yuhua Wang role: CONTACT lat: 39.9075 lon: 116.39723 facility: Beijing Shunyi hospital city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Xuanwu Hospital, Capital Medical University city: Beijing state: Beijing country: China name: Yi Zhao role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06385080 id: 61186372HNC2002 briefTitle: A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Recurrent/Metastatic Head and Neck Cancer acronym: OrigAMI-4 overallStatus: RECRUITING date: 2024-04-22 date: 2026-07-17 date: 2026-07-17 date: 2024-04-25 date: 2024-04-25 name: Janssen Research & Development, LLC class: INDUSTRY briefSummary: The purpose of this study is to determine safety and preliminary efficacy of amivantamab monotherapy, amivantamab in addition to pembrolizumab, and amivantamab in addition to paclitaxel in participants with recurrent/metastatic head and neck cancer. The study will also confirm the recommended Phase 2 combination dose (RP2CD) for amivantamab in addition to paclitaxel. conditions: Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 117 type: ESTIMATED name: Amivantamab name: Pembrolizumab name: Paclitaxel measure: Cohorts 1, 2, and 3B: Objective Response Rate measure: Cohort 3A: Number of Participants With Dose-limiting Toxicities (DLT) measure: Cohort 3A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity measure: Cohorts 1, 2, and 3B: Duration of Response (DoR) measure: Cohorts 1, 2, and 3B: Clinical Benefit Rate (CBR) measure: Cohorts 1, 2, and 3B: Progression-free Survival (PFS) measure: Cohorts 1, 2, and 3B: Overall Survival (OS) measure: Cohorts 1, 2, and 3B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) as a Measure of Severity measure: Cohort 1: Maximum Observed Serum Concentration (Cmax) of Amivantamab measure: Cohort 1: Time to Maximum Observed Serum Concentration (Tmax) of Amivantamab measure: Cohort 1: Area Under the Serum Concentration Curve Verses Time Curve From Time t1 to t2 (AUC[t1-t2]) of Amivantamab measure: Cohort 1: Area Under the Curve From Time Zero to tau (AUC[0-tau]) of Amivantamab measure: Cohort 1: Trough Serum Concentration (Ctrough) of Amivantamab measure: Cohort 1: Accumulation Ratio (R) of Amivantamab 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 hasResults: False

 nctId: NCT06385067 id: JW-PM-DCB-2024 briefTitle: Treatment of Primary Coronary Artery Vascular Lesions With Biolimus Coated Coronary Balloon Dilation Catheter overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2025-12-30 date: 2026-12-30 date: 2024-04-25 date: 2024-04-25 name: JW Medical Systems Ltd class: INDUSTRY briefSummary: The purpose of the study was to further evaluate the long-term safety and efficacy of the Biolimus Coated Coronary Artery Balloon Dilation Catheter in the real world.

The study population was patients with primary coronary vascular lesions with a blood vessel diameter of 2.0mm-2.75mm. conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: Biolimus Coated Coronary Artery Balloon Dilation Catheter measure: Target lesion failure rate (TLF) measure: Interventional success rate measure: Device-related cardiovascular clinical composite endpoint measure: Patient-related cardiovascular clinical composite endpoint measure: Major adverse cardiac events (MACEs) measure: Incidence of thrombotic events as defined by ARC sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06385054 id: L-027 id: 2023-A02612-43 type: REGISTRY domain: ID-RCB id: PEC23063 type: OTHER domain: Biofortis briefTitle: Effect of Probiotics on Infantile Colic Symptoms acronym: EPIC overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-02 date: 2027-02 date: 2024-04-25 date: 2024-04-29 name: Lallemand Health Solutions class: INDUSTRY name: BioFortis briefSummary: The aim of this clinical trial is to assess the impact of a probiotic formulation on participants with infantile colic. It is hypothesized that participants given the probiotic formula will have a significant reduction in their crying duration compared to participants receiving the placebo, after 4 weeks of intervention. conditions: Infantile Colic studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: Probiotic name: Placebo measure: Change in daily crying duration measure: Change in crying patterns measure: Change in sleep duration measure: Change in maternal quality of life measure: Change in bowel habits measure: Change in gut microbiota composition measure: Probiotic strain recovery measure: Safety and tolerability of the intervention measure: Change in fecal immune markers and proteins sex: ALL maximumAge: 8 Weeks stdAges: CHILD facility: Centre Hospitalier de Boulogne-sur-Mer city: Boulogne-sur-Mer zip: 62200 country: France name: Mohamad Hage, MD role: PRINCIPAL_INVESTIGATOR lat: 50.71667 lon: 1.61667 facility: Cabinet privé Dr Regimbart-Trubuil Christine city: Bécon-les-Granits zip: 49370 country: France name: Christine Regimbart-Trubuil, MD role: PRINCIPAL_INVESTIGATOR lat: 47.50134 lon: -0.8 facility: CHU Caen Normandie city: Caen zip: 14033 country: France name: Edouard Lacotte, MD role: PRINCIPAL_INVESTIGATOR lat: 49.18585 lon: -0.35912 facility: CHU Grenoble Alpes city: La Tronche zip: 38700 country: France name: Ellen Katranji, MD role: PRINCIPAL_INVESTIGATOR lat: 45.20429 lon: 5.73645 facility: Hôpital Saint Vincent de Paul city: Lille zip: 59000 country: France name: Pr. Nicholas Kalach, MD role: PRINCIPAL_INVESTIGATOR lat: 50.63297 lon: 3.05858 facility: Centre Hospitalier de Montauban city: Montauban zip: 82000 country: France name: Sabine Charpentier, MD role: PRINCIPAL_INVESTIGATOR lat: 44.01667 lon: 1.35 facility: CHU de NANTES city: Nantes zip: 44000 country: France name: Hugues Piloquet, MD role: PRINCIPAL_INVESTIGATOR lat: 47.21725 lon: -1.55336 facility: Biofortis, Unité d'investigation Clinique city: Paris zip: 75012 country: France name: Stéphanie Cavigoli, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Biofortis, Unité d'investigation Clinique city: Saint-Herblain zip: 44800 country: France name: Isabelle Metreau, MD role: PRINCIPAL_INVESTIGATOR lat: 47.21765 lon: -1.64841 facility: Centre Hospitalier du val d'Ariège city: Saint-Jean-de-Verges zip: 09000 country: France name: Lucas Percheron, MD role: PRINCIPAL_INVESTIGATOR lat: 43.01371 lon: 1.61076 hasResults: False

 nctId: NCT06385041 id: BE-2-83 briefTitle: Cardiac Rehabilitation and Frailty Physical Training Program in Elderly Patients After Open Heart Surgery overallStatus: RECRUITING date: 2021-05-12 date: 2025-09-01 date: 2025-09-01 date: 2024-04-25 date: 2024-04-25 name: Vitalija Stonkuvienė class: OTHER briefSummary: The aim of the research - to evaluate the impact of interactive physical therapy tools for functional capacity, fear of falls, motivation and quality of life after open heart surgery due to ischemic heart disease and frailty in the second stage of rehabilitation. conditions: Frailty Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 150 type: ESTIMATED name: Intervention group 1 name: Intervention group 2 measure: Collecting data from the medical history measure: Frailty level by Edmonton frail scale score measure: Fear of Falling by Falls Efficacy Scale International; FES-I). measure: Quality of life by EuroQoL FiveDimensionsEQ-5D-5L. measure: Motivation by Multidimensional Health Locus of Control scale measure: Change from baseline functional capacity by six minutes walking test (6MWT) measure: Change from baseline physical performance by Short Physical Performance Battery (SPPB) measure: Change from baseline muscular strength by one repetition maximum test (1RM) measure: Change from baseline grip strength by hydraulic hand dinanometer measure: Change from baseline balance parameters by Biodex Balance System SD measure: Change from baseline stance and gait parameters by Zebris Medical GmbH measure: Change from baseline cardiopulmonary exercise capacity by maximal load (maxWatt) measure: Change from baseline cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2) sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva status: RECRUITING city: Kaunas country: Lithuania name: Vitalija Stonkuvienė role: CONTACT lat: 54.90272 lon: 23.90961 hasResults: False

 nctId: NCT06385028 id: 20230213_PIANISSIMO briefTitle: Physical Activity Promotion in Osteoarthritis Patients acronym: PIANISSIMO overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2026-03-31 date: 2026-12-31 date: 2024-04-25 date: 2024-04-25 name: Luxembourg Institute of Health class: OTHER_GOV name: Œuvre Nationale de Secours Grande Duchesse Charlotte briefSummary: The main purpose of this project is to promote physical activity in patients with osteoarthritis. More specifically, this study aims to test the acceptability of an app to promote physical activity in the target population, and consequently the feasibility of such an approach.

A mobile phone application - namely PIANISSIMO - will be developed specifically for this project. It aims to spread knowledge on the benefits of physical activity and collect data on how this knowledge can induce behavior changes toward a more physically active lifestyle.

The intervention is delivered via the app, which will send daily notifications on physical activity and sedentary behavior, and ask the participants to set their weekly goal (i.e., daily steps). The app will also collect daily steps count and ask the participant to fill in questionnaire on pain once a week. conditions: Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: pilot feasibility study primaryPurpose: PREVENTION masking: NONE count: 150 type: ESTIMATED name: Physical activity promotion measure: Weekly number of connections to the application over time measure: Response rate to the weekly questionnaires over time measure: Evolution of physical activity metrics measure: influence of pain on physical activity practice measure: influence of physical activity on pain report measure: long-term evolution of daily steps sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Luxembourg Institute of Health city: Strassen zip: 1445 country: Luxembourg lat: 49.62056 lon: 6.07333 hasResults: False

 nctId: NCT06385015 id: IRB#23-001257 briefTitle: T-UP: Engaging Vulnerable Students in Diabetes Prevention overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-04 date: 2024-05 date: 2025-06 date: 2024-04-25 date: 2024-04-26 name: University of California, Los Angeles class: OTHER name: American Diabetes Association briefSummary: The goal of this study is to enhance reach and uptake of diabetes prevention among young adults, with a focus on recruiting underserved and high-need students who face additional challenges, including food and financial insecurity.

The specific aims are to: 1) Evaluate the efficacy of adolescents and young adults (AYA)-tailored version of the University of California Diabetes Prevention Program (UC DPP) for mitigating type 2 diabetes risk (i.e., weight change) in a pre/post pilot trial. The investigators hypothesize that the AYA-tailored intervention will be effective at producing 5% weight loss from baseline to program completion (at 9-months); and, 2) Assess the feasibility and acceptability of an AYA-tailored version of the UC DPP program. The investigators hypothesize that it will be feasible to recruit the desired number of participants given proposed innovative outreach strategies, and that the AYA-tailored intervention will be deemed acceptable to participants both qualitatively and in regards to their retention in the program at rates similar to the larger UC DPP.

The investigators will randomize participants to the AYA-tailored DPP cohort vs control cohort. Control participants will be offered the opportunity to participate in the AYA-tailored DPP in the following academic year. Participants will be organized into groups within their DPP cohort based on their student status and/or place of residence. The intervention will include 19 sessions (18 in-person and 1 on-demand) covering 24 DPP modules; each session is approximately an hour in length and will be moderated by a lifestyle coach. At the end of each session, intervention participants will receive an email/text with a unique link to a brief REDCap survey to ascertain acceptability of the session. Control group will receive access to materials about study habits, alcohol use, and financial literacy. Control group will receive materials via e-mail for participants to review on their own time and will receive acceptability surveys. A research assistant (RA) will meet with control participants via Zoom to explain the materials. Participants will complete baseline and 9-month follow-up assessments. Participants will complete a 30 minute questionnaire via REDCap and height/weight measurements will be collected by a RA. Participants will be asked to self-report weight and physical activity at the end of the fall and winter quarter; data will be collected via brief REDCap survey. conditions: Diabetes Mellitus, Type 2 conditions: PreDiabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: NONE count: 80 type: ACTUAL name: Tailored DPP Intervention measure: Change in weight (pounds, lbs) between baseline and 9-month follow-up measure: Change in self-reported quality of life (Centers for Disease Control and Prevention Health-Related Quality of Life-14 item (CDC HRQOL-14)) between baseline and 9-month follow-up sex: ALL minimumAge: 17 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: University of California, Los Angeles city: Los Angeles state: California zip: 90095 country: United States lat: 34.05223 lon: -118.24368 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-09-22 uploadDate: 2024-01-23T16:50 filename: ICF_000.pdf size: 203319 hasResults: False

 nctId: NCT06385002 id: 2024-0158 briefTitle: Effect of Combined Administration of Sevoflurane and Remimazolam on Emergence overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-05-31 date: 2025-05-31 date: 2024-04-25 date: 2024-04-26 name: Pusan National University Yangsan Hospital class: OTHER briefSummary: Enhanced recovery after surgery (ERAS) protocols are being explored to improve patient outcomes. The method of inducing anesthesia and maintenance using inhalation anesthetics is common but may delay recovery. Remimazolam, a benzodiazepine-class drug, is noted for its rapid metabolism and fewer hemodynamic changes. Research suggests combining sevoflurane and propofol for anesthesia in adults enhances recovery, while studies in pediatric patients indicate a reduction in emergence agitation with remimazolam. However, the impact of combining sevoflurane and remimazolam on postoperative recovery in adult patients undergoing gynecologic and laparoscopic surgery is not yet studied. The study aims to compare the time to emergence from anesthesia and tracheal extubation between concurrent sevoflurane and remimazolam administration versus sevoflurane alone. conditions: Gynecological Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Remimazolam measure: time to emergence measure: time to tracheal extubation measure: usage of vasopressors measure: severity of cough measure: time to discharge from the recovery room measure: postoperative pain scores measure: scores for postoperative nausea and vomiting sex: FEMALE minimumAge: 19 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06384989 id: MinnesotaHealthSolutions_LL briefTitle: Safety-Enhancing Motor Vehicle Child Safety Seat overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-01 date: 2024-08-15 date: 2024-04-25 date: 2024-04-25 name: Minnesota HealthSolutions class: INDUSTRY briefSummary: This study aims to assess the usability of a load leg design for caregivers who must install the child safety seat into a vehicle. The specific aims are to quantify any errors committed by the participants while installing the car seat and to assess participants' opinions on the car seat's load leg design. conditions: Motor Vehicle Injury conditions: Safety Issues studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Child restraint system with load leg feature measure: Correct use of load leg measure: Load leg error types measure: Other installation errors measure: Opinion on load leg design and instructions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Ohio State University city: Columbus state: Ohio zip: 43210 country: United States name: Julie Mansfield, PhD role: CONTACT phone: 614-366-2101 email: julie.mansfield@osumc.edu lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06384976 id: KYV101-007 briefTitle: A Study of Anti-CD19 CAR T-Cell Therapy, in Subjects With Refractory Primary and Secondary Progressive Multiple Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2029-01 date: 2024-04-25 date: 2024-04-25 name: Kyverna Therapeutics class: INDUSTRY briefSummary: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Primary and Secondary Progressive Multiple Sclerosis conditions: Multiple Sclerosis, Primary Progressive conditions: Multiple Sclerosis, Secondary Progressive conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: KYV-101 name: Standard lymphodepletion regimen name: Anti-CD20 mAB measure: To evaluate efficacy of KYV-101 measure: To characterize the safety and tolerability of KYV-101 measure: To characterize the safety and tolerability of KYV-101 measure: To characterize the safety and tolerability of KYV-101 measure: To evaluate efficacy of KYV-101 measure: To characterize the pharmacokinetics (PK) measure: To characterize the pharmacokinetics (PK) measure: To characterize the Pharmacodynamics (PD) measure: To characterize the Pharmacodynamics (PD) measure: To evaluate the immunogenicity (humoral response) of KYV-101 sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06384963 id: Cer22/02 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: 2024-04-25 date: 2024-04-25 name: Ceryx Medical Australia class: INDUSTRY name: Avania 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: Waikato Hospital city: Hamilton zip: 3240 country: New Zealand name: Martin Stiles, MB ChB role: CONTACT phone: +64 07 957 6080 email: martin.stiles@waikatodhb.health.nz name: Kelly Henderson, BSc role: CONTACT phone: +64 0272564243 phoneExt: 25015 email: Kelly.Henderson@waikatodhb.health.nz lat: -37.78333 lon: 175.28333 hasResults: False

 nctId: NCT06384950 id: 2023-11-005A briefTitle: Evaluating the Role of ChatGPT in Educating Patients With Early-stage Hepatocellular Carcinoma overallStatus: RECRUITING date: 2024-03-22 date: 2024-11-29 date: 2025-03-21 date: 2024-04-25 date: 2024-04-25 name: Taipei Veterans General Hospital, Taiwan class: OTHER_GOV briefSummary: Liver cancer is a leading cause of cancer-related deaths in Taiwan, with its onset linked to factors like chronic liver conditions, cirrhosis, and genetic predispositions. According to the "Barcelona Clinic Liver Cancer (BCLC)" classification, early-stage liver cancer is demarcated by stages 0 to A. Upon such diagnosis, both patients and their families often have numerous questions and concerns, ranging from treatment choices to long-term outcomes. The research proposes a GPT-3.5-based chatbot to assist these patients by providing timely, personalized information, aiming to enrich their understanding of the disease and improve communication between patients and health professionals.

The research methodology employs a Randomized Controlled Trial (RCT) design, dividing participants into a control cohort receiving standard patient education routine and an experimental cohort receiving both the AI chatbot and traditional education routine. The comparative analysis of these cohorts will determine the effectiveness of the AI intervention in improving patients' health literacy and satisfaction. conditions: Carcinoma, Hepatocellular studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: To compare the educational effectiveness of a chatbot integrated with health education information to traditional health education methods. This comparison encompassed aspects such as the patient's health literacy and clinical satisfaction. Based on the findings, recommendations and improvements would be proposed to promote the application and development of large language models in the medical field. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: The research uses a Randomized Controlled Trial (RCT) methodology, dividing patients into a control group undergoing the conventional patient education routine, and an experimental group that leverages both the chatbot and traditional education. By comparing selected outcomes between the two groups, the experiment's effectiveness will be determined. whoMasked: PARTICIPANT count: 450 type: ESTIMATED name: ChatGPT name: patient education with traditional methods. measure: Health literacy score of patients measure: Satisfaction score with medical care measure: Degree of patient anxiety sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taipei Veterans General Hospital status: RECRUITING city: Taipei state: Beitou District zip: 11217 country: Taiwan name: Chun-Ying Wu role: CONTACT phone: +886-28712121 phoneExt: 4190 email: chptaiwan07@gmail.com name: HSIAO-PING CHEN role: CONTACT phone: +886-28712121 phoneExt: 4190 email: chptaiwan07@gmail.com lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06384937 id: GCA-PRO-2022-001-01 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-25 date: 2024-04-25 name: [Redacted] hasResults: False

 nctId: NCT06384924 id: SBU-RAMAN-SKINCANCER briefTitle: Raman Spectroscopy and Skin Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-30 date: 2025-04-30 date: 2024-04-25 date: 2024-04-25 name: Renee Cattell class: OTHER briefSummary: The goal of this observational study is to find out if Raman Spectroscopy, a type of imaging, can be used to determine the size of skin cancer tumors. The main question it aims to answer is:

-Can Raman Spectroscopy help figure out how far a tumor spreads?

This study will take measurements using laser light from an experimental, handheld probe by lightly touching the skin. conditions: Skin Cancer conditions: Basal Cell Carcinoma conditions: Squamous Cell Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Raman Spectroscopy handheld probe (EmVision, FL, USA) name: Raman Spectroscopy laser source (Hubner Photonics Inc, CA, USA) measure: Feasibility of Raman Spectroscopy to observe differences in Raman spectra between visible lesion, skin surrounding lesion and contralateral normal skin. measure: Compare the size of clinically defined margin and Raman-defined margin measure: Compare the dose delivered to surrounding critical structures when using clinically defined margin and Raman-defined margin sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stony Brook Hospital city: Stony Brook state: New York zip: 11794 country: United States name: Renee Cattell, PhD role: CONTACT email: renee.cattell@stonybrookmedicine.edu name: Renee Cattell, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.92565 lon: -73.14094 hasResults: False

 nctId: NCT06384911 id: STUDY00004543 briefTitle: InvesT1D: Promoting Adolescent Investment in Diabetes Care overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-08 date: 2028-02 date: 2024-04-25 date: 2024-04-25 name: Seattle Children's Hospital class: OTHER name: Harvard Pilgrim Health Care briefSummary: The goal of this clinical trial is to see if a financial incentives program called InvesT1D is helpful to support diabetes management in adolescents with type 1 diabetes.

Adolescent participants will be randomized to usual care or receive financial incentives for meeting diabetes self-management and clinical outcomes goals during the study. Researchers will compare changes in glucose levels and person-reported outcomes between groups. conditions: Type 1 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 96 type: ESTIMATED name: Financial Incentives Program measure: Time In Range measure: Time Above Range measure: Time Below Range measure: Hemoglobin A1c (HbA1c) measure: Diabetes Distress measure: Diabetes Family Conflict measure: Adolescent Quality of Life measure: Caregiver Quality of Life measure: Diabetic Ketoacidosis measure: Severe Hypoglycemia measure: Insulin Adminstration sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06384898 id: STUDY00002259 id: UH3AT012413 type: OTHER_GRANT domain: National Center for Complementary and Integrative Health briefTitle: Remote Tai Chi for Knee Osteoarthritis acronym: TAICHIKNEE overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-12 date: 2027-10 date: 2024-04-25 date: 2024-04-25 name: Tufts Medical Center class: OTHER name: Boston Medical Center name: University of California, Los Angeles name: The Cleveland Clinic name: National Center for Complementary and Integrative Health (NCCIH) briefSummary: The goal of this pragmatic randomized trial is to evaluate the effectiveness of remote Tai Chi to treat knee pain in adults with knee osteoarthritis. The main questions the trial aims to answer are:

* Does remote Tai Chi improve the extent to which pain interferes with physical, mental, and social activities (PROMIS-Pain Interference at 3 months, primary outcome), as well as knee pain and function (WOMAC subscales) and analgesic use (secondary outcomes)
* Does remote tai chi decreases healthcare utilization?

Researchers will compare remote Tai Chi added to routine care to routine care alone to see if remote tai chi works to treat knee osteoarthritis pain. Participants will participate in remotely delivered web-based tai chi sessions, twice a week for 12 weeks, or will continue to receive routine care. Participants will be followed for 12 months after randomization. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study is an individually randomized group-treatment (IRGT) trial. Individuals randomly allocated to remote Tai Chi receive the intervention with other participants through an instructor. primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 480 type: ESTIMATED name: Remote Tai Chi measure: PROMIS Pain Interference score measure: PROMIS Pain Interference score measure: PROMIS Pain Interference score measure: WOMAC total score measure: WOMAC total score measure: WOMAC total score measure: SF-12 PCS score measure: SF-12 PCS score measure: SF-12 PCS score measure: Number of knee joint injections measure: WOMAC Pain Score measure: WOMAC Pain Score measure: WOMAC Pain Score measure: WOMAC Pain Score on nominated activity chosen at baseline measure: WOMAC Pain Score on nominated activity chosen at baseline measure: WOMAC Pain Score on nominated activity chosen at baseline measure: WOMAC function score measure: WOMAC function score measure: WOMAC function score measure: WOMAC stiffness score measure: WOMAC stiffness score measure: WOMAC stiffness score measure: Patient's global assessment score measure: Patient's global assessment score measure: Patient's global assessment score measure: PROMIS sleep disturbance OA Knee- Short Form 6a measure: PROMIS sleep disturbance OA Knee- Short Form 6a measure: PROMIS sleep disturbance OA Knee- Short Form 6a measure: Beck Depression Inventory-II score measure: Beck Depression Inventory-II score measure: Beck Depression Inventory-II score measure: SF-12 MCS score measure: SF-12 MCS score measure: SF-12 MCS score measure: Receipt of knee surgery measure: OMERACT/OARSI responder measure: OMERACT/OARSI responder measure: OMERACT/OARSI responder measure: Pain medication use measure: Pain medication use measure: Pain medication use sex: ALL minimumAge: 50 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tufts Medical Center city: Boston state: Massachusetts zip: 02111 country: United States name: Sherwood Alexis, MHA, MBA role: CONTACT phone: 617-636-5405 email: sherwood.alexis@tuftsmedicalcenter.org name: Chenchen Wang, MD role: PRINCIPAL_INVESTIGATOR name: Tim McAlindon, MD role: SUB_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06384885 id: 2024-079 briefTitle: Ultrasound Investigation Into Swimming Induced Pulmonary Edema in Open Water Swimming Athletes acronym: SIPE overallStatus: RECRUITING date: 2024-04-15 date: 2025-06-01 date: 2025-12-01 date: 2024-04-25 date: 2024-04-25 name: Rocky Vista University, LLC class: OTHER briefSummary: Swimming-induced pulmonary edema (SIPE) is a potentially life-threatening condition that can affect swimmers of all abilities. The pathophysiology is not well understood and early identification strategies are not established. Handheld ultrasound is a validated tool for the identification of pulmonary edema and is not well-studied in this population. Understanding the incidence of signs of pulmonary edema and its usefulness as a sign of early pulmonary edema would be beneficial This study evaluates triathletes and open water swimmers at endurance events. A validated protocol for lung ultrasound is used to identify the signs of pulmonary edema. The findings will be analyzed for differences in experience level, type of athlete, gender, age, and environmental factors. The findings may then be used in the future to aid in the early identification and treatment of athletes and military personnel in similar situations to decrease morbidity and mortality. conditions: Swimming Induced Pulmonary Edema studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Ultrasound measure: Lung ultrasound sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rocky Vista University status: RECRUITING city: Parker state: Colorado zip: 80012 country: United States name: Kathryn A Vidlock, MD role: CONTACT phone: 651-226-1642 email: kvidlock@rvu.edu name: Brady Patterson role: PRINCIPAL_INVESTIGATOR name: Harrison Steins role: PRINCIPAL_INVESTIGATOR lat: 39.5186 lon: -104.76136 hasResults: False

 nctId: NCT06384872 id: 230042_RRI_Interv5 briefTitle: Effect of Shoe Cushioning Position and Properties on Running-related Injury Risk acronym: RRI_Interv5 overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2025-09-30 date: 2025-12-31 date: 2024-04-25 date: 2024-04-26 name: Luxembourg Institute of Health class: OTHER_GOV name: DECATHLON SA briefSummary: The main purpose of this project is to investigate the influence of cushioning material at both the rear and the forepart of running shoes on musculoskeletal complaints in leisure-time runners. Therefore, the objectives are to investigate if

1. "Extra soft" cushioning materials can reduce injury risk compared to stiffer materials;
2. Cushioning under the forepart of the shoe also influences injury risk, independently of the cushioning at the rear part;
3. Effects of cushioning material and position depend on the runner's body mass;
4. Perception of cushioning is related to both shoe cushioning and injury risk;
5. Other weight-bearing locomotion activities (i.e., number of steps per day besides running practice) represents an independent risk factor for running-related injury.

This study consists in a 6-month intervention trial during which leisure-time runners are required to follow their usual training schedule. Before the beginning of the study, the participants will receive a pair of running shoes. The three running shoe models will be exactly the same, except for their foam properties at the rear and forepart of the shoe, which will differ by 33 and 37%, respectively. The study shoes will be administered through random allocation. The participants will be required to use these shoes for all running sessions, and only for running activities.

Participants will first fill out a baseline questionnaire. During the intervention, data on running practice will be downloaded from sports watches and their respective app via Strava. Information on the use of the study shoes will be collected via a weekly questionnaire. Participants will be asked to fill out a weekly questionnaire on any musculoskeletal complaints experienced during the past 7 days. A questionnaire on the perception of cushioning will be filled in by the participants at three time points (after 5h of running, 25h of running, and at the end of follow-up).

Primary hypothesis:

- Greater shock absorption properties at the rear part of running shoes are associated with a lower injury risk in recreational runners.

Secondary hypothesis:

* Greater shock absorption properties under the forepart of the shoe are also associated with lower injury risk in recreational runners.
* Runners with low body mass experience a lower injury risk in shoes with greater shock absorption properties.
* Greater perceived cushioning is related to lower injury risk. conditions: Running-related Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: Participants will be stratified according to their sex. Two pre-established randomization list will be prepared by a statistician not involved in any other part of the study before the beginning of the study. To ensure allocation concealment, the study groups as well as the shoes will be coded and the randomization lists will be uploaded in the electronic system by an IT specialist who will not be involved in any other part of the study. The electronic system will provide the investigator with a study group code for each participant, according to the randomization lists. The investigator will upload the shoe ID according to shoe size and study group so that a cross validation will be performed by the electronic system. The investigators in charge of the recruitment, follow-up and data validity check, as well as the participants, will be blinded regarding the shoe version distributed. The shoe code will be broken after completion of data analysis. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1068 type: ESTIMATED name: Shoe Cushioning Position and Properties measure: First running-related injury with a duration of minimum one week measure: First one-day time loss running-related injury measure: First running-related musculoskeletal complaint to the lower limb measure: First substantial running-related injury measure: First overuse running-related injury sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Luxembourg Institute of Health city: Strassen zip: 1445 country: Luxembourg name: Laetitia Garcia, Msc role: CONTACT phone: +352 26970957 email: Laetitia.Garcia@lih.lu lat: 49.62056 lon: 6.07333 hasResults: False

 nctId: NCT06384859 id: Pending briefTitle: Effectiveness of Extracorporeal Shockwave Therapy Combined With Platelet-rich Plasma in the Treatment of Chronic Insertional Achilles Tendinopathy overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2027-05-01 date: 2024-04-25 date: 2024-04-25 name: Mahidol University class: OTHER briefSummary: The goal of this clinical trial is to learn about the effectiveness of extracorporeal shockwave(ESWT) combined with platelet-rich plasma(PRP) to treat chronic insertional tendinopathy. The main questions it aims to answer are:

Does ESWT combined with PRP treatment reduce the symptom and improve functional score after treatment? What medical complication do participants have when receive the treatment?

Researchers will compare ESWT combined with PRP to ESWT treatment alone to see if ESWT combined with PRP works to treat chronic insertional tendinopathy.

Participants will:

* Receive ESWT once a week for 4 weeks then receive PRP injection at a week later or ESWT once a week for 4 weeks
* Visit the clinic at 6 weeks, 3 months, 6 months and 1 year after treatment for checkups and record functional score conditions: Insertional Achilles Tendinopathy studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 94 type: ESTIMATED name: ESWT name: PRP measure: VAS measure: VAS-FA measure: FFI measure: FAAM sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ramathibodi hospital city: Ratchathewi state: Bangkok zip: 10400 country: Thailand name: Prapan Wongrungrote, MD role: CONTACT phone: +66 0810688654 email: prapanw197@gmail.com name: Sukij Laohajaroensombat, MD role: CONTACT phone: +66 022011589 email: sukij.lah@mahidol.ac.th lat: 13.759 lon: 100.53358 hasResults: False

 nctId: NCT06384846 id: AI ACS briefTitle: AI Algorithms in Prediction of ACS Based on Leukocyte Properties overallStatus: RECRUITING date: 2024-02-01 date: 2026-07-31 date: 2026-12-31 date: 2024-04-25 date: 2024-04-25 name: RobotDreams GmbH class: INDUSTRY briefSummary: The goal of this observational study is to find out if artificial intelligence (AI) can accurately predict acute coronary syndrome (ACS) using data on white blood cells in adults. The main question it aims to answer is:

- Can AI algorithms based on white blood cell data predict ACS with accuracy comparable to that of high-sensitivity cardiac troponin (hs-cTn)? Researchers will look at how the AI model's predictions stack up against the standard hs-cTn blood tests to see which is more accurate in diagnosing ACS.

Participants in this study will have already had blood tests as part of their usual care. Their previously collected health information and blood test results will be used to help train and test the AI algorithms. Participants will not undergo any new procedures for the study itself. conditions: Acute Coronary Syndrome conditions: Angina Pectoris conditions: NSTEMI - Non-ST Segment Elevation MI conditions: STEMI - ST Elevation Myocardial Infarction studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 2700 type: ESTIMATED measure: Training of AI models measure: Testing of AI models measure: Training of AI models measure: Testing of AI models: sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Landeskrankenhaus-Universitätsklinikum Graz status: RECRUITING city: Graz state: Styria / Steiermark zip: 8036 country: Austria name: Heiko Bugger, MD role: CONTACT phone: +43 316 385 30177 email: heiko.bugger@medunigraz.at lat: 47.06667 lon: 15.45 hasResults: False

 nctId: NCT06384833 id: Rama briefTitle: Combination of Vitamin C and N-Acetylcysteine to Improve Functional Outcome After Rotator Cuff Repair overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-09-01 date: 2026-05-01 date: 2024-04-25 date: 2024-04-25 name: Mahidol University class: OTHER briefSummary: The goal of this clinical trial is to learn if vitamin C and N-acetylcysteine work to improve shoulder functional score after rotator cuff repair. It will also learn about the safety of vitamin C and N-acetylcysteine. The main questions it aims to answer are:

Do vitamin C and N-acetylcysteine improve the shoulder functional score of participants? Do vitamin C and N-acetylcysteine improve healing of rotator tendon? Researchers will compare vitamin C and N-acetylcysteine to a placebo (a look-alike substance that contains no drug) to see if vitamin C and N-acetylcysteine works to improve shoulder functional score after rotator cuff repair.

Participants will:

Take vitamin C and N-acetylcysteine or a placebo every day for 45 days. Visit the OPD three times at 2 week, 6 month and 12 month after surgery for checkups and tests. conditions: Rotator Cuff Tears studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 110 type: ESTIMATED name: Ascorbic acid name: N-acetyl cysteine name: placebo measure: ASES score measure: UCLA shoulder scale measure: WORC index measure: Tendon healing at 6 months postoperatively sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06384820 id: R3767-ONC-2330 id: 2023-510514-38-00 type: REGISTRY domain: EU CT Number briefTitle: Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC) overallStatus: NOT_YET_RECRUITING date: 2024-11-14 date: 2026-06-08 date: 2030-05-06 date: 2024-04-25 date: 2024-04-25 name: Regeneron Pharmaceuticals class: INDUSTRY briefSummary: This study is researching an investigational drug called REGN2810, also known as cemiplimab, when combined with another investigational drug called REGN3767, also known as fianlimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on a type of skin cancer known as cutaneous squamous cell carcinoma (CSCC).

The aim of the study is to see if cemiplimab or cemiplimab in combination with fianlimab can eliminate or reduce the number of living cancer cells in tumor(s) if taken before surgery.

The study is looking at several other research questions, including:

* Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make it possible to have a less extensive surgery or a different treatment plan after surgery
* Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make the cancer less likely to come back after surgery
* What side effects may happen from taking the cemiplimab or cemiplimab in combination with fianlimab
* How much of the cemiplimab or cemiplimab in combination with fianlimab is in the blood at different times
* Whether the body makes antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects) conditions: Cutaneous Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 140 type: ESTIMATED name: cemiplimab name: fianlimab measure: Pathological complete response (pCR) rate by blinded independent pathological review (BIPR) measure: pCR rate by local pathological review measure: Major pathological response (MPR) measure: Event-free survival (EFS) measure: Disease free survival (DFS) measure: Objective response rate (ORR) prior to surgery measure: Overall survival (OS) measure: Occurrence of treatment-emergent adverse events (TEAEs) measure: Occurrence of immune-mediated adverse events (imAEs) measure: Occurrence of treatment-related TEAEs measure: Occurrence of adverse event of special interest (AESI) measure: Occurrence of treatment-emergent serious adverse events (SAEs) measure: Occurrence of laboratory abnormalities measure: Occurrence of death due to TEAE measure: Occurrence of interruption of study drug(s) due to TEAEs measure: Occurrence of discontinuation of study drug(s) due to TEAEs measure: Occurrence of cancellation of surgery due to TEAE measure: Occurrence of delay to surgery due to TEAE measure: Concentrations of cemiplimab in serum measure: Concentrations of fianlimab in serum measure: Concentrations of other experimental agents (as applicable) in serum measure: Incidence of anti-drug antibodies (ADA) to cemiplimab measure: Incidence of ADA to fianlimab measure: Incidence of ADA to other experimental agents (as applicable) measure: Titer of ADA to cemiplimab measure: Titer of ADA to fianlimab measure: Titer of ADA to other experimental agents (as applicable) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06384807 id: BHV1510-101 (PBI-410-101) briefTitle: A Phase 1/2 Study of PBI-410 in Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-02 date: 2028-02 date: 2024-04-25 date: 2024-04-25 name: Pyramid Biosciences class: INDUSTRY briefSummary: This is a Phase 1/2, first in human (FIH), open-label, multicenter study of PBI-410 in participants with previously treated, advanced solid tumors. conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: Dose escalation followed by enrollment in signal-finding cohorts. primaryPurpose: TREATMENT masking: NONE count: 170 type: ESTIMATED name: PBI-410 measure: Phase 1: Number of patients with adverse events (AEs) measure: Phase 1: Recommended dose for expansion (RDE) and maximum tolerated dose (MTD) measure: Phase 2: Objective Response Rate (ORR) measure: Phase 2: Number of patients with AEs measure: Phase 2: Duration of Response (DoR) measure: Phase 1 and 2: Maximum Plasma Concentration (Cmax) of PBI-410 measure: Phase 1 and 2: Area Under the Concentration versus time Curve (AUClast) from the end of infusion to the last measurable concentration of PBI-410 measure: Phase 1 and 2: Area Under the Concentration versus time curve extrapolated to infinity (AUCinf) measure: Phase 1 and 2: Elimination half-life (t1/2) of PBI-410 in plasma measure: Phase 1: ORR measure: Phase 1: Duration of Response (DoR) measure: Phase 1 and 2: Immunogenicity of PBI-410 measure: Phase 2: Disease control rate (DCR) measure: Phase 2: Progression free survival (PFS) measure: Phase 2: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06384794 id: 2211-VLC-157-MD briefTitle: Study of the ZyMōt Sperm Selection Method and Its Effect on Embryo Ploidy. acronym: ZYMOT2 overallStatus: RECRUITING date: 2023-06-29 date: 2025-07-01 date: 2026-12-31 date: 2024-04-25 date: 2024-04-29 name: Instituto Valenciano de Infertilidad, IVI VALENCIA class: OTHER name: IVI Madrid briefSummary: It has been described that 11% of men with semen values within the normal range established by the World Health Organization (WHO) have sperm DNA fragmentation. This has been associated with a lower fertilization rate, lower embryo development and, therefore, lower reproductive success. Focusing on the study of the integrity of the male genome can provide us information to diagnose infertility in the couple. The use of conventional sperm selection methods such as swim-up or density gradients has been a great advance in the improvement of male fertility. However, these methods use centrifugation in their protocol, a procedure that has been associated with sperm DNA damage. The ZyMōt is a chip based on microfluidic properties that allows the recovery of spermatozoa with lower DNA fragmentation rate without centrifugation of the semen sample. This new sperm selection method maintains all the advantages of conventional techniques, but decreasing DNA fragmentation associates to sperm recoveries techniques eventually improving reproductive rates. This quality would be beneficial for patients with unexplained infertility, recurrent pregnancy loss or clinical varicocele, factors that have been associated with a higher index of DNA fragmentation. However up to date there is evidence-based data supporting such improvement. The main objective of the present project is to evaluate the ZyMōt as a new non-invasive sperm selection device and to see its impact on the euploidy rate, comparing it with a sperm selection technique that is routinely used in the clinic: swim-up. At the same time, the effect that this new chip may have on sperm and other reproductive variables will be analyzed clinically, and molecularly with immunohistochemical and transcriptomic analyses in order to observe the impact of SDF(sperm DNA fragmentation) at the molecular and genomic level in oocytes with low reparative potential oocytes. conditions: Infertility, Male conditions: Sperm Count, Low studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicentric, prospective, experimental study. primaryPurpose: DIAGNOSTIC masking: SINGLE maskingDescription: Embryologists performing IVF/ICSI are blinded to the treatment the sample has undergone. All samples are labeled with the patients Identification number. This is a unique code per patient that does not allow identification of which arm the sample belongs to. whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Sperm capacitation through the ZyMōt®Sperm Separation Device® name: Swim-up measure: EUPLOIDY RATE measure: MOBILITY RATE measure: VITALITY RATE measure: DNA FRAGMENTATION RATE measure: SPERM RETRIEVAL RATE measure: FERTILIZATION RATE measure: USEFUL BLASTOCYS RATE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ivirma Madrid status: RECRUITING city: Madrid zip: 28023 country: Spain name: MONICA TORIBIO role: CONTACT phone: +34 651 79 10 00 email: IVESMADRID@IVIRMA.COM name: Alberto Pacheco, PhD role: SUB_INVESTIGATOR name: Lucía Sánchez, MSc role: SUB_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: Ivirma Valencia status: RECRUITING city: Valencia zip: 46015 country: Spain name: Maria Jose Delossantos, PhD role: CONTACT phone: 34963050900 email: mariajose.delossantos@ivi.es name: Laura Caracena, Mrs role: CONTACT phone: 34963050900 phoneExt: 11054 email: laura.caracena@ivirma.com name: Maria Jose Delossantos, PhD role: PRINCIPAL_INVESTIGATOR name: José María Delosantos, PhD role: SUB_INVESTIGATOR name: Angel Martín, MSc role: PRINCIPAL_INVESTIGATOR name: David Ortega, MSs role: PRINCIPAL_INVESTIGATOR lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06384781 id: 2130836 id: R61DA059892-01 type: NIH link: https://reporter.nih.gov/quickSearch/R61DA059892-01 briefTitle: Development, Refinement, and Validation of a Peer Support Specialist Checklist for Individuals With Opioid Use Disorder / STAMPS: South Carolina Buprenorphine Treatment Initiation, Adherence, and Retention Utilizing Mobile Health Units and Peer Support Specialists overallStatus: RECRUITING date: 2024-04 date: 2025-01 date: 2025-01 date: 2024-04-25 date: 2024-04-25 name: Prisma Health-Upstate class: OTHER name: Clemson University name: National Institute on Drug Abuse (NIDA) briefSummary: This study seeks to develop a tool to better guide and operationalize peer recovery coaching service delivery specifically for patients with opioid use disorder. This study will entail the initial development, acceptability, and validity of this tool in a sample of both peer support specialists (PSSs) and patients with opioid use disorder (OUD). This checklist will be adapted from ACE model PSS interventions for SUD broadly. Open-ended qualitative research questions regarding PSSs roles and responsibilities, patients' needs for recovery support, and perceptions of the checklist will be administered. Participants (PSSs and individuals with OUD) will also answer survey questions in which they indicate their satisfaction and likely to use the tool with the proposed services offered in the checklist. Outcome measures include satisfaction, perceived use of use, and perceived helpfulness of the checklist. We hypothesize that using both PSS and patient input will result in a validated intervention protocol with demonstrated acceptability using it with patients with OUD. conditions: Opioid Use Disorder studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 90 type: ESTIMATED measure: Phase 1: Conceptualization measure: Phase 2: Conceptulization measure: Phase 3: Refinement measure: Phase 4: Validation measure: Phase 5: Preliminary efficacy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prisma Addiction Medicine Center - Mobile Health Clinic status: RECRUITING city: Clinton state: South Carolina zip: 29325 country: United States name: Marisol A Miranda, BS role: CONTACT phone: 864-501-9693 email: marisol.miranda@prismahealth.org name: Kaileigh A Byrne, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.47263 lon: -81.88066 facility: Prisma - Addiction Medicine Center Mobile Health Clinic status: RECRUITING city: Seneca state: South Carolina zip: 29672 country: United States name: Marisol A Miranda, BS role: CONTACT phone: 864-501-9693 email: marisol.miranda@prismahealth.org name: Kaileigh A Byrne, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.68566 lon: -82.9532 hasResults: False

 nctId: NCT06384768 id: EBIst id: 1919B012104428 type: OTHER_GRANT domain: TUBITAK briefTitle: Video Training on Pre-Pregnancy Fear of Birth in Male Partners overallStatus: COMPLETED date: 2022-02-01 date: 2022-05-01 date: 2022-08-30 date: 2024-04-25 date: 2024-04-26 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: This study aimed to evaluate the effect of an online video training on fears surrounding childbirth given to male partners before the pregnancy of their spouses. The study conducted with 43 male (22 intervention; 21 control) participants. Participants were divided into intervention and control groups. The intervention group was given video training on pregnancy and the birth process. \&#34;Descriptive Information Form\&#34; and the "Male-Childbirth Fear Prior to Pregnancy Scale" was used for data collection. Before the intervention, it was found that the fear level of childbirth was low. The video training given to male partners before the pregnancy of their spouses diminished the fear of birth but did not create a significant difference. These findings support long-term training that includes video tutorials for parents before birth. Interactive, participatory birth preparation training is likely to enhance the training's appeal for male partners. conditions: Fear of Childbirth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 43 type: ACTUAL name: Video training measure: Fear of Childbirth sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Istinye University city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06384755 id: 645788 id: 2022_HE2_409659 type: OTHER_GRANT domain: The Dam Foundation id: 645788 type: OTHER domain: Regional Ethics Committee (REK), South-East Norway briefTitle: Honest Open Proud for Psychotic and Bipolar Disorder in Norway acronym: HOP-NOR overallStatus: RECRUITING date: 2024-04-20 date: 2024-12-31 date: 2026-12-31 date: 2024-04-25 date: 2024-04-25 name: Oslo University Hospital class: OTHER name: University of Oslo briefSummary: The purpose of this pilot study is to evaluate the feasibility, acceptability and efficacy of a Norwegian adaptation of the group-based intervention 'Honest Open Proud' among adults with psychotic and bipolar disorders in an outpatient setting. conditions: Psychotic Disorders conditions: Bipolar Disorder conditions: Disclosure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Honest Open Proud program measure: Stigma Stress Scale (Rüsch, Corrigan, Wassel et al., 2009; Rüsch, Corrigan, Powell et al., 2009) measure: Disclosure Distress (Rüsch et al., 2014a) measure: Warwick and Edinburgh Wellbeing Scale (WEMWBS) (Tennant et al 2007) measure: Satisfaction with life (Lehman, 1988) measure: The Questionnaire about the Process of Recovery - 15 (QPR-15) (Niel et al 2007) measure: Internalised Stigma of Mental Illness Inventory (ISMI-10) (Boyd, Otilingam, & Deforge, 2014) measure: Patient Health Questionnaire-4 (PHQ-9) (Kroenke et al 2009) measure: Generalized Anxiety disorder (GAD-7) (Spitzer et al, 2006) measure: Disclosure measure: Feasibility of HOP program measure: Acceptability of HOP program participants measure: Acceptability of HOP peer facilitators sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nydalen DPS, Division of Mental Health and Addiction, Oslo University Hospital status: RECRUITING city: Oslo zip: 0351 country: Norway name: Mari Husa, MD role: CONTACT phone: 0047 95837846 email: mahusa@ous-hf.no name: Magnus Engen, PhD role: CONTACT phone: 0047 41004660 email: UXENMF@ous.hf.no lat: 59.91273 lon: 10.74609 facility: Søndre Oslo DPS, Division of Mental Health and Addiction, Oslo University Hospital status: NOT_YET_RECRUITING city: Oslo zip: 1281 country: Norway name: Hilde Daler, MSc role: CONTACT phone: 0047 23023100 email: uxruhi@ous-hf.no name: Marit Haram, PhD role: CONTACT phone: 0047 21077000 email: mharam@ous.hf.no lat: 59.91273 lon: 10.74609 hasResults: False

 nctId: NCT06384742 id: K23HL157698 type: NIH link: https://reporter.nih.gov/quickSearch/K23HL157698 briefTitle: Shift Worker Intervention for Sleep Health acronym: SWISH overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-09 date: 2027-03 date: 2024-04-25 date: 2024-04-25 name: Oregon State University class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The aim of this study is to pilot test a comprehensive, personalized, media-augmented telehealth intervention ("SWISH") designed to improve sleep health among shift workers. conditions: Shift Work Type Circadian Rhythm Sleep Disorder conditions: Insomnia, Psychophysiological studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participants are asked to refrain from mentioning any information about the treatment they receive when interacting with the investigator or outcomes assessors. Participants are asked not to share details of their treatment with other individuals at their workplace. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Shift Worker Intervention for Sleep Health measure: Retention Rate measure: Session Attendance measure: Implementation Assessment Measure measure: Patient Adherence measure: Therapist Fidelity measure: Acceptability of Study Procedures and SWISH measure: Mean 24-hour sleep duration and efficiency measure: Change in Fatigue Severity Scale measure: Change in Epworth Sleepiness Scale measure: Executive functioning measure: PROMIS Sleep Related Impairment measure: PROMIS Sleep Disturbances sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Oregon State University city: Corvallis state: Oregon zip: 97331-1102 country: United States name: Jessee Dietch, PhD role: CONTACT phone: 541-737-1358 email: jessee.dietch@oregonstate.edu name: Jessee Dietch, PhD role: PRINCIPAL_INVESTIGATOR lat: 44.56457 lon: -123.26204 hasResults: False

 nctId: NCT06384729 id: 123 briefTitle: Effectiveness of the EXOPULSE Mollii Ⓡ Suit in Patients With Multiple Sclerosis overallStatus: RECRUITING date: 2024-04-01 date: 2024-05-01 date: 2024-09-01 date: 2024-04-25 date: 2024-04-25 name: Universidad Europea de Madrid class: OTHER briefSummary: Abstract:

Background:

Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system with unknown etiology, causing a variety of symptoms including impaired balance, coordination, and walking difficulties. The Exopulse Mollii Ⓡ suit is an innovative approach for non-invasive, self-administered electrical stimulation designed to alleviate spasticity and improve motor function in various neurological conditions.

Objective:

To determine the effectiveness of the Exopulse Mollii Ⓡ suit in improving motor control in patients with MS.

Methods:

A randomized, double-blind clinical trial will be conducted, recruiting patients diagnosed with MS , aged 18 or above, with a Functional Ambulation Category (FAC) score between 2 and 4. Patients will be randomly assigned to two groups receiving either inactive or active Exopulse Mollii Ⓡ treatment for 60 minutes, three times a week, for three weeks. Outcome measures include pain, balance, gait speed, risk of falls, perception of walking difficulties, and quality of life assessed using validated scales. Statistical analysis will be performed using SPSS v.29.0.0.0.

Results:

Data on age, sex, weight, and MS-related factors will be collected at baseline. Primary outcomes include changes in pain, balance, and gait speed, while secondary outcomes encompass risk of falls, perception of walking difficulties, and quality of life. Analysis will compare mean differences between groups using appropriate statistical tests.

Conclusion:

This study aims to evaluate the efficacy of the Exopulse Mollii Ⓡ suit in enhancing motor function in MS patients. Findings may contribute to the development of novel therapeutic strategies for managing MS-related symptoms and improving patients' quality of life. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: A randomized, double-blind clinical trial is proposed, in which two researchers will conduct the intervention, and a third researcher will be responsible for programming the suits and attaching the belt to the suit. The data will be analyzed by a fourth researcher. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 22 type: ESTIMATED name: EXOPULSE Mollii Ⓡ measure: referred pain measure: Balance measure: gait speed and distance measure: fall risk measure: perception of walking difficulties measure: perceived quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cecilia Estrada Barranco status: RECRUITING city: Villaviciosa De Odón state: Madrid zip: 28670 country: Spain name: Cecilia Estrada Barranco, PhD role: CONTACT phone: 686166483 email: cecilia.estrada@universidadeuropea.es lat: 40.35692 lon: -3.90011 hasResults: False

 nctId: NCT06384716 id: CEB briefTitle: Evaluation of the Influence of a Core Muscle Control-Based Rehabilitation Program Patients With Multiple Sclerosis overallStatus: RECRUITING date: 2024-02-19 date: 2024-07-01 date: 2024-09-01 date: 2024-04-25 date: 2024-04-25 name: Universidad Europea de Madrid class: OTHER briefSummary: Given the structural relationship of the CORE as a whole, in this study we propose an intervention based on the global motor control of all the structures that make up the CORE to assess its effectiveness on urinary incontinence, sexual dysfunction and balance, as well as its relationship with respiratory function. According to our hypothesis, a global intervention could also be taken into account during conventional treatment in the future, helping to prevent genitourinary dysfunctions derived from alterations in motor control. conditions: Multiple Sclerosis conditions: Pelvic Floor Disorders conditions: Incontinence, Urinary studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a randomised clinical trial. The research will be conducted in accordance with the framework of application of the Helsinki declaration (21) and the law on Personal Data Protection and guarantee of digital rights (Organic Law 3/2018) . The design of this project will follow the definition of the standard elements of a clinical trial protocol: SPIRIT declaration primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 32 type: ESTIMATED name: rehabilitation programme based on motor control of core muscles measure: Difference in the percentage of initial and final maximum activity of the pelvic floor muscles. measure: - Differences between the initial and final thickness of the oblique abdominis and transverse oblique muscles by ultrasound. measure: - Differences in the assessment of health-related quality of life before and after the intervention measured with the I-QOL questionnaire. measure: - Differences in the assessment of female UI before and after intervention using the I-CIQ questionnaire measure: - Difference in the percentage of initial and final maximum activity of the paravertebral musculature activity. measure: - Differences between initial and final amplitude of initial and final diaphragmatic excursion by ultrasound. measure: - Difference between initial and final FVC/- Differences between the initial and final peak expired volume (FEV1) measure: differences between peak expiratory pressure (PEM) and minimum initial and end inspiratory pressure (MIP). measure: balance sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cecilia Estrada Barranco status: RECRUITING city: Madrid country: Spain name: Cecilia Estrada-Barranco, PhD role: CONTACT phone: 686166483 email: cecilia.estrada@universidadeuropea.es name: Esther Delgado, PhD role: CONTACT email: esther.delgado@universidadeuropea.es lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06384703 id: 201518015 briefTitle: The Relationship Between Microbiota and Coronary Ectasia overallStatus: COMPLETED date: 2020-11-03 date: 2021-04-25 date: 2021-06-18 date: 2024-04-25 date: 2024-04-25 name: Konya Beyhekim Training and Research Hospital class: OTHER_GOV name: Necmettin Erbakan University briefSummary: Introduction: It is now known that the microbiota is far beyond the microbial communities living in certain parts of our body and functions like a metabolic organ. In addition, the microbiota, through its metabolites, is involved in the pathophysiology or progression of a wide range of diseases, from atherosclerotic diseases to metabolic diseases and even neurological diseases. Among these metabolites, trimethylamine n-oxide metabolite has been shown to be particularly effective on atherosclerotic heart diseases. conditions: Coronary Ectasia conditions: Microbial Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 2 type: ACTUAL name: Taking blood for kit study measure: death sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Necmettin Erbakan University city: Konya zip: 42050 country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06384690 id: 4331899 briefTitle: Generating Health Evidence From Dietary Supplementation With a Micro-vegetable Blend overallStatus: RECRUITING date: 2024-02-01 date: 2024-11-30 date: 2025-08-31 date: 2024-04-25 date: 2024-04-25 name: University of Exeter class: OTHER name: Advanced Growers Limited name: Ecog Pro Limited briefSummary: Micro-vegetables (MV) are seedlings of larger vegetables. They can be grown quickly and are a concentrated source of micronutrients. MV are thought to have broad health benefits, including many inflammatory conditions. These include metabolic, cardiovascular, and cognitive diseases. This could have important implications for the health of an ageing UK population. Less than a third of British adults consume 5 portions of fruit and vegetables per day; this is the level that reduces risk of morbidity and mortality. Vegetables, including MV may - at least in part - exert their health effects by changing the level and type of bacteria in the mouth and gut. Despite their promise, the MV scientific literature is not yet extensive enough to support definitive health claims. It requires the addition of high-quality studies that are relevant to humans. This study will firstly investigate the anti-inflammatory effects on skeletal muscle and adipose tissue in older adults, using a proteomics approach. Second, this study will assess concentrations of circulating inflammatory markers in the sera collected from participants at baseline and at the conclusion of a 6-week period. Further, this study will describe the effects of six weeks MV consumption on cognition, and the oral and gut microbiome. As the bioactive compounds in the MV are owed to the potential beneficial effects for human health, these will be characterised in sera collected from participants. conditions: Inflammation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: Micro-vegetable blend name: Placebo measure: Tandem Mass Tag (TMT) global proteomics measure: Concentration of broad panel of inflammatory cytokines measure: Concentration of circulating bioactive components measure: Microbiome measure: Simple Reaction Time measure: Digit Vigilance measure: Choice Reaction Time measure: Pattern Separation sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Public Health and Sports Sciences, University of Exeter status: RECRUITING city: Exeter state: Devon zip: EX1 2LU country: United Kingdom name: Cealan Henry role: CONTACT email: c.henry3@exeter.ac.uk lat: 50.7236 lon: -3.52751 hasResults: False

 nctId: NCT06384677 id: 03.03.2023/371 briefTitle: Comparison of Postoperative Analgesia Methods in Patients Undergoing Major Intraabdominal Surgery overallStatus: COMPLETED date: 2023-04-20 date: 2024-02-01 date: 2024-02-01 date: 2024-04-25 date: 2024-04-25 name: Marmara University class: OTHER briefSummary: This study aims to examine the effects of M-TAPA applied for postoperative analgesia in patients who had major intraabdominal surgery on the postoperative pain score, the change in the postoperative total opioid requirement and the side effects. conditions: Abdominal Cancer conditions: Abdomen Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 43 type: ACTUAL name: M-Tapa Block measure: Opioid Consumption measure: NRS Scores measure: the need for rescue analgesia measure: side effects sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marmara University Pendik Research and Training Hospital city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06384664 id: HUM00241242 briefTitle: Cryoablation Effects on Acute and Chronic Pain After Thoracotomy and Thoracoscopy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2028-04 date: 2024-04-25 date: 2024-04-25 name: University of Michigan class: OTHER name: AtriCure, Inc. briefSummary: The researchers will compare the common methods of post-surgical pain control, such as epidural or intercostal nerve block with a newer method called cryoablation. The research team is conducting this study to determine if cryoablation provides more effective pain control when compared to an epidural or intercostal nerve block. conditions: Pain, Postoperative conditions: Intrathoracic Procedure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 80 type: ESTIMATED name: Atricure's crysoSPHERE probe name: Standard of Care measure: Severity of pain in the peri-operative period measure: Inflammatory cytokine levels as measured by blood samples measure: Inflammatory cytokines (IL-1, IL-6, TNF-a) levels correlations to pain score measure: Peri-operative pain scores between different surgical incisions (posterolateral thoracotomy vs thoracoscopy) measure: Peri-operative nerve function between different surgical incisions (posterolateral thoracotomy vs thoracoscopy) measure: Quality of life score as measured by SF-36 Health questionnaire measure: Cost (including postoperative epidural management, narcotic pain medication, and outpatient pain management) measure: Workflow/time measure: Complications following surgery measure: Length of stay measure: Time to ambulation measure: Chronic Pain medication use through 6 months measure: Chronic pain through 6 months. measure: Chronic pain through 6 months. measure: Chronic pain through 6 months. measure: Incentive spirometry volumes in the peri-operative period (POD 1 and 2) measure: Oxygen requirement measure: Hospital charges and hospital reimbursement by different payors 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: Shari L Barnett role: CONTACT phone: 734-936-4561 email: shbailey@umich.edu name: Rishindra Reddy, MD, MBA role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False

 nctId: NCT06384651 id: PRO00037789 briefTitle: Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty acronym: IOTAA overallStatus: RECRUITING date: 2023-12-13 date: 2027-04 date: 2027-12 date: 2024-04-25 date: 2024-04-25 name: The Methodist Hospital Research Institute class: OTHER briefSummary: The purpose of this study is to compare two different antibiotic regimens and techniques during total ankle arthroplasty (TAA).

Primary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic samples between patient groups.

Secondary Objective: Compare 30 day and 90 day post-operative complication rates (infection) between the control (standard IV administration of vancomycin) vs the interventional group (intraosseous administration of vancomycin). The investigators hypothesize that there will be no difference in complication (infection) rates between groups. conditions: Infections conditions: Ankle Arthritis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is a prospective, randomized, single-blinded, controlled trial. 20 patients in each treatment arm: 20 patients will be given IV vancomycin, 20 patients will be given IO vancomycin primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: single blind patient is blinded. Surgeon is not blinded. Lab technician measuring tissue concentrations are blinded. Research coordinator is not blinded. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Intraosseous Vancomycin Injection name: Intravenous Vancomycin measure: Systemic Sample Vancomycin Tissue Concentration - Start of Case measure: Systemic Sample Vancomycin Tissue Concentration - End of Case measure: Capsule or Synovium Sample Vancomycin Tissue Concentration measure: Distal Tibia Sample Vancomycin Tissue Concentration measure: Talar Bone Sample Vancomycin Tissue Concentration measure: 90 day post-operative wound complication and infection rates 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 C Sullivan, BS role: CONTACT phone: 346-238-1603 email: tsullivan@houstonmethodist.org name: Jason S Ahuero, MD role: PRINCIPAL_INVESTIGATOR name: Kevin Varner, MD role: SUB_INVESTIGATOR name: Kwan J Park, MD role: SUB_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06384638 id: coconut periodontitis briefTitle: Coconut Oil in Treatment of Periodontitis overallStatus: COMPLETED date: 2022-02-15 date: 2024-01-16 date: 2024-02-09 date: 2024-04-25 date: 2024-04-25 name: Misr University for Science and Technology class: OTHER briefSummary: Virgin Coconut Oil (VCO) is a vegetable oil extracted from coconut fleshcontains unsaturated fatty acids in the form of oleic acid and linoleic acid and flavonoids which function as anti-inflammatory. Periodontitis is an inflammatory disease of the periodontal tissues with a high prevalence worldwide. The main etiology of plaque periodontitis is biofilm containing colonies of pathogenic microorganisms. The aim of the study is to evaluate and compare the effect of scaling and root debridement alone versus the use of topically applied coconut oil as adjunctive to scaling and root debridement in treatment of Stage II and III Grade B periodontitis. conditions: Periodontal Diseases studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 34 type: ACTUAL name: topical application of coconut oil name: scaling and debridement measure: clinical parameters measure: clinical parameters measure: Biological parameters sex: ALL minimumAge: 35 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of dentistry at MUST city: Giza zip: 02 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06384625 id: 361378 briefTitle: Air Pollution Intervention for Cardiovascular Patients overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-02-01 date: 2025-02-01 date: 2024-04-25 date: 2024-04-25 name: University of Montana class: OTHER name: Providence Heart Institute briefSummary: This pilot study (n=20) is a prospective evaluation of the implementation of an indoor air pollution intervention among patients who have undergone recent percutaneous coronary intervention procedures. The intervention, called Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE), is focused on improving indoor air quality through air filtration, education, and behavioral recommendations. All participants will receive the AIRWISE intervention with the objective of evaluating acceptance and use of the individual intervention components. This implementation study will inform the submission of a larger NIH proposal for a randomized trial. The central study hypothesis is that an intervention program with educational strategies and visual behavioral cues will increase knowledge and awareness of air pollution exposures among the participants and lead to improved intervention compliance. conditions: Coronary Heart Disease conditions: Cardiovascular Diseases conditions: Environmental Exposure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: AIRWISE measure: Evaluate the implementation of an indoor air pollution intervention. measure: Fine particulate matter (PM2.5) measure: Life's Essential 8 sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06384612 id: Adnan Menderes U briefTitle: The Effect Of The Use Of Pocket Cards In An Undergraduate Nursıng overallStatus: COMPLETED date: 2021-09-13 date: 2022-05-22 date: 2023-07-13 date: 2024-04-25 date: 2024-04-25 name: Aydin Adnan Menderes University class: OTHER briefSummary: The aim of this study is to examine the effect of the use of pocket cards by students taking the "Care of a Child with Special Needs" course on students' self-efficacy perceptions and course success.

1. H01. There is no difference between the self-efficacy perception scores of the students in the group who use pocket cards in the care of children with special needs course and the students in the group who do not use pocket cards.
2. H02. There is no significant difference between the course success scores of the students in the group who use pocket cards in the care of children with special needs course and the students in the group who do not use pocket cards. conditions: Student conditions: Self Efficacy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: experimental primaryPurpose: OTHER masking: NONE count: 128 type: ACTUAL name: use of pocket cards measure: Self-Efficacy Perception Scale sex: ALL minimumAge: 18 Years maximumAge: 22 Years stdAges: ADULT facility: Bircan Kahraman Berberoğlu city: Efeler state: Aydin zip: 0900 country: Turkey hasResults: False

 nctId: NCT06384599 id: CS-190 briefTitle: VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-01 date: 2026-06-01 date: 2024-04-25 date: 2024-04-25 name: Adagio Medical class: INDUSTRY briefSummary: The PMCF is a prospective, single-arm, multi-center, controlled study of up to 130 patients designed to collect safety and performance data regarding the use of the Adagio VT Cryoablation System in the treatment of recurrent ventricular tachycardia. conditions: Ventricular Tachycardia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: VT Cryoablation System measure: Primary Performance Endpoint measure: Primary Safety Endpoint measure: Secondary Performance Endpoint measure: Secondary Safety Endpoint sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Essex Cardiothoracic Centre city: Basildon state: Essex zip: SS16 5NL country: United Kingdom name: Neil Srinivasan role: CONTACT lat: 51.56844 lon: 0.45782 hasResults: False

 nctId: NCT06384586 id: CD J8855 briefTitle: Investigation of Dietary Supplement Liquid Shot Products on Mental Energy, Cognition (Acuity),and Mood overallStatus: COMPLETED date: 2022-11-17 date: 2022-12-22 date: 2022-12-22 date: 2024-04-25 date: 2024-04-25 name: The Water Street Collective class: INDUSTRY name: HCD Research name: British American Tobacco (Investments) Limited briefSummary: This is a single center, randomized, double blind, placebo-controlled, crossover study to determine the acute effect of a developmental dietary supplement liquid shot product on cognitive task performance and perceived effect measures related to mood and mental energy. The study will be conducted in healthy participants. conditions: Cognition conditions: Mental Fatigue conditions: Mood studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 45 type: ACTUAL name: Placebo shot name: Functional energy shot measure: Mental energy via Cognitive Demand Battery (CDB) Performance Index; for the functional energy shot versus placebo shot. measure: Mental energy via Cognitive Demand Battery (CDB) Accuracy score for the functional energy shot versus placebo shot. measure: Change in performance on Corsi blocks task for functional energy shot versus placebo measure: Change in performance on Rapid Visual Information Processing (RVIP) for functional energy shot versus placebo measure: Change in performance on Numeric working memory for functional energy shot versus placebo measure: Change in performance on Serial subtraction task for functional energy shot versus placebo measure: Change in Mood via Visual Analogue Scales (VAS) during Cognitive Demand Battery (CDB), for functional energy shot versus placebo measure: Change in physiological state via Profile Of Mood States (POMS) during Cognitive Demand Battery (CDB), for functional energy shot versus placebo sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Schlesinger Group New Jersey city: Iselin state: New Jersey zip: 08330 country: United States lat: 40.57538 lon: -74.32237 hasResults: False

 nctId: NCT06384573 id: DIAN-TU-003 id: The Alzheimer's Association type: OTHER_GRANT domain: DIAN-TU-OLE-21-725093 briefTitle: DIAN-TU Amyloid Removal Trial (ART) in Dominantly Inherited Alzheimer's Disease acronym: DIAN-TU overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2029-11 date: 2029-11 date: 2024-04-25 date: 2024-04-25 name: Washington University School of Medicine class: OTHER name: Alzheimer's Association name: Eisai Inc. briefSummary: This is an open label study to treat dominantly inherited Alzheimer's disease (DIAD) mutation carrier participants from the DIAN-TU-001 gantenerumab Open Label Extension (OLE) period with lecanemab to determine the effects of amyloid removal on age of onset and clinical progression compared to external controls, if amyloid plaque as measured by amyloid PET can be fully removed in DIAD, and the effects of amyloid removal on biomarkers of disease progression. conditions: Alzheimer's Disease conditions: Dementia conditions: Alzheimer's Disease, Familial studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 65 type: ESTIMATED name: lecanemab measure: The primary endpoint for the final analysis is the time to recurrent progression of Clinical Dementia Rating - Sum of Boxes (CDR-SB). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama in Birmingham city: Birmingham state: Alabama zip: 35294 country: United States name: Erik Roberson role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 facility: University of California San Diego Medical Center city: La Jolla state: California zip: 92037 country: United States name: Doug Galasko role: PRINCIPAL_INVESTIGATOR lat: 32.84727 lon: -117.2742 facility: Indiana University School of Medicine city: Indianapolis state: Indiana zip: 46202 country: United States name: Jared Brosch role: PRINCIPAL_INVESTIGATOR lat: 39.76838 lon: -86.15804 facility: Washington University in St. Louis city: Saint Louis state: Missouri zip: 63110 country: United States name: Barbara Snider role: PRINCIPAL_INVESTIGATOR lat: 38.62727 lon: -90.19789 facility: University of Pittsburgh city: Pittsburgh state: Pennsylvania zip: 15213 country: United States name: Sarah Berman role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 facility: University of Washington city: Seattle state: Washington zip: 98195 country: United States name: Suman Jayadev role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 facility: Neuroscience Research Australia city: Randwick state: New South Wales zip: 2031 country: Australia name: William Brooks role: PRINCIPAL_INVESTIGATOR lat: -33.91439 lon: 151.24895 facility: The National Hospital for Neurology and Neurosurgery city: London state: Greater London zip: WC1B 3BG country: United Kingdom name: Catherine Mummery role: CONTACT lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06384560 id: 2023-508707-20-00 briefTitle: Neoadjuvant Triple Treatment for Borderline Resectable Pancreatic Cancer (PREOPANC-5) acronym: PREOPANC-5 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-03 date: 2028-03 date: 2024-04-25 date: 2024-04-25 name: Amsterdam UMC, location VUmc class: OTHER name: Maastricht University Medical Center name: Erasmus Medical Center name: St. Antonius Hospital briefSummary: Since patients with borderline resectable pancreatic cancer (BRPC) have a limited life expectancy, it is important to improve treatment strategies. Therefore, the objective of this study is to investigate whether neoadjuvant triple treatment chemotherapy, immunotherapy and radiotherapy, followed by surgery and chemotherapy and immunotherapy survival in patients with BRPC. conditions: Borderline Resectable Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 66 type: ESTIMATED name: Pembrolizumab measure: Percentage of patients with progression free survival at 18 months (RECIST 1.1) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06384547 id: VRDN-001-303 briefTitle: A Randomized, Active Controlled, Safety and Tolerability Study of VRDN-001 in Participants With Thyroid Eye Disease (TED) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2026-01 date: 2024-04-25 date: 2024-04-25 name: Viridian Therapeutics, Inc. class: INDUSTRY briefSummary: The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in patients with thyroid eye disease (TED). The primary objective of this clinical trial is to evaluate the safety and tolerability of VRDN-001 in patients with TED. conditions: Thyroid Eye Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized, active controlled, safety and tolerability study of VRDN-001, a humanized monoclonal antibody directed against the IGF-1 receptor, in participants with thyroid eye disease (TED) primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 212 type: ESTIMATED name: VRDN-001 10 mg/kg name: VRDN-001 3 mg/kg measure: Treatment Emergent Adverse Event (TEAE) incidence rate measure: Change from baseline in proptosis in the study eye as measured by exophthalmometer at Week 15 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: United Medical Research Institute city: Inglewood state: California zip: 90301 country: United States name: James Peace, MD role: CONTACT phone: 310-645-4673 lat: 33.96168 lon: -118.35313 hasResults: False

 nctId: NCT06384534 id: PVD_6MWD_SOT briefTitle: Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy in Pulmonary Vascular Disease (PVD) overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-11 date: 2024-04-25 date: 2024-04-25 name: University of Zurich class: OTHER briefSummary: The investigators aim to study the effect of SOT in Swiss residents with pulmonary vascular diseases (PVD) defined as pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH). conditions: Pulmonary Vascular Disorder conditions: Chronic Thromboembolic Pulmonary Hypertension conditions: Pulmonary Arterial Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Each participant is its own control primaryPurpose: OTHER masking: NONE count: 28 type: ESTIMATED name: 6-minute walk distance (6MWD) test on ambient air name: 6-minute walk distance test with supplemental oxygen measure: 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air measure: SpO2 at rest and peak 6MWD with SOT vs. ambient air measure: Heart rate at rest and peak 6MWD with SOT vs. ambient air measure: Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air measure: Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air measure: Blood pressure at rest and peak 6MWD with SOT vs. ambient air sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Zürich city: Zurich zip: 8091 country: Switzerland name: Silvia Ulrich, Prof. Dr. role: CONTACT phone: 0041 44 255 22 20 email: silvia.ulrich@usz.ch name: Mona Lichtblau, Dr. role: CONTACT phone: +41442552220 email: mona.lichtblau@usz.ch name: Silvia Ulrich, Prof. Dr. role: PRINCIPAL_INVESTIGATOR lat: 47.36667 lon: 8.54999 hasResults: False

 nctId: NCT06384521 id: STUDY00000500 briefTitle: Lifestyle MIND- Feasibility for Randomized Wait-list Control Trial acronym: MIND overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-04 date: 2025-05 date: 2024-04-25 date: 2024-04-25 name: The University of Texas Health Science Center at San Antonio class: OTHER briefSummary: The goal of this clinical trial is to examine if it is feasible to randomly assign people into two groups and participate in Lifestyle MIND (Mental Illness and/N' Diabetes) at two different times. Lifestyle MIND is a diabetes lifestyle intervention recently developed for people with serious mental illness (SMI). It is known to be helpful for people with SMI who complete it, but the investigators do not know the effect in comparison to those who do not participate in it. The main questions it aims to answer are:

* Does Lifestyle MIND improve diabetes control among people with SMI?
* Will the effect of Lifestyle MIND be sustained 10 weeks after program completion?
* From the provider's perspective, what are the barriers of achieving optimal diabetes treatment outcomes for patients with SMI?

Researchers will compare outcomes of participants in the intervention with those in the wait-list control arm, to see if there will be significant differences in blood glucose level, compliance of diabetes self-management, time staying active, number of emergency department (ED) visits and psychiatric hospitalization, and subjective well-being. conditions: Type 2 Diabetes Mellitus conditions: Serious Mental Illness conditions: Schizophrenia conditions: Major Depression conditions: Bipolar Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Lifestyle MIND measure: Hemoglobin A1c (HbA1c) measure: Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire measure: Hours of Active and Sedentary Behavior measure: Number of emergency department (ED) visits and psychiatric hospitalizations measure: Satisfaction with Life Scale (SWLS) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Texas Health Science Center at San Antonio city: San Antonio state: Texas zip: 78229 country: United States name: Chinyu Wu, PhD role: CONTACT phone: 210-567-8890 email: wuc7@uthscsa.edu name: Chinyu Wu, PhD role: PRINCIPAL_INVESTIGATOR name: Bradley Tragord, ScD role: SUB_INVESTIGATOR lat: 29.42412 lon: -98.49363 hasResults: False

 nctId: NCT06384508 id: NL83340.058.23 briefTitle: Decrease Trauma-related Shame With Virtual Reality: The Effectiveness of SHINE-VR acronym: SHINE-VR overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-10-31 date: 2024-10-31 date: 2024-04-25 date: 2024-04-25 name: Universiteit Leiden class: OTHER name: University of Amsterdam briefSummary: Suffering from PTSD in childhood can have detrimental formative consequences. Researchers have been eager to develop effective interventions and to enhance treatment motivation since the introduction of the diagnosis of PTSD in the DSM. With evolving understanding of the disorder, its definition and criteria have changed over the course of time. The most recent change involves the addition of the criterium D of negative affects or emotions in relation to PTSD, the feeling of shame amongst others. Individuals experiencing interpersonal trauma, such as sexual abuse, are at high-risk developing trauma-related shame, which in turn can impact the course and effectiveness of PTSD treatment. Shame-inducing situations are typically being avoided, and the feelings are not disclosed to peers and other people. Hence, acknowledging and sharing feelings of shame as well as practicing self-compassion have been proposed to reduce the impact of that negative self-conscious emotion. These aspects get partially tackled in evidence-based trauma therapies, however, there appears to be a need for a more specific trauma-related shame intervention in addition to existing treatments. Recent research has focused on developing such interventions for adults and has reported positive effects.

To our knowledge, there is no intervention specifically tackling trauma-related shame in adolescents. Virtual Reality (VR) is a promising tool for such an intervention. Findings suggest that including VR in a treatment results in high treatment satisfaction and that it is highly motivating for its users, which is a crucial component for treatment success.

The goal of this study is to test the effectiveness of a short-term VR shame intervention (SHINE-VR) for adolescents suffering from PTSD after having experienced sexual abuse. The primary objectives of this study to assess the effect of SHINE-VR on trauma-related shame, self-compassion, and PTSD symptom reduction, to investigate whether treatment motivation, an increase in self-compassion, and a decrease in trauma-related shame are associated with PTSD symptom reduction, and the evaluation of SHINE-VR by assessing the feasibility of the intervention. conditions: Shame studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Single Case Experimental Design (ABC) with two different baseline lengths primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The participants are unaware of different baseline lengths whoMasked: PARTICIPANT count: 10 type: ESTIMATED name: SHINE-VR measure: Trauma-related shame measure: Self-compassion measure: PTSD symptoms measure: Treatment motivation sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD facility: iMindU Practice for Child, Adolescent and Adult Psychiatry city: Leiden state: South Holland zip: 2311 EX country: Netherlands name: Marie-Jose van Hoof, MD PhD role: CONTACT name: Marie-Jose van Hoof, MD PHD role: PRINCIPAL_INVESTIGATOR lat: 52.15833 lon: 4.49306 facility: LEVVEL city: Amsterdam country: Netherlands name: Ramon Lindauer, Prof. Dr. role: CONTACT lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06384495 id: STUDY00021475 briefTitle: How Does Cerebellar tDCS Alter Intracortical Inhibition Over Time? overallStatus: NOT_YET_RECRUITING date: 2024-08-15 date: 2025-03-31 date: 2025-03-31 date: 2024-04-25 date: 2024-04-25 name: University of Minnesota class: OTHER briefSummary: Combining cortical tDCS with behavioral interventions has been shown to have beneficial outcomes in individuals post-stroke. However, cerebellar tDCS is a fairly new approach for individuals with unilateral cortical stroke and there has not been reports of duration of effect of tDCS applied to the cerebellum in this population.

Information gained from this study will serve to fill knowledge gaps on the duration of effect of cerebellar tDCS and the effects of polarity.

The purpose of this study is to determine the duration of effect of ventro-lateral cerebellar transcranial direct current stimulation (tDCS) in healthy adults through cortical excitability (CE), cognitive, language and motor assessment measures. Primary aim: Compare baseline CE from left motor cortex of first dorsal interosseous (FDI) and orbicularis oris (OO) areas to CE post cerebellar tDCS at 15 minutes, 45 minutes and 75 minutes. Single-pulse and paired-pulse transcranial magnetic stimulation (TMS) will be used to measure and compare stimulus response curve (S/R curve), cortical silent period (CSP) and short-interval intracortical inhibition (SICI) in the hand area and facial area of the left primary motor cortex at each time point.

Secondary aim: Compare baseline performance on cognition, motor learning and language tasks to performance at 15, 45 and 75 minutes after receiving tDCS. Digit Symbol Substitution Test (DSST), Serial Reaction Time Test (SRTT) and Lexical Decision tasks will be presented via a computer interface. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: REAL-A name: REAL-C name: SHAM measure: stimulus/response curve (S/R Curve) measure: Cortical Silent Period (CSP) measure: Short-interval Intracortical Inhibition (SICI). measure: Digit Symbol Substitution Test (DSST) measure: Serial Reaction Time Test (SRTT) measure: Lexical Decision Task sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06384482 id: SNC115-DLL3 CART-101 briefTitle: SNC115 Injections in Patients With Recurrent/Refractory Small Cell Lung Cancer and Lung Large Cell Neuroendocrine Carcinoma overallStatus: RECRUITING date: 2024-04-30 date: 2025-04-30 date: 2025-12-30 date: 2024-04-25 date: 2024-04-25 name: Shanghai Simnova Biotechnology Co.,Ltd. class: INDUSTRY name: Shanghai Chest Hospital briefSummary: This study is a FIH dose escalation clinical study, with single arm, open label and design, in order to observe the preliminary safety and Pharmacokinetic of SNC115 Injection in participants with Recurrent/refractory small cell lung cancer and Lung large cell neuroendocrine carcinoma. conditions: Recurrent/Refractory Small Cell Lung Cancer Lung Large Cell Neuroendocrine Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: SNC115 injection measure: Safety of SNC115 Injection measure: Safety of SNC115 Injection measure: -Efficacy of SNC115 Injection measure: -Efficacy of SNC115 Injection measure: -Efficacy of SNC115 Injection measure: -Efficacy of SNC115 Injection measure: -Efficacy of SNC115 Injection measure: -Efficacy of SNC115 Injection measure: -PK characteristic of SNC115 Injection. measure: -PK characteristic of SNC115 Injection. measure: PK characteristic of SNC115 Injection. measure: PK characteristic of SNC115 Injection. measure: PK characteristic of SNC115 Injection. measure: PK characteristic of SNC115 Injection. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Chest Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200030 country: China name: Hua Zhong, MD/PhD role: CONTACT phone: 021-22200000 email: ctqxkyy@163.com; eddiedong8@hotmail.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06384469 id: 98984697615 briefTitle: The Impact of Rhinoplasty Approach and Used Autologous Cartilage Grafts on the Nasal Skin-soft Tissue Envelope Metabolism overallStatus: NOT_YET_RECRUITING date: 2025-01-02 date: 2026-01-02 date: 2026-09-01 date: 2024-04-25 date: 2024-04-29 name: University Hospital "Sestre Milosrdnice" class: OTHER briefSummary: This is a prospective observation cohort investigation. Patients, that is participants, undergoing primary functional rhinoplasty will be evaluated in terms of measuring capillary blood lactic acid concentration in the nasal skin-soft tissue envelope immediately after the procedure and 7 days after the procedure.

The aim of our study is to test whether or not different rhinoplasty approaches and volume of the used autologous cartilage grafts impact the nasal skin-soft tissue metabolism. conditions: Rhinoplasty conditions: Nasal Skin-soft Tissue Envelope Metabolism conditions: Lactic Acid conditions: Autologous Cartilage Grafting studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Difference of capillary blood lactic acid concentration in the nasal skin-soft tissue envelope depending on the rhinoplasty approach measure: Correlation between the used autologous cartilage graft volume and lactic acid concentration in the nasal skin-soft tissue envelope sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06384456 id: 23-5708 briefTitle: Topical TRanexamic Acid vs. Placebo on Acute Postoperative Pain Following DRF Fixation acronym: TRADR overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2026-06 date: 2026-09 date: 2024-04-25 date: 2024-04-26 name: University Health Network, Toronto class: OTHER briefSummary: The goal of this study is to find out whether the use of topical tranexamic acid (TXA) into the surgical wound will result in less post-operative pain, less pain killer use, and better post-operative use of the wrist in people undergoing surgery for a wrist fracture compared to not using topical TXA (placebo). conditions: Distal Radius Fractures 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: Topical TRanexamic Acid name: Placebo measure: acute post-op pain measure: opioid use measure: persistent pain measure: unscheduled hand-related procedures measure: Patient reported function sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Toronto Western Hospital city: Toronto state: Ontario country: Canada name: Ryan Paul, MD role: CONTACT email: ryan.paul2@uhn.ca lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06384443 id: 01001099646 briefTitle: Proton Pump Inhibitors in Cirrhotic Patients overallStatus: COMPLETED date: 2020-10-01 date: 2024-03-01 date: 2024-03-01 date: 2024-04-25 date: 2024-04-25 name: National Liver Institute, Egypt class: OTHER briefSummary: Proton pump inhibitors (PPIs) inappropriate use, in patients with cirrhosis, presents a significant clinical challenge. This study evaluates overprescription and misuse of PPIs in cirrhotic patients. The patterns of use of PPIs will be classified into two groups based on adherence to the proven indications: Group A: Inappropriate use of PPI, Group B: Appropriate use of PPI. We will estimate the prevalence of PPI misuse in cirrhotics and correlate it with different factors. conditions: Proton Pump Inhibitor Adverse Reaction conditions: Liver Cirrhosis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 1000 type: ACTUAL measure: Inappropriate use of PPIs measure: Predictors for inappropriate use of PPIs sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Liver institute - Menoufia University city: Shibīn Al Kawm state: Menoufia zip: 32511 country: Egypt lat: 30.55258 lon: 31.00904 hasResults: False

 nctId: NCT06384430 id: MuğlaSKU-NKO briefTitle: Subacromial Impingement Syndrome overallStatus: RECRUITING date: 2024-04-01 date: 2024-08-31 date: 2024-09-01 date: 2024-04-25 date: 2024-04-25 name: Muğla Sıtkı Koçman University class: OTHER briefSummary: Subacromial impingement syndrome is a common shoulder pain disorder. In this study, among the patients who applied to the Physical Medicine and Rehabilitation outpatient clinic of Muğla Training and Research Hospital and were diagnosed with subacromial impingement by anamnesis and clinical tests, inclusion criteria (being between 18-70 years of age, positivity for subacromial impingement syndrome in clinical evaluation (Neer's test, Hawkins Kennedy, supraspinatus palpation test)) and exclusion criteria (under 18 years of age, over 70 years of age, rheumatologic disease diagnosis, symptomatic shoulder osteoarthritis, shoulder instability; shoulder pain in active, passive cervical spine movements, previous shoulder surgery, those with adhesive capsulitis findings (\>50% passive range of motion restriction in 2 planes or full-thickness rotator cuff tear detected on ultrasound), those who received physiotherapy or intra-articular injections in the last 3 months, those with type 2 diabetes or hypothyroidism) will be included in the study. Demographic data of the patients will then be recorded. DASH (Disabilities of the Arm, Shoulder and Hand) and Constant Murley scores will be calculated. 4 years of musculoskeletal ultrasound experience will be recorded by a radiologist using ultrasound (Siemens® V8, LA2-14A probe) in modified Crass position (positioning with the palm of the examined side on the posterior iliac wing) by measuring subacromial bursa thickness, supraspinatus tendon thickness, acromiohumeral distance, supraspinatus tendon thickness/acromiohumeral distance ratio. Demographic data of the patients will then be recorded. DASH (Disabilities of the Arm, Shoulder and Hand) and Constant Murley scores will be calculated. conditions: To Show the Relationship Between Ultrasound Parameters and Shoulder Functional Tests studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 70 type: ESTIMATED name: Shoulder functional tests and ultrasound measure: subacromial bursa thickness measure: supraspinatus tendon thickness measure: acromiohumeral distance sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mugla Egitim Arastima status: RECRUITING city: Mugla country: Turkey name: Nihal KARAYER OZGUL, 1 role: CONTACT lat: 37.21807 lon: 28.3665 hasResults: False

 nctId: NCT06384417 id: STUDY00024858 briefTitle: Using an End-of-life Conversation Game to Engage Patients With Cancer in Advance Care Planning: Phase 2 overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-02 date: 2026-12 date: 2024-04-25 date: 2024-04-25 name: Milton S. Hershey Medical Center class: OTHER briefSummary: The goal of this clinical trial is to explore feasibility, acceptability, and effectiveness of end-of-life conversation game "Hello" as a tool to help individuals with various solid cancer types (including: breast, gastro-intestinal, lung, melanoma, head and neck, and/or genito-urinary cancers) treated at Penn State Health clinics and their loved ones perform advance care planning (ACP). The main questions it aims to answer are:

What modifications and/or adaptations are necessary to Hello for use in cancer populations?

What impact does participation in Hello event have on health care usage (e.g., number of hospitalizations, ICU admissions, emergency department visits, etc.)? How feasible is it to randomize participants to play either Hello for Cancer or Table Topics?

Participants will:

* Complete pre-game questionnaires
* Play either Hello or Table Topics game
* Complete post-game questionnaires
* Participate in a focus group
* Complete a telephone follow up interview 1-4 months after their event

This study is a continuation of NCT06028152. conditions: Breast Cancer conditions: Lung Cancer conditions: Genito-Urinary Cancer conditions: Colorectal Cancer conditions: Gastric Cancer conditions: Pancreatic Cancer conditions: Liver Cancer conditions: Head and Neck Cancer conditions: Melanoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: INVESTIGATOR count: 32 type: ESTIMATED name: Hello for Cancer game name: Table Topics game measure: Feasibility and Acceptability of modified Hello game measure: Healthcare Utilization measure: Advance Care Planning Engagement Measure measure: Advance Care Planning Surrogate Decision Maker Engagement Measure measure: Satisfaction of Intervention Measure measure: Acceptability of Intervention Measure measure: Preliminary efficacy of Hello on ACP behaviors. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Penn State Cancer Institute city: Hershey state: Pennsylvania zip: 17033 country: United States name: Michael Hayes, PhD role: CONTACT phone: 717-531-8521 email: mhayes3@pennstatehealth.psu.edu name: Michael Hayes, PhD role: SUB_INVESTIGATOR name: Monika Joshi role: SUB_INVESTIGATOR lat: 40.28592 lon: -76.65025 hasResults: False

 nctId: NCT06384404 id: 2023-14741 briefTitle: Upfront Surgical Resection for Osteosarcoma acronym: UFSR for OS overallStatus: RECRUITING date: 2024-03-25 date: 2027-12-31 date: 2029-12-31 date: 2024-04-25 date: 2024-04-25 name: Montefiore Medical Center class: OTHER briefSummary: The goal of this pilot study is to learn about patients with newly diagnosed osteosarcoma of an extremity, and whether surgically removing the tumor prior to the administration of any chemotherapy will improve functional outcomes. In order to learn about the patient's experience, the study team will administer questionnaires to the patient and surgeon at various timepoints to assess recovery and the function of the extremity. conditions: Osteosarcoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10 type: ESTIMATED name: Questionnaire measure: Change in Health-Related Quality of Life (HRQoL) score from Historical Controls measure: Event Free Survival sex: ALL minimumAge: 5 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Montefiore Medical Center status: RECRUITING city: Bronx state: New York zip: 10467 country: United States name: Rebecca Zylber role: CONTACT phone: 718-741-2356 email: rzylber@montefiore.org name: Alice Lee, M.D. role: PRINCIPAL_INVESTIGATOR name: David Geller, M.D. role: SUB_INVESTIGATOR lat: 40.84985 lon: -73.86641 hasResults: False

 nctId: NCT06384391 id: 4-2023-1730 briefTitle: Intestinal Ultrasound, Magnetic Resonance Enterography, and Conventional Assessment Tools Before and After Treatment of Intestinal Behcet's Disease overallStatus: RECRUITING date: 2024-04-30 date: 2025-06-30 date: 2025-12-31 date: 2024-04-25 date: 2024-04-25 name: Yonsei University class: OTHER briefSummary: Background: The "treat-to-target" approach has recently been adopted in the treatment of inflammatory bowel disease (IBD). The basic premise is to define specific measurable targets and then adjust treatment until these targets are achieved and maintained. According to the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE)-Ⅱ statement published in 2021, the long-term treatment targets for IBD are clinical remission, endoscopic healing, absence of disability, restoration of quality of life, and normal growth in children. Symptomatic relief and normalization of serum and fecal markers were determined as short-term targets. Transmural healing in Crohn's disease and histological healing in ulcerative colitis are not formal targets but should be assessed as measures of the remission depth.

While endoscopic examination assesses the mucosal inflammatory status of the bowel wall, transmural inflammatory status needs to be evaluated with ultrasound, computed tomography (CT), or magnetic resonance enterography (MRE). Ultrasound is advantageous as it does not utilize ionizing radiation and is less costly and uncomfortable for patients, allowing more frequent use. Recent studies suggest that intestinal ultrasound is beneficial in treatment response assessment and planning in patients with Crohn's disease and ulcerative colitis. However, there is a paucity of study regarding the effectiveness of intestinal ultrasound in management of intestinal Behcet's disease. Furthermore, despite its accuracy and comprehensive imaging capabilities without radiation risk, MRE has not been widely used in the diagnosis and follow-up of the patients with intestinal Behcet's disease, and no studies have reported changes in MRE findings after treatment. conditions: Intestinal Behcet Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 55 type: ESTIMATED measure: Accuracy of intestinal ultrasound in identifying endoscopic remission at 26 weeks after initiation of medical treatment measure: Accuracy of intestinal ultrasound in identifying clinical remission at 26 weeks after initiation of medical treatment measure: Accuracies of magnetic resonance enterography in identifying endoscopic and clinical remission at 26 weeks after initiation of medical treatment measure: Accuracies of magnetic resonance enterography in identifying endoscopic and clinical responses at 26 weeks after initiation of medical treatment sex: ALL minimumAge: 19 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yonsei University Health system, Severance Hospital status: RECRUITING city: Seoul zip: 03722 country: Korea, Republic of name: Hyun Kyung Yang role: CONTACT phone: 82-2-2228-7400 email: hkyang@yuhs.ac lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06384378 id: FP00006640 briefTitle: Systemic and Central Inflammation in AD overallStatus: RECRUITING date: 2023-03-17 date: 2025-12-30 date: 2025-12-30 date: 2024-04-25 date: 2024-04-25 name: The Methodist Hospital Research Institute class: OTHER briefSummary: Inflammation could provide a new focus for therapeutic intervention. In this study, we will measure blood and cerebrospinal fluid (CSF) inflammation biomarkers and compare them to measurements of brain glial activation obtained by positron emission tomography (PET). In addition, we will determine the effect of low-dose interleukin-2 (IL-2) immunotherapy, given over 22 weeks, on these inflammation biomarkers. conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: 11C-ER176 measure: Blood inflammation biomarker levels measure: CSF inflammation biomarker levels measure: Voxel-wise, regional and total brain TSPO VT/fP measured with 11C-ER176 PET sex: ALL minimumAge: 50 Years maximumAge: 86 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Houston Methodist Research Institute status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Alireza Faridar role: CONTACT phone: 713-441-1150 email: afaridar@houstonmethodist.org lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06384365 id: 706014-4 briefTitle: Interaction of Inflammation, Taste Perception and Preferences as a Function of Physical Activity and Body Composition overallStatus: RECRUITING date: 2024-04-15 date: 2024-09-30 date: 2025-04-30 date: 2024-04-25 date: 2024-04-29 name: University of Vienna class: OTHER briefSummary: The aim of this study is to investigate whether differences in taste perception and preference behavior can be attributed to inflammatory processes induced by physical activity. The focus will be on sweet taste and the perception of fat. A non-invasive, observational study design will be used. conditions: Taste, Altered studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 66 type: ESTIMATED name: Physical activity measure: Taste sensitivity measure: Taste preference measure: Body composition measure: Low-grade inflammation measure: Oxidative Stress measure: fungiform papillae density 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: NCT06384352 id: YL211-INT-101-01 briefTitle: A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-05-08 date: 2027-04-07 date: 2029-04-07 date: 2024-04-25 date: 2024-04-29 name: MediLink Therapeutics (Suzhou) Co., Ltd. class: INDUSTRY name: Hoffmann-La Roche briefSummary: This is a multicenter, open-label, Phase 1 study. The study will enroll subjects with advanced solid tumors. It consists of three parts. Part 1 is dose-escalation part. In part 1, the safety and tolerability of YL211 in patients with selected advanced solid tumors will be evaluated and the MTD and RED will be determined.

Part 2 is backfill enrollment part. We will further estimate the safety and efficacy of YL211 in patients with selected adcance tumor to select the RED(s) of YL211.

Part 3 is dose-expansion part. In this part, we will further evaluate the safety and efficacy of YL211 at the MTD/RED(s) in patients with selected advanced solid tumors YL211 will be administered intravenously (IV) until criteria of treatment discontinuation are met. conditions: Advanced Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 155 type: ESTIMATED name: YL211 measure: To evaluate nature and frequency of AEs of YL211 in patients with advanced solid tumors according to NCI CTCAE version 5.0 measure: To evaluate nature and frequency of DLTs in part 1. measure: ORR assessed using RECIST version 1.1 measure: To determine the MTD and select the recommended expansion dose(s) (RED(s)) of YL211 in patients with advanced solid tumors measure: To characterize the AUC of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload measure: To characterize the Cmax of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload measure: To characterize the Ctrough of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload measure: To characterize the Tmax of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload measure: To characterize the CL of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload measure: To characterize the Vd of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload measure: To characterize the t1/2 of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload measure: To evaluate the anti-drug immune response after treatment with YL211 measure: To evaluate DCR of YL211 in patients with advanced solid tumors using RECIST version 1.1 measure: To evaluate DoR of YL211 in patients with advanced solid tumors using RECIST version 1.1 measure: To evaluate SD of YL211 in patients with advanced solid tumors using RECIST version 1.1 measure: To evaluate TTR of YL211 in patients with advanced solid tumors using RECIST version 1.1 measure: To evaluate PFS of YL211 in patients with advanced solid tumors using RECIST version 1.1 measure: To evaluate OS of YL211 in patients with advanced solid tumors using RECIST version 1.1 measure: To evaluate percent change in target lesion of YL211 in patients with advanced solid tumors using RECIST version 1.1 measure: Characterization of genomic alterations that are predictive of response to YL211 measure: The use of circulating tumor DNA (ctDNA) to monitor response to YL211 treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NEXT San Antonio city: San Antonio state: Texas zip: 78229 country: United States name: Site Coordinator role: CONTACT lat: 29.42412 lon: -98.49363 hasResults: False

 nctId: NCT06384339 id: ID-ClimAct-1 briefTitle: ID-ClimAct. Influence of Social Motives of Clients and Staff on the Social Climate of Secure Settings acronym: ID-ClimAct overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2024-09-20 date: 2024-10-20 date: 2024-04-25 date: 2024-04-29 name: University Psychiatric Clinics Basel class: NETWORK name: University of Basel briefSummary: The social climate in secure settings is an essential element to successful rehabilitation. Previous studies indicate that staff characteristics are a relevant factor contributing to a beneficial social climate. Yet, secure settings form a specific and challenging work environment. Staff members are faced with clients who present a variety of difficult emotional and behavioural problems. Social motives for caring and cooperation can be blocked in a threatening environment, favouring dysfunctional interpersonal dynamics between individuals. This observational study explores the reciprocal influences of social motives between clients and staff on the social climate within secure settings. conditions: Social Environment conditions: Correctional Institutions conditions: Rehabilitation of Criminals conditions: Social Dominance conditions: Interpersonal Relations studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED name: CSIV, Social motive name: Interpersonal messages and behavior name: CCS, Social motive measure: Social Climate Perception sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Psychiatric Clinics Basel, Clinic for Forensics city: Basel state: Basel-Stadt zip: 4002 country: Switzerland lat: 47.55839 lon: 7.57327 hasResults: False

 nctId: NCT06384326 id: bagattoni3 briefTitle: Parental Perceptions and Acceptance of Silver Diamine Fluoride in Spain and Italy acronym: SDF overallStatus: COMPLETED date: 2020-09-01 date: 2023-07-01 date: 2023-08-01 date: 2024-04-25 date: 2024-04-25 name: University of Bologna class: OTHER briefSummary: Assessing parental aesthetic acceptability of Silver Diamine Fluoride (SDF) staining is crucial for its potential implementation in paediatric dentistry. This study represents the third part of a wider project initially focused on evaluating SDF aesthetic acceptability in Italy, then comparing it between Spanish and Italian parents conditions: Comparative Study conditions: Aesthetic Perception conditions: Acceptability conditions: SDF studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 501 type: ACTUAL measure: Comparison of SDF's overall acceptance between Spanish and Italian parents measure: Comparison of SDF's specific acceptability in different scenarios of child's behavior between Spain and Italy measure: Parental overall acceptability of SD staining according to demographic background sex: ALL maximumAge: 12 Years stdAges: CHILD facility: Servizio di Assistenza Odontoiatrica per disabili in età evolutiva e di odontoiatria infantile city: Bologna zip: 40125 country: Italy lat: 44.49381 lon: 11.33875 hasResults: False

 nctId: NCT06384313 id: NL86266.068.24 briefTitle: Butyrate-enriched Triglyceride and Diabetes Prevention overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-09-01 date: 2027-09-01 date: 2024-04-25 date: 2024-04-25 name: Maastricht University Medical Center class: OTHER briefSummary: A body of animal studies as well as observational studies in humans demonstrated that butyrate is one SCFA that has pronounced positive effects on body weight control, inflammation, and insulin resistance. Even though the SCFA hexanoate is less researched, it has been shown to be involved in anti-inflammatory processes. Of note, acute human studies showed that fibre-induced metabolic improvements are linked to higher SCFA levels in the systemic circulation. We previously showed that a butyrate/hexanoate-enriched triglyceride oil enhanced systemic butyrate and hexanoate concentrations for a prolonged time. Yet, it remains to be determined whether a chronic increase in circulating butyrate and hexanoate concentrations translate into long-term benefits. We hypothesize that a chronic increase of butyrate/hexanoate in the circulation may improve host metabolism and metabolic health by improving adipose tissue function, reducing systemic lipid overflow and inflammation thereby increasing peripheral insulin sensitivity in individual with overweight/obesity and prediabetes. conditions: Type 2 Diabetes conditions: PreDiabetes conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 48 type: ESTIMATED name: butyrate/hexanoate-enriched triglycerides measure: Peripheral insulin sensitivity measure: hepatic insulin sensitivity measure: adipose tissue insulin sensitivity measure: Energy expenditure (indirect calorimetry) measure: Substrate oxidation (indirect calorimetry) measure: circulating SCFA measure: Faecal SCFA measure: Faecal microbiota composition measure: Circulating hormones such as insulin measure: Circulating metabolites such as glucose measure: body composition measure: body weight measure: Gut permeability sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06384300 id: BMSF briefTitle: Financial Incentives and Motivational Intervention to Improve Gastric Cancer Screening in China overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2027-01-31 date: 2027-07-31 date: 2024-04-25 date: 2024-04-25 name: Peking University class: OTHER briefSummary: Gastric cancer, also known as stomach cancer, is a serious disease that affects the stomach. It's one of the most common types of cancer, and sadly, many people die from it each year. But there's hope! We can catch gastric cancer early with a special test called endoscopy. This test helps doctors find cancer or pre-cancerous changes in the stomach early, when it's easier to treat. However, not enough people get this test, especially in places where healthcare isn't easily available. That's why we're doing this study.

We want to find out if we can encourage more people to get the endoscopy test for gastric cancer. We're going to try two different ways to encourage people to get the test. First, we'll give some people money or other incentives to help cover the costs of getting the test. Second, we'll give others information and support to help them understand why the test is important and how it can help them.

We'll be doing this study in two provinces in China, where gastric cancer is a big problem. We'll ask thousands of people to join the study, and we'll randomly assign them to one of the two groups. Then, we'll see if more people in one group get the endoscopy test compared to the other group.

Our hope is that by finding out what works best, we can help more people catch gastric cancer early and get the treatment they need. This could save many lives and make a big difference in fighting this disease. conditions: Gastric Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 5000 type: ESTIMATED name: Financial Incentives name: Motivational Intervention name: Mixed Intervention measure: Primary Outcome 1 measure: Primary Outcome 2 measure: Secondary Outcome sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06384287 id: APHP231342 briefTitle: Peripheral Tissue Perfusion in Intensive Care acronym: INPPEREA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-05 date: 2027-05 date: 2024-04-25 date: 2024-04-25 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Tissue perfusion has been identified as an early prognosis factor in patients admitted to intensive care. However, little is known about the effects of different hemodynamic interventions performed in clinical routine on peripheral tissue perfusion.

The aim of this work is to study the kinetics of CRT and local skin blood flow following therapeutic intervention (fluid challenge, vasopressor or inotropic drug). conditions: Acute Circulatory Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 180 type: ESTIMATED measure: Skin blood flow variations measure: Capillary refill time measure: Mottling score measure: correlation between Skin blood flow and CRT (baseline and variations) measure: correlation between skin blood flow and Cardiac output measure: correlation between skin blood flow and mean arterial pressure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06384274 id: NEUniversity briefTitle: The Effect of Emotional Freedom Technique and Virtual Reality Glasses on Anxiety and Vital Signs overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2024-10-01 date: 2025-06-01 date: 2024-04-25 date: 2024-04-25 name: Necmettin Erbakan University class: OTHER briefSummary: The aim of the study was to examine the effects of the emotional freedom technique and virtual reality glasses applied to individuals receiving hyperbaric oxygen therapy for the first time on anxiety and vital signs. The hypotheses of this research are that there is a difference between the emotional liberation technique and virtual reality glasses groups and the control group in terms of anxiety and vital signs. conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: Emotional Freedom Technique name: Virtual Reality Glasses measure: State Anxiety Inventory (STAI) measure: Blood Pressure measure: Pulse measure: Respiration measure: Body Temperature measure: Oxygen Saturation sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Gülsüm Gürsoy Açikgöz city: Konya state: Meram country: Turkey name: gülsüm GÜRSOY AÇIKGÖZ role: CONTACT phone: 05535553934 email: 2gulsum5@gmail.com lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06384261 id: OV-AML-1231 briefTitle: A Study Comparing Venetoclax and Azacitidine Plus Cusatuzumab to Venetoclax and Azacitidine in Newly Diagnosed AML Ineligible for Intensive Therapy overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-01 date: 2027-06 date: 2024-04-25 date: 2024-04-25 name: OncoVerity, Inc. class: INDUSTRY briefSummary: The goal of this clinical trial is to learn if participants treated with the experimental drug cusatuzumab added to venetoclax and azacitidine works to treat acute myeloid leukemia (AML) compared to venetoclax and azacitidine. Venetoclax and azacitidine are drugs commonly used to treat AML in patients that are unable to receive chemotherapy to treat AML. The main question the clinical trial aims to answer is does cusatuzumab added to venetoclax and azacitidine prolong the length of time participants live compared to venetoclax and azacitidine? conditions: Leukemia, Myeloid, Acute studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Cusatuzumab name: Venetoclax name: Azacitidine measure: Overall survival measure: Complete Remission rate (CR) measure: Event-free survival (EFS) measure: Composite CR rate (CRc) measure: Rate of CRh and CRi measure: Duration of CR measure: Time to first CR measure: Rate of minimal residual disease (MRD) negativity in patients achieving CR, CRh, or CRi measure: Proportion of participants proceeding to hematopoietic stem cell transplantation (HSCT) measure: OS in participants undergoing HSCT measure: Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study drug discontinuation measure: Incidence of dose modifications due to AEs measure: Number of participants with abnormal laboratory test results measure: Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAb) measure: Overall survival in subgroups of participants according to specified AML risk stratification models measure: Complete Remission rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06384248 id: LTC004-205 briefTitle: Phase II Clinical Study of LTC004 in Patients With Advanced Sarcoma overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2025-12-28 date: 2025-12-28 date: 2024-04-25 date: 2024-04-25 name: Letolab class: INDUSTRY briefSummary: This is a phase II clinical study to evaluate the safety, tolerability and preliminary antitumor activity of LTC004 in patients with locally advanced or metastatic sarcoma；Enrollment of 10 evaluable subjects in Phase I. If ≥2 subjects experience objective remission or SD lasting \>12 weeks, proceed to Phase II to enroll an additional 20 evaluable subjects to further evaluation of the safety and efficacy of LTC004 conditions: Unresectable or Metastatic Sarcoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: LTC004 measure: ORR measure: DOR measure: PFS rate measure: OS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06384235 id: LTC004-203 briefTitle: Phase II Clinical Study of LTC004 in Patients With mCRC overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2025-08-23 date: 2025-08-23 date: 2024-04-25 date: 2024-04-25 name: Letolab class: INDUSTRY briefSummary: This is a phase II clinical study to evaluate the safety and antitumor activity of LTC004 in patients with locally advanced or metastatic CRC，Enrollment of 10 evaluable subjects in Phase I. If ≥2 subjects experience objective remission，proceed to Phase II to enroll an additional 20 evaluable subjects to further evaluation of the safety and efficacy of LTC004 conditions: Locally Advanced or Metastatic CRC studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: LTC004 measure: ORR measure: DOR measure: PFS measure: OS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06384222 id: 235513 id: NCI-2024-03418 type: REGISTRY domain: NCI Clinical Trials Reporting Program (CTRP) briefTitle: Hyperpolarized (HP) 13C Pyruvate Magnetic Resonance Imaging (MRI) MRI as a Response Monitoring Tool to Neoadjuvant Abiraterone overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2027-07-31 date: 2027-07-31 date: 2024-04-25 date: 2024-04-25 name: Ivan de Kouchkovsky, MD class: OTHER briefSummary: This study will evaluate the use of hyperpolarized 13C MRI (HP 13C MRI) and the HP-derived 13C pyruvate-to-lactate conversion rate constant (kPL) as an early response biomarker in men with treatment-naïve, high-risk, localized or locally advanced prostate cancer receiving neoadjuvant therapy. conditions: High Risk Prostate Carcinoma conditions: Prostate Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: Abiraterone acetate name: Prednisone name: Hyperpolarized [1-13C] pyruvate (HP 13C) name: Magnetic Resonance Imaging (MRI) name: Non-investigational radical prostatectomy (RP) name: Prostate-Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) PET/Computerized tomography (CT) measure: Mean changes in intratumoral KPL measure: Pathological response rate measure: Proportion of participants with treatment-related adverse events measure: Proportion of participants completing RP measure: Median Time to Biochemical Recurrence measure: Proportion of participants with a >=50% decline in PSA level from baseline (PSA50) response measure: Proportion of participants with a >=90% decline in PSA level from baseline (PSA90) response measure: Mean PSA nadir 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 name: Maya Aslam role: CONTACT phone: 415-514-8987 email: Maya.Aslam@ucsf.edu name: Ivan de Kouchkovsky, MD role: PRINCIPAL_INVESTIGATOR lat: 37.77493 lon: -122.41942 hasResults: False

 nctId: NCT06384209 id: FBplus2024 briefTitle: The Friendship Bench Plus Trial acronym: FB+ overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-12-28 date: 2027-02-28 date: 2024-04-25 date: 2024-04-25 name: University of Bern class: OTHER name: University of Zimbabwe name: Swiss National Science Foundation briefSummary: The goal of this randomised controlled trial is to enhance the Friendship Bench intervention with antidepressants in adults with moderate to severe depression. The main questions it aims to answer are:

1. Is the combination of the Friendship Bench with nurse-led antidepressants prescribing superior to the Friendship Bench alone?
2. What are the barriers and enablers for the prescription of antidepressants by non-specialists in primary care?

Type of study: Randomized controlled superiority trial

Participants will be randomly selected and allocated into the control arm or intervention arm. Participants in the control arm will receive six sessions of the Friendship Bench Problem Solving Therapy while those in the intervention arm will receive the Friendship Bench intervention plus Fluoxetine (Sertraline for breastfeeding women). conditions: Major Depressive Disorder conditions: Severe Depressive Episode Without Psychotic Symptoms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 296 type: ESTIMATED name: Friendship Bench intervention name: Antidepressants -Fluoxetine measure: Treatment response measure: Remission sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Zimbabwe city: Harare country: Zimbabwe name: Rukudzo Mwamuka, Mbchb,MMed(Psychiatry) role: CONTACT phone: +263777065549 email: ruemwamuka.tsungu@gmail.com name: Jermaine Dambi, PhD role: CONTACT phone: +263773444911 email: jermaine.dambi@friendshipbench.io lat: -17.82772 lon: 31.05337 hasResults: False

 nctId: NCT06384196 id: PID2022-138902OB-I00 briefTitle: Identity-Based Transdiagnostic Therapy for Young People With Anxiety and Depression acronym: IBTTYOUNG overallStatus: NOT_YET_RECRUITING date: 2024-07-02 date: 2025-06-30 date: 2025-11-02 date: 2024-04-25 date: 2024-04-25 name: University of Barcelona class: OTHER name: Badalona Serveis Assistencials name: Nou Barris Mental Health Center briefSummary: Depression and anxiety are the most prevalent mental disorders among both the general population and young adults, and transdiagnostic treatments for these patients are mostly based on cognitive-behavioral therapy (CBT). Based on common (transdiagnostic) principles of treatment (e.g., emotional exposure), these approaches have proliferated and demonstrated their efficacy in comparison to disorder-specific treatments. Although there are a few transdiagnostic approaches for children and adolescents, we could not find anyone targeting young people. For this reason, we propose the Identity-Based Transdiagnostic Therapy (IBTT) as a new treatment modality ideally created to address the challenge of improving the outcomes of psychotherapy for young adults with anxiety and/or depression. The IBTT is a psychological treatment for emotional disorders specifically designed for the youths in terms of their attitudes to treatment (attractiveness, engagement), and highly personalized to their construal of self and others. This project will allow testing the hypothesis that a novel brief psychotherapeutic intervention, IBTT, will be more efficacious in the treatment of the anxiety and/or depression of young adults than the well-established CBT-based Unified Protocol. conditions: Depression conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The main study of this project proposal is a multi-center, single-blind, parallel-group randomized clinical trial (RCT) conducted in Catalonia (Spain). primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 138 type: ESTIMATED name: Identity-Based Transdiagnostic Therapy (IBTT) name: Unified Protocol measure: Depression, Anxiety and Stress Scales (DASS-21) measure: Clinical Outcomes in Routine Evaluation-Short Form B (CORE-SFB) measure: Mini International Neuropsychiatric Interview (MINI) measure: Session Rating Scale 3.0 (SRS 3.0) measure: Life Satisfaction Scale (LSS) measure: Self-Concept Clarity Scale (SCCS) measure: Rosenberg Self-Esteem Scale (RSES) measure: Metacognition Self-Assessment Scale (MSAS) measure: Problem definition form measure: Change Interview measure: Consumer Reports Effectiveness Scale (CRES-4) sex: ALL minimumAge: 16 Years maximumAge: 29 Years stdAges: CHILD stdAges: ADULT facility: Badalona Serveis Assistencials city: Badalona zip: 08911 country: Spain name: Irene Alvarez, PhD role: CONTACT email: iatomas@bsa.cat lat: 41.45004 lon: 2.24741 facility: Associació Centre Higiene Mental Nou Barris city: Barcelona zip: 08042 country: Spain name: Giuseppina Rametti, PhD role: CONTACT email: giusi.rametti@csm9b.com lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06384183 id: KS-1000 briefTitle: Kerecis Real World Registry overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-06 date: 2027-06 date: 2024-04-25 date: 2024-04-26 name: Kerecis Ltd. class: INDUSTRY briefSummary: Multi-center, observational (i.e., non-interventional), open-label, real-world Registry on the Use of Kerecis Devices conditions: Wounds conditions: Pressure Ulcer conditions: Diabetic Foot Ulcer conditions: Venous Leg Ulcer conditions: Surgical Wound conditions: Soft Tissue Reinforcement studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 600 type: ESTIMATED name: Kerecis Fish Skin Graft measure: Fish Skin Graft Device Related failure measure: Fish Skin Graft Device related allergy measure: Target Wound Infection measure: Complete Wound Healing measure: Complete Wound Closure sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06384170 id: IRB00442113 briefTitle: Closed Loop Spinal Cord Stimulation for Neuromodulation of Upper Motor Neuron Lesion Spasticity acronym: CLONUS overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-01 date: 2026-05 date: 2024-04-25 date: 2024-04-26 name: Johns Hopkins University class: OTHER name: Saluda Medical Pty Ltd briefSummary: Spasticity is characterized by increased muscle tension and is a classic consequence of upper motor neuron (UMN) damage in the central nervous system, such as from stroke or trauma. Clinically, it presents as muscle resistance to passive stretching, along with clasp-knife rigidity, clonus, increased tendon reflexes, and muscle spasms. An imbalance of the descending inhibitory and muscle stretch reflexes is thought to be the cause of spasticity. Post-stroke spasticity is a common condition that occurs in 37.5-45% of cases in the acute stage and 19-57.4% in the subacute stage after a stroke. At 6 months post-stroke, spasticity develops in 42.6-49.5% of cases, and at one year, it affects 35-57.4% of individuals. In patients with cerebral palsy (CP), incidence is almost 80% while in those living with spinal cord injury the number approaches up to 93%. Traumatic brain injury (TBI) patients have a higher prevalence on initial admission to neurorehabilitation but one in three patients will have chronic spasticity. However, the Defense and Veterans Brain Injury Center report a rate of TBIs amongst deployed veterans to be around 11-23% mostly from blast and explosive trauma.

There have been studies as early as the 1980s exploring the efficacy of SCS for spasticity control, however, the credibility of many of these studies is constrained due to an incomplete comprehension of spasticity's underlying mechanisms, outdated research methods, and early limitations in implantable device technology. Intrathecal pumps for baclofen have remained as the mainstay for refractory spasticity, however, it comes with associated risks such as chemical dependence leading to acute baclofen withdrawal and requiring frequent refill requirement. Most importantly, it does not yield functional improvement of muscle activity, just suppression of spasticity. Botox is also routinely used but due to heterogeneity in muscle involvement as well as variability in provider skill, results may be inconsistent and short-lasting, requiring frequent clinic visits for repeat injections to the affected muscle groups. SCS may be able to address that gap in spasticity management. conditions: Chronic Pain conditions: Spasticity as Sequela of Stroke conditions: Upper Motor Neuron Lesion studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 12 type: ESTIMATED name: Spinal Cord Stimulation- Closed loop measure: Pain as assessed by Visual Analog Score measure: Spasticity Reduction as assessed by the Modified Ashworth's Score measure: Short Form 36 Health Survey (SF-36) score measure: Medication Use measure: Health Status as assessed by the EuroQol 5 Dimension 5 Level (EQ-5D-5L) measure: Spinal cord neurophysiological wave morphology measure: Spinal cord neurophysiological Current (mA/mV) measure: Spinal Cord Neurophysiological Characteristic- Conduction Velocity (m/s) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins Hospital city: Baltimore state: Maryland zip: 21287 country: United States lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06384157 id: INDV-2000-201 briefTitle: Proof of Concept and Dose-ranging Study of INDV-2000 in Individuals With Moderate to Severe Opioid Use Disorder overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-08 date: 2025-09 date: 2024-04-25 date: 2024-04-29 name: Indivior Inc. class: INDUSTRY briefSummary: The purpose of this study is to measure safety and efficacy and to determine dose-response relationship for INDV-2000 in participants with moderate to severe Opioid Use Disorder (OUD) who are new to treatment, have recently initiated or completed short-term medically supervised withdrawal with transmucosal (TM) buprenorphine, and are interested in transitioning to a non opioid treatment. conditions: Opioid Use Disorder studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: This is a randomized, double-blind, placebo-controlled study where the investigator, assessor, sponsor and participant are masked. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 300 type: ESTIMATED name: INDV-2000 name: Placebo measure: Proportion (probability) of participants without treatment failure by the end of Week 12 (Day 85). measure: Proportion (probability) of visits with opioid abstinence while participants are on IMP alone. measure: Participant's percentage of visits with opioid abstinence during the whole study follow-up. measure: Incidence, severity and relatedness of adverse events, treatment-emergent adverse events, serious adverse events and events leading to discontinuation and deaths. measure: Opioid Craving Assessment measure: Cmax on Day 1 and Day 15/16 measure: Tmax on Day 1 and Day 15/16 measure: AUC0-24 on Day 1 and Day 15/16 measure: Cavg on Day 1 and Day 15/16 measure: Cmin on Day 1 and Day 15/16 measure: CL/F on Day 1 and Day 15/16 measure: Clinical Opiate Withdrawal Scale (COWS) score sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06384144 id: 23QC8155 briefTitle: Machine Learning Miscarriage Management Clinical Decision Support Tool Study acronym: MLMM overallStatus: RECRUITING date: 2023-01-01 date: 2024-06-01 date: 2026-06-01 date: 2024-04-25 date: 2024-04-25 name: Imperial College London class: OTHER briefSummary: Machine learning used to develop an algorithm to determine chance of success with expectant or medical management for an individual patient. Taking into account the following objective measures:

* Demographics: Maternal Age, Parity
* History: Previous CS, Previous SMM/MVA, Previous Myomectomy
* Gestation by LMP
* Presenting symptoms: Bleeding score, Pain score
* USS Measurements: CRL, GS, RPOC 3 dimensions, Vascularity
* Discrepancy between gestation by CRL and LMP

Audit to collate 1000 cases and identify features contributing to an algorithm that can predict outcome of miscarriage management for individualized case management. conditions: Miscarriage in First Trimester studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED name: Expectant Management of First Trimester Miscarriage name: Medical Management of First Trimester Miscarriage measure: Machine learning predictive model development for miscarriage management outcomes. measure: Prospective audit to test and validate predictive model sex: FEMALE minimumAge: 16 Years maximumAge: 55 Years stdAges: CHILD stdAges: ADULT facility: Imperial College Heatlhcare NHS Trust status: RECRUITING city: London zip: W12 0HS country: United Kingdom name: Sughashini Murugesu role: CONTACT phone: 07988390772 email: sughashini.murugesu@nhs.net lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06384131 id: ABI-4334-102 id: 2024-511051-18 type: EUDRACT_NUMBER briefTitle: A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects With Chronic Hepatitis B Virus Infection overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-04-22 date: 2025-04-22 date: 2024-04-25 date: 2024-04-25 name: Assembly Biosciences class: INDUSTRY briefSummary: This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-4334 in treatment-naïve or off-treatment chronic Hepatitis B virus (cHBV) subjects that are Hepatitis B e antigen (HBeAg) positive or negative. The study will enroll up to 5 sequential cohorts of 10 subjects each, for a total of up to 50 subjects, randomized 8:2 to receive ABI-4334 or placebo. conditions: Chronic Hepatitis B studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Triple (Participant, Care Provider, Investigator) whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 50 type: ESTIMATED name: ABI-4334 name: Placebo measure: Primary Outcome Measure measure: Maximum Plasma Concentration (Cmax) of ABI-4334 in subjects with cHBV measure: Minimum Plasma Concentration (Cmin) of ABI-4334 in subjects with cHBV measure: Area Under Plasma Concentration-Time Curve (AUC) of ABI-4334 in subjects with cHBV measure: Time to Maximum Plasma Concentration (Tmax) of ABI-4334 in subjects with cHBV measure: Elimination half-life (t1/2) of ABI-4334 in subjects with cHBV measure: To evaluate the changes in HBV DNA (IU/mL or Log IU/mL) in subjects with cHBV measure: Proportion of subjects with HBV DNA < lower limit of quantification (LLOQ) and/or limit of detection (LOD) measure: Mean time elapsed to subjects achieving HBV DNA < LLOQ and/or LOD sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06384118 id: YZUHL20220047 briefTitle: Effects of a Health Intervention on Hypoglycemic Coping : a Pilot Study overallStatus: COMPLETED date: 2023-08-01 date: 2024-01-17 date: 2024-01-17 date: 2024-04-25 date: 2024-04-25 name: Yating Liu class: OTHER briefSummary: From August 2023 to January 2024, 100 patients with type 2 diabetes who met the inclusion and exclusion criteria were selected from the endocrinology department of The purpose of this study was to construct a hypoglycemia coping intervention program for type 2 diabetic patients based on the IMB theory and to investigate the feasibility, acceptability, and initial effects of the program. conditions: Type 2 Diabetes Mellitus conditions: Hypoglycemia conditions: Health Education studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ACTUAL name: Impact of an IMB theory-based health education intervention on hypoglycemic coping in patients with type 2 diabetes: a pilot study measure: The hypoglycemic coping style measure: hypoglycemic fear behavioral measure: Hypoglycemia fear worry measure: Level of health information access behavior measure: Level of health beliefs measure: Level of diabetes knowledge sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ya ting Liu city: Yangzhou state: 未选择 country: China lat: 32.39722 lon: 119.43583 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-08-01 uploadDate: 2024-04-16T10:45 filename: Prot_SAP_000.pdf size: 233766 hasResults: False

 nctId: NCT06384105 id: PRDE1 briefTitle: Study of the Patient Radiation Dose During Five Endourological Procedures acronym: PRDE overallStatus: RECRUITING date: 2023-12-19 date: 2024-12-18 date: 2024-12-18 date: 2024-04-25 date: 2024-04-25 name: Universiteit Antwerpen class: OTHER briefSummary: In the medical world more and more procedures are performed with the use of ionizing radiation (x-ray), both diagnostic and therapeutic. The main and most known risk is the development of malignancies as a result of the use of ionizing radiation.

Purpose of this study: To examine the patient radiation dose (PRD) if the frames per second (FPS) are set differently during the five most performed endourological procedures where fluoroscopy is used (insertion/replacement of ureteral stent, (mini-)percutaneous nephrolithotomy (PCNL/PNL), ureterorenoscopy (URS) and extracorporeal shock wave lithotripsy (ESWL/SWL)) and to propose an acceptable PRD for these procedures in a multicentric study. conditions: Radiation Exposure conditions: Urolithiasis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 870 type: ESTIMATED name: frames per second measure: Dose limit measure: Difference in PRD measure: PRD different centres measure: PRD difference complicated cases sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AZ Klina status: RECRUITING city: Brasschaat state: Antwerp zip: 2930 country: Belgium name: Vincent De Coninck, MD role: CONTACT phone: +32 3 650 50 56 phoneExt: +32 email: vincent.de.coninck@klina.be lat: 51.2912 lon: 4.49182 facility: UZA status: RECRUITING city: Edegem state: Antwerp zip: 2650 country: Belgium name: Stefan De Wachter, MD role: CONTACT phone: +32 3 821 33 68 phoneExt: +32 email: stefan.de.wachter@uza.be lat: 51.15662 lon: 4.44504 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-07-06 uploadDate: 2024-04-22T15:53 filename: ICF_000.pdf size: 735146 hasResults: False

 nctId: NCT06384092 id: NB240005-NB-V briefTitle: Process Validation in Dermatology: Assessing Methods for UV Exposure (Artificial Source vs. Sunlight) and Efficacy Evaluation of Anti-Tanning Agents overallStatus: COMPLETED date: 2024-03-07 date: 2024-03-13 date: 2024-03-13 date: 2024-04-25 date: 2024-04-29 name: NovoBliss Research Pvt Ltd class: OTHER briefSummary: The rationale of this study is to establish a robust method for assessing sun protection product efficacy in preventing erythema and tanning. Employing both artificial ultraviolet-A Irradiation and natural direct sunlight exposure, the investigation seeks to provide a reliable methodology, ensuring reproducibility and enabling a direct comparison between these methods. Meticulously determining optimal UV dosages, the study prioritizes inducing skin responses for evaluation while avoiding adverse effects like blistering. The localized validation of UV exposure techniques, tailored to the Indian population, contributes significantly to the field by addressing diverse skin types and environmental conditions. By incorporating both artificial and natural (direct sunlight) UV exposure methods, the study aspires to enhance the safety and effectiveness of future dermatological investigations, benefiting both the scientific community and the broader population. conditions: Skin Pigmentation studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Proof of science/concept primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 6 type: ACTUAL name: Test Sun Protection Cream name: Benchmark Sun Protection Cream measure: Changes in Melanine index using instrumental assessment measure: Change in erythema index using instrumental assessment measure: Change in skin erythema/dryness/wrinkles and oedema using draize scale sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: NovoBliss Research Pvt Ltd city: Gandhinagar state: Gujarat zip: 382421 country: India lat: 23.21667 lon: 72.68333 hasResults: False

 nctId: NCT06384079 id: STU00219828 briefTitle: Duration of Ureteral Rest Prior to Ureteral Reconstruction Surgery overallStatus: RECRUITING date: 2024-05 date: 2025-11 date: 2030-11 date: 2024-04-25 date: 2024-04-25 name: Northwestern University class: OTHER briefSummary: Our objective is to assess the effect of duration of ureteral rest, defined as time from conversion of ureteral stent to percutaneous nephrostomy, on stricture length prior to ureteral reconstruction surgery. conditions: Ureteral Stricture studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 25 type: ESTIMATED name: Antegrade and retrograde pyelogram measure: Ureteral stricture length measured by antegrade or retrograde pyelogram measure: Ureteral Stricture Quality will be graded as either narrowed or obliterated segment. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwestern University status: RECRUITING city: Chicago state: Illinois zip: 60611 country: United States name: Emily Ji role: CONTACT phone: 312-695-8146 email: emily.ji@nm.org name: Ziho Lee, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-10-25 uploadDate: 2024-03-01T13:40 filename: Prot_000.pdf size: 140931 hasResults: False

 nctId: NCT06384066 id: STU00219774 briefTitle: Mobile Health Application to Improve Patient Satisfaction After Urethroplasty overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2024-12 date: 2024-04-25 date: 2024-04-25 name: Northwestern University class: OTHER briefSummary: Create a custom urethroplasty mobile application that will guide patients through through the surgical process. conditions: Urethral Stricture studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 80 type: ESTIMATED name: GetWell Mobile Application name: Standard of Care measure: Improve patient satisfaction, education and reported outcomes measure: Change in rate of patient phone calls and messages measure: Rate of emergency department visits sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-10-04 uploadDate: 2024-03-01T13:15 filename: Prot_000.pdf size: 9077970 hasResults: False

 nctId: NCT06384053 id: SAHARA Trial briefTitle: Skin Cancer and Hyperthermia and Radiotherapy acronym: SAHARA overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-07-01 date: 2028-07-01 date: 2024-04-25 date: 2024-04-25 name: Kantonsspital Winterthur KSW class: OTHER name: Luzerner Kantonsspital briefSummary: The SAHARA trial assesses wether combining ultrahypofractionated accelerated radiotherapy (RT) with hyperthermia is as effective as standard hypofractionated high-dose radiation in treating non-melanoma skin cancer (NMSC). conditions: Basal Cell Carcinoma conditions: Squamous Cell Carcinoma Skin conditions: Non-melanoma Skin Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined name: Radiotherapy (RT) measure: Local control measure: Analysis measure: Late toxicities measure: Quality of life assessment sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Kantonsspital Winterthur city: Winterthur state: Kanton Zuerich zip: 8401 country: Switzerland lat: 47.50564 lon: 8.72413 facility: Luzerner Kantonsspital city: Luzern zip: 6000 country: Switzerland name: Winfried Arnold, MD role: CONTACT lat: 47.05048 lon: 8.30635 hasResults: False

 nctId: NCT06384040 id: GR-2019-12370692 briefTitle: Immuno-based Profiling of knEe OA Patients to Predict reSponse to Regenerative Treatment acronym: IMPRESA overallStatus: RECRUITING date: 2021-11-01 date: 2023-09-04 date: 2024-10-30 date: 2024-04-25 date: 2024-04-25 name: Istituto Clinico Humanitas class: OTHER name: Istituto Ortopedico Rizzoli briefSummary: Osteoarthritis (OA) is a highly prevalent degenerative musculoskeletal disease and a major cause of chronic disability worldwide. Its multifactorial origin contributes to determine the heterogeneous phenotypes and one unmet need is the lack of biomarkers to predict the individual response. Platelet-rich-plasma (PRP) injection is a minimally invasive autologous blood-derived approach for which we plan to define specific knee profiles predictive of response. We will take advantage of a unique multidisciplinary approach aimed at analysing clinics, imaging, and biomarkers of associated with clinical response. We will focus on inflammatory (Wnt system, IL1 pathway, PTX3) and antioxidant (primarily, DPP3/Keap1/Nrf2) pathways. We foresee that our results will allow a better allocation of immunomodulatory and regenerative therapies for a personalized approach in knee OA thus maximising the effectiveness of the healthcare allocation. conditions: Osteoarthritis, Knee studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 105 type: ESTIMATED name: platelet-rich plasma knee injection measure: knee OA patients focusing on changes in Wnt and IL1-ß signalling and PTX3 expression measure: To assess the overall oxidative status and antioxidant capacity of the enrolled OA patients and its possible prognostic role with respect to response to PRP treatment sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Clinico Humanitas status: RECRUITING city: Rozzano state: Milano zip: 20089 country: Italy name: Berardo Di Matteo role: CONTACT phone: 02 82241 email: reumatologia@humanitas.it lat: 45.38193 lon: 9.1559 hasResults: False

 nctId: NCT06384027 id: VNI_USG_2024 briefTitle: Effects of Non-invasive Ventilation on Function Diaphragmatic and Caval Distension overallStatus: RECRUITING date: 2024-02-05 date: 2024-04-17 date: 2024-06-10 date: 2024-04-25 date: 2024-04-25 name: Federal University of Paraíba class: OTHER briefSummary: Introduction: Understanding how the applicability of non-invasive ventilation can directly affect the anatomy and diaphragmatic function, as well as the opening diameter of the inferior vena cava in healthy individuals is fundamental to knowing how this therapy can interfere with treatment results. Objective: Identify the acute effects of PEEP and ventilatory support pressure on thickening fraction, diaphragmatic mobility and vena cava distension in healthy people. Methods: This is a crossover, randomized study, blinded to the evaluator and the researcher responsible for the statistical analysis. Volunteers will undergo a NIV session, randomized into groups: CPAP, Bi-level and spontaneous breathing, without NIV support (control). The outcomes evaluated will be diaphragmatic ultrasound and inferior vena cava distensibility. The CPAP levels will be: 5, 10 and 15 cmH2O after 5 minutes of use and in the Bi-level group we will maintain the PEEP value at 5cmH2O and modify the pressure support values to the values: 5, 7 and 10 cmH2O pressure support, with all outcomes also being assessed after 5 minutes. Participants will remain in a supine position, with the right upper limb positioned behind the head, throughout the protocol and all measurements will be collected in the inspiratory and expiratory phases with volumes basal currents. For statistical analysis, intention-to-treat analysis will be employed and groups will be compared using Student's t-test, for continuous variables, or chi-square, for categorical variables. ANOVA split-plot, repeated measures for primary occurrences. Analyzes of covariance to identify differences between groups using baseline scores as covariates. Effect sizes and confidence intervals will be calculated using eta squared (η²). Expected results: Elucidate the effects of different blood pressure levels on diaphragmatic function and inferior vena cava distension. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This is a crossover, randomized study, blinded primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: Non-invasive ventilation measure: Diaphragmatic thickening fraction measure: Diaphragmatic mobility measure: Ultrasound of inferior vena cava distension sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Federal University of Paraiba status: RECRUITING city: João Pessoa state: Paraiba zip: 58051-900 country: Brazil name: Eduardo França, PhD role: CONTACT phone: 5583996575859 lat: -7.115 lon: -34.86306 hasResults: False

 nctId: NCT06384014 id: 2024/56 briefTitle: Examining the Effect of Different Filling Techniques on Healing in Lesional Teeth overallStatus: RECRUITING date: 2024-01-01 date: 2024-08-01 date: 2026-01-01 date: 2024-04-25 date: 2024-04-25 name: TC Erciyes University class: OTHER briefSummary: Microorganisms are an important factor in the development of periradicular diseases. The goal of non-surgical endodontic treatment is to eliminate microorganisms and their byproducts from the root canal system and to create an effective barrier between the root canal system and surrounding tissues. If there is no healing in the periradicular tissues after non-surgical endodontic treatment or if retreatment becomes impossible, surgical endodontic treatment is required. Apical resection is a surgical technique that involves removing the root tip of the tooth and closing the apical portion of the root canal system. An ideal retrograde filling material should be non-toxic, non-carcinogenic and biocompatible. It must also have dimensional stability and sealing properties. Amalgam, glass ionomer cements, and zinc oxide-eugenol based materials have been used for root end fillings in periapical surgery, but the desired success was not achieved. Today, Mineral Trioxide Aggregate (MTA) is preferred as a retrograde filling material due to its superior sealing properties, ability to harden in the presence of blood and moisture, antibacterial effects, biocompatibility and radiopacity.

In the researchers' study, the effect of apical resection after orthograde canal filling and retrograde canal filling during apical resection on postoperative recovery will be compared. In both canal filling techniques, Sure-Seal Root MTA (Sure Dent Corporation-Korea) will be used as the filling material. Sure-Seal Root MTA is a calcium silicate based paste that is typically pre-mixed and ready to apply, exhibits excellent physical properties and does not show shrinkage during the curing process. As the manufacturer states, it is hydrophilic, biocompatible, has ideal setting and working time.

Our faculty has piezosurgical ultrasonics (Mectron ®, Grassobbio BG, Italy). After the root tip resection is performed, the retrograde cavity will be prepared with Woodpecker ultrasonic tips (Guilin, China) compatible with this device. In our study using these materials and devices, a comparative analysis of the effects of different canal filling techniques on lesion healing and improvement in clinical symptoms will be made. conditions: Apical Cyst studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: İki farklı grupta farklı kanal dolum teknikleri uygulandıktan sonra apikal rezeksiyon yapılarak lezyon iyileşmesinin değerlendirilmesi primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: retrograde and orthograde root canal filling measure: Comparison of lesion healing rate after apical resection using different root canal filling techniques sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erciyes Üniversitesi Diş Hekimliği Fakültesi status: RECRUITING city: Kayseri zip: 38039 country: Turkey name: ERASLAN AKYÜZ role: CONTACT phone: 4447138 phoneExt: 0352 email: ipekemamak@hotmail.com lat: 38.73222 lon: 35.48528 hasResults: False

 nctId: NCT06384001 id: STUDY00004032 briefTitle: Meditation for Older Adults With Chronic Low Back Pain overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-10 date: 2025-12 date: 2024-04-25 date: 2024-04-25 name: Florida State University class: OTHER briefSummary: This pilot randomized controlled trial aims to recruit 66 community-dwelling older adults with chronic low back pain and follow up them for 8 weeks. This study aims to test the preliminary effect of a mindfulness-based meditation (MBM) intervention on pain and symptoms among community-dwelling older adults with chronic low back pain, and also to test the effect of the MBM intervention on the host Gut-Brain Axis (GBA). conditions: Chronic Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 66 type: ESTIMATED name: Active MBM name: Sham MBM measure: Change in pain intensity and interference measure: Change in pain sensitivities measure: Change in pain modulation measure: Change in chronic pain self-efficacy measure: Change in anxiety measure: Change in cognitive complaints measure: Change in depression measure: Change in fatigue measure: Change in sleep disturbance measure: Change in pain-related cortical response measure: Measurement and comparison of fecal microbiota alpha diversity, beta diversity, and abundance of microbial taxa in the human gut measure: Chang in inflammatory cytokines sex: ALL minimumAge: 50 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06383988 id: IRB000112187 id: NCI-2023-10870 type: OTHER domain: NCI Trial Identifier id: Lead Organization Identifier type: OTHER domain: WF-2301CD briefTitle: A Web-based Program to Help Caregivers of Lung Patients Learn About Available Supportive Care Resources acronym: CONNECT overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-10 date: 2026-01 date: 2024-04-25 date: 2024-04-25 name: Wake Forest University Health Sciences class: OTHER name: National Cancer Institute (NCI) briefSummary: Clinical trial that tests the feasibility of a web based caregiver support resource, along with caregiver navigation sessions for caregivers of patients with stage II-IV lung cancer. The Caregiver Oncology Needs Evaluation Tool (CONNECT) is a novel web-based intervention designed for the community oncology setting, to systematically connect lung cancer caregivers with tailored supportive care resources. Lung cancer caregivers provide critical and challenging care for their loved ones and are at risk for their own negative psychosocial and physical outcomes. Implementing the CONNECT program along with caregiver navigation may provide additional support to caregivers of patients with stage II-IV lung cancer. conditions: Stage II Lung Cancer conditions: Stage III Lung Cancer conditions: Stage IV Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 240 type: ESTIMATED name: Support for Caregiver - Generic List name: Support for Caregiver - Personalized List name: Internet-Based Intervention - CONNECT name: Patient Navigation measure: Caregiver retention at 12 weeks measure: Caregiver accrual rate measure: Caregiver participation measure: Caregiver retention at 24 weeks measure: Caregiver acceptability measure: Average time (minutes) needed for training for Local Practice Referral Coordinator measure: Desired modality for training (e.g., live webinar, recorded video, paper materials) for Local Practice Referral Coordinator measure: Average time (minutes) needed to identify and enter local resources into the Caregiver Oncology Needs Evaluation Tool (CONNECT) database measure: Frequency of needed resource updates in the CONNECT database measure: Average time (minutes) spent by the Central Caregiver Navigator and Local Practice Referral Coordinators with each caregiver in the CONNECT arm measure: Modality of contact (e.g. phone, virtual web meeting, email) made by the Central Caregiver Navigator and Local Practice Referral Coordinators with each caregiver in the CONNECT arm measure: Number of contacts made by the Central Caregiver Navigator and Local Practice Referral Coordinators with each caregiver in the CONNECT arm measure: Number of referrals facilitated by the Local Practice Referral Coordinator and Central Caregiver Navigator measure: Type of referrals (e.g., in person, online) facilitated by the Local Practice Referral Coordinator and Central Caregiver Navigator measure: Average time (minutes) needed to communicate for Central Caregiver Navigator and Local Practice Referral Coordinator measure: Modalities used for communication (e.g., phone, virtual web meeting, email) for Central Caregiver Navigator and Local Practice Referral Coordinator measure: Improvements for the future trial from Local Practice Referral Coordinator's perspectives from a survey at the end of the study measure: Patient accrual rate measure: Patient participation rate measure: Patient retention at 12 weeks measure: Patient retention at 24 weeks sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06383975 id: CIV-24-01-045634 briefTitle: VEin of MArshall Ethanolization vs Extended Pulmonary Vein PULSEd Field Ablation After Failed PVI for Persistent AF acronym: VEMAPULSE overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2027-04-30 date: 2027-04-30 date: 2024-04-25 date: 2024-04-25 name: Sebastien Knecht class: OTHER name: Boston Scientific Corporation briefSummary: The goal of this clinical trial is to compare two ablation techniques to treat patients with persistent atrial fibrillation (irregular and often very rapid heart rhythm). An ablation is a procedure during which some scars are made on the inside of the heart to break up the electrical signals that cause the irregular heartbeat. In this trial researchers will compare a new technique, which uses tiny electric shocks to make the scars, to the standard technique, which uses heat.

The main question the trial aims to answer is:

• Does the new technique work as well as the standard technique to prevent the irregular heartbeat from returning within one year of the procedure?

Participants will:

* Undergo an ablation with either the new or the standard technique
* Visit the hospital 1, 3, 6, 9 and 12 months after the procedure for a check-up
* Wear a device to register their heart rhythm for 24 hours before the 3 month visit and for 72 hours before the 6, 9 and 12 month visit
* Record their heart rhythm at home every week
* Complete a questionnaire 3, 6, 9 and 12 months after the procedure conditions: Persistent Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Pulsed field ablation with posterior wall isolation name: Radiofrequency ablation and vein of Marshall ethanolization measure: Atrial tachyarrhythmia recurrence within 12 months measure: Safety and procedural related adverse event measure: Duration of the ablation procedure measure: Fluoroscopy time measure: Fluoroscopy dose measure: Effect of the procedure on quality of life measure: Incidence of repeat ablation measure: Unscheduled visits and hospitalization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AZ Sint-Jan Brugge AV city: Brugge zip: 8000 country: Belgium name: Emma Christiaen role: CONTACT email: emma.christiaen@azsintjan.be name: Sébastien Knecht, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 51.20892 lon: 3.22424 hasResults: False

 nctId: NCT06383962 id: CP 21-001-UK02 briefTitle: Post-Market Data Collection to Evaluate the Performance of the Synergy Disc® overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2029-09-01 date: 2034-09-01 date: 2024-04-25 date: 2024-04-25 name: Synergy Spine Solutions class: INDUSTRY name: MCRA briefSummary: This is a real world data collection observational study at a single site. There are both prospective and retrospective cohorts. The study will examine the safety and effectiveness of the Synergy cervical disc system in patients with degenerative cervical disc disease. conditions: Cervical Degenerative Disc Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Synergy cervical spine disc replacement measure: Neck Disability Index (NDI) measure: Device Related or Device Procedure Related Adverse Events measure: Neck and Arm Pain Measurement measure: Patient Satisfaction measure: Motor and Sensory Function in the Arm measure: Nurick's Criteria measure: Odom's criteria sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Royal Orthopaedic Hospital city: Birmingham country: United Kingdom name: Sam Papadopoullos role: CONTACT email: sam.papadopoullos@nhs.net name: Timothy Knight, MD role: PRINCIPAL_INVESTIGATOR name: Shahnawaz Haleem, MD role: SUB_INVESTIGATOR lat: 52.48142 lon: -1.89983 hasResults: False

 nctId: NCT06383949 id: CP 21-001-IRE01 briefTitle: Real World Data Collection on the Synergy Disc overallStatus: RECRUITING date: 2024-02-23 date: 2028-02-23 date: 2033-02-23 date: 2024-04-25 date: 2024-04-25 name: Synergy Spine Solutions class: INDUSTRY name: MCRA briefSummary: This is a real world data collection observational study at a single site. There are both prospective and retrospective cohorts. The study will examine the safety and effectiveness of the Synergy cervical disc system in patients with degenerative cervical disc disease. conditions: Cervical Degenerative Disc Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Synergy Cervical Disc system measure: Neck Disability Index (NDI) measure: Device Related or Device Procedure Related Adverse Events measure: Neck and Arm Pain Measurement measure: Patient Satisfaction measure: Motor and Sensory Function in the Arm measure: Nurick's Criteria measure: Odom's criteria sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mater Misericordiae University Hospital status: RECRUITING city: Dublin country: Ireland name: Jake McDonnell, MD role: CONTACT email: jackmcdonnell@rcsi.ie name: Joseph Butler, MD role: PRINCIPAL_INVESTIGATOR name: Stacy Darwish, MD role: SUB_INVESTIGATOR lat: 53.33306 lon: -6.24889 hasResults: False

 nctId: NCT06383936 id: FAST-K II briefTitle: FAldini Sport Total Joint Arthroplasty-Knee II acronym: FAST-K II overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-12-31 date: 2025-12-31 date: 2024-04-25 date: 2024-04-25 name: Istituto Ortopedico Rizzoli class: OTHER briefSummary: The majority of patients undergoing total knee arthroplasty are elderly individuals with low functional demands, aiming to alleviate pain. However, there exists a subgroup of younger patients, under the age of 65, with higher functional demands. The purpose of this study is to evaluate the return to sports activities in this patient group following a non-cemented total knee arthroplasty procedure and a specific rehabilitation protocol. The investigators expect that with the use of non-cemented prostheses and a specific rehabilitation protocol, many of these patients will safely resume sports activities. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: intensive rehabilitation after uncemented TKA measure: number of patients returning to sports activities assessed by questionnaire measure: clinical and functional outcomes measured as the variation in the Knee Society Score sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06383923 id: BYSYDL2022015 briefTitle: Risk Factors, Prognosis and Prediction Models for Placenta Accreta Without Prior Cesarean Section overallStatus: RECRUITING date: 2023-01-01 date: 2024-12 date: 2024-12 date: 2024-04-25 date: 2024-04-25 name: Peking University Third Hospital class: OTHER briefSummary: 1. Identify the risk factors for Placenta accreta spectrum (PAS) disorders in women without prior caesarean section (CS).
2. Clarify the prognostic factors of the disease and explore individualized treatment options to improve the prognosis of patients with this type of disease;
3. Use the cohort's biological sample database to conduct serology, cytology, and histology studies to explore the abnormal uterine immune microenvironment and the impact on uterine spiral artery remodeling in non-scar uterine-placenta accreta disease. conditions: Placenta Accreta Spectrum studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Placenta Accreta Spectrum measure: Amount of bleeding measure: Hemostatic measures measure: hysterectomy measure: blood transfusion volume sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Third Hospital status: RECRUITING city: Beijing country: China name: Wang Yan, M.D.Ph.D. role: CONTACT phone: 13501282029 email: wjgqhn@263.net lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06383910 id: 10.185.1.58 briefTitle: The Effect Of Square Stepping Exercise Training On Cognitive Functions And Quality Of Life In Geriatric Individuals overallStatus: COMPLETED date: 2021-10-12 date: 2023-12-27 date: 2024-01-05 date: 2024-04-25 date: 2024-04-25 name: Pamukkale University class: OTHER briefSummary: This study was designed to investigate the effects of Square-Stepping Exercise Training on cognitive functions and quality of life in geriatric individuals. The volunteer participants in the study were randomly divided into two groups: a square-stepping exercise group and a control group.

In the study, participants in the exercise training groups received square stepping exercises three days a week for six weeks, while those in the control group did not undergo any training. Both groups were assessed before and six weeks after the training period.

The investigators used several assessment tools including Hodkinson's Mental Test, Montreal Cognitive Assessment, Stroop Test, Trail Making Test, and the Turkish World Health Organization Quality-of-Life Scale. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 56 type: ACTUAL name: Square Stepping Exercise measure: Change on Cognitive Functions from Base on the Montreal Cognitive Assessment In 6 Weeks measure: Change on Cognitive Functions from Base on the Stroop Test In 6 Weeks measure: Change on Cognitive Functions from Base on the Trail Making Test In 6 Weeks measure: Change on Quality of Live from Base on the World Health Organization Quality-of-Life Scale Turkish version In 6 Weeks sex: ALL minimumAge: 65 Years maximumAge: 75 Years stdAges: OLDER_ADULT facility: Pamukkale University city: Denizli country: Turkey lat: 37.77417 lon: 29.0875 hasResults: False

 nctId: NCT06383897 id: HS-10398-101 briefTitle: Phase 1 Study in Healthy Participants and Participants With Kidney Dysfunction overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2025-01-31 date: 2025-01-31 date: 2024-04-25 date: 2024-04-25 name: Jiangsu Hansoh Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: A randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and the impact of food on pharmacokinetics of oral HS-10398 in Chinese healthy participants, and a clinical trial to assess the pharmacokinetic characteristics of oral HS-10398 in Chinese participants with kidney dysfunction conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 116 type: ESTIMATED name: HS-10398 name: HS-10398 Placebo measure: Incidence and severity of adverse events (AEs) measure: Serious adverse events (SAEs) measure: Observed maximum plasma concentration (Cmax) measure: Time to reach maximum plasma concentration (Tmax) measure: Elimination Halflife (T1/2) measure: Apparent clearance（CL/F） measure: Apparent Volume of Distribution（Vd/F） sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: The Affiliated Hospital of Qingdao University city: Qingdao country: China name: Xiaolei Zhang role: CONTACT phone: 0532-82912611 email: qingyilunli@126.com lat: 36.06488 lon: 120.38042 hasResults: False

 nctId: NCT06383884 id: 2024-02-134 briefTitle: Patritumab Deruxtecan in Patients With Solid Tumor Harboring an NRG1 Fusion overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2027-04-30 date: 2029-04-30 date: 2024-04-25 date: 2024-04-25 name: Samsung Medical Center class: OTHER briefSummary: The NRG1 gene is located on chromosome 8 (8p12 region) and encode NRG1. NRG1 gene is translated to generate six different proteins (I-VI) and at least 31 isoforms. NRG1 proteins are structurally related to EGF and contain an EGF-like motif that binds and activates ErbB3 and ErbB4. Upon ligand binding, these receptors form homodimers or heterodimers, which results in phosphorylation of the intrinsic kinase domain, and activation of the PI3K-AKT, MAPK, and other pathways.

The overall incidence of NRG1 fusions is very rare. In many tumor types, only limited numbers of NRG1 fusion variant have been identified. By percentage, there is no organ dominance of the presence of NRG1 fusions. In an analysis of 21, 858 tumor specimens that underwent anchored multiplex PCR for targeted RNA sequencing, the prevalence of NRG1 fusions was 0.2%. Of these, CD74 was the most common partner (29%), followed by ATP1B1 (10%), SDC4 (7%), and RBPMS (5%), and most CD74-NRG1 fusions have been reported in patients with lung IMA. NRG1 fusions result in aberrant expression of the epidermal growth factor (EGF)-like domain of neuregulin-1 (NRG1) on the cell surface binds primarily to ErbB3 and ErbB4, leading to heterodimerization or oligomerization with other ERBB family members. NRG1-mediated activation of ErbB3 promotes dimerization with EGFR, ErbB2, and ErbB4. These partners phosphorylate ErbB3, forming docking sites for SH2-domain proteins, leading to pathologic activation of multiple signal transduction pathways, including the phosphoinositide 3-kinase (PI3K) pathway. Subsequently, ErbB3 expression was noted at high levels, and the proteins were phosphorylated, in fusion-positive cases. Targeting ErbB3 signaling therefore represents a promising therapeutic approach for patients with NRG1 fusion-positive malignancies. conditions: Solid Tumor, Adult studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Patritumab Deruxtecan measure: Objective response rate(ORR) measure: Duration of response (DoR) measure: Progression-free survival(PFS) measure: Disease-control rate(DCR) measure: Best percentage change in the SoD of measurable tumors measure: Overall survival(OS) measure: Incidence of Adverse events (CTCAE v5.0) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsung Medical Center city: Seoul zip: 06351 country: Korea, Republic of name: Se-Hoon Lee, MD, PhD role: CONTACT phone: +82-10-4579-7640 email: sehoon.lee@samsung.com lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06383871 id: HRS-7058-101 briefTitle: A Phase I Clinical Study of HRS-7058 in Patients With Advanced Malignant Tumour overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-06 date: 2026-06 date: 2024-04-25 date: 2024-04-25 name: Shandong Suncadia Medicine Co., Ltd. class: INDUSTRY briefSummary: This study is a multicentre, open phase I clinical study of dose escalation, dose extension and efficacy extension of HRS-7058 in subjects with advanced malignant tumour. To evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS-7058. conditions: Advanced Malignant Tumour studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 151 type: ESTIMATED name: HRS-7058 capsule/ HRS-7058 tablet measure: Dose-limiting toxicity (DLT) measure: maximum tolerated dose (MTD) measure: Phase II recommended dose (RP2D) measure: Safety endpoints: adverse events (AE) measure: Efficacy endpoints: Objective response rate (ORR) assessed based on RECIST v1.1 criterion measure: Efficacy endpoints: duration of response (DoR) assessed based on RECIST v1.1 criterion measure: Efficacy endpoints: disease control rate (DCR) assessed based on RECIST v1.1 criterion measure: Efficacy endpoints: progression-free survival (PFS) assessed based on RECIST v1.1 criterion measure: Efficacy endpoints: overall survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06383858 id: [2023] Ethics Review NO.151 briefTitle: The Project of Gestational Hypertension and Preeclampsia Screening and Prevention Center overallStatus: RECRUITING date: 2023-08-01 date: 2028-12-31 date: 2028-12-31 date: 2024-04-25 date: 2024-04-25 name: The Third Affiliated Hospital of Guangzhou Medical University class: OTHER briefSummary: Preeclampsia is the main cause of illness and death in pregnant women and fetuses. Currently, there is no effective treatment for preeclampsia in clinical practice, and the fundamental treatment is still termination of pregnancy and placental delivery.

Therefore, early prediction of preeclampsia and targeted strengthening of high-risk pregnant women supervision, early intervention and diagnosis and treatment can greatly reduce the serious obstetric complications and perinatal maternal and fetal deaths caused by preeclampsia, which has significant social and clinical significance. conditions: Preeclampsia conditions: Maternal Deaths studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50000 type: ESTIMATED measure: Preeclampsia measure: Premature birth measure: Fetal Growth Restriction measure: Severe complications of preeclampsia sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: FANG HE status: RECRUITING city: Guangzhou state: Guangdong zip: 510150 country: China name: FANG HE, M.D role: CONTACT phone: 13724831279 email: hefangjnu@126.com name: Qingwen Nie, Master role: CONTACT phone: 15622149953 email: qw0621n@163.com lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06383845 id: MAS ESLI briefTitle: Comparison of Erector Spinae Plane Block vs Intravenous Lidocaine for Chronic Pain Post Mastectomy. overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-01 date: 2024-01-31 date: 2024-09-30 date: 2024-04-25 date: 2024-04-25 name: University Tunis El Manar class: OTHER briefSummary: Patients undergoing breast surgery were divided into two groups: Intravenous Lidocaine (Lido-IV) vs Erector Spinae Block (ESP).

For Lido-IV group, patients received a loading dose of Lidocaine than a continuous infusion till the end of surgery.

For ESP group, an ultrasound guided ESP Block was perormed before anesthetic induction.

Persistant pain post mastectomy was assessed by SFM-PQ score at 1, 3 and 6 months post surgery. conditions: Breast Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Erector spinae plane block VS intravenous lidocaine. primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 60 type: ESTIMATED name: Lido-IV name: ESP Block measure: Item 5 of Brief Pain inventory score (BPI Score) measure: Acute pain assessed by Simple Verbal Scale (SVS) measure: Postoperative nausea and vomiting measure: Hospital length of stay measure: DN4 questionnaire (DN4) measure: The short-form McGill Pain Questionnaire (SFM-PQ) sex: FEMALE minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tunisia city: Nabeul zip: 8000 country: Tunisia lat: 36.45606 lon: 10.73763 hasResults: False

 nctId: NCT06383832 id: 20240310_GY briefTitle: Effect of Dapagliflozin on Body Weight in Overweight Women Consuming Different Proportions of Carbohydrate Diet. overallStatus: COMPLETED date: 2021-10-28 date: 2023-12-26 date: 2023-12-26 date: 2024-04-25 date: 2024-04-25 name: Sun Jia class: OTHER briefSummary: In recent years, the prevalence of overweight and obesity has increased dramatically worldwide, of which 34.3% and 16.4% of adults in China are overweight and obese, respectively, ranking first in the world's obese population. Dapagliflozin is a sodium-glucose transporter 2 Inhibitors that inhibits glucose reabsorption and promotes urinary glucose excretion by inhibiting renal proximal tubular sodium-glucose transporter 2 Inhibitors for the treatment of type 2 diabetes mellitus. The urinary glucose excretion induced by dapagliflozin can induce weight loss through energy loss or body water loss caused by osmotic diuresis. In addition, in patients with type 2 diabetes, dapagliflozin may also induce weight loss by reducing body fat as well as subcutaneous and visceral fat.In a randomized controlled trial, type 2 diabetes patients treated with sodium-glucose transporter 2 Inhibitors lost approximately 1-3 kg. Also, sodium-glucose transporter 2 Inhibitors have shown good weight loss in obese people without type 2 diabetes. In real-world studies, a minority of type 2 diabetes patients taking dapagliflozin experienced weight gain. The American Lipid Association defines a low carbohydrate diet as the calorie intake of carbohydrates accounting for 10-25% of the total daily energy intake. In a randomized controlled trial, a low-carbon diet showed a more significant decrease in body weight, fat mass index, whole body fat, and visceral fat after 8 weeks compared to the standard diet. So, this study intends to investigate whether the weight loss effect of dapagliflozin is affected by different dietary structures. conditions: Overweight conditions: Carbohydrate conditions: Sodium-glucose Transporter 2 Inhibitors studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study included a total sample size of 36 subjects and underwent a 12 week intervention with dapagliflozin. Then, subgroup analysis was conducted. According to the 24-hour dietary review method on the 3rd day of each week during the introduction period, the low carbohydrate group accounted for 10-25% of the total energy intake due to carbohydrates, while the non low carbohydrate group accounted for 26% or more of the total energy intake due to carbohydrates. primaryPurpose: TREATMENT masking: NONE count: 36 type: ACTUAL name: Dapagliflozin measure: Changes in Body mass index (BMI) i measure: Changes in fasting blood glucose. measure: Changes in waist circumference. measure: Changes in insulin resistance index. measure: Changes in waist-to-hip ratio. measure: Changes in abdominal circumference. measure: Changes in Blood triglycerides measure: Changes in total cholesterol measure: Changes in low-density lipoprotein、high-density lipoprotein measure: Changes in body fat percentage. measure: Changes in subcutaneous fat volume. measure: Changes in body fat volume. measure: Changes in the relative abundance of gut microbiota. measure: Changes in urine. measure: Changes in β-hydroxybutyric acid. measure: Changes in muscle mass. measure: Changes in fasting insulin. measure: Changes in visceral fat volume. measure: Changes in hip circumference. measure: The incidence of adverse events. sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Zhujiang Hospital of Southern Medical University city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: Zhujiang Hospital city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06383819 id: Long-Cov-III-21 briefTitle: Efficacy and Safety of Longidaza® for the Treatment of Patients With Residual Changes in the Lungs After COVID-19 overallStatus: COMPLETED date: 2022-04-08 date: 2023-12-31 date: 2023-12-31 date: 2024-04-25 date: 2024-04-25 name: NPO Petrovax class: INDUSTRY briefSummary: The goal of this clinical study is to evaluate the efficacy and safety of Longidaza®, lyophilizate for preparation of solution for injection, at a dose of 3000 IU compared to placebo in the treatment of adult patients with residual changes in the lungs after COVID-19 infection conditions: Post-Acute COVID-19 Syndrome conditions: Lung Disease With Polymyositis conditions: Fibrosis conditions: Lung Diseases, Interstitial conditions: Lung; Disease, Interstitial, With Fibrosis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 392 type: ACTUAL name: Longidaza® name: Placebo measure: Change in Forced vital capacity (FVC) (visit 4) measure: Slowing the decline in respiratory function measure: Change in FVC (visit 5) measure: The proportion of patients with an increase in the FVC (%) measure: Dynamics of hemoglobin oxygen saturation (SpO2) measure: The proportion of patients with SpO2 ≥ 93% and < 93% measure: The proportion of patients with desaturation measure: The proportion of patients with an increase in the distance of 6MWT measure: The proportion of patients with a decrease in the severity of dyspnea on the Borg scale measure: The proportion of patients with a decrease in the severity of dyspnea on the Modified Medical Research Council Dyspnea Scale (mMRC) measure: Change in cough severity on the Visual Analogue Scale (VAS) measure: Change in the assessment of the quality of life according to the European Quality of Life 5-Dimension 5-Level Questionnaire (EuroQol-5D-5L) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: State Autonomous Healthcare Institution of the Sverdlovsk region "Aramil City Hospital" city: Aramil zip: 624000 country: Russian Federation lat: 56.6977 lon: 60.8369 facility: Private healthcare institution "Clinical Hospital "RZD-Medicine" of the city of Chelyabinsk" city: Chelyabinsk zip: 454000 country: Russian Federation lat: 55.15402 lon: 61.42915 facility: State Budgetary Healthcare Institution "Regional Clinical Hospital No. 3" city: Chelyabinsk zip: 454021 country: Russian Federation lat: 55.15402 lon: 61.42915 facility: Ural research Institute of Phthisiopulmonology city: Ekaterinburg zip: 620039 country: Russian Federation lat: 56.8519 lon: 60.6122 facility: Alliance Biomedical-Ural Group LLC city: Izhevsk zip: 426061 country: Russian Federation lat: 56.84976 lon: 53.20448 facility: Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" of the Ministry of Health of the Russian Federation. The State Autonomous healthcare institution "Hospital for War Veterans of Kazan" city: Kazan zip: 420012 country: Russian Federation lat: 55.78874 lon: 49.12214 facility: Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" of the Ministry of Health of the Russian Federation city: Kazan zip: 420012 country: Russian Federation lat: 55.78874 lon: 49.12214 facility: State Autonomous Healthcare Institution "Kuzbass Clinical Hospital of Emergency Medical Care named after M.A. Podgorbunsky" city: Kemerovo zip: 650000 country: Russian Federation lat: 55.33333 lon: 86.08333 facility: Medical Center Rhevma-Med LLC city: Kemerovo zip: 650070 country: Russian Federation lat: 55.33333 lon: 86.08333 facility: Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Health of the Russian Federation city: Kirov zip: 610027 country: Russian Federation lat: 58.59665 lon: 49.66007 facility: Federal State Budgetary Institution "National Medical Research Center for Therapy and Preventive Medicine" of the Ministry of Health of the Russian Federation city: Moscow zip: 101990 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Federal Budgetary Institution of Science "Central Research Institute of Epidemiology" of the Federal Service for Supervision of Consumer Rights Protection and Human Well-being city: Moscow zip: 111123 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Unimed-S Zao city: Moscow zip: 119571 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: I.M. Sechenov First Moscow State Medical University city: Moscow zip: 119991 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: ErSi Medical LLC city: Novosibirsk zip: 630005 country: Russian Federation lat: 55.0415 lon: 82.9346 facility: Professorial Clinic LLC city: Perm zip: 614070 country: Russian Federation lat: 58.01046 lon: 56.25017 facility: Energia Zdoroviya LLC city: Saint Petersburg zip: 194156 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Medical Center Reavita Med SPb LLC city: Saint Petersburg zip: 194354 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Reavita Med SPb Medical Center LLC city: Saint Petersburg zip: 194354 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: St. Petersburg State Budgetary Healthcare Institution "City Consultative and Diagnostic Center No. 1". city: Saint Petersburg zip: 194354 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Eco-Safety Research Center LLC city: Saint Petersburg zip: 196143 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Federal State Budgetary Institution "Consultative and Diagnostic Center with Polyclinic" of the Office of the President of the Russian Federation city: Saint Petersburg zip: 197110 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: St. Petersburg State Budgetary Healthcare Institution "Consultative and Diagnostic Center No.85" city: Saint Petersburg zip: 198260 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Astarta LLC city: Saint Petersburg zip: 199226 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Federal State Budgetary Educational Institution of Higher Education "Saratov State Medical University named after V.I. Razumovsky" of the Ministry of Health of the Russian Federation city: Saratov zip: 410012 country: Russian Federation lat: 51.54056 lon: 46.00861 facility: Regional State budgetary healthcare institution "Clinical Hospital No. 1" city: Smolensk zip: 214006 country: Russian Federation lat: 54.7818 lon: 32.0401 facility: Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University" of the Ministry of Health of the Russian Federation city: Tomsk zip: 634050 country: Russian Federation lat: 56.49771 lon: 84.97437 facility: Budgetary healthcare institution of the Voronezh region "Voronezh Regional Clinical Hospital No. 1" city: Voronezh zip: 394066 country: Russian Federation lat: 51.67204 lon: 39.1843 facility: Medical Center for Diagnosis and Prevention plus LLC city: Yaroslavl zip: 150040 country: Russian Federation lat: 57.62987 lon: 39.87368 facility: The State Autonomous Healthcare Institution of the Yaroslavl region "Clinical Hospital No. 9" city: Yaroslavl zip: 150042 country: Russian Federation lat: 57.62987 lon: 39.87368 hasResults: False

 nctId: NCT06383806 id: STU00219933 id: 315-SR-23 type: OTHER_GRANT domain: American Academy of Sleep Medicine Foundation briefTitle: Decreasing Nightmares in Adults With Narcolepsy acronym: DAWN overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-09 date: 2026-09 date: 2024-04-25 date: 2024-04-25 name: Northwestern University class: OTHER briefSummary: The purpose of this clinical trial is learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with narcolepsy. All participants will receive the treatment and will complete three assessments. Half of the participants will receive the treatment after the first assessment, and half will receive it after the second assessment. conditions: Narcolepsy conditions: Narcolepsy Type 1 conditions: Narcolepsy With Cataplexy conditions: Narcolepsy Without Cataplexy conditions: Nightmare conditions: Nightmare Disorder With Associated Other Sleep Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Waitlist control primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Imagery Rehearsal Therapy (IRT) measure: Disturbing Dream and Nightmare Severity Index (DDNSI) measure: Nightmare frequency (sleep diary) measure: PROMIS Anxiety measure: PROMIS Depression sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06383793 id: Northjiangsu000 briefTitle: Comparative Analysis of Short-Term Therapeutic Effects Between the π-Shaped and Overlap Methods for Esophagogastrostomy in Totally Laparoscopic Total Gastrectomy overallStatus: RECRUITING date: 2024-04-01 date: 2024-08-30 date: 2025-12-30 date: 2024-04-25 date: 2024-04-25 name: Northern Jiangsu People's Hospital class: OTHER briefSummary: As of now, although the safety of π-shaped anastomosis and the overlap method has been separately discussed in different contexts, there have been few studies considering a direct comparison of the results of these two methods.

This article aims to explore the differences in the short-term therapeutic effects, surgical effectiveness, and safety between laparoscopic total gastrectomy with esophagogastrostomy using the overlap method and the π-shaped method. The goal is to provide new reference points for surgeons in the clinical decision-making process regarding the choice of anastomotic techniques during totally laparoscopic total gastrectomy. conditions: Gastric Cancer studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: overlap measure: 1 year survival sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yifan Cheng status: RECRUITING city: Yangzhou state: Jiangsu zip: 225000 country: China name: Yifan Cheng role: CONTACT phone: 8615267258283 email: cyfchengyifan528@sina.com lat: 32.39722 lon: 119.43583 hasResults: False

 nctId: NCT06383780 id: SYSKY-2023-901-01 briefTitle: Tislelizumab in Combination With GP or TPC Regimen for the Treatment of Nasopharyngeal Carcinoma With Bone Metastasis. overallStatus: RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2027-05-01 date: 2024-04-25 date: 2024-04-25 name: XIANG YANQUN class: OTHER briefSummary: This is a prospective, open-label phase III clinical trial evaluating the efficacy and safety of the GP（Gemcitabine combined with cisplatin） regimen in combination with Tislelizumab versus the TPC（cisplatin, nab-paclitaxel and capecitabine）regimen in combination with Tislelizumab for the first-line treatment of Nasopharyngeal Carcinoma patients With Bone Metastasis. conditions: Nasopharyngeal Carcinoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Active Comparator:Drug:GP（Gemcitabine combined with cisplatin）regimen combined with Tislelizumab Experimental:Drug：TPC（cisplatin, nab-paclitaxel and capecitabine）regimen combined with Tislelizumab primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: GP combined with Tislelizumab name: TPC combined with Tislelizumab measure: 1-year progression-free survival rate measure: Overall survival measure: incidence of adverse events measure: rate of skeletal-related events measure: Biomarker response (EBV-DNA, bone metabolic markers) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SunYat-senU status: RECRUITING city: Guangzhou state: Guangdong zip: 510060 country: China name: Yanqun Xiang, MD role: CONTACT phone: +86-18666096623 email: xiangyq@sysucc.org.cn name: Weixiong Xia, MD role: CONTACT phone: +86-18520415699 email: xiawx@sysucc.org.cn lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06383767 id: ESG401-301 briefTitle: A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2026-07-31 date: 2026-12-31 date: 2024-04-25 date: 2024-04-25 name: Shanghai Escugen Biotechnology Co., Ltd class: INDUSTRY briefSummary: The aim of this study is to evaluate the efficacy and safety of ESG401 in patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer. conditions: Metastatic Breast Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 378 type: ESTIMATED name: ESG401 name: Eribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice) measure: Progression-free survival (PFS) assessed by IRC per RECIST 1.1 measure: Progression-free survival (PFS) assessed by the investigators per RECIST V 1.1 measure: Overall Survival (OS) measure: Objective Response Rate (ORR) measure: Clinical Benefit Rate (CBR) measure: Duration of Response (DoR) measure: Quality of life evaluated using the NCC-BC-A scale measure: Adverse events(AEs) and severe adverse events (SAEs) measure: Clearance measure: Volume of distribution measure: ADA sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Hospital Chinese Academy of Medical Sciences city: Beijing state: Beijing zip: 100021 country: China name: Fei Ma, PhD role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06383754 id: Clove briefTitle: Clareon Intraocular Lens Stability in Vitrectomy Patients: CLOVE Study overallStatus: COMPLETED date: 2021-06-07 date: 2024-03-08 date: 2024-03-15 date: 2024-04-25 date: 2024-04-25 name: The University of Hong Kong class: OTHER briefSummary: This prospective randomized controlled trial will be conducted to investigate Clareon intraocular lens (IOL) stability in vitrectomy patients. The investigator plans to target the patients undergoing cataract surgery. A randomized study will be conducted with 2 arms, one with Clareon IOL versus a second arm using the Tecnis 1 In this non-inferiority study, the investigator will compare Clareon IOL from Alcon with the existing Tecnis 1 IOL from Precision Lens which is the commonly used intraocular lens in combined vitrectomy cases in Hong Kong. conditions: Senile Cataract conditions: Epiretinal Membrane conditions: Vitreous Hemorrhage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Patients are randomised and masked from the treatment whoMasked: PARTICIPANT count: 50 type: ACTUAL name: Clareon name: Tecnis 1 measure: Position stability of Clareon and Tecnis 1 IOL measure: Visual acuity measure: Refraction measure: Axial movement measure: Decentration measure: Compare intra operative and post operative complication sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Grantham Hospital city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06383741 id: 2023-00541 briefTitle: Predicting Outcomes in ICH Patients on Direct Factor Xa Inhibitors acronym: FIRE-Xa overallStatus: RECRUITING date: 2023-07-10 date: 2026-04-01 date: 2026-04-01 date: 2024-04-25 date: 2024-04-25 name: Insel Gruppe AG, University Hospital Bern class: OTHER briefSummary: This study focuses on direct factor Xa inhibitors (apixaban, edoxaban, rivaroxaban) and the thrombin inhibitor dabigatran, commonly used for stroke prevention in atrial fibrillation. Despite lower intracranial bleeding risks with these drugs, around 0.2-1.0% of patients annually experience intracranial hemorrhage (ICH), predominantly intracerebral.

Treatment options for factor-Xa inhibitor-associated ICH, such as prothrombin complex concentrate (PCC) and andexanet alfa, lack direct comparison evidence except for ongoing trials like ANNEXA-I. This trial assesses hemostatic efficacy and 30-day functional outcomes but leaves gaps regarding anticoagulant activity's role and long-term effects, especially in patients presenting late after drug intake.

The measurement of anti-FXa levels helps guide decisions, yet their link to hematoma expansion remains unknown. Efforts to streamline measurement within 30 minutes for acute decisions have shown variability in levels, with some patients exhibiting high levels even beyond 12 hours post-intake. This lack of data poses challenges, particularly for patients potentially benefiting from treatment beyond the current strict time window.

Early hematoma expansion strongly predicts poor outcomes, but preventing it faces challenges like recurrent events (up to 5% by 3 months) and rehabilitation intensity, potentially negating its benefits. The ANNEXA-I trial evaluates short-term outcomes, highlighting the need for additional data to comprehend long-term ICH prognosis.

The study's objectives involve linking hematoma expansion to anti-FXa levels, determining late-presenting patients' risk of expansion, and identifying predictors of favorable outcomes at 3, 6, and 12 months. Primary endpoints include functional outcomes, while secondary ones encompass expansion rates, anticoagulant activity, and various events at 12 months.

This research aims to bridge gaps in understanding factor-Xa inhibitor-related ICH, addressing both immediate and prolonged outcomes to enhance clinical decision-making. conditions: Intra Cerebral Hemorrhage studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Good functional outcome measure: Good functional outcome measure: Good functional outcome measure: Haematoma expansion measure: Number of patients with significant anticoagulant activity arriving late measure: Absolute haematoma expansion (in ml) between baseline and follow-up imaging measure: Symptomatic haematoma expansion measure: Resumption of anticoagulant therapy after haemorrhage measure: Patients living at home measure: Functionally independent patients (mRS 0-2) measure: Excellent outcome (mRS 0-1) measure: Arterial and venous events at 12 months sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Insel Gruppe AG, Inselspital Bern status: RECRUITING city: Bern zip: 3010 country: Switzerland name: David J. Seiffge, Prof. Dr. med. role: CONTACT phone: +41 31 664 05 09 email: david.seiffge@insel.ch name: Janis P. Rauch, PD Dr. med. role: CONTACT email: janispatricia.rauch@insel.ch lat: 46.94809 lon: 7.44744 hasResults: False

 nctId: NCT06383728 id: ES-2024-014-02 briefTitle: Osimertinib as Neoadjuvant Therapy in Patients With Resectable Stage II-IIIB EGFR-mutated Lung Squamous Cell Carcinoma acronym: GALAXY-02 overallStatus: RECRUITING date: 2024-04-01 date: 2025-10-31 date: 2029-04-30 date: 2024-04-25 date: 2024-04-25 name: The First Affiliated Hospital of Guangzhou Medical University class: OTHER briefSummary: Previous trials, such as ADURA and CTONG, have demonstrated the benefits of neoadjuvant targeted therapy in patient with EGFR mutations , which can effectively reduce the extent of tumors and improve the survival outcomes. However, clinical trials of neoadjuvant targeted therapy in NSCLC have rarely enrolled patients with EGFR-mutated lung squamous cell carcinoma due to its rarity, which means that the safety and feasibility of neoadjuvant osimertinib in patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma remains relatively unknown. conditions: Lung Cancer conditions: Carcinoma, Squamous Cell studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma receive osimertinib (80mg/d, ≥9 weeks) primaryPurpose: TREATMENT masking: NONE count: 51 type: ESTIMATED name: Osimertinib measure: Objective Response Rate, ORR measure: Safety: frequency of severe adverse events measure: Major pathologic response, MPR measure: R0 rate measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Disease control rate (DCR) measure: Duration of remission (DOR) 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: Guangzhou state: Guangdong zip: 510120 country: China name: Shuben Li, Doctor role: CONTACT email: 13500030280@163.com lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06383715 id: 2024-624 briefTitle: Congitive Behavioral Therapy Workshop for Content Moderators overallStatus: RECRUITING date: 2024-05-01 date: 2024-06-01 date: 2024-08-01 date: 2024-04-25 date: 2024-04-26 name: Universidad Europea de Valencia class: OTHER briefSummary: Professional content moderators play a critical role in preventing Internet users from being exposed to more sensitive content. However, recent literature has shown that this work places content moderators at increased risk for several psychological outcomes, including intrusive thoughts and vicarious stress trauma. This pilot study will assess the acceptability and feasibility of a brief (4-session) cognitive-behavioral workshop to reduce these risks. conditions: Work-Related Condition conditions: Work-Related Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Cognitive-Behavioral Therapy Workshop for Content Moderators measure: The Kessler Psychological Distress Scale (K10) measure: Work Satisfaction Scale, JobStat'73 measure: Coping Mechanisms Scale measure: PTSD Checklist-Civilian Version (PCL-C) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: MEGA cloud services status: RECRUITING city: Salamanca zip: 37002 country: Spain name: Valentina Sirna role: CONTACT phone: +34 685 34 79 07 email: support@mega.nz name: Carlos López-Pinar, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.96882 lon: -5.66388 hasResults: False

 nctId: NCT06383702 id: HEX1939-002 briefTitle: Phase III Trial to Evaluate the Efficacy and Safety of Pregabalin in the Treatment of Painful Diabetic Peripheral Neuropathy overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-04-01 date: 2025-04-15 date: 2024-04-25 date: 2024-04-25 name: CSPC Ouyi Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: This study is designed to evaluate the efficacy and safety of pregabalin extended-release tablets in the treatment of neuropathic pain associated with diabetic peripheral neuropathy. Pregabalin has been approved in more than 130 countries for neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and neuralgia associated with spinal cord injury. Pregabalin extended-release tablets were administered once daily, as a single dose after dinner. Compared with pregabalin capsule formulation, it reduces the frequency of medication and improves patient compliance. conditions: Neuropathic Pain Associated With Diabetic Peripheral Neuropathy studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel design primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 358 type: ESTIMATED name: pregabalin sustained-release tablets name: Placebo measure: NRS mean change at week 13 measure: NRS mean change at Weeks 1-12 and 14 measure: Proportion of subjects with NRS reduction measure: MOS-SS score measure: HADS score measure: PGIC score measure: CGIC score sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06383689 id: Az. 297/23-EP briefTitle: Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring acronym: OPERA overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-12-31 date: 2024-04-25 date: 2024-04-25 name: University Hospital, Bonn class: OTHER briefSummary: The notion of genuine placebo effects on epileptic seizure events (i.e., effects beyond methodological study artifacts) is incompatible with the standard model of epilepsy seizure genesis. In this single-blind controlled study, the effectiveness of a covered placebo on (1) the timing of the occurrence of a first epileptic seizure ("seizure pill") versus (2) the subjective well-being ("comfort pill") during pre-surgical video-EEG monitoring will be examined. It is hypothesized that a placebo effect on subjective well-being can be demonstrated, but that epileptic seizure events are not influenced by placebo. conditions: Symptomatic Epilepsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: monocentric single-blinded randomized clinical study on the effectiveness of covered placebo on epileptic seizure occurrence and emotional well-being with 3 study conditions: "seizure pill" (PCB-S), "well-being pill" (PCB-W) and no pill (control) primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Like in psychological studies, only patients can participate in the study who consent to accept that complete study information can only be provided after the entire study was finished (with an option to withdraw consent at that point) as information on ingredients of the study pill (which is placebo) must be concealed for inherent reasons (study on effects of covered placebo). whoMasked: PARTICIPANT count: 90 type: ESTIMATED name: Seizure placebo pill name: Well-being placebo pill measure: Latency to first epileptic seizure measure: Occurrence of an epileptic seizure measure: Early occurrence of an epileptic seizure within the first 72 hours measure: Number of epileptic seizures during the video-EEG measure: Number of early occurring epileptic seizures measure: Daily average frequency of epileptic seizures measure: Very early first epileptic seizure measure: Early epileptic seizure measure: Epileptic seizure within the first three days measure: Emotional well-being measure: Dissociative non-epileptic seizures sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Epileptology, University Hospital Bonn city: Bonn state: NRW zip: 53127 country: Germany name: Rainer Surges, Prof. role: CONTACT phone: +49 228 287-15727 email: rainer.surges@ukbonn.de name: Christian Hoppe, PD Dr. role: CONTACT phone: +49 228 287-16172 email: christian.hoppe@ukbonn.de lat: 50.73438 lon: 7.09549 hasResults: False

 nctId: NCT06383676 id: 1 briefTitle: Effect Of Functional Balance Exercise İn Elderly acronym: RCT overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-20 date: 2024-11-30 date: 2025-05-30 date: 2024-04-25 date: 2024-04-25 name: Tarsus University class: OTHER briefSummary: The elderly population is increasing in Turkey and in the world. Many health problems, such as a decrease in physical and psychological abilities and an increase in chronic problems, occur with aging. It is important to encourage and support practices for the development of exercises to increase physical and cognitive capacity in order to early recognize and reduce the effects of problems that develop with aging. To the best of our knowledge, there is no exercise training to increase reaction time in the elderly in the literature. conditions: Older People conditions: Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study was planned as a randomized controlled study primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Study participants are unaware of their assigned group whoMasked: PARTICIPANT count: 28 type: ACTUAL name: Functional reaction balance training name: Functional balance training measure: The Montreal Cognitive Assessment (MoCA) measure: Stroop Test measure: The Simple Reaction Time measure: The Four Square Step Test (FSST) measure: The short physical performance battery (SPPB) measure: Timed Up and Go Test (TUG) measure: Falls Efficacy Scale ( FES) measure: Mini-BESTest: Balance Evaluation Systems Test sex: ALL minimumAge: 65 Years maximumAge: 85 Years stdAges: OLDER_ADULT facility: Fatma Kübra ÇEKOK city: Ankara zip: 06000 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06383663 id: 308-2019-04-01 briefTitle: A RCT of Supraclavicular Lymph Node Dissection vs. No-dissection in Supraclavicular Lymph Node Metastatic Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-12-31 date: 2029-12-31 date: 2024-04-25 date: 2024-04-25 name: Sun Yat-sen University class: OTHER briefSummary: The purpose of this study was to compare the efficacy of surgical dissection of supraclavicular lymph nodes combined with radiotherapy versus radiotherapy alone in patients with ipsilateral supraclavicular lymph node metastasis. conditions: Breast Cancer conditions: Ipsilateral Supraclavicular Lymph Node Metastasis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Supraclavicular lymph node dissection combined with radiotherapy versus radiotherapy alone primaryPurpose: TREATMENT masking: NONE count: 452 type: ESTIMATED name: Supraclavicular lymph node dissection combined with radiotherapy name: radiotherapy measure: DFS measure: PFS measure: OS measure: pCR rate sex: FEMALE minimumAge: 35 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06383650 id: 124532 briefTitle: Use of 81 vs 325mg of ASA in Treatment of BCVI overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-05 date: 2025-09 date: 2024-04-25 date: 2024-04-25 name: London Health Sciences Centre class: OTHER name: Western University briefSummary: Blunt cerebrovascular injury (BCVI), or injury to the carotid and vertebral arteries, occurs in 1-3% of blunt traumas, often as a result of injury to the head, neck, or chest. If unrecognized or untreated, BCVI can lead to stroke, which occurs in approximately 20% of untreated patients, potentially causing significant and sometimes permanent disability. Early diagnosis and treatment significantly reduce the risk of stroke.

Currently, there is wide variation across centers and trauma care providers in treatment strategies for BCVI and the most recent guidelines are unable to make specific recommendations about the optimal agent and/or dose of treatment to reduce the risk of stroke after BCVI while minimizing bleeding complications in patients with multiple traumatic injuries. Recent systematic reviews and meta-analyses evaluating the most common treatment strategies for BCVI have shown similar stroke rates with the use of anticoagulants (usually heparin) vs. antiplatelets (usually aspirin/ASA), however, treatment with antiplatelets was associated with a lower risk of bleeding complications. The optimal dose of ASA for stroke prevention while minimizing bleeding complications is unknown, and more research is required to inform future care.

This project will investigate two doses of antiplatelet therapy (81 mg daily vs. 325 mg daily aspirin) for BCVI treatment, and will look at the risk of stroke and bleeding complications with each strategy. The goal of the research is to determine whether a large-scale study looking at this question is feasible, which will ultimately help determine the best medical therapy for patients with BCVI. conditions: Carotid Artery Injuries conditions: Traumatic Injury conditions: Vertebral Artery Injury studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Acetylsalicylic Acid measure: Study feasibility measure: Incidence of stroke measure: Incidence of Bleeding Complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06383637 id: KAP-ABR-Interns briefTitle: Antibiotic Use and Resistance KAP Among Dental Interns overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-11-01 date: 2024-12-01 date: 2024-04-25 date: 2024-04-25 name: Cairo University class: OTHER briefSummary: The study is designed as a cross-sectional online-based questionnaire, and it will be distributed among dental interns. Assess the following among dental interns (1) The knowledge, attitude, and practices (KAP) towards antibiotics and antibiotic resistance; (2) The correlation between their KAP score and where they spend their internship year? (4) Development of the curriculum to provide sufficient training and information about antibiotics and antibiotic resistance. conditions: Antibiotic Side Effect conditions: Antibiotic Resistant Infection studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 343 type: ESTIMATED measure: Knowledge of dental interns regarding antibiotic use and resistance sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06383624 id: RC18-4-2023 briefTitle: Impact Of Maternal Spinal Anesthesia-Induced Hypotension At Scheduled Cesarean Delivery On Risk Development Of Transient Tachypnea Of Newborn And Fetal Acidosis overallStatus: COMPLETED date: 2023-04-01 date: 2024-03-01 date: 2024-03-31 date: 2024-04-25 date: 2024-04-25 name: Benha University class: OTHER briefSummary: We will evaluate the association between transient tachypnea of newborns and fetal acidosis development to the degree and duration of maternal hypotension and anesthesia to delivery time during spinal anesthesia at scheduled cesarean delivery. conditions: Transient Tachypnea of Newborn and Fetal Acidosis studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 115 type: ACTUAL measure: Association between transient tachypnea of newborns development to the degree and duration of maternal hypotension during spinal anesthesia at scheduled cesarean delivery measure: Association between fetal acidosis development to the degree and duration of maternal hypotension and anesthesia to delivery time during spinal anesthesia at scheduled cesarean delivery sex: ALL minimumAge: 1 Minute maximumAge: 6 Hours stdAges: CHILD facility: Benha University Hospital city: Cairo zip: 13511 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06383611 id: OTX-0303 briefTitle: Expanded Access to Cyclic Irrigation in Patients Undergoing Exchange Arthroplasty acronym: APEX-EAP overallStatus: AVAILABLE date: 2024-04-25 date: 2024-04-25 name: Osteal Therapeutics, Inc. class: INDUSTRY briefSummary: The objective of the protocol is to provide access to the VT-X7 (Vancomycin, Tobramycin Exchanged in 7 Days) system for subjects with periprosthetic joint infection (PJI) of the hip or knee who lack therapeutic treatment alternatives. conditions: Prosthetic-joint Infection studyType: EXPANDED_ACCESS name: VT-X7 Treatment System sex: ALL minimumAge: 22 Years maximumAge: 84 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06383598 id: 2022KT74-ZY01 briefTitle: PD-L1 Specific [68Ga]-Nb-1 Nanobody Probe for PET Imaging in Solid Tumors overallStatus: RECRUITING date: 2024-05-09 date: 2026-12 date: 2026-12 date: 2024-04-25 date: 2024-04-25 name: Peking University Cancer Hospital & Institute class: OTHER briefSummary: The objective of the study is to constrcut a noninvasive approach 68Ga-Nb-1 PET/CT to detect the PD-L1 expression of tumor lesions in patients with solid tumors and to identify patients benefiting from anti-PD-L1 treatment. conditions: Solid Tumor studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 50 type: ESTIMATED name: 18F-FDG measure: Standardized uptake value（SUV） 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: Hua Zhu role: CONTACT phone: +861088196495 email: zhuhuananjing@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06383585 id: 24-001367 briefTitle: 3D DL Ozteo in the Detection of Osseous Changes in Patients With Inflammatory Arthritis overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-12 date: 2024-04-25 date: 2024-04-25 name: Mayo Clinic class: OTHER name: GE Healthcare briefSummary: This project intends to explore and validate the utility of new MRI pulse sequence, 3D DL oZTEo, in the detection of osseous erosions of the hand in patients with inflammatory arthritis. The detection of osseous structural changes, such as erosive disease, is routinely assessed in patients with rheumatic conditions such as rheumatoid arthritis, as it alters clinical management, and in some cases assists in diagnosis. Currently, this is most often assessed with radiography and conventional MRI. conditions: Inflammatory Arthritis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 25 type: ESTIMATED name: oZTEo measure: The binary (yes/no) presence of bony erosions as detected by hand MRI with and without the addition of the 3D DL oZTEo sequence. measure: The number of erosions (continuous) as detected by hand MRI with and without the addition of the 3D DL oZTEo sequence. 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: NCT06383572 id: 2024-0196 id: NCI-2024-03505 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Phase I/II Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Myeloid Malignancies overallStatus: NOT_YET_RECRUITING date: 2024-10-31 date: 2027-04-01 date: 2029-04-01 date: 2024-04-25 date: 2024-04-25 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To find a recommended dose of PRAME-TCR-NK cells that can be given to patients with AML or MDS. conditions: Lymphodepleting Chemotherapy conditions: Myeloid Malignancies studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 54 type: ESTIMATED name: Cyclophosphamide name: Fludarabine phosphate name: Decitabine 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 name: Jeremy Ramdial, MD role: CONTACT phone: 713-745-0146 email: jlramdial@mdanderson.org name: Jeremy Ramdial, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06383559 id: TJMUCH-GI-GC07 briefTitle: Safety and Efficacy of XELOX Combined With Sintilimab and Lenvatinib in Advanced AFP-positive Gastric Cancer Patients overallStatus: RECRUITING date: 2023-12-01 date: 2026-07-01 date: 2026-09-01 date: 2024-04-25 date: 2024-04-25 name: Tianjin Medical University Cancer Institute and Hospital class: OTHER briefSummary: This is a multi-center, prospective, open label phase 2 study evaluating the safety and efficacy of standard first-line chemotherapy XELOX regimen combined with Sintilimab (anti-PD-1 antibody) and Lenvatinib in the treatment of advanced AFP-positive gastric cancer. This study was conducted in the Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Institute and Hospital. Previous phase 1 dose escalation study (TJMUCH-GI-GC002) has demonstrated that such combinational pattern was well tolerated with promising efficacy. In this study, patients with AFP-positive and HER-2-negative advanced gastric cancer who had not received palliative systematic treatment in the past will be enrolled. Patients who met the inclusion criteria were treated with XELOX regimen combined with Sintilimab plus Lenvatinib every 3 weeks until disease progression or intolerable adverse reactions or death. The treatment regimen is XELOX chemotherapy (oxaliplatin 130mg/ m2, d1, capecitabine 850-1250 mg/m2, bid, d1-14, every 3 weeks) in combination with Sintilimab (\>=60kg, 200 mg; \<60kg, 3mg/kg; intravenous infusion, every 3 weeks) plus Lenvatinib (determined from previous phase 1 study, 16mg, orally once a day). Patients received regular and periodic reviews, with imaging evaluations every 6 weeks. Safety will be evaluated by AE and laboratory tests. conditions: Gastric Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 39 type: ESTIMATED name: Lenvatinib and Sintilimab measure: ORR measure: OS measure: PFS measure: AE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Medical University Cancer Institute and Hospital status: RECRUITING city: Tianjin state: Tianjin country: China name: Ting Deng, MD role: CONTACT phone: 022-23340123 phoneExt: 1053 email: xymcdengting@126.com name: Yi Ba, MD role: CONTACT phone: 022-23340123 phoneExt: 1053 email: bayi@tjmuch.com lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06383546 id: XHEC-C-2024-053-1 briefTitle: Artificial Intelligence-enabled ECG Detection of Congenital Heart Disease in Children: a Novel Diagnostic Tool acronym: AI-ECG-CHD overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-30 date: 2025-12-30 date: 2024-04-25 date: 2024-04-25 name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine class: OTHER briefSummary: Congenital heart disease (CHD) is the most common congenital disease in children. The early detection, diagnosis and treatment of CHD in children is of great significance to improve the prognosis and reduce the mortality of children, but the current screening methods have limitations. Electrocardiogram (ECG), as an economical and rapid means of heart disease detection, has a very important value in the auxiliary diagnosis of CHD.Big data and deep learning technologies in artificial intelligence (AI) have shown great potential in the medical field. The advent of the big data era provides rich data resources for the in-depth study of CHD ECG signals in children. The development of deep learning technology, especially the breakthrough in the field of image recognition, provides a strong technical support for the intelligent analysis of electrocardiogram. The particularity of children electrocardiogram requires the development of a special algorithm model. At present, the research on the application of deep learning models to identify children's electrocardiograms is limited, and the training and verification from large data sets are lacking. Based on the Chinese Congenital Heart Disease Collaborative Research Network, this project aims to integrate data and deep learning technology to develop a set of intelligent electrocardiogram assisted diagnosis system (CHD-ECG AI system) suitable for children with CHD, so as to improve the early detection rate of CHD and improve the efficiency of congenital heart disease screening. conditions: Artificial Intelligence conditions: Electrocardiogram conditions: Deep Learning conditions: Congenital Heart Disease in Children conditions: Diagnosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 30000 type: ESTIMATED measure: Large-scale ECG database for children measure: Artificial intelligence-assisted electrocardiogram model for CHD in Children sex: ALL minimumAge: 3 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine status: RECRUITING city: Shanghai state: Shanghai country: China name: Sun Jing, MD role: CONTACT phone: 15618497517 email: sunjing02@xinhuamed.com.cn lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06383533 id: IRB-2023-385 briefTitle: Disitamab Vedotin Plus Cadonilimab in Patients With HER2 Mutant Advanced or Metastatic Bile Duct Adenocarcinoma overallStatus: RECRUITING date: 2023-05-01 date: 2025-05-01 date: 2025-12-31 date: 2024-04-25 date: 2024-04-26 name: Zhejiang Cancer Hospital class: OTHER briefSummary: It is a single arm, open-label, phase II cinical trial to evaluate the efficacy and safety of Disitamab Vedotin Plus Cadonilimab in second-line treatment of patients with Advanced or Metastatic Bile Duct Adenocarcinoma conditions: Bile Duct Adenocarcinoma Non-Resectable conditions: HER2 Gene Mutation studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: Disitamab Vedotin Plus Cadonilimab measure: Objective response rate(ORR) measure: Overall survival (OS) measure: Progression-free survival (PFS) measure: Disease control rate (DCR) measure: Incidence of Treatment-Emergent 3/4 Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhejiang Cancer Hospital status: RECRUITING city: Hangzhou state: Zhejiang zip: 310022 country: China name: Jieer Ying, Doctor role: CONTACT phone: 13858195803 email: hzyingjieer@163.com lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06383520 id: XLan-0415 briefTitle: Study on the Clinical Application Value of PET Imaging Targeting GPC3 in Hepatocellular Carcinoma overallStatus: RECRUITING date: 2023-09-30 date: 2024-12-30 date: 2025-12 date: 2024-04-25 date: 2024-04-25 name: Wuhan Union Hospital, China class: OTHER briefSummary: This is a diagnostic study. Patients were recruited from patients with clinically suspected or confirmed hepatocellular carcinoma and healthy volunteers were recruited for PET/or PET/CT imaging targeting a GPC3-specific probe (in the case of 68Ga-NOTA-aGPC3-scFv) , to observe the reaction of volunteers and patients after injection of drugs, to evaluate the pharmacokinetics in vivo and the efficacy of diagnosis and staging, and to perform PET CT imaging in patients with contraindications. General Information, clinical data, blood routine, liver and renal function, and other imaging data were collected. The final diagnosis was based on the histopathology of biopsy or surgical specimens. conditions: Malignant Neoplasm of Liver studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: 68Ga-aGPC3-scFv/Fab measure: Visual and standardized uptake values assessment of lesions and biodistribution measure: Radioactivity in the blood and urine samples measure: Concentration of tumor markers (e.g., APF) in participants' blood measure: Pathological sections of tumour tissue sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: China, Hubei Province status: RECRUITING city: Wuhan state: Hubei zip: 430022 country: China name: Xiaoli Lan, PhD role: CONTACT phone: +86-027-83692633 email: lxl730724@hotmail.com lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06383507 id: CHT101 briefTitle: A Clinical Study of Anti-CD70 UCAR-T in Relapsed or Refractory Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2027-04-21 date: 2029-04-21 date: 2024-04-25 date: 2024-04-25 name: Zhejiang University class: OTHER briefSummary: This is a single-center, single-arm ，open-label ，dose escalation and dose extension study. In this study we plan to evaluate the safety and efficacy of CD70-targeting UCAR-T cells in the treatment of CD70-positive refractory or relapsed solid tumors, and obtain recommended doses and infusion patterns. conditions: Metastatic Tumor conditions: Advanced Solid Tumor conditions: Renal Cell Carcinoma conditions: Ovarian Cancer conditions: Cervix Cancer conditions: Head and Neck Squamous Cell Carcinoma conditions: Nasopharyngeal Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: CHT101 measure: Incidence of Adverse events after CD70 UCAR-T cells infusion (Safety and Tolerability) measure: Disease control rate (DCR) measure: Objective response rate (ORR) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06383494 id: IRB-2024-356（IIT） briefTitle: GMA-TulipTM, i-gelTM and the LMA-SupremeTM (LMA-S) Devices in Airway Management overallStatus: RECRUITING date: 2024-04-30 date: 2025-12-30 date: 2025-12-30 date: 2024-04-25 date: 2024-04-26 name: Zhejiang Cancer Hospital class: OTHER briefSummary: Patients were randomly assigned to three extraglottic airway (EGA) devices groups for airway management after anesthesia induced. Fiberoptic bronchoscope (FB) guided glottic exposure grading was performed and other airway management quality was recorded. conditions: Anesthesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 276 type: ESTIMATED name: LMA supreme group name: I-gel group name: GMA-Tulip measure: Glottic exposure grading measure: Peak inspiratory pressures measure: Pharyngalgia measure: Bleeding sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhejiang Cancer Hospital status: RECRUITING city: Hangzhou state: Zhejiang zip: 310022 country: China name: Jiangling Wang, Ph. D role: CONTACT phone: +86 571 88122106 email: wangjl@zjcc.org.cn lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06383481 id: TDK-2024-13362 briefTitle: The Effect of Mobile-Based Education on Postoperative Recovery and Quality of Life in Thyroidectomy Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2025-04-22 date: 2025-08-22 date: 2024-04-25 date: 2024-04-26 name: Ataturk University class: OTHER briefSummary: Thyroid diseases constitute one of the most common health problems around the world and in our country. In its treatment; Drug therapy, radioactive iodine therapy and surgical treatment can be applied alone or together. Advances in the diagnosis of thyroid diseases have led to an increase in the number of thyroidectomies. When there are no complications after thyroidectomy, patients are discharged from the hospital on the day of surgery or are hospitalized for only a few days. In this context, since technical care is given priority, discharge training remains incomplete.

Patients who have had thyroidectomy are discharged within 1-2 days after surgery if no problems occur. For this reason, patient education provided by health professionals and especially nurses may be insufficient. Post-discharge patient education in surgical services can sometimes be ignored, and it is noteworthy that this situation is not given importance due to the busy nature of surgical services. Although short hospital stays after surgery are beneficial in many ways, it increases the need for patient education.

In this study, a mobile application that covers the entire perioperative process and includes education will be developed for patients undergoing thyroidectomy. This developed mobile application aims to manage post-operative problems such as neck pain and discomfort and voice changes experienced by patients, and to improve post-operative recovery, voice quality and, accordingly, quality of life. In this context, it is believed that even in cases where patients cannot access health care professionals, their educational needs will be met, problem management will be provided with applications for the problems they experience, and accordingly, their post-operative recovery, voice and quality of life will increase, starting from the hospital before the surgery until the end of the recovery period, including the home care process after discharge.When the literature on the subject is examined, studies involving education in patients with thyroidectomy are limited. However, no studies have been found on mobile health applications that include training to reduce neck pain and discomfort experienced by thyroidectomy patients, ensure postoperative recovery, and improve voice quality and quality of life. conditions: Thyroid Diseases conditions: Healthy Lifestyle conditions: Thyroid studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 92 type: ESTIMATED name: Mobile based education measure: Postoperative Recovery Index (ASII) measure: SF-36 Quality of Life Scale measure: Visual Comparison Pain Scale(GKAÖ) measure: Turkish- Computer System Usability Questionnaire Short Version (TCSUQ- SV) measure: Neck Pain and Discomfort Scale (BARÖ) measure: Voice Handicap Index (Voice Handicap Index 10)(VHI10) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06383468 id: AK120-301 briefTitle: A Phase III Study to Evaluate the Efficacy and Safety of AK120 in Patients With Moderate to Severe Atopic Dermatitis overallStatus: RECRUITING date: 2024-04-30 date: 2025-01-30 date: 2026-01-30 date: 2024-04-25 date: 2024-04-25 name: Akeso class: INDUSTRY briefSummary: This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis. conditions: Atopic Dermatitis 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: AK120 measure: Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75 measure: Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Friendship Hospital Capital Medical University status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Beijing Luhe Hospital Affiliated to Capital Medical University status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Beijing Tongren 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: Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Chongqing Three Gorges Medical College Affiliated People's Hospital status: RECRUITING city: Chongqing state: Chongqing country: China lat: 29.56278 lon: 106.55278 facility: Chongqing Traditional Chinese Medicine Hospital status: RECRUITING city: Chongqing state: Chongqing country: China lat: 29.56278 lon: 106.55278 facility: The First Affiliated Hospital of Fujian Medical University status: RECRUITING city: Fuzhou state: Fujian country: China lat: 26.06139 lon: 119.30611 facility: The Second Affiliated Hospital of Xiamen Medical College status: RECRUITING city: Xiamen state: Fujian country: China lat: 24.47979 lon: 118.08187 facility: Guangdong Provincial People's Hospital status: RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: Southern Medical University Dermatology Hospital/Guangdong Provincial Dermatology Hospital status: RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: Southern Medical University Southern Hospital status: RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University status: RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital of Guangzhou Medical University status: RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: Zhujiang Hospital of Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: Yuebei People's hospital, Guangdong, China status: RECRUITING city: Shaoguan state: Guangdong country: China lat: 24.8 lon: 113.58333 facility: Shunde Hospital of Southern Medical University status: RECRUITING city: Shunde state: Guangdong country: China lat: 22.84067 lon: 113.2503 facility: Guangdong Medical University Affiliated Hospital status: RECRUITING city: Zhanjiang state: Guangdong country: China lat: 21.28145 lon: 110.34271 facility: The Affiliated Hospital of Guizhou Medical University status: RECRUITING city: Guiyang state: Guizhou country: China lat: 26.58333 lon: 106.71667 facility: Hainan General Hospital status: RECRUITING city: Haikou state: Hainan country: China lat: 20.04583 lon: 110.34167 facility: Hainan Provincial Fifth People's Hospital status: RECRUITING city: Haikou state: Hainan country: China lat: 20.04583 lon: 110.34167 facility: The First Affiliated Hospital of Hainan Medical College status: RECRUITING city: Haikou state: Hainan country: China lat: 20.04583 lon: 110.34167 facility: Chengde Medical College Affiliated Hospital status: RECRUITING city: Chengde state: Hebei country: China lat: 40.9519 lon: 117.95883 facility: The Second Affiliated Hospital of Xingtai Medical College status: RECRUITING city: Xingtai state: Hebei country: China lat: 37.06306 lon: 114.49417 facility: Harbin Medical University Affiliated Second Hospital status: RECRUITING city: Harbin state: Heilongjiang country: China lat: 45.75 lon: 126.65 facility: Heilongjiang Provincial Hospital status: RECRUITING city: Harbin state: Heilongjiang country: China lat: 45.75 lon: 126.65 facility: The Second Affiliated Hospital of Henan University of Science and Technology status: RECRUITING city: Luoyang state: Henan country: China lat: 34.68361 lon: 112.45361 facility: Renmin Hospital of Wuhan University Hubei General Hospital status: RECRUITING city: Wuhan state: Hubei country: China lat: 30.58333 lon: 114.26667 facility: Tongji Hospital status: RECRUITING city: Wuhan state: Hubei country: China lat: 30.58333 lon: 114.26667 facility: Changde First People's Hospital status: RECRUITING city: Changde state: Hunan country: China lat: 29.04638 lon: 111.6783 facility: Xiangya Hospital of Central South University status: RECRUITING city: Changsha state: Hunan country: China lat: 28.19874 lon: 112.97087 facility: The First Affiliated Hospital of South China University status: RECRUITING city: Hengyang state: Hunan country: China lat: 26.88946 lon: 112.61888 facility: Inner Mongolia Medical University Affiliated Hospital status: RECRUITING city: Hohhot state: Inner Mongolia country: China lat: 40.81056 lon: 111.65222 facility: The First Affiliated Hospital of Bengbu Medical College status: RECRUITING city: Bengbu state: Jiangsu country: China lat: 32.94083 lon: 117.36083 facility: Changzhou First People's Hospital status: RECRUITING city: Changzhou state: Jiangsu country: China lat: 31.77359 lon: 119.95401 facility: Yancheng First People's Hospital status: RECRUITING city: Yancheng state: Jiangsu country: China lat: 33.3575 lon: 120.1573 facility: Jiangsu University Affiliated Hospital status: RECRUITING city: Zhenjiang state: Jiangsu country: China lat: 32.21086 lon: 119.45508 facility: The First Affiliated Hospital of Gannan Medical College status: RECRUITING city: Ganzhou state: Jiangxi country: China facility: The First Bethune Hospital of Jilin University status: RECRUITING city: Changchun state: Jilin country: China lat: 43.88 lon: 125.32278 facility: Panjin Liaoyou Gemstone Flower Hospital status: RECRUITING city: Panjin state: Liaoning country: China lat: 41.121 lon: 122.0739 facility: Shenyang Integrated Traditional Chinese and Western Medicine Hospital status: RECRUITING city: Shenyang state: Liaoning country: China lat: 41.79222 lon: 123.43278 facility: Zhongyi Northeast International Hospital status: RECRUITING city: Shenyang state: Liaoning country: China lat: 41.79222 lon: 123.43278 facility: General Hospital of Ningxia Medical University status: RECRUITING city: Yinchuan state: Ningxia country: China lat: 38.46806 lon: 106.27306 facility: Shandong Provincial Dermatology Hospital status: RECRUITING city: Jinan state: Shandong country: China lat: 36.66833 lon: 116.99722 facility: Shandong University Qilu Hospital status: RECRUITING city: Jinan state: Shandong country: China lat: 36.66833 lon: 116.99722 facility: Qingdao Municipal Hospital status: RECRUITING city: Qingdao state: Shandong country: China lat: 36.06488 lon: 120.38042 facility: Shanghai Dermatology Hospital status: RECRUITING city: Shanghai state: Shanghai country: China lat: 31.22222 lon: 121.45806 facility: Baoji Central Hospital status: RECRUITING city: Baoji state: Shanxi country: China facility: Sichuan Provincial People's Hospital status: RECRUITING city: Chengdu state: Sichuan country: China lat: 30.66667 lon: 104.06667 facility: Tianjin Institute of Traditional Chinese Medicine Affiliated Hospital status: RECRUITING city: Tianjin state: Tianjin country: China lat: 39.14222 lon: 117.17667 facility: Xinjiang Uygur Autonomous Region People's Hospital status: RECRUITING city: Urumqi state: Xinjiang country: China lat: 43.80096 lon: 87.60046 facility: The First Affiliated Hospital of Kunming Medical University status: RECRUITING city: Kunming state: Yunnan country: China lat: 25.03889 lon: 102.71833 facility: Hangzhou First People's Hospital status: RECRUITING city: Hangzhou state: Zhejiang country: China lat: 30.29365 lon: 120.16142 facility: Hangzhou Third People's Hospital status: RECRUITING city: Hangzhou state: Zhejiang country: China lat: 30.29365 lon: 120.16142 facility: The Second Affiliated Hospital of Zhejiang University School of Medicine status: RECRUITING city: Hangzhou state: Zhejiang country: China lat: 30.29365 lon: 120.16142 facility: Jiaxing First People's Hospital status: RECRUITING city: Jiaxing state: Zhejiang country: China lat: 30.7522 lon: 120.75 facility: Ningbo First Hospital status: RECRUITING city: Ningbo state: Zhejiang country: China lat: 29.87819 lon: 121.54945 facility: Ningbo Huamei Hospital, University of Chinese Academy of Sciences status: RECRUITING city: Ningbo state: Zhejiang country: China lat: 29.87819 lon: 121.54945 facility: Wenzhou Medical University First Affiliated Hospital status: RECRUITING city: Wenzhou state: Zhejiang country: China lat: 27.99942 lon: 120.66682 hasResults: False

 nctId: NCT06383455 id: Observational briefTitle: Effects of Smoking on Clinical and Microbiological Response in Individuals With Periodontitis overallStatus: COMPLETED date: 2018-09-15 date: 2019-02-01 date: 2019-03-01 date: 2024-04-25 date: 2024-04-25 name: Trakya University class: OTHER briefSummary: This study aimed to compare the distribution of subgingival periodontal pathogens following non-surgical periodontal therapy in smoking and non-smoking people with periodontitis. The main question it aims to answer is:

- Does smoking affect the results of non-surgical periodontal treatment on subgingival flora in participants with periodontal disease?

Researchers performed non-surgical periodontal therapy on 48 participants with stage III/IV periodontitis and recorded clinical measurements. They obtained subgingival plaque samples from periodontal pockets at the onset and after four weeks of treatment, determining the level of periodontopathogens using a polymerase chain reaction-based method. conditions: Periodontitis conditions: Smoking Habit conditions: Subgingival Plaque studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 48 type: ACTUAL name: Non-surgical periodontal therapy measure: Change in levels of periodontopathogens in subgingival plaque after non-surgical periodontal therapy in smokers and non-smokers with stage 3/4 periodontitis measure: Change in clinical attachment level (CAL) measure: Change in probing depth (PD) measure: Change in gingival index (GI) scores measure: Change in plaque index (PI) scores measure: Change in Bleeding on Probing (BOP) sex: ALL minimumAge: 35 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Trakya University city: Edirne zip: 22030 country: Turkey lat: 41.67719 lon: 26.55597 hasResults: False

 nctId: NCT06383442 id: N202103041 briefTitle: HIIT on Overweight Middle-aged Adults acronym: HIIT overallStatus: COMPLETED date: 2021-05-25 date: 2023-07-31 date: 2023-11-22 date: 2024-04-25 date: 2024-04-25 name: Taipei Medical University class: OTHER briefSummary: 36 middle-aged with overweight adults were divided into three groups: 1. L-HIIT group: the long-interval HIIT group (4 × 4 min Exercise/4 min Rest), 2. M-HIIT group: the medium-interval HIIT group (8 × 2 min Exercise/2 min Rest), 3. Control group: no exercise intervention. All groups carried out the training stage for 8 weeks (three sessions per week) and the detraining stage for 4 weeks in order to investigate the effects induced by different HIIT interventions on inflammation, metabolic adaptation, anti-fatigue and exercise performance, and fat loss. conditions: Overweight or Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants were evenly distributed according to a counterbalanced design and divided into three different groups by the body fat percentage of subjects: 1. L-HIIT group: the long-interval HIIT group (4 × 4 min Exercise/4 min Rest), 2. M-HIIT group: the medium-interval HIIT group (8 × 2 min Exercise /2 min Rest), 3. Control group. Target intensities of each interval bout, exercise and rest (Ex./R.), were 85-90% VO2peak/65-70% VO2peak zones, respectively. primaryPurpose: OTHER masking: NONE count: 36 type: ACTUAL name: L-HIIT name: M-HIIT measure: Aerobic Capacity Test measure: Aerobic Capacity Test measure: Anti-fatigue performance measure: skinfold thickness measure: Body composition_body fat measure: Glucose measure: Triglycerides measure: low-density lipoprotein (LDL) measure: high-density lipoprotein (HDL) measure: creatine kinase (CK) level measure: C-reactive protein (CRP) measure: tumor necrosis factor (TNF)-R1 measure: TNF-R2 sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taipei Medical University city: Taipei zip: 110 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06383429 id: P.T-WH-10/2023-521 briefTitle: Relation Between Forward Head Posture and Incidence of Headache in Obese Adults overallStatus: COMPLETED date: 2024-01-01 date: 2024-03-14 date: 2024-04-15 date: 2024-04-25 date: 2024-04-25 name: Ahram Canadian University class: OTHER briefSummary: Cross sectional study to detect relation between forward head posture and headache. We will take information from the patient about:

* Detailed history of patient
* Forward head posture by using mobile application
* Headache disability index conditions: Obese conditions: Headache conditions: Neck Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 40 type: ACTUAL name: forward head posture by using mobile application. And patients will fill out headache disability index. measure: forward head posture measure: BMI measure: headache disability index sex: ALL minimumAge: 20 Years maximumAge: 30 Years stdAges: ADULT facility: Ababa physical therapy center city: Banī Suwayf state: Beni- Suaf zip: 2711860 country: Egypt lat: 29.07441 lon: 31.09785 hasResults: False

 nctId: NCT06383416 id: P.T-INT-10/2023-522 briefTitle: Incidence of Headache and Its Effect on Quality of Life in Geriatric Patients With Chronic Neck Pain overallStatus: COMPLETED date: 2024-01-21 date: 2024-03-20 date: 2024-04-20 date: 2024-04-25 date: 2024-04-25 name: Ahram Canadian University class: OTHER briefSummary: cross sectional study to detect the incidence of headache and its effect on quality of life in geriatric patients with chronic neck pain. Patients will fill out quality of life questionnaire and headache disability index. We will take information from the patients about:

* The frequency of headache occurrence.
* Visual analogue scale of chronic neck pain. Main measures: chronic neck pain will be assessed by visual analogue scale. Patients will fill out quality of life questionnaire and headache disability index. conditions: Geriatric Patients With Neck Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 40 type: ACTUAL name: Neck pain by VAS measure: Visual analogue scale measure: headache disability index measure: SF-36 quality of life questionare sex: ALL minimumAge: 60 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ababa physical therapy center city: Banī Suwayf zip: 2711860 country: Egypt lat: 29.07441 lon: 31.09785 hasResults: False

 nctId: NCT06383403 id: CLIN-60190-463 id: 2024-510695-20-00 type: CTIS briefTitle: A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid. acronym: ELSPIRE overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-06-22 date: 2026-12-21 date: 2024-04-25 date: 2024-04-25 name: Ipsen class: INDUSTRY briefSummary: The participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid (UDCA), which is a medication used in the management and treatment of cholestatic liver disease.

Primary biliary cholangitis is a slowly progressive disease characterised by damage of the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms.

Many patients with PBC may require a liver transplant or may die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment).

The main aim of this study is to determine if elafibranor is better than placebo in reducing ALP levels to a normal value. High ALP levels in the blood can indicate liver disease.

There will be three periods in this study: A screening period (up to 8 weeks) to assess whether the participant can take part; a treatment period (up to 52 weeks) where eligible participants will be grouped as per their blood ALP levels and randomly assigned to either receive elafibranor or placebo, and a follow-up period (4 weeks) where participants' health will be monitored.

Participants will be twice as likely to receive elafibranor than placebo (2:1 ratio).

Participants will undergo blood sampling, urine collections, physical examinations, clinical evaluations, electrocardiograms (ECG: recording of the electrical activity of heart), ultrasound examinations (a noninvasive test that passes a probe over skin to look at the bladder, urinary tract, and liver), and Fibroscan® examinations (a noninvasive test that passes a probe on skin to measure stiffness of the liver).

They will also be asked to fill in questionnaires. Each participant will be in this study for up to 64 weeks (15 months). conditions: Primary Biliary Cholangitis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 72 type: ESTIMATED name: Elafibranor name: Placebo measure: Percentage of participants with normalisation of Alkaline Phosphate (ALP) Levels measure: Percentage of participants with normalisation of ALP Levels measure: Change from baseline in ALP levels measure: Percentage of participants with normalisation of ALP Levels and ≥15% decrease from Baseline measure: Percentage of participants with ≥40% decrease from Baseline in ALP Levels measure: Percentage of participants with ALP <0.5 × Upper Limit of Normal (ULN) measure: Changes from baseline in Total Bilirubin (TB) Levels measure: Percentage of participants with TB <0.7 × ULN measure: Percentage of participants with normalisation of ALP and TB <0.7 × ULN measure: Percentage of participants with normalisation of TB and ALP Levels measure: Percentage of participants with complete biochemical response measure: Change from baseline in PBC Worst Itch Numeric Rating Scale (NRS) score measure: Percentage of participants with moderate to severe pruritus at baseline (i.e. score ≥4) with a clinically meaningful response in PBC Worst Itch NRS measure: Change from baseline in 5-D itch score measure: Change from baseline in Patient Global Impression of Severity (PGI-S) scores measure: Patient Global Impression of Change (PGI-C) scores measure: Change from baseline in PBC-40 Quality of Life (QoL) scores measure: Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a scores measure: Percentage of participants experiencing Treatment- Emergent Adverse Events (TEAEs), treatment- related TEAEs, Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs). measure: Percentage of participants developing clinically significant changes in physical examination measure: Percentage of participants developing clinically significant changes in vital signs measure: Percentage of participants developing clinically significant changes in Electrocardiogram (ECG) Readings measure: Percentage of participants developing clinically significant changes in laboratory parameters sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06383390 id: 18584 id: J1I-MC-GZBO type: OTHER domain: Eli Lilly and Company id: 2023-508630-34-00 type: OTHER domain: EU CTR Number briefTitle: The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Renal Function in Adults Living With Obesity (TRIUMPH-OUTCOMES) overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2029-02 date: 2029-02 date: 2024-04-25 date: 2024-04-25 name: Eli Lilly and Company class: INDUSTRY briefSummary: The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function. The trial will enroll adults with body mass index 27 kg/m\^2 or higher and Atherosclerotic Cardiovascular Disease and/or chronic kidney disease. conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 10000 type: ESTIMATED name: Retatrutide name: Placebo measure: Time to First Occurrence of Composite Endpoints measure: Time to First Occurrence of Composite Endpoint of End Stage Kidney Disease (ESKD), ≥ 40% Sustained Decline in Estimated Glomerular Filtration Rate (eGFR), CV Death or Renal Death measure: Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events (MACE-3) measure: Time to First Occurrence of Composite Endpoint of CV death, or hospitalization or urgent visit due to HF measure: Time to Occurrence of All-Cause Death measure: Time to First Occurrence of composite endpoint of ≥ 40% Sustained Decline in eGFR, End-Stage Renal Disease (ESRD), or Renal Death measure: Percentage change from Baseline in Albuminuria urinary albumin/creatinine ratio (UACR) in Participants with UACR ≥30 mg/g (0.03 mg/mg) at baseline sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Central Research Associates city: Birmingham state: Alabama zip: 35205 country: United States name: David D. DeAtkine role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 facility: Alliance for Multispecialty Research, LLC city: Daphne state: Alabama zip: 36526 country: United States name: Michael T. 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Saglik Bakanligi - Hitit Universitesi Corum Egitim ve Arastirma Hastanesi city: Corum zip: 19040 country: Turkey name: Lütfü Bekar role: PRINCIPAL_INVESTIGATOR lat: 40.54889 lon: 34.95333 facility: Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi city: Gaziantep zip: 27310 country: Turkey name: Fatih Mehmet Erdur role: PRINCIPAL_INVESTIGATOR lat: 37.05944 lon: 37.3825 facility: Dr. Siyami Ersek Göğüs Kalp Ve Damar Cerrahisi Eğitim Ve Araştırma Hastanesi city: Istanbul zip: 34668 country: Turkey name: Baris Gungor role: PRINCIPAL_INVESTIGATOR lat: 41.01384 lon: 28.94966 facility: Kartal Koşuyolu Yüksek İhtisas Eğitim ve Araştirma Hastanesi city: Istanbul zip: 34865 country: Turkey name: Gokhan Alici role: PRINCIPAL_INVESTIGATOR lat: 41.01384 lon: 28.94966 facility: Erciyes Universitesi Tıp Fakultesi Hastaneleri city: Kayseri country: Turkey name: Ismail Kocyigit role: PRINCIPAL_INVESTIGATOR lat: 38.73222 lon: 35.48528 facility: Ophthalmology city: Kocaeli zip: 41380 country: Turkey name: Necmi Eren role: PRINCIPAL_INVESTIGATOR lat: 39.62497 lon: 27.51145 facility: T.C. Saglik Bakanligi - Dumlupinar Universitesi Kutahya Evliya Celebi Egitim ve Arastirma Hastanesi city: Kütahya zip: 43100 country: Turkey name: Taner Sen role: PRINCIPAL_INVESTIGATOR lat: 39.42417 lon: 29.98333 facility: Homecroft Surgery city: Redruth state: Cornwall zip: TR16 4ET country: United Kingdom name: Mark Simon Danielsen role: PRINCIPAL_INVESTIGATOR lat: 50.23315 lon: -5.22434 facility: Rame Medical Ltd city: Torpoint state: Cornwall zip: PL11 2TB country: United Kingdom name: Lawrence Barnes role: PRINCIPAL_INVESTIGATOR lat: 50.37505 lon: -4.19566 facility: FutureMeds - Birmingham city: Birmingham zip: B21 9RY country: United Kingdom name: Tehmina Ahmed role: PRINCIPAL_INVESTIGATOR lat: 52.48142 lon: -1.89983 hasResults: False

 nctId: NCT06383377 id: Pre-market parallel study briefTitle: Evaluation of Performance, Safety and Benefit of the Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation overallStatus: RECRUITING date: 2024-04-26 date: 2025-03-31 date: 2030-03-31 date: 2024-04-25 date: 2024-04-25 name: Wishbone SA class: INDUSTRY name: EVAMED name: Pharmalex name: Advimago briefSummary: This investigation is a pre-market, prospective, multi-center, randomized, single blinded, parallel controlled clinical investigation performed in at least 5 clinical centers for confirmatory purposes of the use of WHA as intended in the filling of extraction sockets to enhance preservation of the alveolar socket. conditions: Bone Regeneration conditions: Safety Issues studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The parallel group will be treated with the product Bio-Oss® in a 1:1 randomization. Bio- Oss® is a natural bone mineral of bovine origin. Bio-Oss® is available as granules of spongious bone. Sterilization of Bio-Oss® is carried out by irradiation. Bio-Oss® has a macro- and microporous structure similar to human spongious bone. Bio-Oss® supports the in-growth of new bone at the implantation site by serving as a stable scaffold for osteoblasts; over time it is subject to the physiological remodeling process. Bio-Oss® is slowly resorbable, depending on the physiological environment of the individual patient, or integrated into the host bone. The highly purified osteoconductive mineral structure is produced from natural bone in a multistage purification process, adhering to the strictest safety regulations. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Patients will not be informed of their randomization assignment until the 1 year post implant placement follow-up visit. At this timepoint, the primary endpoint will have been achieved (at the implant placement visit) as well as the majority of the secondary endpoints. After the bone grafting surgery, all patients will receive an identic implant cart that does not break the blinding of the study. 1 year after implant placement, the patients will receive their definitive implant cart. whoMasked: PARTICIPANT count: 96 type: ESTIMATED name: Tooth extraction and bone graft procedure measure: Bone reconstruction as measured by CBCT (in mm) after bone grafting procedure. measure: Assessment of the bone density at implant placement. measure: Evaluation of the implant primary stability. measure: Assessment of the implant osteointegration after implant placement measure: Implant survival rate and success evaluated at 3-, 6- and 12-months and 3- and 5- To evaluate implant survival and success 3-, 6- and 12- months and 3- and 5-years after implant placement measure: Collection of all adverse events (AEs) related to the device and/or procedure, and assessment of incidence, type, severity, seriousness measure: Evaluation of patient satisfaction at 6- and 12-months after implant placement using questionnaire. measure: Evaluation of the peri-implant marginal tissue health status at 6 and 12 months after implant placement. measure: Evaluation of the evolution of the interproximal bone level 3- and 12-months after implant placement. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinique de la Source DentalMe status: RECRUITING city: Louvain-la-Neuve state: Brabant Wallon zip: 1348 country: Belgium name: Sami El Masri role: CONTACT email: dentiste.elmasri@gmail.com name: Laurane Pansaers role: SUB_INVESTIGATOR lat: 50.66829 lon: 4.61443 facility: Cabinet Debaty-Techy status: RECRUITING city: Aubel state: Liège zip: 4880 country: Belgium name: Bertrand Debaty role: CONTACT email: bertranddebaty@gmail.com lat: 50.70189 lon: 5.85812 facility: Clinique du Faubourg DentalMe status: RECRUITING city: Chaudfontaine state: Liège zip: 4053 country: Belgium name: Souheil Salem role: CONTACT email: souhsal@yahoo.fr lat: 50.5828 lon: 5.6341 facility: Centre Hospitalier Université de Liège status: RECRUITING city: Liège zip: 4000 country: Belgium name: Bruno De Carvalho role: CONTACT email: mailto:bruno.decarvalho@chuliege.be name: Lemmy Liegeois role: SUB_INVESTIGATOR name: Gilles Szotek role: SUB_INVESTIGATOR lat: 50.63373 lon: 5.56749 facility: Centre Oxalys status: RECRUITING city: Namur zip: 5020 country: Belgium name: Adrien Bolette role: CONTACT email: bolette.adrien@gmail.com lat: 50.4669 lon: 4.86746 hasResults: False

 nctId: NCT06383364 id: SHS-Pharm - 1 - 2024 briefTitle: The Effect of a Medication Coordinator on the Quality of Patients Medication Treatment acronym: MEDCOOR overallStatus: ENROLLING_BY_INVITATION date: 2024-05-01 date: 2025-06-01 date: 2025-06-01 date: 2024-04-25 date: 2024-04-25 name: University of Southern Denmark class: OTHER briefSummary: To examine the effect of a Medication Coordinator, who facilitates medication reviews in close collaboration with patients using My Medication Plan to reduce the risk of post-hospital inappropriate medication usage. conditions: Medication Administered in Error studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: CARE_PROVIDER count: 140 type: ESTIMATED name: Medication Coordinator measure: Reduction of potentially inappropriate medication according to Potentially Inappropriate Medication List measure: Evaluation of patients experiences quality of life with the EQ-5D and EQ-VAS. measure: Evaluation of patients experienced quality of life with visual analogue scale (VAS). measure: Evaluation of patients experienced treatment burden with the questionnaire Multimorbidity treatment burden questionnaire (MTBQ). measure: Evaluation of patients experienced medication burden with visual analogue scale (VAS). measure: Patient readmission 30 days after hospital discharge measure: Patient contact to the ward 30 days after hospital discharge sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sygehus Sønderjylland city: Aabenraa state: Southern Denmark zip: 6200 country: Denmark lat: 55.04434 lon: 9.41741 hasResults: False

 nctId: NCT06383351 id: BQ001 briefTitle: Patients' Illness Perception of Peri-implant Diseases. A Cross-sectional Study overallStatus: RECRUITING date: 2024-04-16 date: 2024-05 date: 2024-05 date: 2024-04-25 date: 2024-04-25 name: University of Siena class: OTHER briefSummary: Despite extensive research on periodontitis, little attention has been given to the symptoms and perception of peri-implant diseases and their impact on oral health-related quality of life. The study aims to assess patient perception of these diseases and their impact on quality of life through a cross-sectional observational study. Patients will be recruited from the Unit of Periodontics at "Le Scotte" University Hospital and will undergo diagnosis followed by questionnaire assessments. No follow-up visits are planned, and validated questionnaires will be administered to evaluate perception and impact on quality of life. Study procedures will include recording biometric peri-implant parameters and administering questionnaires such as the Brief Illness Perception Questionnaire (BIPQ) and Oral Health Impact Profile-14 (OHIP-14). conditions: Peri-implant Mucositis conditions: Perception conditions: Survey conditions: Questionnaires conditions: Peri-Implantitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 150 type: ESTIMATED name: Questionnaire measure: Assessment of patient's perception of their peri-implant disease through the Brief Illness Perception Questionnaire (Brief IPQ) measure: Assessment of peri-implant disease's impact on the oral health-related quality of life through the Oral Health Impact Profile 14. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AOUS status: RECRUITING city: Siena zip: 53100 country: Italy name: Nicola Discepoli role: CONTACT phone: 3395256148 email: nicola.discepoli2@unisi.it lat: 43.31822 lon: 11.33064 hasResults: False

 nctId: NCT06383338 id: PEGASUS briefTitle: A Study Investigating the Change in Metabolism Phenotype in Paediatric, Adolescent & Young Adults With Hodgkin or Non-Hodgkin Lymphoma. acronym: PEGASUS overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2026-05 date: 2024-04-25 date: 2024-04-25 name: Murdoch Childrens Research Institute class: OTHER briefSummary: PEGASUS aims to test acceptability and feasibility of studying phenoconversion (the change in metabolism phenotype) using probe medications in a paediatric oncology patient population. The study will be conducted in patients (6-25 years of age) with Hodgkin lymphoma or non-Hodgkin lymphoma as exemplar cohort, but with the understanding that cancer-directed and supportive care medicines of the CYP3A4, CYP2C19, and CYP2D6 metabolic pathways are commonly utilised for the treatment of many paediatric, adolescent, young adult, and adult cancers.

The study involves administration of the probe medication at timepoints which align with pre-determined hospital visits for the treatment of lymphoma and subsequent blood draws to measure the metabolism of the probe medications.

The acceptability and feasibility of this study will inform future studies in phenoconversion within the paediatric cancer population to direct more personalised precision medicine. conditions: Hodgkin Lymphoma conditions: Non Hodgkin Lymphoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 10 type: ESTIMATED name: Omeprazole name: Dextromethorphan measure: Proportion of patients who consent to study and complete baseline and at least two longitudinal timepoints with successful measurement of probe drug MR (Metabolic ratio) measure: Percentage of participants completing all required longitudinal blood sampling measure: Proportion of participants with successful detection of probe drug overall and at each sampling timepoint measure: Proportion of participants where phenotype can be classified according to MR overall at each sampling timepoint measure: The level of acceptability of participation in pharmacogenomic & phenoconversion testing using the PEGASUS specific survey tool (based on the Theoretical Framework of Acceptability [TFA]) measure: Percentage of participants experiencing an adverse event (AE) during probe drug administration measure: Incidence of genotype and phenotype mismatch, overall and across longitudinal timepoints measure: Proportion of participants with disease staging and biomarkers of extent of disease measure: Proportion of participants with a systemic inflammatory state measure: Proportion of participants taking medications involving the CYP P450 pathway measure: Participant demographic information measure: Proportion of participants with other environmental factors measure: Longitudinal inflammatory profile of participants with Hodgkin or non-Hodgkin Lymphoma as measured by a panel including serum levels of procalcitonin, c-reactive protein and cytokine analysis. sex: ALL minimumAge: 6 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Peter MacCallum Cancer Centre city: Melbourne state: Victoria zip: 3000 country: Australia name: Marliese Alexander, Doctor of Philosophy role: CONTACT lat: -37.814 lon: 144.96332 hasResults: False

 nctId: NCT06383325 id: Livertoxcicity in AL briefTitle: Livertoxcicity in Acute Leukemia Patients During Chemotherapy Treatment overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-08-01 date: 2024-04-25 date: 2024-04-25 name: Assiut University class: OTHER briefSummary: Detection of hepatotoxcicity in acute leukemia and study the outcome of acute leukemia patients that suffer from hepatic toxiciyt conditions: Liver Toxicity, Chemically-Induced studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 70 type: ESTIMATED name: Chemotherapy measure: Detection of hepatotoxcicity in acute leukemia during chemotherapy treatment sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06383312 id: E-10840098-772.02-4248 briefTitle: Magnetic Reflexologic Insoles for Primary Dysmenorrhea overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-08 date: 2024-09 date: 2024-04-25 date: 2024-04-25 name: Istanbul Medipol University Hospital class: OTHER briefSummary: In the study, easy-to-access and easy-to-use reflexologic magnetic insoles were used in women with primary dysmenorrhea who did not want to receive medical treatment; In addition to reducing symptoms such as pain, nausea, dizziness, fainting, vomiting, weakness, constipation/acute gastroenteritis, it is aimed to increase individuals' participation in daily life activities and increase their quality of life by increasing their emotional state. conditions: Primary Dysmenorrhea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: two groups; treatment group and sham group primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Reflexologic Magnetic Insole Group name: Orthopedic Insole Group measure: McGill Pain Questionnaire-Short Form: measure: Menstruation Attitude Questionnaire measure: Menstruation Symptom Questionnaire measure: Visual Analogue Scale (VAS) sex: FEMALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Istanbul Medipol University city: Istanbul zip: 34815 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06383299 id: AnkaraYbuMNC briefTitle: The Validity and Reliability Study of Turkish Version of Calgary Sleep Apnea Quality of Life Index overallStatus: COMPLETED date: 2021-01-01 date: 2021-07-01 date: 2021-08-01 date: 2024-04-25 date: 2024-04-25 name: Ankara Yildirim Beyazıt University class: OTHER briefSummary: The aim of this study is to investigate its validity and reliability of the questionarre whose original English name was "Calgary Sleep Apnea Quality of Life Index" which we plan to translate into Turkish as Sleep Apnea Quality of Life Index. conditions: Obstruvtive Sleep Apnea Syndrome (OSAS) studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 60 type: ACTUAL measure: Calgary Sleep Apnea Quality of Life İndex (C-SAQLI) measure: Short Form 36 measure: Epworth Sleepiness Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Yildirim Beyazıt University city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06383286 id: AnkaraYBUfby briefTitle: The Relationship Between Physical Activity Levels and Anxiety, Depression, Stress of Disabled Athletes overallStatus: COMPLETED date: 2020-12-01 date: 2021-03-01 date: 2022-03-01 date: 2024-04-25 date: 2024-04-25 name: Ankara Yildirim Beyazıt University class: OTHER briefSummary: It is aimed to investigate the relationship between anxiety, depression, stress and physical activities of disabled athletes prepared for the paralympic games to be held in Tokyo in 2021, 3 times in total at 2-3 months intervals, and to determine the change over time conditions: Paralympic Athletes studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 56 type: ACTUAL measure: State-Trait Anxiety Inventory (STAI) measure: The Center for Epidemiological Studies Depression Scale (CES-D) measure: Fatigue Severity Scale measure: International Physical Activity Questionnaire short form measure: Perceived Stress Scale (PSS-14) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Yıldırım Beyazıt Univercity city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06383273 id: MELT-3-001 briefTitle: A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR) overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2025-01 date: 2024-04-25 date: 2024-04-25 name: Melt Pharmaceuticals class: INDUSTRY name: MedTrials Incorporated name: Evolution Research Group name: Catalent name: Pharmalex briefSummary: The goal of this clinical trial is to learn if MELT-300 works on procedural sedation in adult participants undergoing cataract extraction with lens replacement (CELR). It will also learn about the safety of MELT-300. Researchers will compare MELT-300 to a placebo (a look-alike substance that contains no drug) to see if MELT-300 works on procedural sedation in adult participants undergoing CELR. Researchers will also include a comparator SL midazolam to confirm the benefit of inclusion of ketamine in the combined drug product.

The main questions it aims to answer are:

1. Does MELT-300 is effective in comparison to placebo on procedural sedation for cataract surgery?
2. To determine the effectiveness of MELT-300 compared with midazolam on procedural sedation (to determine the contribution of ketamine component and inform the risk of ketamine in MELT-300)
3. To determine the time to achieve preoperative target sedation level with MELT-300
4. What medical problems do participants have when taking MELT-300 vs placebo

Eligible participants will admitted to the study unit on Day 1. Participants will be randomized prior to surgery 4:1:1 to

1. MELT-300 (i.e. 1 MELT-300 sublingual tablet which contains 3 mg midazolam and 50 mg of ketamine)
2. Midazolam (i.e. 1 matching midazolam sublingual tablet which contains 3 mg midazolam)
3. Placebo (i.e. 1 matching placebo sublingual tablet)

Participants will receive study medication 30 (± 5) minutes, without food or water, before planned surgery start (defined as instillation of topical ocular anesthetic gel \[i.e.. 3 drops of chloroprocaine hydrochloride ophthalmic gel)\].

The effectiveness of MELT-300 will be performed after study medication is administered before surgery, in the course of surgery, and postoperative on Day 1 (end of surgery defined as just prior to drape removal). The safety of MELT-300 will be performed at baseline, in the course of surgery, postoperatively on Day 1, and on Day 3 ± 1 day post dose of study medication. conditions: Cataract studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multi-Center Study primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double-masked whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 486 type: ESTIMATED name: MELT-300 sublingual tablet name: Midalozam sublingual tablet name: Placebo sublingual tablet measure: Percentage of Participants Achieving Successful Procedural Sedation measure: Percentage of Participants Requiring Rescue Sedation Medication measure: Percentage of Participants Achieving Preoperative Procedural Sedation Without Need For Rescue Sedation Medication measure: Percentage of Participants Requiring Rescue Sedation Medication Preoperatively measure: Percentage of Participants Requiring Rescue Sedation Medication Intraoperatively measure: Assessment of Sedation Scores in Participants Without Requiring Rescue Sedation Medication measure: Percentage of Participants Able to Complete the Surgery measure: Percentage of Participants Able to Complete the Surgery Without Intervention (Other Than Rescue Sedation Medication) measure: Duration to Achieve Preoperative Target Sedation (RSS level 2 or 3) measure: Percentage of Participants Reporting Treatment Emergent Adverse Events (TEAEs) measure: Percentage of Participants Reporting Adverse Events Special Interest (AESIs) measure: Mean Change from Baseline in Blood Pressure (mmHg) measure: Mean Change from Baseline in Heart Rate [beats per minute (bpm)] measure: Mean Change from Baseline in Respiratory Rate (breath per minute) measure: Mean Change from Baseline in Body Temperature (degrees Fahrenheit) measure: Mean Change from Baseline in Pulse Oximetry (%) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06383260 id: 009-0001-7719-1189 briefTitle: Assessing the Prevalence of Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Undiagnosed Young Adults:A Cross Sectional Study overallStatus: COMPLETED date: 2023-07-01 date: 2023-09-01 date: 2023-09-01 date: 2024-04-25 date: 2024-04-25 name: Jinnah Sindh Medical University class: OTHER briefSummary: To asses the prevalence of Attention deficit hyperactivity disrorder in undiagnosed young adults. conditions: Finding the Prevalence of ADHD in Undiagnosed Young Adults studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 200 type: ACTUAL name: Behavioral diagnostic measure: Assess the prevalence of undiagnosed ADHD in Young adults sex: ALL minimumAge: 18 Years maximumAge: 24 Years stdAges: ADULT facility: JSMU city: Karachi state: Sindh zip: 75330 country: Pakistan lat: 24.8608 lon: 67.0104 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-09-01 uploadDate: 2024-04-21T04:06 filename: Prot_SAP_000.pdf size: 834129 hasResults: False

 nctId: NCT06383247 id: AMU-PD-multicenter briefTitle: The Efficacy of Repetitive Transcranial Magnetic Stimulation With Precision Neuronavigation in Parkinson's Disease overallStatus: NOT_YET_RECRUITING date: 2024-11-01 date: 2028-12-31 date: 2030-12-31 date: 2024-04-25 date: 2024-04-29 name: Anhui Medical University class: OTHER briefSummary: Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive and widely used neuromodulation technology. Small sample studies have shown that rTMS treatment can significantly improve the symptoms of Parkinson's disease(PD) and delay the progression of the disease. In order to further explore the effectiveness of rTMS in the treatment of PD and lay the foundation for its clinical promotion, our research team plans to conduct a randomized double-blind controlled study of rTMS in the treatment of PD in multiple centers across the country. conditions: Parkinson Disease conditions: Transcranial Magenetic Stimualtion conditions: Supplementary Motor Area studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 312 type: ESTIMATED name: transcranial magnetic stimulation measure: Movement Disorder Society- Unified Parkinson's Disease Rating Scale III scores measure: Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅰ scores measure: Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅱ scores measure: Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅳ scores sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cognitive Neuropsychology Lab Anhui Medical University city: Hefei state: Anhui zip: 230032 country: China lat: 31.86389 lon: 117.28083 hasResults: False

 nctId: NCT06383234 id: PAR 89/21 briefTitle: REduced Pain After Bariatric Surgery - Sleeve Gastrectomy acronym: REPABS-SG overallStatus: COMPLETED date: 2022-01-10 date: 2023-09-21 date: 2023-09-28 date: 2024-04-25 date: 2024-04-25 name: Fondazione Policlinico Universitario Campus Bio-Medico class: OTHER briefSummary: This study aims to analyze the effect of laparoscopic guided transversus abdominis plane (LG-TAP) block compared to placebo for postoperative analgesia following laparoscopic sleeve gastrectomy. One group of participants received a (LG-TAP) block with local anesthetic while the other group received (LG-TAP) block with saline solution (placebo). conditions: Pain conditions: Postoperative Pain conditions: Acute Pain conditions: Analgesia conditions: Bariatric Surgery Candidate conditions: Anesthesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 110 type: ACTUAL name: LG-TAP block with local anesthetic name: LG-TAP block with saline solution name: Port site infiltration measure: Pain Score measure: Morphine Consumption measure: Toradol Consumption measure: Nausea and/or vomiting measure: Lenght of Hospital Stay measure: Time to walking measure: Time to first flatus measure: Surgical Complication sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario Campus Bio-medico city: Rome zip: 00128 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06383221 id: 83244570 briefTitle: Study of the Intervention Effect of Stepped-care Models on Depression Symptoms During Pregnancy. overallStatus: NOT_YET_RECRUITING date: 2024-05-20 date: 2025-10-20 date: 2026-03-10 date: 2024-04-25 date: 2024-04-25 name: Fangbiao Tao class: OTHER briefSummary: In this study, pregnant women were screened and managed for depression in three time windows: early pregnancy, mid-pregnancy, and late pregnancy. Pregnant women who screened positive for depression during pregnancy were dynamically enrolled in the study and stratified into randomized groups based on gestation period (early/mid/late) and randomly assigned to the intervention and control groups on a 1:1 basis. Pregnant women in the intervention group attended a three-week "mental fitness boot camp" and were assessed at 3 weeks, and if they still screened positive for depression, they were offered 4 times one-on-one counseling sessions by the obstetrician. The control group received routine care. conditions: Perinatal Depression conditions: Stepped Care studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 600 type: ESTIMATED name: "Mental Fitness Boot Camp - Advanced Counseling" Step-by-Step Care measure: Edinburgh Postnatal Depression Scale measure: Generalized Anxiety Disorder measure: World Health Organization Five-item Well-Being Index sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06383208 id: 2024-ZF-13 briefTitle: Cardiovascular-Renal Adverse Prognosis Assessment System for Coronary Heart Disease With Chronic Kidney Disease Based on Metabolomics acronym: CRUISE-MET overallStatus: RECRUITING date: 2024-04-01 date: 2027-03-31 date: 2027-03-31 date: 2024-04-25 date: 2024-04-25 name: China-Japan Friendship Hospital class: OTHER briefSummary: Coronary heart disease (CHD) combined with chronic kidney disease (CKD) affects a substantial portion of the population and carries a significant disease burden, often leading to poor outcomes. Despite efforts to strictly control traditional risk factors, the efficacy in improving outcomes for patients with both CHD and CKD has been limited. Recent advancements in lipid metabolism research have identified new lipid metabolites associated with the occurrence and prognosis of CHD and CKD. Our preliminary trial has shown that levels of certain lipid metabolites, such as Cer(18:1/16:0), HexCer(18:1/16:0), and PI(18:0/18:1), are notably elevated in patients with CHD and reduced kidney function compared to those with relatively normal kidney function. This suggests that dysregulation of these non-traditional lipid metabolites may contribute to residual risk for adverse outcomes in these patients.

Furthermore, the emerging concept of "cardiovascular-kidney-metabolic syndrome" and the availability of new treatment options highlight the urgent need for a risk stratification tool tailored to modern management strategies and treatment goals to guide preventive measures effectively. To address this, we propose to conduct a prospective cohort study focusing on CHD combined with CKD. This study aims to comprehensively understand the clinical characteristics, diagnosis, treatment status, and cardiovascular-kidney prognosis in these patients. Through advanced metabolomics analysis, we seek to identify lipid metabolism profiles and non-traditional lipid metabolites associated with the progression of coronary artery disease in CHD-CKD patients. Leveraging clinical databases and metabolomics data, we will develop a robust risk prediction model for adverse cardiovascular-kidney outcomes, providing valuable guidance for clinical diagnosis, treatment decisions, and ultimately improving patient prognosis. conditions: Chronic Kidney Diseases conditions: Coronary Heart Disease conditions: Lipid Metabolism Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 470 type: ESTIMATED name: lipid metabolomics measure: Incidence of cardiovascular adverse events measure: Incidence of Renal composite endpoint event measure: Incidence of All-cause mortality measure: Incidence of Repeat revascularization measure: Incidence of bleeding sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: China-Japan Friendship Hospital status: RECRUITING city: Beijing state: Beijing country: China name: Chen Qiang, MD role: CONTACT phone: +86 13882712184 email: dawangchen@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06383195 id: SBA 24/189 briefTitle: The Reliability and Validity of the Ankylosing Spondylitis Performance Index (ASPI) in Enthesitis-Related Arthritis overallStatus: RECRUITING date: 2024-03-21 date: 2026-03-20 date: 2026-03-20 date: 2024-04-25 date: 2024-04-25 name: Hacettepe University class: OTHER briefSummary: This study assesses the test-retest reliability, construct validity, and minimal detectable change of the Ankylosing Spondylitis Performance Index (ASPI) in assessing the physical function of patients with Enthesitis-related arthritis (ERA). conditions: Enthesitis Related Arthritis conditions: Enthesitis Related Arthritis, Juvenile studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED measure: Ankylosing Spondylitis Performance Index (ASPI) measure: Childhood Health Assessment Questionnaire (CHAQ) measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) measure: Bath Ankylosing Spondylitis Functional Index (BASFI) measure: Bath Ankylosing Spondylitis Metrology Index (BASMI) measure: Modified Paediatric Mini Mental Scale (MPMMS) sex: ALL minimumAge: 7 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Hacettepe University status: RECRUITING city: Ankara country: Turkey name: Sinan Buran, RA role: CONTACT email: pt.sinanburan@gmail.com lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06383182 id: Y (2024) 054 briefTitle: Change in Serum Biomarkers After Endovascular Treatment for Acute Anterior Circulation Large Vessel Occlusion overallStatus: NOT_YET_RECRUITING date: 2024-05-07 date: 2026-12-30 date: 2026-12-30 date: 2024-04-25 date: 2024-04-25 name: General Hospital of Shenyang Military Region class: OTHER briefSummary: Acute ischaemic stroke (AIS) results in high rates of neurological morbidity and mortality, especially in patients with large vessel occlusion (LVO). Endovascular therapy (EVT) has been approved as the most effective treatment for patients with LVO , but about half patients undergoing EVT did not achieve good outcome. The mechanisms of poor prognosis are complex. How to accurately identify serological biomarkers related to patients' clinical prognosis is an important research topic nowadays. conditions: Ischemic Stroke studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: endovascular treatment measure: Dynamic changes in serum biomarkers after endovascular treatment measure: favourable functional outcome, defined as modified Rankin Scale (mRS) 0-2 measure: excellent functional outcome, defined as modified Rankin Scale (mRS) 0-1 measure: distribution of modified Rankin Scale (mRS) score measure: early neurological improvement, defined as 4 or more decrease in National Institute of Health stroke scale (NIHSS) measure: changes in National Institute of Health stroke scale (NIHSS) measure: symptomatic intracranial hemorrhage (sICH) measure: occurence of new stroke or other vascular events measure: the association between cerebral circulation time (CCT) and clinical outcomes measure: the association between serum biomarkers and clinical outcomes measure: the association between serum biomarkers and status of vessel recanalization sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: General Hospital of Northern Theater Command city: ShenYang zip: 110840 country: China lat: 41.79222 lon: 123.43278 hasResults: False

 nctId: NCT06383169 id: wanglizhong briefTitle: Impact of External Drainage of the Lumbar Cistern in Patients With Hydrocephalus Following Meningioma Surgery and Its Influence on Patient Satisfaction overallStatus: COMPLETED date: 2019-05-01 date: 2022-05-01 date: 2022-05-30 date: 2024-04-25 date: 2024-04-25 name: First Hospital of Zhangjiakou City class: OTHER briefSummary: This study aims to investigate the effect of external lumbar cistern drainage in preventing postoperative hydrocephalus in patients who have undergone meningioma surgery and its impact on patient satisfaction. conditions: Investigate the Effect of External Lumbar Cistern Drainage in Preventing Postoperative Hydrocephalus in Patients Who Have Undergone Meningioma Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 86 type: ACTUAL measure: Comparison of general clinical data measure: Comparison of the response rate measure: Comparison of GCS scores and intracranial pressure measure: Comparison of KPS scores and satisfaction sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: First Hospital of Zhangjiakou City city: Zhangjiakou country: China lat: 40.81 lon: 114.87944 hasResults: False

 nctId: NCT06383156 id: MD157/2023 briefTitle: The Use of Lung US, Fluoroscopy and Auscultation to Confirm Proper Positioning of Left Sided DLT : A Comparative Study overallStatus: NOT_YET_RECRUITING date: 2024-04-17 date: 2024-09-18 date: 2024-10-01 date: 2024-04-25 date: 2024-04-25 name: Ain Shams University class: OTHER briefSummary: The aim of this study is to compare between The Use of Lung ultrasound, Fluoroscopy and Auscultation to Confirm Proper Positioning of Left Sided DLT in elective thoracic surgeries. conditions: Endotracheal Tube Wrongly Placed During Anesthetic Procedure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 90 type: ESTIMATED name: Double lumen endotracheal tube measure: the specificity in confirming the position of the LDLT and matching the observation of flexible bronchoscope measure: sensitivity and accuracy in confirming the position of the LDLT. sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06383143 id: AC-020-IT briefTitle: Promoting Diagnosis and Management of AL in Italy (ProDigALIty) acronym: ProDigALIty overallStatus: RECRUITING date: 2023-05-01 date: 2025-05-01 date: 2025-05-01 date: 2024-04-25 date: 2024-04-25 name: IRCCS Policlinico S. Matteo class: OTHER briefSummary: We plan to establish a dedicated network of Italian Hematologic Departments interconnected with the Amyloidosis Research and Treatment Center in Pavia to:

1. Implement a biomarker-based screening strategy to promote early diagnosis of AL amyloidosis among at-risk patients, including patients with monoclonal gammopathy of undetermined significance, MGUS, and altered free light chain ratio (aFLCR), and patients with smoldering multiple myeloma (SMM)
2. Expedite and facilitate patients' referral and their enrollment in ongoing pre-clinical/clinical studies, also to reflect a broader spectrum of the real-world population of patients with AL amyloidosis in Italy;
3. Investigate the clinical utility of novel diagnostic technologies, including light chain sequencing and N-glycosylation analysis conditions: AL Amyloidosis conditions: Smoldering Multiple Myeloma conditions: Monoclonal Gammopathy of Undetermined Significance studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 760 type: ESTIMATED name: no intervention measure: Assess proportion of patients with newly diagnosed AL identified through the biomarker-based screening of at-risk patient measure: Assess the proportion of patients with deep haematological response after frontline therapy (best response evaluation) in the new enhanced, contemporary, real-world series of AL patients enrolled during the study. measure: 3. Identify associations of clonal light chain features with different clinical features at baseline. measure: Description of the baseline characteristics and 6-months outcome, as well as the time to AL development for patients with AL identified through the biomarker-based screening measure: Description of the baseline characteristics of MGUS/SMM patients with abnormal FLCR measure: Identification of clinical and biological correlates of hematological response measure: To verify whether implementing a dedicated pipeline for referral of AL patients to the National Referral Center will increase the proportion of patients from spoke centers measure: Identification of associations of clonal light chain features with event-free survival measure: Validation of existing algorithms for predicting AL amyloidosis status sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliera Policlinico Consorziale status: RECRUITING city: Bari country: Italy name: PELLEGRINO MUSTO, MD role: CONTACT phone: 080 5593471 email: ematologiacontrapianto@policlinico.ba.it name: PELLEGRINO MUSTO, MD role: PRINCIPAL_INVESTIGATOR name: Angela Minervini, MD, PhD role: SUB_INVESTIGATOR lat: 41.11148 lon: 16.8554 facility: Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco status: RECRUITING city: Catania country: Italy name: Francesco Di Raimondo, MD role: CONTACT phone: 095/378.1956 email: segremat@unict.it name: Francesco Di Raimondo, MD role: PRINCIPAL_INVESTIGATOR name: Concetta Maria Sebastiana Conticello, MD, PhD role: SUB_INVESTIGATOR lat: 37.49223 lon: 15.07041 facility: Fondazione Irccs Policlinico San Matteo status: RECRUITING city: Pavia country: Italy name: GIOVANNI PALLADINI, MD, PhD role: CONTACT phone: +390382502994 email: segreteria.amiloidosi@smatteo.pv.it name: GIOVANNI PALLADINI, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Luca Arcaini, MD role: PRINCIPAL_INVESTIGATOR name: Mario Ulisse Nuvolone, MD, PhD role: SUB_INVESTIGATOR lat: 45.19205 lon: 9.15917 facility: EMATOLOGIA - Città della Scienza e Salute - Torino status: RECRUITING city: Torino country: Italy name: FRANCESCA MARIA GAY, MD, PhD role: CONTACT phone: 011.633.5550 - 5935 email: ematologia@cittadellasalute.to.it name: FRANCESCA MARIA GAY, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Stefania Oliva, MD, PhD role: SUB_INVESTIGATOR lat: 45.07049 lon: 7.68682 hasResults: False

 nctId: NCT06383130 id: 24SM8792 briefTitle: London Asthma Diagnostics Study acronym: LADS overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2026-07 date: 2024-04-25 date: 2024-04-25 name: Imperial College London class: OTHER name: Asthma UK name: General Practitioners Research Institute briefSummary: The goal of this trial is to learn if the addition of oscillometry with reversibility testing increases diagnostic accuracy in adult asthma diagnosis, when added to current standard of care tests: spirometry with reversibility testing and Fractional Exhaled Nitric Oxide (FeNO). The main question it aims to answer is:

- Does oscillometry with reversibility testing increase diagnostic accuracy in detection of asthma in adults when added to spirometry with reversibility and FeNO?

Researchers will evaluate the diagnostic accuracy of this approach with the reference standard, which is a clinically adjudicated diagnosis of asthma by two respiratory clinicians based on history and investigation results.

Participants will

* Undergo oscillometry testing alongside their routine asthma investigations within their scheduled clinic visit
* Optionally participate in our sub-studies on new breath and nasal swab tests for asthma
* Optionally participate in our qualitative substudy on patients views and attitudes to asthma testing and oscillometry conditions: Asthma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 225 type: ESTIMATED name: Oscillometry with reversibility testing name: Breath volatile testing name: Nasal eosinophil peroxidase name: Handheld capnometry measure: To evaluate the diagnostic accuracy (sensitivity, specificity) of a combination of oscillometry ± reversibility, spirometry ± reversibility and FeNO measure: To conduct an analysis comparing the diagnostic accuracy of (i) oscillometry ± reversibility with spirometry ± reversibility, (ii) spirometry±reversibility with FeNO and (iii) oscillometry ±reversibility and FeNO measure: To compare the concordance of positive and negative test results for (i) oscillometry±reversibility, (ii) spirometry ±reversibility and (iii) Fractional Exhaled Nitric Oxide (FeNO) measure: To collect data on (i) testing time, (ii) testing burden, (iii) general feasibility of implementation of the asthma diagnostic tests measure: To evaluate the diagnostic accuracy of the targeted reactive aldehyde species (RASP) panel in breath for asthma diagnosis measure: To evaluate the diagnostic accuracy of nasal biomarker eosinophil peroxidase (EPX) measure: To evaluate the diagnostic accuracy of tidal breath CO2 waveforms using the N-Tidal handheld capnometry device sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Imperial College Healthcare NHS Trust city: London zip: W2 1PG country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Imperial College Healthcare NHS Trust city: London zip: W21NY country: United Kingdom name: Eleanor Quek, MBBS role: CONTACT phone: 07411429994 email: e.quek@imperial.ac.uk name: Salman Siddiqui, PhD role: CONTACT email: s.siddiqui@imperial.ac.uk name: Salman Siddiqui, PhD role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: Nottingham University Hospitals NHS Trust city: Nottingham zip: NG7 2UH country: United Kingdom name: Matthew Martin, PhD role: CONTACT email: matthew.martin4@nottingham.ac.uk name: Matthew Martin, PhD role: SUB_INVESTIGATOR lat: 52.9536 lon: -1.15047 hasResults: False

 nctId: NCT06383117 id: UL1TR002378 type: NIH link: https://reporter.nih.gov/quickSearch/UL1TR002378 id: KL2TR002381 type: NIH link: https://reporter.nih.gov/quickSearch/KL2TR002381 briefTitle: Understanding Effects of Calcium on the Gut-Bone Axis overallStatus: COMPLETED date: 2023-10-17 date: 2024-02-23 date: 2024-02-23 date: 2024-04-25 date: 2024-04-25 name: University of Georgia class: OTHER name: National Center for Advancing Translational Sciences (NCATS) briefSummary: The study team is inviting 13 healthy people to complete a study to explore how calcium affects hormones and bones after eating. Participants will be asked to complete two study visits within eight weeks. Before each visit, participants will be asked to not eat or drink (except water) for 9 hours. At each visit, participants will eat the same meal provided by the research team. Along with their meal, they will take a pill - in one session, this will be a calcium supplement, and in the other, a placebo (a pill with no calcium), but they won't know which one they are taking at which session. A phlebotomist will draw blood before the meal and pill, then again several times after eating. Blood draws will take place over three hours. During that time, participants will complete questionnaires about health, diet, and physical activity.

Blood will be analyzed to check on various health indicators, like bone health markers and certain hormones, to see how they change after the meal. The difference in these health indicators between the calcium and placebo sessions will help the study team understand the impact of calcium on health after eating. This could help increase knowledge of the impact of calcium on hormones and bone health. conditions: Healthy conditions: Adult conditions: Calcium conditions: Bone Resorption conditions: Endocrine; Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized placebo crossover trial primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: Investigator, participants, team distributing pills blinded to treatment arm whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 14 type: ACTUAL name: Calcium carbonate name: Placebo Control measure: Difference in GIP (gastric inhibitory peptide) area under the curve between calcium and placebo measure: Difference in GLP-1 (glucagon-like peptide 1) area under the curve between calcium and placebo measure: Difference in CTX (carboxy-terminal collagen crosslinks) area under the curve between calcium and placebo measure: Difference in P1NP (N-terminal propeptide) area under the curve between calcium and placebo measure: Difference in insulin area under the curve between calcium and placebo measure: Difference in glucose area under the curve between calcium and placebo measure: Difference in PTH (parathyroid hormone) area under the curve between calcium and placebo sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: University of Georgia Clinical and Translational Research Unit city: Athens state: Georgia zip: 30606 country: United States lat: 33.96095 lon: -83.37794 hasResults: False

 nctId: NCT06383104 id: MyoLupus briefTitle: Myofascial Techniques and Proprioceptive Neuromuscular Facilitation in Patients With Systemic Lupus Erythematosus. overallStatus: RECRUITING date: 2024-04-22 date: 2024-05-28 date: 2024-06-26 date: 2024-04-25 date: 2024-04-25 name: Universidad Católica San Antonio de Murcia class: OTHER briefSummary: Introduction. Systemic lupus erythematosus is an autoimmune disease. The musculoskeletal system is affected in 90% of patients. The most common manifestations are myalgias, arthralgias and arthritis.

Objective. To analyse the efficacy of an intervention using myofascial techniques and proprioceptive neuromuscular facilitation in patients with systemic lupus erythematosus.

Methods. Randomised clinical study with 20 patients with systemic lupus erythematosus, randomised to an experimental and control group. The intervention will last 4 weeks, with a periodicity of 2 weekly sessions of 50 minutes each. The intervention of the experimental group will consist of a protocol using myofascial and proprioceptive neuromuscular facilitation techniques.

Expected results. Improvement of knee and ankle pain intensity, functional capacity, basic mobility skills, strength, balance, agility and fatigue. conditions: System; Lupus Erythematosus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Intervention measure: Change from baseline joint pain after treatment and at 4 weeks measure: Change from baseline functional capacity after treatment and at 4 weeks measure: Change from baseline functionality after treatment and at 4 weeks measure: Change from baseline joint pain after treatment and at 4 weeks sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Universidad Católica San Antonio, Murcia status: RECRUITING city: Murcia zip: 30107 country: Spain name: RUBEN CUESTA-BARRIUSO, PhD role: CONTACT phone: +34 968278545 email: rcuesta@ucam.edu lat: 37.98704 lon: -1.13004 hasResults: False

 nctId: NCT06383091 id: IRB00380938 briefTitle: Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy acronym: Man Total Thy overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-12 date: 2026-12 date: 2024-04-25 date: 2024-04-25 name: Johns Hopkins University class: OTHER briefSummary: In this clinical trial, the investigators are seeking to learn if a course of voice therapy, including neck massage, stretches and pain science education in addition to voice exercise and scar massage will effectively treatment patient complaints of swallowing or voice changes after total thyroidectomy as compared to voice exercise and scar massage alone.

The main questions it aims to answer are:

Will neck massage, stretches and pain science education reduce patient complaints of swallowing changes after total thyroidectomy?

Will neck massage, stretches and pain science education reduce patient complaints of voice changes after total thyroidectomy?

Will neck massage, stretches and pain science education reduce patient complaints of scar tethering and quality changes after total thyroidectomy?

Will neck massage, stretches and pain science education improve quality of life after total thyroidectomy?

Participants will:

Participate in 4 visits with the participant's endocrine/laryngology surgeon. One prior and 3 after surgery for endoscopic evaluation and tests.

Participate in 5 Speech-Language Pathology Sessions for intervention exercises and tests. One prior and 4 after surgery.

Complete a journal of the participant's Home Exercise Practice conditions: Total Thyroidectomy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is meant to be a parallel study. However, The Speech Language Pathologists will not be blinded as the Speech Pathologists are providing each regimen. If a participant in either group requires more intensive sessions or a differing regimen given the severity of complaints, the participants will receive it as per the recommendation of the Speech-Language Pathologist so as not to unblind the PI. An intent to treat analysis will be performed to accurately describe the data in the case of crossover and/or dropout. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: Anterior Neck Manual Therapy name: Pain Neuroscience Education name: Neck Stretches name: Scar massage name: Voice Exercises name: Placebo Anterior Neck Manual Therapy name: Placebo Pain Neuroscience Education name: Placebo Neck Stretches measure: Acoustic measures of voice clarity measure: Acoustic measures of speaking voice pitch measure: Acoustic measures of speaking voice quality subjectively measure: Swallowing Quality of Life as assessed by the Eating Assessment Tool - 10 measure: Laryngeal sensation measure: Scar Tethering Distance measure: Scar Quality as assessed by The Patient and Observer Scar Assessment Scale measure: Voice Quality of Life as measures by the Voice Related Quality of Life - 10 measure: Adverse Effects in the Experimental Group sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins Hospital city: Baltimore state: Maryland zip: 21287 country: United States name: Claire Ligon, Masters of Education role: CONTACT phone: 434-390-6387 email: cligon4@jhmi.edu name: Kristine Pietsch, Masters of Arts role: CONTACT phone: 518-461-3610 email: kteets1@jhmi.edu name: Claire Ligon, Masters of Education role: SUB_INVESTIGATOR name: Kristine Pietsch, Masters of Arts role: SUB_INVESTIGATOR name: Michelle Wilson, Masters of Science role: SUB_INVESTIGATOR lat: 39.29038 lon: -76.61219 facility: Suburban Hospital city: Bethesda state: Maryland zip: 20817 country: United States name: Claire Ligon, Masters of Education role: CONTACT phone: 434-390-6387 email: cligon4@jhmi.edu name: Vaninder Dhillon, Medical Doctor role: CONTACT phone: 925-360-5939 email: vdhillo2@jhmi.edu name: Vaninder Dhillon, Medical Doctor role: PRINCIPAL_INVESTIGATOR name: Claire Ligon, Masters of Education role: SUB_INVESTIGATOR name: Michelle Wilson, Masters of Science role: SUB_INVESTIGATOR lat: 38.98067 lon: -77.10026 hasResults: False

 nctId: NCT06383078 id: MA-PC-II-012 briefTitle: HR070803 in Combination With Oxaliplatin, S-1 Versus NALIRIFOX as Adjuvant Therapy for Pancreatic Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2027-03-01 date: 2027-12-30 date: 2024-04-25 date: 2024-04-25 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: The purpose of this study is to evaluate the efficacy and safety of HR070803 in Combination With Oxaliplatin plus Tegafur compared to HR070803 in combination with oxaliplatin, 5-fluorouracil/leucovorin (5FU/LV) treatment as adjuvant therapy in patients with resected pancreatic cancer. conditions: Efficacy and Safety studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: HR070803 name: Oxaliplatin name: Tegafur name: Folinic acid name: 5-Fluorouracil measure: 1-year Disease-free survival rate measure: Overall survival (OS) measure: Disease-free survival（DFS） sex: ALL minimumAge: 20 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06383065 id: YDU/2020/76-1007 briefTitle: Respiratory Physiotherapy in Type 2 Diabetes and Bariatric Surgery overallStatus: COMPLETED date: 2020-02-01 date: 2021-04-30 date: 2022-01-30 date: 2024-04-25 date: 2024-04-25 name: Near East University, Turkey class: OTHER briefSummary: The aim of this study is to investigate the early effects of Inspiratory Muscle Training (IMT) applied before and after bariatric surgery on respiratory function, respiratory muscle strength and functional capacity in individuals with type 2 diabetes.

The study will be conducted with 40 individuals with type 2 diabetes aged between 25-65. Individuals will be randomly assigned to the IMT (trained at 30% of maximum inspiratory pressure with an IMT threshold device) and control group. As measurement parameters, a 6-minute walk test for functional capacity, a spirometry test for respiratory function, and a portable device (Cosmed Pony FX Desktop Spirometer, USA) will be used for respiratory muscle strength. Hand grip strength will be measured with a Baseline dynamometer. All measurements will be repeated on the first day before surgery and on the fourth day before discharge after surgery. conditions: Type 2 Diabetes conditions: Bariatric Surgery Candidate studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ACTUAL name: IMT Group measure: Respiratory Muscle Strength measure: Respiratory Function measure: Functional Capacity: The 6-minute walk test measure: Hand Grip Strength sex: ALL minimumAge: 25 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Near East University city: Nicosia country: Cyprus lat: 35.17531 lon: 33.3642 hasResults: False

 nctId: NCT06383052 id: NYM032Z01 briefTitle: A Phase 1/2 Study of 177Lu-NYM032 Injection in mCRPC overallStatus: RECRUITING date: 2024-04-30 date: 2024-11-30 date: 2024-11-30 date: 2024-04-25 date: 2024-04-25 name: Norroy Bioscience Co., LTD class: INDUSTRY briefSummary: 177Lu-NYM032 injection is a radioligand therapeutic agent that targets prostate specific membrane antigen (PSMA)-expressing prostate tumors. NYM032 is a small molecular with strong affinity for PSMA. conditions: Metastatic Castration-resistant Prostate Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: 177Lu-NYM032 injection measure: Number of Patients With Dose Limiting Toxicity (DLT) measure: Maximum Tolerated Dose (MTD) sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affliated Hospital of Jiangnan University status: RECRUITING city: Wuxi zip: 214000 country: China name: Chunjing Yu role: CONTACT phone: 15312238622 email: ycj_wxd1978@163.com lat: 31.56887 lon: 120.28857 hasResults: False

 nctId: NCT06383039 id: ZSoy briefTitle: Transcranial Direct Current Stimulation and Balance acronym: tDCS overallStatus: COMPLETED date: 2022-05-16 date: 2022-09-06 date: 2023-05-13 date: 2024-04-25 date: 2024-04-25 name: Zeynep Soy class: OTHER briefSummary: Postural control is an adaptive sensorimotor process involving continuous integration of sensory information from three channels. These; visual, somatosensory (proprioceptive) and vestibular senses. The study will be carried out at Istanbul Medipol University. 30 healthy individuals between the ages of 18-25 will be included. To each individual Anodal-supplementary motor area tDCS, Anodal-cerebellar tDCS, Sham tDCS applications will be cross-applied. tDCS application will take 20 minutes and each individual will receive 3 sessions in total. There will be a 72-hour rest period between sessions. Individuals assessed with Demographic Information Form for demographic information, Wii-Fit and Balance Error Scoring System for Static Balance Evaluation, Star Balance Test and Timed Get Up and Go Test for Dynamic Balance Assessment. The aim of this study is to investigate the effect of transcranial direct current stimulation applied on the supplementary motor area and cerebellum on static and dynamic balance in healthy individuals. conditions: Balance studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: All participants received 3 different interventions at different times. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants were not informed which type of current was applied. whoMasked: PARTICIPANT count: 30 type: ACTUAL name: Transcranial Direct Current Stimulation measure: Demographic Information Form measure: Wii-Fit measure: balance error scoring system measure: star excursion balance test measure: Time Up & Go Test sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Istanbul Medipol University city: Istanbul state: Beykoz country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06383026 id: PRO00047199 briefTitle: Transgender and Gender-Diverse Breast Cancer Screening Pilot overallStatus: RECRUITING date: 2024-04-17 date: 2027-12 date: 2028-02 date: 2024-04-25 date: 2024-04-25 name: Medical College of Wisconsin class: OTHER briefSummary: This investigation is a prospective breast cancer screening study open to all transgender and gender-diverse persons (regardless of sex assigned at birth). Using a mixed methods approach, the study will 1) gather prospective quantitative breast imaging data in conjunction with gender-affirming therapy and family cancer history and 2) investigate TGD persons perceptions and experiences in the breast cancer screening program, and 3) identify individual and systems-level barriers to breast cancer screening. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 130 type: ESTIMATED name: Breast Cancer Screening name: Survey/Interview name: Focus Group measure: Callback and Biopsy Rates after Breast Cancer Screening measure: Reflexive Thematic Analysis of the Physical, Cognitive, and Emotional Experience of Breast Cancer Screening in Transgender and Gender Diverse Persons measure: Reflexive Thematic Analysis on the Individual & System-Level Barriers to Breast Cancer Screening sex: ALL minimumAge: 30 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical College of Wisconsin status: RECRUITING city: Milwaukee state: Wisconsin zip: 53226 country: United States name: Chandler S Cortina, MD, MS role: CONTACT email: ccortina@mcw..edu lat: 43.0389 lon: -87.90647 hasResults: False

 nctId: NCT06383013 id: BB-101-BBCBB1A briefTitle: Phase II Study of BB-101 for the Treatment of Diabetic Lower Leg and Foot Ulcers overallStatus: RECRUITING date: 2024-02-29 date: 2027-12-31 date: 2028-12-31 date: 2024-04-25 date: 2024-04-25 name: Blue Blood Biotech Corp. class: INDUSTRY briefSummary: This is a randomized, double-blinded, vehicle-controlled, parallel, phase II study to evaluate the efficacy and safety of topical BB-101 for the treatment of diabetic lower leg and foot ulcer. conditions: Diabetic Foot Ulcer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 96 type: ESTIMATED name: BB-101 measure: Efficacy Evaluation measure: Safety Evaluation measure: Secondary Efficacy Evaluation measure: Exploratory Objectives sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare status: RECRUITING city: Taipei country: Taiwan name: Shug-Cheng Chang, MD role: CONTACT lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06383000 id: BLZ2024MOH briefTitle: Assessment of Effectiveness of Continuous Non-invasive Haemodynamic Monitor by Compared to Invasive Blood Pressure and Pulse Oximeter Monitoring on Patients Undergoing General Anesthesia Surgeries for More Than 60 Minutes overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-25 date: 2024-04-25 name: BLZ Technology (Wuhan) Co.,Ltd class: INDUSTRY briefSummary: The goal of this observational study is to assess whether the continuous non-invasive haemodynamic monitor MOH200 (measuring blood pressure as well as pulse rate) is effective or not in people undergoing general anesthetic surgeries for more than 60 minutes with planned invasive blood pressure and pulse oximeter monitoring.

Researchers will compare blood pressure data derived from MOH200 to the invasive blood pressure (IBP) data to see if the MOH200 is effective to measure the blood pressure of a surgical person. Also, researchers will compare pulse rate data drived from MOH200 to that from the pulse oximeter to see if the MOH200 is effective to measure the pulse rate of a surgical person.

Participants will be asked to be applied with MOH200 monitoring while IBP monitoring and pulse oximeter are applied. And after 30 minutes of the surgery, researchers will monitor the adverse effects occurred on the skin of participants to assess the safety of MOH200. conditions: General Anesthesia conditions: Blood Pressure conditions: Pulse Rate conditions: Arterial Line studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 55 type: ESTIMATED measure: Continuous Non -invasive Blood Pressure Measurement from MOH200 measure: Invasive Blood Pressure Measurement from Arterial Line measure: Pulse Rate Measurement from MOH200 measure: Pulse Rate Measurement from Pulse Oximeter measure: The Occurrence of Pressure Pores sex: ALL minimumAge: 4 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06382987 id: IM011-1124 briefTitle: A Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan (RePhlect) acronym: RePhlect overallStatus: RECRUITING date: 2024-01-22 date: 2029-12-31 date: 2029-12-31 date: 2024-04-25 date: 2024-04-25 name: Bristol-Myers Squibb class: INDUSTRY briefSummary: This is a prospective, observational, real-world study of adult participants in Japan with physician-reported diagnosis of plaque psoriasis treated with deucravacitinib or apremilast. conditions: Plaque Psoriasis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED name: Deucravacitinib name: Apremilast measure: Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib. measure: Number of participants who achieved Physician's Global Assessment (PGA) of 0/1 from baseline to follow-up measure: Number of participants who achieved Absolute Psoriasis Area and Severity Index (aPASI) of ≤2 from baseline to follow-up measure: Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0 /1 from baseline to follow-up measure: Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation) measure: Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib or apremilast measure: Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0/1 from baseline to follow-up measure: Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation) from baseline to follow-up measure: Number of participants treated with deucravacitinib with a change in Physician's Global Assessment (PGA) from baseline to follow-up measure: Number of participants treated with deucravacitinib with a change in Dermatology Life Quality Index (DLQI) from baseline to follow-up measure: Number of participants achieving a Dermatology Life Quality Index (DLQI) score of ≤5 from baseline to follow-up measure: Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 75 from baseline to follow-up measure: Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 90 from baseline to follow-up measure: Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤5 from baseline to follow-up measure: Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤3 from baseline to follow-up measure: Number of participants who achieve a National Psoriasis Foundation (NPF) Acceptable Body Surface Area response from baseline to follow-up measure: Number of participants who achieve an absolute scalp-specific Physician's Global Assessment (ss-PGA) of 0/1 from baseline to follow-up measure: Number of participants who achieve an absolute Physician's Global Assessment-Fingernail (PGA-F) of 0/1 from baseline to follow-up measure: Number of participants who achieve an absolute Palmoplantar Physician's Global Assessment (pp-PGA) of 0/1 from baseline to follow-up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mebix. Inc. status: RECRUITING city: Minato-ku state: Tokyo zip: 1070052 country: Japan name: Minoru Tonogai, Site 0001 role: CONTACT lat: 34.2152 lon: 135.1501 facility: Fukuoka University Hospital status: RECRUITING city: Fukuoka country: Japan lat: 33.6 lon: 130.41667 hasResults: False

 nctId: NCT06382974 id: 3-3-14 briefTitle: Evaluation of the Osteoinductivity of Atorvastatin Combined With β-TCP overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2026-03 date: 2024-04-25 date: 2024-04-25 name: Cairo University class: OTHER briefSummary: This case series study aims to evaluate the local effects of Atorvastatin (which belongs to the family of lipid-lowering drugs, known as statins) combined with β-TCP (which is a synthetic osteoconductive bone graft), on the volume of the residual bone defects and on hastening the bone regeneration after radicular jaw cyst enucleation using CBCT-based volumetric analysis to calculate the shrinkage rate of these defects. conditions: Infection conditions: Bone Loss studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A case series study. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Cyst enucleation and bone grafting measure: Shrinkage Rate measure: Inflammation sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Cairo University city: Cairo country: Egypt role: CONTACT phone: 23634965 email: surgery@dentistry.cu.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06382961 id: SZUS_231101 briefTitle: Postoperative Dexmedetomidine in Prevention of Postoperative Delirium overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-11 date: 2024-03-06 date: 2024-04 date: 2024-04-25 date: 2024-04-25 name: Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd. class: INDUSTRY name: Shenzhen People's Hospital name: Dongyuan People's Hospital name: Kunming Children's Hospital briefSummary: The goal of this clinical trial is to learn how postoperative infusion of dexmedetomidine would influence postoperative delirium in elderly patients undergoing lung surgery. The main questions it aims to answer are :

1. Does postoperative dexmedetomidine reduce the incidence of delirium after lung surgery?
2. Does postoperative dexmedetomidine introduce other medical problems? Researchers will compare dexmedetomidine and sufentanil to see if dexmedetomidine works to reduce delirium.

Participants will undergo routine postoperative care:

1. Patient-controlled self anesthesia with sufentanil only or combination of sufentanil and dexmedetomidine
2. Postoperative visit twice a day for at least seven days conditions: Delirium in Old Age conditions: Anesthesia; Adverse Effect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 287 type: ACTUAL name: Dexmedetomidine injection name: Sufentanil injection measure: Incidence of postoperative delirium measure: Incidence of postoperative nausea and vomiting measure: incidence of postoperative complications measure: Pain intensities sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Kunming Children's Hospital city: Kunming state: Yunnan zip: 650100 country: China lat: 25.03889 lon: 102.71833 hasResults: False

 nctId: NCT06382948 id: MedOPP545 id: 2024-512926-27-00 type: CTIS briefTitle: Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i. acronym: ADELA overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-09 date: 2028-04 date: 2024-04-24 date: 2024-04-26 name: MedSIR class: OTHER name: Stemline Therapeutics, Inc. briefSummary: This trial will study a type of advanced breast cancer (ABC) defined as endocrine receptor (ER)-positive/human epidermal growth factor receptor 2(HER2)-negative and estrogen receptor 1 (ESR1)-mutated. Patients will be treated with elacestrant, a compound that acts as a selective estrogen receptor degrader, and everolimus (or placebo), a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer.

The main purpose of the study is to analyze the efficacy (to find out how effective a treatment is) of elacestrant plus everolimus therapy in patients who have ER-positive/HER2-negative, ESR1-mutated, ABC progressing to endocrine therapy and cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. The efficacy of elacestrant plus everolimus combination will be determined by assessing the period from elacestrant plus everolimus (or placebo) treatment initiation until to the first occurrence of disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason, whichever occurs first, defined as progression free survival.

Rigorous eligibility criteria based on specific co-morbidities and clinicopathologic features of their disease have been designed to minimize the risk of patients participating in this study. The anticipated favorable clinical benefits of elacestrant combined with everolimus are projected to outweigh the risks of this treatment. This study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations. conditions: Advanced Breast Cancer conditions: ER-positive Breast Cancer conditions: HER2-negative Breast Cancer conditions: ESR1 Gene Mutation studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double-blind, parallel group (two arms: elacestrant plus everolimus, and elacestrant plus placebo). primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: A blinded, independent IRC will perform a review of radiographic images and clinical information collected on study to determine the protocol-defined endpoints of disease response and progression. Further information on the independent review process will be provided in the BIRC Charter. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 240 type: ESTIMATED name: Everolimus name: Elacestrant name: Placebo name: Auxiliary Medicinal Product - Dexamethasone name: Auxiliary Medicinal Product - Luteinizing hormone-releasing hormone (LHRH) analogues measure: To demonstrate superiority of elacestrant+everolimus vs. elacestrant+placebo in prolonging PFS based on a BIRC in patients with ER[+]/HER2[-], ESR1-mutated, ABC that have previously received ET+CDK4/6i (all patients). measure: To compare overall survival (OS) between treatment groups, in all patients. measure: To compare investigator-assessed PFS based on local assessment between treatment groups, in all patients. measure: To compare objective response rate (ORR) between treatment groups, in all patients. measure: To compare clinical benefit rate (CBR) between treatment groups, in all patients. measure: To compare overall time to response (TTR) between treatment groups, in all patients. measure: To compare duration of response (DoR) between treatment groups, in all patients. measure: To compare best percentage of change in tumor burden between treatment groups, in all patients. measure: To describe the changes in health-related quality-of-life (HRQoL) from baseline using the EuroQoL 5 Dimension 5 Level (EQ-5D-5L) scale. measure: To describe the changes in HRQoL from baseline using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). measure: To describe the changes in HRQoL from baseline using the EORTC Quality of Life Questionnaire Breast Cancer module (EORTC QLQ-BR45). measure: To assess adverse events (AEs) between treatment groups in all patients. measure: To assess adverse events leading to study treatment withdrawal. measure: To assess adverse events leading to dose modification. measure: To assess the number of participants with abnormal hematology and/or chemistry values that are related to treatment. measure: To assess the number of participants with changes on vital signs and/or AEs that are related to treatment. measure: To assess the number of participants with changes on cardiac function measured by ECG QT Interval Corrected by Fridericia formula (QTcF) that are related to treatment effect . measure: To assess the number of participants with changes on Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) that are related to treatment. measure: Exploratory endpoint: protein expression studies using blood samples to investigate the potential association with clinical outcomes. measure: Exploratory endpoint: analysis of allele mutation frequencies in circulating tumor DNA (ctDNA) in blood samples to investigate the potential association with clinical outcomes. measure: Exploratory endpoint: Genetic studies using blood samples to investigate the potential association with clinical outcomes. measure: Exploratory endpoint: Analysis of medical imaging (radiomics) to identify potential biomarkers associated with clinical outcomes. measure: Exploratory endpoint: Pharmacokinetic (PK) parameter of maximum (Peak) Observed Serum Concentration (Cmax). measure: Exploratory endpoint: Pharmacokinetic (PK) parameter of Plasma Through Concentration (Ctrough). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06382935 id: 34-24 briefTitle: Impact of Non-surgical Periodontal Treatment of miRNome overallStatus: RECRUITING date: 2024-04-20 date: 2024-09-22 date: 2024-10-15 date: 2024-04-24 date: 2024-04-24 name: University of Catania class: OTHER briefSummary: A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment by means of minimally invasive approach MINST or Q-SI (quadrantwise) approach in subjects with periodontitis on miRNome in gingival crevicular fluid conditions: Periodontitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Non-surgical periodontal treatment Subgingival biofilm ultrasonic debridement with MINST or Q-SI primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Sealed envelopes whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Probin Pocket Depth reduction measure: Probing Pocket Depth sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AOU Policlinico G. Rodolico status: RECRUITING city: Catania zip: 95124 country: Italy name: Gaetano Isola, DDS role: CONTACT phone: 0953785652 email: gaetano.isola@unict.it lat: 37.49223 lon: 15.07041 hasResults: False

 nctId: NCT06382922 id: PAPAML022019 briefTitle: Role of Antifungal Prophylaxis in Elderly Patients With Acute Myeloid Leukemia During Consolidation Therapy overallStatus: RECRUITING date: 2023-03-29 date: 2024-07-30 date: 2025-06-01 date: 2024-04-24 date: 2024-04-29 name: University of Rome Tor Vergata class: OTHER briefSummary: In previous retrospective study (SEIFEM 2016 study) the investigators evaluated the incidence of proven/probable invasive aspergillosis (IA) and the role of mold active primary antifungal prophylaxis (PAP) in a "real life" setting of acute myeloid leukemia (AML )patients receiving intensive consolidation therapy. All cases of proven/probable IA, observed during consolidation chemotherapy in adult and pediatric AML patients between 2011 and 2015, were retrospectively collected in a multicenter study involving 38 Italian hematologic centers. The investigators observed 56 (2.2%) cases of IA \[43 probable (1.7%) and 13 proven (0.5%)\]. The overall mortality rate and the mortality rate attributable to IA (AMR) on day 120 were 16% and 9%, respectively. In multivariate analysis, parameters that influenced the outcome were age ≥60 years and treatment with high doses of cytarabine (HDAC).

The investigators also observed that centers involved in this survey had different antifungal policies during the AML consolidation phase. The results from this study show that in a large real-world setting the mold active PAP, with itraconazole or posaconazole, decreases the rate of IA after consolidation course.

In SEIFEM 2016 study the investigators demonstrated that the incidence of IA during the AML consolidation is low. However, the mortality is not negligible, mainly in older patients. Further, a sub-analysis in the subset of patients older than 60 years demonstrated that patients who didn't receive mold active prophylaxis had higher incidence of IA than patients who received mold active prophylaxis (15% vs 6%). Therefore, as prophylaxis seems to prevent IA in consolidation, further studies should be performed especially in elderly patients treated with HDAC to confirm our data and to identify the subset of patients who require PAP. conditions: Invasive Aspergillosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: the incidence of proven, probable and possible IA in patients enrolled in the study in both groups of patients measure: overall mortality rate sex: ALL minimumAge: 60 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tor Vergata University status: RECRUITING city: Roma state: RM zip: 00133 country: Italy name: Maria Ilaria Del Principe role: CONTACT phone: 3394080659 email: del.principe@med.uniroma2.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06382909 id: 202302 briefTitle: Effect of Probiotic Compound K11T e K11TMax in ASD acronym: ASD overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-22 date: 2024-07-07 date: 2025-04-07 date: 2024-04-24 date: 2024-04-29 name: Deivis de Oliveira guimaraes class: NETWORK name: SENAI CIMATEC briefSummary: The research is characterized as a randomized, double-blind clinical trial (phase III) in which administered the probiotic K11-T (with and without added amino acids, fatty acids and vitamins) to children between 3 and 11 years old with Autism Spectrum Disorder - ASD, being subsequently assessed outcomes related to inflammatory markers and neuropsychiatric and sociopedagogical criteria. To this end, the study will create three groups, one of which will be a control group, which will receive a placebo, the other will receive the probiotic without micronutrients and another will receive the probiotic with added nutrients. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double blind, randomized, with placebo control primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 505 type: ACTUAL name: Inflammatory level name: Cognitive assessment name: Pedagogical assessment measure: Inflammation biomarker 1 measure: Inflammation biomarker 2 measure: Inflammation biomarker 3 measure: Inflammation biomarker 4 measure: Inflammation biomarker 5 measure: Neuropsychological Assessment measure: Psychiatric Assessment measure: Psychopedagogical Assessment measure: Comparative of outcomes between arm that took K11-T and arm that took K11-Tmax. sex: ALL minimumAge: 3 Years maximumAge: 11 Years stdAges: CHILD facility: Gon1 P&D city: Vitoria state: ES zip: 29050335 country: Brazil lat: -20.31944 lon: -40.33778 facility: Gon1 gestora de Projetos city: Vitória state: ES zip: 29050335 country: Brazil lat: -20.31944 lon: -40.33778 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-03-22 uploadDate: 2024-04-18T21:12 filename: Prot_000.pdf size: 369916 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-03-22 uploadDate: 2024-04-16T10:55 filename: ICF_001.pdf size: 192688 hasResults: False

 nctId: NCT06382896 id: FirstAHXiamenU-YB-2 briefTitle: Effect of Oliceridine on Rebound Pain overallStatus: RECRUITING date: 2024-01-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-24 date: 2024-04-25 name: The First Affiliated Hospital of Xiamen University class: OTHER briefSummary: The purpose of this clinical study was to identify the risk factors for postoperative pain outburst in patients undergoing arthroscopic knee surgery after Oliceridine and nerve block, and to evaluate the effect of oxeridine on early rehabilitation exercise in patients. A total of 320 patients undergoing arthroscopic knee arthroscopy under general anesthesia combined with femoral nerve block were selected to record the time and duration of postoperative pain outbreak, pain degree, age, gender, operation type, previous surgical history and other related risk factors. conditions: Rebound Pain conditions: Arthroscopic Knee Surgery conditions: Oliceridine studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 320 type: ESTIMATED name: No intervention measure: Time of onset of postoperative rebound pain measure: The duration of the rebound pain measure: The degree of the rebound pain measure: age measure: sex measure: Surgical procedure measure: Previous surgical history measure: Movement recovery time sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital of Xiamen University status: RECRUITING city: Xiamen state: Fujian zip: 361000 country: China name: Bin Yang, doctor role: CONTACT phone: 13859986036 email: yangbin4332@outlook.com lat: 24.47979 lon: 118.08187 hasResults: False

 nctId: NCT06382883 id: FINELO2024 briefTitle: Lifestyle and Physical Activity as Part Of Obstructive Sleep Apnea Treatment acronym: ELO overallStatus: RECRUITING date: 2024-04-22 date: 2026-07-31 date: 2026-07-31 date: 2024-04-24 date: 2024-04-24 name: Filha ry class: OTHER name: University of Jyvaskyla name: Organisation for Respiratory Health in Finland name: Central Finland Hospital District briefSummary: The goal of this clinical trial is to investigate the effects of an individually tailored lifestyle intervention on symptoms and severity of obstructive sleep apnea (OSA), physical activity (PA) levels and sedentary behavior (SB), as well as health and wellbeing in overweight participants with moderate to severe OSA treated with CPAP. Emphasis of the individually tailored SEMC-intervention (protocol of the Sports Medicine Outpatient Clinic of The Wellbeing Services County of Central Finland) is on increasing the amount of total physical activity.

The main questions the trial aims to answer are:

* Can individually tailored lifestyle intervention, in combination with CPAP therapy, alleviate the severity or symptoms of OSA in overweight participants with moderate to severe OSA?
* Does the addition of an individually tailored lifestyle intervention to CPAP therapy improve the quality of life, increase physical functioning, change body composition, and increase physical activity levels or decrease sedentary behavior of participants diagnosed with moderate to severe OSA?
* Can enhanced behavioral support (EBS), when integrated with lifestyle intervention and CPAP therapy, lead to more substantial and enduring changes in participants' levels of physical activity or sedentary behavior?

Participants will be randomized to either SEMC-intervention group, combination of SEMC-intervention and EBS, or to a control group.

In this study, it is hypothesized that participants receiving SEMC-intervention in combination with CPAP therapy will experience greater alleviation of OSA severity and symptoms, improve their quality of life, body composition and physical functioning, as well as increase physical activity levels and decrease their sedentary behavior compared to the control group. In addition, it is hypothesized that participants receiving SEMC-intervention and EBS in combination with CPAP therapy will increase their physical activity levels, and decrease their sedentary behavior to a greater extent, and these changes will be more sustained compared to merely SEMC-intervention or control group. conditions: Obstructive Sleep Apnea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Individually tailored lifestyle and physical activity intervention name: Individually tailored lifestyle and physical activity intervention combined with enhanced behavioral support -intervention (EBS) measure: Change in apnea-hypopnea-index (AHI) measure: Change on sleep apnea symptoms measure: Change in the mean daily total light physical activity time measure: Change in the mean daily total moderate to vigorous (MVPA) physical activity time measure: Change in the mean daily total sedentary time measure: Change in 6-minute walk distance (6MWD) in meters measure: Change in hand grip strength in kilograms measure: Change in waist circumference in centimeters measure: Change in body weight in kilograms measure: Change in visceral fat area (VFA) in square centimeters measure: Change in muscle mass in kilograms measure: Change in Quality of Life RAND 36-Item Health Survey sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Central Finland Hospital District status: RECRUITING city: Jyväskylä zip: 40620 country: Finland name: Merja Perhonen role: CONTACT email: merja.perhonen@hyvaks.fi name: Antti Saarinen role: CONTACT email: antti.saarinen@filha.fi lat: 62.24147 lon: 25.72088 hasResults: False

 nctId: NCT06382870 id: 107.2023fbu briefTitle: Simulation-Based Training for Child Neglect and Abuse overallStatus: NOT_YET_RECRUITING date: 2024-05-29 date: 2024-06-15 date: 2024-06-29 date: 2024-04-24 date: 2024-04-24 name: Fenerbahce University class: OTHER briefSummary: Child abuse and neglect is a broad structure that includes physical abuse, sexual abuse, emotional abuse and neglect. Child neglect and abuse is one of the primary areas of responsibility of health professionals, which negatively affects child health and threatens public health in the long term. All healthcare professionals are legally obligated to report known or suspected cases of child abuse and neglect. Health professionals, in particular, play an important role in stopping child abuse by assessing children, identifying risk factors, and reporting suspected child maltreatment to authorities. Early diagnosis of a neglected and abused child is important in reducing the recurrence of maltreatment.

Regarding the evaluation of child neglect and abuse, healthcare professionals should approach a child who presents with suspicious injuries, thinking that he or she may be abused. The key here is to be aware of the problem. Health professionals should carefully examine children and fulfill their responsibilities by identifying possible clues to abuse and neglect. It is recommended that clues to recognize neglect and abuse be taught within the scope of in-service training for healthcare professionals working in hospitals. conditions: Simulation-based Training studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 24 type: ESTIMATED name: education measure: The awareness level sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06382857 id: 823779-MDF Niger briefTitle: Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition overallStatus: RECRUITING date: 2024-05-02 date: 2025-11-01 date: 2026-02-01 date: 2024-04-24 date: 2024-04-29 name: Epicentre class: OTHER name: Epicentre, Niger name: National Nutrition Direction, Niger name: Ministry of Public Health and Social Affairs, Niger name: Regional Direction of Public Health, Maradi briefSummary: This study is an individually randomized controlled trial comparing microbiome-directed foods to standard nutritional therapy among children aged 6 to \< 24 months with uncomplicated acute malnutrition in terms of programmatic recovery by 12 weeks from admission and sustained recovery at 24 weeks from admission. conditions: Malnutrition, Child studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 7356 type: ESTIMATED name: MDF name: RUTF name: RUSF measure: Programmatic recovery by 12 weeks from admission measure: Sustained recovery at 24 weeks from admission measure: Default measure: Non-response measure: Time to recovery measure: For MAM children: Deterioration to SAM measure: Change in weight gain measure: Change in weight-for-length Z (WLZ) measure: Change in length-for-age Z (LAZ) measure: Change in weight-for-age Z (WAZ) measure: Change in MUAC measure: Serious adverse events measure: Hospitalization measure: Death measure: Motor, cognitive, language, social-emotional, and mental health skills measure: Cost effectiveness measure: Dietary intake measure: Adherence measure: Microbiome profile at enrollment, week 4, program discharge, and study discharge measure: Plasma proteome profile at enrollment, week 4, program discharge, and study discharge measure: Environmental enteric dysfunction at enrollment, program discharge, and study discharge measure: Change of fat mass and fat-free mass at program discharge and study discharge measure: Micronutrient status at enrollment, program discharge and study discharge measure: Immuno-sufficiency at week 2, week 4, program discharge, week 12 and study discharge (SAM only) sex: ALL minimumAge: 6 Months maximumAge: 23 Months stdAges: CHILD facility: Epicentre Niger status: RECRUITING city: Maradi country: Niger name: Ousmane Guindo, MD role: CONTACT email: ousmane.guindo@epicentre.msf.org name: Ibrahim Ngoumboute, MD role: CONTACT email: ibrahim.ngoumboute@epicentre.msf.org lat: 13.5 lon: 7.10174 hasResults: False

 nctId: NCT06382844 id: PI23/00486 id: PI2023 08 1416 type: REGISTRY domain: Ethics Committee for Drug Research of the Salamanca Health Area briefTitle: Novel Flow-cytometry Approaches to Improve the Detection of Tumor Cells in CTCL overallStatus: RECRUITING date: 2024-01-01 date: 2026-09-30 date: 2026-12-31 date: 2024-04-24 date: 2024-04-25 name: Instituto de Investigación Biomédica de Salamanca class: OTHER name: Carlos III Health Institute briefSummary: Identification and quantitation of circulating tumor cells in patients with cutaneous T-cell lymphoma -mycosis fungoides (MF)/Sézary syndrome (SS)- are required for diagnosis and precising the actual staging and response to treatment. The current flow cytometry techniques used in clinical laboratories do not correctly allow to compare results in a clinical setting. Furthermore, now we know that the phenotype of tumor cells partially overlaps with that of normal TCD4+ cells, and it is rather heterogeneous. The GENERAL OBJECTIVE of this project is to apply flow-cytometry standardized strategies for rapid, specific, sensitive, and reproducible detection and quantitation of tumor cells in patients with MF/SS. For this purpose, in the first phase of the project we will design an optimal combination of markers to detect tumor cells by spectral flow-cytometry, and then the specificity and analytical sensitivity of the new combination/procedure will be assessed in blood samples -to be later applied to skin samples-, and finally reference databases will be created for the automatic analysis of cytometry data. In a second phase of the project, the developed method will be validated in a multicenter manner, through the demonstration of its practical applicability and clinical utility (speed and precision) in blood samples (and skin, where appropriate) for diagnosis, staging, and treatment monitoring. In parallel, the tumor microenvironment (residual normal immune system) will be explored -by applying the panel designed in the first phase together with additional immune-monitoring panels by flow cytometry-, and its relationship with clinical-biological heterogeneity of the tumor will be analyzed. In the two phases of the project, cytometry data will be compared with the gold standard approach to identify tumor T cells (through the identification of clonal rearrangement by PCR and/or NGS, performed on cell populations previously sorted by flow cytometry). conditions: Cutaneous T-Cell Lymphoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Detection and quantitation of (blood) tumor cells in patients with mycosis fungoides (MF) / Sézary syndrome (SS). measure: Optimizing Marker Combination for Specific Identification and Quantification of Sézary Cells using Spectral Flow Cytometry sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Instituto de Investigación Biomédica de Salamanca (IBSAL) status: RECRUITING city: Salamanca zip: 37007 country: Spain name: Ricardo López Pérez, PhD role: CONTACT phone: +34 923 29 12 00 phoneExt: 55144 email: uicec.gestion@ibsal.es name: Esperanza López Franco, PhD role: CONTACT phone: +34 923 29 12 00 phoneExt: 55779 email: uicec.coordinacion@ibsal.es lat: 40.96882 lon: -5.66388 hasResults: False

 nctId: NCT06382831 id: IndonesiaU240201 briefTitle: Opioid Free Versus Opioid Balanced Anesthesia in Ophthalmic Surgery overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-08-01 date: 2024-10-01 date: 2024-04-24 date: 2024-04-24 name: Indonesia University class: OTHER briefSummary: Anesthesia without the use of opioid (Opioid free anesthesia) is an alternative to conventional opioid balanced anesthesia, with less post operative nausea and vomiting, and comparable analgesia. This study aim to compare the effect of opioid free versus opioid balanced anesthesia in ophthalmology surgery conditions: Anesthesia and Analgesia conditions: Anesthesia, Endotracheal studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 104 type: ESTIMATED name: Dexmedetomidine name: Fentanyl measure: Postoperative nausea and vomiting (PONV) measure: Pain score measure: Time to laryngeal mask exertion measure: Adverse effect sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06382818 id: PROICM 2023-10 PRO briefTitle: Personalization of Breast Radiotherapy According to Loco-regional Recurrence Risk and Toxicity Probability acronym: PROBA overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2027-04-26 date: 2036-04-26 date: 2024-04-24 date: 2024-04-24 name: Institut du Cancer de Montpellier - Val d'Aurelle class: OTHER briefSummary: Our objective is based on a personalized approach of adjuvant breast radiotherapy by selecting patients according to tumor recurrence and toxicity risk. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: * COHORT A = Low risk of recurrence / Low risk of breast toxicity
* COHORT B = Low risk of recurrence / High risk of breast toxicity
* COHORT C = High risk of recurrence / Low risk of breast toxicity
* COHORT D = High risk of recurrence / High risk of breast toxicity primaryPurpose: TREATMENT masking: NONE count: 854 type: ESTIMATED name: COHORT A name: COHORT B name: COHORT C name: COHORT D measure: Rate of patients without any grade 2 or more fibrosis, nor radio-induced sarcoma measure: Acute toxicity measure: Late toxicity measure: Local recurrence rate (LRR) measure: Relapse-free survival (RFS) rate measure: Overall survival (OS) rate measure: Radiation-induced Breast Sarcoma prevalence sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institut Du Cancer de Montpellier city: Montpellier country: France name: MOUSSION AURORE role: CONTACT phone: 0467613102 email: aurore.moussion@icm.unicancer.fr name: AZRIA DAVID role: PRINCIPAL_INVESTIGATOR name: MEGE ALICE role: PRINCIPAL_INVESTIGATOR name: BRETON-CALLU CHRISTEL role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 hasResults: False

 nctId: NCT06382805 id: HasanKU_FTR_AA_02 briefTitle: Comparison of the Effects of Kinesio Tape and High-intensity Laser Therapy in Lateral Epicondylitis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-01 date: 2024-11-15 date: 2024-04-24 date: 2024-04-25 name: Hasan Kalyoncu University class: OTHER briefSummary: Lateral epicondylitis is a common upper extremity disease that occurs with tenderness in the lateral epicondyle, the common attachment point of the wrist extensor muscles, and pain during resisted wrist extension. The main purpose of treating lateral epicondylitis is to reduce pain and increase functionality, but there is no accepted standard treatment method. The purpose of this study is to compare the effectiveness of kinesio tape and high intensity laser in the treatment of lateral epicondylitis. conditions: Tennis Elbow conditions: Physical Therapy conditions: Kinesiotaping conditions: Laser studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There are three groups in the study. The groups consist of the control group, kinesio tape group and high intensity laser group primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Physiotherapy program name: Kinesio Tape name: High Intensity Laser therapy measure: Pain Measurement measure: Hand grip strength measure: Patient-Rated Tennis Elbow Evaluation measure: Pain Sensitivity Measurement sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Hasan Kalyoncu University city: Gaziantep zip: 27000 country: Turkey lat: 37.05944 lon: 37.3825 hasResults: False

 nctId: NCT06382792 id: 2024PI059 briefTitle: Osteolysis of Allograft Prosthetic Composite After Shoulder Resection for Tumors overallStatus: ENROLLING_BY_INVITATION date: 2024-05-01 date: 2024-05-01 date: 2024-05-01 date: 2024-04-24 date: 2024-04-24 name: Central Hospital, Nancy, France class: OTHER briefSummary: The gold standard after shoulder resection for tumors is reconstruction by reverse prosthesis and allograft. This is an intervention also performed for more frequent etiologies (revisions of prosthesis, non cancerous humeral bone loss ...).

The results in these etiologies are good, and do not find any particular mechanical complications (including no osteolysis of the graft). In the case of reconstruction for cancer, the numbers of patients are lower (rare pathologies) and some studies on small numbers found osteolysis of the allograft. The aim of this study is to analyze the presence or not osteolysis in these patients, and to quantify it precisely by scanner measurement (no data yet in the literature). conditions: Shoulder Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 6 type: ESTIMATED name: proximal humeral resection for tumor and allograft prosthetic composite reconstruction measure: Osteolysis (bone stock in cm3) measure: Constant score measure: Complications measure: Revision sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Central Hopital city: Nancy zip: 54000 country: France lat: 48.68439 lon: 6.18496 hasResults: False

 nctId: NCT06382779 id: 2024PI057 briefTitle: Proximal Humerus Reconstruction After Resection for Tumors : Comparison Between Allograft Prosthetic Composite and Cement Sleeve Prosthetic Composite overallStatus: ENROLLING_BY_INVITATION date: 2024-04-15 date: 2024-05-01 date: 2024-05-01 date: 2024-04-24 date: 2024-04-24 name: Central Hospital, Nancy, France class: OTHER briefSummary: Proximal humerus is a common site for primary bone tumors and metastatic disease. Reconstruction with reverse shoulder arthroplasty (RSA) after resection is a surgical challenge and presented high risk of complication. The options for reconstruction after proximal humerus tumor resection are limited, and depend on the soft tissue conditions and bone loss. The most commonly used techniques include long cemented stem alone (in case of limited resection), allograft prosthetic composite (APC), massive prosthesis. In some cases two step procedure are performed : first step is resection and RSA with cement sleeve, and second step is APC or massive prosthesis. conditions: Shoulder Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 32 type: ESTIMATED name: reverse shoulder arthroplasty measure: Constant score measure: complication measure: mortality measure: revision sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHRU - Centre chirurgical emile galle city: Nancy zip: 54000 country: France lat: 48.68439 lon: 6.18496 hasResults: False

 nctId: NCT06382766 id: SMU in malnutrition briefTitle: Skeletal Muscle Ultrasonography in Detection of Malnutrition overallStatus: NOT_YET_RECRUITING date: 2025-03 date: 2026-03 date: 2026-03 date: 2024-04-24 date: 2024-04-24 name: Assiut University class: OTHER briefSummary: * To detect the role of Skeletal Muscle Ultrasonography in Detection of Malnutrition and Prediction of The Outcome among critically ill children.
* To assess the accuracy and validity of muscle ultrasonography in assessment of the nutritional status of critically ill child compared with other different nutritional assessment tools . conditions: Skeletal Muscle Ultrasonography studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED name: Skeletal Muscle Ultrasonography measure: accuracy of Skeletal Muscle Ultrasonography in Detection of Malnutrition and Prediction of The Outcome among critically ill children comared with other traditional nutritional assessment tools . sex: ALL minimumAge: 1 Month maximumAge: 5 Years stdAges: CHILD hasResults: False

 nctId: NCT06382753 id: 20-24-PAR briefTitle: Impact of Periodontal Supportive Therapy in Patients With Gingivitis and Periodontitis overallStatus: RECRUITING date: 2024-04-20 date: 2024-06-30 date: 2024-06-30 date: 2024-04-24 date: 2024-04-24 name: University of Catania class: OTHER briefSummary: The study evaluated the number of sessions of periodontal supportive treatment in patients with gingivitis in order to evaluate the risk of periodontitis development. conditions: Gingivitis conditions: Periodontitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 150 type: ESTIMATED name: Gingival inflammation measure: Bleeding on Probing sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AOU Policlinico G. Rodolico status: RECRUITING city: Catania zip: 95124 country: Italy name: Gaetano Isola, DDS role: CONTACT phone: 0953785652 email: gaetano.isola@unict.it lat: 37.49223 lon: 15.07041 hasResults: False

 nctId: NCT06382740 id: AOP2097 briefTitle: Selection Protocol for Liver Transplantation in Patients Aged Over 70 Years acronym: Over70-LT overallStatus: RECRUITING date: 2022-10-01 date: 2025-10-01 date: 2025-10-01 date: 2024-04-24 date: 2024-04-24 name: Azienda Ospedaliera di Padova class: OTHER briefSummary: Increased life expectancy and aging population has led to a trend of increasing liver transplant (LT) volume in the elderly. Nowadays, advanced age is not considered an absolute contraindication for LT but elderly LT candidates typically have an age-associated burden of comorbid conditions that can pose several clinical challenges during the selection/evaluation process for LT. Specific algorithms for elderly patient selection for LT are not well established; however, consensus agreement is that elderly LT candidates need a more rigorous selection process.

This study proposes a "step by step" algorithm of selection for liver transplant candidates more than 70 years. conditions: End Stage Liver DIsease conditions: Liver Transplantation conditions: Old Age studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 18 type: ESTIMATED name: Liver transplantation measure: 1 year patient survival measure: 1 year graft survival measure: 3 months mortality and morbidity sex: ALL minimumAge: 71 Years maximumAge: 75 Years stdAges: OLDER_ADULT facility: U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova status: RECRUITING city: Padova zip: 35128 country: Italy name: Umberto Cillo, MD role: CONTACT email: cillo@unipd.it lat: 45.40797 lon: 11.88586 hasResults: False

 nctId: NCT06382727 id: ER008 briefTitle: CONTINUation of Enteral Nutrition Prior to Extubation Compared to Standard Care acronym: CONTINUE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-24 date: 2024-04-24 name: Emma Ridley class: OTHER briefSummary: Critically ill patients admitted to the Intensive Care Unit (ICU) often need to be connected to a breathing machine (ventilator) and are unable to eat. During this time, liquid nutrition is delivered via a feeding tube to the stomach or bowel (termed enteral nutrition (EN)) to ensure nutrition needs are provided until such time that the patient can eat normally.

The delivery of nutrition via EN is frequently interrupted due to procedures and changes in the gastrointestinal system that can cause digestion to be slow. One of the main contributors to EN interruptions is fasting prior to removal of the breathing tube (termed extubation).

The practice of pausing EN prior to the removal of the breathing tube is historical and based on evidence for patients who are not within the ICU. There is currently no scientific consensus on whether pausing of EN is necessary, or for how long. Because of this, some clinicians choose to pause EN prior to removal of the breathing tube and some clinicians continue to provide EN.

This study is a pilot randomised controlled trial of fasting patients for at least 4 hours prior to removal of the breathing tube compared with not pausing EN. The investigators hypothesise that this will reduce the number of hours of fasting in the 24 hours prior to extubation. conditions: Critical Illness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: CONTINUE is a multi-centre, open-label, prospective parallel, pilot randomised controlled trial being conducted in Australia. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 60 type: ESTIMATED name: EN will be continued up to extubation (EN will not be withheld prior to extubation) measure: Fasting time (hours) measure: Reintubation rate measure: Days alive and free of mechanical ventilation measure: Commencement of antibiotics measure: Ratio of oxygen saturation (SpO2)/ fraction of inspired oxygen (FiO2) measure: ICU length of stay measure: In-hospital mortality measure: Nutrition delivery measure: Recruitment rate measure: Protocol compliance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gold Coast University Hospital city: Southport state: Queensland zip: 4215 country: Australia name: James Mccullogh, Dr role: CONTACT lat: -27.96724 lon: 153.39796 facility: St Vincent's Hospital Melbourne city: Fitzroy state: Victoria zip: 3065 country: Australia name: Alastair Brown, Dr role: CONTACT lat: -37.79839 lon: 144.97833 facility: The Alfred Hospital city: Melbourne state: Victoria zip: 3004 country: Australia name: Emma Ridley, A/Prof role: CONTACT name: Sean Keem, Dr role: CONTACT lat: -37.814 lon: 144.96332 hasResults: False

 nctId: NCT06382714 id: 2023-12/13 briefTitle: Virtual Museum Visit on Dialysis Symptoms and Anxiety in Hemodialysis Patients overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-08-30 date: 2024-12-31 date: 2024-04-24 date: 2024-04-24 name: Cumhuriyet University class: OTHER briefSummary: The main purpose of dialysis used in the treatment of end-stage renal failure is; By relieving the patient from uremic symptoms, controlling excess fluid, electrolyte and acid base disorders, improving the well-being of the patients and also improving the quality of life of the patients. In addition to its contribution to the continuation of life, dialysis can significantly affect the biological and physiological balance and normal life order of patients. Some of these effects may be negative on patients. During this process, patients may frequently experience symptoms such as changes in fluid-electrolyte balance, increased fatigue, and weakness, as well as psychopathological conditions such as anxiety. In this context, it is extremely important to handle patients from a holistic perspective and keep their homeostatic balance under control during the hemodialysis process. In addition to pharmacological treatments, many integrative methods are used in the management of symptoms for reasons such as being low in cost, having fewer side effects than pharmacological treatments, and strengthening the immune system. Museum visit, one of these integrative treatment methods, has become an area of art therapy where help is received for various reasons such as coping with the symptoms of chronic diseases, reducing the side effects of medications, preventing mental depression, strengthening healthy behaviors, and avoiding tension and loss of control. In this context, the research was planned as a randomized controlled study investigating the effect of virtual museum tour on dialysis symptom index and anxiety in hemodialysis patients..T.R. The "https://sanalmuze.gov.tr" site belonging to the Ministry of Culture and Tourism will be shown to the patients five times and the virtual museum visit will be made by showing the patient's preferred museum five times among the 53 museums prepared by the General Directorate of Information Technologies of the Ministry of Culture and Tourism, and the Initiative Group, Control It will be compared with its group. Research data; It will be collected using the Patient Information Form, Dialysis Symptom Index and Beck Anxiety Scale (BAI). At the end of the study, the data will be evaluated in the SPSS program. The museum visit applied to the Intervention Group will also be applied to the control group after the study is completed, taking into account the ethical dimension. conditions: DIALYSIS SYMPTOMS AND ANXIETY studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: For the intervention group, a museum visit with virtual reality glasses will be applied. measure: Dialysis Symptom Index (DSI) measure: Beck Anxiety Scale (BAI) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mukadder city: Mollaoğlu state: Sivas zip: 58140 country: Turkey name: Mukadder Mollaoğlu, Prof Dr. role: CONTACT phone: 90 5055723985 email: mukaddermollaoglu2@gmail.com name: Songül Mollaoğlu, Assoc Prof role: CONTACT phone: 90 532 480 08 32 email: songulmollaoglu@gmail.com lat: 39.70028 lon: 30.28306 hasResults: False

 nctId: NCT06382701 id: Kayseri briefTitle: Effect of Aromatherapy on Pain, Anxiety and Satisfaction in Cannulation overallStatus: ACTIVE_NOT_RECRUITING date: 2021-09-06 date: 2024-06-30 date: 2024-06-30 date: 2024-04-24 date: 2024-04-24 name: TC Erciyes University class: OTHER briefSummary: The most active members of the healthcare professionals responsible for hemodialysis units are nurses, and they have a key role in pain, anxiety and satisfaction management as they are responsible for cannulation. Therefore, complementary and integrated practices need to be implemented based on evidence to strengthen the independent role of nurses in managing pain and anxiety. conditions: Hemodialysis Patients studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study was designed as a randomized controlled and double-blind study to evaluate the effect of clove oil applied to arterio-venous fistula on pain and anxiety caused by cannulation and to determine the effect of the application on satisfaction. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: Pre-cannulation spray application to the intervention and placebo groups will be provided by an interviewer trained by the researchers. Cannulations will be performed by nurses in the institution where the study is conducted. Data will be collected by the responsible nurses in the institutions.

Patients participating in the study, researchers, and the nurse in charge will not know who is in the intervention and placebo groups.

The research will be completed in twelve sessions over four weeks. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: aromatherapy name: placebo measure: Visual Analog Scale (VAS) measure: State and Trait Anxiety Inventory (STAI) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erciyes University city: Melikgazi state: Kayseri zip: 38260 country: Turkey hasResults: False

 nctId: NCT06382688 id: 23-08-0010 briefTitle: IV Administration of ChromaDex's Niagen® as Compared to NAD+ overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-13 date: 2024-03-08 date: 2024-08-31 date: 2024-04-24 date: 2024-04-24 name: Franklin Health Research class: OTHER briefSummary: This is a 2-part study evaluating the effects of IV administration of NR on healthy adult populations. Study 1 involved all four arms with 37 people. The second study only included the active NR and NAD+ arms to further evaluate tolerability and comfort of the IV. conditions: Healthy Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 53 type: ACTUAL name: NAD+ (nicotinamide adenine dinucleotide) IV name: Niagen® (nicotinamide riboside) IV name: Niagen® (nicotinamide riboside) oral name: Placebo measure: Blood Pressure measure: Heart rate measure: Total NAD measured through dried blood spot testing measure: Glucose measure: Insulin Levels measure: total NAD measured through blood and plasma measure: Tolerable Infusion Rate measure: Complete Blood Count measure: Comprehensive Metabolic Panel measure: Sleep Scale measure: Energy Scale measure: Subjective Experience sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nutraceuticals Research Institute city: Franklin state: Tennessee zip: 37067 country: United States lat: 35.92506 lon: -86.86889 hasResults: False

 nctId: NCT06382675 id: TA-PF-01-DE id: CIV-23-11-044643 type: OTHER domain: Unique identification number EUDAMED briefTitle: Clinical Performance of the New Plasma Filter PX2 in TPE Treatments acronym: plasmaFlux overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2025-03 date: 2024-04-24 date: 2024-04-24 name: Fresenius Medical Care Deutschland GmbH class: INDUSTRY name: KLIFO GmbH briefSummary: The plasma filter is applied for a single use in extracorporeal blood purification therapy. The intended purpose is the separation of plasma from blood by filtration, in conditions, which are associated with increased concentration of plasma components where a rapid depletion slows down or stops a pathogenic process.

The investigation involves the collection of treatment data of the new Plasma Filter PX2 in combination with the multiFiltrate and multiFiltratePRO in therapeutic plasma exchange (TPE) treatments. The multiFiltrate and multiFiltratePRO are devices for extracorporeal blood purification treatments. No further control treatments will be investigated in this one arm design. The design is considered to be appropriate to reflect daily clinical practice and to contribute to empirical evidence of performance of the new Plasma Filter PX2. No specific treatment schedule is defined by the study protocol. The TPE treatment is performed with the plasma filter PX2 (investigational device) according to clinical practice established in each of the participating centers and are prescribed at the discretion of the treating physician. The participation in the study will have no influence on the treatment plan. The documentation of the treatment includes the therapy up to the tenth (10th) treatment. conditions: Autoimmune Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Interventional, single arm, multi-centric, open-label primaryPurpose: TREATMENT masking: NONE count: 46 type: ESTIMATED name: Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2 measure: Analysis of TPE treatments with the Plama Filter PX2 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Klinikum Aschaffenburg-Alzenau city: Aschaffenburg state: Bavaria zip: 63739 country: Germany name: Stefan Büttner, Dr. med. role: CONTACT email: Stefan.buettner@klinikum-ab-alz.de lat: 49.97704 lon: 9.15214 facility: Städtisches Klinikum Braunschweig city: Braunschweig state: Niedersachsen zip: 38126 country: Germany name: Gabriele Eden, Dr. med. role: CONTACT email: g.eden@skbs.de lat: 52.26594 lon: 10.52673 hasResults: False

 nctId: NCT06382662 id: PMDAC-01 briefTitle: Effect of Metaxalone 640 mg (M640) on Truck Driving Ability and Cognition Compared to Other Skeletal Muscle Relaxants overallStatus: RECRUITING date: 2024-04-15 date: 2025-04-15 date: 2025-04-15 date: 2024-04-24 date: 2024-04-26 name: Primus Pharmaceuticals class: INDUSTRY name: Sun Valley Arthritis Center briefSummary: Every participant will receive active study drug and (tone) 1 comparator, in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit. There will be (four) 4 visits. conditions: Cognitive Impairment studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This is a prospective, randomized, single-blind, pilot study to assess degree of drowsiness, cognition, and driving risk following a single dose of oral metaxalone 640 mg (M640) versus metaxalone 800 mg in healthy subjects. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: metaxalone m640 name: Tizanidine measure: Change from baseline, Standard Deviation of Lateral Position measure: Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes measure: Change from baseline of participants' subjective report of drowsiness on a 10-point scale measure: Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test) measure: The number of product related adverse events experienced by participants from Visit 1 through Visit 4 sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Valley Arthritis Center status: RECRUITING city: Peoria state: Arizona zip: 85381 country: United States name: Study Investigator role: CONTACT phone: 623-566-3550 email: jtuber@svacltd.com name: Study Coordinator role: CONTACT phone: 623-566-3550 lat: 33.5806 lon: -112.23738 hasResults: False

 nctId: NCT06382649 id: 202403051 briefTitle: Rivastigmine for Antimuscarinic Delirium acronym: RIVA-AM overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-07 date: 2026-07 date: 2024-04-24 date: 2024-04-25 name: Washington University School of Medicine class: OTHER name: American Academy of Clinical Toxicology briefSummary: Antimuscarinic delirium (AMD) is a common and dangerous toxicology condition caused by poisoning by medications and other chemicals that block muscarinic receptors. Physostigmine, the standard antidote for AMD, currently has very limited availability in the United States due to an interruption of production.

Recent case reports and small observational studies suggest that rivastigmine might be useful in the treatment of AMD, but there is not direct prospective evidence comparing rivastigmine to physostigmine or supportive care. In order to investigate the effectiveness of rivastigmine, the investigators propose a randomized, placebo-controlled clinical trial of rivastigmine for AMD. The investigators hypothesize that patients treated with rivastigmine for antimuscarinic delirium will experience more rapid resolution of agitation and delirium than those treated with placebo. conditions: Anticholinergic Toxicity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: Rivastigmine name: Placebo measure: Time to control of agitation and delirium measure: Duration of agitation and delirium measure: Total amount of sedatives administered measure: Use of sedative infusions measure: Use of physical restraints measure: Disposition measure: Time to medical clearance measure: Oversedation measure: Intubation measure: Seizure measure: Gastrointestinal upset measure: Bradycardia sex: ALL minimumAge: 10 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Washington University School of Medicine city: Saint Louis state: Missouri zip: 63110 country: United States name: Kevin Baumgartner role: CONTACT phone: 314-273-1109 email: baumgartner.k@wustl.edu lat: 38.62727 lon: -90.19789 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-04-10 uploadDate: 2024-04-19T15:42 filename: ICF_000.pdf size: 1060713 hasResults: False

 nctId: NCT06382636 id: 23-101 briefTitle: Engaging Patients in Prenatal Genetic Testing Decisions as a Pathway to Improve Obstetric Outcomes acronym: OPUS overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2027-02-28 date: 2027-02-28 date: 2024-04-24 date: 2024-04-24 name: The Cleveland Clinic class: OTHER briefSummary: The goal of this study is to ensure that pregnant patients have the resources and support needed to access Prenatal Screening \& Diagnostic Testing (PS\&D) in an informed and evidence-based fashion by developing an innovative digital tool to support patients' decision-making and contributing fundamental knowledge to advance science in a way that promotes patients' access to new prenatal applications of genomic science and technology. Our central hypothesis is that, by focusing on patient engagement as a key driver to improve patient outcomes, the use of an evidence-based artificial-intelligence (AI) powered patient engagement tool will increase patients' ability to seek information and structure a decision-making process that, in turn, increases informed decisions about PS\&D and decreases decisional conflict associated with those decisions.

Using data from NEST (Ensuring Patients Informed Access to NIPT \[non-invasive prenatal testing\]), the investigators designed the next iteration of NEST, a point-of care shared decision-making tool powered by artificial intelligence (AI) to provide a personalized and dynamic decision support tool: Obstetric Prenatal Genetic Testing Engagement Solution (OPUS). OPUS is an AI-enabled healthcare chatbot (a computer program capable of processing and simulating human conversation) that provides patients with personalized information and decision-making support at different stages of the PS\&D pathway. It functions using a series of questions contained in the NEST with a branching logic sequence of questions and answers based on the responses to and from the patient, using a conversational and adaptable interaction. It also contains nested tiers of information, ranging from introductory to detailed information about patient engagement, health literacy, the different PS\&D options, and resources to learn about insurance coverage for PS\&D. OPUS was designed to be accessed by patients with different technological resources and preferences, using a cell phone, a mobile device, or a computer. conditions: Prenatal Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 600 type: ESTIMATED name: Standard Care name: Obstetric Prenatal Genetic Testing Engagement Solution (OPUS) AI Chatbot measure: Patient activation sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Neighborhood Family Practice city: Cleveland state: Ohio zip: 44102 country: United States name: Heidi Gullett, MD role: CONTACT phone: 216-368-0776 email: hlg31@case.edu lat: 41.4995 lon: -81.69541 facility: MetroHealth Medical Center city: Cleveland state: Ohio zip: 44109 country: United States name: Angela Ranzini, MD role: CONTACT phone: 216-778-3513 email: aranzini@metrohealth.org lat: 41.4995 lon: -81.69541 facility: Cleveland Clinic city: Cleveland state: Ohio zip: 44195 country: United States name: Ruth Farrell, MD, MA role: CONTACT phone: 216-445-7085 email: farrelr@ccf.org name: Christina Collart, MEd role: CONTACT phone: 216-470-9796 email: collarc@ccf.org lat: 41.4995 lon: -81.69541 hasResults: False

 nctId: NCT06382623 id: 43 briefTitle: Efficacies of Different Managements in Patients With Trigger Finger overallStatus: COMPLETED date: 2022-10-01 date: 2023-06-30 date: 2023-06-30 date: 2024-04-24 date: 2024-04-24 name: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital class: OTHER briefSummary: The aim of the study is to compare the effectiveness of peritendinous steroid injection under ultrasound guidance and percutaneous A1 pulley release procedures in terms of disease stage, pain, and severity of locking in patients with trigger finger. conditions: Trigger Finger studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 30 type: ACTUAL name: The percutaneous A1 pulley release name: The peritendinous Betamethasone group measure: Stage of the disease measure: Pain intensity measure: severity of triggering sex: ALL minimumAge: 18 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: NCT06382610 id: 2024-002 briefTitle: Pharmacokinetics of Melatonin Administered in Oral, Lotion, and Bubble Bath Formulations overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2024-12-15 date: 2024-12-15 date: 2024-04-24 date: 2024-04-24 name: University of Redlands class: OTHER briefSummary: Melatonin is a hormone that promotes sleep that is available without a prescription in the United States. In addition to oral supplements, melatonin can be purchased in the form of lotions and bubble baths with unknown dosage and no frequency or age recommendations. In this study, researchers will examine how quickly melatonin in lotion and bubble bath is absorbed compared to oral tablets, as well as how long the melatonin lasts in the body. conditions: Sleep studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Repeated measures crossover trial primaryPurpose: BASIC_SCIENCE masking: NONE count: 10 type: ESTIMATED name: Melatonin measure: Salivary melatonin level measure: Side effects sex: ALL minimumAge: 18 Years maximumAge: 22 Years stdAges: ADULT facility: University of Redlands city: Redlands state: California zip: 92373 country: United States lat: 34.05557 lon: -117.18254 hasResults: False

 nctId: NCT06382597 id: AWFiS/2024_2_P-GM briefTitle: Four Weeks of Nordic Hamstring Exercises Impact the Strength and Balance of the Hamstring Muscle Group overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-10 date: 2024-07-10 date: 2024-04-24 date: 2024-04-24 name: Gdansk University of Physical Education and Sport class: OTHER briefSummary: The aim of the study is to assess the impact of 4 weeks of eccentric Nordic Hamstring Exercise training on changes in the hamstring muscle group, as well as to analyze parameters such as maximum muscle strength of the knee flexors, RFD (rate of force development) and static balance, dynamics for the dominant leg. conditions: Hamstring Injury studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 2 type: ESTIMATED name: Nordic hamstring exercise measure: Biodex Balance System measure: Biodex System sex: ALL minimumAge: 19 Years maximumAge: 26 Years stdAges: ADULT hasResults: False

 nctId: NCT06382584 id: IRB_23.09.01 briefTitle: Impact of Treatment With Oral Anticoagulants of Patients With Fractures of the Upper End of the Femur acronym: ANTI_XA overallStatus: COMPLETED date: 2022-01-01 date: 2023-06-01 date: 2023-06-01 date: 2024-04-24 date: 2024-04-24 name: Centre Hospitalier Universitaire de Nīmes class: OTHER briefSummary: In 2023, oral anticoagulant treatments (anti Xa: apixaban , rivaroxaban, etc.) are tending to replace anti vitamin K treatments in many medical indications. Their prescription is increasing rapidly in the elderly.

In this context, the Nimes University Hospital receives a large number of elderly patients who have suffered a fracture of the end of the femur requiring surgery and who are taking anti Xa drugs.To avoid massive intra- and post-operative haemorrhage, surgical management is postponed because of the need to suspend the treatment, allowing a return to near-normal biological haemostasis within a few days. No consensus has been reached on the withdrawal period required to authorise surgery, as the elimination kinetics of the drug are altered in this context (elderly patients, dehydration, hypovolaemia, impaired renal function). A plasma assay (threshold of \<30 to 60 ng/mL) has been proposed without any real justification. This waiting period exposes the elderly to excess mortality. Reversing these treatments by adding coagulation factors would be an attractive alternative, as it would allow surgery to be performed earlier, but this would expose patients to an increased thrombotic risk.

Before considering a prospective randomised study (early vs delayed surgery on AOD), we wish to retrospectively analyse data on patients admitted to the Nimes University Hospital on anti Xa and operated on for fracture of the upper end of the femur between 1 January 2022 and 1 June 2023 conditions: Direct Oral Anticoagulants (DOACs) conditions: Femoral Fractures conditions: Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 610 type: ACTUAL name: Femoral fracture surgery measure: Hospital Mortality measure: Duration of the surgery measure: Transfusion measure: Postoperative comorbidities measure: Hospital stay measure: Anti Xa assay sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: CHU de NIMES city: Nimes zip: 30029 country: France lat: 43.83333 lon: 4.35 hasResults: False

 nctId: NCT06382571 id: 026/66 briefTitle: Factors Associated With Sub - Targeted Therapeutic Dose Of Renin - Angiotensin Blockage Among Chronic Heart Failure With Reduced Ejection Fraction Patients overallStatus: COMPLETED date: 2016-01-01 date: 2020-12-31 date: 2021-12-31 date: 2024-04-24 date: 2024-04-24 name: Chulalongkorn University class: OTHER briefSummary: Objective: To analyze factors associated with Thai heart failure with reduced ejection fraction patients who received sub-target doses of Angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor-neprilysin inhibitors (ARNIs), and angiotensin receptor blockers (ARBs).

Methods: The retrospective cohort study was designed to collect data on Thai heart failure with reduced ejection fraction patients at Out-patient Clinic, Trat Hospital and Phrapokklao Hospital from January 2016 to December 2020. Thirteen factors were analyzed to determine their association with the sub-target group. conditions: Heart Failure With Reduced Ejection Fraction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 396 type: ACTUAL name: Renin-Angiotensin System Inhibitor measure: factors associated with sub - target dose of ACEIs,ARBs,ARNI sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06382558 id: s68470 id: C2M/23/060 type: OTHER_GRANT domain: KU Leuven briefTitle: Validity and Reliability of Sensorimotor Processing Paradigm overallStatus: RECRUITING date: 2024-04-10 date: 2024-12-31 date: 2024-12-31 date: 2024-04-24 date: 2024-04-24 name: KU Leuven class: OTHER briefSummary: Sensorimotor function of the upper limb is often impaired after stroke, even in the chronic phase (minimum 6 months after stroke). Currently, an optimal assessment for sensory processing, one of the most important sensory functions, does not exists. However, our research team has developed a novel assessment paradigm using the KINARM End-Point robot to assess the level of sensory processing of the upper limb. Within a previous study, the investigators examined the validity within 20 chronic stroke patients and 80 age-matched healthy controls by comparing the novel robotic assessment with a set of existing clinical and robotic assessments for the upper limb. The investigators hypothesize that the stroke patients will show a poorer performance on this novel assessment compared to the healthy controls, that the novel assessment will show better correlation coefficients with other sensory tests compared to motor tests, that the novel assessment can differentiate between different motor subgroups of chronic stroke patients, and that the novel assessment shows good test-retest reliability. conditions: Stroke studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED measure: Kinarm: Passive and active discrimination task measure: Kinarm: Arm position matching task measure: Kinarm: Visually guided reaching task measure: Erasmus modified Nottingham sensory assessment measure: Tactile discrimination test measure: Tactile functional object recognition measure: Stereognosis section of the original Nottingham sensory assessment measure: Wrist position sense test measure: Perceptual threshold of touch measure: Fugl-Meyer upper extremity assessment measure: Action research arm test measure: Barthel index measure: Montreal cognitive assessment measure: Star cancellation test sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: KU Leuven status: RECRUITING city: Leuven zip: 3001 country: Belgium name: Geert Verheyden, Prof. Dr. role: CONTACT lat: 50.87959 lon: 4.70093 hasResults: False

 nctId: NCT06382545 id: Approval number 36.3.22 briefTitle: Post-instrumentation Pain After Use of the Fanta and M3 Pro Gold Systems overallStatus: COMPLETED date: 2021-11-01 date: 2022-06-30 date: 2022-07-30 date: 2024-04-24 date: 2024-04-24 name: Ahram Canadian University class: OTHER briefSummary: Comparing the intensity of post-operative pain following endodontic treatment of posterior teeth with Fanta (Pepsi gold) (FPG) and M3-pro+ Gold (assorted) (MPG) rotary files. conditions: Endodontic Treatment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ACTUAL name: Fanta (Pepsi gold) (FPG) name: M3-pro+ Gold (assorted) (MPG) measure: comparing the intensity of post-instrumentation pain sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of Oral and Dental medicine, Ahram Canadian University city: Giza zip: 12573 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06382532 id: AFMMUChina_NSRT briefTitle: Diagnosis of Depressive Disorder Malinger Using the Niacin Skin Response Test (NSRT) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-05-01 date: 2024-04-24 date: 2024-04-24 name: Air Force Military Medical University, China class: OTHER briefSummary: This study will explore the specific response characteristics of the niacin skin response test in the population with depressive disorder malinger. The investigators expect that depressive disorder malinger can be discriminated by the niacin skin reaction test. conditions: Depressive Disorder conditions: Malingering studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 410 type: ESTIMATED name: Niacin skin reaction test measure: Niacin reaction test measure: Model specificity and sensitivity measure: The F Scale in Minnesota Multiphasic Personality Inventory sex: MALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Air Force Medical Center city: Beijing state: Beijing zip: 100142 country: China name: Jin Wang role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06382519 id: Thal in VEOIBD briefTitle: Thalidomide Therapy for VEOIBD overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-12-31 date: 2026-12-31 date: 2024-04-24 date: 2024-04-24 name: Children's Hospital of Fudan University class: OTHER briefSummary: This is a single center, observational study to investigate the clinical outcomes of thalidomide treatment for very early onset inflammatory bowel disease conditions: Inflammatory Bowel Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Thalidomide measure: endoscopic response rate measure: clinical response rate measure: biomarker remission rate measure: growth development measure: clinical remission rate with steroid-free measure: adverse event measure: treatment persistence sex: ALL minimumAge: 28 Days maximumAge: 6 Years stdAges: CHILD hasResults: False

 nctId: NCT06382506 id: 2024/138 briefTitle: The Effect of Hazelnut Flour on Blood Glucose acronym: Hazelnut overallStatus: COMPLETED date: 2024-03-21 date: 2024-04-21 date: 2024-04-21 date: 2024-04-24 date: 2024-04-24 name: Ege University class: OTHER briefSummary: One of the factors affecting human health is nutrition. The effects of foods on blood glucose are still under investigation. The Glycemic Index (GI), which is associated with many diseases today, is a value that measures the rate at which carbohydrate-containing foods raise blood glucose. It is thought that the loaves of bread produced will be a product with low GI value and can be consumed by celiacs and diabetics. It is aimed to investigate the effect of adding different amounts of hazelnut flour to bread recipes using gluten-free corn flour on blood glucose. conditions: Obesity conditions: Celiac Disease conditions: Blood Glucose conditions: Flour Sensitivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 24 type: ACTUAL name: Consumption of Cornbread with Hazelnut Bread measure: One loaf of bread was consumed each week and the study will continue for a month. Blood glucose measurements were performed with a glucometer at 0 (fasting), 15, 30, 45, 60, 90, and 120 minutes after each bread consumption. measure: This classification as obese and normal-weight individuals was made with the BIA (Bioelectrical impedance analysis) method. This classification was understood by anthropometric measurements made in the first week. sex: FEMALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Avrasya University city: Trabzon zip: 61000 country: Turkey lat: 41.005 lon: 39.72694 hasResults: False

 nctId: NCT06382493 id: B-2011-648-005 briefTitle: Tegoprazan-containing Sequential for H. Pylori overallStatus: RECRUITING date: 2021-02-01 date: 2024-12-12 date: 2024-12-12 date: 2024-04-24 date: 2024-04-24 name: Seoul National University Bundang Hospital class: OTHER briefSummary: As H. pylori eradication, we prepared a randomized controlled clinical trial whether tegoprazan-containing 10-day sequential treatment was effective compared to conventional PPI-containing 10-day sequential eradication therapy conditions: Helicobacter Pylori Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 400 type: ESTIMATED name: Tegoprazan-containing sequential H. pylori eradication therapy measure: Eradication rate measure: Adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Bundang Hospital status: RECRUITING city: Seongnam-si state: Gyeonggi-do zip: 463-707 country: Korea, Republic of name: Nayoung Kim, M.D.,Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 37.43861 lon: 127.13778 hasResults: False

 nctId: NCT06382480 id: 90/2023 briefTitle: PROTeIn-rich Meals to Control Glucose acronym: PROTIME overallStatus: RECRUITING date: 2024-04-12 date: 2026-12-31 date: 2027-02-28 date: 2024-04-24 date: 2024-04-24 name: German Institute of Human Nutrition class: OTHER name: Charite University, Berlin, Germany name: Helmholtz Center Munich name: Hasso Plattner Institute, Potsdam, Germany briefSummary: The overall aim is to identify the dietary pattern for prevention and treatment of type 2 diabetes. The specific aim of this pilot project is to compare effects of two diets with different diurnal distribution of carbohydrates and protein on the glucose metabolism in subjects with prediabetes and type 2 diabetes and its effects on inflammatory status. conditions: Overweight conditions: Obesity conditions: Prediabetes conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The trial will have a cross-over design and compare metabolic effects of two isocaloric 4-week interventions with opposite timely distribution of macronutrient intake divided by a 4-week wash-out phase. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ESTIMATED name: Diet with specific macronutrient composition. measure: Mean 24-hour glucose measure: Measurement of height measure: Measurement of body weight measure: Waist and hip circumference / waist to hip ratio measure: Systolic and diastolic blood pressure measure: Body fat and lean mass measure: Energy expenditure and substrate oxidation rates measure: Hepatic values (gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT)) measure: Renal values (creatinine, urea, uric acid) measure: Intra- und inter-day glycemic variability measure: Glucose levels in meal tolerance test (MTT) measure: Metabolic hormones (insulin, C-peptide, glucagon, glucagon-like peptite 1(GLP-1), gastric inhibitory polypeptide (GIP), peptide YY (PYY), ghrelin, adiponectin, leptin) measure: Inflammatory markers and T cell populations analyses measure: Satiety and hunger scores measure: Sleep/wake timing and sleep quality measure: Physical activity measure: Adipose tissue transcriptome measure: Gene expression in peripheral blood mononuclear cells (PBMC) measure: Gut microbiota and microbiome-derived metabolites measure: Determination of decision behavior sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Olga Ramich status: RECRUITING city: Potsdam state: Potsdam-Rehbrücke zip: 14558 country: Germany name: Olga Ramich, PD Dr. role: CONTACT phone: +4933200882749 email: olga.ramich@dife.de name: Marina D'Urso role: CONTACT phone: +4933200882690 email: marina.durso@dife.de lat: 52.39886 lon: 13.06566 hasResults: False

 nctId: NCT06382467 id: 2401-136-016 briefTitle: Comparison of Remimazolam and Propofol Combination vs. Propofol in IOM overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-06 date: 2024-04-24 date: 2024-04-24 name: Chung-Ang University Gwangmyeong Hospital class: OTHER briefSummary: This study aims to compare total intravenous anesthetic agents: combined remimazolam and propofol vs. propofol monotherapy. The comparison parameters are intraoperative hypotension, patient's involuntary movement, neurophysiological monitoring quality, onset time, recovery time, and postoperative rescue anti-emetics requirements. conditions: Neurologic Disorder studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 56 type: ESTIMATED name: Remimazolam besylate + propofol MCT name: Propofol MCT measure: Incidence of intraoperative hypotension measure: Amount and number of inotropic agents measure: Incidence of participants' intraoperative involuntary movement measure: scores of neurophysiologic monitoring quality measure: onset time of study drugs measure: The administration number of rescue anti-emetic agents measure: Time-weighted average of intraoperative hypotension measure: recovery time of study drugs (remimazolam+propofol or propofol) sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06382454 id: E2-23-5921 briefTitle: Upper Extremity Robot-Assisted Therapy in Stroke Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2025-03-30 date: 2025-03-30 date: 2024-04-24 date: 2024-04-24 name: Hacettepe University class: OTHER name: Interact Medical Technologies Inc. briefSummary: Upper extremity hemiparesis is one of the most common symptoms after stroke. Robot-assisted therapies have been used as an approach to rehabilitation of upper extremity hemiplegia in recent years. Robot-assisted therapy is an approach to post-stroke rehabilitation that uses robotic devices to provide motor or task-oriented training to patients. When the literature is examined, there are studies showing that robot-assisted therapies are similar or superior to conventional methods. In order to provide the most effective rehabilitation approach in upper extremity robots, it is suggested that it may be more accurate to consider the robotic device as a training platform consisting of various therapeutic techniques and principles, not as a tool alone. A robotic system will be used to overcome the disadvantages of the existing robotic systems in the literature such as not providing support to the patient at the time of need, not providing fluidity in shoulder movements by not taking into account the scapulohumeral rhythm in upper extremity movements, long installation times, and ignoring task-oriented training. The system to be used is a self-aligning exoskeleton system for robot-assisted upper extremity rehabilitation. The system provides safe and versatile rehabilitation at increasing intensity and also allows for objective assessments. The aim of this clinical study was to evaluate the efficacy of robot-assisted upper limb rehabilitation in stroke patients. conditions: Stroke conditions: Upper Extremity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Assist-On Arm Robot Group name: Control Group measure: Modified Ashworth Scale measure: Fugl-Meyer Assessment Upper Extremity measure: Action Research Arm Test measure: Box and Block Test measure: Nine Hole Peg Test measure: ACTIVLIM measure: ABILHAND Assessment measure: Stroke Impact Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hacettepe University, Faculty of Physical Therapy and Rehabilitation city: Ankara state: Altındağ, Ankara zip: 06100 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06382441 id: KC/KE-23-0122/ER-4 briefTitle: A Tele-exercise Program for Breast Cancer Survivors overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-01 date: 2024-05-31 date: 2024-05-31 date: 2024-04-24 date: 2024-04-24 name: Hong Kong Baptist University class: OTHER briefSummary: The research protocol outlines a pilot study for a home-based and group-based tele-exercise program designed for breast cancer survivors. The study is a randomized controlled trial (RCT) led by Dr. Yang Gao from Hong Kong Baptist University, with multiple other investigators from Kwong Wah Hospital and the university itself.

Breast cancer is identified as the most prevalent cancer among women globally and in Hong Kong. The document states that adjuvant therapies post-surgery, such as radiation and chemotherapy, can have both short-term and long-term side effects, which may affect the survivors' physical and mental health.

The study is based on evidence that physical activity levels often decrease after a breast cancer diagnosis and that exercise can mitigate the side effects of treatment, improving health and quality of life. The pilot aims to test the acceptability and feasibility of a 12-week tele-exercise program that combines psychological theories and behaviour change techniques, transitioning from supervised to unsupervised exercise to build sustainable exercise habits.

The study will enrol 24 patients, randomly assigning them to an intervention group or an active control group. The intervention group will receive 12 online training sessions plus 4 psychological counselling sessions, whereas the control group will receive educational essays on exercise and health.

The training sessions for the intervention group will include various exercises with increasing intensity and duration over the 4 weeks, monitored by a pulse oximeter to ensure exercises are done at the appropriate heart rate. The sessions will be led by qualified coaches, with Dr. Gao overseeing quality control. conditions: Behavior, Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 24 type: ACTUAL name: tele-exercise measure: Acceptability (quantitative) measure: Acceptability (qualitative) measure: Recruitment rate measure: Retention rate measure: Attendance rate measure: Compliance rate measure: Cardiorespiratory fitness measure: muscle strength measure: balance measure: % body fat measure: skeletal muscle mass measure: height measure: Shoulder joint range of motion (ROM) of affected side measure: Limb circumference and lymphedema measure: Health-related quality of life measure: Physical activity level (min/week) sex: FEMALE minimumAge: 40 Years maximumAge: 64 Years stdAges: ADULT facility: Xiong Zhennan city: Kowloon Tong state: Kowloon country: Hong Kong lat: 22.33312 lon: 114.17969 facility: Yan SUN city: Kowloon Tong state: Kowloon country: Hong Kong lat: 22.33312 lon: 114.17969 hasResults: False

 nctId: NCT06382428 id: T-DAYICAN-002 briefTitle: The Effects of Pelvic Floor Muscle Training Applied With the Telerehabilitation Method in the Postpartum Period overallStatus: COMPLETED date: 2022-12-30 date: 2023-11-30 date: 2024-01-30 date: 2024-04-24 date: 2024-04-24 name: Izmir Tinaztepe University class: OTHER name: Biruni University name: Yeditepe University name: Fenerbahce University briefSummary: Pelvic floor muscle training (PFMT) is routinely recommended to treat and prevent pelvic floor symptoms in the postpartum period. However, due to the high cost, remoteness of the location, and responsibilities of the baby, women cannot participate in PFMT whenever and wherever they want. Telerehabilitation (TR) may be an effective method to facilitate women's access to PFMT. Therefore, our study aims to compare the short and medium-term effects of PFMT applied with the TR method on pelvic floor symptoms, symptom-related quality of life and pelvic floor muscle function with supervised PFMT. This randomized controlled study was conducted at Yeditepe University Hospital Bağdat Street Polyclinic Pelvic Floor Center and online synchronous platform on women aged 18-35 and between the 6th and 8th weeks postpartum. Participants were randomly assigned to the synchronized PFMT performed with the telerehabilitation method (TR-PFMT) group and the supervised PFMT (S-PFMT) group. The same PFMT program was carried out in both groups for 45-50 minutes, 2 days a week for 8 weeks, by two physiotherapists specialized experienced in the pelvic floor. The program was carried out via a synchronous online platform (Skype™ program) in the TR-PFMT group, and as a face-to-face session in the S-PFMT group. Participants' pelvic floor symptoms were evaluated with the Pelvic Floor Distress Inventory-20 (PFDI-20), symptom-related quality of life was evaluated with the Pelvic Floor Impact Questionnaire-7 (PFIQ-7), and pelvic floor muscle function was evaluated with superficial electromyography. Evaluations were made 3 times in total: before the exercise program, after the exercise program and at the 8th week after the exercise program (6th month postpartum). conditions: Pelvic Floor Disorders conditions: Postpartum Disorder conditions: Quality of Life conditions: Mothers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 58 type: ACTUAL name: Pelvic floor muscle training measure: Pelvic Floor Distress Inventory-20 to measure the total pelvic floor symptoms measure: Pelvic Floor Distress Inventory-20 to measure the pelvic organ prolapse symptoms measure: Pelvic Floor Distress Inventory-20 to measure the colorectal-anal symptoms measure: Pelvic Floor Distress Inventory-20 to measure the urinary symptoms measure: Pelvic Floor Impact Questionnaire-7 to measure the total pelvic floor symptoms related quality of life measure: Pelvic Floor Impact Questionnaire-7 to measure the pelvic organ prolapse symptoms related quality of life measure: Pelvic Floor Impact Questionnaire-7 to measure the colorectal-anal symptoms related quality of life measure: Pelvic Floor Impact Questionnaire-7 to measure the urinary symptoms related quality of life measure: Surface electromyography (EMG) to measure the pre-basal activity of the pelvic floor muscles measure: Surface electromyography (EMG) to measure the phasic activity of the pelvic floor muscles measure: Surface electromyography (EMG) to measure the tonic activity of the pelvic floor muscles measure: Surface electromyography (EMG) to measure the endurance activity of the pelvic floor muscles measure: Surface electromyography (EMG) to measure the post-baseline rest activity of the pelvic floor muscles sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Yeditepe University city: Istanbul zip: 34010 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06382415 id: VINCat_PDO_2 briefTitle: Organ/Space Surgical Site Infection and Recurrence and Survival in Rectal Cancer Surgery acronym: VINCat_PDO_2 overallStatus: COMPLETED date: 2011-01-01 date: 2016-12-31 date: 2024-03-31 date: 2024-04-24 date: 2024-04-24 name: Hospital de Granollers class: OTHER briefSummary: In rectal cancer surgery, the organ/space surgical site infection (O/S-SSI) has an impact on patient's prognosis. Its influence in the oncologic outcomes remains controversial. The main objective is to assess the possible effect of O/S-SSI on long-term overall survival and cancer recurrence. conditions: Rectal Cancer conditions: Organ-Space Surgical Site Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3826 type: ACTUAL measure: Rate of overall cancer recurrence measure: Overall survival measure: Rate of Organ-space surgical site infection measure: Rate of surgical complications 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: NCT06382402 id: 23.0924 briefTitle: A CCTA Guided Management Strategy Versus a Standard of Care Strategy in Type 2 NSTEMI overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2026-04-30 date: 2026-04-30 date: 2024-04-24 date: 2024-04-25 name: University of Louisville class: OTHER briefSummary: This study design is a prospective randomized control trial to compare outcomes between the utilization of coronary computed tomography angiography (CCTA) vs conservative treatment in type 2 NSTEMI. The targeted population is expectedly heterogeneous and inpatient setting who are admitted and diagnosed with type 2 NSTEMI. conditions: Myocardial Injury studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 700 type: ESTIMATED name: CCTA scan measure: MACE measure: Cardiovascular (CV) mortality measure: Nonfatal MI, stroke measure: Hospitalization for unstable angina measure: Hospitalization for heart failure measure: Unplanned revascularization measure: All-cause mortality measure: In-hospital and 90-day costs measure: Patient quality of life at 90 days measure: Diagnostic certainty scores measure: Individual components of the primary endpoint sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Louisville School of Medicine, Division of Cardiovascular Diseases city: Louisville state: Kentucky zip: 40202 country: United States name: Dinesh Kalra, MD role: CONTACT phone: 502-588-7010 email: diniesh.kalra@louisville.edu name: Rongras Damrongwatanasuk, MD role: CONTACT phone: 502-588-7010 email: rongras.damrongwatanasuk@louisville.edu lat: 38.25424 lon: -85.75941 hasResults: False

 nctId: NCT06382389 id: DR220204 id: 2023-504691-18-00 type: CTIS briefTitle: Efficacy of EMONO as an add-on Therapy to Conventional Antidepressants for the Treatment of Depressive Symptoms in Nursing-home Residents With Neurocognitive Disorders: a Randomized Controlled Trial- acronym: PROTO-EHPAD overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-08 date: 2026-08 date: 2024-04-24 date: 2024-04-24 name: University Hospital, Tours class: OTHER briefSummary: Depression in neurocognitive disorders (Alzheimers' disease and related disoders) is a highly prevalent condition, especially in nursing homes. While it is associated with significant distress, the current conventional antidepressants have shown only modest efficacy and exposed to potentially severe side effects.

Recent evidence suggests that nitrous oxide (N2O) in its most commonly used packaging of EMONO (Equimolar Mixture of Oxygen and Nitrous Oxide) has rapid antidepressant properties and a good safety profile. However, no study has investigating the antidepressant effect of EMONO in a population of depressed older adults with moderate to severe neurocognitive disorders in nursing homes.

The principal goal of the PROTO-EHPAD study is to compare the changes in depressive symptoms in such individuals in a randomized controlled trial with a follow up period of 8 weeks, with a dosage escalation procedure. conditions: Depression conditions: Neurocognitive Disorders studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel assignement primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 96 type: ESTIMATED name: EMONO name: Medical air measure: Changes in the CORNELL depression severitý scale between S4 (one week after the last administration of MEOPA or medical air) and S1 (baseline). measure: CORNELL scale and GDS scale at weeks 1, 2, 3, 4 and 8 measure: CGI-S and CGI-I scales at weeks 1, 2, 3, 4 and 8 measure: The measurement of well-being by the EVIBE visual analogue scale at weeks 1, 2, 3, 4, and 8 measure: Collection of adverse events at all study visits sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06382376 id: 2024-60 briefTitle: The Effect of Analgesia Methods Applied in Gynecological Cancer Surgeries on Postoperative Analgesia overallStatus: COMPLETED date: 2023-06-01 date: 2023-12-01 date: 2024-03-01 date: 2024-04-24 date: 2024-04-26 name: Bakirkoy Dr. Sadi Konuk Research and Training Hospital class: OTHER_GOV briefSummary: The aim of this study is to compare the effectiveness of intrathecal morphine and four-quadrant transversus abdominis plane block applied for postoperative analgesia in gynecological cancer surgeries.

The key question(s) it aims to answer are:

\[Is intrathecal morphine more effective in postoperative analgesia?\] Patients who underwent gynecological cancer surgery were examined retrospectively. The investigators evaluated the effect of intrathecal morphine and four-quadrant transversus abdominis plane block applied for postoperative analgesia on pain scores and postoperative opioid use. conditions: Gynecological Cancer Surgery conditions: Regional Anesthesia Morbidity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 71 type: ACTUAL name: Intrathecal morphine administered group, Four quadrant transversus abdominis plane block applied group measure: postoperative numerical rating scale measure: postoperative opioid use sex: FEMALE minimumAge: 18 Years maximumAge: 80 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: NCT06382363 id: UW21-363 briefTitle: Improving T2DM Detection Using Spot cHbA1c Test - a Cluster RCT acronym: DM-REACH overallStatus: RECRUITING date: 2022-06-11 date: 2024-09-30 date: 2024-09-30 date: 2024-04-24 date: 2024-04-24 name: The University of Hong Kong class: OTHER name: Hospital Authority, Hong Kong name: Food and Health Bureau, Hong Kong briefSummary: Objectives: To evaluate the effectiveness of active opportunistic screening using point-of-care capillary Hemoglobin-A1c (POC-cHbA1c) testing, compared to venous HbA1c (vHbA1c) testing, in improving detection of type 2 diabetes mellitus (T2DM) among at-risk primary care patients.

Design: Pragmatic cluster randomized controlled trial.

Setting: 8 public primary care clinics in Hong Kong.

Participants: A minimum of 776 patients (97 per clinic) who have ≥1 risk factor for T2DM, but no known diagnosis of DM or DM screening in the past 12 months.

Intervention: Participants at intervention clinics (n=4) will be offered free POC-cHbA1c testing on-site, immediately informed of test results and DM risk, and scheduled for confirmatory oral glucose tolerance test (OGTT) if screened positive (i.e. HbA1c≥5.6%). Participants at control clinics will be offered free vHbA1c testing scheduled on a separate day, informed of test results and DM risk via phone, and scheduled for confirmatory OGTT if screened positive.

Main outcome measures: Primary outcomes are uptake rate of POC-cHbA1c versus vHba1c testing, and difference in proportion of T2DM detected between intervention and control groups.

Secondary outcomes include number-needed-to-screen to detect one more T2DM case.

Data analysis: Participants' characteristics and test uptake rates will be summarized by descriptive statistics. Difference in the proportion of T2DM detected between groups will be compared using Chi-squared test. Number-needed-to screen to identify one additional patient with DM will be calculated.

Expected results: A greater proportion of T2DM patients will be detected by POC-cHbA1c than vHbA1c due to a higher screening test uptake rate among the studied population. conditions: Diabetes Mellitus conditions: Pre-diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 776 type: ESTIMATED name: POC-cHbA1c testing measure: Proportional difference in detection of T2DM measure: Uptake rate measure: Proportion of high-risk HbA1c concentration measure: Difference in uptake rate of OGTT measure: Number-needed-to-screen to detect one more T2DM case measure: Proportion of patients who refuse to join the study sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aberdeen Jockey Club General Out-Patient Clinic status: RECRUITING city: Hong Kong country: Hong Kong name: Linda Chan role: CONTACT phone: 25185657 email: lmjchan@hku.hk lat: 22.27832 lon: 114.17469 facility: Kwun Tong Community Health Centre status: RECRUITING city: Hong Kong country: Hong Kong name: Linda Chan role: CONTACT phone: 25185657 email: lmjchan@hku.hk lat: 22.27832 lon: 114.17469 facility: Lek Yuen General Out-Patient Clinic status: RECRUITING city: Hong Kong country: Hong Kong name: Linda Chan role: CONTACT phone: 25185657 email: lmjchan@hku.hk lat: 22.27832 lon: 114.17469 facility: Li Po Chun General Out-Patient Clinic status: RECRUITING city: Hong Kong country: Hong Kong name: Linda Chan role: CONTACT phone: 25185657 email: lmjchan@hku.hk lat: 22.27832 lon: 114.17469 facility: Ma On Shan Family Medicine Centre status: RECRUITING city: Hong Kong country: Hong Kong name: Linda Chan role: CONTACT phone: 25185657 email: lmjchan@hku.hk lat: 22.27832 lon: 114.17469 facility: Sai Ying Pun Jockey Club General Out-patient Clinic status: RECRUITING city: Hong Kong country: Hong Kong name: Linda Chan role: CONTACT phone: 25185657 email: lmjchan@hku.hk lat: 22.27832 lon: 114.17469 facility: Tseung Kwan O (Po Ning Road) General Out-patient Clinic status: RECRUITING city: Hong Kong country: Hong Kong name: Linda Chan role: CONTACT phone: 25185657 email: lmjchan@hku.hk lat: 22.27832 lon: 114.17469 facility: Yau Ma Tei Jockey Club Specialist Clinic status: RECRUITING city: Hong Kong country: Hong Kong name: Linda Chan role: CONTACT phone: 25185657 email: lmjchan@hku.hk lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06382350 id: KHL-002-2024 briefTitle: Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems acronym: SAFEDRIVE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-09 date: 2026-05 date: 2024-04-24 date: 2024-04-24 name: University Hospital, Motol class: OTHER briefSummary: The study aims to compare glycemic excursions during several life situations (such as periods of driving, periods of night sleep, periods of occupation, periods of physical activity, and periods of stress) in patients with type 1 diabetes treated with closed-loop system and multiple daily insulin dose therapy conditions: Type 1 Diabetes Mellitus conditions: Type 1 Diabetes Mellitus With Hypoglycemia conditions: Drive studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: MiniMed 780 G measure: The frequency of hypoglycemia (<3.9 mmol/l) during the driving periods measure: Period of time spent in a range between 3.9 and 4.5 mmol/l (a risky period) during driving. measure: Specific CGM analysis in relation to recorded the daily activities sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06382337 id: A03010240S briefTitle: Immediate Dental Implants in The Upper Anterior Region overallStatus: NOT_YET_RECRUITING date: 2024-04-21 date: 2025-03 date: 2025-04 date: 2024-04-24 date: 2024-04-24 name: Mansoura University class: OTHER briefSummary: The aim of the study will be to evaluate maxillary anterior teeth replacement with immediate dental implant utilizing vestibular socket therapy versus ice cream cone technique both clinically and radiographically. conditions: Teeth Loss conditions: Alveolar Bone Resorption studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 16 type: ESTIMATED name: Group A : ice cream cone technique name: Group B : the vestibular socket therapy measure: Bone changes measure: soft tissue changes sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Faculty of Dentistry Mansoura University city: Mansoura zip: 7650001 country: Egypt role: CONTACT phone: 050 2248512 email: dentfac@mans.edu.eg name: Mohamed Fa Shoeib, demonstrator role: PRINCIPAL_INVESTIGATOR lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06382324 id: 202301280B0 briefTitle: The Psychological Impact of Mindfulness Intervention to Anterior Cruciate Ligament Reconstruction overallStatus: RECRUITING date: 2024-04 date: 2025-06 date: 2025-12 date: 2024-04-24 date: 2024-04-24 name: Chang Gung Memorial Hospital class: OTHER briefSummary: Anterior cruciate ligament (ACL) reconstruction surgery is a common procedure performed by orthopedic surgeons. Postoperatively, patients often experience pain, muscle tension, and concerns about their ability to return to sports. These factors influence the recovery and return to sports capabilities of ACL patients. According to research, only 64% of patients are able to recover to their pre-injury level after surgery, and the success rate for returning to competitive sports is only 56%. Psychological factors during the recovery process may explain this disparity. ACL injury is associated with anxiety, pain reaction, and emotional disorders, with fear of re-injury being the most common obstacle to returning to sports, accounting for 19%. A study by Lentz et al. (2015) also found no significant differences in pain assessments between individuals who were afraid of re-injury and those who were able to return to sports at six months and one year after surgery. This suggests that fear of pain may limit activity and increase the risk of unsuccessful return to sports.

Mindfulness intervention is a psychological approach that involves non-judgmental awareness and focus on moment to moment. Mindfulness practice is known to reduce stress in athletes, promote recovery, enhance athletic performance, and improve sleep quality. Good sleep quality contributes to emotional stability and physical recovery. Even short daytime naps can be beneficial for athletes. A review of 37 studies of moderate quality found that daytime napping can improve physical and cognitive performance, psychological state, and nighttime sleep.

Therefore, investigators hypothesize that integrating mindfulness practice into daytime napping may lead to improved spirit upon waking, reduce sleep inertia, and over time, potentially increase the rate of return to sports after ACL reconstruction. conditions: Anterior Cruciate Ligament (Acl) Reconstruction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention method:

* Mindfulness napping group: listening to a record of mindfulness meditation practice for 40 minutes.
* Control group: listening to light music for 40 minutes. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The outcome assessor of polysomnography did not know the data belongs which group whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: mindfulness practice of body scan name: listening to light music measure: Electroencephalogram (EEG) measure: Electrooculography (EOG) measure: Electromyography (EMG) measure: ECG (Electrocardiography) measure: Nasal/Oral airflow measure: Thermistor measure: Chest and abdominal belt measure: Oximetry measure: Snoring measure: Karolinska Sleepiness Scale (KSS) measure: Five Facet Mindfulness Questionnaire (FFMQ) measure: State-Trait Anxiety Inventory (STAIS) measure: Anterior Cruciate Ligament Return to Sport After Injury Scale (ACL-RSI) (Short Version) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: ChangGungMH status: RECRUITING city: Keelung zip: 204004 country: Taiwan name: Jian-Hong Chen role: CONTACT phone: 096-130-7506 email: psydr.jc@gmail.com name: Chang Gung Memorial Hospital role: PRINCIPAL_INVESTIGATOR lat: 25.12825 lon: 121.7419 hasResults: False

 nctId: NCT06382311 id: 221824 briefTitle: A Study to Find and Confirm the Dose and Assess Safety, Reactogenicity and Immune Response of a Vaccine Against Pandemic H5N1 Influenza Virus in Healthy Younger and Older Adults overallStatus: RECRUITING date: 2024-04-18 date: 2024-08-21 date: 2025-05-21 date: 2024-04-24 date: 2024-04-24 name: GlaxoSmithKline class: INDUSTRY briefSummary: The aim of this study is to evaluate the safety, reactogenicity and immunogenicity of the Flu Pandemic messenger RNA (mRNA) vaccine (including dose-finding and dose-confirmation) administered healthy adults 18 to 85 years of age. conditions: Influenza, Human studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: Data will be collected in an observer-blind manner in Phase 1 and Phase 2. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1080 type: ESTIMATED name: Flu Pandemic mRNA_Dose level 1 name: Flu Pandemic mRNA_Dose level 2 name: Flu Pandemic mRNA_ Dose level 3. name: Flu Pandemic mRNA_ Dose level 4 name: Flu Pandemic mRNA_Dose level 5 name: Flu Pandemic mRNA_Dose level 6 name: Flu Pandemic mRNA_Dose level 7 name: Placebo measure: Percentage of participants with solicited administration site events [Phase 1 and Phase 2 Part A] measure: Percentage of participants with solicited administration site events [Phase 1 and Phase 2 Part A] measure: Percentage of participants with solicited systemic events [Phase 1 and Phase 2 Part A] measure: Percentage of participants with solicited systemic events [Phase 1 and Phase 2 Part A] measure: Percentage of participants with unsolicited adverse events (AEs) [Phase 1 and Phase 2 Part A] measure: Percentage of participants with unsolicited adverse events (AEs) [Phase 1 and Phase 2 Part A] measure: Percentage of participants with medically attended adverse events (MAAEs) [Phase 1 and Phase 2 Part A] measure: Percentage of participants with serious adverse events (SAEs) [Phase 1 and Phase 2 Part A] measure: Percentage of participants with adverse events of special interest (AESIs) [Phase 1 and Phase 2 Part A] measure: Phase 1: Percentage of participants with increased in FDA toxicity grading for hematology and clinical chemistry laboratory parameters from baseline to any level of FDA toxicity grading at Day 8 measure: Phase 1: Percentage of participants with increased in FDA toxicity grading in hematology and clinical chemistry laboratory parameters from baseline to any level of FDA toxicity grading at Day 29 measure: Phase 1: Percentage of participants with increased in haematology and clinical chemistry laboratory parameters from normal values at baseline to abnormal values at Day 8 measure: Phase 1: Percentage of participants with increased in hematology and clinical chemistry laboratory parameters from normal values at baseline to abnormal values at Day 29 measure: Percentage of participants with anti- hemagglutinin inhibition (HI) titers >= 1:40 at Day 43 [Phase 1 and Phase 2 Part A] measure: Percentage of participants with solicited administration site events [Phase 2 Part B] measure: Percentage of participants with solicited systemic events [Phase 2 Part B] measure: Percentage of participants with unsolicited AEs [Phase 2 Part B] measure: Percentage of participants with MAAEs [Phase 2 Part B] measure: Percentage of participants with SAEs [Phase 2 Part B] measure: Percentage of participants with AESIs [Phase 2 Part B] measure: Percentage of participants with increased in FDA toxicity grading for hematology and clinical chemistry laboratory parameters from baseline to any level of FDA toxicity grading at Day 8 [Phase 2 Part B] measure: Percentage of participants with increased in hematology and clinical chemistry laboratory parameters from normal values at baseline to abnormal values at Day 8 [Phase 2 Part B] measure: Percentage of participants with anti-HI titers >= 1:40 at Day 22 [Phase 2 Part B] measure: Geometric mean titers (GMTs) of HA antibody titers [Phase 1 and Phase 2 Part A] measure: Geometric mean increase (GMI) of HA antibody titers [Phase 1 and Phase 2 Part A] measure: Geometric mean increase (GMI) of anti-HI antibody titers [Phase 1 and Phase 2 Part A] measure: Geometric mean increase (GMI) of anti-HI antibody titers [Phase 1 and Phase 2 Part A] measure: Geometric mean increase (GMI) of anti-HI antibody titers [Phase 1 and Phase 2 Part A] measure: Percentage of participants with HA antibody Seroconversion rate (SCR) [Phase 1 and Phase 2 Part A] measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 1 and Phase 2 Part A] measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 1 and Phase 2 Part A] measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 1 and Phase 2 Part A] measure: Percentage of participants with anti-HI antibody titers >= 1:40 [Phase 1 and Phase 2 Part A] measure: Percentage of seropositive participants for the HA antibody titers [Phase 1 and Phase 2 Part A] measure: GMT of Anti-HI antibody titers [Phase 2 Part B] measure: GMI of anti-HI antibody titers [Phase 2 Part B] measure: GMI of anti-HI antibody titers [Phase 2 Part B] measure: GMI of anti-HI antibody titers [Phase 2 Part B] measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 2 Part B] measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 2 Part B] measure: Seroconversion rate (SCR) of anti-HI antibody titers [Phase 2 Part B] measure: Percentage of participants with anti-HI antibody >= 1:40 [Phase 2 Part B] measure: Percentage of participants with seropositivity of anti-HI antibody titers [Phase 2 Part B] sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Anniston state: Alabama zip: 36207 country: United States 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: Almena L Free role: PRINCIPAL_INVESTIGATOR lat: 33.65983 lon: -85.83163 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Little Rock state: Arkansas zip: 72204 country: United States 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: Derek Lewis role: PRINCIPAL_INVESTIGATOR lat: 34.74648 lon: -92.28959 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Fort Collins state: Colorado zip: 80525 country: United States 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: Michael Thakor role: PRINCIPAL_INVESTIGATOR lat: 40.58526 lon: -105.08442 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Fort Myers state: Florida zip: 33912 country: United States 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: Pedro P Ylisastigui role: PRINCIPAL_INVESTIGATOR lat: 26.62168 lon: -81.84059 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: West Palm Beach state: Florida zip: 33409 country: United States 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: Mira Baron role: PRINCIPAL_INVESTIGATOR lat: 26.71534 lon: -80.05337 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Chamblee state: Georgia zip: 30341 country: United States 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: Adebowale Akintayo role: PRINCIPAL_INVESTIGATOR lat: 33.89205 lon: -84.29881 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: El Dorado state: Kansas zip: 67042 country: United States 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: Michael Rausch role: PRINCIPAL_INVESTIGATOR lat: 37.81724 lon: -96.86225 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Lenexa state: Kansas zip: 66219 country: United States 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: Carlos A Fierro role: PRINCIPAL_INVESTIGATOR lat: 38.95362 lon: -94.73357 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Lexington state: Kentucky zip: 40509 country: United States 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: Mark S Adams role: PRINCIPAL_INVESTIGATOR lat: 37.98869 lon: -84.47772 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Kansas City state: Missouri zip: 64114 country: United States 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: Martha Sue Fanning role: PRINCIPAL_INVESTIGATOR lat: 39.09973 lon: -94.57857 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Omaha state: Nebraska zip: 68144 country: United States 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: Tamara Doehner role: PRINCIPAL_INVESTIGATOR lat: 41.25626 lon: -95.94043 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Las Vegas state: Nevada zip: 89102 country: United States 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: Raj Singh role: PRINCIPAL_INVESTIGATOR lat: 36.17497 lon: -115.13722 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Rochester state: New York zip: 14609 country: United States 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: Matthew G Davis role: PRINCIPAL_INVESTIGATOR lat: 43.15478 lon: -77.61556 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Greensboro state: North Carolina zip: 27408 country: United States 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: Alexander Vance Murray role: PRINCIPAL_INVESTIGATOR lat: 36.07264 lon: -79.79198 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Winston-Salem state: North Carolina zip: 27103 country: United States 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: Robert Dean Rosen role: PRINCIPAL_INVESTIGATOR lat: 36.09986 lon: -80.24422 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Edmond state: Oklahoma zip: 73013 country: United States 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: Kyle Rickner role: PRINCIPAL_INVESTIGATOR lat: 35.65283 lon: -97.4781 facility: GSK Investigational Site status: RECRUITING city: Yukon state: Oklahoma zip: 73099 country: United States 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: Robert J. Lockwood role: PRINCIPAL_INVESTIGATOR lat: 35.50672 lon: -97.76254 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Philadelphia state: Pennsylvania zip: 19111 country: United States 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: Max Mercado role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 facility: GSK Investigational Site status: RECRUITING city: Austin state: Texas zip: 78705 country: United States 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: Laurence Chu role: PRINCIPAL_INVESTIGATOR lat: 30.26715 lon: -97.74306 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Norfolk state: Virginia zip: 23502 country: United States 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: Mary Bailey role: PRINCIPAL_INVESTIGATOR lat: 36.84681 lon: -76.28522 facility: GSK Investigational Site status: NOT_YET_RECRUITING city: Seattle state: Washington zip: 98015 country: United States 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: Ashley Fuller role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06382298 id: PROJECT00009332 briefTitle: Cottonseed Oil Versus Matched PUFA Effects overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2026-12 date: 2028-05 date: 2024-04-24 date: 2024-04-26 name: University of Georgia class: OTHER name: United States Department of Agriculture (USDA) briefSummary: Cardiovascular disease risk factors, including higher BMIs and poor cholesterol profiles, are on the rise and contribute to the United States' growing disease burden. Cottonseed oil (CSO) is found readily in the food supply, and the investigator's previous studies have demonstrated that incorporating CSO into the diet is sufficient to improve fasting cholesterol profile and improve postprandial lipid and/or glycemic responses in both healthy, and at-risk populations. This study aims to compare CSO to a fatty acid composition-matched diet, on changes in fasting and postprandial lipid metabolism and markers of chronic disease risk.

The specific aims are:

* Examine the impact of CSO vs. PUFA on fasting and postprandial lipids.
* Examine the impact of CSO on other markers of chronic disease risk.

Participants will be asked to:

* Consume provided meal replacement shakes daily for 28-days.
* Attend three weekly short visits for fasting blood draws, body measurements, and collect the next week of study materials,
* Attend two longer (5.5h) testing visits which include eating a standardized breakfast meal and having blood drawn periodically before and after breakfast.

Researchers will compare CSO vs. PUFA and control groups (receiving a mixture of oils) to see if CSO is unique in imparting health benefits when compared with similar matched oil diets. conditions: Dyslipidemia conditions: Overweight and Obesity conditions: Nutrition, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Three groups of 28-day parallel feeding trials with two groups receiving 20% of energy needs from CSO, or matched PUFA diet, and one group serving as control receiving 20% of energy needs as a mixture of oils that match the fatty acid profile of the average American intake. primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Participants are blinded to oil intervention group. Investigator blinded to participant's oil intervention group. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 90 type: ESTIMATED name: COTTONSEED OIL name: MATCHED PUFA DIET name: CONTROL measure: Change in fasting serum lipoprotein and cholesterol concentrations measure: Change in fasting serum lipoprotein particle numbers measure: Change in fasting and postprandial plasma triglyceride concentrations measure: Change in fasting and postprandial plasma non-esterified fatty acid (NEFA) concentrations measure: Change in fasting and postprandial plasma glucose concentrations measure: Change in fasting and postprandial plasma insulin concentrations measure: Change in fasting and postprandial plasma appetite control hormones concentrations measure: Change in fasting and postprandial subjective feelings related to appetite measure: Change in fasting and postprandial plasma Malondialdehyde (MDA) measure: Change in fasting and postprandial plasma total antioxidant capacity measure: Change in fasting inflammatory cytokine concentrations measure: Change in fasting plasma markers of coagulation potential measure: Change in fasting and postprandial plasma angiopoietin-like (ANGPTL) proteins measure: Change in fasting insulin resistance metrics measure: Desaturation index measure: Change in fasting serum hepatic enzymes measure: Change in fasting serum hepatic proteins measure: Change in fasting serum bilirubin measure: Change in additional fasting plasma inflammatory cytokine concentrations measure: Change in additional fasting plasma markers of coagulation potential measure: Change in acute dietary intake measure: Change in blood pressure measure: Change in body weight measure: Change in body composition measure: Change in diet composition measure: Change in fasting tocopherol concentrations measure: Change in anthropometric circumferences measure: Change in resting metabolic rate measure: Change in Perceived Stress measure: Change in anxiety measure: Change in self reported physical activity levels measure: Change in Body Mass Index (BMI) sex: ALL minimumAge: 25 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Georgia city: Athens state: Georgia zip: 30602 country: United States lat: 33.96095 lon: -83.37794 hasResults: False

 nctId: NCT06382285 id: 0206-22-ASF briefTitle: The Effect of a Prolonged Peripheral Nerve Block on the Level of Pain After a Knee Replacement overallStatus: NOT_YET_RECRUITING date: 2024-10-30 date: 2025-10-30 date: 2026-01-31 date: 2024-04-24 date: 2024-04-24 name: Assaf-Harofeh Medical Center class: OTHER_GOV briefSummary: The aim of this study is to examine the effect of a prolonged peripheral nerve block (utilizing continuous adductor canal block) on the level of pain after a knee replacement surgery conditions: Knee Replacement Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study will include 50 patients who underwent a knee replacement surgery, who will be randomized to 2 groups. 6 hours after surgery the two groups will be connected to a prolonged block pump. One group will receive the peripheral block ropivacaine 0.2% according to the protocol of 8-10 cc per hour up to 24 hours after surgery. The second group will receive saline according to the same protocol primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 50 type: ESTIMATED name: Continues peripheral block measure: Pain level measure: Analgesic use measure: Physiotherapy sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06382272 id: IRB23-2027 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-24 date: 2024-04-24 name: [Redacted] hasResults: False

 nctId: NCT06382259 id: H24-Acute-Movement-Breaks briefTitle: The Acute Effect of Movement Breaks on Glycemic Responses in Individuals With Type 2 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-04-19 date: 2025-07-15 date: 2025-07-15 date: 2024-04-24 date: 2024-04-24 name: University of British Columbia class: OTHER name: McMaster University briefSummary: To conduct a randomized crossover trial to determine the acute impact of low-intensity movement breaks on glycemic control in physically inactive individuals living with type 2 diabetes using continuous glucose monitoring. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Movement breaks measure: Mean 24-h glucose concentration determined using continuous glucose monitoring assessed using continuous glucose monitoring measure: Time in range determined using continuous glucose monitoring measure: Time above range determined using continuous glucose monitoring measure: Time below range determined using continuous glucose monitoring measure: Glycemic variability determined using continuous glucose monitoring measure: Two-hour glucose area under the curve following standardized breakfast, lunch and dinner meals sex: ALL minimumAge: 30 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06382246 id: H24-Acute-ExSnacks briefTitle: The Acute Effect of "Exercise Snacks" on Glycemic Responses in Individuals With Type 2 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-04-19 date: 2025-07-15 date: 2025-07-15 date: 2024-04-24 date: 2024-04-24 name: University of British Columbia class: OTHER name: McMaster University briefSummary: To conduct a randomized crossover trial to determine the acute impact of exercise snacks on glycemic control in physically inactive individuals living with type 2 diabetes using continuous glucose monitoring. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized controlled crossover design primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Exercise snacks measure: Mean 24-h glucose concentration determined using continuous glucose monitoring assessed using continuous glucose monitoring measure: Time in range determined using continuous glucose monitoring measure: Time above range determined using continuous glucose monitoring measure: Time below range determined using continuous glucose monitoring measure: Glycemic variability determined using continuous glucose monitoring measure: Two-hour glucose area under the curve following standardized breakfast, lunch and dinner meals sex: ALL minimumAge: 30 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06382233 id: PRO-FUTURE project briefTitle: The PRO-FUTURE Project acronym: PRO-FUTURE overallStatus: RECRUITING date: 2024-01-30 date: 2026-01-30 date: 2028-01-30 date: 2024-04-24 date: 2024-04-24 name: University of Campania "Luigi Vanvitelli" class: OTHER name: University of Milan name: A.O.R.N. Santobono-Pausilipon name: University of Modena and Reggio Emilia name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico briefSummary: The goal of this observational study is to learn about specific biomarkers of unilateral ureteropelvic junction obstruction (UPJO) in children undergoing surgical intervention for unilateral UPJO compared with controls. The main question it aims to answer are:

* Are Urinary single-cell and extracellular vesicles (EVs) screening useful to stage the intrarenal injury and repair processes in UPJO babies?
* Do babies with unilateral UPJO have a whole blood gene expression profiling (WBGEP) allowing an accurate unilateral UPJO diagnosis? conditions: Ureteropelvic Junction Obstruction conditions: Chronic Kidney Diseases studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 85 type: ESTIMATED name: Identification of Diagnostic Biomarkers measure: Urine Biomarkers measure: Blood Biomarkers sex: ALL minimumAge: 1 Day maximumAge: 5 Years stdAges: CHILD facility: Univeristà degli Studi della Campania Luigi Vanvitelli status: RECRUITING city: Naples state: Campania zip: 80138 country: Italy name: Pierluigi Marzuillo role: CONTACT name: Pierluigi Marzuillo role: PRINCIPAL_INVESTIGATOR name: Paolo Montaldo role: PRINCIPAL_INVESTIGATOR name: Carmine Noviello role: PRINCIPAL_INVESTIGATOR name: Alfonso Papparella role: SUB_INVESTIGATOR name: Stefano Guarino role: SUB_INVESTIGATOR name: Anna Di Sessa role: SUB_INVESTIGATOR name: Grazia Cirillo role: SUB_INVESTIGATOR name: Giusy Capasso role: SUB_INVESTIGATOR lat: 40.85216 lon: 14.26811 facility: Department of Clinical Sciences and Community Health, University of Milano status: ACTIVE_NOT_RECRUITING city: Milan country: Italy lat: 45.46427 lon: 9.18951 facility: Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico status: RECRUITING city: Milan country: Italy name: Giovanni Montini role: CONTACT name: Giovanni Montini role: PRINCIPAL_INVESTIGATOR name: Alfredo Berrettini role: PRINCIPAL_INVESTIGATOR name: Michele Gnech role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: Obstetrics and Gynecology Unit, University of Modena and Reggio Emilia status: RECRUITING city: Modena country: Italy name: Giovanni Grandi role: CONTACT name: Giovanni Grandi role: PRINCIPAL_INVESTIGATOR name: Stefano Puliatti role: SUB_INVESTIGATOR lat: 44.64783 lon: 10.92539 facility: AORN Santobono-Pausilipon status: RECRUITING city: Naples country: Italy name: Giovanni Di Iorio role: CONTACT name: Giovanni Di Iorio role: PRINCIPAL_INVESTIGATOR name: Agnese Roberti role: SUB_INVESTIGATOR lat: 40.85216 lon: 14.26811 hasResults: False

 nctId: NCT06382220 id: R550 briefTitle: Low Dose Bupivacaine Versus Prilocaine Regarding Hemodynamic Stability and Safety in Geriatrics overallStatus: RECRUITING date: 2024-04-23 date: 2024-07-25 date: 2024-08-15 date: 2024-04-24 date: 2024-04-25 name: Fayoum University Hospital class: OTHER briefSummary: Orthopedic interventions under spinal anesthesia is considered a common practice in elderly patients undergo surgery, and may be associated with lower risks of death, delirium,and major medical complications .

Spinal anesthesia can cause disastrous hemodynamical changes in the form of hypotension and bradycardia in elderly patients due to limited physiological reserve and presence of systemic illness . The degree of hypotension is proportional to the extent of sympathetic blockade. thus unilateral Spinal anesthesia described by Tanasichuk et AL. was used aiming to minimize these hymodynamical changes compared to bilateral block by restricting the extent of sympathetic blockade.

Bupivacaine has been used in spinal anaesthesia in orthodecic surgeries . It provides a short motor block onset time with a long motor block duration . If bupivacaine is used, the main disadvantage is the significant inter-individual variability with clinically significant differences in onset time, dermatomal spread and motor block duration . Prilocaine is a local anaesthetic agent that belongs to the same family as bupivacaine. In the last decade and with the development of day surgery, prilocaine 2% has become more commonly used for orthopaedic surgical procedures . Prilocaine induces a shorter motor block with less urinary retention, which better facilitates enhanced recovery after surgery . Usually, doses administered in spinal anaesthesia vary from 20 to 80 mg . Given the intermediate motor block duration,

The aim of this study

To compare between Unilateral low dose spinal anesthesia using bupivacaine versus prilocaine regarding hemodynamical stability and safety in below knee orthopedic surgeries in elderly people. conditions: Recruitment studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Bupivacain measure: The rate of occurrence of hypotension sex: ALL minimumAge: 60 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fayoum University hospital status: RECRUITING city: Fayoum state: Faiyum Governorate zip: 63514 country: Egypt name: Mohamed A Hamed, MD role: CONTACT phone: 01118560065 phoneExt: 02 email: mah07@fayoum.edu.eg name: Mahdy A Abdelhady, MD role: CONTACT phone: 0120363256 phoneExt: 02 email: maa45@fayoum.edu.eg lat: 29.30995 lon: 30.8418 hasResults: False

 nctId: NCT06382207 id: HM20029298 briefTitle: Effectiveness of the Eko Digital Stethoscope in Capturing Infant ECGs overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2024-12 date: 2024-04-24 date: 2024-04-24 name: Virginia Commonwealth University class: OTHER name: Eko Devices, Inc. briefSummary: When a newborn is diagnosed with tachyarrhythmia, they are generally started on medical therapies, most commonly a beta-blocker, while being observed in an inpatient setting. In most academic institutions, current practice is to provide parental teaching on use of a stethoscope to auscultate their child when there is suspicion for distress, in addition to requiring cardiopulmonary resuscitation (CPR) classes. Fortunately, newer technologies have emerged that allow for capture of cardiac rhythm that may provide a buffer between the infant and the emergency room. conditions: Tachyarrhythmia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This proof-of-concept study will enroll infants, defined as individuals \<1 year of age. It will assess the feasibility and effectiveness of a physician and parent/caregiver in using the Eko DUO and CORE 500 to capture ECGs in patients \<10 kg in a clinic and home setting. primaryPurpose: DIAGNOSTIC masking: NONE count: 50 type: ESTIMATED name: Eko Duo electronic stethoscope name: CORE 500 electronic stethoscope measure: Number and proportion of good-quality ECG recordings taken by physicians, for DUO and for CORE 500 measure: Number and proportion of good-quality ECG recordings taken by parents/caregivers, with a physician present in the exam room using the CORE 500 measure: Number and proportion of good-quality ECG recordings taken by parents/caregivers, with a physician absent from the exam room, for CORE 500 measure: Number and proportion of good-quality ECG recordings taken by parents/caregivers, at home, for CORE 500 only sex: ALL maximumAge: 1 Year stdAges: CHILD facility: Virginia Commonwealth University city: Richmond state: Virginia zip: 23298 country: United States lat: 37.55376 lon: -77.46026 hasResults: False

 nctId: NCT06382194 id: STUDY00014522 id: 1R21AG076362-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R21AG076362-01 briefTitle: Decision Making Tool for Firearm Storage overallStatus: RECRUITING date: 2024-04-01 date: 2024-06-30 date: 2024-07-31 date: 2024-04-24 date: 2024-04-24 name: University of Washington class: OTHER name: National Institute on Aging (NIA) briefSummary: This is a one-arm pilot study testing the feasibility and acceptability of a decision aid about safe firearm storage. conditions: Dementia, Mild conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 66 type: ESTIMATED name: Decision aid measure: Firearm storage (adapted from the National Firearm Survey) measure: Low-Literacy Decisional Conflict Scale measure: Knowledge Questionnaire measure: Feasibility of intervention delivery measure: Acceptability of Intervention Measure sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: University of Washington status: RECRUITING city: Seattle state: Washington zip: 98104 country: United States name: Rachel Ross, MPH role: CONTACT phone: 509-596-1438 email: rross4@uw.edu name: Elizabeth A Phelan, MD role: PRINCIPAL_INVESTIGATOR name: Laura Prater, PhD role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06382181 id: 2023- ENFPOD-2621979 id: Silvia Corchón Arreche type: OTHER domain: University of Valencia id: Omar Cauli type: OTHER domain: University of Valencia briefTitle: A Multimodal Intervention for Community-dwelling Individuals With Unwanted Loneliness overallStatus: COMPLETED date: 2023-04-01 date: 2023-07-01 date: 2023-07-31 date: 2024-04-24 date: 2024-04-24 name: University of Valencia class: OTHER briefSummary: The absence of social relationships negatively affects physical, psychological, and social health. In other words, it alters people's quality of life and makes active aging difficult. The investigators have designed a study to reduce unwanted loneliness in people over 65 living in the community through multiple interventions (music therapy, health education, and physical exercise). conditions: Loneliness conditions: Mental Health Disorder studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants were assigned to three groups in parallel for the duration of the study primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 20 type: ACTUAL name: Music therapy for community-dwelling individuals with unwanted loneliness name: Health education for community-dwelling individuals with unwanted loneliness name: Physical exercise for community-dwelling individuals with unwanted loneliness measure: Score on the Jong Gierveld Loneliness Scale measure: Score on Goldberg Anxiety and Depression Scale sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Valencia city: Valencia zip: 46010 country: Spain lat: 39.46975 lon: -0.37739 facility: Vanessa Ibáñez del Valle city: Valencia zip: 46010 country: Spain lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06382168 id: D19-11186 briefTitle: Phase I/II Study of DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2025-03-31 date: 2025-06-30 date: 2024-04-24 date: 2024-04-24 name: Delta-Fly Pharma, Inc. class: INDUSTRY briefSummary: This Phase I/II trial evaluates the safety and preliminary efficacy of DFP-10917 combined with venetoclax in relapsed or refractory acute myeloid leukemia. DFP-10917 is given as a 14-day continuous IV infusion every 28 days, alongside a 14-day oral course of venetoclax following an initial dose ramp-up. The initial phase tests a starting dose of 4 mg/m²/day of DFP-10917 with 400 mg daily of venetoclax. The Data Monitoring Committee reviews toxicity after one treatment cycle. If DLTs are minimal, more patients are added to confirm safety. If the lower dose level shows tolerability, it proceeds to the Phase II expansion to assess the treatment's effectiveness against leukemia using a Simon's two-stage design, targeting up to 17 participants. conditions: Leukemia, Myeloid, Acute studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 39 type: ESTIMATED name: DFP-10917 name: Venetoclax measure: Number of patients with dose-limiting toxicities assessed by CTCAE v5.0. measure: Number of patients with treatment-related adverse events assessed by CTCAE v5.0. measure: Recommended Phase 2 dose of DFP-10917 in combination with venetoclax (the dose at which <2 out of 6 patients experience a dose-limiting toxicity during the safety assessment period). measure: The proportion of patients who achieve complete remission. measure: The proportion of patients who achieve complete remission or complete remission with incomplete hematologic recovery. measure: The proportion of patients achieving complete remission or complete remission with incomplete hematologic recovery, and morphologic leukemia-free state. measure: Overall survival. measure: Progression-free survival. measure: Maximum concentration of DFP-10917. measure: Area under the curve of DFP-10917. measure: Volume of distribution of DFP-10917. measure: Clearance of DFP-10917. measure: Time to maximum concentration of venetoclax. measure: Maximum concentration of venetoclax. measure: Elimination half-life of venetoclax. measure: Area under the curve of venetoclax. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UCI Chao Family Comprehensive Cancer Center city: Orange state: California zip: 92868 country: United States name: Kiran Naqvi role: PRINCIPAL_INVESTIGATOR lat: 33.78779 lon: -117.85311 facility: Atrium Health Wake Forest Baptist Comprehensive Cancer Center city: Winston-Salem state: North Carolina zip: 27157 country: United States name: Timothy Pardee role: PRINCIPAL_INVESTIGATOR lat: 36.09986 lon: -80.24422 facility: Simmons Cancer Center: UT Southwestern city: Dallas state: Texas zip: 75235 country: United States lat: 32.78306 lon: -96.80667 facility: University of Vermont Cancer Center city: Burlington state: Vermont zip: 05401 country: United States name: Diego Adrianzen Herrer role: PRINCIPAL_INVESTIGATOR lat: 44.47588 lon: -73.21207 facility: University of Virginia Cancer Center city: Charlottesville state: Virginia zip: 22911 country: United States name: Michael Keng role: PRINCIPAL_INVESTIGATOR lat: 38.02931 lon: -78.47668 hasResults: False

 nctId: NCT06382155 id: 111-210 briefTitle: A Phase 2 Study of Vosoritide in Children With Idiopathic Short Stature overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-06 date: 2036-12 date: 2024-04-24 date: 2024-04-24 name: BioMarin Pharmaceutical class: INDUSTRY briefSummary: The purpose of this study is to evaluate i) the effect of multiple doses of vosoritide and ii) the effect of the therapeutic dose of vosoritide compared to human growth hormone (hGH), in children with idiopathic short stature (ISS). conditions: Idiopathic Short Stature studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Vosoritide Injection name: Human Growth Hormone name: Placebo measure: Change from baseline in Annualized Growth Velocity (AGV) measure: Change from baseline in height measure: Change from baseline in height Z-score measure: Incidence of treatment-emergent adverse events measure: Change from baseline in AGV Z-score (average stature reference) measure: Change from baseline in height measure: Change from baseline in height Z score measure: Change from baseline at prespecified timepoints in urine cyclic guanine monophosphate (cGMP) measure: Change from baseline at pre-specified timepoints in serum collagen X marker (CXM) measure: Change from baseline in bone age minus chronological age at pre-specified timepoints measure: Change from baseline in total body (less head) bone mineral density (BMD) Z-score measure: Change from baseline in lumbar spine BMD Z-score measure: Change from baseline in total body (less head) bone mineral content (BMC) measure: Change from baseline in lumbar spine BMC measure: Maximum concentration (Cmax) of vosoritide in plasma measure: Area under the plasma vosoritide concentration time-curve from time 0 to infinity (AUC0-∞) measure: Area under the plasma vosoritide concentration time-curve from time 0 to the last measurable concentration (AUC0-t) measure: Elimination half-life of vosoritide (t½) measure: Apparent clearance of vosoritide measure: Apparent volume of distribution of vosoritide based upon the terminal phase (Vz/F) measure: Time vosoritide is present at maximum concentration (Tmax) sex: ALL minimumAge: 3 Years maximumAge: 10 Years stdAges: CHILD hasResults: False

 nctId: NCT06382142 id: BL-B01D1-307 briefTitle: A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-05 date: 2024-04-24 date: 2024-04-24 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 designed to evaluate the efficacy and safety of BL-B01D1 in patients with unresectable locally advanced or metastatic Triple-Negative breast cancer after taxane failure. conditions: Triple-Negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 436 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 maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University Shanghai Cancer Center city: Shanghai state: Shanghai country: China name: Jiong Wu role: CONTACT name: Jiong Wu role: PRINCIPAL_INVESTIGATOR name: Jian Zhang role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06382129 id: BL-B01D1-302 briefTitle: A Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-05 date: 2024-04-24 date: 2024-04-24 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 locally advanced or metastatic EGFR wild-type non-small cell lung cancer after failure of anti-PD-1/PD-L1 monoclonal antibodies and platinum-based chemotherapy. conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 558 type: ESTIMATED name: BL-B01D1 name: Docetaxel measure: Overall survival (OS) measure: Progression-free survival (PFS) 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: Jie Wang role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06382116 id: BL-B01D1-301 briefTitle: A Study Comparing BL-B01D1 With Platinum Based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-05 date: 2024-04-24 date: 2024-04-24 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 locally advanced or metastatic non-squamous non-small cell lung cancer with EGFR-sensitive mutations after EGFR-TKI failure. conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 428 type: ESTIMATED name: BL-B01D1 name: Pemetrexed+Cisplatin or Carboplatin 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: Sun Yat-sen University Cancer Center city: Guangzhou state: Guangdong country: China name: Li Zhang role: CONTACT lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06382103 id: B2024-108R briefTitle: Biomarkers and Molecular Mechanism Study of Hepatocellular Carcinoma After Radical Resection and Conversion Therapy overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-05-20 date: 2026-05-20 date: 2024-04-24 date: 2024-04-24 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: Blood samples will be tested to identify circulating tumor DNA and plasma protein levels to potentially improve prediction of long term prognosis and guide treatment options of patients with hepatocellular carcinoma underwent surgical resection. conditions: Hepatocellular Carcinoma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: ctDNA monitoring name: Plasma proteomic analysis measure: Correlation between ctDNA level and recurrence-free survival (RFS) measure: Correlation between specific plasma protein expression level and recurrence-free survival (RFS) measure: Correlation between tumor mutation numbers and recurrence-free survival (RFS) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: 180 Fenglin Road city: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06382090 id: PamukkaleU-SBE-BB-01 briefTitle: Premenstrual Syndrome and Laughter Yoga overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2024-05-24 date: 2025-05-24 date: 2024-04-24 date: 2024-04-24 name: Pamukkale University class: OTHER briefSummary: In addition to physical and emotional effects, premenstrual syndrome can negatively affect the participation in classes, school success, social activities and family relationships of young adolescents in high school. Many non-pharmacological treatments have been found to improve premenstrual syndromes in adolescents. Laughter yoga, one of these methods, is a practice consisting of deep breathing exercises and laughter exercises. Laughter yoga has been studied in different sample groups (elderly people, nurses, dialysis patients, etc.) and positive results have been obtained. In this study, the effect of laughter yoga on premenstrual symptoms in adolescents will be examined. conditions: Premenstrual Syndrome conditions: Laughter studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups: comparative experiment and control primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 68 type: ESTIMATED name: Laughter yoga measure: Premenstrual Symptom Scale sex: FEMALE minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD hasResults: False

 nctId: NCT06382077 id: CPSP5502 briefTitle: Chronic Post Surgical Pain-Cardiac acronym: CPSP-Cardiac overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2025-04-25 date: 2025-10-25 date: 2024-04-24 date: 2024-04-24 name: Ondokuz Mayıs University class: OTHER briefSummary: The CPSP-Cardiac is a large, multi-center, observational study with the aim to investigate the incidence of chronic pain in the 3rd month postoperatively in cardiac surgery and its affecting factors. conditions: Chronic Post-surgical Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1176 type: ESTIMATED measure: The incidence of chronic postsurgical pain measure: Postoperative opioid consumption in the first 24 hours measure: Postoperative pain scores measure: The incidences of postoperative nausea and vomiting measure: The number of patients with side effects and complications measure: Time to extubation measure: Length of stay in the intensive care unit measure: Length of stay in the hospital measure: Chronic pain status at 3 and 6 months measure: Psychological assessment measure: Quality of life assessment measure: Postoperative complications at 3 and 6 months sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ondokuz Mayis University city: Samsun state: Atakum zip: 55139 country: Turkey lat: 41.27976 lon: 36.3361 facility: Istanbul University city: Istanbul country: Turkey name: Zerrin Sungur role: CONTACT lat: 41.01384 lon: 28.94966 facility: Marmara University city: Istanbul country: Turkey name: Alper Kararmaz role: CONTACT lat: 41.01384 lon: 28.94966 facility: Burhan Dost city: Samsun zip: 55270 country: Turkey name: BURHAN DOST role: CONTACT phone: 05327042493 email: burhandost@hotmail.com lat: 41.27976 lon: 36.3361 hasResults: False

 nctId: NCT06382064 id: 2024H0089 briefTitle: Evaluation of Wear Experience With One Week Reusable Contact Lenses in Habitual Two Week Reusable Lens Wearers overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-16 date: 2024-09 date: 2025-05 date: 2024-04-24 date: 2024-04-24 name: Ohio State University class: OTHER briefSummary: This open-label study is of current Acuvue® Oasys® wearers (2 - week replacement, reusable lenses) who are satisfied with their current lenses. Subjects will be refit into one week reusable contact lenses and will wear lenses for approximately 2 weeks. Subjects will return for vision and lens fit assessments and will complete surveys about their wear experience. conditions: Myopia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Subjects will be fit into Acuvue Oasys contact lenses at the first visit to wear for 2 weeks. Subjects will then be fit into PRECISION7 lenses at the second visit to wear for 2 weeks. primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Biweekly replacement contact lenses name: One week replacement contact lenses measure: Subjective assessment of lens wear experience sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Ohio State University College of Optometry city: Columbus state: Ohio zip: 43210 country: United States lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06382051 id: CAIN457ACA06 briefTitle: Modifying PEST for Psoriatic Arthritis Screening acronym: ScreenX overallStatus: NOT_YET_RECRUITING date: 2024-06-28 date: 2025-04-30 date: 2025-04-30 date: 2024-04-24 date: 2024-04-24 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: The purpose of this study is to assess the impact of adding two questions and pictures to the validated PEST on the potential diagnosis of PsA in participants with moderate-to-severe plaque PsO in Canada.

Patients will be enrolled in the study for up to 66 days and will be asked to fill-out a PsA screening questionnaire at their first dermatologist visit. Patients screening positive for PsA will have a second visit with a rheumatologist where a full PsA diagnosis assessment will be performed. A remote 'end of study' (EOS) visit will be conducted by the dermatologist to document the patient's biologic Disease-Modifying Antirheumatic Drugs (bDMARDs) treatment choice and status. conditions: Plaque Psoriasis conditions: Psoriatic Arthritis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 502 type: ESTIMATED name: PEST Screening group measure: Positive Predictive Value (PPV) for PEST and PEST+2 in adult patients with moderate-to-severe plaque PsO who are candidates for bDMARDs measure: Proportion of patients scoring negative on PEST and positive on PEST+2 with a confirmed new PsA diagnosis or suspicion of PsA by a rheumatologist measure: Proportion of patients with a confirmed new PsA diagnosis or suspicion of PsA by a rheumatologist measure: Proportion of patients with a false positive score between each group measure: Description of the baseline characteristics of the positive screening score and negative screening score patients for both PEST and PEST+2 tests measure: Patient acceptability/user experience of the PEST+2 questionnaire measure: Administration of dermatologist quantitative surveys measure: Qualitative interview with selected dermatologists measure: Intervention Appropriateness Measure (IAM) sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06382038 id: HZKY-PJ-2024-19 briefTitle: Smart Technology Facilitated Patient-centered Care for Patients With Pulmonary Thromboembolism acronym: SmaPE overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-10-31 date: 2026-10-31 date: 2024-04-24 date: 2024-04-24 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 pulmonary thromboembolism (PTE) on the long-term outcome of PTE patients, in order to enhance clinical practice and establish a foundation of evidence for managing patients with PTE. conditions: Venous Thromboembolism conditions: Pulmonary Thromboembolisms conditions: Clinical Decision Support Systems conditions: Digital Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 3078 type: ESTIMATED name: mobile venous thromboembolism application (mVTEA) measure: VTE-related composite event measure: Patient satisfaction with anticoagulant treatment measure: Generic quality of life measure: Recurrent VTE measure: Chronic thromboembolic pulmonary hypertension (CTEPH) measure: Major bleeding measure: VTE-related hospitalization 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: NCT06382025 id: Alkinstorybook briefTitle: Preoperative Information With Storybook for Pediatric Anesthesia overallStatus: COMPLETED date: 2018-03-09 date: 2020-02-20 date: 2020-05-29 date: 2024-04-24 date: 2024-04-24 name: Trakya University class: OTHER briefSummary: Impacts of non-pharmacologic methods that help patients get prepared cognitively for processes of surgery and anesthesia on pediatric surgery patients' preoperational stress levels and anxiety levels had been examined in the scope of this comprehensive research project. In this project, a goal-oriented 8-9 minutes animation cartoon that is informative and educational had been developed, and pediatric surgery patients had been asked to watch this animation during preoperative period. conditions: Animation, Cartoons, Preoperative Care, Anesthesia, Pediatric studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: INVESTIGATOR count: 168 type: ACTUAL name: showing cartoons -storybook name: showing cartoons - standard measure: preoperative anxiety scale measure: State-trait anxiety inventory (STAI FORM TX-1, TX-2) for parents measure: Children's Hospital of Eastern Ontario Pain (CHEOP) Scale measure: Pediatric Anesthesia Emergence Delirium (PAED) scale sex: ALL minimumAge: 5 Years maximumAge: 10 Years stdAges: CHILD facility: Trakya University city: Edirne state: Edi̇rne zip: 22030 country: Turkey lat: 41.67719 lon: 26.55597 hasResults: False

 nctId: NCT06382012 id: 2024-15703 briefTitle: Antiemetic Fosaprepitant To Remedy Nausea and Vomiting acronym: AFTR NV RCT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-12 date: 2024-12 date: 2024-04-24 date: 2024-04-26 name: Montefiore Medical Center class: OTHER briefSummary: The study team proposes a randomized, double-blind, RCT to address the following goal: to determine the relative efficacy and adverse event profile of fosaprepitant compared to the standard of care antiemetic ondansetron. Fosaprepitant and its active metabolite aprepitant are a relatively new class of antiemetic that exclusively acts in the central nervous system by blocking neurokinin (NK-1) which is a key signaling molecule in the centrally mediated aspects of the vomiting reflex. Currently, fosaprepitant and aprepitant both have only two United Stated Food and Drug Administration (USFDA) approved indications for nausea and vomiting: chemotherapy-induced and postoperative. Neurokinin inhibitors are highly effective and generally well-tolerated. Therefore, this class of medication may be a more appropriate medication for the millions of patients with nausea and vomiting that seek care in EDs. Intravenous fosaprepitant is converted to the active metabolite aprepitant on the order of minutes and is significantly cheaper to procure at this time. The outcome for the efficacy analysis will be no need for additional medication to treat nausea and vomiting within 2 hours of investigational medication administration. The primary outcome for the tolerability analysis will be the development of any new symptom within 2 hours of medication administration. conditions: Nausea and Vomiting conditions: Nausea conditions: Vomiting 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: 250 type: ESTIMATED name: Fosaprepitant 150 mg name: Ondansetron 4 mg measure: Sustained Relief from NV measure: Severity of Nausea measure: Need for rescue antiemetic medication measure: Medication Preference measure: Functional disability measure: Vomiting measure: Hospitalization measure: Fluid Treatment measure: Mean Fluid Volume measure: Length of Stay measure: QTc Interval (QT interval corrected for heart rate) measure: Revisit Rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Montefiore Medical Center (Montefiore and Weiler EDs) city: Bronx state: New York zip: 10467 country: United States name: Mustfa K Manzur, MD role: CONTACT phone: 718-920-6626 email: mmanzur@montefiore.org lat: 40.84985 lon: -73.86641 hasResults: False

 nctId: NCT06381999 id: M602011083 briefTitle: Validity and Inter-rater Reliability for Early Recognition of Spasticity Using the Decision Tree Tool acronym: I-REFER overallStatus: COMPLETED date: 2023-10-27 date: 2024-02-26 date: 2024-02-26 date: 2024-04-24 date: 2024-04-24 name: Merz Therapeutics GmbH class: INDUSTRY briefSummary: The aim of this study is to investigate the validity and Inter-rater reliability for early recognition of spasticity by nurses and physiotherapists using the decision tree tool. conditions: Post-stroke Spasticity studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 73 type: ACTUAL measure: Assessment of the level of agreement between the nurse group and gold-standard group (trained, specialized physicians) in their decision for toxin treatment referral measure: Assessment of the level of agreement between the physiotherapist and/or occupational therapist group and gold-standard group (trained, specialized physicians) in their decision for toxin treatment referral sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gailtal-Klinik city: Hermagor zip: 9620 country: Austria lat: 46.62722 lon: 13.36722 hasResults: False

 nctId: NCT06381986 id: SHJ002-SJP2 briefTitle: Efficacy and Safety of SHJ002 Ophthalmic Solution in the Treatment of Corneal Erosion in Sjogren's Patients overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-01 date: 2025-02 date: 2024-04-24 date: 2024-04-24 name: Sunhawk Vision Biotech, Inc. class: INDUSTRY briefSummary: The purpose of this study is to measure efficacy and safety with 0.25% SHJ002 sterile ophthalmic solution compared to vehicle in treating corneal erosion in Sjogren's patients.

SHJ002 is an antisense oligonucleotide to neutralize a specific microRNA. conditions: Corneal Erosion studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double-Blinded, Parallel, Vehicle-Controlled primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double-Blinded, Parallel, Vehicle-Controlled whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 122 type: ESTIMATED name: SHJ002 name: Vehicle measure: To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measured by corneal fluorescein staining (CFS) score measure: To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by central corneal fluorescein staining (cCFS) score measure: To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by Visual Analogue Scale (VAS) measure: To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by Symptom Assessment in Dry Eye (SANDE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kaohsiung Medical Chung-Ho Memorial Hospital city: Kaohsiung zip: 807 country: Taiwan name: Shiuh-Liang Hsu, MD role: CONTACT phone: +886-73121101 email: shiuhlianghsu@gmail.com name: Shiuh-Liang Hsu, MD role: PRINCIPAL_INVESTIGATOR name: Li-Yi Chiu, MD role: SUB_INVESTIGATOR lat: 22.61626 lon: 120.31333 hasResults: False

 nctId: NCT06381973 id: ELTGOL briefTitle: Ventilation Distribution in COPD Patients During Breathing Exercises overallStatus: RECRUITING date: 2024-04-15 date: 2024-08-01 date: 2024-08-01 date: 2024-04-24 date: 2024-04-25 name: William Poncin, PT, PhD class: OTHER briefSummary: ELTGOL (Slow Expiration with the Opened Glottis in the Lateral posture) is an airway clearance technique performed in the lateral decubitus position. This technique focuses on optimizing ventilation of the infralateral lung (when the subject is lying in the lateral posture) to enhance local air-liquid interaction. Previous studies on ventilation differences between the infra- and supralateral lungs were conducted on healthy, young, male subjects, without the application of thoracic or abdominal pressure.

This study aimed to assess ventilation distribution in right lateral recumbency in patients with chronic obstructive pulmonary disease (COPD), as well as healthy individuals, and investigate the impact of thoracic and abdominal manual pressures during ELTGOL on ventilation distribution. conditions: Chronic Obstructive Pulmonary Disease conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: ELTGOL_Physio name: ELTGOL_Auto name: PEP name: 1L-Tidal-Breathing name: Spontaneous Breathing measure: Impedance variation using Electrical Impedance Tomography sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cliniques universitaires Saint-Luc status: RECRUITING city: Brussels state: Brussels Capital zip: 1200 country: Belgium name: William Poncin role: CONTACT phone: +320470592032 phoneExt: +320470592032 email: william.poncin@uclouvain.be lat: 50.85045 lon: 4.34878 hasResults: False

 nctId: NCT06381960 id: 2022LJ014 briefTitle: Clinical Study on the Prevention and Treatment of Postoperative Metastasis of Lung Cancer by Fuzheng Quxie Recipe overallStatus: RECRUITING date: 2023-01-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-24 date: 2024-04-24 name: Jianhui Tian class: OTHER briefSummary: To address the clinical challenge of postoperative metastasis in stage IIA-IIIA non-small cell lung cancer with negative driver gene expression, there is a lack of effective diagnostic and therapeutic measures. Based on this, investigators propose to carry out a clinical study on the prevention and treatment of postoperative metastasis of IIA-IIIA stage lung cancer with negative driver gene expression with the formula of supporting the positive and dispelling the evil. conditions: Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 356 type: ESTIMATED name: Fuzheng Quxie Recipe measure: Disease-free survival, DFS measure: Overall survival,OS measure: Minimal residual disease, MRD measure: Circulating Tumour Cell Assay measure: Chinese Medicine Symptom Score measure: Quality of life assessment measure: Immunological indicators measure: Tumour marker measure: Peripheral blood systemic immunoinflammatory index sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Chest Hospital status: RECRUITING city: Changning state: Shanghai country: China name: Tianhui Tian role: CONTACT phone: +8613816562972 email: tjhhawk@shutcm.edu.cn name: Fan Xu role: CONTACT phone: +8618762866303 email: 1183596839@qq.com facility: Shanghai General Hospital status: RECRUITING city: Hongkou state: Shanghai country: China name: Tianhui Tian role: CONTACT phone: +8613816562972 email: tjhhawk@shutcm.edu.cn name: Fan Xu role: CONTACT phone: 18762866303 email: 1183596839@qq.com facility: Shanghai Traditional Chinese Medicine-Integrated Hospital status: RECRUITING city: Hongkou state: Shanghai country: China name: Tianhui Tian role: CONTACT phone: +8613816562972 email: tjhhawk@shutcm.edu.cn name: Fan Xu role: CONTACT phone: +8618762866303 email: 1183596839@qq.com facility: Shanghai Municipal Hospital of Traditional Chinese Medicine status: RECRUITING city: Jing'an state: Shanghai zip: 200071 country: China name: Tianhui Tian, Professor role: CONTACT phone: +8613816562972 email: tjhhawk@shutcm.edu.cn name: Fan Xu, Dr role: CONTACT phone: 18762866303 email: 1183596839@qq.com facility: Shanghai Pulmonary Hospital status: RECRUITING city: Yangpu state: Shanghai country: China name: Tianhui Tian role: CONTACT phone: +8613816562972 email: tjhhawk@shutcm.edu.cn name: Fan Xu role: CONTACT phone: +8618762866303 email: 1183596839@qq.com typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2022-12-21 uploadDate: 2024-04-18T10:13 filename: Prot_000.pdf size: 825047 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2022-12-21 uploadDate: 2024-04-18T10:14 filename: ICF_001.pdf size: 151196 hasResults: False

 nctId: NCT06381947 id: 19092023 briefTitle: Efficacy and Safety of Bempedoic Acid in Association With Anti-PCSK9 and Ezetimibe in Statin-intolerant Patients acronym: BESAFE overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-06-30 date: 2025-06-30 date: 2024-04-24 date: 2024-04-24 name: University of Salerno class: OTHER briefSummary: Statin intolerance occurs in up to 15-20% of treated patients. The combined use of Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitors with ezetimibe is commonly performed in these patients, and has been associated with an estimated LDL-C reduction of 65-70%. This drug combination may be insufficient to reach the LDL-C target in high- and very-high-risk patients with statin intolerance, also considering the goals recommended by the current international guidelines. Also, PCSK9 inhibitor dosage escalations frequently fail to achieve the target. Doubling the dosage of alirocumab from 75 mg to 150 mg, when administrated as monotherapy, determines a further reduction of only 3,6% of LDL-C serum level. The full dose of Evolocumab (420 mg every two weeks), was approved only in the setting of homozygous familiar hypercholesterolemia.

Bempedoic acid is an oral, once-daily prodrug, metabolized in the liver to an active inhibitor of ATP-citrate lyase, blocking cholesterol synthesis upstream of 3-hydroxy-3-methylglutaryl-coenzyme A reductase and thereby increasing hepatic expression of the LDL receptor and decreasing circulating LDL-C levels.

The CLEAR (Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen) Harmony trial demonstrated that bempedoic acid in addition to maximally tolerated statin therapy did not lead to a higher incidence of adverse events compared to placebo and significantly lowered LDL-C levels. In the CLEAR Serenity study, bempedoic acid showed a safe and effective profile compared with placebo in patients with statin intolerance. In the CLEAR Tranquility, it provided an oral therapeutic option complementary to ezetimibe in patients intolerant to high-dose statins who required additional LDL-C lowering.

The synergistic effect of bempedoic acid plus PCSK9 inhibitors has been investigated by one phase 2 trial (NCT03193047), which showed a statistical superiority of bempedoic acid plus evolocumab strategy versus placebo plus evolocumab in terms of percent change in LDL-C up to 2 months. To date, no randomized phase 3 clinical trial have evaluated the effect of bempedoic acid in association with anti-PCSK9 and ezetimibe in statin-intolerant patients not attaining the recommended LDL-C target.

The investigators hypothesized that the association of bempedoic acid with PCSK9 inhibitors and ezetimibe may be safe and effective in reducing LDL-C in statin-intolerant patients. conditions: Dyslipidemias conditions: Statin Adverse Reaction conditions: Cardiovascular Diseases conditions: Lipid Metabolism Disorders studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This is an investigator-initiated, phase 4, open-label, multicentre, 2-way crossover trial primaryPurpose: PREVENTION masking: NONE count: 130 type: ESTIMATED name: Lipid-lowering therapy combination with PCSK9 inhibitors, bempedoic acid and ezetimibe name: Lipid-lowering therapy combination with PCSK9 inhibitors and ezetimibe measure: Mean percentage change in LDL-C after 12 weeks of treatment measure: Mean absolute change from baseline to week 12 in low-density lipoprotein cholesterol measure: Percentage of patients reaching the recommended LDL-C target measure: Changes in plasmatic levels of total cholesterol after 12 weeks of treatment measure: Changes in plasmatic levels of HDL cholesterol after 12 weeks of treatment measure: Changes in plasmatic levels of non-HDL cholesterol after 12 weeks of treatment measure: Changes in plasmatic levels of fasting glucose after 12 weeks of treatment measure: Changes in plasmatic levels of glycated haemoglobin after 12 weeks of treatment measure: Changes in plasmatic levels of fasting insulinemia after 12 weeks of treatment measure: Changes in plasmatic levels of HOMA index after 12 weeks of treatment measure: Changes in plasmatic levels of hs-CRP after 12 weeks of treatment measure: Changes in plasmatic levels of lipoprotein(a) after 12 weeks of treatment measure: Changes in plasmatic levels of apolipoprotein B after 12 weeks of treatment measure: Changes in PCSK9 serum levels before starting the treatment and after 12 weeks of treatment measure: Number of participants with abnormal uric acid level, abnormal AST/ALT level, ALT or AST >3x ULN, and/or unexplained creatine kinase (CK) >3x ULN measure: The number and type of adverse events measure: MACE at 12 and 28 weeks measure: Rehospitalization at 12 and 28 weeks measure: Death at 12 and 28 weeks sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-05-02 uploadDate: 2024-04-08T09:09 filename: Prot_SAP_000.pdf size: 452473 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-05-02 uploadDate: 2024-04-08T09:09 filename: ICF_001.pdf size: 193521 hasResults: False

 nctId: NCT06381934 id: 2024-00335; kt23ChristCrain4 briefTitle: Validation of New Diagnostic Indices to Simplify Hyponatremia Therapy Assessment in Patients on Thiazide Diuretics overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-04 date: 2027-04 date: 2024-04-24 date: 2024-04-24 name: University Hospital, Basel, Switzerland class: OTHER briefSummary: This study is looking at two new parameters, aSID and ChU, to see if these can help physicians to distinguish between different causes of low sodium levels (hyponatremia) in Patients taking a medicament against high blood pressure (thiazide). Researchers also want to see if using these new parameters to decide on treatment works just as well, or better, than the current standard treatments. conditions: Thiazide Associated Hyponatremia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 136 type: ESTIMATED name: Standard Care name: aSID/ChU Guided Therapy measure: Serum Sodium Level measure: Descriptive analyses: Changes in aSID in relation to changes in serum sodium levels measure: Descriptive analyses: Changes in ChU in relation to changes in serum sodium levels measure: Diagnostic performance analyses of: aSID and ChU measure: Diagnostic performance analyses of: aSID measured in blood gas analysis measure: Diagnostic performance analyses of: clinical volume status assessment measure: Diagnostic performance analyses of: not-invasive instrumental volume status assessment measure: Diagnostic performance analyses of: other hormones such as aldosterone, renin, arginine-vasopressin sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Basel city: Basel zip: 4031 country: Switzerland name: Laura Potasso, Dr. med. sc. role: CONTACT phone: +41 61 328 58 76 email: laura.potasso@usb.ch name: Mirjam Christ-Crain, Prof. Dr. med. role: CONTACT phone: +41 61 328 70 80 email: mirjam.christ-crain@usb.ch name: Laura Potasso, Dr. med. sc. role: PRINCIPAL_INVESTIGATOR name: Mirjam Christ-Crain, Prof. Dr. med. role: SUB_INVESTIGATOR lat: 47.55839 lon: 7.57327 hasResults: False

 nctId: NCT06381921 id: B2023-0046 briefTitle: Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain acronym: OIME overallStatus: NOT_YET_RECRUITING date: 2025-05-01 date: 2027-10-31 date: 2029-02-28 date: 2024-04-24 date: 2024-04-24 name: University of Connecticut class: OTHER name: Yale University briefSummary: The objectives of the study are to 1) Conduct telemetric biosignals (EDA, ECG, and EMG) recording in healthy controls and IBS participants experiencing cutaneous and visceral pain; and 2) Validate the OIME index as a biomarker for quantifying pain in IBS participants and its capability to assess the treatment of IBS pain via an ambulatory trial. conditions: Abdominal Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled ambulatory trial primaryPurpose: DIAGNOSTIC masking: NONE count: 120 type: ESTIMATED name: IBS-PPSM intervention measure: Pain intensity and interference measure: IBS-related symptoms measure: Electrodermal activity (EDA) measure: Electrocardiogram (ECG) measure: Electromyogram (EMG) measure: Objective integrated multimodal electrophysiological index sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06381908 id: 1-10-72-19-24 briefTitle: The Effects of Combined Energy and Carbohydrate Restriction on Exercise Capacity acronym: CHO-EX overallStatus: RECRUITING date: 2024-04-01 date: 2024-12-15 date: 2024-12-15 date: 2024-04-24 date: 2024-04-24 name: University of Aarhus class: OTHER name: University of Southern Denmark name: University Ghent briefSummary: The effect of calorie restriction combined with low or moderate carbohydrate availability on exercise capacity, metabolism and metabolic health indicators will be measured in a randomized parallel group design. Forty overweight (BMI 25-30) and relatively inactive women (20-35 of age) will be included. These will be randomized into one of two experimental groups both receiving a calorie-restricted diet (-1000 kcal) combined with either low carbohydrate availability or moderate carbohydrate availability across a 10 day period. Laboratory-based physical capacity tests and blood and muscle sampling will be performed before and after the intervention. In addition, an additional follow-up test day will be performed after continuing the diet for another 48 h and then standardizing the pre-testing carbohydrate availability before repeating the tests of physical capacity. conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study is performed as a randomized single-blinded parallel group design. Randomization is performed into two groups using minimization based on a predetermined estimated VO2max middle value of 30. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The study is labelled as a single-blinded study because the investigators are blinded to the group allocation (the group allocation and diet handling is managed by a researcher not involved in other aspects of the data collection or processing). The participants are not informed about their allocated condition, however, it is conceivably possible for them to recognize this based on the food provided. However, the direction of the hypothesis will not be evident to the participants. Moreover, we include questionnaires before the post-tests related to their perceived diet allocation and their perception of the effect of the diet on the test assessments. whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Calorie-restriction with low carbohydrate name: Calorie-restriction with moderate carbohydrate measure: Time to exhaustion measure: Sprint performance measure: Exercise tolerance measure: Muscle glycogen levels measure: Physical activity level measure: Maximal fat oxidation capacity measure: Muscle metabolic enzyme activity measure: Blood lipid profile measure: Continuous glucose levels measure: Fasting blood glucose and insulin measure: Long-term glycemic control (HbAc1) sex: FEMALE minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: Section for Sport Science, Department of Public Health, Aarhus University status: RECRUITING city: Aarhus C zip: 8000 country: Denmark name: Mette Hansen, PhD role: CONTACT phone: +4551666551 email: mhan@ph.au.dk lat: 56.15674 lon: 10.21076 hasResults: False

 nctId: NCT06381895 id: SYSKY-2023-467-01 briefTitle: The Efficacy of Radiomics to Predict Tumor Microenvironment Markers and Comprehensive Therapy for Bladder Cancer overallStatus: COMPLETED date: 2023-05-30 date: 2024-02-01 date: 2024-02-20 date: 2024-04-24 date: 2024-04-24 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: The aim of this study was to develop an radiomic model based on CT images to evaluate markers of the bladder cancer microenvironment, such as TSR,TIL, and IP. Secondly, the association of the radiomic model with clinical outcomes and immunotherapy response was investigated. conditions: Bladder Cancer conditions: Radiomics conditions: Immunotherapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1200 type: ACTUAL measure: Tumour-infiltrating lymphocytes (TIL) measure: overall survival measure: cancer-specific survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen Memorial Hospital city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06381882 id: MiPac briefTitle: The Role of the Human Microbiome in Patients After Pancreatic Resection. acronym: MiPac overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-11-01 date: 2024-04-24 date: 2024-04-24 name: St. Antonius Hospital class: OTHER briefSummary: The goal of this observational study is to classify patients that undergo pancreatic resection for presumed pancreatic or periampullary malignancy into high and low risk groups for postoperative complications based on longitudinal saliva, rectal/faecal, tumor, blood and/or bile microbiome profiles.

To identify the dynamics of the microbiome, as well as the possibly related short-term and long-term complications, multiple samples at different timepoints are needed from the patients. conditions: Pancreas Cancer conditions: Pancreas Neoplasm conditions: Pancreas Adenocarcinoma conditions: Periampullary Cancer conditions: Periampullary Carcinoma conditions: Microbial Colonization studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Pancreatic resection measure: Risk stratification postoperative complications measure: Long time oncological outcomes - site of recurrence measure: Long time oncological outcomes - disease free survival measure: Long time oncological outcomes - overall survival measure: Complications neoadjuvant chemotherapy measure: Complications adjuvant chemotherapy measure: Response to neoadjuvant chemotherapy measure: Complications bile duct drainage measure: Postoperative endocrine insufficiency measure: Postoperative exocrine insufficiency sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06381869 id: CRNHA 2018-2 briefTitle: Bioavailability of Pea Protein in Young and Old Volunteers acronym: NUTRALYS overallStatus: COMPLETED date: 2019-01-10 date: 2019-06-13 date: 2019-06-13 date: 2024-04-24 date: 2024-04-24 name: Roquette Freres class: INDUSTRY name: CRNH Auvergne name: Université d'Auvergne briefSummary: The aim of this study done in healthy, non-malnourished young and elderly subjects, is to measure the bioavailability of protein intake and the variation of metabolic markers following consumption of pea protein " NUTRALYS ® S85 plus" or a reference protein brought in water either alone or at the end of a standardized meal. conditions: Healthy Male Volunteers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 30 type: ACTUAL name: Pea protein (NUTRALYS ® S85 plus) in water name: Pea protein (NUTRALYS ® S85 plus) within meal name: Whey protein in water name: Whey protein within meal measure: Leucine blood concentration measure: Essential amino acids blood concentration (µmol/L) measure: Non essential amino acid blood concentration (µmol/L) measure: Blood glucose concentration (g/L) measure: Blood insulin concentration (μIU/ml) measure: Blood lipid profile (glycerol concentration in mg/l and non-esterified fatty acids concentration in mg/l) measure: Blood inflammatory profile (TNF-α blood concentration in pg/ml and IL-6 blood concentration in pg/ml) sex: MALE minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Unité d'Exploration en Nutrition Centre de Recherche en Nutrition Humaine d'Auvergne city: Clermont-Ferrand zip: 63009 country: France lat: 45.77966 lon: 3.08628 hasResults: False

 nctId: NCT06381856 id: EPM_2024-00227-01 briefTitle: Improving Participation of Autistic Children and Adolescents in the Habilitation Process acronym: IMPAC overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-05 date: 2025-12 date: 2024-04-24 date: 2024-04-24 name: Region Örebro County class: OTHER briefSummary: This project aims to explore the impact of a survey-based and a meeting-based needs assessment models on 7 to 17 year old autistic children's participation in the needs assessment process at the initial reception when enrolled at a Child and Youth Habilitation Centre. conditions: Autism Spectrum Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED measure: The child's involvement measure: The Mental Health Continuum - Short Form measure: The "Your child's strengths, abilities and special needs"-questionnaire. measure: The collaboration with the neuropsychiatric team questionnaire measure: Cantril ladder measure: Individual interviews measure: Type and number of goals in the childrens' individual habilitation plans sex: ALL minimumAge: 7 Years maximumAge: 17 Years stdAges: CHILD facility: University Health Care Research Center city: Örebro zip: 70182 country: Sweden lat: 59.27412 lon: 15.2066 hasResults: False

 nctId: NCT06381843 id: WSKCT004 briefTitle: A Clinical Study to Evaluate the Safety and Immunogenicity of the Recombinant COVID-19 Vaccine (Sf9 Cell) as a Booster overallStatus: COMPLETED date: 2022-08-02 date: 2023-03-29 date: 2023-12-30 date: 2024-04-24 date: 2024-04-25 name: WestVac Biopharma Co., Ltd. class: INDUSTRY name: West China Hospital briefSummary: A observer-blind, randomized, controlled, investigator-initiated clinical trial to evaluate the safety and immunogenicity of a booster vaccination with Recombinant COVID-19 vaccine (Sf9 Cell) in a population aged 18-60 years old who have completed 3 doses vaccination with COVID-19 Vaccine (Vero Cell), Inactivated ≥ 6 months at least 6 months prior to enrolment. The study uses a non-inferiority design to compare between schedules with Recombinant COVID-19 Vaccine (Sf9 Cell) versus COVID-19 Vaccine (Vero Cell) Inactivated as the booster dose. Participants, laboratory and analysing statisticians will remain blind to treatment allocation.

A total of 120 participants will be enrolled, participants will be randomized 1:1 to receive a single dose of Recombinant COVID-19 vaccine (Sf9 Cell) (test group) or COVID-19 Vaccine (Vero Cell), Inactivated. conditions: COVID-19 conditions: SARS-CoV-2 Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 120 type: ACTUAL name: Recombinant COVID-19 Vaccine (Sf9 Cell) name: COVID-19 Vaccine (Vero Cell), Inactivated measure: Incidence of adverse drug reactions (ADRs) measure: Geometric mean titer (GMT) of specific neutralizing antibody against SARS-CoV-2 prototype strain measure: Geometric mean titer (GMT) of specific neutralizing antibody against SARS-CoV-2 Omicron variant measure: Geometric mean increase (GMI) of specific neutralizing antibody against SARS-CoV-2 prototype strain measure: Geometric mean increase (GMI) of specific neutralizing antibody against SARS-CoV-2 Omicron variant measure: GMT and GMI of specific neutralizing antibody against SARS-CoV-2 prototype strain measure: GMT and GMI of specific neutralizing antibody against SARS-CoV-2 omicron variant measure: GMT and GMI of IgG antibodies against SARS-CoV-2 S protein RBD sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: West China Hospital of Sichuan University city: Chengdu state: Sichuan country: China lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06381830 id: ASCT+CART briefTitle: Clinical Study of CAR-T Cell Therapy Following ASCT for R/R B-cell Non-Hodgkin's Lymphoma overallStatus: RECRUITING date: 2024-01-01 date: 2027-01-01 date: 2027-01-01 date: 2024-04-24 date: 2024-04-24 name: The First Affiliated Hospital of Soochow University class: OTHER name: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd name: Suzhou Hongci Hematology Hospital, Suzhou, China briefSummary: The study is designed to evaluate the efficacy and safety of chimeric antigen receptor T-cell therapy following autologous stem cell transplantation for relapsed/refractory B-cell Non-Hodgkin's lymphoma. conditions: Lymphoma, B-Cell conditions: Autologous Stem Cell Transplantation studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: Apheresis name: Autologous Stem Cell Transplantation name: CAR-T Cell Therapy measure: Overall Response Rate (ORR) measure: Progression-free Survival（PFS） measure: Duration of Response(DOR) measure: Complete Response Rate measure: Overall Survival（OS） measure: Adverse events profile sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Soochow University status: RECRUITING city: Suzhou state: Jiangsu zip: 215000 country: China name: Caixia Li, M.D. role: CONTACT phone: +86 512 67781856 email: licaixia@suda.edu.cn lat: 31.30408 lon: 120.59538 hasResults: False

 nctId: NCT06381817 id: 2024112 briefTitle: Haplo-cord HCT vs. Haplo-HCT for T-ALL Patients overallStatus: RECRUITING date: 2024-04-01 date: 2028-03-31 date: 2028-03-31 date: 2024-04-24 date: 2024-04-26 name: The First Affiliated Hospital of Soochow University class: OTHER name: Children's Hospital of Soochow University name: Ruijin Hospital name: Nanfang Hospital, Southern Medical University name: Fujian Medical University Union Hospital name: First Affiliated Hospital Xi'an Jiaotong University name: Wuhan Union Hospital, China name: Zhejiang University briefSummary: The goal of this clinical trial is to learn if haploidentical hematopoietic cell transplantation combined with an unrelated cord blood unit (haplo-cord HCT) works to treat acute T cell lymphoblastic leukemia (T-ALL). It will also learn about the safety of the transplantation. The main questions it aims to answer are:

Dose co-infusion of cord blood in haploidentical hematopoietic cell transplantation (haplo-HCT) lower the rate of relapse? What medical problems do participants have when having haplo-cord HCT? Researchers will compare haplo-cord HCT to haplo-HCT to see if haplo-cord HCT works to treat T-ALL.

Participants will be infused an unrelated cord blood unit at the same day of haploidentical graft infusion. conditions: Acute T Cell Lymphoblastic Leukemia conditions: Haploidentical Hematopoietic Stem Cell Transplantation conditions: Cord Blood studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 146 type: ESTIMATED name: Haplo-cord HCT name: Haplo-HCT measure: Progression-free survival measure: Overall survival measure: Cumulative incidence of relapse measure: Non-relapse mortality measure: Adverse events sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Soochow University status: RECRUITING city: Suzhou state: Jiangsu zip: 215000 country: China name: Yang XU role: CONTACT phone: 86+051267781850 email: xuyang1020@126.com name: Yang Xu role: PRINCIPAL_INVESTIGATOR lat: 31.30408 lon: 120.59538 hasResults: False

 nctId: NCT06381804 id: 24YL9001 briefTitle: Effect of Shotblocker and Palm Stimulator overallStatus: RECRUITING date: 2024-04-19 date: 2024-05 date: 2024-05 date: 2024-04-24 date: 2024-04-24 name: Necmettin Erbakan University class: OTHER briefSummary: This study discusses the advancements in nursing, particularly focusing on intramuscular injections, their complications, and innovative non-pharmacological methods such as the Shotblocker and palm stimulator to reduce pain. These methods, based on the gate control theory, aim to minimize discomfort during injections by applying tactile stimulation, which has proven effective in various studies. conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 96 type: ESTIMATED name: shotblocker name: palm stimulator measure: Visual analog scale (VAS) pain Scale score sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Necmettin Erbakan University status: RECRUITING city: Meram country: Turkey name: Gülden Basit role: CONTACT phone: (0 332) 320 40 29 email: guldenbasit@gmail.com role: CONTACT phone: (0 332) 320 40 29 name: Merve Öz role: SUB_INVESTIGATOR lat: 37.82985 lon: 32.46777 hasResults: False

 nctId: NCT06381791 id: PRO00036811 briefTitle: CBD for Pain Following Orthopedic Shoulder Surgery acronym: CBD overallStatus: RECRUITING date: 2024-05-01 date: 2026-12-30 date: 2027-12-30 date: 2024-04-24 date: 2024-04-24 name: The Methodist Hospital Research Institute class: OTHER briefSummary: The goal of the study is to learn if Epidiolex (cannabidiol) works as a additional pain medication in patients who have had orthopedic shoulder surgery. It is also to learn about safe dosages and identify any side effects after surgery.

Researchers will compare Epidiolex to a placebo solution to see if Epidiolex lowers pain after shoulder surgery.

Participants will:

* track their pain and what medications they use every day in a provided pain diary. A researchers will call every seven days to check on the participant and diary.
* Complete two short surveys. Once before surgery and once after.
* Have bloodwork tested after surgery conditions: Shoulder Osteoarthritis conditions: Rotator Cuff Injuries studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is designed as a randomized, double-blinded controlled trial. Patients will be recruited in clinic preoperatively prior to their scheduled procedure. Patients and the treating physician/research study team will be blinded to the treatment arm. Patients will be randomized to either the test group, which will be prescribed Epidiolex (cannabidiol) postoperatively in addition to the standard pain regimen, or the control group, which will have a placebo provided in addition to the standard pain regimen. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: Epidiolex name: Placebo oral solution measure: Primary - Pain Journal measure: Survey Data measure: Pain Disability Index (PDI) measure: Pain, Enjoyment, General Activity (PEG) Scale measure: Patient Health Questionnaire 4 (PHQ-4): The four-item patient health questionnaire for anxiety measure: Pittsburgh Sleep Quality Index (PSQI) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Houston Methodist Hospital status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Haley M Goble, MHA, CRCC role: CONTACT phone: 713-441-3930 email: hmgoble@houstonmethodist.org name: Patrick C McCulloch, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06381778 id: 112006-E briefTitle: Taiwan Registry of Hypertrophic Cardiomyopathy (THIC) Research Synopsis overallStatus: RECRUITING date: 2023-02-06 date: 2027-12-01 date: 2027-12-01 date: 2024-04-24 date: 2024-04-24 name: Far Eastern Memorial Hospital class: OTHER briefSummary: Hypertrophic cardiomyopathy (HCM) is hallmarked by the presence of left ventricular hypertrophy (LVH) and may present various symptoms including arrhythmia and heart failure. Mutations in the genes related to sarcomeric proteins and metabolic disorders are known causes of HCM. However, it remains required to further explore the prevalence of HCM in the context of Taiwanese' genetic background. Additionally, certain rare diseases that affect the heart, including Fabry disease, cardiac amyloidosis, may present LVH, which makes precise diagnosis among HCM and these diseases more challenging. In this TSOC multi-center registry, we aim to systematically evaluate the clinical, genetic, biochemical features,prevalence, and possible natural course of HCM and relevant rare diseases such as Fabry disease in Taiwan. In the meanwhile, we may also generate the specific "red-flag" signs of Fabry disease in Taiwan. conditions: Hypertrophic Cardiomyopathy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 2600 type: ESTIMATED measure: Death measure: CV death sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Far Eastern Memorial Hospital status: RECRUITING city: New Taipei City zip: 220 country: Taiwan name: Yen-Wen Wu, MD, PhD role: CONTACT phone: 886-2-8966-7000 phoneExt: 1090 email: wuyw0502@gmail.com name: Yen-Wen Wu, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 25.01111 lon: 121.44583 hasResults: False

 nctId: NCT06381765 id: Serratus-Pectointercostal briefTitle: Serratus Plane Block and Pectointercostal Block overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-01 date: 2024-08-01 date: 2024-04-24 date: 2024-04-24 name: Cukurova University class: OTHER briefSummary: ASA I-II female patients aged over 18 who will undergoing breast reduction surgery will recruit to the study. Patients will divide into 2 groups. Deep serratus plane block will perform with 0,25 %bupivacaine 20 ml at the midaxillary 5. rib, bilaterally for Group I. At Group II, deep serratus plane block ( 0,25 %bupivacaine 20 ml) at the midaxillary 5.th rib+ pectointercostal plane block (0,25% bupivacaine 15 ml) at 4-5.th intercostal space will perform bilaterally . General anesthesia with sevoflurane and remifentanil will perform to the all patients. Postoperative pain scores, morphine consumption and complications will record till the 24.th hours. conditions: Postoperative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Serratus plane bock and pectointercostal block measure: postoperative morphine consumption measure: postoperative visual analog scale scores sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06381752 id: CPMvsPT briefTitle: Value of Continuous Passive Motion in Rehabilitation After Total Knee Replacement overallStatus: COMPLETED date: 2019-06-25 date: 2020-03-31 date: 2020-03-31 date: 2024-04-24 date: 2024-04-24 name: Johannes Gutenberg University Mainz class: OTHER briefSummary: Immediate rehabilitation after total knee arthroplasty (TKA) differs in terms of volume, intensity but also type of treatment. Continuous passive motion after TKA is so far only investigated for replacing physiotherapy. This study is conducted to investigate CPM when it partially replaces group physiotherapy in terms of functional and patient-reported outcomes. conditions: Total Knee Arthroplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 175 type: ACTUAL name: Continuous passive motion name: standard rehabilitation measure: Staffelstein Score measure: Oxford Knee Score (OKS) measure: Range of motion (ROM) measure: Visual Analogue Scale (VAS) measure: Return to work sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitaetsmedizin der JGU Mainz city: Mainz state: Rheinland-Pfalz zip: 55131 country: Germany lat: 49.98419 lon: 8.2791 hasResults: False

 nctId: NCT06381739 id: M011 briefTitle: A Trial of a Next Generation COVID-19 Vaccine Delivered by Inhaled Aerosol acronym: AeroVax overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-07 date: 2026-07 date: 2024-04-24 date: 2024-04-25 name: McMaster University class: OTHER name: Canadian Institutes of Health Research (CIHR) briefSummary: The goal of this clinical trial is to study the safety of a new inhaled vaccine to prevent COVID infection and learn about the immune responses that are made in the lungs and the blood after vaccination. Participants will be randomized (like the toss of a coin) to receive the experimental vaccine or a placebo (a look-alike solution that contains no vaccine).

To be in the study participants will have to have already had three doses of a messenger ribonucleic acid (mRNA) COVID vaccine and be generally healthy. Participants are given a single dose of the vaccine by breathing in a fine mist that goes directly into the lungs.

During follow-up participants will:

* visit the clinic for checkups and blood tests at 2, 4 and 8 weeks after vaccination
* report their symptoms for 24 weeks after getting the vaccine.

In some participants, the researchers will collect cells from the lung 4 weeks after vaccination (a test known as a bronchoscopy). conditions: COVID-19 Infection studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 350 type: ESTIMATED name: ChAd-triCoV/Mac name: Control measure: Antigen specific T cell responses in blood. measure: Antigen specific T cell responses in bronchoalveolar lavage (BAL). measure: Any grade 3, 4, or 5 adverse events that are possibly or probably related to study vaccine. measure: Confirmed COVID infection by reverse transcriptase polymerase chain reaction (RT-PCR) measure: CD4 and CD8 T cell responses specific for the spike (S1), nucleoprotein (N) and polymerase (POL) SARS-CoV-2 antigens expressed by the vaccine, including those expressing memory T cell markers, in the peripheral blood. measure: Neutralizing and total antibody levels in BAL and blood measure: Any adverse events, including grade 1 or 2 or where relationship to vaccine/placebo administration or study procedures is judged not related or unlikely. measure: Tissue-resident memory surface marker expression airway T cells sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Health Sciences Centre city: Hamilton state: Ontario zip: L8S 4K1 country: Canada lat: 43.25011 lon: -79.84963 hasResults: False

 nctId: NCT06381726 id: Progetto AIRC IG-2022 ID 27184 briefTitle: Personalized Rendering of Motor System Functional Plasticity Potential to Improve Glioma Resection and Quality of Life overallStatus: RECRUITING date: 2024-03-07 date: 2028-02-28 date: 2028-02-28 date: 2024-04-24 date: 2024-04-24 name: University of Milan class: OTHER name: University of Turin, Italy briefSummary: Background Lower-grade-gliomas affect young patients, thus the longest progression-free-survival (PFS) with a high level quality of life is crucial. Surgery most significantly impacts on tumor natural history, postponing recurrence, improving symptoms, decreasing the need of adjuvant therapies, with extent of resection, gross-total and supra-total (GTR and STR), strongly associating with longest PFS. Achievement of GTR or STR depends on the degree of functional reorganization induced by glioma. Consequently, a successful treatment fostering neural circuit reorganization before surgery, would increase the chance of GRT/STR.

Hypothesis The plastic potential of motor system suggests that reorganization of circuits controlling hand movements could be presurgically fostered in LGG patients by enhancing plasticity with up-front motor-rehabilitation and/or by decreasing tumor infiltration with up-front chemotherapy. Advanced neuroimaging allows to infer the neuroplasticity potential. Intraoperative assessment of the motor circuits functionality will validate reliability of preoperative analyses.

Aims The project has 4 aims, investigating: A) the presurgical functional (FC) and structural (SC) connectomics of the hand-motor network to picture the spontaneous reorganization and the influence of clinical, imaging and histomolecular variables; B) the dynamic of FC and SC after tumor resection; C) changes in FC and SC maps after personalized upfront motor rehabilitation and/or chemotherapy; D) the effect of FC and SC upfront treatment on the achievement of GTR/STR preserving hand dexterity.

Experimental Design Resting-state fMRI and diffusion-MRI will provide FC and SC maps pre- and post-surgery; personalized up-front motor rehabilitation and/or chemotherapy will be administered; Intraoperative brain mapping procedures will generate data to validate the maps.

Expected Results

1. Provide a tool to render the motor functional reorganization predictive of surgical outcome.
2. Identify demographic, clinical and imaging variables associated with functional reorganization.
3. Describe the gain induced by up-front treatment.
4. Distinguish "patterns" predicting chance for GTR/STR from "patterns" suggesting need for up-front treatment.

Impact On Cancer Results will increase the achievement of GTR/STR, preserving motor integrity, with dramatic impact on LGGs natural history. conditions: Glioma conditions: Glioma, Malignant studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients immediately candidate for resection will be assessed neurologically, neuropsychologically and by functional MRI. Extent of resection will be assessed on \<48hrs and 2-month MRI. Neurological and neuropsychological assessment will be performed during regular follow-up. Patients not requiring an adjuvant treatment according to tumor board meeting will be submitted to functional MRI at 4-8 and 12 months from surgery. Patients not immediately eligible for resection will be submitted to biopsy for histomolecular definition. Patients not requiring radiation therapy will be submitted to neurological, neuropsychological, and functional MRI evaluation. Upon clinical context, patients will undergo motor rehabilitation and/or chemotherapy. After 3-6 months, patients will undergo functional MRI and evaluated for surgery. Neurological and neuropsychological evaluation will be performed at treatment initiation, every month during treatment, at admission for surgery and 1 month after surgery. primaryPurpose: TREATMENT masking: NONE count: 400 type: ESTIMATED name: Resting State Functional Magnetic Resonance Imaging (rs-fMRI) name: Up-front Motor Rehabilitation name: Up-front Chemotherapy measure: Muscle power measure: Motor praxia measure: Comprehensive neuropsychological assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Ospedale Galeazzi Sant'Ambrogio status: RECRUITING city: Milan state: Lombardy zip: 20157 country: Italy name: Lorenzo Bello, MD role: CONTACT phone: 0039-340-217-1453 email: lorenzo.bello@unimi.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06381713 id: ONZ-2024-0158 briefTitle: Effect and Cost-utility of of High Intensity vs. Low Intensity Speech Intervention in Children With Cleft Palate overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-12 date: 2027-12 date: 2024-04-24 date: 2024-04-24 name: University Ghent class: OTHER name: Research Foundation Flanders briefSummary: Achieving speech that is understandable and acceptable to others is the key outcome in cleft treatment. Therefore, speech therapy provided by a speech-language pathologist is necessary. This intervention is traditionally provided twice per week for 30 minutes for months or even years by first-line speech-language pathologists. Unfortunately, this low intensity intervention is based on a historical context rather than scientific evidence. This means that current speech therapy knows several shortcomings including poor outcomes, treatment fatigue and high costs related to year-long therapy. Because of these issues, the use of high intensity speech intervention is proposed. Even though solid proof-of-concepts exist for this model, it has not yet found its way into clinical practice.

Before this intensity can be implemented and utilized in clinical practice, the effect of this novel program on a larger societal scale must be determined. This project will compare the effect of high intensity and low intensity speech intervention in children with a cleft palate in terms of speech, quality of life, and cost-utility as provided by first-line speech-language pathologists by conducting a large-scale randomized controlled trial. The final goal is to utilize this program in clinical practice and to create awareness of the benefits for children with a cleft palate among stakeholders. conditions: Cleft Palate Children conditions: Speech Therapy conditions: Speech Disorders in Children conditions: Cleft Lip and Palate studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: High intensive combined phonetic-phonological intervention name: Low intensive combined phonetic-phonological intervention measure: Consonant proficiency measure: Incremental cost-utility ratio measure: Incremental cost-effectiveness ratio measure: Intelligibility in Context measure: Health-related quality of life measure: Speech Function measure: Speech Distress measure: Communication attitudes of children aged 4 and 5 years measure: Communication attitudes of children aged 6 years and older sex: ALL minimumAge: 4 Years maximumAge: 12 Years stdAges: CHILD hasResults: False

 nctId: NCT06381700 id: DF CO2405/0014 (P) briefTitle: Effectiveness of MySmile App for Improving the Oral Health of Secondary School Children: overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-06 date: 2025-06 date: 2024-04-24 date: 2024-04-24 name: University of Malaya class: OTHER briefSummary: The goal of this cluster-randomised control trial is to assess the effectiveness of the MySmile app for improving oral health in secondary school children. The main questions it aims to answer are:

1. Will the MySmile app be more effective in improving secondary school children's dental plaque and gingival health over and above the existing school dental service (SDS)?
2. Will the MySmile app be more effective in improving secondary school children's oral health knowledge, attitudes, and behaviours over and above the existing SDS?
3. Is the MySmile app easy to use by secondary school children?
4. Is the MySmile app acceptable to use from the perspective of secondary school children?

Participants in the intervention group will receive the SDS and MySmile app. The control group will receive SDS only. Therefore the researcher will compare between the intervention and control group in terms of dental plaque, gingival health, oral health knowledge, oral health attitudes and oral health behaviours. conditions: Oral Disease conditions: Gingival Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 303 type: ESTIMATED name: MySmile app name: Control measure: The mean decrement in plaque score will be assessed using the Plaque Control Record developed by O'Leary Drake and Naylor in 1972 measure: The mean increment in gingival health will be assessed using Gingival Index developed by Silness and Loe in 1963 measure: The mean increment of oral health knowledge, attitude and practice using validated questionnaires. sex: ALL minimumAge: 15 Years maximumAge: 17 Years stdAges: CHILD facility: Muhammad Hamidie bin Saari city: Kuala Lumpur state: Wilayah Persukutuan Kuala Lumpur zip: 50480 country: Malaysia name: Zamros Yuzadi Mohd Yusof, PHD role: CONTACT name: Zamros Yuzadi Mohd Yusof, PHD role: PRINCIPAL_INVESTIGATOR name: Marhazlinda Jamaludin, Master role: PRINCIPAL_INVESTIGATOR name: Unaizah Hanum Obaidellah, PHD role: PRINCIPAL_INVESTIGATOR name: Nazirah Ab Mumin, PHD role: PRINCIPAL_INVESTIGATOR lat: 3.1412 lon: 101.68653 hasResults: False

 nctId: NCT06381687 id: 2023-3118978 id: PID2022-141095NB-I00 type: OTHER_GRANT domain: Spanish Ministry of Science, Innovation and Universities briefTitle: A Movement and Music Programme in Early Childhood Education and Care (The MoviMusi Study Protocol) acronym: MOVIMUSI overallStatus: RECRUITING date: 2024-03-20 date: 2024-07-31 date: 2025-07-31 date: 2024-04-24 date: 2024-04-24 name: University of Valencia class: OTHER briefSummary: The early childhood education and care (ECEC) environment is an important setting for providing children with daily opportunities for movement and music, supporting holistic child development in the early years. To date, there are no studies evaluating the implementation of a holistic programme in the ECEC context in the areas of movement behaviour, motor, and musical skills. The main aim is to examine the impact over time of a holistic movement and music programme on correlates of movement behaviour, gross and fine motor skills, and musical skills in young children (1-3 years). The secondary aims are to examine the impact of the movement and music programme on the perceptions of the educational community, as well as the barriers and facilitators they perceive in the process of baseline assessment, construction, and implementation of the movement and music programme in their own ECEC community. This cluster-randomised controlled trial (intervention and control groups) with public ECEC centres will be performed over a 24-month period. Baseline measurements will be taken in the first year of the project, and the longitudinal evaluation of the implementation of the movement and music programme in the second year. educational community's perceptions about the barriers and facilitators associated with the correlates of movement behaviour will be taken into account, as will the results of the assessment of gross and fine motor and musical skills identified in the first year of the project, with a special focus on the structured and unstructured opportunities for movement and music both in the ECEC settings and at home. This research project aims to fill a knowledge gap during a period of childhood that has rarely been explored, either nationally or internationally (1-3 years), and to position movement and music teaching practices as key contexts in the curriculum development of infant and toddler education. conditions: Fundamental Motor Skills conditions: Physical Activity conditions: Music Intervention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The allocation of ECECs to the intervention versus control group will be randomised in a blinded procedure at the end of the first year, following the baseline assessment. Once ECEC centres meeting the selection criteria are identified, they will be randomised to one of the trial arms. primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 312 type: ESTIMATED name: A multi-component, multi-level programme (MoviMusi) measure: Physical activity measure: Sleep time measure: Motor skills measure: Musical skills measure: Sedentary time measure: For young children, the first secondary outcome measure is physical activity and sedentary time during unstructured and structured physical activity opportunities. measure: For young children, the second secondary outcome measure will be the play patterns during unstructured outdoor free play. measure: For ECEC educators, the first secondary outcome will be the perceived barriers and facilitators for the inclusion of movement and music as curricular practices in the ECEC institution. measure: For ECEC educators, the second secondary outcome will be the perceived impact of the implementation of the movement and music program. measure: For families, the first secondary outcome is the perceived barriers and facilitators to PA in young children. measure: For families, the second secondary outcome is the perceived barriers and facilitators to the inclusion of music at home. measure: For families, the third secondary outcome are the means of transport to ECEC settings and barriers to active comm measure: For families, the fourth secondary outcome is the habitual perceived PA and sedentary behaviour in the child's home environment. measure: For families, the fifth secondary outcome is the perceived barriers and facilitators to PA in young children. sex: ALL minimumAge: 14 Months maximumAge: 22 Months stdAges: CHILD facility: University of Valencia status: RECRUITING city: Valencia state: Comunidad Valenciana zip: 46021 country: Spain name: Vladimir Martínez-Bello, Ph.D. role: CONTACT phone: 34961625473 email: vladimir.martinez@uv.es name: María del Mar Bernabé-Villodre, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Herminia Vega-Perona, Ms.Sc. role: SUB_INVESTIGATOR name: José Díaz-Barahona, Ph.D. role: SUB_INVESTIGATOR name: Yolanda Cabrera García-Ochoa, Ph.D. role: SUB_INVESTIGATOR name: Sandra Molines-Borrás, Ph.D. role: SUB_INVESTIGATOR name: Felipe Gertrudix, Ph. D. role: SUB_INVESTIGATOR name: Juan Carlos Montoya-Rubio, Ph. D. role: SUB_INVESTIGATOR name: María Ángeles Fernández-Vilar, Ph. D. role: SUB_INVESTIGATOR name: José Manuel Azorín, Ph. D. role: SUB_INVESTIGATOR name: Nataliya Filenko, Ph. D. role: SUB_INVESTIGATOR name: Daniel Martínez-Bello, Ph.D. role: SUB_INVESTIGATOR name: Ángela Martínez, Ph.D. role: SUB_INVESTIGATOR lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06381674 id: OHSU: 25890 id: HT9425-23-1-0845 type: OTHER_GRANT domain: Department of Defense briefTitle: Wearable Technology to Characterize and Treat mTBI Subtypes: Biofeedback-Based Precision Rehabilitation acronym: SuBTyPE overallStatus: NOT_YET_RECRUITING date: 2024-05-13 date: 2028-09-30 date: 2028-09-30 date: 2024-04-24 date: 2024-04-24 name: Oregon Health and Science University class: OTHER name: United States Department of Defense briefSummary: Current clinical assessment tools are often not sensitive enough to detect and treat some subtle (yet troubling) problems after mTBI. In this study, the investigators will use wearable sensors to both assess and treat people with mTBI. Specifically, the investigators will provide immediate feedback, with visual and/or auditory, on movement quality during physical therapy. This immediate feedback on performance may improve outcomes as the investigators will measure multiple body segments including head movements simultaneously with balance and walking exercises. Such complex movements are needed for safe return to high level activity and military duty. The investigators will test this approach against a standard vestibular rehabilitation program. There are few potential risks to this study such as increasing symptoms and a small fall risk. Benefits include physical therapy for balance problems regardless of therapy with or without biofeedback. An indirect benefit is to have data on correct dosage of physical therapy. The investigators will also distinguish which concussion subtype profiles benefit most from physical therapy. This will help healthcare providers and patients by providing more information to help establish clinical guidelines and new tools for physical therapy. conditions: Mild Traumatic Brain Injury, Concussion conditions: Rehabilitation conditions: Balance Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There will be two groups in this study that will be randomized concurrently into two different rehabilitation programs. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Parties that will be masked include those collecting and analyzing data before and after rehabilitation (post-doctorate fellows, research assistants, and statistician). whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Vestibular therapy for mTBI augmented with audio and visual real-time biofeedback name: Vestibular therapy for mTBI measure: Patient Global Impression of Change (PGIC) measure: Concussion Clinical Profiles Screening (CP Screening) measure: Dizziness Handicap Index (DHI) measure: Quality of Life After Brain Injury (QOLIBRI) measure: The Patient Reported Outcomes Measurement Information System (PROMIS)-Satisfaction with Participation in Social Roles-Short Form 4a measure: Hospital Anxiety and Depression Scale (HADS) measure: Headache Impact Test (HIT-6) measure: Insomnia Severity Index (ISI) measure: Neck Disability Index (NDI) measure: Convergence Insufficiency Symptom Survey (CISS) measure: Vertigo Symptom Scale (VSS) measure: Concussion Symptom Subtypes Inventory (CSSI) measure: Automated Neuropsychological Assessment Metric (ANAM) measure: Dynamic Visual Acuity ( DVA-Clinical) measure: Ocular Motor Function Tests measure: Video Head Impulse Test (vHIT) measure: Functional Gait Assessment (FGA) measure: Complex Turning Course (CTC) measure: Modified Balance Error Scoring System (mBESS) measure: Modified Clinical Test for Sensory Integration on Balance (mCTSIB) measure: Instrumented One Minute Walk (Single and Dual Task) measure: Hybrid Assessment of Mobility (HAM-4) measure: Tandem Gait (Single and Dual Task) measure: Vestibular Ocular Motor Screening (VOMS) measure: Central Sensorimotor Integration Testing (CSMI) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Oregon Health & Science University city: Portland state: Oregon zip: 97239-3098 country: United States lat: 45.52345 lon: -122.67621 facility: Fort Sam Houston city: San Antonio state: Texas zip: 78234 country: United States lat: 29.42412 lon: -98.49363 facility: University of Utah city: Salt Lake City state: Utah zip: 84112 country: United States lat: 40.76078 lon: -111.89105 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form: Protocol and ICF date: 2024-02-13 uploadDate: 2024-03-07T11:25 filename: Prot_SAP_ICF_000.pdf size: 1554413 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan: Updated Statistical Analysis Document date: 2024-04-02 uploadDate: 2024-04-04T19:41 filename: SAP_001.pdf size: 112584 hasResults: False

 nctId: NCT06381661 id: APHP240385 briefTitle: Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Bayesian Basket Trial acronym: PALETTE overallStatus: NOT_YET_RECRUITING date: 2026-04-01 date: 2029-05-01 date: 2032-04-01 date: 2024-04-24 date: 2024-04-24 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: PALETTE is a perpetual adaptive platform to efficiently study sepsis interventions within 'treatable traits' in all-ages patients enabling prompt evaluation of pandemic treatments. Treatable traits, therapeutic targets identified by phenotypes or endotypes (defined by biological mechanism or by treatment response) through validated biomarkers (measurable characteristic reflecting normal or pathogenic processes, or treatment responses), may include multi-omics, cellular, immune, metabolic, endocrine features, or intelligent algorithms. PALETTE Bayesian adaptive design enables parallel investigations of multiple interventions for sepsis, and quick inclusion of pandemic pathogens. PALETTE's new conceptual model will respond to the challenges of standard approaches, i.e. series of sepsis trials, each investigating one or two interventions, expensive, time consuming, and inappropriate in pandemic context. conditions: Sepsis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomization will concern 3 specific domains (immunomodulation, coagulation, and corticosteroids); in each domain, patients will be randomly allocated between control (standard of care) and 1-4 experimental treatments using parallell arms primaryPurpose: TREATMENT masking: NONE count: 2000 type: ESTIMATED name: Tocilizumab name: Baricitinib name: Anakinra name: Hydrocortisone name: Hydrocortisone and fludrocortisone name: Heparin name: Low molecular weight heparin name: Recombinant humanThrombomodulin( rhTM) name: Sivelestat name: Fresh frozen plasma name: Usual care measure: All-cause mortality measure: Number of patients with persistent life-supportive therapies measure: Composite of the two primary outcomes measure: Overall Survival measure: Overall Survival measure: Overall Survival measure: Number of hospital free days measure: Number of hospital free days measure: Time to recover walking measure: Time to resume previous social and professional activities measure: Quality of life score for adults assessed by SF-36 measure: Quality of life score for adults assessed by EQ-5D-5L measure: Quality of life score for children assessed by FFS measure: Quality of life score for adults assessed by SF-36 measure: Quality of life score for adults assessed by EQ-5D-5L measure: Quality of life score for children assessed by FFS measure: Quality of life score for adults assessed by SF-36 measure: Quality of life score for adults assessed by EQ-5D-5L measure: Quality of life score for children assessed by FFS measure: Number of adverse events measure: Incidence of new sepsis episodes measure: Incidence of new sepsis episodes measure: Incidence of new sepsis episodes measure: Incidence of new unscheduled hospitalizations measure: Incidence of new unscheduled hospitalizations measure: Incidence of new unscheduled hospitalizations measure: Incidence of sequels in neurocognitive, neuromuscular; cardiovascular, respiratory, renal, metabolic, and immune systems sex: ALL minimumAge: 37 Weeks maximumAge: 100 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06381648 id: 23228/LyMIC briefTitle: Detecting Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma (LyMIC) acronym: LyMIC overallStatus: RECRUITING date: 2023-04-15 date: 2026-06-18 date: 2026-06-18 date: 2024-04-24 date: 2024-04-25 name: City of Hope Medical Center class: OTHER briefSummary: Lymph node metastasis (LNM) is a major prognostic factor in intrahepatic cholangiocarcinoma (ICC), and accurate preoperative prediction of the presence or absence of LNM has significant clinical implications in determining treatment strategy. Despite this, there are currently no reliable biomarkers established to detect LNM in ICC.

This study seeks to develop a liquid biopsy assay that can accurately detect LNM before treatment in ICC patients. conditions: Cholangiocarcinoma conditions: Cholangiocarcinoma, Intrahepatic conditions: Cholangiocarcinoma Resectable conditions: Cholangiocarcinoma; Liver studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 200 type: ESTIMATED name: LyMIC (Lymph Node Metastasis in Intrahepatic Cholangiocarcinoma) 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: 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: Takayuki Noma, MD role: SUB_INVESTIGATOR lat: 34.13945 lon: -117.97729 facility: Department of Gastroenterological Surgery I, Graduate School of Medicine, Hokkaido University status: RECRUITING city: Hokkaido state: Sapporo zip: 060-8648 country: Japan name: Akinobu Taketomi, PhD role: CONTACT email: akinobutaketomi@yahoo.co.jp name: Kazuki Wakizaka, PhD role: SUB_INVESTIGATOR name: Akinobu Taketomi, PhD role: PRINCIPAL_INVESTIGATOR lat: 43.41104 lon: 142.88878 facility: Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University status: RECRUITING city: Fukuoka zip: 812-8582 country: Japan name: Masaki Mori, PhD role: CONTACT email: m_mori@surg2.med.kyushu-u.ac.jp name: Masaki Mori, PhD role: PRINCIPAL_INVESTIGATOR name: Takeo Toshima, PhD role: SUB_INVESTIGATOR lat: 33.6 lon: 130.41667 facility: Department of Surgery, Tokushima University status: RECRUITING city: Tokushima zip: 770-8503 country: Japan name: Mitsuo Shimada, PhD role: CONTACT email: mitsuo.shimada@tokushima-u.ac.jp name: Yuma Wada, PhD role: SUB_INVESTIGATOR name: Takayuki Noma, MD role: SUB_INVESTIGATOR name: Yuji Morine, PhD role: SUB_INVESTIGATOR name: Tetsuya Ikemoto, PhD role: SUB_INVESTIGATOR name: Yu Saito, PhD role: SUB_INVESTIGATOR name: Mitsuo Shimada, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.06667 lon: 134.56667 hasResults: False

 nctId: NCT06381635 id: FD-BUE-REC: IRB000124920 briefTitle: Effect of Aloe Vera Gel and Manuka Honey on Radiation Induced Oral Mucositis overallStatus: RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2025-01-01 date: 2024-04-24 date: 2024-04-24 name: Ain Shams University class: OTHER briefSummary: The goal of this \[ type of study: Clinical trial\] is to test effectiveness of Aloe Vera Gel and Manuka Honey in management of Radiation Induced Mucositis in head and neck cancer patients.

The main question \[s\] \] is to \[ learn about, test, compare etc.\] it aims to answer are:

1. Is Aloe Vera Gel and Manuka Honey effective in management of Radiation Induced Mucositis?
2. Does Aloe Vera Gel and Manuka Honey affect the level of TGFβ1 and EGF in saliva of patients with radiation induced mucositis? participants will be asked to apply Aloe Vera Gel and Manuka Honey or saline three times daily during radiotherapy and 6 months after radiotherapy. conditions: Radiation Mucositis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Manuka honey mixed with aloe vera gel measure: Change from World Health Organization Oral Toxicity Scale Grading of Oral Mucositis measure: the level of salivary transforming growth factor beta 1 measure: the level of salivary Epidermal Growth factor (EGF) sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ain shams University status: RECRUITING city: Cairo zip: 11565 country: Egypt name: hani wlliam, MD role: CONTACT phone: +20 0001000093885 email: ethicscommittee.fdasurec@gmail.com lat: 30.06263 lon: 31.24967 facility: Fatma E.Sayed status: RECRUITING city: Cairo country: Egypt name: Fatma E. Hassanein, PHD role: CONTACT phone: +201000093885 email: fatmahassanein@dent.asu.edu.eg name: Asma Abou Bakr role: CONTACT email: Asmaa.Aboubakr@bue.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06381622 id: CTA no: 2023-510028-63-00 briefTitle: Combining Lidocaine and Ropivacaine for an Infraclavicular Brachial Plexus Nerve Block overallStatus: RECRUITING date: 2024-04-18 date: 2024-08-03 date: 2024-09-03 date: 2024-04-24 date: 2024-04-24 name: Nordsjaellands Hospital class: OTHER briefSummary: The aim of the study is to investigate how the combination of ropivacaine (a slow onset, long duration local anesthetic) with lidocaine (a rapid onset, shorter duration local anesthetic) affects the onset and duration of a lateral infraclavicular plexus brachialis (LIC) block in patients undergoing non-acute hand surgery. conditions: Nerve Block conditions: Anesthesia, Local conditions: Forearm Fracture conditions: Surgery conditions: Brachial Plexus Block studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 78 type: ESTIMATED name: Ropivacaine 0.5% Injectable Solution name: Lidocaine epinephrine name: Ropivacaine 0.75% Injectable Solution measure: Total time to breakthrough pain measure: The onset of sensory block measure: Total duration of sensory blockade measure: Total duration of motor blockade measure: Degree of motor blockade measure: Pain intensity at pain breakthrough measure: Duration of maximum pain intensity after the blockade has ended measure: Occurence of adverse events (AE) and serious adverse events (SAE) measure: Failed blockade measure: The patient's experience of the treatment (patient satisfaction) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nordsjælland Hospital status: RECRUITING city: Hillerød zip: 3400 country: Denmark name: Lars H Lundstrøm, PhD role: CONTACT phone: 48296512 phoneExt: 45 email: lars.hyldborg.lundstroem.02@regionh.dk name: Christian Rothe, PhD role: CONTACT phone: 48297459 phoneExt: 45 email: christian.rothe@regionh.dk lat: 55.92791 lon: 12.30081 hasResults: False

 nctId: NCT06381609 id: 69HCL22_0901 briefTitle: Peer Support in Alcohol Dependence acronym: PEERSIAD overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-11-01 date: 2027-11-01 date: 2024-04-24 date: 2024-04-24 name: Hospices Civils de Lyon class: OTHER briefSummary: Alcohol use disorder (AUD) affects between 4% and 6% of French adults, and requires appropriate medical treatment.

However, 20-40% of patients with AUD are lost to follow-up at an early stage. Consequently, it is important for addiction departments to implement and evaluate innovative tools and interventions, including the involvement of peer support, to help patients remain in care, and to assess whether peer support has a positive impact on their clinical outcome.

Addiction peer support specialists (APSSs) are individuals who have personally experienced addiction, and who have decided to use their experience to assist other people going through a similar situation, after completing a specific official graduation.

Compared to other caregivers, APSSs may induce in patients a sense of identification which could improve the patient motivation to engage and remain in care.

This is the main hypothesis and the main scientific objective of the PEERSIAD study, which will aim to confirm that accompanying patients with AUD using APSSs after alcohol detoxification, reduces the rate of lost-to-follow-up and improves the overall clinical outcome. conditions: Alcohol Use Disorder studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 626 type: ESTIMATED name: Quality life questionnaire AQoLS name: Quality life questionnaire Euroqol EQ-5D-5L name: Peer support consultations measure: Unplanned cessation of care at 6 months measure: Number of unfulfilled consultations measure: Euroqol-5D-5L questionnaire score measure: Difference in costs (in euros) measure: Number of AUD criteria according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) measure: Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) score measure: average number of standard drinks declared per week measure: Alcohol Quality of Life Scale (AQoLS) score measure: State-Trait Anxiety Inventory (STAI-Y) score measure: Montgomery-Åsberg Depression Rating Scale (MADRS) score measure: Cannabis Use Disorders Identification Test - Revised (CUDIT-R) score measure: type of opioid use measure: frequency of opioid use measure: type of psychostimulant use measure: frequency of psychostimulant use measure: Fagerström test score measure: Health Care Satisfaction Questionnaire (HCSQ) score measure: Number of hospitalisations measure: Service organization description measure: Description of type of support and missions performed by Peer Support measure: Acceptability of Intervention Measure (AIM) score measure: AIM score measure: Adoption of intervention measure: Intervention fidelity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CH Le Vinatier city: Bron zip: 69500 country: France name: Monique GUENIN, MD-PhD role: CONTACT phone: +33 4 37 91 55 55 email: monique.guenin@ch-le-vinatier.fr name: Monique GUENIN, MD-PhD role: PRINCIPAL_INVESTIGATOR lat: 45.73333 lon: 4.91667 facility: Hôpital Beaujon city: Clichy zip: 92110 country: France name: Delphine MOISAN, MD-PhD role: CONTACT phone: +33 1 40 87 58 82 email: delphine.moisan@aphp.fr name: Delphine MOISAN, MD-PhD role: PRINCIPAL_INVESTIGATOR lat: 48.90018 lon: 2.30952 facility: GH Nord, Hospices Civils de Lyon city: Lyon zip: 69004 country: France name: Benjamin ROLLAND, Professor role: CONTACT name: Benjamin ROLLAND, Professor role: PRINCIPAL_INVESTIGATOR name: François BAILLY, MD-PhD role: SUB_INVESTIGATOR lat: 45.74848 lon: 4.84669 facility: CHS St Anne city: Paris zip: 75014 country: France name: Clément VANSTEENE, MD-PhD role: CONTACT name: Clément role: CONTACT name: VANSTEENE, MD-PhD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Bichat Hospital city: Paris zip: 75018 country: France name: Pierre-Alexis GEOFFROY, MD-PhD role: CONTACT phone: +33 1 40 25 82 60 email: pierrealexis.geoffroy@aphp.fr name: Pierre-Alexis GEOFFROY, MD-PhD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06381596 id: 2023-1715 id: A536000 type: OTHER domain: UW- Madison id: SMPH/OPHTHAL&VIS SCI/GEN type: OTHER domain: UW- Madison id: Protocol Version 3/6/2024 type: OTHER domain: UW- Madison briefTitle: Retinal Fundus Flavoprotein Fluorescence in Age Related Macular Degeneration acronym: FPF in AMD overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-24 date: 2024-04-24 name: University of Wisconsin, Madison class: OTHER briefSummary: The goal of this clinical trial is to learn if the areas of stressed cells in the retina correlate to areas of disease identified in standard imaging and whether the images are helpful to identify potential areas of concern before symptoms or disease occurs. The main question it aims to answer is:

* to evaluate patterns of increased autofluorescence FPF in the setting of geographic atrophy

Participants will undergo FPF imaging using the OcuMet Beacon system. conditions: Geographic Atrophy conditions: Age-Related Macular Degeneration studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: OcuMet Beacon measure: Limits of agreement between the fundus autofluorescence (FAF) area of GA images taken with the Heidelberg Spectralis to the flavoprotein fluorescence (FPF) area of GA with images taken with the OcuMet Beacon measure: Compare the cross-sectional associations between FPF intensity (average pixel intensity over a 5.5 mm-diameter region centered at the macula) to FAF area at the time of measurement measure: Compare the cross-sectional associations between best corrected visual acuity (BCVA - using Early Treatment Diabetic Retinopathy Study, greater number of letters read correctly equals better vision) to FAF area at the time of measurement sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Ophthalmology and Visual Sciences city: Madison state: Wisconsin zip: 53705 country: United States name: Amy Remm role: CONTACT phone: 608-262-3377 email: amy.remm@wisc.edu name: Mihai Mititelu, MD, MPH role: PRINCIPAL_INVESTIGATOR lat: 43.07305 lon: -89.40123 hasResults: False

 nctId: NCT06381583 id: 23228/EMERALD briefTitle: A Liquid Biopsy for High-risk Pre-cancer Screening of Esophageal Adenocarcinoma acronym: EMERALD overallStatus: RECRUITING date: 2023-04-15 date: 2026-06-18 date: 2026-06-18 date: 2024-04-24 date: 2024-04-25 name: City of Hope Medical Center class: OTHER briefSummary: This study aims to develop a highly sensitive, specific, and cost-effective blood assay for the early detection of esophageal adenocarcinoma and its precursor lesions, using advanced machine learning and state-of-the-art biological analyses. conditions: Esophagus Cancer conditions: Esophageal Cancer Stage conditions: Esophageal Cancer conditions: Esophageal Neoplasms conditions: Esophagus Adenocarcinoma conditions: Esophagus, Barrett conditions: Barrett Esophagus conditions: Barrett Adenocarcinoma conditions: Barrett Epithelium conditions: Barretts Esophagus With Dysplasia conditions: Barrett's Esophagus Without Dysplasia conditions: Barretts Esophagus With High Grade Dysplasia conditions: Barretts Esophagus With Low Grade Dysplasia conditions: Barrett Esophagus, Long-Segment conditions: Barrett's Esophagus With Dysplasia, Unspecified conditions: Barrett's Esophagus With Esophagitis conditions: Gastroesophageal Reflux conditions: Reflux Disease conditions: Esophageal Adenocarcinoma conditions: Esophageal Dysplasia conditions: Esophageal Neoplasms Malignant studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED name: EMERALD (Esophageal MicroRNAs for BaRRett's esophagus, Adenocarcinoma, and Dysplasia) 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: 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: Alessandro Mannucci, MD role: SUB_INVESTIGATOR lat: 34.13945 lon: -117.97729 hasResults: False

 nctId: NCT06381570 id: VICTORY/OZM-138 briefTitle: Pilot Study of Vinblastine and Tovorafenib in Pediatric Patients With Recurrent/Progressive RAF Altered Low Grade Gliomas acronym: VICTORY overallStatus: RECRUITING date: 2024-03-21 date: 2026-03-21 date: 2029-03-21 date: 2024-04-24 date: 2024-04-24 name: Daniel Morgenstern class: OTHER name: The Hospital for Sick Children briefSummary: This is a Pilot, multicenter, open-label study of patients less than or equal to 25 years, with recurrent or progressive LGG harboring a CRAF or BRAF alteration, including BRAF V600 mutations and KIAA1549: BRAF fusions. Patients with BRAF or CRAF alterations will be identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) of 1988 or other similarly certified laboratories.

The study will be conducted in two sequential phases:

Phase A: A Feasibility (combination dose finding) phase, followed by Phase B: An Efficacy phase. The maximum tolerated dose (MTD)/Recommended Phase 2 Dose (RP2D) of the combination as determined in Phase A would be the dose used in Phase B. The patients on Phase A who were below the MTD/RP2D would be eligible for intra-patient dose escalation to MTD/RP2D subject to criteria outlined later conditions: Low-grade Glioma studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 57 type: ESTIMATED name: Tovorafenib measure: MTD/RP2D measure: Safety and Tolerability measure: Overall response rate measure: Pharmacokinetics (Cmax vinblastine and tovorafenib) measure: Pharmacokinetics (AUC of vinblastine and tovorafenib) measure: Progression free survival measure: Duration of response measure: Clinical Benefit rate sex: ALL minimumAge: 0 Weeks maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: The Hospital for Sick Children status: RECRUITING city: Toronto state: Ontario zip: M5G 1X8 country: Canada name: Nirav Thacker role: CONTACT phone: 6137377600 phoneExt: 6525 email: nthacker@cheo.on.ca lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06381557 id: YRPG-PMS-ZYJN-RCT-2022-01 briefTitle: Cancer-related Fatigue in Patients With Breast Cancer Treatment With Zhengyuan Capsules acronym: CRF overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-03-01 date: 2027-03-01 date: 2024-04-24 date: 2024-04-24 name: Qiang Fu class: OTHER name: Yangtze River Pharmaceutical Group Co., Ltd. briefSummary: Traditional Chinese medicine（TCM） has achieved some meaningful results in improving the symptoms and quality of life of cancer patients, but many research results need to be further verified by clinical trials with larger samples and better design.This study aims to investigate effectiveness and safety of Zhengyuan Capsules for cancer-related fatigue in patients with breast cancer. conditions: Cancer-related Fatigue studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 240 type: ESTIMATED name: Zhengyuan Capsules name: Placebo contains 5%-10% Zhengyuan Capsule total mixed powder measure: Fatigue degree with the Brief Fatigue Inventory（BFI） measure: Fatigue degree the Revised Piper Fatigue Scale（PFS⁃R） measure: Fatigue degree with the MD Anderson Symptom Inventory（MDASI） measure: Change of patients' functional status with Karnofsky performance status (KPS) measure: Quality of Life Questionnaire-Breast Cancer Module 23（QLQ-BR23） measure: Adverse reaction rates, including the damage of liver and renal functions that reflected by increased alanine aminotransferase, aspartate aminotransferase and creatinine urea nitrogen respectively sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06381544 id: fbu_nurs_elmali_002 briefTitle: The Effect of Aromatherapy Use in Nursing Skills Training overallStatus: COMPLETED date: 2024-02-12 date: 2024-02-19 date: 2024-03-06 date: 2024-04-24 date: 2024-04-24 name: Fenerbahce University class: OTHER briefSummary: Nursing education is an education in which theory and practice are intertwined and requires the development of both cognitive and motor skills of students. The laboratory environment is a bridge between classroom learning and clinical practice. In order for students to transform the target behavior into a skill, it takes place in the laboratory on inanimate models under the supervision of the instructor. It has been assumed that there is a strong relationship between learning and anxiety; while a moderate level of anxiety is necessary for learning, a high level of anxiety causes a decrease in learning.

Many studies have reported that students experience anxiety before their first clinical/practice experience. During skills training, it is observed that students are stressed, their hands are shaking, and they do not feel comfortable, especially before practices involving invasive interventions. This is a factor that makes learning skills training difficult. Therefore, it is important for the student to be comfortable, self-confident, and mentally open to learning during skill training. New applications and different techniques for skill training are important in this sense. It is reported that aromatherapy application has positive effects on reducing anxiety and increasing concentration.

RESEARCH HYPOTHESES:

H0: Aromatherapy has no effect on students' anxiety and learning levels during skill training.

H1: Aromatherapy reduces the anxiety experienced by students during skills training.

H2: Aromatherapy has a positive effect on students' learning nursing skills. conditions: Nursing Students studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 69 type: ACTUAL name: Aromatherapy application measure: Difference between skill learning of students in the aromatherapy group and the control group measure: Difference between anxiety levels of students in the aromatherapy group and the control group sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fenerbahce University city: Istanbul state: Atasehir zip: 34758 country: Turkey lat: 41.01384 lon: 28.94966 facility: Fenerbahce University city: Ataşehir state: Istanbul zip: 34758 country: Turkey lat: 40.9833 lon: 29.1167 hasResults: False

 nctId: NCT06381531 id: 4410 briefTitle: Tracing Brain Tumors Through Deep Time acronym: TRACE overallStatus: NOT_YET_RECRUITING date: 2024-06-10 date: 2027-06-10 date: 2027-06-10 date: 2024-04-24 date: 2024-04-24 name: Tata Memorial Centre class: OTHER name: Indian Statistical Institute, Kolkata briefSummary: Brain tumors involve different age groups with a wide range of tumor types involving different anatomical compartments of the brain. The evolution of the brain in vertebrates, including the most recent homo species (including humans), has occurred through increasing structural complexity in more evolved species. In the retrospective study, we will investigate the location of the tumors and different structural aspects of skull anatomy in patients with brain tumors. The information will be compared with the anatomical evolution of the brain and skull in vertebrates to look for possible associations, which can provide insights into evolutionary biology. conditions: Brain Tumor conditions: Oncology studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 10000 type: ESTIMATED name: Imaging with CT and MRI measure: Age-based density maps of brain tumor location measure: Anthropometric analysis of skulls sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Tata Memorial Hospital city: Mumbai state: Maharashtra zip: 400012 country: India name: Dr Archya Dasgupta, MD role: CONTACT lat: 19.07283 lon: 72.88261 hasResults: False

 nctId: NCT06381518 id: Z2023165 briefTitle: Switching From Intravenous to Subcutaneous Infliximab in Adult Patients With Inflammatory Bowel Disease acronym: SHUFFLE overallStatus: ENROLLING_BY_INVITATION date: 2024-03-12 date: 2025-05-01 date: 2025-05-01 date: 2024-04-24 date: 2024-04-24 name: Zuyderland Medisch Centrum class: OTHER briefSummary: The aim of this study is to evaluate the IFX exposure (AUC), effectiveness, presence of ADAbs and treatment burden before and after switching from IV to SC IFX maintenance treatment in a real-world cohort of IBD patients with quiescent disease on IFX monotherapy and combination therapy of IFX and an immunomodulator.

Methods: this is a prospective, single centre, open-label cohort study, conducted in Zuyderland Medical Centre in which 36 adult IBD patients in remission on stable IV IFX therapy are switched to SC CT-P13 of which 18 patients use an immunomodulator in addition to IFX (cohort 2). After the switch to SC CT-P13, patients are followed for 24 weeks.

The study is subdivided into two phases: the IV IFX treatment phase before switching and the SC CT-P13 treatment phase after the switch. After enrolment, the subject receives a final dose of IV IFX according to their own maintenance schedule. Primary endpoints are the Area under the concentration-time curve (AUC) at steady state (1) before and after the switch to SC CT-P13 and (2) with or without concomitant immunomodulator during SC therapy. AUCs will be estimated using pharmacokinetic modelling in MwPharm. Besides IFX trough level, treatment related time expenditure, quality-of-life and patient satisfaction will be assessed before and after the switch. conditions: IBD conditions: Infliximab conditions: Crohn Disease conditions: Ulcerative Colitis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: This is a prospective, single centre, open-label cohort study, conducted in Zuyderland Medical Centre in which adult IBD patients in remission on stable IV IFX therapy are switched to SC CT-P13 and is designed to compare the pharmacokinetics of SC CT-P13 to IV IFX and relate this to the pharmacodynamics. primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Switch to SC CT-P13. measure: Area under the curve (AUC) at steady state measure: Quality of life score measure: Patient satisfaction measure: Time expenditure sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zuyderland Medical Centre city: Sittard country: Netherlands lat: 50.99833 lon: 5.86944 hasResults: False

 nctId: NCT06381505 id: STUDY02002103 briefTitle: RetracTOR/ Retractor for Image Guided Trans-Oral Surgery overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-12-31 date: 2025-12-31 date: 2024-04-24 date: 2024-04-26 name: Ryan J. Halter class: OTHER name: Dartmouth College briefSummary: This study aims to demonstrate that a polymer retractor functions the same as a standard metal retractor used during endoscopy and throat surgery. The retractor is the device that holds the mouth open so the surgeon can easily access the mouth and throat. For example, this study aims to confirm that the mouth is held open the same amount with a polymer retractor as it is with a metal retractor. Benchtop experiments have demonstrated that the metal and polymer retractor's function the same, and thus this study will use this in patients. conditions: Oral Cavity Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED measure: Comparing intraoperative surgical working volume (SWV) of a radiolucent retractor (custom device) as compared to SWV of standard-of-care metal retractors. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dartmouth-Hitchcock Medical Center city: Lebanon state: New Hampshire zip: 03756 country: United States name: Joseph Paydarfar, MD role: CONTACT phone: 603-650-8123 email: joseph.a.paydarfar@hitchcock.org lat: 43.64229 lon: -72.25176 hasResults: False

 nctId: NCT06381492 id: 2024-0057 id: A536130 type: OTHER domain: UW- Madison id: SMPH/ORTHO&REHAB/PHYS THER type: OTHER domain: UW- Madison id: Protocol Version 11/20/2023 type: OTHER domain: UW- Madison briefTitle: Quantifying Patellar Tendon Microstructure Using DTI overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2024-12 date: 2024-04-24 date: 2024-04-24 name: University of Wisconsin, Madison class: OTHER briefSummary: The goal of this observational study is to understand how diffusion tensor imaging (DTI) relates to other traditional measures and knee function. The main question it aims to answer is:

Will regions of known patellar tendon pathology present with smaller DTI scalar parameters, shorter fiber length, and lower fiber density compared to the contralateral tendon and healthy regions in the ipsilateral tendon.

Participants will:

* undergo MRI and ultrasound imaging
* perform knee function test
* complete questionnaires conditions: Patellar Tendinopathy conditions: Anterior Cruciate Ligament Reconstruction studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: MRI name: Ultrasound (US) measure: Compare scalar parameters of known patellar tendon pathology to the contralateral tendon measure: Compare DTI scalar parameters of known patellar tendon pathology to the healthy regions in the ipsilateral tendon sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Wisconsin - Madison city: Madison state: Wisconsin zip: 53705 country: United States name: Maria Flory role: CONTACT phone: 608-262-8652 email: flory@ortho.wisc.edu lat: 43.07305 lon: -89.40123 hasResults: False

 nctId: NCT06381479 id: B031 briefTitle: Exploring the Effects of Probiotics on Workplace Related Stress Symptoms overallStatus: RECRUITING date: 2024-04-19 date: 2024-12-31 date: 2025-03-31 date: 2024-04-24 date: 2024-04-29 name: National Taiwan Sport University class: OTHER name: Bened Biomedical Co., Ltd. briefSummary: There is still a lack of research to explore the interaction between high-pressure workers and probiotics to improve the intestinal microbiota, sleep, inflammation and anti-oxidation. A total of 120 subjects are expected to be recruited and divided into two groups of 60 subjects, receiving probiotics or placebo, and completing a 8-week trial period. conditions: Stress conditions: Sleep Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: probiotics name: placebo measure: Cortisol measure: Perceived Stress Scale (PSS) measure: Job Stress Scale measure: Overwork Survey measure: Insomnia Severity index (ISI) measure: The State Trait Anxiety Inventory (STAI) measure: Depression Anxiety Stress Scales (DASS-42) measure: The Quality of Life, Enjoyment, and Satisfaction Questionnaire-16, QLESQ-16 measure: VAS-GI measure: Patient Global Impression scales of Improvement rated by patient, PGI-C measure: Serotonin measure: GABA measure: Norepinephrine measure: Immunoglobulin A, IgA measure: adrenocorticotropic hormone, ACTH measure: Total Antioxidant Capacity , TAC sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Graduate Institute of Sports Science, National Taiwan Sport University status: RECRUITING city: Taoyuan zip: 33301 country: Taiwan name: Chi-Chang Huang, PI role: CONTACT phone: +88633283201 phoneExt: 2409 email: john5523@ntsu.edu.tw lat: 24.95233 lon: 121.20193 hasResults: False

 nctId: NCT06381466 id: D7250C00001 briefTitle: A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral AZD0233 Compared With Placebo in Healthy Adult Participants. overallStatus: RECRUITING date: 2024-04-01 date: 2025-03-20 date: 2025-03-20 date: 2024-04-24 date: 2024-04-24 name: AstraZeneca class: INDUSTRY name: Parexel briefSummary: The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of AZD0233 following single and multiple ascending dose (SAD and MAD) administration in healthy participants. conditions: Dilated Cardiomyopathy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 96 type: ESTIMATED name: AZD0233 name: AZD0233 Placebo measure: Number of participants with adverse events (AEs) and serious adverse events (SAEs) measure: Maximum observed plasma (peak) drug concentration (Cmax) of AZD0233 measure: Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast) of AZD0233 measure: Area under the concentration-time curve in the dose interval (AUCtau) of AZD0233 measure: Area under plasma concentration time-curve from zero to infinity (AUCinf) of AZD0233 measure: Time to reach peak or maximum observed concentration or response following drug administration (tmax) of AZD0233 measure: Terminal elimination half-life (t1/2) of AZD0233 measure: Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD0233 measure: Apparent volume of distribution at steady state following extravascular administration (Vz/F) of AZD0233 measure: Terminal rate constant (λz) of AZD0233 measure: Accumulation ratio for Cmax (Rac Cmax) of AZD0233 measure: Accumulation ratio for AUC (Rac AUC) of AZD0233 measure: Renal clearance (CLR) of AZD0233 measure: Cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)] of AZD0233 measure: Cumulative amount of unchanged drug excreted into urine (Aeinf) of AZD0233 measure: Percentage of dose excreted unchanged in urine from time t1 to t2 [Fe(t1-t2)] of AZD0233 sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Research Site status: RECRUITING city: Glendale state: California zip: 91206 country: United States lat: 34.14251 lon: -118.25508 hasResults: False

 nctId: NCT06381453 id: 23-5037 briefTitle: Belimumab in Autoimmune Hepatitis acronym: BELief overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2028-04-30 date: 2029-04-30 date: 2024-04-24 date: 2024-04-24 name: University Health Network, Toronto class: OTHER name: GlaxoSmithKline briefSummary: Background: Autoimmune hepatitis (AIH) is a rare chronic and lifelong liver disease. Untreated, disease progresses to end-stage cirrhosis and the focus of therapy is with immunosuppression. Current therapies are limited, not targeted, and associated with side effects that patients report reduce quality of life. AIH is believed to arise as a consequence of genetic \& environmental risks. Disease is characterised by impaired immunoregulation, that favours a chronic and relapsing hepatitis. As well as recognising an important role for cytotoxic T cells and regulatory T cells, it has become apparent that in AIH, as well as other related autoimmune conditions, that B-cells are important. AIH is characterised by a plasma cell rich interface hepatitis and elevated IgG concentrations. Furthermore B-cell lineages interact with regulatory T-cells. Off-label use of Rituximab, an anti-CD20 agent, has been described for patients with AIH. A number of other ways of effectively targeting B-cells in the treatment of related autoimmune diseases have also been developed, but there have been limited studies in people living with autoimmune hepatitis. Belimumab is a human monoclonal antibody that inhibits B-cell activating factor (BAFF), also known as B-lymphocyte stimulator. It is approved in the Canada to treat systemic lupus erythematosus and lupus nephritis. It has not been studied before in AIH, but off-label reports are published. In an open-label clinical trial of people living with autoimmune hepatitis, the investigator will now formally study the effect of adding Belimumab to existing standard of care, with the goal being to evaluate treatment efficacy, the ability to reduce the burden of existing therapies whilst still controlling AIH disease, and to describe the tolerability \& safety of Belimumab in people with AIH. Study Design: Open label, multi-centre, Canadian clinical trial. Patient population: Patients with autoimmune hepatitis, excluding patients with decompensated liver disease, who either have active disease despite standard of care (Group A), or who are maintained with disease remission using standard of care therapy (Group B). 48 patients will be recruited. Intervention: Weekly sub-cutaneous Belimumab. Duration: 72 weeks with interim analysis after 24 patients have been treated for 24 weeks; target recruitment 48 patients. Evaluation: Safety, Serum liver tests, quality of life, exploratory immunologic biomarkers, optional liver biopsy or fine needle liver aspirate. Primary end-point: Group A: 50% or more of subjects have an ALT\<2x ULN \& corticosteroids at a dose of \</= 5mg of Prednisone (or equivalent); Group B: 50% or more of subjects able to maintain remission (normal ALT, normal IgG) on monotherapy with Belimumab. Conclusion: Using a combination of makers of treatment efficacy and safety the investigator will test the hypothesis that Belimumab should be further formally evaluated for people living with AIH. conditions: Autoimmune Hepatitis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: Belimumab Auto-Injector [Benlysta] measure: To investigate the effect of treatment with Belimumab on AIH disease activity and corticosteroid use in the management of AIH measure: To investigate the effects of treatment with Belimumab on AIH disease activity and treatment burden measure: To measure the effects of treatment with Belimumab on AIH disease activity and treatment burden measure: To see the effects of treatment with Belimumab on AIH disease activity and treatment burden measure: To measure the effects of Belimumab on markers of AIH disease activity measure: To evaluate the effects of Belimumab on markers of AIH disease activity measure: To outline the effects of Belimumab on Patient Reported Outcomes (PRO) measure: To assess the effects of Belimumab on Patient Reported Outcomes (PRO) measure: To measure the effects of Belimumab on Patient Reported Outcomes (PRO) measure: To evaluate the safety of Belimumab in patients with autoimmune hepatitis measure: To assess the safety of Belimumab in patients with autoimmune hepatitis measure: Safety and Tolerability measure: To report the safety of Belimumab in patients with autoimmune hepatitis sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06381440 id: PROGR-EX_MNESYS briefTitle: Traditional Versus Progressive Robot-assisted Gait Training in People With Multiple Sclerosis and Severe Gait Disability acronym: PROGR-EX overallStatus: RECRUITING date: 2023-11-15 date: 2024-11-30 date: 2024-11-30 date: 2024-04-24 date: 2024-04-24 name: University Hospital of Ferrara class: OTHER name: Universita di Verona name: Università degli Studi di Ferrara briefSummary: Multiple sclerosis (MS) is a demyelinating neurodegenerative disease. Qualitative alterations in walking function in MS people involve 75% of subjects with MS and are determined by reduced coordination, mobility, balance, and increased risk of falling. Robot assisted gait training (RAGT) devices seem effective in MS patients with severe motor disabilities, failing to show significant superiority when compared to intensive overground gait rehabilitation (OGT). This study aims to evaluate the effects of a low-intensity RAGT at progressively increasing intensity compared to conventional RAGT and OGT. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Control Trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Lokomat device (Hocoma AG, Volketswil, Switzerland). name: Conventional walking training measure: Walking function measure: Mobility measure: Walking endurance measure: Balance measure: Spasticity measure: Perceived quality of life measure: Perceived walking ability measure: Fatigue measure: Anxiety measure: Depression measure: Kinesiophobia measure: Adaptation to medical condition measure: Coping strategies measure: Muscle oxygen consumption measure: Hemodynamic cortical activation measure: Electrical brain activity measure: miRNA expression measure: Acceptability of robot intervention sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Neuroscience and Rehabilitation, University Hospital of Ferrara status: RECRUITING city: Ferrara state: Emilia Romagna zip: 44124 country: Italy name: Sofia Straudi, MD, PhD role: CONTACT phone: 0532236185 email: s.straudi@ospfe.it name: Sofia Straudi, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Fabio Manfredini, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Nicola Lamberti, PhD role: SUB_INVESTIGATOR name: Andrea Baroni, PhD role: SUB_INVESTIGATOR name: Giulia Fregna, MSc role: SUB_INVESTIGATOR name: Michela Rimondini, PhD role: SUB_INVESTIGATOR name: Marialuisa Gandolfi, MD, PhD role: SUB_INVESTIGATOR name: Luigi Zerbinati, MD role: SUB_INVESTIGATOR lat: 44.83804 lon: 11.62057 hasResults: False

 nctId: NCT06381427 id: 01NVF22109 briefTitle: Perioperative Interdisciplinary, Intersectoral Process Optimization in Heart Failure acronym: PeriOP-CARE HF overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-08-31 date: 2027-03-01 date: 2024-04-24 date: 2024-04-24 name: University of Giessen class: OTHER name: Deutsche Luft und Raumfahrt briefSummary: Chronic heart failure affects up to three million people in Germany, with prevalence increasing with age. It is a leading cause of cardiovascular disease-related deaths. Patients with heart failure undergoing non-cardiac surgery face higher risks of complications and death compared to those with coronary artery disease. Despite guidelines recommending comprehensive preoperative evaluation, there is no systematic risk assessment structure in place, leading to inadequate perioperative care. This study aims to evaluate a multidisciplinary approach for high-risk patients aged 65 and above, regardless of prior heart failure diagnosis, to mitigate postoperative complications. The investigators measure the NTpro BNP before surgery and include patients with NTproBNP\> 450 in this study and randomize them either to the standard care group or the intervention group.The hypothesis is that standardized risk screening and multidimensional care (Intervention group) can reduce complications in these patients undergoing non-cardiac surgery. conditions: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 1057 type: ESTIMATED name: Interdisciplinary decision-making for perioperative care measure: combined primary endpoint at 90 days post-operation : re-hospitalization,AKI, bacterial infection and cardiac decompensation measure: Incidence of acute kidney injury measure: Incidence of any, treatable, suspected, or confirmed bacterial infection measure: Incidence of cardiac decompensation measure: Incidence of re-hospitalization measure: Mortality measure: Incidence of myocardial infarction (STEMI, NSTEMI) measure: Incidence of Myocardial Injury after Non-Cardiac Surgery (MINS) measure: Quality of life assessed using PHQ-9 measure: Quality of life assessed using GAD-7 measure: Utilization of services and costs sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Justus Liebig University Giessen, University Hospital Giessen and Marburg city: Gießen zip: 35390 country: Germany name: Michael Sander, PhD role: CONTACT phone: +4964198544401 name: Birgit Aßmus, PHD role: CONTACT lat: 50.58727 lon: 8.67554 hasResults: False

 nctId: NCT06381414 id: ChildhoodEarlyOralAging briefTitle: Childhood Early Oral Aging Syndrome: Prevalence, Etiological Factors, and Consequences on Occlusion overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-31 date: 2024-12-20 date: 2024-04-24 date: 2024-04-24 name: University of Nove de Julho class: OTHER briefSummary: The Early Oral Aging Syndrome (EOAS) is a broad concept concerning changes in oral health caused by systemic diseases of different origins, which are related to the current lifestyle in the pediatric population. Enamel defects associated with intrinsic and extrinsic factors promote the acceleration of dental structure loss in an early manner, causing impairment of function, aesthetics, and quality of life. In this context, this study aims to identify the prevalence of early childhood tooth wear and its severity using the Early Childhood Oral Aging Syndrome (EOAS) index as a diagnostic and epidemiological survey instrument, considering current alterations found in the pediatric population and verifying possible factors associated with each severity level. Participants aged 3 to 6 years old, enrolled in the pediatric dentistry clinic of the University Nove de Julho, will be selected. Children with imperfect amelogenesis and dentinogenesis, genetic syndromes, and undergoing orthodontic treatment will be excluded from the research. A questionnaire on general health, sleep quality, nutrition, hygiene habits, and parafunctional habits will be administered. Subsequently, a clinical examination will be conducted using the new Early Childhood Oral Aging Syndrome (EOAS) index with scores ranging from 0 to 3 to assess dental wear and dental management, and scores I to III that should be used concomitantly in cases of enamel defects presence, in addition to measuring the Vertical Dimension of Occlusion (VDO). EOAS scores will be computed and statistically analyzed for deciduous dentition with a significance level of P\<0.05. conditions: Aging studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 183 type: ESTIMATED name: Observation measure: Assessment of Tooth Wear and Dental Management measure: Presence of Enamel Defects measure: Vertical Dimension of Occlusion sex: ALL minimumAge: 3 Years maximumAge: 6 Years stdAges: CHILD facility: Nove de Julho University city: São Paulo state: SP zip: 03155-000 country: Brazil lat: -23.5475 lon: -46.63611 hasResults: False

 nctId: NCT06381401 id: MS-492-2023 briefTitle: Bupivacaine 0.125% Versus Bupivacaine 0.25% in Superficial Cervical Plexus Block on Operative Field Visibility for Adults Undergoing Tympanomastoid Surgeries overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2024-06-28 date: 2024-07-05 date: 2024-04-24 date: 2024-04-24 name: Cairo University class: OTHER briefSummary: Bleeding is one of the most common complications in tympanomastoid surgery that could prolong the time of operation and also might lead to morbidity. Pain is also one of the most annoying complications of tympanomastoid surgeries. Thus, adequate surgical field visualization is utmost important. A bloodless field allows optimal exposure and identification of vital neurovascular structures. Even small bleeding, inconsequential for the patient's volume status, can create great technical difficulty in the confined space of the tympan, leading to prolonged surgery, incomplete procedures, and increased complications.

To decrease bleeding, different interventions have been proposed, including reverse Trendelenburg position, the application of topical vasoconstrictors, regional anesthesia, laryngeal mask airways, different ventilation strategies, and - most importantly - controlled systemic hypotension, with target mean arterial pressures (MAP) generally between 60 and 70 mmHg. However, induced hypotension can lead to cerebral, renal and mesenteric hypoperfusion, organ damage, and other serious complications.

The use of regional nerve blocks as an alternative to hypotensive anesthesia has gained popularity in recent years. The superficial cervical plexus block (SCPB) provides effective analgesia and reduces sympathetic activity, resulting in reduced bleeding and improved surgical conditions. The superficial cervical plexus (SCP) provides sensory innervation to the ear and surrounding structures, reducing pain perception during and after surgery.

To our knowledge, this is the first randomized controlled clinical trial investigating the effect of combined general anesthesia with SCPB using 0.125% versus 0.25% bupivacaine during tympanomastoid surgery.

This study aims to compare the efficacy of two different concentrations of bupivacaine 0.125% \& 0.25% in Superficial Cervical Plexus Block in patients undergoing tympanomastoid surgery on operative field visualization, intraoperative hemodynamic stability, and postoperative analgesia.

We hypothesize that bupivacaine 0.125% would be non-inferior to bupivacaine 0.25% in achieving optimal surgical field visualization, hemodynamic stability, surgeon satisfaction and postoperative analgesia.

This prospective randomized controlled double-blinded study will be carried out on 60 patients between 21 to 70 years, with ASA I-II and undergoing tympanomastoid surgery. They were equally divided into two groups: Group A: Patients received SCPB using 0.25% bupivacaine (5ml of bupivacaine 0.5% + 5ml normal saline). Group B: Patients received SCPB using 0.125% bupivacaine (2.5ml of bupivacaine 0.5% + 7.5ml normal saline). conditions: Surgical Field Visualization, Acute Postoperative Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: bupivacaine 0.25% name: bupivacaine 0.125% measure: The total consumption of IV glyceryl trinitrate (GTN) measure: Fentanyl consumption measure: Postoperative pain measure: Postoperative hospital stay sex: ALL minimumAge: 21 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06381388 id: NL86587.041.24 briefTitle: Interaction Between the Brain Hemispheres - Key to Motor Recovery After Stroke acronym: InterAct overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-12-31 date: 2028-06-30 date: 2024-04-24 date: 2024-04-24 name: Jord Vink class: OTHER briefSummary: Rationale: Acute stroke leaves many patients with functional deficits, of which upper extremity motor impairment is one of the most disabling. Evidence from imaging and electrophysiological studies converge on the idea that impaired motor function after stroke is associated with disrupted network activity in the brain. Non-invasive brain stimulation methods, like transcranial magnetic stimulation (TMS), can be used to restore disrupted network activity and have been shown to successfully facilitate recovery of motor function in patients with stroke. Application of continuous theta burst stimulation (cTBS), an inhibitory form of TMS, to the contralesional motor cortex has been shown to improve the recovery of motor function in patients with stroke. However, responsiveness to this treatment varies considerably between stroke patients and the mechanisms through which contralesional cTBS facilitates recovery of motor function remain unclear.

Objective: To determine if contralesional cTBS normalizes interhemispheric inhibition from the contralesional to ipsilesional primary motor cortex stroke patients with motor impairments. Age-matched healthy persons will serve as controls.

Study design: A prospective, open-label within-subject intervention study

Study population: 40 patients with first-ever ischemic stroke in one hemisphere and a unilateral paresis of the upper extremity, and 40 age-matched controls.

Main endpoints: Primary endpoint: Interhemispheric inhibition from the contralesional to ipsilesional primary motor cortex. Secondary endpoints: contralesional intracortical inhibition; effect of contralesional TMS interference on finger tapping frequency. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: cTBS measure: Interhemispheric inhibition (IHI) measure: Ipsilesional resting motor threshold (RMT) measure: Contralesional resting motor threshold (RMT) measure: TMS interference measure: Intracortical inhibition (ICI) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: De Hoogstraat Revalidatie city: Utrecht country: Netherlands name: Anne Visser-Meily, MD, PhD role: CONTACT lat: 52.09083 lon: 5.12222 hasResults: False

 nctId: NCT06381375 id: 24-2-2024 briefTitle: Drug-drug Interactions With Anti-tuberculous Drugs overallStatus: RECRUITING date: 2024-04-30 date: 2024-12-01 date: 2025-02-15 date: 2024-04-24 date: 2024-04-24 name: Cairo University class: OTHER briefSummary: This study aims to assess the prevalence and the outcome of prescribing drugs known to have major drug-drug interactions with anti-tuberculous drugs among Kasr Alainy tuberculous patients. conditions: Drug-drug Interaction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: Anti Tuberculosis Drug measure: Estimate the prevalence of prescribing drugs known to have major drug-drug interaction(s) with anti-tuberculous drugs among Kasr Alainy tuberculous patients measure: 2. Assess the outcome of prescribing drugs known to have major drug-drug interaction(s) with anti-tuberculous drugs among Kasr Alainy tuberculous patients (response to treatment and the prevalence of life-threatening events). sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Omnia Azmy Nabeh status: RECRUITING city: Cairo zip: 11562 country: Egypt name: Omnia Azmy Nabeh, MD role: CONTACT phone: 01066969673 email: omnia.azmy@kasralainy.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06381362 id: IGOMIPS briefTitle: Italian Registry of Minimally Invasive Pancreatic Surgery acronym: IGOMIPS overallStatus: RECRUITING date: 2019-02-28 date: 2029-02-28 date: 2029-02-28 date: 2024-04-24 date: 2024-04-24 name: Associazione Italiana per lo Studio del Pancreas class: OTHER briefSummary: Assess the prevalence of minimally invasive pancreatic surgery in the country and its outcomes conditions: Pancreatic Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2300 type: ESTIMATED name: Minimally invasive pancreatic surgery measure: Postoperative short-term outcomes measure: Long-term oncological outcomes measure: Rate of cases that after a minimally invasive approach had to be converted to and open approach measure: Surgeon learning curve measure: Surgeon learning curve measure: Surgeon learning curve measure: Surgeon learning curve sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Giovanni Capretti status: RECRUITING city: Milan country: Italy name: Giovanni Capretti, Dr. role: CONTACT phone: +390282247646 email: giovanni.capretti@hunimed.eu name: Alessandro Zerbi, Prof. role: PRINCIPAL_INVESTIGATOR name: Giovanni Capretti, Dr. role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06381349 id: GPOEM-GEMS briefTitle: Predicting Outcomes of GPOEM Using Gastric Electrical Mapping acronym: GPOEM-GEMS overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-06-01 date: 2024-04-24 date: 2024-04-24 name: Chris Varghese class: OTHER briefSummary: Gastric peroral endoscopic myotomy (GPOEM) is a minimally-invasive procedure that involves dividing the pylorus, to enhance gastric emptying in gastroparesis patients. This is a single-arm, multi-centre, prospective observational study to determine the clinical utility of Gastric Alimetry in predicting GPOEM treatment outcomes. The investigators further aim to develop a clinical decision rule to inform patient selection. Gastric Alimetry will be conducted \<1 month prior to GPOEM. All subjects will then be followed up for 12 months. conditions: Gastroparesis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Gastric Alimetry test measure: Gastroparesis Cardinal Symptom Index (GCSI) measure: Patient Assessment of Upper GastroIntestinal Disorders-Quality of Life (PAGI-QoL) measure: EQ-5D scores measure: Patient assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM) measure: Patient Health Questionnaire - 8 (PHQ-8) measure: Generalized Anxiety Disorder 7-item (GAD-7) measure: Perceived Stress Scale 4 (PSS-4) measure: Brief Illness Perception Questionnaire-Revised measure: Alimetry® Gut-Brain Wellbeing (AGBW) measure: Work Productivity and Activity Impairment (WPAI) measure: Change in Gastric Alimetry Phenotype sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06381336 id: TRAKSILVER2022 briefTitle: A Digital Home-Based Physiotherapy Program for Active Aging acronym: TRAK overallStatus: COMPLETED date: 2022-03-23 date: 2022-11-07 date: 2022-11-07 date: 2024-04-24 date: 2024-04-25 name: Trak Health Solutions S.L. class: INDUSTRY name: Basque Health Service name: University of the Basque Country (UPV/EHU) briefSummary: This clinical trial will aim to understand the effects of the TRAK-SILVER digital platform on pre-frail and older adults living at home, assessing its impact on physical activity level, emotional variables, and overall quality of life. Participant satisfaction with the digital treatment will also be evaluated.

This research will provide insight into the utility and acceptance of the digital platform as a personalised and accessible digital physiotherapy program for this population, advancing understanding in the field.

The participants will undergo a 3-month physiotherapy program using the TRAK-SILVER platform or a paper guide based on their assigned group. Additionally, weekly uploads of health-promoting audiovisual content will enhance the intervention's holistic approach to improving older adults' well-being and functional capacity. conditions: Frail Elderly Syndrome conditions: Older Adults studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized two-group design with pretest-posttest assessment was used to analyse the effectiveness of the TRAK-SILVER application. Seventy-two adults aged 65 and above were stratified by gender and physical functioning capacity (SPBB) and then randomly assigned to either the experimental (EG) or control group (CG). EG received the TRAK-SILVER platform as a treatment methodology. The CG did not have access to the platform and was instructed to continue with the standard care program through exercise sheets. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 72 type: ACTUAL name: TRAK-SILVER platform measure: Short Physical Performance Battery (SPPB measure: Gait Speed measure: Timed Up and Go Test measure: 6-minute walk test (6MWT) measure: Berg Balance Scale measure: Number of steps count measure: Geriatric Depression Scale-15 (GDS) measure: De Jong Gierveld Loneliness Scale (JGLS) measure: Quality of life (QoL) questionnaire measure: Client Satisfaction Questionnaire (CSQ) sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Social Center of Orio (Zahartzaroa) city: Orio state: Basque Country zip: 20810 country: Spain lat: 43.2787 lon: -2.12537 hasResults: False

 nctId: NCT06381323 id: PA2024 briefTitle: The Clinical Efficacy and Safety of Finerenone in the Treatment of Primary Aldosteronism overallStatus: RECRUITING date: 2024-03-01 date: 2027-03-01 date: 2027-04-01 date: 2024-04-24 date: 2024-04-24 name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School class: OTHER briefSummary: The purpose of our research is to clarify the therapeutic efficacy and safety of Finerenone in patients with Primary Aldosteronism and explore the effective clinical predictive indicators of Finerenone in the treatment of Primary Aldosteronism. conditions: Primary Aldosteronism conditions: Finerenone conditions: Mineralocorticoid Receptor Antagonist studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 55 type: ESTIMATED name: Finerenone measure: 24h systolic BP drop value measure: The change of diastolic BP from the baseline level after Finerenone treatment measure: Hypertension remission rate measure: Change of serum potassium level measure: Change of plasma renin activity measure: Change of ARR measure: Change of UACR measure: Change of eGFR measure: Incidence of Treatment-Adverse Events as assessed by gynaecomastia, mastodynia, menstrual abnormalities, impotence, hyperkalemia and other adverse events. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Endocrinology, Drum Tower Hospital affiliated to Nanjing University Medical School status: RECRUITING city: Nanjing state: Jiangsu zip: 210008 country: China name: Dalong Zhu, MD,PhD role: CONTACT phone: 86-25-83-105302 email: zhudalong@nju.edu.cn name: Ping Li, MD,PhD role: CONTACT phone: 86-25-83-105302 email: li78321@yeah.net name: Dalong Zhu, MD,PhD role: PRINCIPAL_INVESTIGATOR name: Ping Li, MD,PhD role: SUB_INVESTIGATOR lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06381310 id: 202310077DINB briefTitle: Ultrasound-guided Cannulation of Difficult Hemodialysis Arteriovenous Access overallStatus: RECRUITING date: 2024-02-26 date: 2024-10-30 date: 2024-10-30 date: 2024-04-24 date: 2024-04-24 name: National Taiwan University Hospital class: OTHER name: National Taiwan University Hospital Bei-Hu Branch briefSummary: Patients with ESRD are able to maintain life by undergoing renal replacement therapy, including hemodialysis (HD), peritoneal dialysis (PD) or kidney transplantation. HD continues to be the primary option. Arteriovenous fistula (AVF) and arteriovenous graft (AVG) are the common access sites for hemodialysis (HD) patients. AVF is the best access for dialysis , which is known as the lifeline of hemodialysis patients, but requires 6 to 8 weeks to maturate. Long-term use of an AVF for dialysis requires the ability of the dialysis staff to cannulate it successfully with large-bore needles thrice weekly. With increasing AVF prevalence as well as aging and more obese populations in the developed world, increasing numbers of difficult-to-cannulate AVFs are being encountered in practice.

Traditionally, after maturation, cannulation of new AVF/AVG was performed by trained renal nurses through physical examination, namely listening to bruits and feeling for thrills to guide needle placement, known as "blind" cannulatio. However, physical examination is not reliable for first and difficult access cannulation (e.g., small or partial stenosis, deep-seated AVF/AVG, presence of clots, after multiple failed attempts with hematoma /swelling, and/or immature access with small vessel caliber), rendered higher rate of cannulation failure and lower AVF and AVG survival. Unfortunately, cannulation failure result in access damage, vessel intimal lining damage leading to stenosis, thrombosis, or aneurysm formation contributing to AVF failure, treatment delay and increased requirement for central venous access devices (CVAD). Patients with early AVF failure have much higher mortality risk, particularly if they are older and female. Van Loon et al. revealed that up to 90% of the first cannulation had complications (i.e., infiltration including hematoma formation and missed cannulation). With a high rate of AVF maturation failure (38-60%) in general, cannulation failure may be avoidable if a more in-depth assessment was done before the attempt.

Ultrasound (US) guided cannulation effective in identifying access location and patency. Roshan et al. reported a case study on bedside ultrasonography for AVF cannulation. The study showed decreased cannulation failure, vessel wall damage, thrombosis, and hematoma formation risks also reduced missed cannulation and increased staff confidence in performing cannulation.

Therefore, this study aims to explore the effects of ultrasound technology on arteriovenous access successful cannulation for patients with end-stage kidney disease to provide reliable research integration evidence as the basis for future clinical care. conditions: Successful Cannulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: asus-handheld-ultrasound LU710L measure: cannulation success rate measure: cannulation satisfaction sex: ALL minimumAge: 20 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Taiwan University Hospital Bei-Hu Branch status: RECRUITING city: Taipei City country: Taiwan name: Tsuei-Wun Chang role: CONTACT phone: 886-23717101 phoneExt: 218501 lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06381297 id: OndokusMU id: Ondokuz Mayıs University type: REGISTRY domain: Clinical research ethics committee briefTitle: Speech in Noise Discrimination Skills in Multiple Sclerosis Patients. overallStatus: COMPLETED date: 2020-10-09 date: 2023-03-23 date: 2023-04-23 date: 2024-04-24 date: 2024-04-24 name: Asuman Kucukoner class: OTHER briefSummary: The aim of this clinical trial was to determine the effect of multiple sclerosis on speech reception and discrimination in noise and to compare the effects on the medial olivocochlear reflex, which is thought to affect speech intelligibility in noise, with a control group.

The main questions it aims to answer are:

Does MS disease affect the ability to discriminate speech in noise? Does MS affect contralateral suppression results assessing medial olivocochlear function? Is there a correlation between the ability to discriminate speech in noise and contralateral suppression skills of MS patients? Data from MS patients and healthy participants will be compared. Thirty relapsing remitting MS patients and 30 healthy participants admitted to the clinic will be evaluated. conditions: Multiple Sclerosis-Relapsing-Remitting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Multiple sclerosis patient group and healthy control group. primaryPurpose: DIAGNOSTIC masking: NONE count: 60 type: ACTUAL name: Hearing test name: Speech in noise discrimination test name: Montreal Cognitive Assessment Scale name: Symbol Number Modalities Test (SDMT) measure: Pure tone Audiometry Test measure: Speech Audiometry measure: Speech Discrimination in Noise Test measure: Otoacoustic Emission Test measure: Contralateral Suppression Test measure: Montreal Cognitive Assessment Scale measure: Symbol Digit Modalities Test sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Ondokuz Mayıs University city: Samsun zip: 55300 country: Turkey lat: 41.27976 lon: 36.3361 hasResults: False

 nctId: NCT06381284 id: MG-001 briefTitle: Feasibility of Engaging and Capturing Undiagnosed Myasthenia Gravis Participants Through a Social Media Campaign Paired With a Self-moderated Assessment overallStatus: RECRUITING date: 2024-03-28 date: 2024-05-27 date: 2025-05-27 date: 2024-04-24 date: 2024-04-26 name: ZS Associates class: INDUSTRY name: University of California, San Francisco briefSummary: This is a fully remote, site-less, prospective, observational study enrolling adults in the United States (excluding U.S. territories) with undiagnosed neuromuscular symptoms. The main study objective is to evaluate the feasibility of a social media recruitment campaign tied to a participant reported symptom survey and self-administered physical assessment tool to influence undiagnosed participants to seek care for suspected Myasthenia Gravis (MG). conditions: Myasthenia Gravis conditions: Neuromuscular Manifestations conditions: Neuromuscular Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Social media recruitment name: Self-Assessment name: Follow-up measure: Social media recruitment feasibility measure: MG Exercise Assessment Tool validity measure: Time to diagnosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ZS Associates status: RECRUITING city: Evanston state: Illinois zip: 60201 country: United States name: Ananda V Pandurangadu, MD role: CONTACT phone: 1-847-448-1001 email: support@unearthrootcause.com name: Ananda Vishnu Pandurangadu, MD role: PRINCIPAL_INVESTIGATOR name: Pritikanta Paul, MD role: SUB_INVESTIGATOR lat: 42.04114 lon: -87.69006 hasResults: False

 nctId: NCT06381271 id: TRUST TAVR Registry briefTitle: Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation overallStatus: RECRUITING date: 2018-10-30 date: 2034-10 date: 2034-10 date: 2024-04-24 date: 2024-04-24 name: Xijing Hospital class: OTHER briefSummary: The purpose of this multicenter, prospective and observational registry is to evaluate the safety and efficacy of TAVR for treatment of pure severe aortic valve regurgitation. Baseline characteristics, procedural and clinical data will be collected conditions: Aortic Valve Regurgitation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Transcatheter aortic valve replacement measure: Combined clinical efficacy outcomes measure: Combined early safety and clinical efficacy outcomes measure: Rate of technical success measure: Rate of device success measure: Combined clinical efficacy outcomes measure: Rate of all-cause mortality measure: Valve-related long-term clinical efficacy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xijing Hospital status: RECRUITING city: Xi'an state: Shannxi zip: 710032 country: China name: Rutao Wang, M.D., Ph.D. role: CONTACT phone: +86-15091095796 email: rutaowang@qq.com name: Ruining Zhang, BSc role: CONTACT phone: +86-15802990370 email: ruining-zhang@qq.com name: Ling Tao, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 34.25833 lon: 108.92861 hasResults: False

 nctId: NCT06381258 id: SDF briefTitle: Fetal Cardiac Function overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2024-11 date: 2024-04-24 date: 2024-04-24 name: Assiut University class: OTHER briefSummary: The aim of our study is to evaluate the effect of PE and FGR on fetal cardiac function. Pregnancies with preeclampsia and FGR, and preeclampsia with normal fetal growth are evaluated by echocardiography and compared with uncomplicated pregnancies. conditions: Fetal Growth Retardation studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 32 type: ESTIMATED name: Ultrasound measure: Cardiac systolic function measure: Cardiac diastolic function sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06381245 id: KB/265/2023 briefTitle: First-time Ablation of Atrial Fibrillation Registry acronym: DIPE overallStatus: RECRUITING date: 2023-12-01 date: 2026-03-31 date: 2026-03-31 date: 2024-04-24 date: 2024-04-24 name: Medical University of Warsaw class: OTHER briefSummary: Atrial fibrillation (AF) is a prevalent cardiac arrhythmia affecting millions globally, with projections indicating a doubling of cases by 2050. AF is linked to heightened cardiovascular risks like stroke and increased healthcare costs. Ablation, targeting the arrhythmia substrate, is a method to manage AF, yet recurrence rates remain high (20-45% in the first year). Studies highlight the impact of comorbidities, AF characteristics, ablation techniques, and myocardial remodeling markers on AF progression and ablation efficacy. However, there's no definitive guidance on selecting these factors for predicting treatment success.

The aim of this study is to investigate predictors of successful AF ablation in the following areas: (a) clinical factors, (b) electrophysiological, (c) electrocardiographic, (d) ultrasound, (e) cardiac anatomy, (f) biomarkers. conditions: Atrial Fibrillation conditions: Arrhythmia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: PPG-based remote heart rhythm/rate monitoring name: ECG-based remote heart rhythm/rate monitoring name: Transthoracic and transesophageal echocardiography examination name: Liver ultrasound examination name: Rotational angiography with three-dimensional reconstruction name: Blood-derived biomarker analysis name: Mobile health-based spirometry measure: Late AF recurrence measure: Late recurrence of AF or atrial tachycardia or atrial flutter measure: Early recurrence of AF measure: Early recurrence of AF or atrial tachycardia or atrial flutter measure: Time to AF recurrence and the impact of early recurrence on late AF recurrence measure: The superiority of monitoring using mobile health devices over traditional heart rhythm monitoring measure: Progression or regression of AF measure: Modification of treatment, including antiarrhythmic treatment measure: AF-related quality of life and symptoms measure: Periprocedural complications measure: Heart rate variability and rate measure: Blood biomarker levels measure: Ablation procedure parameters measure: Cardiac remodelling sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Warsaw status: RECRUITING city: Warsaw country: Poland name: Monika Gawałko, MD, PhD role: CONTACT phone: 22 599 19 58 phoneExt: +48 email: monika.gawalko@wum.edu.pl name: Monika Gawałko, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Paweł Balsam, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Piotr Lodziński, MD, PhD role: SUB_INVESTIGATOR name: Michał Marchel, MD, PhD role: SUB_INVESTIGATOR name: Michał Peller, MD, PhD role: SUB_INVESTIGATOR name: Bartosz Krzowski, MD, PhD role: SUB_INVESTIGATOR name: Cezary Maciejewski, MD, PhD role: SUB_INVESTIGATOR name: Maria Boszko, MD role: SUB_INVESTIGATOR name: Michał Gawlik, MD role: SUB_INVESTIGATOR name: Karolina Mitrzak, MD role: SUB_INVESTIGATOR name: Alicja Skrobucha, MD role: SUB_INVESTIGATOR name: Mateusz Wawrzeńczyk, MD role: SUB_INVESTIGATOR lat: 52.22977 lon: 21.01178 hasResults: False

 nctId: NCT06381232 id: VIOME-001 briefTitle: Collection and Analyses of Physiological, Physical, and Molecular Data From a Diverse Population overallStatus: RECRUITING date: 2018-07-23 date: 2028-07-23 date: 2028-07-23 date: 2024-04-24 date: 2024-04-24 name: Viome class: INDUSTRY briefSummary: The purpose of the study is to collect and analyze physiological, physical, and molecular data from a diverse population to increase our understanding of how such parameters are associated with health and disease. conditions: General Health conditions: Wellness studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 20000 type: ESTIMATED name: No Intervention measure: Molecular Determinants of Health and Disease sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Viome Life Sciences status: RECRUITING city: Bothell state: Washington zip: 98011 country: United States name: Momchilo Vuyisich role: CONTACT phone: 425-300-6933 email: studies@viome.com lat: 47.76232 lon: -122.2054 hasResults: False

 nctId: NCT06381219 id: s67001 briefTitle: Pediatric Eosinophilic Esophagitis (pedEoE): Effect of Allergen Heat Denaturation on EoE Remission: a Pilot Trial overallStatus: RECRUITING date: 2023-12-19 date: 2026-12-31 date: 2028-12-31 date: 2024-04-24 date: 2024-04-24 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: The objective of the study is to study whether the introduction of heated food products (more specifically heated hen's egg and/or cow's milk) in children with EoE would be possible without re-occurrence of the eosinophilic inflammation, while the intake of less heated products might cause disease recidive. Moreover, we would like to study whether the gradual re-introduction of less heated products after the most heated form is tolerated, could lead to tolerance induction in EoE. conditions: Eosinophilic Esophagitis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 36 type: ESTIMATED name: Implementation of cow's milk in decreasingly heated forms name: Implementation of hen's egg in decreasingly heated forms measure: Maintained remission of EoE measure: Maintained remission only in step 1 of the diet measure: Association of remission with circulating IgG4 levels measure: Association of remission with IgG4 levels on biopsy measure: In vitro B cell test to mimic B cell activation after stimulation measure: Correlation between QoL and remission measure: Associated atopy measure: Associated food allergies sex: ALL minimumAge: 12 Months maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: UZ Leuven Gasthuisberg status: RECRUITING city: Leuven state: Vlaams-Brabant zip: 3000 country: Belgium name: Dominique Bullens, Prof. Dr. role: CONTACT phone: 0032 16 34 38 01 email: dominique.bullens@kuleuven.be name: Marleen Jannis role: CONTACT phone: 0032 16 34 38 01 email: marleen.jannis@uzleuven.be lat: 50.87959 lon: 4.70093 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-07-05 uploadDate: 2023-10-25T10:35 filename: Prot_000.pdf size: 696874 hasResults: False

 nctId: NCT06381206 id: No 475 briefTitle: Silodosin in Management of Lower Ureteral Stones overallStatus: COMPLETED date: 2022-10-20 date: 2023-10-20 date: 2023-10-25 date: 2024-04-24 date: 2024-04-24 name: Syrian Private University class: OTHER briefSummary: This research aims to study the effectiveness of silodosin in the management of lower ureter stones larger than 6 mm in diameter in terms of affected ureter (right or left), the size of the stone, the degree of hydronephrosis, the rate of stone expulsion(day), whether the stone was completely expelled or not, and the side effects of silodosin. conditions: Stone, Kidney studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ACTUAL name: Silodosin measure: Stone expulsion (yes) measure: Stone expulsion (no) sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Damascus university city: Damascus zip: 1 country: Syrian Arab Republic lat: 33.5102 lon: 36.29128 hasResults: False

 nctId: NCT06381193 id: ESTR-01-2022 briefTitle: Study for the Management of Chronic and Functional Constipation Through the Intake of Probiotics and Prebiotics overallStatus: COMPLETED date: 2023-03-03 date: 2023-07-10 date: 2023-07-10 date: 2024-04-24 date: 2024-04-24 name: Centros de Investigación de Nutrición y Salud class: OTHER name: Nutribiotica briefSummary: The goal of this clinical trial is to learn if supplementation with prebiotics and/or probiotics can lead to an improvement in symptoms of patients with functional constipation. The main objectives are:

* To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation, after 8 weeks.
* To evaluate the stool consistency after 8 weeks (Bristol scale).
* To evaluate the quality of life scale score for patients with Constipation (CVE20 and GSRS scales), after 8 weeks.

Participants are randomized into the following groups:

* Group A: 20 assigned to probiotic + placebo
* Group B: 20 assigned to prebiotic + placebo
* Group C: 20 assigned to probiotic + prebiotic
* Group D: 20 assigned to the placebo + placebo

Participants took 4 units of product per day (2 of each assigned product) for 2 months. conditions: Functional Constipation 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: ACTUAL name: Probiotic name: Prebiotic name: Probiotic + Prebiotic name: Placebo measure: 1. To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation. measure: To evaluate the stool consistency (Bristol scale). measure: To evaluate the quality of life scale score for patients with constipation (Quality of life questionnaire for patients with constipation, CVE-20) measure: To evaluate the quality of life scale score for patients with constipation (Gastrointestinal Symptom Assessment Scale, GSRS scale). sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centros de Investigación en Nutrición y Salud SL. (Clínica CINUSA) city: Madrid zip: 28036 country: Spain lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06381180 id: Warrior CARE: CBH briefTitle: Warrior CARE: Cannabis Behavioral Health acronym: CBH overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2030-12-31 date: 2030-12-31 date: 2024-04-24 date: 2024-04-24 name: Wayne State University class: OTHER briefSummary: This study is a randomized, controlled clinical trial to examine the therapeutic potential of cannabinoids for treating veterans with PTSD and suicidal ideation. conditions: Post Traumatic Stress Disorder conditions: Cannabis Use conditions: Suicide conditions: Veterans conditions: Marijuana studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 500 type: ESTIMATED name: Tetrahydrocannabinol name: Cannabidiol name: Placebo measure: Assessing change in PTSD diagnosis and its symptom severity from pre-treatment to post-treatment using the CAPS-5 assessment. measure: Assessing change in PTSD diagnosis and its symptom severity throughout the study using the PCL-5 assessment measure: Assessing Suicidality over time using the C-SSRS assessment. measure: Assessing Suicidality throughout the study using the SBQ-R assessment. measure: Assessing mood and anxiety symptoms throughout the study using the BDI-II and STAI-Y Questionnaires. measure: Assess emotional state pre- and post-treatment using the PANAS questionnaire. measure: Assess feelings of loneliness pre- and post-treatment using UCLA's 3-ILS assessment. measure: Assess childhood and lifetime trauma pre- and post-treatment using the ACE, CTQ, and PCTI questionnaires. measure: Assess dissociative symptoms pre- and post-treatment using the MDI and DSS assessments. measure: Assess drug effects, liking, and symptoms after cannabis administration using the SCERF and SES visual analog scales. measure: Assess ethnic-racial discrimination pre- and post-treatment using the CERIS-A and TSDS Questionnaires. measure: Assess demographics using a self-report assessment measure: Assess toxicant exposure commonly experienced during war using the KGWIC and BPE assessments. measure: Assess smoking habits and history using the FTND assessment measure: Assess general health and history pre- and post-treatment using the SF-36 assessment. measure: Assess healthcare utilization throughout the study. measure: Assess pain pre- and post-treatment using the BPI assessment. measure: Assess sleepiness pre- and post-treatment using the ESS questionnaire. measure: Assess overall quality of life pre- and post-treatment using the QOL questionnaire. measure: Assess substance use throughout the study using the TLFB assessment. measure: Assess neurocognitive and executive function pre- and post-treatment using the WCST, WMS, CVLT, HMDD, WCS, IGT tasks measure: Assess physiological measures throughout the study as a safety check measure: Assess biological samples for genetic markers associated with the endocannabinoid system and other biomarkers (e.g., cortisol) and measure THC and CBD. sex: ALL minimumAge: 19 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wayne State University city: Detroit state: Michigan zip: 48201 country: United States name: Nareen Sadik, B.S. role: CONTACT lat: 42.33143 lon: -83.04575 hasResults: False

 nctId: NCT06381167 id: Endoscopic decompression briefTitle: Endoscopic Decompression Versus Microscopic Decompression in Lumbar Canal Stenosis overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-05 date: 2027-10 date: 2024-04-24 date: 2024-04-24 name: Assiut University class: OTHER briefSummary: To compare between the clinical and surgical efficacies of bi-portal endoscopic and microscopic decompressive laminectomy in patients with degenerative lumbar spinal stenosis. conditions: Lumbar Spinal Stenosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 52 type: ESTIMATED name: Endoscopic Decompressive Laminectomy measure: Oswestry Disability Index ODI scores for low back pain and neuropathic pain measure: visual analog scale (VAS) score for low back and lower extremity radiating pain measure: European Quality of Life-5 Dimensions (EQ-5D) score measure: painDETECT score sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06381154 id: MC230404 id: NCI-2024-03078 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-009036 type: OTHER domain: Mayo Clinic Institutional Review Board id: MC230404 type: OTHER domain: Mayo Clinic id: P01CA084203 type: NIH link: https://reporter.nih.gov/quickSearch/P01CA084203 id: P30CA015083 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA015083 briefTitle: Photoradiation With Verteporfin to Facilitate Immunologic Activity of Pembrolizumab in Unresectable, Locally Advance or Metastatic Pancreatic Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-05 date: 2029-07-04 date: 2029-07-04 date: 2024-04-24 date: 2024-04-24 name: Mayo Clinic class: OTHER name: National Cancer Institute (NCI) briefSummary: This phase II trial tests how well photoradiation with verteporfin and pembrolizumab plus standard of care chemotherapy works in treating patients with pancreatic cancer that cannot be removed by surgery (unresectable), that has spread to nearby tissue or lymph nodes (locally advanced) or to other places in the body (metastatic). Photoradiation uses light activated drugs, such as verteporfin, that become active when exposed to light. These activated drugs may kill tumor cells. Vertoporfin may also increase tumor response to immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as modified fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFIRINOX), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Photoradiation with verteporfin and pembrolizumab plus standard of care chemotherapy may kill more tumor cells in patients with unresectable, locally advanced or metastatic pancreatic cancer. conditions: Locally Advanced Pancreatic Adenocarcinoma conditions: Metastatic Pancreatic Adenocarcinoma conditions: Stage II Pancreatic Cancer AJCC v8 conditions: Stage III Pancreatic Cancer AJCC v8 conditions: Stage IV Pancreatic Cancer AJCC v8 conditions: Unresectable Pancreatic Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Computed Tomography name: Endoscopic Ultrasound name: Fluorouracil name: Irinotecan name: Leucovorin name: Lymph Node Biopsy name: Magnetic Resonance Imaging name: Oxaliplatin name: Pembrolizumab name: Photodynamic Therapy name: Positron Emission Tomography name: Questionnaire Administration name: Verteporfin measure: Overall response rate (ORR) measure: Duration of response (DOR) measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Incidence of adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester 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: Vinay Chandrasekhara, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06381141 id: CLN-619-002 briefTitle: A Study of CLN-619 (Anti-MICA/MICB Antibody) in Patients With Relapsed and Refractory Multiple Myeloma overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-09 date: 2027-03 date: 2024-04-24 date: 2024-04-24 name: Cullinan Therapeutics Inc. class: INDUSTRY briefSummary: A Phase 1b, Multicenter, Open-Label, Study to Investigate the Safety and Efficacy of CLN-619 (anti-MICA/MICB Antibody) in Patients with Relapsed and Refractory Multiple Myeloma conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: CLN-619 measure: Proportion of participants reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Changes in Eastern Cooperative Oncology Group (ECOG) performance measure: Incidence of Dose-Limiting toxicity (DLTs) measure: Best Overall Response (BOR) per patient measure: Overall Response Rate (ORR) measure: Duration of Response (DoR) measure: Clinical Benefit Rate (CBR) measure: Progression Free Survival (PFS) measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06381128 id: CAA by CT in children with CHD briefTitle: Coronary Arteries Anomalies by CT in Children With CHD overallStatus: NOT_YET_RECRUITING date: 2025-01-01 date: 2026-01-01 date: 2029-12-31 date: 2024-04-24 date: 2024-04-24 name: Assiut University class: OTHER briefSummary: Delineate coronary artery anatomy and detection of coronary anomalies in children with complex cardiac anomalies by cardiac CT-angiography before total surgical correction. conditions: Cardiac Congenital Defects studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED name: Cardiac CT measure: Detection of coronary arteries anomalies by computed tomography angiography in children with congenital heart disease sex: ALL minimumAge: 1 Day maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06381115 id: 23-006685 briefTitle: App-Based Optimization of Long-Term CPAP Adherence and Quality of Life overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-11 date: 2024-11 date: 2024-04-24 date: 2024-04-24 name: Mayo Clinic class: OTHER name: Arizona State University (ASU) briefSummary: The purpose of this study is to optimize the time of CPAP usage to at least 6 hours a night for 6 nights per week for people who have OSA with the help of a smartphone application called SmartWell24. This application aims to target CPAP adherence. conditions: Obstructive Sleep Apnea studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: SleepWell24 Application measure: CPAP Adoption measure: Change in Quality of Life measure: Change in sleep time measure: Change in physical activity measure: Change in sedentary time sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Arizona city: Scottsdale state: Arizona zip: 85259 country: United States lat: 33.50921 lon: -111.89903 facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06381102 id: 20240134 briefTitle: Transcutaneous Vagus Nerve Stimulation (taVNS) Dosage Study 1 overallStatus: RECRUITING date: 2024-04-13 date: 2024-10-01 date: 2024-10-01 date: 2024-04-24 date: 2024-04-24 name: University of Miami class: OTHER briefSummary: The purpose of this research study is to investigate the effects of different forms of a gentle form of electrical stimulation applied to the ear, known as transcutaneous auricular vagus nerve stimulation (taVNS). The research team is interested in how the different forms affect comfort and tolerability, as well as how well it works. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: transcutaneous auricular vagus nerve stimulation 30/30 name: transcutaneous auricular vagus nerve stimulation 10/10 measure: Tolerability measured by tolerability questionnaire measure: Tolerability measured by self-report measure: Change in heart rate variability (HRV) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Miami status: RECRUITING city: Miami state: Florida zip: 33136 country: United States name: Gabriel Gonzalez, DPT role: CONTACT phone: 305-243-8117 email: gxg651@miami.edu name: Marlon Wong, PT, PhD role: PRINCIPAL_INVESTIGATOR name: Gabriel Gonzalez, DPT role: SUB_INVESTIGATOR name: Jessica Bolanos, DPT role: SUB_INVESTIGATOR lat: 25.77427 lon: -80.19366 hasResults: False

 nctId: NCT06381089 id: VNS004 briefTitle: Effect Of Robotic Rehabilitation And Vagus Nerve Stimulation In Ischemia Stroke Patients acronym: ERRVNS overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2024-07-10 date: 2024-08-10 date: 2024-04-24 date: 2024-04-24 name: SEFA HAKTAN HATIK class: OTHER briefSummary: This study was conducted in patients with ischemic stroke; This study was conducted to examine the effect of robotic rehabilitation and transcutaneous auricular vagal nerve stimulation applied in addition to robotic rehabilitation on the patient's functional level and autonomic nervous system.

40 people over the age of 18 participated in the study. They were randomly divided into two groups: robotic rehabilitation and transcutaneous auricular vagal nerve stimulation applied in addition to robotic rehabilitation. While the robotic rehabilitation group received Lokomat and neurological rehabilitation, the other group received stimulation with the Vagustim device, which is applied non-invasively through the ear, in addition to Lokomat and neurological rehabilitation. Spasticity, autonomic nervous system, walking speed, motor function, quality of life, muscle activity and pain were evaluated in both groups before starting treatment and six weeks after treatment. In the study, significance was evaluated at p\<0.05 level. conditions: Ischemic Stroke conditions: Vagus Nerve Stimulation conditions: Robotic Rehabilitation conditions: Autonomic Nervous System studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Robotic Rehabilitation name: Transcutaneous Auricular Vagal Nerve Stimulation measure: Numerical Pain Rating Scale measure: Stroke Specific Quality of Life Scale measure: 10 Meter Walk Test measure: Fugl-Meyer Assessment Lower Extremity measure: Modified Ashworth Scale measure: Electromyography measure: Autonomic Nervous System sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06381076 id: IRB202400087 briefTitle: Examining the Impact of High-protein Oral Supplement With Liposomal Curcumin on Inflammation Markers and Oxidative Stress in Adults Undergoing Hemodialysis. overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-12 date: 2025-12 date: 2024-04-24 date: 2024-04-26 name: University of Florida class: OTHER briefSummary: A 12-week double-blind randomized control trial will be conducted among adults on hemodialysis (n=15) to determine the impact of liposomal curcumin in a high-protein product on inflammation markers and oxidative stress. Participants will be randomized via a computer-generator into either the control or intervention group. Participants in each group will be given a total of 38 g of a high protein product with or without 7 mls of liposomal curcumin for a total of 8 weeks. At baseline, weeks 8 and 12, participants will have blood sampled and complete a 3-day 24-hour recalls (2 non-dialysis days and 1 dialysis day) and a quality of life survey. conditions: Chronic Kidney Disease 5D studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized comparator-controlled trial primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participants will receive a 3-digit coded product that either contains 7 mls of liposomal curcumin or food colorant. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: Liposomal curcumin name: Food colorant measure: high-sensitivity C-reactive protein measure: Advanced glycation end products measure: fatty acid byproduct - 4-hydroxynon-enal measure: fatty acid byproduct - malondialdehyde measure: fatty acid byproduct - 8-F2 isoprostanes measure: Klotho sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06381063 id: PI2023_843_0152 briefTitle: Non-steroidal Anti-inflammatory in Cardiac Surgery acronym: KETOPAIN overallStatus: RECRUITING date: 2024-03-27 date: 2027-03 date: 2027-07 date: 2024-04-24 date: 2024-04-24 name: Centre Hospitalier Universitaire, Amiens class: OTHER name: University Hospital, Rouen name: University Hospital, Lille briefSummary: Non-steroidal anti-inflammatory drugs (NSAID) are part the multimodal strategy in pain management after surgery. However, major concerns are raised in cardiac surgery given the potential side effects of NSAID with more bleeding and acute kidney injury. The investigators hypothesized that NSAID are safe in the early postoperative course after cardiac surgery with respect to contraindication. conditions: Acute Postoperative Pain conditions: Non-steroidal Anti-inflammatory Drugs conditions: Cardiac Surgery conditions: Pain Intensity conditions: Multimodal Pain Management studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 238 type: ESTIMATED name: pain management name: ketoprofen name: PLacebo measure: reduction in pain intensity during chest physiotherapy at 24 hours from the end of surgery measure: NSAIDs reduce postoperative at rest at 24 hours from the end of surgery measure: Change in pain trajectory during the first 7 days after cardiac surgery measure: Change in cumulative opioid within 48 hours after surgery measure: Change in pulmonary postoperative complications within 7 days after surgery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Amiens Picardie status: RECRUITING city: Amiens country: France name: Osama ABOU ARAB role: CONTACT email: abouarab.osama@chu-amiens.fr name: Emmanuel BESNIER, MD role: PRINCIPAL_INVESTIGATOR name: Mouhamed MOUSSA, MD role: PRINCIPAL_INVESTIGATOR lat: 49.9 lon: 2.3 hasResults: False

 nctId: NCT06381050 id: SHR-7631-101 briefTitle: The Clinical Study of SHR-7631 for Injection in Patients With Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2027-04 date: 2024-04-24 date: 2024-04-24 name: Suzhou Suncadia Biopharmaceuticals Co., Ltd. class: INDUSTRY briefSummary: This study is an open-label, phase I clinical trial of SHR-7631 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion. conditions: Advanced Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: SHR-7631 measure: Maximum tolerated dose (MTD) or maximum administered dose (MAD) measure: Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) (CTCAE v5.0) measure: PK parameter: Tmax measure: PK parameter: Cmax measure: PK parameter: AUC0-t measure: PK parameter: AUC0-∞ measure: PK parameter: t1/2 measure: PK parameter: MRT (mean residence time) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06381037 id: PID2021-127986OB-I00 briefTitle: Quality of Life and Psychological Strengths of Older People acronym: QUALIFRAG overallStatus: RECRUITING date: 2023-09-01 date: 2026-01-31 date: 2026-08-31 date: 2024-04-24 date: 2024-04-24 name: CEU San Pablo University class: OTHER briefSummary: As the 2019 coronavirus pandemic (COVID-19) overspreads around the world, and scientists try to elucidate about the complexity of the virus, there is clear potential for it to become a long-lasting global illness. In this picture, Spain has emerged as one of the most affected countries with a high prevalence rate. The possibility of illness or even death, the uncertainty of the future, or the required physical estrangement, make this epidemic a highly stressful situation with potential long-term consequences on the physical and psychological wellbeing of the population, just isolation raises the probability of health problems like depression and anxiety. However, the same event does not affect everybody equally. The ultimate effect of a stressor will depend on its appraisal as a threat and the resources the person counts on to copy and several biopsychosocial variables could play an important role, as risk or protective factors. conditions: Quality of Life conditions: Skills, Coping studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Quantitative, observational and longitudinal study with three measurements (pre-intervention, post-intervention and monitoring). primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 110 type: ESTIMATED name: "How to improve your strengths and quality of life". measure: Quality of life measure: Psychological wellbeing measure: Loneliness measure: Anxiety and depression Anxiety and depression measure: Gratitude measure: Experiential acceptance measure: Resilience measure: Family functioning sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: San Pablo CEU University (Campus Montepríncipe) status: RECRUITING city: Alcorcón state: Madrid zip: 28925 country: Spain name: Leyre Galarraga Cristóbal role: CONTACT phone: 913724700 phoneExt: 14607 email: leyre.galarragacristobal@ceu.es name: Gema Pérez Rojo role: CONTACT phone: 913724700 phoneExt: 14999 email: gema.perezrojo@ceu.es lat: 40.34582 lon: -3.82487 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2023-12-01 uploadDate: 2023-12-11T03:43 filename: SAP_000.pdf size: 70923 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-01 uploadDate: 2023-12-11T03:42 filename: ICF_001.pdf size: 71559 hasResults: False

 nctId: NCT06381024 id: 2022 A02702-41 briefTitle: A Study of Telemonitoring in Cancer Patients acronym: MINERVA overallStatus: RECRUITING date: 2023-04-04 date: 2024-12-30 date: 2024-12-30 date: 2024-04-24 date: 2024-04-24 name: Centre Hospitalier de Bligny class: OTHER name: Exystat name: Cureety name: Pharmaspecific name: ProPens briefSummary: The goal of this prospective, randomized, unblinded, single-centre, interventional study is to assess the effectiveness of standard of care with Cureety, compared to standard of care alone, to reduce the number of all telephone calls during the first 4 months of oral or intravenous cancer treatment for patients older than 18 years of age, initiating oral or intravenous cancer treatment at the Centre Hospitalier de Bligny.

Patients initiating either oral or intravenous chemotherapy for cancer will be randomly allocated in a 1:1 ratio to either:

* In-person care alone (Standard of care group).
* In-person care with Cureety telemonitoring (Standard of care with Cureety group).

Participants will:

* be monitored with digital application Cureety (Standard of care with Cureety group)
* fill out quality of life questionnaire (baseline, 2 months, 4 months)
* fill out satisfaction questionnaire (2 months, 4 months)
* have the ongoing and incoming phone calls logged (duration and type) conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients initiating either oral or intravenous chemotherapy for cancer will be randomly allocated in a 1:1 ratio to either:

* In-person care alone (Standard of care group).
* In-person care with telemonitoring (Standard of care with Cureety group).

The randomization will be stratified by:

• Oral versus intravenous cancer treatment. The number of patients initiating oral treatment at randomization will be restricted to 20 patients. primaryPurpose: TREATMENT masking: NONE count: 82 type: ESTIMATED name: remote patient monitoring measure: Number of all telephone calls during the first 4 months of oral or intravenous cancer treatment measure: Duration of all telephone calls during the first 4 months of oral or intravenous cancer treatment measure: Numbers of telephone calls during the first 4 months of cancer treatment in subgroups measure: Hospital-free survival rate measure: Quality of life at 2 and 4 months after initiation of cancer treatment. measure: Patient satisfaction with the healthcare provided measure: CH Bligny staff satisfaction with the healthcare provided sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier de Bligny status: RECRUITING city: Briis-sous-Forges zip: 91640 country: France name: Ingrid Alexandre, MD role: CONTACT phone: +33169263138 email: i.alexandre@chbligny.fr name: Ingrid Alexandre, MD role: PRINCIPAL_INVESTIGATOR lat: 48.62399 lon: 2.12112 hasResults: False

 nctId: NCT06381011 id: BEUFTR-4 briefTitle: Local Vibration in Cervical Radiculopathy overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-06-01 date: 2024-09-01 date: 2024-04-24 date: 2024-04-24 name: Bitlis Eren University class: OTHER briefSummary: The aim of this study is to evaluate the effect of local vibration application on the upper extremity pain, paresthesia, neck pain, and limitations in cervical joint range of motion experienced by patients with cervical radiculopathy. conditions: Cervical Radiculopathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The evaluator and the researcher administering the local vibration application will be different. Patients will be blinded to their group assignment. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 34 type: ESTIMATED name: Local Vibration measure: Neck Pain measure: Upper Limb Pain measure: Paresthesia measure: Cervical Range of Motion measure: The Change in the Pressure Pain Threshold of the Upper Trapezius measure: The Change in the Viscoelastic Properties of the Upper Trapezius sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bitlis Eren University city: Bitlis state: Merkez zip: 13000 country: Turkey name: Ömer Dursun, Asst. Prof. role: CONTACT phone: 5426088687 phoneExt: +90 email: fztomrdrsn@gmail.com name: Erhan Dincer, M.Sc. role: CONTACT phone: 5442543857 phoneExt: +90 email: fzterhan@hotmail.com lat: 38.40115 lon: 42.10784 hasResults: False

 nctId: NCT06380998 id: EPCPHCFAPAEWPSPSWAG briefTitle: Effects of Petroleum Compounds on Psychological Health and Cognitive Functions overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2025-10-01 date: 2027-10-01 date: 2024-04-24 date: 2024-04-24 name: Assiut University class: OTHER briefSummary: Over the last decade, awareness of the effects of hydrocarbon fuels on neurodegenerative disorders has increased significantly, as they are ubiquitous environmentally toxic chemicals that affect the central nervous system and result in irreversible neuronal damage, as many hydrocarbons can cross the blood-brain barrier through multiple pathways and cause direct toxicity. conditions: Cognitive Deterioration studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 196 type: ESTIMATED name: whey protien measure: Effects of petroleum compounds on psychological health and cognitive functions of petrol station workers in Assiut measure: To explore the relation between the level of petroleum hydrocarbon metabolites and the severity of psychological heath and cognitive functions disturbance of petrol station workers measure: To explore the role of supplements with whey protein in ameliorating these effects measure: To assess the relationship between the psychological effects, cognitive functions, and nutritional status of petroleum station workers sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of medicine city: Assiut state: Assiut University zip: 71515 country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06380985 id: NURA-009-23F id: 1I01CX002715-01A1 type: OTHER_GRANT domain: Clinical Science Research & Development briefTitle: Personalized Approach Bias Modification in Heavy Drinking Veterans With Mild to Moderate Traumatic Brain Injury acronym: TABM overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-06-30 date: 2027-12-31 date: 2024-04-24 date: 2024-04-26 name: VA Office of Research and Development class: FED briefSummary: The project will examine the neural associations of alcohol approach-bias and investigate the extent to which a neuroscience-based personalized cognitive training program will remediate alcohol approach-bias and improve recovery outcomes among heavy drinking Veterans with alcohol use disorder (AUD) and a history of mild-moderate traumatic brain injury (mmTBI). Alcohol approach-bias modification (ApBM) is a cognitive training intervention designed to interrupt and modify automatic approach processes in response to alcohol cues. Modification of alcohol approach-bias and reductions in heavy alcohol use can be expected to reduce behaviors of self-harm and violence, increase adherence to medical care, reduce drinking-related medical costs, and promote healthier relationships. The long-term goal is to demonstrate the efficacy of ApBM to promote recovery from AUD in Veterans with chronic mmTBI. The investigators also aim to identify neural mechanisms associated with ApBM and other neurocognitive predictors of successful recovery. The evidence garnered from this study will be useful to inform the development of other behavioral and pharmacological treatments for Veterans with AUD with a history of mmTBI. conditions: Alcohol Use Disorder conditions: Mild-Moderate Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This will be a Phase II double-blind, randomized, sham-controlled clinical trial. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The identity of ApBM and Sham will not be known to investigators or patients. To maintain the blind, the participant and the research coordinator (naïve to ApBM) administering the participant's training will be blind to whether "1" or "2" is ApBM or Sham. The research coordinator will receive the patient assignment from statistical software at time of randomization. The key that determines assignment of ApBM or Sham to condition "1" or "2" will be known by an addiction research program affiliate PI otherwise uninvolved in the current study. They will document this key in a locked electronic file. The study blind will be broken on completion of the study and after the study database has been locked. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: Personalized VR Alcohol Approach Bias Modification (ApBM) Condition name: Sham Condition measure: Percent of Heavy Drinking Days measure: Cue-induced fMRI BOLD-signal craving activation contrasts measure: Cognitive flexibility sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: San Francisco VA Medical Center, San Francisco, CA city: San Francisco state: California zip: 94121-1563 country: United States name: David L Pennington role: CONTACT phone: 415-221-4810 phoneExt: 24504 email: david.pennington2@va.gov name: Yim Fan Wong, BS role: CONTACT phone: (415) 221-4810 phoneExt: 22329 email: yimfan.wong@va.gov name: David L Pennington role: PRINCIPAL_INVESTIGATOR lat: 37.77493 lon: -122.41942 hasResults: False

 nctId: NCT06380972 id: HDM6009A-301 briefTitle: A Prospective, Randomized, No-treatment Controlled, Evaluator-blinded Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Microspherical Injectable to Improve Forehead Contour overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-09 date: 2025-10 date: 2024-04-24 date: 2024-04-24 name: AQTIS Medical B.V. class: OTHER briefSummary: A Prospective, Multicenter, Randomized, No-treatment-controlled, Evaluator-blinded, Superiority Clinical Trial to Evaluate the Efficacy and Safety of Polycaprolactone Based Facial Injectable to Improve Forehead Contour conditions: Forehead Contouring studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: the method of endpoint blind evaluation is adopted, that is, it's blinded for the evaluator. whoMasked: OUTCOMES_ASSESSOR count: 189 type: ESTIMATED name: Polycaprolactone (PCL) Based Facial Injectable measure: The response rate for improving the forehead contour is assessed by the blinded investigator using the Asian Sloping Forehead Scale (ASFS) measure: The response rate of forehead contour improvement assessed by blinded investigator using Asian Sloping Forehead Scale (ASFS) measure: The response rate of forehead contour improvement assessed by injection investigator using Asian Sloping Forehead Scale (ASFS) measure: The global aesthetic improvement rate assessed by the injection investigator based on the Global Aesthetic Improvement Scale (GAIS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Second Provincial General Hospital city: Guangzhou state: Guangdong zip: 510317 country: China name: Shengkang Luo role: CONTACT phone: 02089168071 email: luoshengkang63@hotmail.com name: WEIJIN HONG role: CONTACT phone: 02089168071 name: shengkang luo role: PRINCIPAL_INVESTIGATOR name: weijin hong role: SUB_INVESTIGATOR lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06380959 id: 223K879 briefTitle: Art-based Activities in Stroke Patients overallStatus: COMPLETED date: 2023-10-02 date: 2023-12-31 date: 2024-02-29 date: 2024-04-24 date: 2024-04-29 name: Ege University class: OTHER briefSummary: Introduction and Aim: Life after stroke begins a difficult period in which functional capacity is very limited. Disability persists for a long time, and various problems such as hemiparesis, hemiplegia, dysarthria, dysphagia, urinary and bowel incontinence, which are frequently encountered after stroke, can affect the quality of life in the long term. As non-pharmacological approaches, especially non-invasive methods, have gained attention, creative arts-based therapies have often been recommended for stroke survivors because they have an arts-based approach without side effects. It is thought that the study conducted will contribute to the literature as there are not many studies in the literature. The aim of this study is to examine the effects of art-based activities on stroke patients' hope and self-efficacy levels. Its sub-purpose is to reveal the feelings and thoughts that arise with art objects obtained from art-based activities applied to stroke patients.

Materials and Methods: The study was conducted as a randomised controlled design. After the groups were determined, art-based activities module was applied to the intervention group for one week, while no additional intervention was made to the control group. Research data were collected using "Individual Introduction Form", "Herth Hope Index", "Generalized Self-Efficacy Scale. Data were analyzed with Statistical Package for the Social Sciences 25.0 package program. Written permission was obtained from the relevant ethics committee, hospital and participants to conduct the study. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised Controlled primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 72 type: ACTUAL name: Art Based Activity measure: Herth Hope Index measure: Generalized Self-Efficacy Scale measure: Individual Introduction Form measure: Art Object Concretization Form sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ege University city: Bornova state: İzmir zip: 35100 country: Turkey lat: 38.47921 lon: 27.2399 hasResults: False

 nctId: NCT06380946 id: 978/91 briefTitle: Influence of Injectable Platelet Rich Fibrin on Different Orthodontic Tooth Movements During Clear Aligner Therapy overallStatus: ENROLLING_BY_INVITATION date: 2024-06-01 date: 2024-10-01 date: 2024-11-01 date: 2024-04-24 date: 2024-04-24 name: Al-Azhar University class: OTHER briefSummary: The aim of this prospective clinical project will be to assess the effect of platelet rich fibrin on the rate of different orthodontic tooth movements during clear aligner therapy. conditions: Effect of Platelet Rich FibrinDuring Clear Aligner Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: BASIC_SCIENCE masking: NONE count: 78 type: ESTIMATED name: iPRF measure: Influence of injectable platelet rich fibrin rate of different orthodontic tooth movements by millimeter sex: ALL minimumAge: 15 Years maximumAge: 22 Years stdAges: CHILD stdAges: ADULT facility: AlAzhar university city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06380933 id: B11103008 briefTitle: The Effects of Receiving Warm Footbath With Lavender Essential Oil on Sleep and Comfort overallStatus: COMPLETED date: 2022-09-01 date: 2022-09-01 date: 2024-02-28 date: 2024-04-24 date: 2024-04-24 name: Dalin Tzu Chi General Hospital class: OTHER briefSummary: Purposes: Describe the background information and clinical characteristics of respirator-dependent patients, verify the sleep and comfort effects of respirator-dependent patients whether or not they receive a lavender essential oil warm water foot bath, and compare changes of the sleep, comfort, heartbeat, and blood pressure in respirator-dependent patients before and after receiving a lavender essential oil warm water foot bath. conditions: Sleep Quality conditions: Comfort studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: two-group crossover design trial and block randomly assigns groups after gender stratification. The experimental group first received a foot bath with lavender essential oil at 41-42C warm water for 20 minutes for 3 days, then rested for 3 days, and then received routine care for 3 days; the control group first received routine care for 3 days, then rested for 3 days, and then received lavender essential oil 41-42C warm water foot bath for 20 minutes for 3 days. primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 94 type: ACTUAL name: experimental group measure: Richards-Campbell Sleep Questionnaire measure: Numerical Rating of Comfort sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hsu Mei-Lian city: Chiayi City country: Taiwan lat: 23.47917 lon: 120.44889 hasResults: False

 nctId: NCT06380920 id: Digital Health App briefTitle: Function Definition and Clinical Validation of Digital Health App: Using Weight Management as An Example overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-12-31 date: 2024-12-31 date: 2024-04-24 date: 2024-04-25 name: National Cheng-Kung University Hospital class: OTHER briefSummary: This project anticipates addressing the obesity epidemics problem which has caused unhealthy lifestyle in billions of obesities and overweight people worldwide. The investigators propose on digital health solution in providing healthcare-on-demand, for personalized health, healthy lifestyle and weight management. This study proposes on using Cognitive Behavior Therapy (CBT) in decreasing individual's food craving, which is administered through AI (Assistive Intelligence) tracking. As with any new medicine, uncertain long-term effects and high costs of these new drugs are also critical factors considered by physicians and policy makers worldwide. Researchers have also reported on 85% of people re-gaining premedication weight after 5 years. There is no easily available self-controlled monitoring strategy/intervention for the unhealthy lifestyle is believed to be one of the main problems. Therefore, the investigators propose on the research and development of self-managing digital health APP (application) for 12 months over two phases, with three months to design APP and nine months to confirm the clinical validation. During the first phase, the investigators propose on design of an "AI Mindful Eating" App, to enhance individual's healthy lifestyle with subsequent weight-loss. Based on "gut-brain-axis", this is anticipated to be achieved by using CBT and AI is used to recognize nutrition and mood within mobile images. This facilitates fulfilling lifestyle and long-term weight-loss. Finally, the study proposes to complete function definition and clinical validation for our AI Humanity APP. By scheduled check-up program by monitoring and analyzing body weight, body fat, anthropometric and metabolic change data between case and control groups. The investigators intend to disclose the effect of the AI assistant APP in weight management and metabolic disease prevention. conditions: Weight Loss conditions: Body Fat Rate Loss conditions: Body Composition Change studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: "AI Mindful Eating" App name: Outpatient regular follow-up measure: weight change measure: Parameters of Metabolic syndrome sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06380907 id: ZL-1102-002 briefTitle: A Phase 2 Study of ZL-1102 in Patients With Chronic Plaque Psoriasis overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-02-28 date: 2026-03 date: 2024-04-24 date: 2024-04-26 name: Zai Lab (Hong Kong), Ltd. class: INDUSTRY name: Zai Lab (US) LLC briefSummary: A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Dose-Ranging, Phase 2 Study to Evaluate the Efficacy and Safety of Different Doses of ZL-1102 Topical gel (A Human VH IL-17A Antibody Fragment) in the Treatment of Chronic Plaque Psoriasis conditions: Plaque Psoriasis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: ZL-1102 1% w/w gel BID for 16 weeks name: ZL-1102 3% w/w gel BID for 16 weeks name: ZL-1102 3% w/w gel QD for 16 weeks name: Placebo ZL-1102 0% w/w gel BID for 16 weeks name: Placebo ZL-1102 0% w/w gel QD for 16 weeks measure: Efficacy of different doses of ZL-1102 compared to Vehicle at Week 16. measure: The proportion of patients achieving IGA treatment success. measure: The proportion of patients achieving IGA score of 0 or 1. measure: The percent change from baseline in mPASI score. measure: The proportion of patients achieving mPASI 75 at Week 2, 4, 8, 12, and 20. measure: The proportion of patients achieving mPASI 50/90/100 at Weeks 2, 4, 8, 12, 16, and 20. measure: Time to achieve mPASI 50/75/90. measure: Time to achieve IGA score of 0 or 1. measure: Time to achieve 1- or 2-point improvement in IGA. measure: Incidence of Treatment Related Adverse Events through Week 20. measure: Mean local tolerability scores (LTS) measure: Serum concentration of ZL-1102. measure: Anti-drug antibody (ADA) of ZL-1102. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zai Lab Site 5013 city: Phillip state: Australian Capital Territory zip: 2606 country: Australia lat: -31.13333 lon: 150.85 facility: Zai Lab Site 5016 city: Kotara state: New South Wales zip: 2289 country: Australia lat: -32.95 lon: 151.68333 facility: Zai Lab Site 5017 city: Woolloongabba state: Queensland zip: 4102 country: Australia lat: -27.48855 lon: 153.03655 facility: Zai Lab Site 5014 city: Carlton state: Victoria zip: 3053 country: Australia lat: -37.8 lon: 144.96667 facility: Zai Lab Site 5002 city: Melbourne E. state: Victoria country: Australia lat: -37.81667 lon: 144.9879 facility: Zai Lab Site 5015 city: Melbourne state: Victoria zip: 3124 country: Australia lat: -37.814 lon: 144.96332 hasResults: False

 nctId: NCT06380894 id: 2020/2239 briefTitle: Virtual Reality Cognitive Training for Mild Cognitive Impairment overallStatus: COMPLETED date: 2021-01-27 date: 2022-09-30 date: 2023-01-31 date: 2024-04-24 date: 2024-04-24 name: Changi General Hospital class: OTHER briefSummary: This study aims to assess the feasibility and efficacy of a 10-weekly multi-domain VRCT program on the cognitive function (i.e. attention, memory, and executive functioning) of older adults with MCI. conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ACTUAL name: Virtual Reality Cognitive Training name: Active Control measure: Change from Baseline in Memory Performance on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtests at Week 11 measure: Change from Baseline in Attention Performance on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) subtest at Week 11 measure: Change from Baseline in Attention Performance on the Colour Trails Test 1 at Week 11 measure: Change from Baseline in Executive Function Performance on the Frontal Assessment Battery (FAB) at Week 11 measure: Change from Baseline in Executive Function Performance on the Colour Trails Test 2 at Week 11 sex: ALL minimumAge: 65 Years maximumAge: 85 Years stdAges: OLDER_ADULT facility: Changi General Hospital city: Singapore 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: 2021-01-27 uploadDate: 2024-04-15T09:12 filename: Prot_SAP_000.pdf size: 384298 hasResults: False

 nctId: NCT06380881 id: SHR-2017-102 briefTitle: PK/PD Study of SHR-2017 Injection in Patients With Bone Metastases overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2025-07 date: 2024-04-24 date: 2024-04-24 name: Suzhou Suncadia Biopharmaceuticals Co., Ltd. class: INDUSTRY briefSummary: To evaluate the pharmacokinetic characteristics, pharmacodynamic characteristics, safety, tolerability and immunogenicity of SHR-2017 injection in patients with bone metastases, and to evaluate the efficacy of SHR-2017 injection in the treatment of skeletal-related event and cancer pain. conditions: Patients With Bone Metastases studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: SHR-2017 measure: The Pharmacokinetic parameters of SHR-2017 after administration, including Cmax measure: The Pharmacokinetic parameters of SHR-2017 after administration, including Tmax measure: The Pharmacokinetic parameters of SHR-2017 after administration, including AUC0-t measure: The Pharmacokinetic parameters of SHR-2017 after administration, including AUC0-∞ measure: The Pharmacokinetic parameters of SHR-2017 after administration, including t1/2 measure: The Pharmacokinetic parameters of SHR-2017 after administration, including CL/F measure: The pharmacodynamic parameter of SHR-2017 after administration include uNTX/uCr measure: The pharmacodynamic parameter of SHR-2017 after administration include β-CTX measure: The pharmacodynamic parameter of SHR-2017 after administration include BALP [Time measure: Change from baseline in worst pain/average pain at the designated bone metastasis pain site after dosing measure: Incidence of skeletal-related event measure: Average daily total opioids consumption sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Cancer Hospital city: Beijing state: Beijing zip: 100142 country: China name: Huiping Li role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06380868 id: Nanjing-2 briefTitle: IVI-guided Versus Angiography-guided PCI in Patients With Diabetes Mellitus acronym: IVI-DIABETES overallStatus: ENROLLING_BY_INVITATION date: 2024-06-10 date: 2026-06-01 date: 2027-07-20 date: 2024-04-24 date: 2024-04-24 name: Nanjing First Hospital, Nanjing Medical University class: OTHER name: Shanxi Provincial People's Hospital briefSummary: Intravascular ultrasound (IVUS) serves as a beneficial instrument during percutaneous coronary intervention (PCI) procedures, affording insight into lesion characteristics and stent implantation. The ULTIMATE trial recently evidenced that IVUS-guided Drug-Eluting Stent (DES) implantation notably ameliorated clinical outcomes in all-comers, especially in patients who underwent an optimal procedure defined by IVUS, as opposed to angiography guidance, resonating with findings from the IVUS-XPL study, OCTOBER trial, and RENOVATE COMPLEX PCI trial, further confirmed by more recent IVUS-ACS trial.

Optical coherence tomography (OCT) has a resolution 10 times higher than that of IVUS and can provide valuable information at each step of PCI.

Regrettably, a dearth of prospective, randomized, multicenter trials exists that scrutinize the benefits of IVI-guided as opposed to angiography-guided PCI in patients suffering from diabetes mellitus. However, several trials have presented subgroup analyses reporting the reduction of clinical events by IVUS but not OCT guidance in patients with diabetes mellitus, which served as the foundation for the design of this trial. conditions: Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will undergo 1:1 randomization to either intravascular imaging (including intravascular ultrasound or optical coherence tomography)-guided DES implantation which will be the treatment group or Angio-guided DES implantation which will be the control group, stratified by research sites. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Randomization will be performed in the catheter laboratory by an invasive nurse. Staff in the catheter laboratory will be not blinded to the treatment allocation. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 1332 type: ESTIMATED name: Intravascular imaging-guided PCI name: Angiography-guided PCI group measure: Rate of target vessel failure (TVF) measure: Rate of target vessel failure without procedure-related MI measure: Rate of cardiac death measure: Rate of all-cause death measure: Rate of procedure-related myocardial infarction (PMI) measure: Rate of spontaneous myocardial infarction (SMI) measure: Rate of clinically-driven revascularization measure: Rate of stent thrombosis sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanjing First Hospital city: Nanjing state: Jiangsu zip: 210006 country: China lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06380855 id: GIHSYSU-34 briefTitle: Flexible Colonoscope Assisted Hybrid Transanal Total Mesorectal Resection (taTME) overallStatus: RECRUITING date: 2022-08-24 date: 2025-08-24 date: 2025-08-24 date: 2024-04-24 date: 2024-04-24 name: Sun Yat-sen University class: OTHER briefSummary: The investigators propose to use flexible endoscopy combined with transanal total mesorectal resection to further reduce anal injury. conditions: Rectal Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 5 type: ESTIMATED name: Flexible colonoscope assisted hybrid transanal total mesorectal resection measure: Success rate of operation sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University status: RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Liang Kang, MD, PhD role: CONTACT phone: 008613602886833 email: eonkang@163.com lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06380842 id: 2023HX1970 briefTitle: Organ Dysfunction Change in Acute Necrotizing Pancreatitis Patients With Sepsis After Open Necrosectomy overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-12-30 date: 2026-12-30 date: 2024-04-24 date: 2024-04-24 name: Chunling Jiang class: OTHER briefSummary: The purpose of this study is to characterize organ dysfunction change in acute necrotizing pancreatitis patients with sepsis after open necrosectomy. conditions: Necrotizing Pancreatitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Necrotizing Pancreatitis patients' organ dysfunction progression measure: Measure organ dysfunction change after open necrosectomy with respect to time measure: incidence of a composite of major complications measure: Incidence of ICU mortality measure: Incidence of hospital mortality measure: Incidence of 28-day mortality measure: Incidence of one year mortality measure: ICU length of hospital stay measure: Length of hospital stay measure: The pancreatic symptoms score measure: The levels of inflammatory factor CRP measure: The levels of inflammatory cytokines IL-6 measure: The levels of inflammatory procalcitonin sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06380829 id: Adnan Menderes briefTitle: Psychometric Properties of the Self-Care Assessment Scale for 3-6 Year Old Children With Cerebral Palsy-Parent Form overallStatus: COMPLETED date: 2023-06-05 date: 2023-12-05 date: 2024-02-10 date: 2024-04-24 date: 2024-04-24 name: Aydin Adnan Menderes University class: OTHER briefSummary: This study is a methodological study to develop the self-care assessment scale-parent form of children with CP aged 3-6 years and test its validity and reliability.

Q1. Is the Self-Care Assessment Scale for 3- to 6-year-old Children with CP a valid scale? Q2. Is the Self-Care Assessment Scale for 3- to 6-year-old Children with CP a reliable scale? conditions: Cerebral Palsy conditions: Self Care studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 127 type: ACTUAL name: Questionnaire measure: To asses Turkish validity and reliability of Self-Care Assessment Scale for Children with CP aged 3-6 years sex: ALL minimumAge: 3 Years maximumAge: 6 Years stdAges: CHILD facility: Bircan Kahraman Berberoğlu city: Aydın zip: 0900 country: Turkey lat: 37.84501 lon: 27.83963 hasResults: False

 nctId: NCT06380816 id: CRUKD/24/001 id: ISRCTN26628699 type: REGISTRY domain: ISRCTN briefTitle: A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2029-11 date: 2029-11 date: 2024-04-24 date: 2024-04-24 name: Cancer Research UK class: OTHER name: UCB Biopharma SRL briefSummary: This clinical trial is looking at UCB4594. This is the first time the drug is being tested in humans. UCB4594 is a type of drug called a monoclonal antibody. It has been designed to work by targeting a protein called human leucocyte antigen G (HLA-G) that is found in high levels on some cancer cells. By attaching itself to this protein it may help the immune system to attack and kill the cancer cells.

The four main aims of the clinical trial are to find out:

1. The best dose of UCB4594 that can be given safely to participants in the trial.
2. What the side effects of UCB4594 are and how they can be managed.
3. What happens to UCB4594 inside the body and how it affects cancer cells.
4. Whether UCB4594 can cause cancer to shrink. conditions: Advanced Solid Tumours conditions: Squamous Cell Carcinoma of Head and Neck conditions: Carcinoma, Non-Small-Cell Lung conditions: Colorectal Neoplasms conditions: Triple Negative Breast Neoplasms conditions: Carcinoma, Renal Cell (Clear Cell Only) conditions: Esophageal Neoplasms conditions: Stomach Neoplasms (Excluding Gastrointestinal Stromal Tumors) conditions: Uterine Cervical Neoplasms conditions: Ovarian Neoplasms conditions: Pancreatic Neoplasms studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 167 type: ESTIMATED name: UCB4594 measure: Recommended Phase 2 dose (RP2D) of UCB4594 measure: Frequency of adverse events (AEs) considered at least possibly related to UCB4594 (up to 18 cycles). measure: Number of patients achieving a complete response (CR)/immune CR (iCR) or partial response (PR)/immune PR (iPR) to UCB4594 (all modules). measure: Maximum concentration of UCB4594 (monotherapy modules; Modules A and B). measure: Minimum concentration of UCB4594 (monotherapy modules; Modules A and B). measure: Area under the curve of UCB4594 (monotherapy modules; Modules A and B). measure: Steady state volume of distribution of UCB4594 (monotherapy modules; Modules A and B). measure: Clearance of UCB4594 (monotherapy modules; Modules A and B). measure: Frequency of AEs considered at least possibly related to UCB4594 (up to end of AE reporting period). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Christie NHS Foundation Trust city: Manchester country: United Kingdom name: Fiona Thistlethwaite, Prof role: CONTACT phone: +44 (0)161 9187672 email: fiona.thistlethwaite@nhs.net lat: 53.48095 lon: -2.23743 facility: University Hospital Southampton NHS Foundation Trust city: Southampton country: United Kingdom name: Ioannis Karydis, Prof role: CONTACT email: I.Karydis@soton.ac.uk lat: 50.90395 lon: -1.40428 hasResults: False

 nctId: NCT06380803 id: 4-2020-1385 briefTitle: Surgical Skill Labs for Robotic Mastectomy and Educational Program Using a Surgical Guide by Artificial Intelligence acronym: ROMCAPO+AI overallStatus: RECRUITING date: 2021-04-29 date: 2025-01-26 date: 2025-01-26 date: 2024-04-24 date: 2024-04-24 name: Severance Hospital class: OTHER name: National Research Foundation of Korea briefSummary: The goal of this prospective study is to investigate the satisfaction, NASA-Task Load Index (TLX), and surgical proficiency of a robotic breast surgery education program using cadaver or porcine models, as well as to develop an AI-based surgical guide for utilization within the educational program in trainees for robotic breast surgery.

The main question\[s\]it aims to evaluate :

* Satisfaction questionnaire of a educational program
* NASA-TLX of a educational program
* global evaluative assessment of robotic skills (GEARS) of a robotic breast surgery for surgical proficiency

Participants will participate the educational program and fill out a satisfaction questionnaire and NASA-TLX.

The tutor evaluates GEARS for 15 minutes at the beginning and end of training.

After the development of the surgical guide based on AI, researchers will compare a training group with or without surgical guide to see the effect of the surgical guide. conditions: Breast Neoplasms conditions: Surgery conditions: Educational Problems conditions: Surgical Procedure, Unspecified studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 64 type: ESTIMATED name: A educational program measure: Satisfaction questionnaire of a educational program measure: NASA-Task Load index of a educational program measure: Global Evaluative Assessment of Robotic Skills of a robotic breast surgery for surgical proficiency measure: The comparison of satisfaction questionnaire of a educational program between the group with the surgical guide and without the surgical guide measure: The comparison of NASA-Task Load index of a educational program between the group with the surgical guide and without the surgical guide measure: The comparison of Global Evaluative Assessment of Robotic Skills of a robotic breast surgery for surgical proficiency between the group with the surgical guide and without the surgical guide sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Yonsei University College of Medicine status: RECRUITING city: Seoul zip: 120-752 country: Korea, Republic of name: Hyung Seok Park, MD, PhD role: CONTACT phone: +82-2228-2100 email: imgenius@yuhs.ac lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06380790 id: 8423 briefTitle: Effect of Laser-aided Csf on the Rate of Leveling and Alignment of Mandibular Anterior Crowding overallStatus: RECRUITING date: 2023-05-01 date: 2024-05 date: 2024-10 date: 2024-04-24 date: 2024-04-24 name: Cairo University class: OTHER briefSummary: To test the effect of laser-aided circumferential supracrestal fiberotomy on the rate of leveling and alignment conditions: Orthodontics studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 26 type: ESTIMATED name: Laser-aided csf name: placebo laser-aided csf measure: Rate of tooth movement measure: Pain level measure: Periodontal health sex: FEMALE minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Faculty of dentistry cairo university status: RECRUITING city: Cairo country: Egypt name: Cairo University role: CONTACT phone: 0223638755 email: ortho@dentistry.cu.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06380777 id: DDT system for sarcopenia briefTitle: Establishment and Application of Digital Diagnosis and Treatment System for Sarcopenia overallStatus: RECRUITING date: 2023-09-01 date: 2028-12-31 date: 2028-12-31 date: 2024-04-24 date: 2024-04-24 name: Peking Union Medical College Hospital class: OTHER briefSummary: The goal of this observational study is to establish a digital diagnosis and treatment system for sarcopenia, integrating research outcomes into a unified approach encompassing a digital vaccine (early warning screening model), digital drug (intervention model associated with pathogenesis), and digital rehabilitation (preventive system combining early warning and treatment). This aims to create a digital visual tertiary prevention network for sarcopenia.

Research aims:

Evaluate the effectiveness of the digital vaccine through a cross-sectional epidemiological survey.

Establish a specialized cohort for sarcopenia through a longitudinal investigation, implementing the digital drug and digital rehabilitation interventions.

Participants will:

Engage in screening and assessment based on inclusion and exclusion criteria.

Be monitored longitudinally, with tailored interventions for those with muscle atrophy and regular follow-ups for at-risk individuals.

Key outcomes will focus on sarcopenia indicators, serum biomarkers, and clinical endpoints such as fracture rates, weakness classification, and quality of life. conditions: Sarcopenia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10000 type: ESTIMATED measure: Appendicular skeletal muscle mass index measure: Hand grip strength measure: Gait speed measure: Concentration of insulin measure: Concentration of adiponectin measure: Concentration of leptin measure: Concentration of insulin like growth factor -1(IGF-1) measure: Concentration of interleukin 18 (IL-18) measure: Concentration of tumor necrosis factor - α (TNF-α) measure: Concentration of TNF-like weak inducer of apoptosis (TWEAK) measure: Concentration of fibroblast growth factor -19 (FGF-19) measure: Concentration of myostatin measure: Concentration of chemoattractant protein-1 (MCP-1) measure: Concentration of activin sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital status: RECRUITING 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: NCT06380764 id: RC.11.3.2024 briefTitle: Greater Occipital Nerve Block Value in Management of Postdural Puncture Headache overallStatus: COMPLETED date: 2023-03-02 date: 2023-07-25 date: 2023-12-01 date: 2024-04-24 date: 2024-04-24 name: Benha University class: OTHER briefSummary: Neuraxial techniques are well tolerated and effective options for labor analgesia and anesthesia for caesarean section, and may protect high risk women against severe maternal morbidity. However, neuraxial techniques still have drawbacks especially postdural puncture headache (PDPH) and may be associated with chronic headache, back pain and postnatal depression. PDPH is a relatively common acute complication of neuraxial techniques that was traditionally considered benign and self-limiting, but it significantly impacts patients' general health and quality of life.

Greater Occipital Nerve (GON) originates from C2-3 segments and through its muscular relations it is divided as proximal and distal parts; the most proximal part lies between obliquus capitis inferior and semispinalis and then passes through the semispinalis to pierce the trapezius muscle. In distal region of trapezius fascia, the GON is crossed by the occipital artery and exits the trapezius fascia into the nuchal line about 5-cm lateral to midline. Functionally, GON provides motor supplies to the muscles while passing through it and its main sensory supply is in the occipital region. conditions: Postdural Puncture Headache studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 152 type: ACTUAL name: Greater Occipital Nerve Block name: Bilateral suboccipital intramuscular injection name: Epidural Blood Patch name: Normal Saline 10 mL Injection name: Lidocaine 2% Injectable Solution measure: The extent of reduction of consumed analgesia sex: ALL minimumAge: 25 Years maximumAge: 55 Years stdAges: ADULT facility: Benha university city: Banhā state: El Qalyoubia zip: 13511 country: Egypt lat: 30.45906 lon: 31.17858 hasResults: False

 nctId: NCT06380751 id: D9722C00001 briefTitle: Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer acronym: EvoPAR-BR01 overallStatus: NOT_YET_RECRUITING date: 2024-04-18 date: 2029-03-30 date: 2030-07-18 date: 2024-04-24 date: 2024-04-24 name: AstraZeneca class: INDUSTRY briefSummary: The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer. conditions: Advanced Breast Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE maskingDescription: Open label count: 500 type: ESTIMATED name: Saruparib (AZD5305) name: Camizestrant name: Abemaciclib name: Ribociclib name: Palbociclib name: Fulvestrant name: Letrozole name: Anastrozole name: Exemestane measure: Progression-Free Survival measure: Overall Survival measure: Progression Free Survival 2 measure: Time to chemotherapy measure: Objective Response Rate measure: Duration of Response measure: Participant-reported tolerability measure: Time to deterioration in patient-reported global health status/QoL as measured by the global health status/QoL scale within the The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) measure: Change from baseline in patient-reported global health status/QoL as measured by the global health status/QoL scale within the The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) measure: Plasma concentrations of saruparib (AZD5305) measure: Plasma concentrations of camizestrant measure: Samples will be used to develop companion diagnostics by analyzing their performance characteristics and calculate their consistency with clinical trial assays used for enrolment onto the study. sex: ALL minimumAge: 18 Years maximumAge: 130 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site city: Toronto state: Ontario zip: M5G 2M9 country: Canada lat: 43.70011 lon: -79.4163 facility: Research Site city: Montreal state: Quebec zip: H3T 1E2 country: Canada lat: 45.50884 lon: -73.58781 facility: Research Site city: Montréal state: Quebec zip: H2X 0A9 country: Canada lat: 45.50884 lon: -73.58781 facility: Research Site city: Saskatoon state: Saskatchewan zip: S7N 4H4 country: Canada lat: 52.13238 lon: -106.66892 facility: Research Site city: Toronto zip: M4N 3M5 country: Canada lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06380738 id: D0817R00074 id: D0817R00074 type: OTHER domain: AstraZeneca briefTitle: Real-World Clinical Experience of Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Olaparib + Abiraterone (PROceed) acronym: PROceed overallStatus: RECRUITING date: 2024-02-14 date: 2027-01-31 date: 2027-01-31 date: 2024-04-24 date: 2024-04-24 name: AstraZeneca class: INDUSTRY name: Merck Sharp & Dohme LLC briefSummary: PROceed is a multisite, prospective, observational study that describes the real-world use and clinical experience of mCRPC patients treated with the combination of olaparib and abiraterone in the mCRPC setting. Clinical outcomes will be assessed in patients who are either NHA-naive or NHA-exposed prior to initiating olaparib + abiraterone treatment, respectively. Patient demographic and clinical characteristics, as well as treatment received prior and subsequent to olaparib + abiraterone, will also be described. The study plans to enroll patients for a maximum of 2 years and follow up patients from initiation of olaparib until 1 year post last patient in. conditions: Metastatic Castration-resistant Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED measure: Time to treatment discontinuation measure: Time to first subsequent therapy sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: RECRUITING city: Aschaffenburg country: Germany lat: 49.97704 lon: 9.15214 facility: Research Site status: RECRUITING city: Berlin country: Germany lat: 52.52437 lon: 13.41053 facility: Research Site status: NOT_YET_RECRUITING city: Berlin country: Germany lat: 52.52437 lon: 13.41053 facility: Research Site status: RECRUITING city: Duisburg country: Germany lat: 51.43247 lon: 6.76516 facility: Research Site status: NOT_YET_RECRUITING city: Franckfurt country: Germany facility: Research Site status: RECRUITING city: Halle country: Germany lat: 51.48159 lon: 11.97948 facility: Research Site status: RECRUITING city: Herzogenaurach country: Germany lat: 49.56798 lon: 10.88565 facility: Research Site status: NOT_YET_RECRUITING city: Leipzig country: Germany lat: 51.33962 lon: 12.37129 facility: Research Site status: NOT_YET_RECRUITING city: Lueneburg country: Germany lat: 53.2509 lon: 10.41409 facility: Research Site status: RECRUITING city: Muhlheim country: Germany lat: 50.11667 lon: 8.83333 facility: Research Site status: RECRUITING city: Nurnberg country: Germany lat: 49.45421 lon: 11.07752 facility: Research Site status: RECRUITING city: Russelsheim country: Germany lat: 49.98955 lon: 8.42251 facility: Research Site status: RECRUITING city: Speyer country: Germany lat: 49.32083 lon: 8.43111 facility: Research Site status: RECRUITING city: Wetzlar country: Germany lat: 50.56109 lon: 8.50495 hasResults: False

 nctId: NCT06380725 id: jshim8zay6vd briefTitle: The Treatment of High Intensity Transcranial Current Stimulation for Alzheimer's Disease overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-08 date: 2024-12 date: 2024-04-24 date: 2024-04-24 name: Anhui Provincial Hospital class: OTHER_GOV briefSummary: Alzheimer's disease (AD) is a neurodegenerative disorder characterized by progressive cognitive dysfunction and behavioral impairment. It is currently the most common type of dementia in the old age. At present, the clinical treatment of Alzheimer's disease is expensive and has side effects, so it is very important to explore new methods of treatment for AD. Investigators designed a prospective, randomized, double-blinded and placebo-controlled trial to investigate the effect of transcranial alternating current stimulation (tACS) on cognitive function in AD patients and to assess the biological effectiveness of the treatment. conditions: Alzheimer's Disease conditions: Mild Cognitive Impairment conditions: Dementia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Investigators designed a randomized double-blinded placebo-controlled trial by randomly dividing subjects into two groups: one is the treatment group and the other is the placebo group. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Investigators designed a double-blinded trial in which neither the investigator nor the subjects know whether they will be received the treatment or a placebo. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Transcranial alternating current stimulation(real stimulation) name: Transcranial alternating current stimulation(sham stimulation) measure: Cognitive appraisal measure: Global Cognitive appraisal measure: Psychobehavioral assessment measure: Near-infrared spectroscopy measure: Event related potential measurement measure: Peripheral blood biomarkers measure: Magnetic Resonance Imaging measure: Incidence of side effects sex: ALL minimumAge: 45 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06380712 id: 6509 briefTitle: HYPERTESSA "HyperTessa User Experience Study (HTUX)" overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2024-09-30 date: 2024-10-31 date: 2024-04-24 date: 2024-04-24 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Background: Hypertension is the primary cause of cardiovascular diseases and premature death in the world. Hypertension management starts with the control of blood pressure, whatever it is the type and severity. The optimum control of blood pressure requires regular and frequent auto-monitoring of blood pressure values, adherence to medication plan, and modification of lifestyle behaviours, including diet, quit smoking, and physical activity. This study is a pilot project to assess acceptance ad usability of a digital health solution to be used by patients diagnosed with hypertension. Materials and methods: Prior to the development of the solution, a literature research was performed, then focus group meetings were conducted with senior experts in the digital field, physicians treating hypertension, and patients. A mobile app and web platform were created to help patients in monitoring and reporting data about health status and lifestyle. In order to execute the study, first the physicians in charge of the study will register in the webApp, creating a personal account. Then, patients who meet the inclusion criteria are proposed to participate to the study and, in case of agreement, will be asked to sign the informed consent (IC) statement and the privacy policy. After the phase of profile setting and onboarding, the patient will start to use the mobile App for hypertension management. Once the patient has used the App for the observation period, the physician will be allowed to analyze the data to understand the level of acceptance and regular usage from each patient. This physician will perform this analysis using a web-based portal which is part of the digital solution. Results: During the study, data about usage patterns will be collected. Specific data about usability and acceptance will be gathered through the use of User Experience Questionnaire (UEQ) and unstructured interviews and tests. After each patient has completed the observation period, all the data will be analysed using mainly descriptive statistics to obtain metrics related to usage patterns, usability and adherence. The study results from this pilot phase will be used to modify the digital solution, leveraging an incremental, iterative logic following a co-design and agile methodology. After incorporating the feedback from this pilot and further enriching the solution, next phases of the study are forseen in order to assess the care benefit of such technology in terms of improved treatment outcomes, due to better adherence, higher motivation in practicing healthy lifestyle, better information, and personalized support from HCP. conditions: Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: User Experience / User Acceptance Indicators for patients measure: User Experience / User Acceptance Indicators for Healthcare Professionals sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario A. Gemelli., IRCCS city: Rome country: Italy name: Andrea Flex, MD, PhD role: CONTACT phone: + 39 06 3015 4293 email: andrea.flex@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06380699 id: HJG-CZQH-QHRD106-I briefTitle: Study to Assess PK, Safety and Tolerability in Healthy Subjects overallStatus: COMPLETED date: 2023-03-16 date: 2023-11-16 date: 2023-12-25 date: 2024-04-24 date: 2024-04-26 name: Changzhou Qianhong Bio-pharma Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of QHRD106 in Chinese healthy subjects with single and multiple doses. conditions: Acute Ischemic Stroke studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 56 type: ACTUAL name: QHRD106 Injection name: Yurekline name: placebo measure: Safety as assessed by incidence, severity, and causality of adverse events measure: Plasma measurements of QHRD106 measure: Concentration of bradykinin in plasma sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Nanjing Drum Tower Hospital city: Nanjing state: Jiangsu zip: 210008 country: China lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06380686 id: AIO-KHT-0322/ass briefTitle: Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome acronym: HEAT overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2029-05 date: 2030-05 date: 2024-04-24 date: 2024-04-24 name: AIO-Studien-gGmbH class: OTHER name: Merck Sharp & Dohme LLC briefSummary: Prospective, open, non-interventional, multi-center clinical registry study with the aim to establish a comprehensive research platform reflecting the real-world treatment landscape for recurrent/metastatic head and neck tumor patients. conditions: Squamous Cell Carcinoma of the Oral Cavity conditions: Squamous Cell Carcinoma of the Oropharynx conditions: Squamous Cell Carcinoma of the Hypopharynx conditions: Squamous Cell Carcinoma of the Larynx studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: data collection measure: Sociodemographic factors measure: Treatments measure: Response rates measure: Treatment decision measure: Progression-free survival measure: Time-to-treatment-failure measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitätsklinikum Essen city: Essen zip: 45147 country: Germany name: Victor Grünwald, Prof. Dr. role: CONTACT phone: +49 201 723 85584 email: viktor.gruenwald@uk-essen.de lat: 51.45657 lon: 7.01228 hasResults: False

 nctId: NCT06380673 id: s68299 briefTitle: Stepwise Heat-Denaturated Protein Introduction for Tolerance Induction in Food Allergy acronym: TEHITI overallStatus: RECRUITING date: 2024-04-22 date: 2028-12-30 date: 2029-12-30 date: 2024-04-24 date: 2024-04-24 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: This interventional study aims to validate an early heated protein introduction protocol in cow's milk allergic children who already developed tolerance towards extensively heated cow's milk, in order to speed up the development of complete cow's milk tolerance. Natural complete tolerance induction towards cow's milk takes several years of strict cow's milk avoidance with high risk of anaphylaxis by accidental cow's milk intake. By shortening the time towards complete tolerance, not only the quality of life of both children and parents ameliorates drastically, the time frame for potential anaphylactic reactions is also strongly reduced and can be considered as a preventive strategy to reduce allergic reactions too. Moreover, this strategy has proved efficient for hen's egg allergy. The main question this study wants to answer is whether a 12 months stepwise heated cow's milk introduction (either by gradual reduction of the cooking time or by the use of the Flemish Milk Ladder) in 20'-cooked cow's milk tolerant subjects, results in a larger proportion of complete cow's milk tolerant children after 12 months compared to natural tolerance induction (with 20' cooked milk introduction only). conditions: Food Allergy conditions: Cow Milk Allergy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 90 type: ESTIMATED name: Implementation of cow's milk in decreasingly heated forms name: Implementation of heated cow's milk name: No intervention measure: Complete cow's milk tolerance after 12 months of stepwise heated cow's milk introduction measure: Time to complete tolerance in all three arms measure: Quality of life in all three arms measure: Clinical reactions measure: Side effects measure: IL-10-producing cow's milk specific regulatory T and B cells measure: BATs to mimic the outcome of cow's milk provocation tests sex: ALL minimumAge: 1 Year maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Imelda Hospital Bonheiden status: RECRUITING city: Bonheiden country: Belgium name: Katrien Coppens, MD role: CONTACT lat: 51.02261 lon: 4.54714 facility: AZ Sint-Jan status: RECRUITING city: Brugge country: Belgium name: Kate Sauer, MD role: CONTACT lat: 51.20892 lon: 3.22424 facility: AZ Maria Middelares status: RECRUITING city: Ghent country: Belgium name: Jasmine Leus, MD role: CONTACT lat: 51.05 lon: 3.71667 facility: Jessa Hospital status: RECRUITING city: Hasselt country: Belgium name: Sophie Verelst, MD role: CONTACT lat: 50.93106 lon: 5.33781 facility: UZ Leuven Gasthuisberg status: RECRUITING city: Leuven country: Belgium name: Dominique MA Bullens, Prof. Dr. role: CONTACT phone: +32016343801 email: dominique.bullens@kuleuven.be lat: 50.87959 lon: 4.70093 hasResults: False

 nctId: NCT06380660 id: ACE-106-001 briefTitle: Study of ACE-86225106 to Treat Patients With Advanced Solid Tumors overallStatus: RECRUITING date: 2024-03-22 date: 2028-12-21 date: 2029-03-21 date: 2024-04-24 date: 2024-04-24 name: Acerand Therapeutics (Shanghai) Limited class: INDUSTRY briefSummary: The purpose of this study is to determine if the experimental treatment with poly-ADP ribose polymerase (PARP) inhibitor, ACE-86225106 is safe, tolerable and has anti-cancer activity in adult patients with advanced solid tumors. conditions: Solid Tumor, Adult conditions: BRCA1 Mutation conditions: BRCA2 Mutation conditions: Ovarian Cancer conditions: Breast Cancer conditions: Prostate Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 298 type: ESTIMATED name: ACE-86225106 tablet measure: Number of participants experiencing adverse events (AEs)/serious adverse events (SAEs) measure: The number of patients experiencing dose limiting toxicity (DLT), as defined in the protocol measure: Recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) measure: Objective Response Rate (ORR) measure: Duration of Response (DoR) and Time to Response (TTR) measure: Progression Free Survival (PFS) measure: Overall Survival (OS) measure: Pharmacokinetic (PK) parameters and Pharmacodynamic (PD) marker change measure: Serum tumor marker change: CA125, etc. (OC), prostatic specific antigen (PSA, prostate cancer) decreased, and specific tumor markers for other tumor types may also be included (to be assessed by clinical investigators) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fujian Cancer Hospital status: RECRUITING city: Fuzhou state: Fujian country: China lat: 26.06139 lon: 119.30611 facility: Sun Yat-Sen University Cancer Center status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: Hubei Cancer Hospital status: RECRUITING city: Wuhan state: Hubei country: China lat: 30.58333 lon: 114.26667 facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology status: NOT_YET_RECRUITING city: Wuhan state: Hubei country: China lat: 30.58333 lon: 114.26667 facility: Hunan Cancer Hospital status: RECRUITING city: Changsha state: Hunan country: China lat: 28.19874 lon: 112.97087 facility: Fudan University Shanghai Cancer Center status: RECRUITING city: Shanghai state: Shanghai country: China lat: 31.22222 lon: 121.45806 facility: Zhejiang Cancer Hospital status: RECRUITING city: Hangzhou state: Zhejiang country: China lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06380647 id: 0004 briefTitle: Comparison of Prophylactic Acyclovir and Placebo in Prevention of Eczema Herpeticum in Pediatric Burns acronym: childburn overallStatus: COMPLETED date: 2019-10-01 date: 2020-09-30 date: 2020-09-30 date: 2024-04-24 date: 2024-04-24 name: King Edward Medical University class: OTHER briefSummary: Introduction: Early detection is important in treating patients with Eczema Herpeticum (EH), which may arise in paediatric burn patients. As soon as a clinical diagnosis is confirmed, antiviral medications should be started to ensure an early resolution of the disease. Several studies have indicated that acyclovir is the best treatment for EH lesions in the majority of individuals.

Objective: Compare efficacy of the prophylactic acyclovir and placebo in preventing eczema Herpeticum in paediatric burn patients conditions: Herpes Virus Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Sample size of 64 patients (32 patients in each group) was estimated by using 5% level of significance, 90% power of test with expected percentage of patients given prophylactic acyclovir as 81.3% and patients given placebo as 42.9%. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: parents were blinded to group allocation whoMasked: PARTICIPANT count: 64 type: ACTUAL name: Intravenous Acyclovir measure: Number of participants with positive Tzanck smear sex: ALL minimumAge: 1 Month 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: NCT06380634 id: NYalcinbas briefTitle: The Effectiveness of Motivational Interviewing in Reducing the Use of Household Chemicals and Personal Care Products During Pregnancy overallStatus: COMPLETED date: 2023-01-23 date: 2023-12-31 date: 2024-02-20 date: 2024-04-24 date: 2024-04-24 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: Objective: The aim of the study is to examine the effect of motivational interviewing on reducing the use of household chemicals and personal care products during pregnancy. conditions: Motivational Interview conditions: Cosmetic Product Causing Toxic Effect studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The research was conducted in a prospective pre-test, post-test based randomized controlled experimental research design. primaryPurpose: SCREENING masking: NONE maskingDescription: The groups were randomized into 2 groups using a web-based randomization program (http://www.randomizer.org). The researcher included pregnant women who met the inclusion criteria in the outpatient clinics on certain days of the week, in accordance with the randomization process. count: 130 type: ACTUAL name: Experimental group- Motivational Interview measure: Evaluation Form for Use of Domestic Chemicals and Personal Care Products measure: Self Efficacy Competence Scale measure: Endocrine Disruptors Attitude Scale sex: FEMALE minimumAge: 20 Years maximumAge: 43 Years stdAges: ADULT facility: Istanbul University Cerrahpasa city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-02-05 uploadDate: 2024-04-17T16:09 filename: Prot_000.pdf size: 142041 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-02-05 uploadDate: 2024-04-17T16:13 filename: SAP_001.pdf size: 234444 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-30 uploadDate: 2024-04-17T16:05 filename: ICF_002.pdf size: 75804 hasResults: False

 nctId: NCT06380621 id: IRC/1386/018 briefTitle: Bilateral vs Unilateral Totally Extraperitoneal Repair Among Patients With Unilateral Inguinal Hernia overallStatus: COMPLETED date: 2018-03-15 date: 2019-02-15 date: 2019-03-15 date: 2024-04-24 date: 2024-04-24 name: B.P. Koirala Institute of Health Sciences class: OTHER briefSummary: The goal of this clinical trial is to investigate the feasibility of bilateral laparoscopic exploration for all unilateral cases followed by laparoscopic bilateral TEP repair in all cases with a contralateral occult hernia and to compare complications, recurrence rates, postoperative pain, and operative duration with prospectively performed unilateral repairs in young to middle-aged patients presenting with unilateral hernias in the surgery outpatient department.

The main questions it aims to answer are:

* To compare complications, recurrence rates, postoperative pain, and operative duration between both groups.
* Incidence of occult contralateral hernia Patients attending the OPD for unilateral inguinal hernia were counseled about the trial and fully encouraged to understand the difference between two procedures for unilateral hernia: bilateral exploration and bilateral TEP repair, upon which if a contralateral occult inguinal hernia was observed, documented, and controls were taken from the patients who denied bilateral exploration and underwent unilateral TEP repair. The allotment of patients was done in two groups of 30 patients each.

Researchers will compare Group A( bilateral TEP) with Group B (unilateral TEP) to see if complications, recurrence rates, postoperative pain, and operative duration occur in each group conditions: Inguinal Hernia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ACTUAL name: Totally Extra Peritoneal repair (TEP) repair measure: To compare pain in between patients of bilateral totally extra peritoneal repair and unilateral totally extra peritoneal repair. measure: To measure incidence of intra- and post-operative complication between patients of unilateral and bilateral TEP repair sex: ALL minimumAge: 16 Years maximumAge: 55 Years stdAges: CHILD stdAges: ADULT facility: Bikash Kumar Sah city: Dharān Bāzār state: Koshi zip: 56700 country: Nepal lat: 26.81248 lon: 87.28355 typeAbbrev: Prot_ICF hasProtocol: True hasSap: False hasIcf: True label: Study Protocol and Informed Consent Form date: 2018-03-15 uploadDate: 2024-04-21T09:41 filename: Prot_ICF_000.pdf size: 450800 hasResults: False

 nctId: NCT06380608 id: 0047-23-ASF briefTitle: Levels of Fear, Anxiety and Wound Healing Among Aental Surgery Patients Under Local Versus General Anesthesia overallStatus: RECRUITING date: 2023-09-01 date: 2024-09-30 date: 2024-12-31 date: 2024-04-24 date: 2024-04-24 name: Zoya Haitov Ben Zikri class: OTHER_GOV briefSummary: Tooth extraction is one of the most common procedures in dentistry. Surgical extraction of damaged wisdom teeth involves bone resection and injury to the soft tissue. Dental care often evokes high levels of anxiety.In addition, stress causes poor regulation of endocrine, autocrine and paracrine systems during the three stages of wound healing of the soft oral tissues. Therefore, special considerations are necessary when performing dental surgery on highly stressed patients. One of the options used in the last decade is to perform this procedure under general anesthesia.

A stress response stimulates the secretion of cortisol hormone. Cortisol levels were found to be significantly higher before dental surgery, while after the operation the hormone level dropped significantly.

The aim of the study is to assess the level of anxiety/fear and monitor the wound healing process among patients who are about to undergo surgery to remove wisdom teeth or no more than 3 jaw implants under local anesthesia in the dental clinic compared to patients who are about to undergo the same surgery under general anesthesia. conditions: Wisdom Teeth Extraction or Jaw Implant studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 46 type: ESTIMATED name: Local anesthesia name: General anesthesia measure: Fear and anxiety measure: Wound heeling sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shamir (Asaf Harofe) Medical center status: RECRUITING city: Be'er Ya'aqov zip: 60930 country: Israel name: sara Bar Yehuda, MD role: CONTACT phone: 972528981004 email: sarabar1@shamir.gov.il lat: 31.93864 lon: 34.83749 hasResults: False

 nctId: NCT06380595 id: 23 -1533 briefTitle: Complex EVAR in Inflammatory and Infective Abdominal and Thoracoabdominal Aortic Aneurysms acronym: CEVARII overallStatus: ENROLLING_BY_INVITATION date: 2024-02-21 date: 2025-03 date: 2026-03 date: 2024-04-24 date: 2024-04-24 name: CEVARII class: OTHER name: University of Iowa name: University of Colorado, Denver name: University of Trieste name: University of Copenhagen name: University of Colorado, Colorado Springs briefSummary: Complex endovascular aortic repair in inflammatory and infective perivisceral abdominal aortic aneurysms and thoracoabdominal aortic aneurysms (CEVARII) study is a collaborative international effort among vascular surgeons to establish a database on the global experience in the management of INAAs and IAAs. Ethical approval for the study was obtained from the Colorado Multiple Institutional Review Board (COMIRB) under protocol number 23-1533. conditions: Inflammatory Abdominal Aortic Aneurysm conditions: Aneurysm, Infected conditions: Aneurysm, Mycotic conditions: Abdominal Aortic Aneurysm conditions: Thoracoabdominal Aortic Aneurysm studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 220 type: ESTIMATED name: Complex endovascular aortic repair (cEVAR) measure: Primary Graft Patency measure: Bowel Ischemia measure: Presence of aortic aneurysm endoleak after surgery measure: Aneurysm-related mortality (ARM) measure: Conversion to Open Surgical Repair (OSR) measure: Aortic rupture measure: Post-operative infection-related complication (IRC) measure: The duration of preoperative, perioperative, and postoperative duration of anti-microbial or immunosuppressive pharmacologic therapies. measure: Assessment of Adverse Events (AEs) described in the protocol. measure: All Cause Mortality measure: Continued Aortic sac growth. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado Healthcare city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 hasResults: False

 nctId: NCT06380582 id: NL85595.068.23 briefTitle: Indoor Air Quality, Temperature and Cognitive Performance acronym: AEOLUS overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2024-12-21 date: 2024-12-21 date: 2024-04-24 date: 2024-04-24 name: Maastricht University Medical Center class: OTHER briefSummary: Study design: A cross-over single-blinded treatment design will be used. Participants will undergo 4 different conditions: (1) low air flow and 23°C, (2) low air flow and 35°C, (3) high air flow and 23°C, and (4) high air flow and 35°C. Participants will be blinded to the air quality level; however, it is not possible to blind them to the temperature condition, as they will be able to perceive it as different.

Study population: The population consists of healthy young and middle-aged adults of both sexes between 18 and 40 years.

Intervention (if applicable): Each participant undergoes 4 conditions in randomized order. Two conditions consist of poor air quality defined as 3,000 ppm carbon dioxide and 23°C or 35°C temperature, respectively. conditions: Indoor Air Quality, Temperature and Cognitive Performance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 22 type: ESTIMATED name: Temperature and Airflow combination measure: Cognition measure: Cognition measure: Heart Rate (bpm) measure: Metabolic Rate (ml/kg/min) measure: Blood Pressure (mmHg) measure: Blood samples measure: Saliva samples measure: Breathing rate measure: Temperature (C) measure: Humidity % measure: Carbon dioxide (CO2) concentration (ppm) sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06380569 id: E-1139-21 Community Setting briefTitle: A Strength-Based Intervention to Improve Job Interview Skills in Young Adults in a Community Setting overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-12-01 date: 2024-04-24 date: 2024-04-24 name: Kessler Foundation class: OTHER briefSummary: We are looking to evaluate how effective a strength-based intervention may be in improving job interview skills in young adults. We are examining the effects of this intervention in young adults who may have difficulty with job interviews, and who may want to improve these skills. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Kessler Foundation Strength Identification and Expression (KF-STRIDE®) primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: KF-STRIDE® measure: Mock Job Interview measure: Employment Status measure: Time-to-reach Employment measure: Strength Knowledge and Strengths Use Scale (SKUS) measure: Youth Interview- Self Efficacy and Anxiety measure: Job Search Behavior Scale measure: Work Readiness Scale measure: Global Assessment of Character Strengths (GACS) measure: Rosenberg Self-Esteem Scale (RSES) sex: ALL minimumAge: 14 Years maximumAge: 26 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06380556 id: 25.05.2022/68 briefTitle: The Effect of Mechanical Vibration and ShotBlocker on Pain Levels During Heel Lance in Healthy Term Neonates overallStatus: COMPLETED date: 2022-11-10 date: 2023-01-30 date: 2023-07-13 date: 2024-04-24 date: 2024-04-24 name: Istanbul Medeniyet University class: OTHER briefSummary: This study was conducted to determine the effect of mechanical vibration and ShotBlocker methods on pain level, crying time and procedure time during heel prick blood collection in healthy term infants. conditions: Procedural Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In the study, participants were assigned to groups by block randomization. Type of delivery (vaginal and cesarean section), gender (male and female) and birth weight (2500-3000 g, 3001-3500 g, 3501 and above) variables were used for block randomization. Blocks were repeated three times in each group and 36 participants were assigned to each. A randomization list with 2 X 2 X 3 X 3 blocks was developed using an online randomization tool. In the study, the group to which the first participant was assigned was determined by a sealed envelope method. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Using the block randomization technique, participants were divided into three groups. A web-based randomization list generation tool was used to assign participants to groups. Control and intervention groups were coded as A, B and C using the sealed envelope method. Randomization information was withheld from the researcher involved in data collection until data was collected. The researcher determines which group each baby is in. The researcher found out during the painful procedure. (investigator blinding).

Within the scope of the research, parents knew which group the baby was in. However, due to the nature of the sample group, the babies were blind.

To avoid statistical bias, study groups were coded as A, B and C; statistical blinding was performed (statistician blinding). whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 108 type: ACTUAL name: ShotBlocker name: Mechanical vibration measure: Procedural pain score- Neonatal Infant Pain Scale (NIPS) measure: Crying time measure: Procedure time sex: ALL minimumAge: 38 Weeks maximumAge: 42 Weeks stdAges: CHILD facility: Istanbul Medeniyet University city: Istanbul state: Kadıköy zip: 34720 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06380543 id: BILINCE briefTitle: ERCP Biliary Cannulation Success Using ESGE Algorithm acronym: BILINCE overallStatus: RECRUITING date: 2019-12-12 date: 2024-10-31 date: 2024-12-31 date: 2024-04-24 date: 2024-04-24 name: IRCCS San Raffaele class: OTHER name: Societa Italiana di Endoscopia Digestiva briefSummary: Papillary cannulation attempts have been shown to be an independent predictor of post-ERCP pancreatitis (PEP) when they are repeated more than 5 times or for 5 minutes or when the pancreatic duct is opacified or cannulated by using guidewire more than 1 time. In order to reduce complications, the 2016 ESGE guideline recommends a precise sequence of alternative cannulation techniques to the primary guidewire approach before exceeding the stated limits. However, there are no published data about the routinary application of this biliary cannulation algorithm.

The investigators hypothesised that the ESGE algorithm predicts an increased cannulation success. Nevertheless, it's unclear if this benefit is also associated with a decreased risk of complications, mainly post-procedural pancreatitis. conditions: Biliary Tract Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 800 type: ESTIMATED measure: Success of ERCP biliary cannulation rate measure: ERCP complication rates sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS OSpedale San Raffaele status: RECRUITING city: Milano zip: 20132 country: Italy name: Alberto Mariani, MD role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06380530 id: SIMULA briefTitle: Advanced Surgical Simulation Processes in the Correction of Skeletal Defects and Deformities acronym: SIMULA overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-05 date: 2029-05 date: 2024-04-24 date: 2024-04-24 name: Istituto Ortopedico Rizzoli class: OTHER name: Ospedale Pediatrico Bambino Gesù name: Istituto Giannina Gaslini name: Galeazzi Orthopedic Institute name: Istituto Nazionale Tumori Regina Elena name: Policlinico San Matteo name: Istituto Clinico Humanitas briefSummary: Virtual Surgical Planning (VSP), Computer-Aided Surgical Simulation (CASS) for bone corrections, and the customization of implants and devices through 3D printing, known as Patient-Specific Instruments (PSI) and Graft-Specific Instruments (GSI), are assuming increasingly central roles in orthopedic clinical and surgical practice.

One area witnessing notable advancement is the treatment of musculoskeletal disorders (MMS) in children, adolescents, and young adults. These disorders involve severe and rare abnormalities in skeletal formation and development across three-dimensional planes, often affecting multiple limbs. Managing such deformities is complex, challenging to standardize, and prone to unpredictable clinical, radiographic, and functional outcomes.

The application of 3D modeling and printing technologies offers a deeper understanding of deformities and facilitates improved prediction, precision, reproducibility, and safety in surgical interventions.

The Musculoskeletal Apparatus Network (RAMS Network) centers are equipped with advanced 3D laboratories for surgical simulation and planning, aligned with the overarching goal of improving surgery quality through "in-silico" medicine (ISM) principles.

At present, numerous complex surgeries involving Virtual Surgical Planning (VSP) and sterilizable 3D-printed Patient-Specific Instruments (PSI) and/or Graft-Specific Instruments (GSI) are being simulated and performed at the Rizzoli Institute. Preliminary data from previous protocols indicate a significant reduction in surgical time with the implementation of VSP and the utilization of PSI and GSI.

The aim of this study is to enhance the current process of simulating, planning, and designing surgical support tools within 3D Printing Point-of-Care (3D POC) facilities. To achieve this, it is imperative to expand case volumes and systematically organize, categorize, and standardize simulation and planning procedures. conditions: Musculoskeletal Deformity conditions: Musculoskeletal Abnormalities conditions: Musculoskeletal Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Deformity correction measure: Achieved skeletal corrections measure: Achieved skeletal corrections measure: Operating room times measure: Fluoroscopy times measure: Blood loss measure: Intra- and peri-operative complications measure: Suitability of PSIs measure: Suitability of GSIs measure: Suitability of bone graft measure: Clinical-functional outcome measure: Clinical-functional outcome measure: Cost analysis sex: ALL minimumAge: 2 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: IRCCS Istituto Ortopedico Rizzoli city: Bologna state: BO zip: 40136 country: Italy name: Grazia Chiara Menozzi role: CONTACT phone: 0516266 phoneExt: 484 email: graziachiara.menozzi@ior.it lat: 44.49381 lon: 11.33875 facility: Istituto Clinico Humanitas city: Rozzano state: MI country: Italy lat: 45.38193 lon: 9.1559 facility: Istituto Giannina Gaslini city: Genova country: Italy name: Giorgio Marrè Brunenghi, MD role: CONTACT email: giorgiomarre@gaslini.org lat: 44.40478 lon: 8.94438 facility: Galeazzi Orthopedic Institute city: Milano country: Italy name: Fabio Verdoni, MD role: CONTACT email: fabio.verdoni@grupposandonato.it lat: 45.46427 lon: 9.18951 facility: Policlinico San Matteo city: Pavia country: Italy name: Gianluigi Pasta, MD role: CONTACT lat: 45.19205 lon: 9.15917 facility: Istituto Nazionale Tumori Regina Elena city: Roma country: Italy name: Roberto Biagini, MD role: CONTACT email: roberto.biagini@ifo.it lat: 41.89193 lon: 12.51133 facility: Ospedale Pediatrico Bambino Gesù city: Roma country: Italy name: Pier Francesco Costici, MD role: CONTACT email: pierfrancesco.costici@opbg.net lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06380517 id: ATS23 id: 2UG1EY011751 type: NIH link: https://reporter.nih.gov/quickSearch/2UG1EY011751 briefTitle: Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age acronym: ATS23 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-01 date: 2027-05-01 date: 2024-04-24 date: 2024-04-24 name: Jaeb Center for Health Research class: OTHER name: National Eye Institute (NEI) name: Pediatric Eye Disease Investigator Group briefSummary: In children 4 to 7 years of age, to determine if treatment with 1 hour per day 6 days per week of watching dichoptic movies/shows wearing the Luminopia headset is non-inferior to treatment with 2 hours of patching per day 7 days per week with respect to change in amblyopic eye distance VA from randomization to 26 weeks. conditions: Amblyopia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 238 type: ESTIMATED name: Luminopia name: Eye Patch measure: Change in amblyopic eye logMAR distance VA between randomization and 26 weeks sex: ALL minimumAge: 4 Years maximumAge: 7 Years stdAges: CHILD typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-04-01 uploadDate: 2024-04-18T09:58 filename: Prot_000.pdf size: 715474 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-04-17 uploadDate: 2024-04-18T15:02 filename: SAP_001.pdf size: 4154847 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-04-17 uploadDate: 2024-04-18T09:59 filename: ICF_002.pdf size: 248300 hasResults: False

 nctId: NCT06380504 id: RSWITCH-Ethiopia briefTitle: Increasing the Coverage of Severe Acute Malnutrition (SAM) Treatment in Ethiopia acronym: R-SWITCH overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2026-06-30 date: 2027-06-30 date: 2024-04-24 date: 2024-04-24 name: International Food Policy Research Institute class: OTHER name: Ethiopian Public Health Association name: UNICEF briefSummary: The R-SWITCH intervention aims to address the low coverage of treatment for severe wasting (SAM) by leveraging existing community groups to deliver an integrated package focused on prevention, screening, referral, and treatment of SAM. It includes behavior change communication on child nutrition and health, active screening, improved passive screening at health posts, and follow-up of referred cases and those enrolled in outpatient treatment programs (OTP). The primary objectives of the R-SWITCH studies are to assess the intervention's impact on OTP coverage, identify implementation barriers and facilitators, and evaluate its cost-efficiency and cost-effectiveness. conditions: Acute Malnutrition, Severe conditions: Malnutrition, Child conditions: Wasting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Cluster randomized controlled trial. Unit/cluster of assignment is health post catchment area. Parallel Assignment: baseline-endline design primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE maskingDescription: Evaluator teams will be blinded from intervention allocation count: 1080 type: ESTIMATED name: R-SWITCH integrated intervention package measure: Period prevalence of SAM OTP treatment coverage in children 6-59 months of age measure: Point prevalence of SAM OTP treatment coverage in children 6-59 months of age measure: Period prevalence of SAM OTP treatment coverage in the subgroup of treatment eligible children 6-59 months of age measure: Screening coverage of SAM measure: Screening coverage of severe underweight measure: Platform specific screening coverage of SAM measure: Growth Monitoring Promotion (GMP) consultation attendance measure: AFD group meeting attendance measure: AFD home visit coverage measure: Prevalence of SAM measure: Prevalence of wasting measure: Prevalence of stunting measure: Prevalence of underweight and severe underweight measure: Mean height-for-age Z-score (HAZ) measure: Mean weight-for-height Z-score (WHZ) measure: Mean weight-for-age Z-score (WAZ) measure: Mean mid-upper arm circumference (MUAC) measure: Caregiver's knowledge related to breastfeeding, complementary feeding,child health and hygiene, the condition of severe acute malnutrition, outpatient therapeutic programs, screening of wasting measure: Vaccination coverage measure: Introduction of (semi) solid and soft complementary foods measure: Minimum dietary diversity in infants and young children (6-23 mo) measure: Nr of food groups consumed by infants and young children (6-59 mo) measure: Minimum meal frequency in infants and young children measure: Minimum acceptable diet in infants and young children measure: Continuous breastfeeding 12-23 months measure: Egg and/or flesh food consumption measure: Sweet beverage consumption measure: Zero vegetable or fruit consumption consumption measure: Minimum milk feeding frequency for non-breastfed children measure: Weight-for-length Z-score and MUAC at Severe Acute Malnutrition (SAM) Outpatient Therapeutic Feeding program (OTP) measure: SAM OTP adherence measure: Weight gain rate during SAM OTP measure: SAM OTP outcomes (drop-out, death, transfer, non-response rates) measure: SAM OTP duration sex: ALL minimumAge: 6 Months maximumAge: 5 Years stdAges: CHILD hasResults: False

 nctId: NCT06380491 id: REF.2338 id: UNAM-PAPIIT 32-IN216919 type: OTHER domain: Universidad Nacional Autonoma de Mexico (UNAM) briefTitle: Melatonin's Effect on Nighttime Blood Pressure and Sleep in OSA Patients (MEBP-OSA) acronym: MEBP-OSA overallStatus: RECRUITING date: 2023-06-22 date: 2024-11-22 date: 2025-01-22 date: 2024-04-24 date: 2024-04-25 name: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran class: OTHER name: Universidad Nacional Autonoma de Mexico name: Emory University briefSummary: The goal of this clinical trial is to learn if melatonin works to treat comorbid insomnia in adults with OSA and nocturnal non-dipping blood pressure pattern.

The main question it aims to answer is:

Does melatonin maintain sleep during night and recover the dipping blood pressure pattern? conditions: Obstructive Sleep Apnea of Adult studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients with a non-dipper pattern in blood pressure will randomly enter one of two options: 1) usual medical treatment; 2) treatment with melatonin plus usual care. primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Melatonin 3 MG Oral Tablet measure: Melatonin at a dose of 3 mg before sleep time, after a period of 30 days changes the time awake after sleep onset (WASO), and recovers the dipper pattern of blood pressure sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ) status: RECRUITING city: Mexico City country: Mexico lat: 19.42847 lon: -99.12766 hasResults: False

 nctId: NCT06380478 id: CPRO-000012 briefTitle: Safety and Efficacy of the Bi-Aspheric Monofocal IOL overallStatus: RECRUITING date: 2024-03-05 date: 2024-12-05 date: 2024-12-25 date: 2024-04-24 date: 2024-04-24 name: ICARES Medicus, Inc. class: INDUSTRY name: AST Products, Inc. briefSummary: This is an observational, single-center, non-control, open-label post-marketing study. Patients implanted with an aspicio™ Monofocal Intraocular Lens will be scheduled for a follow-up visit at least 3 months after the surgery to undergo a routine basic ophthalmological examination. conditions: Cataract studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 30 type: ESTIMATED name: aspicio Monofocal IOL measure: CDVA measure: Defocus curve measure: UDVA measure: UIVA measure: CIVA measure: IOL glistening measure: PCO measure: Satisfaction questionnaire measure: AE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chang Gung University Hospital status: RECRUITING city: Taoyuan state: Guishan District zip: 333 country: Taiwan name: Lisa Chen role: CONTACT email: lisa.phchen@gmail.com name: Yih-Shiou Hwang, MD role: PRINCIPAL_INVESTIGATOR lat: 24.95233 lon: 121.20193 hasResults: False

 nctId: NCT06380465 id: 23-11-1838 briefTitle: The Effect of Anthocyanin Intake From Purple Sweet Potato in Cerebral Small Vessel Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2025-04-30 date: 2025-04-30 date: 2024-04-24 date: 2024-04-24 name: Indonesia University class: OTHER name: Fakultas Kedokteran Universitas Indonesia name: Universitas Padjadjaran name: Institut Pertanian Bogor name: School of Science and technology, Kwansei Gakuin University briefSummary: Cerebral small vessel disease (CSVD) is a major cause of disability, cognitive impairment, and functional loss in the elderly. CSVD occurs due to damage to arterioles, capillaries, and venules in the brain parenchyma, and can cause clinical and neuroimaging symptoms. CSVD also accounts for up to 25% of all ischemic stroke cases, and making it the second leading cause of death in the world after ischemic heart disease.

Purple sweet potatoes, scientifically known as Ipomoea batatas (L.) Lam., contains of high anthocyanin specifically peonidin and cyanidin that has antioxidant, anti-inflammatory, and potentially phytoestrogenic activity. These anthocyanins have been linked to a reduced risk of obesity, diabetes, and high cholesterol. They also show potential in improving endothelial function, thereby enhancing blood vessel vasomotor function and potentially reducing the risk of cardiovascular diseases. Anthocyanins and their metabolites can cross the blood-brain barrier and affect signaling pathways, gene expression, and protein function at the molecular level. In addition to their ability to enhance vascular flow, anthocyanins can also help mitigate the risk factors associated with CSVD by counteracting oxidative stress in the body. These findings exploring the potential benefits of anthocyanins for individuals with CSVD by giving purple sweet potatoes extract comparing with placebo.

The outcomes that will be assessed are vasomotor reactivity measured by Breath Holding Index in Transcranial Doppler, Nitric Oxide, L-Arginine and Adiponectin levels in blood, Cognitive Test and Gait. conditions: Cerebral Small Vessel Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The participant who meet the inclusion criteria and have signed the consent will be subjected to a baseline assessment followed by randomization into 2 groups/arms consisting of 2 treatments (1 group getting the water extract pf purple sweet potato) and 1 control group that got placebo. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The research was conducted using a single-blind approach, where the participants were unaware of the intervention being implemented whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: The water extract of "Biang" variety purple sweet potato measure: Breath Holding Index measure: Nitric Oxide measure: L-Arginine measure: Adiponectin measure: Cognitive measure: Gait sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-02 uploadDate: 2024-04-18T03:49 filename: ICF_000.pdf size: 332637 hasResults: False

 nctId: NCT06380452 id: SKABUP id: 2023-507925-41-00 type: OTHER domain: EU-Trial-Nr. (EMA) briefTitle: Therapy for Scabies With Two Differently Concentrated Permethrin Creams acronym: SKABUP overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-07 date: 2028-12 date: 2024-04-23 date: 2024-04-23 name: Infectopharm Arzneimittel GmbH class: INDUSTRY name: Winicker Norimed GmbH briefSummary: The multi-center, prospective, randomized, double-blind phase III clinical trial will primarily investigate the efficacy and safety of treatment of scabies with Permethrin Cream 5% (approved drug InfectoScab 5% Cream) in direct comparison with Permethrin Cream 10%.

The trial participants will be randomly assigned and blinded to either Permethrin Cream 5% or Permethrin Cream 10%. conditions: Scabies studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The SKABUP study is a prospective, randomized, double-blind, 2-arm superiority study in a group sequential design with recruitment stop and interim analysis after 172 patients. If there is no evidence of superiority in the interim analysis, the study will be continued unchanged up to the planned number of 220 patients and will be terminated and analyzed regularly. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: double-blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 220 type: ESTIMATED name: 5% Permethrin Creme name: 10% Permethrin Creme measure: clinical efficacy (yes/no) measure: effectiveness at Visit 1 measure: frequency of therapy success measure: itching measure: patients with evidence of mites measure: patients with use of antiscabiosa not compliant with the protocol measure: patients with new scabies efflorescences measure: patients with "additional confirmed" treatment failure measure: AEs, SAEs, ADRs, SUAWs sex: ALL minimumAge: 2 Years maximumAge: 85 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06380439 id: 23-10-1763 briefTitle: The Effect of Wrist Ankle Acupuncture on Post-Total Hip Arthroplasty Pain overallStatus: RECRUITING date: 2024-04-23 date: 2024-07 date: 2024-07 date: 2024-04-23 date: 2024-04-29 name: Indonesia University class: OTHER briefSummary: Total hip arthroplasty is one of the most cost-effective orthopedic surgical procedures which can restore hip function and improve the patient's quality of life. However, total hip arthroplasty is significantly associated with postoperative pain. Pain after total hip arthroplasty surgery can adversely affect the patient's early postoperative recovery, postoperative mobility, and hinder rehabilitation.

Wrist ankle acupuncture (WAA) is a simpler acupuncture technique, using fewer points, shallow needle insertion and lighter stimulation. Wrist-ankle acupuncture as multimodal analgesia after orthopedic surgery is useful for reducing pain and reduce the incidence of post-surgical side effects. The primary aim of this study is to investigate whether wrist ankle acupuncture therapy gives better and results for post total hip arthroplasty pain than sham wrist ankle acupuncture conditions: Pain, Postoperative conditions: Hip Osteoarthritis conditions: Hip Fractures conditions: Hip Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: wrist ankle acupuncture measure: Visual Analog Scale measure: recovery rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cipto Mangunkusumo Hospital status: RECRUITING city: Jakarta Pusat state: Jakarta zip: 10430 country: Indonesia name: Cipto Mangunkusumo Hospital role: CONTACT phone: 1 500 135 lat: -6.1818 lon: 106.8223 facility: Fatmawati Hospital status: RECRUITING city: Jakarta zip: 12430 country: Indonesia name: Fatmawati Hospital role: CONTACT phone: 0217501524 lat: -6.21462 lon: 106.84513 facility: Persahabatan Hospital status: RECRUITING city: Jakarta zip: 13230 country: Indonesia name: Persahabatan Hospital role: CONTACT phone: (021) 4891708 lat: -6.21462 lon: 106.84513 hasResults: False

 nctId: NCT06380426 id: APHP230441 id: IDRCB : 2023-A02003-42 type: OTHER domain: ANSM briefTitle: Real-life Evaluation of WEGOVY (Semaglutide) Treatment in Adults With Monogenic Obesity (ObGeSema) acronym: ObGeSema overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-04-30 date: 2027-11-30 date: 2024-04-23 date: 2024-04-23 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Rare genetic forms of obesity, so called monogenic obesity are linked to alteration in energy balance involving hypothalamic pathways.

More than 60 genes encoding for proteins located in the hypothalamic leptin/melanocortin pathway have been described in the French National Protocol for Diagnostic and Care (PNDS).

The natural history of monogenic obesity is characterized by an early onset in childhood, with a major increase in weight in adolescence and young adulthood. The worsening of obesity exposes these patients to severe complications.

Severe obesity and eating disorders have a major impact on the quality of life of the person but also of the family and caregivers. Clinical management is complex and requires comprehensive, specialized and multidisciplinary management. But the usual lifestyle approaches have so far shown disappointing results, similarly to bariatric surgery which leads to a more frequent weight regain in the situation of monogenic obesity, justifying new approaches.

In this context, evaluating the response to treatment in the particular condition of monogenic obesity is crucial to propose therapeutic options as early as possible to limit weight evolution and its complications.

GLP-1 (glucagon-like peptide 1) based innovative therapies have recently emerged as a promising option for treatment of obesity and its complications. This is the case for Semaglutide 2.4mg/week (WEGOVY®), developed by Novo Nordisk. However, there is a lack of data to confirm that semaglutide could be also effective in monogenic obesity.

The hypothesis in this study is that treatment with Semaglutide 2.4mg/week (WEGOVY®) could be as effective in monogenic obesities as in common obesity. conditions: Monogenic Obesity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 175 type: ESTIMATED measure: Change in weight and Body Mass Index (BMI) measure: Change in weight and Body Mass Index (BMI) measure: Reduction of body weight equal to or above 5% measure: Change in Hunger score measure: Change in eating behaviour measured by Food Craving questionnaire measure: Change in eating behaviour measured by the Binge Eating Scale (BES) measure: Change in eating behaviour measured by the Dutch Eating Behaviour Questionnaire (DEBQ) measure: Change in eating behaviour measured by the Dykens questionnaire measure: Change in eating behaviour measured by the Child Eating Behaviour Questionnaire (CEBQ) measure: Change in the International physical activity questionnaire (IPAQ - short form) measure: Change in Digestive disorders (GIQLI ) measure: Change in sleep disorder (MCTQ score) measure: Change in score of quality of life scores (patient and parents) measure: Change in anxiety and depression score measure: Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre de référence Syndrome de Prader-Willi et autres obésités avec troubles du comportement alimentaire (PRADORT). Service de Nutrition, GH Pitié-Salpêtrière, APHP city: Paris zip: 75013 country: France name: Emilie GUILLON role: CONTACT email: emilie.guillon-ext@aphp.fr name: Sarra POCHON role: CONTACT phone: +33(1)42167574 email: sarra.pochon@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06380413 id: 78972024.7.0000.5313 briefTitle: Tai Chi Chuan Combined With Walking on Physical and Mental Parameters of Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-05-20 date: 2024-12-31 date: 2025-07-31 date: 2024-04-23 date: 2024-04-23 name: Federal University of Pelotas class: OTHER briefSummary: Background: Tai Chi Chuan, a Chinese martial art style, is a mind-body modality that has shown positive impacts on health markers in various populations, particularly older adults. This study aims to investigate the effects of a 12-week program of Tai Chi Chuan exercises based on the Yang 16-movement form and walking on older adults' physical and mental markers.

Methods: This study is a randomized, single-blinded, two-arm, parallel, superiority trial. Forty older adults between 60 and 75 years old who are not engaged in any systematic strength and aerobic training program will be recruited. Candidates with language and cognitive problems, a history of cardiovascular diseases (except controlled hypertension), osteoarticular limitations and fractures, severe injuries, and prosthetic placement in the last six months will be excluded. Participants will be randomly allocated on a 1:1 ratio to a 12-week intervention with Tai Chi Chuan and walking two times per week, or an active-control group with walking two times per week. Physical measures will be muscle strength (i.e., knee extensors maximum strength and lower limbs functional performance -primary outcomes-, dynamic knee extensors endurance, handgrip strength, back-leg-chest strength), functional capacity, static balance, muscle thickness and muscle quality of quadriceps. Mental measures will be quality of life, sleep quality, cognitive function, and depressive and anxiety symptoms. Outcomes will be measured before and after 12 weeks of intervention. The analysis plan will use an intention-to-treat approach and protocol criteria.

Discussion: The conceptual hypothesis is that the intervention training program with Tai Chi Chuan and walking will lead to greater improvements in both physical and mental parameters due to its multi-component character compared to the walking active-control group. conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is a randomized, single-blinded, two-arm, parallel, superiority trial. Forty healthy and physically inactive subjects, 60 to 75 years of age, are recruited. Participants are randomly allocated on a 1:1 ratio to a 12-week intervention of Tai Chi Chuan plus walking program twice a week, or an active-control group of walking twice a week. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Blinding will be implemented for the outcome assessors. All tests and questionnaires will be supervised by an evaluator blinded to the participant's group. Due to the type of intervention, the investigator conducting exercise sessions and participants will not be blinded. whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Tai Chi Chuan Plus Walking name: Walking measure: Maximal dynamic strength measure: Functional test - 30-s Chair-stand test measure: Dynamic muscular endurance measure: Isometric handgrip strength measure: Isometric back-leg-chest strength measure: Functional tests - arm curl measure: Functional tests - 8-ft Up-and-Go measure: Functional tests - Chair Sit-and-Reach measure: Functional tests - Back Scratch measure: Funcional tests - 6-min Walk measure: Static balance - 30-second single-leg stance test measure: Quadriceps muscle thickness measure: Quadriceps muscle quality measure: Objective cognitive function - Trail Making Test (TMT) measure: Objective cognitive function - Controlled Oral Word Association Test (COWAT) measure: Quality of Life - Abbreviated World Health Organization Quality of Life (WHOQOL-Bref) measure: Sleep quality - Pittsburgh Sleep Quality Index measure: Depressive and anxiety symptoms is measured using the Hospital Anxiety and Depression Scale (HADS) measure: Body mass measure: Height measure: Waist and hip circumferences measure: Monitoring the intensity of training sessions - Borg Category-Ratio 10 (CR-10) measure: Follow-up questionnaire measure: Adherence assessments measure: Health Questionnaire measure: Level of physical activity - International Physical Activity Questionnaire (IPAQ) - extended version measure: Cognitive screening - Mini-mental state examination (MMSE) sex: ALL minimumAge: 60 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Escola Superior de Educação Física e FIsioterapia city: Pelotas state: Rio Grande Do Sul zip: 96055630 country: Brazil name: Cristine L Alberton, PhD role: CONTACT lat: -31.77194 lon: -52.3425 hasResults: False

 nctId: NCT06380400 id: 0000-0001-5786-4385 briefTitle: The Effect of Foot Bath on Birth Pain and Birth Comfort overallStatus: RECRUITING date: 2024-02-01 date: 2024-07-30 date: 2024-07-30 date: 2024-04-23 date: 2024-04-23 name: Selcuk University class: OTHER briefSummary: Although childbirth is seen as a natural, happy, meaningful and universal experience, women are often faced with severe pain, discomfort and a sensory state that can be overwhelming. There are two ways to reduce labour pain: pharmacological (drugs) and non-pharmacological (non-drug methods). Non-pharmacological methods, in particular, attempt to relieve pain by addressing emotional, cognitive, behavioural and socio-cultural dimensions. These methods provide relief and reduce the perception of pain. One of the non-pharmacological methods used to reduce labour pain is footbaths. Footbaths are widely used as a nurse/midwife intervention in many countries. Footbathing is a simple technique used to induce a sense of comfort and relaxation. It involves gently immersing the patient's legs and feet (below the knees) in a basin of warm water. Local heat treatments are generally safe and are considered an effective form of complementary medicine. In its simplest form it means "a tool to be part of supportive care, promoting peace, positive emotions, comfort, satisfaction and enjoyment". The mechanisms responsible for the effects of footbathing are not fully understood, but soaking the feet in warm water and stimulating the sense of touch through massage or washing can reduce sympathetic nerve activity, thereby reducing pain and increasing comfort. In other words, reducing pain during labour means providing support and comfort to the woman. This study was designed to evaluate the effect of a foot bath applied in the first stage of labour on labour pain and comfort in nulliparous women. conditions: Parturition studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 196 type: ESTIMATED name: Foot bath measure: Visuell analog scale score of the pregnant woman measure: Birth comfort scale score of the pregnant woman sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Habibe Bay Ozcalik status: RECRUITING city: Konya zip: 42250 country: Turkey name: Habibe Bay Ozcalik role: CONTACT phone: 05424469343 email: habiberk@hotmail.com lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06380387 id: H-21046543 briefTitle: Whole Body Metabolism in Children Before and After Treatment of CNS Tumor overallStatus: RECRUITING date: 2023-03-23 date: 2025-12 date: 2026-12 date: 2024-04-23 date: 2024-04-23 name: Rigshospitalet, Denmark class: OTHER briefSummary: At the center of pediatric oncology in Copenhagen the investigators experience that the children with brain tumor, more or less have a healthy body with normal skeletal muscle mass and are physical active to the same level as their friends at the same age. The treatment period for brain tumor is approximately two years. After the treatment period, the children are more sedative with less interest in coming out doing physical activities and thus the investigators suspect that they have altered hormonal response, low skeletal muscle mass and perhaps are in risk of developing metabolic syndrome.

By comparing children with newly diagnosed CNS tumor with children finished treated for CNS tumor, we wish to describe the metabolic path during the approximately two years treatment period these children go through. These results will also be compared with results from healthy controls.

The investigators aim to include 10 children (aged 6-18 years) with newly diagnosed CNS tumor, 10 children (aged 6-18 years) finished treated for CNS tumor and 10 healthy controls (aged 6-18 years). By using stable isotope technique the investigators will investigate systemic fat, glucose and protein metabolism together with liver protein degradation and glucose production. Furthermore, by using DXA scan the investigators will describe the quality and distribution of skeletal muscle. Lastly, the investigators will determine the skeletal muscle signal pathway and metabolism in skeletal muscle via the Bergström biopsy technique in vastus lateralis. conditions: CNS Tumor, Childhood studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 30 type: ESTIMATED name: Meal measure: Protein breakdown measure: Protein synthesis measure: Phenylalanine concentration measure: Phe oxidation to TYR measure: Whole-body protein synthesis measure: Whole-body protein degradation measure: Netto protein balance measure: Glucose Rate of appearance measure: Total glucose Rate of appearance measure: Total glucose Rate of disappearance measure: Endogenous glucose measure: Oral phenylalanine Rate of appearance measure: Phenylalanine oxidation measure: Rate of Appearance of Palmitate in Plasma measure: Rate of Disappearance of Palmitate measure: Concentration of ketones measure: Glucose measure: Quality of Skeletal Muscle measure: Protein synthesis rate measure: Pain score measure: Life quality score measure: Muscle biopsy measure: Incretins measure: Glucagon measure: Liver parameters ALT, AST, GGT measure: Bilirubin measure: International normalized ratio (INR) measure: LDH measure: Insulin measure: catecholamines measure: Blood pressure measure: Waist- and hip circumference measure: Lipids measure: Concentration of Plasma Amino Acids measure: Concentration of Plasma Glucose measure: Concentration of Plasma Palmitate measure: Concentration of Plasma Free Fatty Acids measure: Level of HbA1c sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Department of Pediatrics and Adolescent Medicine and Copenhagen Neuromuscular Center, Rigshospitalet status: RECRUITING city: Copenhagen state: Copenhagen Ø zip: 2100 country: Denmark name: Mette Cathrine Ørngreen, MD, DMSc role: CONTACT phone: 35455935 email: mette.cathrine.oerngreen.01@regionh.dk name: Mette Cathrine Ørngreen, MD, DMSc role: PRINCIPAL_INVESTIGATOR lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06380374 id: 2024\01 briefTitle: Gamification in Disaster Nursing Education overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-07-01 date: 2024-07-22 date: 2024-04-23 date: 2024-04-23 name: Selcuk University class: OTHER briefSummary: This research will be conducted as a randomized controlled study with a parallel design to evaluate the effectiveness of the disaster nursing training program prepared with a gamification strategy based on multiple intelligence theory for final-year public health nursing students. Research hypothesis "H1a: The disaster nursing knowledge level of the students participating in the program, which is prepared with a Gamification Strategy Based on Multiple Intelligence Theory, differs from the control group. H1b: The perception of volunteering towards disaster nursing differs for the students included in the Program Prepared with Gamification Strategy Based on Multiple Intelligence Theory compared to the control group. H1c: The self-efficacy level of students involved in the Program Prepared with Gamification Strategy Based on Multiple Intelligences Theory regarding disaster nursing differs from the control group." conditions: Gamification conditions: Nursing Students conditions: Multiple Intelligence Theory conditions: Disaster Nursing studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 72 type: ESTIMATED name: Gamification in Disaster Nursing Education measure: Level of knowledge related to disaster nursing services measure: Volunteer intention to become a disaster nurse measure: Perception of self-efficacy related to disaster nursing sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Selcuk University Faculty of Nursing city: Konya state: Selcuklu zip: 42000 country: Turkey name: Sema Yilmaz Dean, MD role: CONTACT phone: +903322230763 email: hemsirelikfakultesi@selcuk.edu.tr lat: 37.87135 lon: 32.48464 hasResults: False

 nctId: NCT06380361 id: SEN-ONCO-1 briefTitle: InvestigatioN of a Smart Probe for Lung lEsion Characterization Using Impedance Technology acronym: INSPECT overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-03-31 date: 2025-04-01 date: 2024-04-23 date: 2024-04-23 name: Sensome class: INDUSTRY briefSummary: The objective of the study is to evaluate the feasibility of the BioSpy System sensor to differentiate tissues that are encountered during bronchoscopic biopsy of endobronchial tumors and peripheral lung nodules and masses. conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patient with suspected lung cancer coming to the hospital for bronchoscopic biopsy will be selected for this trial. primaryPurpose: OTHER masking: NONE maskingDescription: No masking count: 30 type: ESTIMATED name: BioSpy System measure: The ability of BioSpy System to acquire electrophysiological measurements in the relevant tissues during bronchoscopic biopsy. measure: The ability of BioSpy Sysem to differentiate the lesion from healthy tissue measure: The ability of BioSpy Sysem to differentiate various lesion types sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06380348 id: JMT101-012 briefTitle: JMT101 in Combination With Osimertinib, Versus Cisplatin-pemetrexed in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Exon 20ins Mutations overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2027-03-26 date: 2028-03-26 date: 2024-04-23 date: 2024-04-23 name: Shanghai JMT-Bio Inc. class: INDUSTRY briefSummary: This is a multicenter, randomized, open-label, parallel-controlled phase 3 study. This study aims to evaluate the efficacy and safety of JMT101 combined with Osimertinib compared with Cisplatin combined with pemetrexed in participants with local advanced or metastatic non-small-cell lung cancer harboured EGFR 20ins mutation without prior systemic therapy.

Primary objective of this study is to assess the efficacy of JMT101 combined with Osimertinib versus Cisplatin combined with pemetrexed using by （Independent Review Center）IRC-assessed Progression Free Survival (PFS) per RECIST 1.1 as primary endpoint. Approximately 398 participants are estimated to be randomized into the study. Participants enrolled will be randomized to JMT101 or Cisplatin chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without) and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (0 versus 1). conditions: Local Advanced or Metastatic NSCLC studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 398 type: ESTIMATED name: JMT101 Injection name: Osimertinib tablet name: Cisplatin injection name: Pemetrexed injection measure: Progression Free Survival (PFS) as assessed by Independent Review Center (IRC) per RECIST 1.1 measure: Overall Survival (OS) measure: Overall Response Rate (ORR) by IRC per RECIST 1.1 measure: Duration of Response (DoR) by IRC per RECIST 1.1 measure: PFS by investigator per RECIST 1.1 measure: ORR by investigator per RECIST 1.1 measure: DoR by investigator per RECIST 1.1 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06380335 id: RTX001-01S briefTitle: Study in Patients With Decompensated Liver Cirrhosis acronym: OPAL overallStatus: RECRUITING date: 2023-10-10 date: 2024-12-31 date: 2026-11-03 date: 2024-04-23 date: 2024-04-23 name: Resolution Therapeutics Limited class: NETWORK briefSummary: OPAL is a multicenter observational study, following the natural disease trajectory of participants who have permanent damage to their liver caused by scarring, sometimes also referred to as liver cirrhosis. These participants will also have recently had an acute worsening of their liver disease, which is also known as a hepatic decompensating event, which has resulted in them being admitted to hospital or required them to seek medical attention as an outpatient. conditions: Liver Cirrhosis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 240 type: ESTIMATED measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation. measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation. measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation. measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation. measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation. measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation. measure: Follow the natural history of patients admitted to hospital with hepatic decompensation. measure: Follow the natural history of patients admitted to hospital with hepatic decompensation. measure: Follow the natural history of patients admitted to hospital with hepatic decompensation. measure: Follow the natural history of patients admitted to hospital with hepatic decompensation. measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation. measure: Explore clinical and laboratory parameters. measure: Evaluate the effect of disease progression on biomarkers of inflammatory activity sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bristol Royal Infirmary status: RECRUITING city: Bristol zip: BS2 8HW country: United Kingdom lat: 51.45523 lon: -2.59665 facility: Royal Infirmary Edinburgh status: RECRUITING city: Edinburgh zip: EH16 4SA country: United Kingdom lat: 55.95206 lon: -3.19648 facility: Royal Liverpool Hospital status: RECRUITING city: Liverpool zip: L7 8XP country: United Kingdom lat: 53.41058 lon: -2.97794 facility: Royal Free Hospital status: RECRUITING city: London zip: NW3 2QG country: United Kingdom lat: 51.50853 lon: -0.12574 facility: King's College Hospital status: RECRUITING city: London zip: SE5 9RS country: United Kingdom lat: 51.50853 lon: -0.12574 facility: St George's Hospital status: RECRUITING city: London zip: SW17 0QT country: United Kingdom lat: 51.50853 lon: -0.12574 facility: St Mary's Hospital status: RECRUITING city: London zip: W2 1NY country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Nottingham University Hospital status: RECRUITING city: Nottingham zip: NG5 1PB country: United Kingdom lat: 52.9536 lon: -1.15047 facility: Sunderland Royal Hospital status: RECRUITING city: Sunderland zip: SR4 7TP country: United Kingdom lat: 54.90465 lon: -1.38222 hasResults: False

 nctId: NCT06380322 id: PBRC 2023-034 briefTitle: Military Health and Nutrition Examination Study acronym: MHANES overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-12-01 date: 2026-12-01 date: 2024-04-23 date: 2024-04-23 name: Pennington Biomedical Research Center class: OTHER name: U.S. Army Medical Research and Development Command briefSummary: The Military Health and Nutrition Examination Study (MHANES) is a Department of Defense funded study conducted by Pennington Biomedical Research Center and the US Army Research Institute of Environmental Medicine. This cross-sectional study will assess, in a large, diverse sample of Army Service Members (n=600), food and supplement intake, cardiovascular health, body composition, biomarkers of nutritional status, measures of health status, injury prevalence, mental wellbeing, gut microbiome composition, and physical performance outcomes. The proposed study is modeled after the National Health and Nutrition Examination Survey (NHANES) and customized for the Army population. conditions: Hypertension conditions: Type 2 Diabetes conditions: Dyslipidemias conditions: Cardiovascular Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 600 type: ESTIMATED measure: Dietary intake measure: Dietary quality measure: Depression measure: Anxiety measure: Resilience measure: Posttraumatic stress disorder measure: Self-efficacy measure: Mood measure: Physical activity measure: Physical activity measure: Physical performance measure: Physical injuries measure: Sleep duration and quality measure: Sleep duration and quality measure: Eating behavior (Satiety) measure: Eating behavior (Fast Eating Rate) measure: Eating behavior (Slow Eating Rate) measure: Blood pressure measure: Anthropometric and body composition measures measure: Measures of anemia and iron status, nutrient status, hormone status, stress, cardiometabolic health, and inflammation measure: Albumin, iodine, and other biomarkers of health measure: Gut microbiome composition measure: Prescription and over-the-counter medication and supplement use measure: Resting metabolic rate (RMR) measure: Heart rate variability (HRV) measure: Genomics sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pennington Biomedical Research Center city: Baton Rouge state: Louisiana zip: 70808 country: United States name: Claire E Berryman, PhD, RD role: CONTACT email: claire.berryman@pbrc.edu lat: 30.45075 lon: -91.15455 hasResults: False

 nctId: NCT06380309 id: LY001-I001 briefTitle: A Clinical Study on Evaluating Intravenous Administration of IDOV-SAFE overallStatus: RECRUITING date: 2024-05-06 date: 2025-11-30 date: 2027-10-30 date: 2024-04-23 date: 2024-04-23 name: Peking University class: OTHER briefSummary: Subjects were inoperable Chinese patients with histologically or cytologically confirmed advanced malignant solid tumors (mainly focusing on MSS type colorectal cancer) who had failed standard systemic therapy.

In the first stage, each subject was given three doses on day 1, day 3 and day 5, and was divided into 4 dose groups, including 1 subject in the first dose group and 3-6 subjects in each of the last three dose groups. The second stage was the dose extension stage, with 2 dose groups, at least 10 subjects were enrolled in the selected group, and the administration method was the same as that of the first stage. There were about 20-60 cases in the two stages. conditions: Advanced Malignant Solid Tumor of Digestive System studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: IDOV-SAFE measure: Occurrence of dose-limiting toxicity (DLT) measure: Incidence of adverse events (AE) measure: The level of (non-essential) viral DNA in tumor tissue measure: Tumor markers measure: Anti-vaccinia virus neutralizing antibody test(VV-Nab) measure: Levels of viral DNA in blood measure: Levels of viral DNA in saliva measure: T cell subsets measure: Cytokines measure: ORR measure: DCR measure: DOR measure: PFS measure: OS sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Cancer Hospital status: RECRUITING city: Beijing country: China name: Lin Shen role: CONTACT phone: +86 10 8819 6561 email: doctorshenlin@sina.cn lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06380296 id: 2024-10240 briefTitle: Outcomes of NeoMTA and NeoPUTTY Pulpotomies in Primary Molars overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-09 date: 2027-03 date: 2024-04-23 date: 2024-04-23 name: McGill University Health Centre/Research Institute of the McGill University Health Centre class: OTHER briefSummary: The goal of this clinical trial is to evaluate the outcomes of different medications used for pulpotomies (baby root canal) in children. The main question it aims to answer is: • what are the long-term clinical and radiographic success of pulpotomies in baby teeth using two different medications (NeoMTA and NeoPUTTY) over a 24-month follow-up period? Healthy children aged between 3 and 10 years undergoing dental treatment under general anesthesia who have deep caries lesions approximating or reaching the nerve will be invited to participate in this study. Pulpotomies (baby root canal) will be performed by trained dentists following a protocol. Children will receive pulpotomies either with NeoMTA or NeoPUTTY, two medications indicated for the procedure. Participants will be asked to come for an appointment at 1, 6, 12 and 24 months after the procedure. Researcher will compare the clinical and radiographic performance of pulpotomies (baby root canal) done with both medications. conditions: Pulp Disease, Dental studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Primary molars pulpotomies with NeoMTA name: Primary molar pulpotomies with NeoPUTTY measure: Success rate of a primary molar pulpotomy measure: Radiographic success of a primary molar pulpotomy sex: ALL minimumAge: 3 Years maximumAge: 10 Years stdAges: CHILD hasResults: False

 nctId: NCT06380283 id: 2024-10221 briefTitle: The Feasibility and Clinical Utility of the Use of Virtual Reality for the Management of Pediatric Dental Anxiety overallStatus: RECRUITING date: 2024-03-21 date: 2025-07 date: 2026-01 date: 2024-04-23 date: 2024-04-23 name: McGill University Health Centre/Research Institute of the McGill University Health Centre class: OTHER briefSummary: The use of virtual reality (VR) in pediatric healthcare settings helps to reduce children's pain and anxiety. However, this technology has not been used consistently in pediatric dentistry. Consequently, the goal of this study is to investigate the effectiveness of using a Virtual Reality headset as a distraction technique during dental procedures in children and identify patient and clinician's opinions regarding its use.

This study incorporates a single-site, randomized clinical trial design with two paralleled study groups. One group will receive dental treatment following regular standard of care of behavior management while the second group will receive dental treatment using a Virtual Reality distraction headset. Patients in both groups will complete a questionnaire to assess their perception of pain and anxiety before and after the intervention, as well as their satisfaction with the dental treatment. The dentist providing the treatment will also report their observations relating to patient behavior during dental treatment. conditions: Children, Only conditions: Dental Anxiety conditions: Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 128 type: ESTIMATED name: Virtual reality headset measure: Children's pain perception during dental treatment measure: Children's fear during dental treatment measure: Children's acceptability of virtual reality intervention during dental care measure: Oral health care provider's acceptability of virtual reality during dental care sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Division of Dentistry, Montreal Children's Hospital, McGill University Health Centre status: RECRUITING city: Montreal state: Quebec country: Canada name: Beatriz Ferraz dos Santos, DDS, MSc role: CONTACT phone: +1 (514) 412-4400 phoneExt: 23357 email: beatriz.ferrazdossantos@muhc.mcgill.ca lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06380270 id: LUMHS/B12/Temp/14.04.2024 briefTitle: Safety and Human Tolerance of Oral Probiotic Streptococcus Salivarius K12 overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-10-31 date: 2024-12-31 date: 2024-04-23 date: 2024-04-23 name: Liaquat University of Medical & Health Sciences class: OTHER briefSummary: Streptococcus salivarius K12, an oral probiotic strain, has emerged as a promising tool in promoting oral health. Found naturally in the mouth, S. salivarius K12 works by establishing itself in the oral cavity and producing antimicrobial compounds, such as bacteriocins, including salivaricin A2 (SalA2) and the 2,740-Da salivaricin B (SboB) lantibiotics, which inhibit the growth of harmful bacteria including Streptococcus pyogenes. By maintaining a healthy balance of oral microbiota, this probiotic may help prevent common oral health issues such as bad breath, throat infections, and tooth decay. While further research is needed to fully elucidate its mechanisms and efficacy, S. salivarius K12 holds potential as a natural and safe adjunct to oral hygiene practices for promoting overall oral health and hygiene. conditions: Strep Throat studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 54 type: ESTIMATED name: Oral probiotic Streptococcus salivarius K12 sachet measure: Effect on oral health physical condition measure: Effect on other physical features measure: Effect on vital signs measure: Effect on vital signs measure: Effect on vital signs measure: Effect on vital signs measure: Effect on blood biochemistry measure: Effect on blood biochemistry measure: Effect on blood biochemistry measure: Effect on blood biochemistry measure: Effect on blood electrolytes balance measure: Effect on hematology measure: Incidence of inflammation measure: Incidence of gastrointestinal side effects measure: Incidence of Adverse events (AEs) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Liaquat University of Medical and Health Sciences city: Jāmshoro zip: 76090 country: Pakistan name: Dr. Amjad Khan, DPhil role: CONTACT phone: 03000506955 email: amjadkhan@lumhs.edu.pk lat: 25.43773 lon: 68.28522 hasResults: False

 nctId: NCT06380257 id: ANBA briefTitle: Anorexia Nervosa and Brain in Adolescence overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2030-08 date: 2030-12 date: 2024-04-23 date: 2024-04-23 name: Kuopio University Hospital class: OTHER briefSummary: Aims of this follow-up study are to investigate effects of anorexia nervosa on brain structure and functions in adolescence. conditions: Anorexia Nervosa studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Observational study methods measure: Neuroimaging measure: Neuroimaging measure: Psychiatric evaluation measure: Body composition measurement measure: Laboratory tests sex: ALL minimumAge: 16 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06380244 id: 1072.6120.136.2023 briefTitle: Opioid-free Anesthesia as an Alternative to General Anesthesia in Abdominal Surgery overallStatus: RECRUITING date: 2024-03-10 date: 2025-12-31 date: 2025-12-31 date: 2024-04-23 date: 2024-04-23 name: Jagiellonian University class: OTHER briefSummary: Due to the increasing number of reports of cancer progression in people undergoing surgery under general anesthesia using opioids, OFA is believed to have a favorable long-term prognostic effect, especially in cancer patients. The opioid-free protocol is also used in postoperative analgesia. It is estimated that up to 75% of surgical patients experience chronic postoperative pain, which has a particularly negative impact on the quality of life.

The investigators would like to compare pain during the first 48 postoperative hours of patients undergoing abdominal surgery who would be anesthetized with opioids and without opioids (patients would be randomly assigned to a group) (1, 2, 6, 12, 24 and 48 h after operations). A secondary objective will be to measure total oxycodone consumption in the postoperative period in both groups. Other secondary objectives: assessment of postoperative nausea and vomiting (PONV). conditions: Analgesics, Opioid conditions: Anesthesia, Endotracheal conditions: Anesthesia, General studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: anesthesia without opioids measure: Pain level measure: Total long acting opioid consumption in oxycodone equivalents sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jagiellonian University status: RECRUITING city: Kraków state: Malopolskie zip: 31501 country: Poland name: Tomasz Skladzien, phd md role: CONTACT phone: 506602250 phoneExt: 48 email: t.skladzien@interia.pl lat: 50.06143 lon: 19.93658 hasResults: False

 nctId: NCT06380231 id: IRU-YAZILE-001 briefTitle: Skin-to-skin Contact Between Premature Infant and Mother overallStatus: COMPLETED date: 2019-11-01 date: 2019-12-01 date: 2020-12-01 date: 2024-04-23 date: 2024-04-23 name: Istanbul Rumeli University class: OTHER briefSummary: Aim: To determine the effect of kangaroo mother care (KMC) on perfusion index, heart rate, and oxygen saturation in premature infants who were discharged early and admitted to the neonatal intensive care in the following days. conditions: Kangaroo-mother Care studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 76 type: ACTUAL name: kangaroo mother care (KMC) measure: power analysis measure: The effect of kangaroo mother care sex: ALL minimumAge: 24 Weeks maximumAge: 37 Weeks stdAges: CHILD facility: TC Istanbul Rumeli University city: Istanbul state: Haliç zip: 34445 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06380218 id: 2023-A00249-36 briefTitle: Evaluation of Nutritional Prevention Program for Women's Cardiovascular Health on Quality of Life (SAFE) acronym: SAFE overallStatus: RECRUITING date: 2023-07-11 date: 2025-03-01 date: 2025-08-01 date: 2024-04-23 date: 2024-04-23 name: Institut Pasteur de Lille class: OTHER briefSummary: The objective is to evaluate the effect of a nutritional prevention program associated with the consumption of "Primevère margarine" on the quality of life of women at risk of cardiovascular disease after 10 group coaching sessions in nutrition and physical activity. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 50 type: ESTIMATED name: Nutrional and physical activity program measure: Change from baseline on quality of life of women with cardiovascular risk at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on life behaviours at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on well-being at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on stress management at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on food behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on food behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on food and physical activity knowledge at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on motivation to change behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on physical behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on recovery capacity at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on static balance at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on flexibility at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on handgrip strengh at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on lower limb strengh at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on endurance at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on lipids metabolism at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on glucose metabolism at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on cardiovascular risk at 3 months after a nutritional prevention program measure: Change from baseline on BMI at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on waist circumference at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on body composition at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on systolic and diastolic blood pressure at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Satisfaction of Primevere products sex: FEMALE minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NutrInvest - Institut Pasteur de Lille status: RECRUITING city: Lille state: Nord zip: 59019 country: France name: Coralie Berthier, PhD role: CONTACT phone: 0320877333 phoneExt: 0033 email: coralie.berthier@pasteur-lille.fr name: Bérengère Legendre role: CONTACT phone: 0320877346 phoneExt: 0033 email: berengere.legendre@pasteur-lille.fr name: Jean-Michel Lecerf, MD role: PRINCIPAL_INVESTIGATOR lat: 50.63297 lon: 3.05858 hasResults: False

 nctId: NCT06380205 id: INCB54707-111 briefTitle: A Study to Evaluate the Drug Interaction Between Povorcitinib and the Oral Contraceptive Levonorgestrel/Ethinyl Estradiol in Healthy Adult Females overallStatus: RECRUITING date: 2024-05-07 date: 2024-06-07 date: 2024-06-07 date: 2024-04-23 date: 2024-04-24 name: Incyte Corporation class: INDUSTRY briefSummary: The purpose of this study is to evaluate the drug interaction between povorcitinib and the oral contraceptive levonorgestrel/ethinyl estradiol in healthy adult females. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Povorcitinib name: Levonorgestrel/Ethinyl estradiol measure: Levonorgestrel (LNG) concentration in plasma measure: Ethinyl estradiol (EE) concentration in plasma measure: Number of participants with Treatment-emergent Adverse Events (TEAEs) measure: Additional LNG/EE PK parameters in plasma measure: Povorcitinib concentration in plasma sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Celerion Clinical Research Unit status: RECRUITING city: Tempe state: Arizona zip: 85283 country: United States lat: 33.41477 lon: -111.90931 hasResults: False

 nctId: NCT06380192 id: HJ22-DEE-RETRO briefTitle: Developmental and Epileptic Encephalopathy of Genetic Etiology: Natural History Through Reuse of Clinical Data acronym: DEE-RETRO overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-03-31 date: 2026-03-31 date: 2024-04-23 date: 2024-04-23 name: Imagine Institute class: OTHER briefSummary: Developmental and Epileptic Encephalopathy (DEE) are a heterogeneous group of neurodevelopmental disorders linked to both epilepsy and its underlying etiology, independently of epileptiform activity.

The creation of a database with retrospective follow-up of a large number of patients on a national scale will enable better knowledge of specific biomarkers, and thus a better classification and understanding of the natural evolution of DEE according to their etiology. This will enable better, more personalized therapeutic management of patients, depending on etiology and the presence or absence of these biomarkers. The investigators will also be able to draw up management recommendations, which are currently non-existent. conditions: Developmental and Epileptic Encephalopathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 400 type: ESTIMATED measure: Identification of early diagnostic of a neurodevelopmental trajectory in children with epileptic and developmental encephalopathies measure: Identification of predictive biomarkers of a neurodevelopmental trajectory in children with epileptic and developmental encephalopathies measure: Identification of patient subgroups presenting the identified biomarkers measure: Assessment of patients' quality of life measure: Assessment of age-related adaptive behavior measure: Assessment of behavioral disorders measure: Assessment of autism spectrum disorders sex: ALL maximumAge: 17 Years stdAges: CHILD hasResults: False

 nctId: NCT06380179 id: USUHS.2023-126 briefTitle: Photomedicine Project 14: PBMT for Performance Enhancement in SOF acronym: SOF overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-08 date: 2026-01 date: 2024-04-23 date: 2024-04-23 name: Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR) class: UNKNOWN name: Uniformed Services University (USU) of the Health Sciences name: 1st Special Forces Group (Airborne), United States Army name: United States Army Special Operations Command name: The Geneva Foundation briefSummary: Special Operations Forces (SOF) train continually to maintain peak performance. Thus, they are nearly always in a state of recovery, and in need of noninvasive therapies to address the taxing workload. Photobiomodulation therapy (PBMT) is a noninvasive treatment where a low-level laser is applied to the body to enhance healing, recovery, and performance. Army Tactical Human Optimization Rapid Rehabilitation and Reconditioning (THOR3) provides a consistent avenue for implementation of PBMT as a modality. Studies in athletes have shown performance and recovery benefits with pre-and post-workout focal application of PBMT. While there is less evidence on the potential cognitive/behavioral effects of a systematic application of PBMT, self-reported fatigue has also been found to be significantly lower in groups with focal PBMT application as compared to placebo. Further, PBMT research in healthy military tactical athletes is limited. PBMT may be a promising tool for enhancing physical performance by accelerating musculoskeletal and psychological recovery in the SOF population. The investigators aim to study the physiologic and behavioral effects of PBMT application post-exercise on performance in SOF Operators.

The Intent: The investigators propose to conduct a single-blinded randomized-control trial with sham control to investigate the effectiveness of providing PBMT post physical training in a SOF population.

The specific aims of this study are to:

1. Analyze and describe the physiologic effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training.
2. Analyze and describe the behavioral effects, if any, of PBMT application post-exercise in Special Forces Operators undergoing coach-led training.
3. Evaluate the overall clinical utility of focal PBMT subsequent to physical training in a US Army SOF, tactical athlete population. conditions: Photobiomodulation Therapy conditions: Photomedicine conditions: Low-Level Laser Therapy conditions: Performance Enhancement conditions: Quadriceps conditions: Special Operations Readiness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Approach: Special Operators attending THOR3 coach led training will be invited to participate. After consenting and screening for inclusion/exclusion, participants will be randomized into two groups: 1) sham PBMT and 2) PBMT (applied to quadriceps up to 3 times per week, post coach-led training, taking approximately 5-20 minutes each time). Baseline measurements will include body fat percentage, height, weight and military/demographic information. Metrics for counter movement jump and self-reported delayed muscle onset soreness will be taken at baseline and weekly for three weeks. Isokinetic dynamometer measurements for the lower extremities, and self-reported exertion and fatigue will be taken at baseline and at the 3-week follow-up (post three-week intervention). Oura rings will be assigned at baseline and will continuously measure sleep, heart rate, Sp02, and activity. Activity and pain will also be self-reported throughout the duration of the study. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: In order to facilitate participant blinding to their randomized study group, all participants (regardless of their assigned study group) will be asked to wear blackout glasses and headphones during their treatment. whoMasked: PARTICIPANT count: 116 type: ESTIMATED name: THOR3 training + Photobiomodulation Therapy (PBMT) name: THOR3 training + sham PBMT measure: Countermovement Jump (CMJ) initial baseline: deceleration/concentric impulse measure: Countermovement Jump (CMJ) initial baseline: peak force production measure: Countermovement Jump (CMJ) initial baseline: rate of force production measure: Countermovement Jump (CMJ) initial baseline: unilateral performance comparison measure: Countermovement Jump (CMJ) week 1 follow-up: deceleration/concentric impulse measure: Countermovement Jump (CMJ) week 1 follow-up: peak force production measure: Countermovement Jump (CMJ) week 1 follow-up: rate of force production measure: Countermovement Jump (CMJ) week 1 follow-up: unilateral performance comparison measure: Countermovement Jump (CMJ) week 2 follow-up: deceleration/concentric impulse measure: Countermovement Jump (CMJ) week 2 follow-up: peak force production measure: Countermovement Jump (CMJ) week 2 follow-up: rate of force production measure: Countermovement Jump (CMJ) week 2 follow-up: unilateral performance comparison measure: Countermovement Jump (CMJ) week 3 follow-up: deceleration/concentric impulse measure: Countermovement Jump (CMJ) week 3 follow-up: peak force production measure: Countermovement Jump (CMJ) week 3 follow-up: rate of force production measure: Countermovement Jump (CMJ) week 3 follow-up: unilateral performance comparison measure: Isometric Quadriceps Strength Testing initial baseline measure: Isometric Hamstrings Strength Testing initial baseline measure: Isokinetic Quadriceps Strength Testing initial baseline measure: Isokinetic Hamstrings Strength Testing initial baseline measure: Isometric Quadriceps Strength Testing 3-week follow-up measure: Isometric Hamstrings Strength Testing 3-week follow-up measure: Isokinetic Quadriceps Strength Testing 3-week follow-up measure: Isokinetic Hamstrings Strength Testing 3-week follow-up measure: Defense and Veteran's Pain Rating Scale (DVPRS) initial baseline measure: Defense and Veteran's Pain Rating Scale (DVPRS) daily reports measure: Visual Analog Scale (VAS) initial baseline measure: Visual Analog Scale (VAS) week 1 follow-up measure: Visual Analog Scale (VAS) week 2 follow-up measure: Visual Analog Scale (VAS) week 3 follow-up measure: Borg Modified Rating of Perceived Exertion (RPE) initial baseline measure: Borg Modified Rating of Perceived Exertion (RPE) 3-week follow-up measure: Elloumi fatigue scale initial baseline measure: Elloumi fatigue scale 3-week follow-up measure: Quick Physical Activity Rating scale (QPAR) measure: Oura Ring Sleep Data: sleep metrics - sleep duration measure: Oura Ring Sleep Data: sleep metrics - time in bed measure: Oura Ring Sleep Data: sleep metrics - light sleep length measure: Oura Ring Sleep Data: sleep metrics - rapid eye movement (REM) sleep length measure: Oura Ring Sleep Data: sleep metrics - deep sleep length measure: Oura Ring Sleep Data: sleep metrics - sleep latency measure: Oura Ring Sleep Data: sleep metrics - sleep efficiency score measure: Oura Ring Sleep Data: sleep metrics - sleep quality score measure: Oura Ring Sleep Data: Readiness trends - body temperature changes measure: Oura Ring Sleep Data: Readiness trends - heart rate changes measure: Oura Ring Sleep Data: Readiness trends - heart rate variability (HRV) measure: Oura Ring Sleep Data: Readiness trends - respiration rate measure: Oura Ring Sleep Data: Readiness trends - blood oxygen saturation measure: Oura Ring Sleep Data: Readiness trends - sleep regularity measure: Oura Ring Sleep Data: Readiness trends - readiness score measure: Body Measurements: Height (cm) measure: Body Measurements: Weight (kg/lbs) measure: Body Measurements: Body composition (% body fat) measure: Body Measurements: C1 - proximal thigh circumference (cm) measure: Body Measurements: C2 - distal thigh circumference (cm) measure: Body Measurements: L1 - length of thigh (cm) sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-03-20 uploadDate: 2024-03-29T15:19 filename: Prot_SAP_000.pdf size: 435470 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-03-19 uploadDate: 2024-03-29T15:20 filename: ICF_001.pdf size: 165533 hasResults: False

 nctId: NCT06380166 id: A23-356 briefTitle: Hepatitis C Lab Testing Comparison Study overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-07 date: 2024-09 date: 2024-04-23 date: 2024-04-23 name: HealthPartners Institute class: OTHER briefSummary: Hepatitis C (HCV) HCV antibody assays are the standard of care test used to screen for HCV, but confirmation of acute infection is relegated in the current US guidelines to polymerase chain reaction (PCR) which often takes multiple days and may result in a loss to follow up and treatment, especially in high prevalence populations. HCV core antigen is a new, research use only immunoassay intended for use on the Abbott Alinity i system, an FDA-cleared instrument for clinical chemistry and immunoassay testing. The aim of the study is to evaluate the 48-hour stability of HCV core antigen in fresh serum and plasma specimens collected from individuals with a detectable HCV viral load (HCL VL), as per a recent antibody assay test, under multiple specimen storage conditions mirroring those employed in clinical laboratories. conditions: Hepatitis C studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 25 type: ESTIMATED name: Hepatitis C core antigen measure: Serum on the clot stability measure: Serum off the clot stability measure: Plasma on the gel stability measure: Plasma off the gel stability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06380153 id: HM005PS1S07 briefTitle: To Evaluate the Pharmacokinetics of Hemay005 Tablets in Patients With Renal Impairment overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-23 date: 2024-04-23 name: Ganzhou Hemay Pharmaceutical Co., Ltd class: INDUSTRY briefSummary: The aim of this study was to evaluate the pharmacokinetics of Hemay005 tablets in subjects with mild to moderate renal impairment and normal renal function, and to provide a basis for the formulation of clinical medication regimens for patients with renal impairment. conditions: Psoriasis studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Hemay005 measure: Relevant pharmacokinetic parameters，Peak Plasma Concentration（Cmax） measure: Relevant pharmacokinetic parameters，Area under the plasma concentration versus time curve（AUC0-t） measure: Relevant pharmacokinetic parameters，Area under the curve from time 0 extrapolated to infinite time (AUC0-inf) measure: Relevant pharmacokinetic parameters，half-life (T1/2) measure: Relevant pharmacokinetic parameters，clearance (CL/F) measure: Relevant pharmacokinetic parameters，volume of distribution (Vz/F) measure: Relevant pharmacokinetic parameters ，Renal clearance rate（CLr） sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06380140 id: cami3zgmxf3vqyc30ndmdqh6gfjid1 briefTitle: Relationship Between Acute Phase Markers and Post-operative Pain in Open Tension-free Inguinal Hernia Repair: An Observational Study overallStatus: RECRUITING date: 2023-05-03 date: 2024-03-03 date: 2025-12-31 date: 2024-04-23 date: 2024-04-23 name: University of Roma La Sapienza class: OTHER briefSummary: Many patients undergoing inguinal hernia repair are prone to developing acute and chronic post-operative pain.

The aim of the study is to show a possible correlation between pain and acute phase proteins in order to:

* predict the severity of pain;
* select most suitable pain relief therapy for the patient. conditions: Post Operative Pain conditions: Inguinal Hernia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 71 type: ESTIMATED name: Open Tension-free Inguinal Hernia Repair measure: Relationship Between Post-operative Pain and C Reactive Protein (CRP) in Open Tension-free Inguinal Hernia Repair measure: Relationship Between Post-operative Pain and D-dimer in Open Tension-free Inguinal Hernia Repair measure: Relationship Between Post-operative Pain and Fibrinogen in Open Tension-free Inguinal Hernia Repair measure: Relationship Between Post-operative Pain and white blood cell count in Open Tension-free Inguinal Hernia Repair measure: Relationship Between Post-operative Pain and Neutrophil to Lymphocyte Ratio (NLR) in Open Tension-free Inguinal Hernia Repair sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Augusto Lauro status: RECRUITING city: Roma zip: 000186 country: Italy name: Augusto Lauro role: CONTACT phone: +39 388 8663 879 email: augusto.lauro@uniroma1.it lat: 41.89193 lon: 12.51133 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-05-03 uploadDate: 2024-04-18T14:17 filename: Prot_SAP_000.pdf size: 274127 hasResults: False

 nctId: NCT06380127 id: CEFADE012021 briefTitle: Feasibility and Effectiveness of Concurrent Exercise Training on Frail Older Adults Living in Nursing Homes overallStatus: COMPLETED date: 2021-10-01 date: 2023-09-30 date: 2023-12-15 date: 2024-04-23 date: 2024-04-24 name: Universidade do Porto class: OTHER briefSummary: The present study is a crossover randomized controlled trial that aims to investigate the effects of concurrent exercise training over usual care on physical performance, muscle strength, and myokines concentrations in frail older adults living in nursing homes.The main questions it aims to answer is: Can a 12-week exercise intervention provide beneficial effects on physical performance, muscle strength and myokines among the most frail participants? Researchers will compare this intervention to usual care. Nursing homes (comprising participants) will be randomly assigned to a sequence of interventions (AB or BA), being A -exercise and B usual care. Participants will be assessed before and after each intervention. conditions: Frailty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The trial will follow a 28-week crossover design: 12 weeks for the first intervention period, a 4-week washout, and another 12 weeks for the second intervention period. Nursing homes (clusters) were randomized into sequences (AB or BA), where intervention A involve concurrent exercise training, and B is usual care.

Data collection will occurre at four points: baseline, post-first intervention period, post-washout/pre-second intervention period and post-crossover. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 46 type: ACTUAL name: Exercise training measure: Change from Baseline on Short Physical Performance Battery (SPBB) measure: Change from Baseline on Handgrip test measure: Change from baseline on isokinetic knee strength measure: Change from Baseline on circulating levels of myostatin measure: Change from Baseline on circulating levels of Decorin sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Faculty of Sports, University of Porto city: Porto zip: 4000 country: Portugal lat: 41.14961 lon: -8.61099 hasResults: False

 nctId: NCT06380114 id: STUDY00009296 briefTitle: Stand Up 2 HPV: Standing Orders to Improve HPV Vaccination overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-04 date: 2027-11 date: 2024-04-23 date: 2024-04-25 name: University of Rochester class: OTHER name: National Institutes of Health (NIH) briefSummary: Each year in the U.S., ≥20,000 women and 14,000 men are affected by HPV-related cancers, including cervical and oropharyngeal cancer. However, in 2020, only 59% of U.S. adolescents aged 13-17 were up-to-date for HPV vaccination, and rates for 11-12 year olds, the primary target age group for HPV vaccination (when the immune reaction is better and before exposure to HPV infection), are even lower. Standing orders (written protocols that authorize designated members of the healthcare team to vaccinate without first obtaining a patient-specific physician order) have been shown to work in inpatient settings and for adults, but have not been evaluated for HPV vaccine, which some parents consider controversial. Also, the ways in which organizational readiness for change (resources, motivation, staff attributes, leadership support and culture) moderate the effect of standing orders has not been studied. A physician's recommendation is correlated with HPV vaccine acceptance, and the investigators have developed a successful online, interactive, communication education program that will be adapted to train nurses and staff in addition to physicians. The investigators propose testing standing orders for HPV vaccine in an Accountable Care Organization (ACO) in Western New York, and assessing which provider and practice factors moderate the effect of standing orders. Advantages of this setting include a diverse group of rural, urban and suburban practices, and the ACO provides data infrastructure and analytics that allow practices to evaluate vaccination rates in real time.

Using a 2-arm cluster randomized trial (n=40 practices), the investigators will assess the effectiveness of standing orders (SO) + HPV communication education (intervention arm) relative to HPV communication education alone (control arm) on HPV vaccination for 11-17 year-olds. conditions: Hpv studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 16000 type: ESTIMATED name: Communication name: Standing Orders measure: HPV vaccination sex: ALL minimumAge: 11 Years maximumAge: 17 Years stdAges: CHILD hasResults: False

 nctId: NCT06380101 id: NEAAR-LARC briefTitle: Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC) acronym: NEAAR-LARC overallStatus: RECRUITING date: 2023-09-08 date: 2024-12 date: 2025-06 date: 2024-04-23 date: 2024-04-23 name: University of South Florida class: OTHER briefSummary: This clinical study aims to assess feasibility, safety, tolerability, and compliance of a Nonessential Amino Acid Restriction (NEAAR) medical food in adult patients with locally advanced rectal cancer during standard of care short course radiotherapy followed by standard of care chemotherapy. conditions: Rectal Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: NEAAR Medical Food measure: Rate of CTCAE v5.0 non-hematological Grade 3 and higher diarrhea measure: Proportion of clinical complete response 8 weeks post SCRT-TNT with NEAAR medical food defined by the MSK Regression Schema measure: Absolute and relative change from baseline of circulating non-essential amino acids measure: Proportion of clinical complete response at Week 4 post SCRT with NEAAR medical food measure: molecular ctDNA response. sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of South Florida status: RECRUITING city: Tampa state: Florida zip: 33606 country: United States name: Jennifer Burgess, MS role: CONTACT phone: 434-806-6445 email: jburgess@tgh.org name: Veronique Perry, MSHA role: CONTACT phone: 2549873658 email: vperry@tgh.org name: Richard Tuli, MD role: PRINCIPAL_INVESTIGATOR lat: 27.94752 lon: -82.45843 hasResults: False

 nctId: NCT06380088 id: VEM-DINOGMI-24 briefTitle: Improving Motor Skills: The Role of Music and Encouragement overallStatus: COMPLETED date: 2022-07-01 date: 2023-08-05 date: 2024-03-15 date: 2024-04-23 date: 2024-04-23 name: Universita degli Studi di Genova class: OTHER briefSummary: This study used a randomised crossover design to analyse the effect of three different experimental interventions - i.e. standard conditions, music and verbal encouragement - on performance in an isometric endurance task, comparing results between untrained and trained individuals. The interval between each intervention was set at seven days. The outcome measures are muscle activity and fatigue, assessed by surface electromyography, and task duration.

Isometric endurance task requires participants to keep their arm flexed at a 90° angle while holding a dumbbell with a supine grip loaded to 80% of 1RM on the dominant side of the body. During execution, the back and head should remain in contact with a vertical wall, with the feet shoulder width apart and firmly planted on the floor. The bar is held with the dominant arm while the other arm remains in a neutral position close to the body. It is imperative to avoid any form of rocking or movement that would make it easier to maintain the position. The test officially begins when the bar is handed to the subject, who is already in the correct position, and ends as soon as the angle of the arm varies by more than five degrees from the starting position. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 25 type: ACTUAL name: Isometric Task measure: Duration of the task measure: Biceps Brachii muscle fatigue measure: Triceps Brachii muscle fatigue measure: Biceps Brachii activity measure: Triceps Brachii activity sex: ALL minimumAge: 27 Years maximumAge: 40 Years stdAges: ADULT facility: Università degli Studi di Genova city: Genova zip: 16122 country: Italy lat: 44.40478 lon: 8.94438 hasResults: False

 nctId: NCT06380075 id: 2024-0480 id: A536000 type: OTHER domain: UW Madison id: SMPH/OPHTHAL&VIS SCI/GEN type: OTHER domain: UW Madison id: Protocol Version 3/22/24 type: OTHER domain: UW Madison briefTitle: COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Inherited Retinal Disease acronym: COCO-IRD overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-23 date: 2024-04-23 name: University of Wisconsin, Madison class: OTHER briefSummary: The goal of this research study is to compare two ultrawide field cameras to the gold standard imaging system to evaluate the back of the eye. The main question it aims to answer is the same results and information can be acquired from all of the cameras for evaluating and monitoring inherited retinal diseases (IRDs).

Participants will:

* undergo pupillary dilation
* have photographs taken of the inside of the eyes using three different cameras conditions: Retinal Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 50 type: ESTIMATED name: Spectralis FAF imaging name: Optos imaging name: Clarus imaging measure: Compare FAF retinal patterns by Clarus and standard Spectralis FAF imaging measure: Compare FAF retinal patterns by Optos and standard Spectralis FAF imaging measure: Compare FAF retinal patterns by Clarus and Optos FAF imaging measure: Compare Spectralis FAF imaging to Spectralis OCT imaging measure: Prevalence of FAF retinal pattern changes beyond the standard 30 degress in Clarus and Optos ultrawide field images measure: Prevalence of other autofluorescence abnormalities unique to the IRD across all imaging sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Ophthalmology and Visual Sciences city: Madison state: Wisconsin zip: 53705 country: United States name: Amy Remm role: CONTACT phone: 608-262-3377 email: amy.remm@wisc.edu name: Kimberly Stepien, MD role: PRINCIPAL_INVESTIGATOR lat: 43.07305 lon: -89.40123 hasResults: False

 nctId: NCT06380062 id: Choline Prostate Cancer briefTitle: Choline Metabolites in People With Prostate Cancer and Those With Benign Hyperplasia overallStatus: COMPLETED date: 2012-01-12 date: 2015-11-30 date: 2015-11-30 date: 2024-04-23 date: 2024-04-25 name: Universität des Saarlandes class: OTHER briefSummary: The aim of this study was to investigate plasma concentrations of one-carbon metabolites and phospholipid classes in participants with primary prostate cancer and those with benign hyperplasia. Moreover, the metabolites were studied in relation to tumor grade and age. conditions: Primary Prostate Urothelial Cancer conditions: Benign Prostatic Hyperplasia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 350 type: ACTUAL name: Plasma concentration of choline measure: Plasma choline concentrations measure: Whole blood choline concentrations measure: Plasma and whole blood folate forms measure: Plasma phospholipids measure: Plasma S-adenosylmethionine concentrations measure: Plasma betaine concentrations measure: Plasma methylmalonic acid concentrations measure: Plasma homocysteine concentrations sex: MALE minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Saarland city: Homburg state: Saarland zip: 66424 country: Germany lat: 49.32637 lon: 7.33867 hasResults: False

 nctId: NCT06380049 id: 0720242110 id: 20240012366 type: OTHER domain: Ministry of Food and Drug Safety briefTitle: Predicting Fall Risk in Stroke Patients Using a Machine Learning Model and Multi-Sensor Data overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2025-04-28 date: 2026-04-28 date: 2024-04-23 date: 2024-04-23 name: Seoul National University Hospital class: OTHER name: Ministry of Trade, Industry & Energy, Republic of Korea briefSummary: The study assesses a machine learning model developed to predict fall risk among stroke patients using multi-sensor signals. This prospective, multicenter, open-label, sponsor-initiated confirmatory trial aims to validate the safety and efficacy of the model which utilizes electromyography (EMG) signals to categorize patients into high-risk or low-risk fall categories. The innovative approach hopes to offer a predictive tool that enhances preventative strategies in clinical settings, potentially reducing fall-related injuries in stroke survivors. conditions: Stroke conditions: Fall studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 90 type: ESTIMATED name: EMG Analysis Software measure: Sensitivity of the Machine Learning Model measure: Specificity of the Machine Learning Model measure: Area Under the Receiver Operating Characteristic Curve measure: Matthews Correlation Coefficient sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06380036 id: 003AEstb/EC/01/2022 briefTitle: Two Approaches to Lower the Chances of Recurrence of Anal Fistula After Surgery overallStatus: COMPLETED date: 2022-11-01 date: 2023-10-31 date: 2023-10-31 date: 2024-04-23 date: 2024-04-23 name: Sairah Sadaf class: OTHER_GOV briefSummary: A total of 80 patients with complex fistula in ano of both genders were included. All patients in Group A underwent a loose seton technique. In group B, video-assisted fistula tract surgery (VAAFTS) was performed.Twice daily Sitz baths, analgesics, and stool bulking agents (bran) were used in follow-up care. Repeated examinations were carried out every four weeks and recurrence was noted at the end of three months conditions: Fistula in Ano studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ACTUAL name: video assisted fistula tract surgery measure: recurrence 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: NCT06380023 id: 2022.354 briefTitle: An Investigation Into the Dispersion Pattern During Coughing and Open Nasopharyngeal Suction Using Various Barrier Devices overallStatus: COMPLETED date: 2022-09-01 date: 2024-03-03 date: 2024-03-03 date: 2024-04-23 date: 2024-04-23 name: North District Hospital class: OTHER name: The Hong Kong Polytechnic University briefSummary: The aim of the study is to examine the air dispersion pattern and the environmental influence of open airway suction in general ward setting. Secondly, the study is aimed at identifying a simple \& practical enclosure device in general ward. Suction will be performed in manikin in supine lying.

Nasopharyngeal suction will be performed by physiotherapist with working experience more than 1 years. Besides, surgical mask \& enclosure tent will be adopted as the enclosure barrier device in this study.

Research Question

1. To assess the extent of the environmental contamination during coughing and simulated airway suction
2. To measure the air particle count during coughing and simulated open airway suction.
3. To evaluate how effective the enclosure barrier in reducing the air particle dispersion during open airway suction. conditions: Airway Aspiration studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 13 type: ACTUAL name: Enclosure barrier measure: Air particle count measure: A fluorescent Dye sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: North District Hospital city: Hong Kong zip: 000000 country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06380010 id: IASO HOSPITAL (ATHENS-GREECE) briefTitle: Mediterranean Diet Intervention in Adolescents With Polycystic Ovary Syndrome overallStatus: COMPLETED date: 2019-12-01 date: 2020-03-31 date: 2020-06-30 date: 2024-04-23 date: 2024-04-23 name: Iaso Maternity Hospital, Athens, Greece class: OTHER name: Harokopio University name: University of Peloponnese briefSummary: The aim of the present randomized controlled study was to examine wether a clinical decision support stystem would increase the adherence to the Mediterranean diet (MD) of adolescent girls, aged 15-17 years, diagnosed with polycystic ovary syndrome. The intervention lasted for 3 months and in total, 40 girls were randomly assigned to either the MD group (n=20) or a Control group receiving general nutritional advice (n=20). Anthropometry, nutritional intake, psychological well-being, and blood markers were analyzed at the begninning and the end of the trial. conditions: Polycystic Ovary Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Recruitment involved adolescents with polycystic ovary syndrome. Participants, who expressed their willingness to take part, attended personal meetings with the appointed dieticians who provided comprehensive explanations on the objectives, methods, and the potential benefits/risks of the study. A leaflet with related information was provided to all patients. Every eligible volunteer, and their guardian, signed a written informed consent and then kept a hard copy of the signed document. All eligible females were recruited in 12/2019 and were randomly allocated in groups of one to either the Control group (CG) or the Intervention group (IG). The IG received a personalized Mediterranean dietary plan, delivered through a clinical decision support system, while the CG received general dietary advice. Every participant had two individual sessions with the assigned dietician, at the beginning and at the trial endpoint, which involved anthropometry, dietary assessment, and blood withdrawal. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Treatment allocation was not revealed to the appointed statistician until the end of the study and release of the final outcomes. whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Mediterranean diet group measure: Adherance to the Mediterranean diet measure: Improvement of psychological well-being sex: FEMALE minimumAge: 15 Years maximumAge: 17 Years stdAges: CHILD facility: IASO Hospital city: Athens zip: 15123 country: Greece lat: 37.97945 lon: 23.71622 hasResults: False

 nctId: NCT06379997 id: SANTA LUCIA IRCCS briefTitle: Oral Supplementation Compared With Hyaluronic Acid Infiltration in Rotator Cuff Tendinopathies overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2025-11-01 date: 2025-12-31 date: 2024-04-23 date: 2024-04-25 name: I.R.C.C.S. Fondazione Santa Lucia class: OTHER briefSummary: The present study aims to investigate the effectiveness of oral supplementation with a nutraceutical containing Collagen, Hyaluronic Acid, Vitamin C, and Manganese in functional outcome and pain reduction in cases of shoulder rotator cuff tendinopathy compared to a cycle of intra-articular hyaluronic acid injections.

The project involves the recruitment of 50 adult individuals presenting with shoulder pain and instrumental evidence of rotator cuff tendinopathy. All participants will receive one intra-articular injection of 1 ml of triamcinolone acetonide 40 mg. After the injection, participants will be divided into two groups according to Good Clinical Practice guidelines. One group will begin taking one vial per day for 56 days of an oral supplement containing Hyaluronic Acid, Collagen, Vitamin C, and Manganese (HA-COL) (Tendogenial®, B2Pharma) starting from the day following enrollment (Group 1). The other group will undergo a cycle of 3 intra-articular injections with hyaluronic acid (HA) (Hyalotend®, Fidia) (Group 2).

The hypothesis is that oral supplementation with HA-COL may have the same efficacy as intra-articular hyaluronic acid treatment in reducing pain and improving shoulder functionality.

Functional assessments will be conducted by a clinician unaware of the participants' group assignment. The following assessment scales will be used:

Numeric Rating Scale (NRS) for pain (from 0 to 10), evaluating 3 aspects of pain: 1) pain at rest, 2) nocturnal pain, 3) pain during movement.

Shoulder Disability Questionnaire (SDQ) for functionality.

Assessments will be conducted at the following time points:

T0) Before the administration of corticosteroid intra-articular injection (baseline).

T1) Seven days after the start of HA-COL intake for Group 1 and before the first intra-articular HA injection for Group 2 (T1, seven days from T0).

T2) At mid-cycle of oral HA-COL supplementation for Group 1 (28 days of intake) and seven days after the last HA injection for Group 2 (T2, 21 days from T1).

T3) Follow-up at 28 days from T2, at the end of the 56-day oral treatment cycle for Group 1, and 28 days after the last injection for Group 2 (T3, 56 days from T0). conditions: Tendinitis of Shoulder conditions: Hyaluronic Acid conditions: Dietary Supplements conditions: Shoulder Pain studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The enrolling physiatrist, in agreement with the patient and adhering to Good Clinical Practice standards related to safety and clinical-anthropomorphic characteristics, will decide whether to continue the treatment with oral supplements (Group 1 - G1) or with intra-articular hyaluronic acid (Group 2 - G2) primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Both study groups will undergo assessment using pain and functional scales by a clinician who is blinded to the treatment group whoMasked: INVESTIGATOR count: 50 type: ESTIMATED name: Collagen, Hyaluronic Acid, Vitamin C, and Manganese name: Intra-articular infiltration measure: Numeric rating scale (NRS) measure: Shoulder Disability Questionnaire (SDQ) for shoulder functionality sex: ALL minimumAge: 30 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06379984 id: 855013 briefTitle: Rapid Outpatient Low-dose Initiation of Buprenorphine for OUD With Fentanyl Use acronym: ROLDI overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-23 date: 2024-04-24 name: University of Pennsylvania class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: The goal of this clinical trial is to learn if buprenorphine can be started for opioid use disorder with fentanyl use without requiring or precipitating opioid withdrawal. To be eligible, participants must have moderate or severe opioid use disorder and must have fentanyl detected on a urine drug test.

Participants will be admitted to a monitored research unit for the trial. They will be randomized to start buprenorphine with either standard initiation or with a new approach called rapid outpatient low-dose initiation (ROLDI).

For standard initiation, participants will be instructed to arrive to the unit with at least 8 hours since last fentanyl use. Once they have at least moderately severe opioid withdrawal (Clinical Opiate Withdrawal Scale \[COWS\] 11 or higher), participants will receive 2 mg, 2 mg, 4 mg, and then 8 mg sublingual buprenorphine, with doses every 2 hours. They will then continue 8-12 mg twice daily. This is the current standard of care.

For ROLDI, participants will not be required to have a period abstinence, they will have no or minimal withdrawal (COWS 4 or less) when starting buprenorphine, and participants will take 0.5 mg, 0.5 mg, 1 mg, 1 mg, 1 mg, and then 4 mg sublingual buprenorphine with dosing every two hours. They will then continue 8-12 mg twice daily.

The main aim of this clinical trial is to assess whether ROLDI is safe, feasible, acceptable to patients, and worthwhile to study in a larger trial. The secondary aim is to describe fentanyl and norfentanyl pharmacokinetics (that is to say, fentanyl and norfentanyl concentration in blood and urine) during early abstinence to understand why some people using fentanyl develop precipitated withdrawal with standard initiation. conditions: Opioid Use Disorder studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Buprenorphine measure: Successful initiation of buprenorphine maintenance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06379971 id: 23-2327 briefTitle: Maternal Choline Supplementation and Cannabis Use During Pregnancy: Impact on Early Brain Development overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2029-04 date: 2029-04 date: 2024-04-23 date: 2024-04-23 name: University of Colorado, Denver class: OTHER briefSummary: The goal of this study is to determine if providing a nutritional supplement, phosphatidylcholine, to pregnant women who have used cannabis products during the current pregnancy improves the offspring's brain-related development during the first 18 months. Participating pregnant women will receive either phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. The primary outcomes are the child's brain responses to sound at 4 weeks corrected age, and infant behaviors at 3 months and 18 months corrected age as reported by the primary caregiver. Secondary outcomes include motor, socio-emotional, language and cognitive development. conditions: Child Development conditions: Cannabis Use studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phosphatidylcholine or placebo primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Placebo name: Choline measure: Infant Behavior Questionnaire-Revised (IBQ-R) Orienting/Regulation Index measure: Auditory Sensory Gating (P50) measure: Child Behavior Checklist (CBCL) 1 1/2-5 measure: Maternal Plasma Choline Levels measure: Bayley Scales of Infant and Toddler Development sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: UC Health city: Aurora state: Colorado zip: 80045 country: United States name: Sharon Hunter, PhD role: CONTACT phone: 303-724-6246 email: sharon.hunter@cuanschutz.edu lat: 39.72943 lon: -104.83192 hasResults: False

 nctId: NCT06379958 id: IST-05 briefTitle: Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects overallStatus: NOT_YET_RECRUITING date: 2024-04-12 date: 2024-05-31 date: 2024-09-30 date: 2024-04-23 date: 2024-04-23 name: Modern Biosciences Ltd class: INDUSTRY briefSummary: A DDI study consisting of 3 parts conducted as an open label, fixed sequence study in healthy adult subjects. conditions: Pharmacokinetics studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 36 type: ESTIMATED name: leramistat 40mg name: Itraconazole 200 mg name: Phenytoin 100 Mg Oral Capsule name: Simvastatin 40mg measure: leramistat: Area under the curve - AUC0 t measure: leramistat: Area under the curve - AUC0 24 measure: leramistat: Area under the curve - AUC0 inf measure: leramistat: Maximum observed concentration - Cmax measure: leramistat: Time of the maximum observed concentration - Tmax measure: leramistat:Elimination rate constant -Kel measure: leramistat: Half life - t½ measure: leramistat: Plasma Clearance -CL/F measure: leramistat: Volume of distribution - Vz/F measure: Incidence of adverse event. sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Celerion city: Belfast country: United Kingdom name: Phase 1 Unit role: CONTACT name: Nadine Abdullah role: PRINCIPAL_INVESTIGATOR lat: 54.59682 lon: -5.92541 hasResults: False

 nctId: NCT06379945 id: PI23/01103 id: PI2024 01 1484 type: REGISTRY domain: Ethics Committee for Drug Research of the Salamanca Health Area briefTitle: Unified platforM for a Better integRal Evaluation of MyeLodyspLastic Syndromes in SpAin-Strategy for Unraveling Personalized genoMic Medicine in Public heAlth System (UMBRELLA-SUMMA) acronym: UMBRELLA-SUMMA overallStatus: RECRUITING date: 2024-01-01 date: 2026-01-01 date: 2026-12-31 date: 2024-04-23 date: 2024-04-23 name: Instituto de Investigación Biomédica de Salamanca class: OTHER name: Carlos III Health Institute briefSummary: Myelodysplastic Syndromes (MDS) are heterogeneous clonal diseases characterized by difficult diagnosis, complex prognostic stratification and unsatisfactory treatment. Based on that, UMBRELLA SUMMA aims to provide better clinical management and personalized medicine to MDS patients in Spain through improving diagnosis (1), prognosis (2 and 3), and treatment (2), and facilitating future investigations (4) of the disease.

More concretely, we propose: 1. The application of new technologies such as Optical Genome Mapping (OGM) in the diagnosis of those MDS cases whose cytogenetic alterations cannot be identify by other methods, as well as the implementation of this technology using peripheral blood avoiding more invasive methods for patients. 2. To provide all Spanish Group of MDS (GESMD) members who require it with the newly prognostic stratification of their patients (IPSS-M) by making Next Generation Sequencing (NGS) accessible for all of them. 3. Validate and improve a new prognostic system (AIPSS-MDS) previously developed within the GESMD, thanks to artificial intelligence, one of the tools with the most projection in the field of medicine currently. 4. To build and register ISCIII collections of cells, genetic material and/or plasma from all prospective MDS patients.

On the other hand, the dynamics of coexisting mutations in a specific context of chromosomal abnormalities could be defining the clinical fate of each patient. Based on that, the IBSAL team recently proposed three models of MDS evolution based on NGS data from three different cytogenetic subgroups: normal karyotype, trisomy 8 and 5q deletion. The IBSAL proposal aims to deepen into the pathophysiological mechanisms of MDS evolution in these three models through in vitro and in vivo functional studies and single-cell multiomics approaches. conditions: Myelodysplastic Syndromes studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: Structural variants and complex rearrangements in MDS measure: Mutations in MDS measure: Overall survival and leukemia-free survival in patients with MDS measure: ISCIII collections of viable samples sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fundación Instituto de Investigación Germans Trias i Puyol status: RECRUITING city: Badalona state: Barcelona zip: 08916 country: Spain name: Francesc Solé, PhD role: CONTACT phone: 935 57 28 06 phoneExt: 4040 email: fsole@carrerasresearch.org lat: 41.45004 lon: 2.24741 facility: Hospital Universitario Vall d´Hebron status: RECRUITING city: Barcelona zip: 08035 country: Spain name: David Valcárcel Ferreiras, PhD role: CONTACT phone: 934 89 30 00 email: dvalcarcel@vhio.net lat: 41.38879 lon: 2.15899 facility: Clínica Universitaria de Navarra status: RECRUITING city: Pamplona zip: 31008 country: Spain name: Felipe López Cardoso, PhD role: CONTACT phone: 848 42 87 00 email: fprosper@unav.es lat: 42.81687 lon: -1.64323 facility: Complejo Asistencial Universitario de Salamanca status: RECRUITING city: Salamanca zip: 37007 country: Spain name: María Díez Campelo, PhD role: CONTACT phone: +34 923 29 11 00 phoneExt: 55418 email: mdiezcampelo@usal.es name: Sandra Muntión Olave, PhD role: CONTACT phone: +34 923 29 11 00 phoneExt: 55015 email: terapiacelular@usal.es lat: 40.96882 lon: -5.66388 hasResults: False

 nctId: NCT06379932 id: APHP240433 briefTitle: Pain and Muscle Biopsy acronym: BIODOMU overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2024-12-01 date: 2024-12-01 date: 2024-04-23 date: 2024-04-23 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Few studies have been conducted on pain assessment during and after open muscle biopsy. Furthermore, no clinical factors likely to influence pain perception during and after open muscle biopsy have been evaluated in previous studies.The proposed observational study aims to study pain perception in subjects over the aged of 18 years old who underwent an open muscle biopsy for a suspected myopathic disorder. Describing the main characteristics of pain during and after open muscle biopsy using a questionnaire will not only clarify this aspect, which is little studied in the literature, but will also provide information for improving analgesic management of the procedure.Studying the prognostic aspects of pain perception will give healthcare professionals an idea of which patients are at risk of suffering greater adverse effects from the procedure, so that they can be offered a personalised service in the future. conditions: Neuromuscular Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Surveys completion measure: To describe the characteristics and intensity of pain during and after open muscle biopsy on the basis of a questionnaire including NRS scale. measure: To identify prognostic factors that may influence pain perception and to gather opinions to improve quality service measure: Gather patient feedback on procedures, facilities and reception to improve our service to patients. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06379919 id: C Acnes in TSA briefTitle: Wound Irrigation Comparative Effectiveness Study overallStatus: RECRUITING date: 2024-03-20 date: 2025-05-31 date: 2027-05-31 date: 2024-04-23 date: 2024-04-26 name: Orthopaedic Education and Research Institute (dba Hoag Orthopedics) class: OTHER name: Irrimax Corporation briefSummary: The primary objective of this study is to compare the presence of C acnes in bacteriologic cultures taken from participant samples of subcutaneous and deep tissue prior to deep surgical irrigation using either Normal Saline Irrigation (Group 1) or Irrisept Irrigation (Group 2). Secondary objectives are evaluation of patient reported outcome measures and range of motion in relation to C acnes presence among subjects in the two groups. conditions: Cutibacterium Acnes Contamination studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants are assigned at the beginning of the study to treatment arm involving 1 of 2 types of irrigation treatment for their surgery. They continue in that arm through the length of the study and complete the same study procedures, as well as same standard of care. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participants and Microbiology lab assessing cultures are blinded to the assigned irrigation treatment arm throughout the length of the study. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 126 type: ESTIMATED name: Irrisept Irrigation name: Saline Irrigation Solution Delivery measure: C Acnes Presence measure: American Shoulder and Elbow Surgeons Patient Reported Outcome Measure measure: Shoulder Range of Motion (ROM) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hoag Orthopedics status: RECRUITING city: Orange state: California zip: 92868 country: United States name: Edward Quilligan, BS role: CONTACT phone: 949-526-1570 email: Edward.quilligan@hoagorthopedics.org name: Kalyn Smith, BS role: CONTACT phone: (949) 526-1570 email: kalyn.smith@hoagorthopedics.org lat: 33.78779 lon: -117.85311 hasResults: False

 nctId: NCT06379906 id: DMD, UE and Balance briefTitle: Upper Extremity Muscle Strength, Balance and Functional Skills in DMD overallStatus: COMPLETED date: 2023-11-10 date: 2023-12-10 date: 2024-03-10 date: 2024-04-23 date: 2024-04-25 name: Halic University class: OTHER name: Biruni University name: Istanbul University briefSummary: This study aims to examine the relationship between upper extremity muscle strength, balance and functional skills of children with DMD. conditions: Duchenne Muscular Dystrophy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 32 type: ACTUAL name: Assessment measure: Upper Extremity Muscle Strength Measurements measure: Trunk Control Measurement Scale measure: Functional Reach Test measure: Timed Up & Go Test measure: Pediatric Evaluation of Disability Inventory sex: MALE minimumAge: 5 Years maximumAge: 12 Years stdAges: CHILD facility: Haliç University city: Istanbul state: Eyüpsultan country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06379893 id: 300128 id: 2024-510839-22-00 type: CTIS briefTitle: A Real-World Evidence Study to Evaluate the Effects of Voltaren Use on Mobility and Quality of Life in Participants With Knee Osteoarthritis Pain overallStatus: NOT_YET_RECRUITING date: 2024-04-19 date: 2024-11-15 date: 2024-11-15 date: 2024-04-23 date: 2024-04-23 name: HALEON class: INDUSTRY briefSummary: The purpose of this study is to investigate how topical diclofenac use can improve functional mobility and physical activity primarily, as well as other quality-of-life (QoL) parameters such as sleep, mood, and engagement in daily activities in participants with knee OA. conditions: Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 195 type: ESTIMATED name: Voltaren Gel 1% (diclofenac sodium) (US only) name: Voltaren Gel 1.16% (diclofenac diethylammonium) (EU only) name: Voltaren Gel 2.32% (diclofenac diethylammonium) (EU only) measure: Change from Baseline in the Average Minutes of Moderate and Vigorous Physical Activity (MVPA) at Week 1 measure: Change from Baseline in the Average Minutes of MVPA at Week 2 measure: Change from Baseline in the Average Minutes of MVPA at Week 3 measure: Change from Baseline in Daily Average Number of Steps Taken at Days 7, 14 and 21 measure: Change from Baseline in Daily Average Number of Stairs Climbed/Descended at Days 7, 14 and 21 measure: Change from Baseline in Ratio of Sedentary/Non-sedentary Time at Days 7, 14 and 21 measure: Change from Baseline in Gait, Assessed Through Speed and Step Irregularity at Days 7, 14 and 21 measure: Change from Baseline in Indices of Morning Stiffness at Days 7, 14 and 21 measure: Change from Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function Subscale Score on Days 7,14, and 21 measure: MVPA on Each Day of the Study measure: WOMAC Physical Function Subscale Score on Days 7,14, and 21 measure: Change from Baseline in Self-reported Pain Intensity Assessed Through Numeric Rating Scale (NRS) measure: Change from Baseline in the WOMAC Subscale Score on Days 7, 14, and 21: Pain measure: Change from Baseline in the WOMAC Subscale Score on Days 7, 14, and 21: Stiffness measure: Change from Baseline in Sleep/Alertness Assessed Using Karolinska Sleepiness Scale on Days 7, 14, and 21 measure: Change from Baseline in Health-related Quality of Life Assessed Using European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire on Days 7, 14, and 21 sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06379880 id: 2023-031 id: 2024-A00120-47 type: OTHER domain: ID-RCB Number briefTitle: Impact on Quality of Life and Health of the CONTINUUM+ CONNECT Remote Monitoring Solution acronym: FEGALA overallStatus: RECRUITING date: 2024-04-25 date: 2024-11-25 date: 2025-02-25 date: 2024-04-23 date: 2024-04-29 name: Institut de cancérologie Strasbourg Europe class: OTHER name: Continuum Plus Santé name: Plateforme nationale qualité de vie et cancer name: WeShare briefSummary: FEGALA is a comparative, multicenter, randomized, prospective, open-label study comparing the results observed at 3 months (± 15 days) on the EORTC QLQ-C30 scale in a group of patients with metastatic cancer followed on an outpatient basis and benefiting from the CONTINUUM+ CONNECT solution (with or without nursing support at home) versus comparable patients benefiting from conventional monitoring. conditions: Prostatic Neoplasms conditions: Lung Neoplasms conditions: Breast Neoplasms conditions: Colorectal Neoplasms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 506 type: ESTIMATED name: CONTINUUM+ CONNECT remote monitoring measure: Effect of the CONTINUUM+ CONNECT solution on the results in terms of physical health on the EORTC QLQ-C30 questionnaire in patients with metastatic cancer followed in outpatient settings who did not require assistance in self-assessment measure: Effect of CONTINUUM+ CONNECT solution on the results at 3 months (± 15 days) post-inclusion in terms of physical health on the EORTC QLQ-C30 questionnaire in patients with metastatic cancer followed in outpatient settings measure: Effect of CONTINUUM+ CONNECT solution on all dimensions of EORTC QLQ-C30 questionnaires (at 3 months) measure: Effect of CONTINUUM+ CONNECT solution on all dimensions of EORTC QLQ-C30 questionnaires (at 6 months) measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - breast cancer group measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - lung cancer group measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - prostate cancer group measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - colorectal cancer group measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - breast cancer group measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - lung cancer group measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - prostate cancer group measure: Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - colorectal cancer group measure: Frequency of grade 3 - 4 adverse events present at 3 months post-inclusion measure: Frequency of grade 3 - 4 adverse events present at 6 months post-inclusion measure: Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 3 months following inclusion measure: Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 6 months following inclusion measure: Satisfaction of professionals regarding CONTINUUM+ CONNECT solution and its functioning measure: Satisfaction of patients regarding CONTINUUM+ CONNECT solution and its functioning sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sainte-Catherine, Institut du Cancer Avignon-Provence status: NOT_YET_RECRUITING city: Avignon zip: 84918 country: France name: Julien GRENIER, MD role: CONTACT lat: 43.94834 lon: 4.80892 facility: Polyclinique de Blois status: NOT_YET_RECRUITING city: Blois zip: 41260 country: France name: Yann MOTTAZ, MD role: CONTACT name: Yann MOTTAZ, Md role: PRINCIPAL_INVESTIGATOR lat: 47.58333 lon: 1.33333 facility: Pôle Santé République status: RECRUITING city: Clermont-Ferrand zip: 63000 country: France name: Pierre DALLOZ, MD role: CONTACT name: Pierre DALLOZ, MD role: PRINCIPAL_INVESTIGATOR lat: 45.77966 lon: 3.08628 facility: centre Georges François Leclerc status: NOT_YET_RECRUITING city: Dijon zip: 21079 country: France name: Leila BENGRINE, MD role: CONTACT name: Leila BENGRINE, MD role: PRINCIPAL_INVESTIGATOR lat: 47.31667 lon: 5.01667 facility: Chu Dupuytren status: NOT_YET_RECRUITING city: Limoges zip: 87042 country: France name: Tiffany DARBAS, MD role: CONTACT name: Tiffany DARBAS, MD role: PRINCIPAL_INVESTIGATOR lat: 45.83153 lon: 1.25781 facility: Centre d'oncologie de Gentilly status: RECRUITING city: Nancy zip: 54100 country: France name: Laurene GAVOILLE, MD role: CONTACT name: Laurene GAVOILLE, MD role: PRINCIPAL_INVESTIGATOR lat: 48.68439 lon: 6.18496 facility: Hôpitla privé des Côtes d'Armor - Centre CARIO-HPCA status: NOT_YET_RECRUITING city: Plérin zip: 22190 country: France name: Jérôme MARTIN-BABAU, MD role: CONTACT name: Jérôme MARTIN-BABAU, MD role: PRINCIPAL_INVESTIGATOR lat: 48.54249 lon: -2.77983 facility: Institut Jean Godinot status: RECRUITING city: Reims zip: 51100 country: France name: Christelle JOUANNAUD, MD role: CONTACT name: Christelle JOUANNAUD, MD role: PRINCIPAL_INVESTIGATOR lat: 49.25 lon: 4.03333 facility: CHU de Saint-Etienne status: NOT_YET_RECRUITING city: Saint-Priest-en-Jarez zip: 42270 country: France name: Pierre CORNILLON, MD role: CONTACT name: Pierre CORNILLON, MD role: PRINCIPAL_INVESTIGATOR lat: 45.47501 lon: 4.37614 facility: Institut de cancérologie Strasbourg Europe status: RECRUITING city: Strasbourg zip: 67033 country: France name: Manon VOEGELIN role: CONTACT name: Philippe BARTHELEMY, MD role: PRINCIPAL_INVESTIGATOR lat: 48.58392 lon: 7.74553 facility: Hôpitaux Universitaires de Strasbourg status: NOT_YET_RECRUITING city: Strasbourg zip: 67091 country: France name: Bertrand MENNECIER, MD role: CONTACT name: Bertrand MENNECIER, MD role: PRINCIPAL_INVESTIGATOR lat: 48.58392 lon: 7.74553 hasResults: False

 nctId: NCT06379867 id: HSK3486-112 briefTitle: A Study to Evaluate the Effects of HSK3486 Administration on Cardiac Repolarization in Healthy Subjects overallStatus: RECRUITING date: 2024-04-07 date: 2024-05-30 date: 2024-08-30 date: 2024-04-23 date: 2024-04-26 name: Haisco Pharmaceutical Group Co., Ltd. class: INDUSTRY briefSummary: Assess the effects of a single IV bolus of HSK3486 single dose on cardiac repolarization for healthy subjects. conditions: Anesthesia studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: HSK3486 name: Placebo name: Moxifloxacin measure: ΔQTcI measure: ΔHR, ΔQTcF, ΔPR, and ΔQRS measure: Categorical outliers for QTcI, QTcF, HR, PR, and QRS intervals measure: AE and SAE measure: Cmax measure: AUClast measure: t1/2 sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Beijing GoBroad Boren Hospital status: RECRUITING city: Beijing country: China name: Jie Hou role: CONTACT phone: 18611422958 email: jie.hou@gohealtharo.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06379854 id: RCRAHS-ISB/REC/MS-PT/01814 briefTitle: Trunk Rotation And Lateral Flexion Exercises In Stroke Patients overallStatus: RECRUITING date: 2024-04-01 date: 2024-06 date: 2024-06 date: 2024-04-23 date: 2024-04-23 name: Riphah International University class: OTHER briefSummary: In this study we want to introduce the beneficiary combine effects of chest mobilization and chest physiotherapy exercises by using cough peak flow meter and chest expansion in stroke patients. by using theses combine exercises physiotherapist can develop target rehabilitation strategies for stroke survivors. conditions: Stroke, Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 54 type: ESTIMATED name: chest physiotherapy name: trunk rotation exercises,deep diaphragmatic also chest physiotherapy measure: Trunk Impairment Scale: measure: Peak Flow Meter measure: Chest Expansion: sex: ALL maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Shahida Khaliq Health Centre status: RECRUITING city: Islamabad zip: 44080 country: Pakistan name: Sara Jahan, MSPT role: CONTACT phone: +923415182331 email: saira.jahan@riphah.edu.pk lat: 33.72148 lon: 73.04329 hasResults: False

 nctId: NCT06379841 id: STUDY00007357 briefTitle: Green Hysteroscopy overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-23 date: 2024-04-23 name: Emory University class: OTHER briefSummary: The purpose of this study is to determine whether green draping in the operating room prior to a hysteroscopy results in a decreased operating room time.

Secondary aims are to determine whether there are any differences in infection rate, complication rate, fluid deficit, operating room turnover time conditions: Hysteroscopy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 100 type: ESTIMATED name: Green Draping Procedure name: Full Draping Procedure measure: Difference in operative times measure: Infection Rate measure: Post Operative complication Rate measure: Peri operative Complication Rate measure: Number of cases of Fluid deficits measure: Operative room turnover time in Full Draping sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emory Hospital city: Atlanta state: Georgia zip: 30322 country: United States lat: 33.749 lon: -84.38798 facility: Emory Dunwoody Clinic city: Atlanta state: Georgia zip: 30338 country: United States lat: 33.749 lon: -84.38798 facility: Emory Saint Joseph's Hospital city: Atlanta state: Georgia zip: 30342 country: United States lat: 33.749 lon: -84.38798 hasResults: False

 nctId: NCT06379828 id: 2024-0140 briefTitle: Self-assessment Tool for Implementing the ESCNH overallStatus: NOT_YET_RECRUITING date: 2024-06-03 date: 2025-10-01 date: 2026-09-01 date: 2024-04-23 date: 2024-04-25 name: European Foundation for the Care of Newborn Infants class: OTHER briefSummary: This study aims to develop a tool for hospitals to self-assess the implementation of the European Standards of Care for Newborn Health (ESCNH), standards defining best-practice procedures for neonatal care. The tool shall support healthcare professionals across Europe to measure the level of implementation of the ESCNH, to identify variations in care delivery, and ultimately to improve neonatal care. To achieve this, healthcare professionals from all relevant backgrounds and parent representatives will be invited to take part in an electronic Delphi consensus approach. A subsequent pilot-testing among at least 10 hospitals across Europe will refine the developed tool, indicate potential errors, ensure user-friendliness, and improve the applicability. conditions: Development of a Tool to Assess the Level of Implementing the European Standards of Care for Newborn Health conditions: Testing of the Developed Self-assessment Tool in European Hospitals conditions: Self-Assessment studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Please note that this is an observational study; not applicable measure: Online self-assessment tool (including statements and questions) measure: Response rates measure: Demographics and characteristics measure: User-friendliness score of the self-assessment tool measure: Applicability score of the formulation of the questions measure: Qualitative feedback on illustration of output measure: Appraisal on the utilisation of the self-assessment tool measure: Scalability of the self-assessment tool and dissemination sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: European Foundation for the Care of Newborn Infants (EFCNI) city: Munich state: Bavaria zip: 81379 country: Germany name: Isabel Geiger, Dr. role: CONTACT phone: 0049 89 89 0 83 26-0 email: isabel.geiger@efcni.org name: Julia Hoffmann, Dr. role: CONTACT email: julia.hoffmann@efcni.org name: Luc Zimmermann, Prof. role: PRINCIPAL_INVESTIGATOR lat: 48.13743 lon: 11.57549 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-04-17 uploadDate: 2024-04-17T07:49 filename: Prot_SAP_000.pdf size: 200372 hasResults: False

 nctId: NCT06379815 id: EMRL-23-03 briefTitle: Effect of Oral Lactate Ingestion on Appetite Regulation overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08 date: 2024-08 date: 2024-04-23 date: 2024-04-23 name: Wilfrid Laurier University class: OTHER name: Natural Sciences and Engineering Research Council, Canada briefSummary: The goal if this study is to determine how oral lactate ingestion affects markers of appetite regulation. Researchers will compare oral lactate ingestion to a sodium chloride placebo. Participants will consume the lactate or placebo solution and then have blood samples and assessments of appetite over the course of 90 min. Free-living energy intake will be measured for 3 days surrounding each experimental session. conditions: Appetitive Behavior studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants will consume a sodium lactate and sodium chloride placebo in a double-blind, crossover design. primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: The allocation of lactate and placebo will be completed by a researcher not involved in data collection. Both the participant and the researchers collecting and analyzing the data will be blinded to the treatment allocation. This will be completed in a counter-balanced order. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 12 type: ESTIMATED name: Sodium Lactate name: Sodium Chloride measure: Blood Lactate measure: Acylated ghrelin measure: Total ghrelin measure: Subjective appetite perception measure: Free-living energy intake sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False

 nctId: NCT06379802 id: 2023-00546-01 briefTitle: Lifestyle Intervention With Physical Activity and Diet acronym: LI-PAD overallStatus: RECRUITING date: 2024-02-12 date: 2025-12-31 date: 2027-12-31 date: 2024-04-23 date: 2024-04-23 name: Vastra Gotaland Region class: OTHER_GOV briefSummary: The aim of this pilot randomized controlled trial LI-PAD is to identify whether a 6-month intervention approach to individually optimize lifestyle behavior, physical activity, and diet, is feasible and leads to larger improvements in body weight, cardiovascular disease risk factors, and health-related quality of life compared to simple written lifestyle advice, in individuals with overweight or obesity.

The intervention group will be offered individual support for lifestyle behavioral change (precision health) and the control group will be offered written lifestyle advice, following national recommendations. In total, 60 population-based participants and 60 controls from the Gothenburg area, aged 45-65 years, will be recruited. conditions: Overweight studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 120 type: ESTIMATED name: Individualized physical activity and diet measure: Change in body weight 1 measure: Change in body weight 2 measure: Change in body weight 3 measure: Change in body weight 4 measure: Length in cm measure: Weight in kilograms measure: Cardiovascular disease risk factor change - Body Mass Index (BMI) measure: Cardiovascular disease risk factor change - Waist-to-hip ratio 1 measure: Cardiovascular disease risk factor change - Waist-to-hip ratio 2 measure: Cardiovascular disease risk factor change - Waist-to-hip-ratio 3 measure: Cardiovascular disease risk factor change - Waist-hip-ratio 4 measure: Cardiovascular disease risk factor change - Blood pressure 1 measure: Cardiovascular disease risk factor change - Blood pressure 2 measure: Cardiovascular disease risk factor change - Blood pressure 3 measure: Cardiovascular disease risk factor change - Blood pressure 4 measure: Cardiovascular disease risk factor change - Long-term blood glucose control using glycated haemoglobin (HbA1c) measure: Cardiovascular disease risk factor change - Serum (total) Cholesterol (S-Cholesterol) measure: Cardiovascular disease risk factor change - High density lipoprotein (HDL) measure: Cardiovascular disease risk factor change - Low densitiy lipoprotein (LDL) measure: Cardiovascular disease risk factor change - Triglycerides measure: Cardiovascular disease risk factor change - Aerobic fitness (predicted V02 max) measure: Cardiovascular disease risk factor change - Physical activity level measure: Change in functional lower extremity muscle strength measure: Change in upper extremity muscle strength - Hand grip strength measure: Change in muscle strength - Shoulder flexion measure: Change in muscle strength - Ankle Plantar measure: Cardiovascular disease risk factor change - Healthy food intake measure: Change in resting energy expenditure 1 measure: Change in resting energy expenditure 2 measure: Change in resting energy expenditure 3 measure: Change in resting energy expenditure 4 measure: Change in respiratory quotient 1 measure: Change in respiratory quotient 2 measure: Change in respiratory quotient 3 measure: Change in respiratory quotient 4 measure: Change in health-related quality of life - Proportions of problems in five dimensions measure: Change in health-related quality of life - Index score measure: Change in health-related quality of life - Visual analog score of present health status measure: Change in health-related quality of life - Health status categories measure: Change in self-reported physical activity level measure: Change in exposure pattern to the food environment measure: Change in exposure pattern to the built environment measure: Process evaluation measure 1 - Extent to which intervention was implemented as planned measure: Process evaluation measure 2 - Number of sessions of each intervention component delivered measure: Process evaluation measure 3 - Number of sessions of each intervention component received measure: Process evaluation measure 4 - Satisfaction with individual lifestyle counselling measure: Process evaluation measure 5 - Satisfaction with the lifestyle school measure: Process evaluation measure 6A - Perceived facilitators measure: Process evaluation measure 6B - Perceived barriers measure: Process evaluation measure 7 - Reach sex: ALL minimumAge: 45 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre for lifestyle intervention status: RECRUITING city: Gothenburg country: Sweden name: Mats Börjesson, Prof. role: CONTACT email: mats.borjesson@gu.se name: Carina Persson, Ass. prof. role: CONTACT email: carina.perssson@vgregion.se lat: 57.70716 lon: 11.96679 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-04-12 uploadDate: 2024-04-12T10:31 filename: Prot_000.pdf size: 411005 hasResults: False

 nctId: NCT06379789 id: R131L1265-HEMB-2318 id: 2023-507260-40-00 type: REGISTRY domain: EU CTR Number briefTitle: A Trial to Learn if REGV131-LNP1265 is Safe and Works to Help the Body Make Clotting Factor in Pediatric, Adolescent and Adult Patients With Hemophilia B acronym: BEYOND-9 overallStatus: NOT_YET_RECRUITING date: 2024-07-25 date: 2032-07-03 date: 2032-07-03 date: 2024-04-23 date: 2024-04-23 name: Regeneron Pharmaceuticals class: INDUSTRY name: Intellia Therapeutics briefSummary: Participants in this study have a genetic mutation, specifically in the coagulation (blood clotting) Factor 9 gene that causes severe or moderately severe hemophilia B. This study is researching an experimental gene insertion therapy (the adding of a gene into your DNA) called REGV131-LNP1265, also called the "study drug". Gene insertion therapy aims to teach the body how to produce clotting factor long-term, without the need for factor replacement therapy.

The main aim of this study is to find a safe and well-tolerated dose of the study drug by checking the side effects that may happen from taking it.

The study is looking at several other research questions including:

* How much study drug is in the blood at different times
* Whether the body makes antibodies against parts of the study drug, which could make the drug less effective or could lead to side effects. Antibodies are proteins produced by the body's immune system in response to a foreign substance
* Whether the body makes antibodies against the clotting factor replacement therapy
* How quality of life is affected by hemophilia B and if it changes after taking study drug
* How joint health is affected by hemophilia B and if it changes after taking study drug
* How often visits are required for the emergency room, urgent care center, physician's office, hospital, telephone or online are required as a result of bleeding events, and if the frequency changes after taking study drug
* How often factor replacement therapy is needed, both on a regular basis for prevention of bleeding, and as needed to treat bleeding events (and it if changes after taking study drug)
* Whether there is a difference in 2 different methods for measuring Factor 9 activity in the blood conditions: Hemophilia B studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: REGV131 name: LNP1265 measure: Incidence of treatment-emergent adverse events (TEAEs) measure: Severity of TEAEs measure: Coagulation Factor IX (FIX) functional activity measured using the chromogenic substrate assay measure: Change in FIX functional activity in plasma, measured using the chromogenic substrate assay measure: Annualized bleeding rate (ABR) following sustained FIX functional activity among participants receiving the RDE measure: Change in FIX functional activity in plasma measured using the chromogenic substrate assay measure: ABR following sustained FIX functional activity among participants receiving the RDE measure: FIX functional activity in plasma over time during the study period using the chromogenic substrate assay measure: Annualized treated bleeding rate (tABR) following sustained FIX functional activity, among participants receiving the RDE measure: Annualized utilization (IU/kg/year) of FIX replacement therapy following sustained FIX functional activity among participants receiving the RDE measure: Remaining free of FIX replacement therapy among those receiving the RDE following sustained FIX expression measure: Remaining zero spontaneous bleeding events among those receiving the RDE over sustained FIX functional activity period measure: Concentrations of REGV131 components measure: Concentrations of LNP1265 components measure: Detection of antibodies to the F9 transgene product FIX protein measure: Detection of total binding antibodies (TAbs) to the adeno-associated virus 8 (AAV8) capsid proteins measure: Detection of neutralizing antibodies/transduction inhibitors (NAb/TI) to the adeno-associated virus 8 (AAV8) capsid proteins measure: Detection of antibodies to LNP1265 measure: Detection of antibodies to CRISPR-associated protein 9 (Cas9) protein measure: Detection of vector DNA in blood measure: Detection of vector DNA in saliva measure: Detection of vector DNA in nasal secretions measure: Detection of vector DNA in semen measure: Detection of vector DNA in urine measure: Detection of vector DNA in feces measure: Incidence of TEAEs measure: Severity of TEAEs measure: Detection of vector DNA in relevant matrices based on data analysis of Part 1 Dose Confirmation Cohort measure: Detection of vector DNA in relevant matrices over time based on data analysis from adult cohorts over time sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06379776 id: LabForSIMS-LC1 briefTitle: 3D Model - Classification of Thoracic and Lumbar Spinal Fractures. overallStatus: NOT_YET_RECRUITING date: 2024-05-25 date: 2026-09-30 date: 2026-09-30 date: 2024-04-23 date: 2024-04-23 name: Université Paris-Sud class: OTHER briefSummary: The goal of this clinical trial is to evaluate and compare the effectiveness of a 3D interactive model versus traditional teaching methods in enhancing the teaching of thoracic and lumbar spine fractures classification (AO Spine) among orthopedic residents.

The main questions this study aims to answer are:

Does the use of a 3D interactive model improve residents' knowledge regarding the AO Spine classification of spine fractures compared to traditional teaching methods? To what extent does the utilization of a 3D interactive model enhance understanding of spinal anatomy, injury mechanisms, pathophysiology, and fracture diagnosis among surgical residents?

Participants will be randomly assigned to either:

Group A: Access to the 3D interactive model depicting thoracic and lumbar spine fractures based on the AO Spine classification. They can explore fractures, access textual information, and anatomical annotations.

Group B: Traditional teaching materials including slides, texts, and diagrams illustrating spine fractures according to the AO Spine classification.

Researchers will compare the post-training knowledge and confidence levels in managing spine fractures between the two groups to assess the efficacy of the 3D model.

Participants will be required to fill out pre- and post-training questionnaires assessing their knowledge, experience with 3D educational tools, confidence levels in managing spine fractures, and satisfaction with the teaching method.

The study aims to ascertain if the use of the 3D model significantly enhances residents' comprehension of spine fractures compared to conventional teaching methods within the orthopedic curriculum. conditions: Lumbar Spine Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Education through a 3D model name: Education through a traditional pedagogical support measure: Specific Questionnaire measure: Objective Structured Assessment of Technical Skills (OSATS) measure: Subjective questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06379763 id: 170/2024 briefTitle: Effect of Diaphragmatic Breathing Exercise on Pain and Sleep Quality in Individuals With Non-specific Chronic Neck Pain overallStatus: RECRUITING date: 2024-03-01 date: 2024-05-30 date: 2024-06-30 date: 2024-04-23 date: 2024-04-23 name: University of Jordan class: OTHER briefSummary: This research focuses on adding diaphragmatic breathing to conventional physiotherapy sessions, particularly for patients suffering from chronic neck pain aged between 20-40 years in Jordan. Chronic neck pain is recognized as one of the most prevalent musculoskeletal pain disorders, significantly impacting physical, social, and psychological aspects of life. This issue leads to a decline in functional performance and work productivity, negatively affecting both individual and societal levels. Several factors, such as poor posture and prolonged use of smartphones, contribute to the exacerbation of non-specific chronic neck pain. These problems also affect respiratory muscles, particularly the diaphragm responsible for primary respiration, resulting in a shift from abdominal to chest breathing. This alteration increases the use of neck muscles, subsequently intensifying neck pain and negatively impacting sleep quality in these individuals. The primary objective of this therapeutic study is to investigate the role of adding diaphragmatic breathing to physiotherapy sessions in alleviating pain and improving sleep quality.

RCT study will investigate the effect of adding the diaphragmatic breathing to conventional physiotherapy treatment on pain and sleep quality over one month. conditions: Non-specific Chronic Neck Pain conditions: Diaphragmatic Breathing Exercise studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized clinical trial (RCT) Participants will be randomly allocated into two groups using the block randomization method. The following groups will be formed: experimental group A (diaphragmatic breathing plus conservative physiotherapy intervention, cervical neck ROM, neck stretching exercises), and group B, primaryPurpose: TREATMENT masking: SINGLE maskingDescription: the participants will not know which of exercises that will be giving for them more better in experimental or control group whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: diaphragmatic breathing exercise name: conventional physiotherapy exercise measure: neck pain measure: neck pain measure: sleep quality sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: The university of Jordan status: RECRUITING city: Amman zip: 11942 country: Jordan name: ISLAM ALNAQEEB, master role: CONTACT phone: 00962797246713 email: islam.alnaqeeb01@gmail.com name: Musab Abu beidar, master role: CONTACT phone: 00962790319243 email: musababubaider@gmail.com lat: 31.95522 lon: 35.94503 hasResults: False

 nctId: NCT06379750 id: STOPNCD briefTitle: Using Healthcare Financing and Digital Technology to Improve Hypertension Prevention and Control in Tanzania overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-03-01 date: 2028-03-01 date: 2024-04-23 date: 2024-04-23 name: Queen's University class: OTHER name: Kilimanjaro Clinical Research Institute name: Muhimbili University of Health and Allied Sciences briefSummary: The aim of our proposed program is to develop and implement a multilevel, multicomponent and health-financing intervention that will facilitate the scale up of evidence-based strategies to improve non-communicable diseases prevention, detection and control in Tanzania. We will accomplish this by: 1) adapting two intervention components that are candidates for inclusion in a highly effective optimized strategy (called STOP-NCDs) and; (b) Assess their individual and combined effectiveness and 2) conducting a robust, mixed-methods evaluation of the implementation process and assess factors that may influence implementation and sustainability for delivering and scaling the optimized STOP-NCDs strategy. We will select and/or adapt intervention components making up the optimized STOP-NCDs strategy. Using a hybrid clinical-effectiveness implementation design, we will conduct a study in 2 sequential phases: 1) A clinical-effectiveness phase in which we evaluate the effect of our combined strategies (task-sharing and WelTel) versus Usual Care, on rates of systolic BP reduction at 12 months; as well as other secondary outcomes including diagnosis and treatment of diabetes and, patient knowledge of CVD risks and prevention, and, other features of health provider NCD prevention activities. 2) A post-implementation phase in which we use the RE-AIM framework to evaluate changes in the adoption and maintenance of our combined strategies in participating iCHF health facilities across Kilimanjaro region. We will use the WelTel communication and Patient Management platform for to deliver culturally and contextually appropriate evidence-based text messaging to patients. It allows for quality improvement and is a unique tool for our program to scaling low-cost interventions that provide capabilities for tracking of health system service uptake, quality-metrics at health facilities, drug stock-out management, and patient-centered behavioral health interventions. Deployment of WelTel will allow for integration of NCD prevention targeted health services to all adult iCHF members across differing life stages and NCD risk and have a significant impact on increasing quality of care and sustainability of health financing and performance-based incentives through improved prescribing, patient engagement, medication adherence and healthy behaviour change. conditions: Hypertension conditions: Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: OTHER masking: NONE count: 1320 type: ESTIMATED name: Nurse-delivered care using WelTel check-ins and BCC SMS name: Community-based peer-support model measure: Systolic blood pressure measure: Blood pressure control sex: ALL minimumAge: 21 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06379737 id: 359n/AO/23 id: MASI_CARIVARI21_01 type: OTHER_GRANT domain: Fondazione Cariparo briefTitle: Multi-systemic Rehabilitative Interventions in Long COVID-19 Patients in Two Different Settings: a Randomized Controlled Trial acronym: MULTI-COVID overallStatus: COMPLETED date: 2023-01-01 date: 2023-12-20 date: 2023-12-20 date: 2024-04-23 date: 2024-04-23 name: Padua University General Hospital class: OTHER briefSummary: Objective: This study aimed to evaluate the effectiveness of a multisystem rehabilitation program for Long Covid patients in two different settings.

Design: Randomized controlled trial. Settings: Health resort and home-based. Participants: 72 Long Covid patients. Interventions: Patients were randomly assigned into two groups: Group A (n=36) received health resort intervention, and Group B (n=36) received home-based care. Both groups underwent a 5-week rehabilitation program, involving motor, respiratory, and cognitive exercises, two sessions per week.

Outcomes: Assessments were conducted before (T0) and after treatment (T1), at 3 (T2) and 6 months (T3), including respiratory and physical function, handgrip strength, fatigue, pain, quality of life, psychological function, and satisfaction. conditions: Long COVID studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 72 type: ACTUAL name: Multi-systemic Rehabilitation measure: Numerical Rating Scale (NRS) measure: Hand grip strength measure: Barthel Dyspnea Scale measure: Fatigue Assessment Scale measure: Beck's Depression Inventory (BDI measure: Beck Anxiety Inventory (BAI) measure: 12-Item Short Form Health Survey (SF-12) measure: Patients satisfaction sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universityof Padua city: Padova zip: 35128 country: Italy lat: 45.40797 lon: 11.88586 hasResults: False

 nctId: NCT06379724 id: 150349 briefTitle: Burn Study- Tranexamic Acid Versus Thrombin in Split Thickness Skin Graft overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-12 date: 2026-12 date: 2024-04-23 date: 2024-04-23 name: University of Kansas Medical Center class: OTHER briefSummary: Investigators hypothesize that topical tranexamic acid will have better or comparable efficacy to topical thrombin in reducing hematoma formation at the wound base. The purpose of the study is to demonstrate that topical tranexamic acid will be a non-inferior alternative medication to the current standard of care,THROMBIN-JMI® , and at a lower cost to the health system. conditions: Burns conditions: Skin Graft Complications studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, randomized, blinded, non-inferiority study primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Subjects will be blinded to their randomization group. Study subject number will be linked to their randomization group. Blinding may be broken if the subject experiences an adverse reaction to the medication utilized for their group so that they are aware that they cannot receive the medication in the future. The research coordinator will have the code to the blind. The surgical team will not be blinded as the overall consistency of the topical agents will differ and may be apparent. whoMasked: PARTICIPANT count: 62 type: ESTIMATED name: Tranexamic acid name: Thrombin JMI name: skin graft measure: The number of participants with hematoma occurrence measure: The rate of percentage of graft take adherence amongst participants measure: Comparison of number of participants that require re-operation measure: Difference in cost between two hemostatic agents sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06379711 id: H22-03727 briefTitle: Cardiopulmonary Changes Following Spinal Cord Stimulation in Individuals With Spinal Cord Injury overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2028-08-01 date: 2028-08-01 date: 2024-04-23 date: 2024-04-23 name: University of British Columbia class: OTHER briefSummary: The aim of this study is to examine the mechanisms of transcutaneous spinal cord stimulation (tSCS) for improving cardiovascular and pulmonary function in individuals with chronic motor-complete spinal cord injury (SCI) by measuring vascular related endothelial biomarkers, plasma catecholamines, and respiratory parameters. conditions: Spinal Cord Injuries conditions: Cardiovascular Diseases conditions: Cardiopulmonary Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pre-Post Study primaryPurpose: TREATMENT masking: NONE count: 22 type: ESTIMATED name: Transcutaneous Spinal Cord Stimulation (tSCS) measure: Circulating endothelial biomarkers in EMV/µL (Park et al., 2023) measure: Plasma catecholamines in nmol/L (Claydon & Krassioukov, 2008) measure: Spirometric parameters for lung volume in ml/kg (Aung et al., 2019) for FVC measure: Spirometric parameters for lung volume in ml/kg (Aung et al., 2019) for FEV1 sex: ALL minimumAge: 19 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Blusson Spinal Cord Centre city: Vancouver state: British Columbia zip: V5Z 1M9 country: Canada lat: 49.24966 lon: -123.11934 hasResults: False

 nctId: NCT06379698 id: CHUBX 2023/78 briefTitle: Rein 3D PRINT PERSONALIZE acronym: R3DP-P overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-06-15 date: 2027-06-15 date: 2024-04-23 date: 2024-04-23 name: University Hospital, Bordeaux class: OTHER briefSummary: The goal of this clinical trial is to compare preoperative information and patient experience using a personalized versus a generic 3D printed models of patients' tumoral kidney before and after nephron-sparing surgery. The main outcome measure will be based on semi-structured interviews with the patient and the carers. conditions: Tumoral Kidney studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 90 type: ESTIMATED name: personalized 3D model pré-opérative education name: generic 3D model pré-opérative education measure: Qualitative assessment of patient experience 1 measure: Qualitative assessment of patient experience 2 measure: Qualitative assessment of patient experience 3 measure: Description of interactions between carers and patients measure: Comparison of the evolution and frequency of terms used by patients in the 2 groups during their care. measure: Studying the use of the 3D-printed kidney model introduced during the medical information consultation up to the post-operative visit by describing the life of the model throughout the entire care process measure: To study the level of understanding of renal anatomy and surgical issues according to the type of tool (personalized vs generic 3D printed model) measure: Comparison of the level of health literacy between the two groups at different times with changes in the average score on the literacy questionnaire (HLSEU-Q16: European Health Literacy Survey Questionnaire) measure: Description of the changes perceived by carers in patients management in both group sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Bordeaux city: Bordeaux country: France name: Gaëlle MARGUE, Docteur role: CONTACT lat: 44.84044 lon: -0.5805 hasResults: False

 nctId: NCT06379685 id: SOPH190-0923/I briefTitle: Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface. overallStatus: NOT_YET_RECRUITING date: 2024-09-30 date: 2025-04-30 date: 2025-04-30 date: 2024-04-23 date: 2024-04-23 name: Laboratorios Sophia S.A de C.V. class: INDUSTRY briefSummary: This is a phase I clinical study to evaluate the safety and tolerability of PRO-190 ophthalmic solution through the incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, changes in the ocular comfort index (OCI) score, and IOP measurement compared to Systane Ultra®. conditions: Dry Eye conditions: Dry Eyes Chronic conditions: Dry Eye Syndromes studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase I, controlled, comparative, controlled, comparative. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Single-blind whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: PRO-190 name: Systane Ultra® measure: Incidence Unexpected Related Adverse Reactions measure: Changes in the ocular comfort index (OCI) score in between interventions measure: Changes in Best Corrected Visual Acuity (BCVA) measure: Changes in tear film breakup time measure: Changes in intraocular pressure (IOP) measure: Changes in the integrity of the ocular surface (fluorescein staining) measure: Changes in lissamine green staining sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06379672 id: 2023[No.193] briefTitle: Resonance Breathing Training for Long Covid-related Myocardial Injury overallStatus: NOT_YET_RECRUITING date: 2024-05-25 date: 2024-08-25 date: 2024-09-05 date: 2024-04-23 date: 2024-04-23 name: Chengdu Sport University class: OTHER briefSummary: An investigation of the efficacy of resonance breathing training in the rehabilitation of patients with Long covid-related myocardial injury conditions: Long COVID conditions: Myocardial Injury studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: Resonance breathing measure: New YorkHeart Association (NYHA) measure: left ventricle global longitudinal strain, LVGLS measure: hypertension measure: Average heart rate sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06379659 id: IR.MUI.MED.REC.1402.449 id: IRCT20110908007513N18 type: REGISTRY domain: IRAN registry of clinical trials (IRCT) briefTitle: Effectiveness of Intrauterine Growth Hormone Administration as an add-on Therapy to Conventional Hormone Therapy Compared to Placebo in Patients With Thin Endometrium Undergoing Frozen Thawed Embryo Transfer overallStatus: RECRUITING date: 2024-05 date: 2024-07 date: 2024-11 date: 2024-04-23 date: 2024-04-29 name: Isfahan University of Medical Sciences class: OTHER briefSummary: The purpose of this clinical trial is to see if intrauterine growth hormone infusions can help subjects reach a suitable endometrial thickness in patients who are resistant to routine hormonal therapy for embryo transfer in the In Vitro Fertilization (IVF) cycle.

The primary aim of this study is to assess the effectiveness of injecting Growth hormone directly into the uterus to enhance endometrial thickness. Additionally, we aim to compare the likelihood of pregnancy between patients receiving the Growth hormone infusion and those receiving a placebo. conditions: Thin Endometrium conditions: Infertility Female conditions: Infertility studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study was designed as a randomized controlled exploratory clinical trial, controlled with a parallel placebo group and random allocation using an online based system. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: In this study, a double-blind methodology will be employed to minimize bias. Patients will be administered medication without knowing the study group and placebo or treatment intervention. To ensure uniformity between growth hormone and placebo, which has a similar appearance to the placebo, will be prepared by an individual informed of the enrolled patients in the study and will be provided to the administering physician. The evaluator assessing outcomes such as clinical pregnancy rate and endometrial thickness will not know which treatment each patient received. Laboratory staff will also be unaware of the treatment groups. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: Growh hormone name: Placebo measure: Endometrial thickness measure: Clinical Pregnancy Rate measure: Response to treatment measure: Implantation rate measure: IVF cancellation rate measure: Early pregnancy complications sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Isfahan Shahid Beheshti hospital, Hazrat e Maryam Fertility Center status: RECRUITING city: Isfahan zip: 8174673461 country: Iran, Islamic Republic of name: Nastaran Zamani Dehkordi role: CONTACT phoneExt: +989133842958 email: nastaran14zd@gmail.com name: Hatav Ghasemi Dehkordi role: CONTACT phoneExt: +989131134081 email: hatav.tehrani2014@gmail.com name: Hatav Ghasemi Tehrani role: PRINCIPAL_INVESTIGATOR lat: 32.65246 lon: 51.67462 hasResults: False

 nctId: NCT06379646 id: YTS109-003 briefTitle: An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2025-04-21 date: 2026-04-21 date: 2024-04-23 date: 2024-04-23 name: China Immunotech (Beijing) Biotechnology Co., Ltd. class: INDUSTRY name: Shanghai Changzheng Hospital briefSummary: An exploratory clinical study of the safety and efficacy of YTS109 cell injection in subjects with recurrent/refractory autoimmune disease conditions: Systemic Lupus Erythematosus conditions: Systemic Sclerosis conditions: Inflammatory Myopathy conditions: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis conditions: Antiphospholipid Syndrome conditions: Sjogren's Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: YTS109 measure: Safety outcomes measure: Efficacy outcomes for SLE measure: Efficacy outcomes for Sjogren's Syndrome measure: Efficacy outcomes for Systemic Sclerosis measure: Efficacy outcomes for Inflammatory Myopathy measure: Efficacy outcomes for Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis measure: Efficacy outcomes for Antiphospholipid Syndrome measure: Peak Plasma Concentration (Cmax) of YTS109 measure: Time to Peak (Tmax) of YTS109 measure: Area under the plasma concentration versus time curve (AUC) of YTS109 measure: PD parameters sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06379633 id: s67010 briefTitle: Virtual Reality Exposure for Socially Anxious Adolescents acronym: VIRTUS overallStatus: RECRUITING date: 2024-03-27 date: 2026-06 date: 2026-06 date: 2024-04-23 date: 2024-04-23 name: KU Leuven class: OTHER name: Utrecht University briefSummary: Overall in this project, the primary goal is to evaluate the efficacy of virtual reality exposure (VRE) for adolescents with elevated social anxiety using a three-arm randomized controlled trial: (1) virtual reality exposure (VRE); (2) in vivo exposure (IVE); and (3) waitlist (WL) - the control condition.

It is predicted that both VRE and IVE will be more successful in decreasing social anxiety symptoms than the WL condition at post-assessment and that VRE will be as effective as in vivo in reducing social anxiety symptoms. Furthermore, it is expected that there will be no difference between the two active conditions in the long term (at 3- months \& 6-months follow up). Similar results are expected in the secondary outcome measures, intended to capture the participants' general well-being.

Moreover, the study has the following (secondary) objectives:

* To elucidate potential working mechanisms of VRE and IVE
* To identify predictors of adolescents' response to VRE and IVE
* To assess to what extent adolescents accept VRE and IVE and how they experience it conditions: Social Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned to one of the three conditions and will remain in that condition throughout the training sessions. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: All pre-assessments and post-assessment will be conducted by researchers who will be blind to the participants' allocated condition. whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: In vivo exposure name: (Virtual reality) exposure measure: Brief version of the Social Phobia and Anxiety Inventory (SPAI-18) measure: Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-CA) - Avoidance subscale measure: Behavioral assessment task (BAT) - Peak anxiety measure: Brief Resilience Scale (BRS) measure: Multidimensional Adolescent Functioning Scale (MAFS) - Peer and General functioning subscales measure: Revised Children's Anxiety and Depression Scale (RCADS) measure: Self-Efficacy Questionnaire for Children (SEQ-C) - Social efficacy subscale measure: Social Phobia Weekly Summary Scale (SPWSS) measure: Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-CA) - Fear subscale measure: Adolescent Social Cognitions Questionnaire (ASCQ) measure: Behavioral assessment task (BAT) - Anticipatory anxiety measure: Behavioral assessment task (BAT) - Physiological assessment measure: Behavioral assessment task (BAT) - Physiological assessment measure: Behavioral assessment task (BAT) - Physiological assessment measure: Behavioral assessment task (BAT) - Task duration measure: Behavioral assessment task (BAT) - Confederate rating measure: Behavioral inhibition system / behavioral activation system scale (BIS/BAS) measure: Experiences in Close Relationship Scale - Relationship Structures (ECR-RS) measure: Immersive Tendency Questionnaire (ITQ) - Factor Involvement measure: Unified Theory of Acceptance and Use of Technology (UTAUT-A) - Attitudes subscale measure: Unified Theory of Acceptance and Use of Technology (UTAUT-EC) - Expectancy subscale measure: VR experience, motivation, need for connection/relatedness, openness to experiences measure: Preference for treatment question measure: Credibility and Expectancy Questionnaire (CEQ) measure: Working Alliance Inventory-Short Form (WAI-S) measure: Exposure log questions - expectancy violation & expectancy change measure: Exposure log open-ended questions - expectancy violation & expectancy change measure: Exposure log questions - within- & between- session habituation measure: Exposure log question- Self-efficacy measure: Exposure log question - Presence measure: Exposure log questions - Participant feedback measure: Acceptability interview sex: ALL minimumAge: 12 Years maximumAge: 16 Years stdAges: CHILD facility: Psychological Institute (PSI) of KU Leuven status: RECRUITING city: Leuven zip: 3000 Leuven country: Belgium name: Jella De Lee, MSc role: CONTACT phone: +3216373075 email: jella.delee@kuleuven.be name: Elizabeth S. Uduwa-vidanalage, MSc role: CONTACT email: s.e.uduwavidanalage@uu.nl name: Dirk Hermans, PhD role: PRINCIPAL_INVESTIGATOR name: Iris Engelhard, PhD role: SUB_INVESTIGATOR name: Katharina Meyerbröker, PhD role: SUB_INVESTIGATOR name: Sara Scheveneels, PhD role: SUB_INVESTIGATOR name: Jella De Lee, MSc role: SUB_INVESTIGATOR name: Elizabeth S Uduwa-vidanalage, MSc role: SUB_INVESTIGATOR lat: 50.87959 lon: 4.70093 hasResults: False

 nctId: NCT06379620 id: 22-5544 briefTitle: Pilot Open Label Use of the Hi-OXSR for the Treatment of Post COVID-19 Cognitive Dysfunction acronym: Hi-OXSR overallStatus: COMPLETED date: 2022-11-29 date: 2024-03-04 date: 2024-03-04 date: 2024-04-23 date: 2024-04-25 name: University Health Network, Toronto class: OTHER briefSummary: During the worldwide COVID-19 pandemic a large number patients reported different functional complaints one month or later after recovery from the acute infection. This entity had a number of names including "long-COVID" or "post COVID condition". Long-COVID is on the rise and no effective treatment exists yet to improve cognitive function. Recent research has shown that people with even mild COVID had a greater decline in executive function, notably in their ability to perform complex tasks. What drives post-COVID cognitive changes is still a mystery and there are no effective treatments available. One hypothesis is that there is persistent immune activation resulting in reduction in cerebral blood flow. There is evidence that increased CO2 may decrease inflammation, and decreased CO2 may increase inflammation.

Objectives: The primary objective of this pilot study is to assess the safety and tolerability of the use of Hi-OX sequential rebreathing for the treatment of post-COVID cognitive dysfunction. The secondary objective is to identify the effects of the use of the Hi-OX rebreathing treatment in changing post-COVID cognitive dysfunction. conditions: Post COVID-19 Condition studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is an open label, pilot treatment study. Screening data will be reviewed to determine subject eligibility. Upon successful completion of all screening procedures, subject will be considered eligible for enrollment.

The subject will self-administer oxygen gas at 1to 3LPM via a Hi-OxSR Sequential Rebreathing mask, twice a day for 30 minutes with ventilation supplemented by the subject's rebreathed exhaled air. Total treatment is for 14 days. Subjects will be asked to return to the clinic for additional evaluations on Days 15 and 45. primaryPurpose: TREATMENT masking: NONE count: 37 type: ACTUAL name: Hi-OxSR Sequential Rebreathing mask (oxygen concentrator) measure: Safety of use of Hi-OX sequential rebreathing device sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Health Network city: Toronto state: Ontario zip: M5G 2C4 country: Canada lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06379607 id: HFNC2024 briefTitle: High Flow Nasal Cannula Rates in Pediatric Asthma overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2025-09-30 date: 2025-09-30 date: 2024-04-23 date: 2024-04-23 name: University of Rochester class: OTHER briefSummary: This is a randomized, open-label, 3-armed feasibility trial will examine conventional oxygen therapy (COT) vs high flow nasal cannula at 4L/min flow vs HFNC at 2L/kg/min flow (max 60L/min) in moderate to severe pediatric asthma exacerbations. conditions: Pediatric Asthma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 27 type: ESTIMATED name: "High Flow" High Flow Nasal Cannula name: "Low Flow" High Flow Nasal Cannula measure: Percent of participants enrolled measure: Mean Change in Pediatric Asthma Severity Score (PASS) measure: Mean Change in Respiratory Rate measure: Mean Total Duration of Continuous Albuterol measure: Percentage of Children with Escalation of Respiratory Support measure: Mean Total Duration of Respiratory Support measure: Percentage of Participants placed on Adjunct Asthma Therapies measure: Percentage of Participants who needed Sedation measure: Percentage of Participants on Antibiotics measure: Mean PICU Length of Stay (LOS) measure: Mean Hospital Length of Stay (LOS) sex: ALL minimumAge: 3 Years maximumAge: 17 Years stdAges: CHILD hasResults: False

 nctId: NCT06379594 id: 294633 briefTitle: UK Based Remote Brain Health Clinic (BHC) for Patients With Mild Cognitive Impairment (MCI) acronym: BHC overallStatus: ENROLLING_BY_INVITATION date: 2022-06-20 date: 2027-12 date: 2028-06 date: 2024-04-23 date: 2024-04-23 name: South London and Maudsley NHS Foundation Trust class: OTHER briefSummary: This project aims to understand the feasibility, acceptability and real-world evidence of a novel UK-based remote brain health clinic for patients with mild cognitive impairment (MCI). A timely and accurate diagnosis of dementia is a priority in the UK and MCI is indicative of future risk of cognitive decline. An accurate etiological diagnosis of MCI (MCI-subtyping - distinguishing those who are likely to go on to develop dementia and those who are not) is vital for treatment planning. Whilst the assessment of molecular biological markers (biomarkers) for etiological diagnosis of MCI and Alzheimer's disease (AD) is increasingly recommended and employed internationally, the uptake is low in UK memory clinics. The Brain Health Clinic (BHC) has been specifically designed as a state-of-the-art diagnostic centre for those with MCI. Procedures will include a range of clinical and biomarker assessments, with molecular biomarkers based on lumbar puncture and cerebrospinal fluid (CSF) analysis. Additionally, the clinic will employ remote neuropsychiatric assessments using digital and telephonic methods. This allows for regular contact, whilst adhering to changes in clinical practice and national guidance due to the COVID-19 pandemic. Our overarching objectives are to first establish the acceptability and feasibility of the remote Brain Health Clinic and its novel clinical and biomarker assessment programme. Then secondly establish the impact of care under the Brain Health Clinic on i) care management decisions (e.g. follow-up and treatment planning); ii) time to etiological diagnosis of MCI (MCI-subtyping); and iii) time to diagnosis of dementia and severity of dementia at the time of diagnosis. conditions: Mild Cognitive Impairment conditions: Mild Cognitive Impairment Due to Alzheimer's Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: To establish acceptability and feasibility of a novel remote brain health clinic for those with MCI. measure: To establish acceptability and feasibility of a novel remote brain health clinic for those with MCI. measure: To establish the acceptability and feasibility of the following procedures/ biomarker assessment in a Brain Health Clinic measure: 2. To establish the acceptability and feasibility of administering the following cognitive assessments remotely in a brain health clinic measure: To establish the validity of novel MRI analysis software tools measure: 5. To investigate the acceptability and feasibility of remote tablet-based cognitive training measure: To establish the impact of the remote Brain Health Clinics novel clinical and biomarker assessment programme measure: To establish the impact of the remote Brain Health Clinics novel clinical and biomarker assessment programme measure: To establish the impact of the remote Brain Health Clinics novel clinical and biomarker assessment programme measure: To establish the impact of the remote Brain Health Clinics novel clinical and biomarker assessment programme sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: King's College London city: London state: Denmark Hill zip: SE5 8AF country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06379581 id: 2022-04900-02 briefTitle: Skin Cancer Diagnostics Using Photoacoustic Imaging overallStatus: RECRUITING date: 2023-01-01 date: 2025-10-01 date: 2025-10-01 date: 2024-04-23 date: 2024-04-24 name: Region Skane class: OTHER name: Lund University briefSummary: In this clinical study, photoacoustic imaging will be used on patients with suspected skin cancer (primarily melanoma, basal cell carcinoma, and squamous cell carcinoma) to determine the tumor borders both superficially and at a depth. conditions: Skin Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Tumor thickness measure: Tumor size sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Ophthamology, Lund, Skåne University Hospital status: RECRUITING city: Lund zip: 22185 country: Sweden name: Malin Malmsjö, Professor role: CONTACT phone: +46722335060 email: malin.malmsjo@med.lu.se lat: 55.70584 lon: 13.19321 hasResults: False

 nctId: NCT06379568 id: SichuanPPHLC01 briefTitle: Risk of Aspergillus Infection in Patients With Chronic Lung Disease overallStatus: COMPLETED date: 2022-07-01 date: 2024-01-31 date: 2024-01-31 date: 2024-04-23 date: 2024-04-23 name: Lin Chen class: OTHER briefSummary: Large doses of systemic corticosteroids ，severe lung tissue damage and longer COPD diagnosis may increase the risk of IPA in patients with chronic structural lung disease. By comparing the risk factors of aspergillus colonization group and aspergillus infection group, the main risk factors of aspergillus pneumonia were determined. conditions: Fungal Infection Lungs studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 209 type: ACTUAL name: No intervention measure: Descriptive statistical index measure: Independent risk factor for aspergillus pneumonia measure: The area under ROC curve of risk factors for aspergillus pneumonia measure: Threshold analysis of aspergillus pneumonia sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sichuan Provincial People's Hospital city: Chengdu state: Sichuan zip: 610072 country: China lat: 30.66667 lon: 104.06667 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-01-31 uploadDate: 2024-04-17T04:01 filename: Prot_SAP_000.pdf size: 101446 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-01-31 uploadDate: 2024-04-14T12:03 filename: ICF_001.pdf size: 105933 hasResults: False

 nctId: NCT06379555 id: 2023-A02756-39 briefTitle: Wrist Fractures Management With Arthroscopic Assistance Under Walant - Exploratory Study acronym: WALANPOIGNE overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-01 date: 2026-01 date: 2024-04-23 date: 2024-04-23 name: GCS Ramsay Santé pour l'Enseignement et la Recherche class: OTHER briefSummary: Wrist articular fractures are more difficult to treat and rehabilitation takes longer. Furthermore, these joint fractures are frequently accompanied by ligament lesions of the carpal bones.

For these reasons, it is strongly recommended to check the interior of the wrist joint. This check can be done with wrist arthroscopy. Therefore, fracture reduction can be improved, "step of stairs" can be eliminated under arthroscopic control and ligament rupture of carpal bones can be treated.

WALANT anesthesia (Wide Awake Local Anesthesia No Tourniquet) designates a new local anesthesia technique. This technique which allows to maintain the arm or fingers mobility offers several significant advantages:

* Greater precision of the surgical procedure.
* A reduction in discomfort, risks and related adverse effects to anesthesia.
* Faster recovery.

WALANT technique is very comfortable for patient and fits perfectly with principles of Enhanced Recovery in Surgery.

In this context, this study is based on the hypothesis that it is possible to combine arthroscopy and the WALANT anesthesia technique for reducing wrist fractures conditions: Wrist Fractures studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Walanpoigne measure: Failure percentage measure: Pain assessment measure: Patient experience measure: Wrist mobility measure: Functional characteristics of the wrist measure: Functional characteristics of the wrist measure: Complications sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06379542 id: XC8-03-05-2023 briefTitle: Efficacy and Safety of XC8, Film-coated Tablets, in Children With Acute Respiratory Viral Infections overallStatus: RECRUITING date: 2023-12-04 date: 2025-12-31 date: 2025-12-31 date: 2024-04-23 date: 2024-04-23 name: Valenta Pharm JSC class: INDUSTRY briefSummary: The study is planned to evaluate the therapeutic efficacy and safety of XC8, film-coated tablets, in the treatment of dry non-productive cough on the background of acute respiratory infections in children from 6 to 17 years compared with placebo. conditions: Acute Respiratory Infection studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 252 type: ESTIMATED name: XC8 name: Placebo measure: Decrease in percentage of patients with ≥50% reduction in number of cough attacs by day 5 relative to day 1 measure: Number of cough attacks by day 5, day 8, day 11 and day 15 measure: Time (days) from visit 1 until clinical cough cure is achieved measure: Proportion of patients with presence of ≤ 1 score for the "daytime cough" and "nighttime cough" sections Daytime and nighttime cough scales by days 5, 8, 11, and 15 after visit 1 measure: Change (score) in cough severity by digital rating scale by days 5, 8, 11 and 15 compared to visit 1 measure: Percentage of patients needed acetylcysteine measure: Proportion of patients with complete resolution of all symptoms of acute respiratory infection by days 4, 7, 10 and 14 measure: Percentage of patients with each category of Global Physician-Researcher Assessment of Therapy Effectiveness at visits 2, 3, 4, and 5 measure: Number of adverse events (AEs) measure: Adverse reactions measure: Serious adverse events (SAEs) measure: Percentage of patients with AEs measure: Percentage of patients who interrupted treatment sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD facility: City Pediatric Outpatient Clinic number 5 status: RECRUITING city: Perm zip: 614066 country: Russian Federation name: Olga Perminova, MD, PhD role: CONTACT phone: +7 (912) 882 0549 email: perminova20062006@yandex.ru lat: 58.01046 lon: 56.25017 facility: Professors' Clinic LLC. status: RECRUITING city: Perm zip: 614070 country: Russian Federation name: Svetlana Teplykh, MD, PhD role: CONTACT phone: +7 (919) 498 2931 email: profkliniki@mail.ru lat: 58.01046 lon: 56.25017 facility: St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 44" status: RECRUITING city: Saint Petersburg zip: 192071 country: Russian Federation name: Olga V Trusova, MD,PhD role: CONTACT phone: +7 (812) 417-40-02 email: o-tru@mail.ru lat: 59.93863 lon: 30.31413 facility: ArsVite North-West, LLC status: RECRUITING city: Saint Petersburg zip: 194223 country: Russian Federation name: Svetlana G Lazareva, MD role: CONTACT phone: +7-812-335-29-58 email: alexlaz58@rambler.ru lat: 59.93863 lon: 30.31413 facility: PiterKlinika LLC status: RECRUITING city: Saint Petersburg zip: 196158 country: Russian Federation name: Tatiana Pak, MD,PhD role: CONTACT phone: +7 (981) 851 8150 email: pte@list.ru lat: 59.93863 lon: 30.31413 facility: St. Petersburg State Budgetary Healthcare Institution "City Pediatric Polyclinic No. 35" status: RECRUITING city: Saint Petersburg zip: 196191 country: Russian Federation name: Tatiana I Antonova, MD, PhD role: CONTACT phone: +7-812-246-46-45 email: antian@bk.ru lat: 59.93863 lon: 30.31413 hasResults: False

 nctId: NCT06379529 id: USCOPD2022B briefTitle: The COPD CARE Study: Evaluating the Impact of a Virtual-First COPD Service on Major Cardiac and Respiratory Events overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-09 date: 2025-12 date: 2024-04-23 date: 2024-04-23 name: NuvoAir Medical PC class: INDUSTRY name: Optum, Inc. briefSummary: A 12 month interventional study of up to 1,050 people with COPD to determine if the NuvoAir virtual-first clinical service leads to fewer moderate and severe COPD exacerbations and cardiac events, reduces healthcare utilization, and lowers the total cost of care compared to a control cohort that receives standard care only. conditions: COPD Exacerbation conditions: COPD conditions: Cardio/Pulm: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Pragmatic evaluation of a clinical service using a prospective cohort comparison of intervention vs propensity matched controls. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 1050 type: ESTIMATED name: NuvoAir clinical service measure: Moderate & Severe Exacerbations measure: Severe COPD Exacerbations measure: Major Adverse Cardiac Event measure: 30-Day COPD Related Readmissions measure: All-Cause Hospitalizations measure: All-Cause Readmissions measure: Days Hospitalized due to COPD measure: Cost of Care Related to COPD measure: Medication Adherence measure: Quality of Life (QOL) measure: Short-Acting Beta-Agonists Used measure: Courses of Oral Antibiotics/Steroids measure: Self-efficacy measure: Patient Activation measure: Cat Score measure: mMRC Dyspnea Scale measure: Physical Activity sex: ALL minimumAge: 30 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06379516 id: NB240004-NB-V briefTitle: Process Validation in Dermatology: Assessing Wound Creation Methods and Treatment Efficacy overallStatus: COMPLETED date: 2024-01-17 date: 2024-01-26 date: 2024-02-16 date: 2024-04-23 date: 2024-04-23 name: NovoBliss Research Pvt Ltd class: OTHER briefSummary: The primary objective of this study is to validate controlled methods of wound, including 1%w/v SLS, 3%w/v SLS, and 24-24 times tape stripping, on the forearms of subjects.

The study aims to standardize the procedures for creating wounds and systematically evaluate the effects of these methods on various skin parameters. conditions: Validation of the Process of Wound Creation and Evaluation studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Proof of science/concept primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 5 type: ACTUAL name: Moisturising Cream (5%) name: Moisturising Cream (10%) name: Coconut Oil measure: Trans Epidermal Water Loss (TEWL) measure: Skin hydration measure: Skin surface topography measure: Dermatological Assessment sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: NovoBliss Research Pvt Ltd city: Gandhinagar state: Gujarat zip: 382421 country: India lat: 23.21667 lon: 72.68333 hasResults: False

 nctId: NCT06379503 id: 2021/37-04 briefTitle: Effect of Heart Yoga Applıed To Patıents Undergoıng Cardıovascular Surgery on Sleep, Depressıon And Qualıty of Lıfe overallStatus: COMPLETED date: 2021-12-15 date: 2023-01-18 date: 2023-06-18 date: 2024-04-23 date: 2024-04-23 name: Dokuz Eylul University class: OTHER briefSummary: This type of study is a randomized controlled trial. The aim is to contribute to the literature by comparing the effects of heart yoga on the depression level, sleep and quality of life of patients who do and do not do heart yoga.

The main elements it aims to answer are:

* Heart yoga applied to patients who have undergone heart surgery improves their sleep quality compared to those who have not.
* Heart yoga applied to patients who have undergone heart surgery reduces the level of depression compared to those who have not.
* Heart yoga applied to patients who have undergone heart surgery increases the quality of life compared to those who have not.

Patients who accept the study will practice heart yoga simultaneously with heart yoga videos via an online link every other day for 12 weeks after heart surgery.

Researchers will compare intervention and control groups to see if there are any effects on sleep quality, depression level, and quality of life. conditions: Cardiac Disease conditions: Yoga conditions: Nursing Caries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: randomized controlled trial primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: HEART YOGA name: routine nursing care measure: sleep quality measure: depression measure: life quality sex: ALL minimumAge: 45 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dokuz Eylül Üniversitesi Hastanesi city: İ̇zmi̇r state: Balçova zip: 35330 country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06379490 id: CTA no: 2024-510572-20-00 id: 2024-510572-20-00 type: CTIS id: P-2023-296 type: OTHER domain: Privacy - Region Hovedstaden briefTitle: Ultrasound-guided Infraclavicular Block With Lidocaine or Ropivacaine for Closed Reduction of Distal Radius Fractures overallStatus: RECRUITING date: 2024-04-23 date: 2024-08-01 date: 2025-09-01 date: 2024-04-23 date: 2024-04-24 name: Nordsjaellands Hospital class: OTHER briefSummary: To investigate the feasibility of the lateral infraclavicular plexus brachialis (LIC) block for acute closed reduction of distal radius fractures, the investigators will compare the pain-relieving and muscle-relaxing properties of the LIC block with short- and long-acting local anesthetics in different concentrations but at the same volume. In addition to motor and sensory blockade during repositioning, feasibility will also be assessed by other patient-related and block-related factors, as well as by factors related to the repositioning and plastering procedure. conditions: Distal Radius Fractures conditions: Lidocaine conditions: Ropivacaine conditions: Fracture Dislocation conditions: Closed Reduction of Fracture and Application of Plaster Cast conditions: Colles' Fracture studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 63 type: ESTIMATED name: Ropivacaine 0.2% Injectable Solution name: Lidocaine epinephrine name: Ropivacaine 0.5% Injectable Solution measure: Block success measure: Degree of sensory and motor blockade measure: Total duration of sensory blockade measure: Total duration of motor blockade measure: Pain intensity before block performance measure: Time to pain relief/lowest pain intensity measure: Pain intensity during closed reduction measure: Pain intensity during cast application measure: Time to pain breakthrough after the blockade has ended measure: Maximum pain intensity after the blockade has ended measure: Duration of maximum pain intensity after the blockade has ended measure: Amount of strong painkillers consumed by patients within 24 hours after closed reduction measure: Grading of closed reduction difficulty measure: Quality of closed reduction evaluated by X-ray imaging measure: Attempts used for closed reduction measure: Grading of casting difficulty measure: The patient's experience of the treatment measure: Occurence of adverse events (AE) and serious adverse events (SAE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Copenhagen University Hospital - North Zealand status: RECRUITING city: Hillerød zip: 3400 country: Denmark name: Anders K. Nørskov, PhD role: CONTACT phone: 48 29 74 59 phoneExt: +45 email: anders.kehlet.noerskov@regionh.dk name: Kai H. W. Lange, DMSc role: CONTACT phone: 48 29 42 52 phoneExt: +45 email: kai.henrik.wiborg.lange@regionh.dk lat: 55.92791 lon: 12.30081 hasResults: False

 nctId: NCT06379477 id: refractive error surprises briefTitle: Correction of Refractive Error Surprises After Cataract Surgery in Adults overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-05-31 date: 2025-06-30 date: 2024-04-23 date: 2024-04-23 name: Assiut University class: OTHER briefSummary: A refractive surprise can be defined as the failure to achieve the intended postoperative refractive target or the presentation of unexpected and, unwanted post-operative refractive error. It can cause anisometropia or dominance switch and is a source of patient dissatisfaction due to unmet expectations.The best way to manage refractive surprise is to prevent it. The 2017 NICE guidelines on the management of cataracts provide advice on prevention of refractive surprise through accurate biometry, A-constant optimisation, intraocular lens (IOL) formula selection and avoiding wrong lens implant errors.Benchmark standards for NHS cataract surgery dictate that 85% of eyes should be within 1 dioptre (D) and 55% within 0.5D of target spherical equivalent refraction following surgery. conditions: Refractive Errors studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 63 type: ESTIMATED name: Refractive surgeries measure: Diagnosis and treatment of the resulting refractive error surprises sex: ALL minimumAge: 55 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06379464 id: CALM2303 briefTitle: Screening of New Markers of Gut Microbiota in Stroke and Depression: a Cross-sectional Study overallStatus: RECRUITING date: 2023-09-01 date: 2024-06-30 date: 2024-12-30 date: 2024-04-23 date: 2024-04-23 name: Zhujiang Hospital class: OTHER briefSummary: Objectives of Study： Through the cross-sectional study of stroke and depression, key biomarkers are targeted by screening disease-associated intestinal bacteria, metabolites and immune factors through multi-omics techniques. conditions: Acute Ischaemic Stroke conditions: Depression studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 320 type: ESTIMATED measure: The severity of neurological damage in stroke patients measure: The functional recovery outcomes after stroke measure: The severity of symptoms in patients with depression sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhujiang Hospital of Southern Medical University status: RECRUITING city: Guanzhou state: Guangdong zip: 510145 country: China name: Hongwei Zhou, Professor role: CONTACT phone: 186 8848 9622 email: hzhou@smu.edu.cn hasResults: False

 nctId: NCT06379451 id: [2023]YLJSA088 briefTitle: An Clinical Study of NKG2D-CAR-NK Cells for the Treatment of Refractory Recurrent Multiple Myeloma overallStatus: NOT_YET_RECRUITING date: 2024-04-18 date: 2025-12-31 date: 2025-12-31 date: 2024-04-23 date: 2024-04-23 name: Changzhou No.2 People's Hospital class: OTHER briefSummary: Multiple myeloma (MM) is a malignant disease characterized by the abnormal proliferation of clonal plasma cells. However, multiple myeloma remains an incurable disease and requires the exploration of more effective treatment methods to improve the efficacy of relapsed refractory multiple myeloma and prolong survival time.Currently, clinical application of CAR-T is mostly based on autologous T cell preparation, while relapsed/refractory AML patients have undergone multiple chemotherapy treatments, resulting in impaired self-T cell function, which affects the efficacy and prognosis of CAR-T therapy. Therefore, it is necessary to find new alternative treatments. NK cells are important immune cells in the body and are an important component of innate immunity. Compared with CAR-T cell therapy, CAR-NK cells have unique advantages in adoptive cell therapy. NKG2D receptor is an activating receptor expressed on NK cells, which can recognize NKG2D ligands (NKG2DL) expressed on tumor cells, activating NK cell killing activity through NKG2D-NKG2DL interaction. Therefore, the investigators plan to treat relapsed multiple myeloma by infusing NKG2D-CAR-NK cells to evaluate its efficacy and safety. conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 9 type: ESTIMATED name: NKG2D Chimeric Antigen Receptor NK Cell Injection 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: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Changzhou Second People's Hospital city: Changzhou state: Jiangsu zip: 213000 country: China name: Wei Qin, doctor role: CONTACT phone: +8618796912763 email: qinwei19840601@163.com lat: 31.77359 lon: 119.95401 hasResults: False

 nctId: NCT06379438 id: 06/16022018 briefTitle: Treatment of Aphtous Ulcers With Photodynamic Therapy overallStatus: COMPLETED date: 2018-03-05 date: 2019-03-01 date: 2019-03-08 date: 2024-04-23 date: 2024-04-23 name: Yuzuncu Yıl University class: OTHER briefSummary: The search for methods that can shorten the treatment process of aphthous ulcers, the etiology of which is not fully understood, continues. The aim of this study was to determine whether photodynamic therapy (PDT) is a clinically effective alternative in the treatment of oral aphthous ulcers. conditions: Oral Ulcer conditions: Aphthous Recurrent Ulcers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ACTUAL name: Photodynamic therapy (indocyanine green+laser) measure: Ulcer wound healing with diameter measurement measure: Level of recovery measure: Pain evaluation with Visual Analogue Scale sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Yuzuncu Yil University city: Van state: Merkez zip: 65080 country: Turkey lat: 38.49457 lon: 43.38323 hasResults: False

 nctId: NCT06379425 id: 23-0050 briefTitle: Impact of Preoperative Opioid-free Multimodal Analgesia on Time to Trial of Void in Ambulatory Urogynecologic Surgeries overallStatus: RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2026-03-01 date: 2024-04-23 date: 2024-04-23 name: Northwell Health class: OTHER briefSummary: This is a double-arm randomized control trial evaluating the impact of preoperative opioid-free analgesia on time to trial of void in ambulatory urogynecologic surgeries. The investigators hypothesize that receipt of acetaminophen, celecoxib and gabapentin preoperatively versus acetaminophen alone will reduce the time to trial of void in patients undergoing same-day minor urogynecologic procedures. conditions: Pain, Postoperative conditions: Postoperative Pain, Acute studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: NONE count: 70 type: ESTIMATED name: Acetaminophen name: Celecoxib name: Gabapentin measure: Time to initiation of active trial of void sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Northwell Health South Shore Surgery Center status: RECRUITING city: Bay Shore state: New York zip: 11706 country: United States name: Kathleen R Catalano, MSN, RN-BC role: CONTACT phone: 631-647-5550 email: kcatalano@southshoresurg.com name: Nirmala Pillalamarri, MD role: PRINCIPAL_INVESTIGATOR name: Steliana Fakas, MD role: SUB_INVESTIGATOR lat: 40.7251 lon: -73.24539 hasResults: False

 nctId: NCT06379412 id: Zhujianghmy briefTitle: A Cross-sectional Study on the Association of Peptidoglycan Fragments Derived From Gut Microbiota With Colorectal Cancer overallStatus: RECRUITING date: 2023-07-01 date: 2024-12 date: 2024-12 date: 2024-04-23 date: 2024-04-26 name: Zhujiang Hospital class: OTHER briefSummary: The goal of this observational study is to explore the association of peptidoglycan fragments derived from gut microbiota with colorectal cancer (CRC). The main question it aims to answer is: Are peptidoglycan fragments from the gut microbiota associated with the progression of colorectal cancer? Participants will provide biological specimens (blood, feces, colon tissue obtained during surgery) conditions: Colorectal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED name: observational study, no intervention measure: HPLC-MS/MS was used to detect peptidoglycan fragment content in biological specimens of 200 participants sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Zhujiang Hospital of Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: He Xiaolong, Professor role: CONTACT phone: 186 2007 1640 email: 307660349@qq.com lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06379399 id: IRB-2023-1072 briefTitle: Trifluridine/Tipiracil Combined With Cetuximab in the Treatment of Third-line and Above RAS/BRAF Wild-type mCRC overallStatus: RECRUITING date: 2024-04 date: 2025-03 date: 2025-12 date: 2024-04-23 date: 2024-04-23 name: Wangxia LV class: OTHER briefSummary: This study is a single-center, prospective, single-arm exploratory study aimed at evaluating the efficacy and safety of trifluridine/tipiracil in combination with cetuximab in the treatment of third-line and above RAS/BRAF wild-type metastatic colorectal cancer. conditions: Colorectal Cancer Metastatic studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 26 type: ESTIMATED name: Cetuximab name: Trifluridine/Tipiracil measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Overall Response Rate (ORR) measure: Disease Control Rate( DCR) measure: Quality of life: EORTC QLQ-C30 measure: Adverse Events(safety) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhejiang Cancer Hospital status: RECRUITING city: Hangzhou state: Zhejiang zip: 310022 country: China name: Wangxia Lv role: CONTACT phone: +86-13757141026 email: lvwangxia@163.com lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06379386 id: TRACE TAVR Registry briefTitle: Long-term Prognosis and Valve Durability of TAVR overallStatus: RECRUITING date: 2016-01 date: 2025-12 date: 2030-12 date: 2024-04-23 date: 2024-04-23 name: Xijing Hospital class: OTHER briefSummary: This registry aims to evaluate the long-term prognosis and valve durability of transcatheter aortic valve replacement (TAVR) in a real-world setting. Baseline characteristics, procedural data, and clinical outcomes will be collected in a prospective and observational manner. conditions: Aortic Valve Stenosis and Insufficiency studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Transcatheter aortic valve replacement measure: All-casuse mortality measure: Valve-related long-term clinical efficacy measure: Combined early safety and clinical efficacy outcomes measure: Rate of technical success measure: Rate of device success measure: Combined clinical efficacy outcomes measure: Valve-related long-term clinical efficacy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xijing Hospital status: RECRUITING city: Xi'an state: Shannxi zip: 710032 country: China name: Rutao Wang, M.D., Ph.D. role: CONTACT phone: +86-15091095796 email: rutaowang@qq.com name: Ruining Zhang, BSc role: CONTACT phone: +86-15802990370 email: ruining-zhang@qq.com name: Ling Tao, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 34.25833 lon: 108.92861 hasResults: False

 nctId: NCT06379373 id: 2023-KLS-190-02 briefTitle: Peripheral Mechanisms of Humoral Immune Effector-mediated Tourette's Syndrome and the Role of Tuina Intervention overallStatus: RECRUITING date: 2023-02-01 date: 2024-12-31 date: 2025-12-31 date: 2024-04-23 date: 2024-04-23 name: The First Affiliated Hospital of Zhejiang Chinese Medical University class: OTHER briefSummary: Tourette syndrome is a refractory type of tic disorder. Previous clinical studies have confirmed that Tuina has a good effect on TS, but the mechanism of action is still uncertain. Studies have found that the pathogenesis of TS may be related to immune factors, and patients will accompanied by the overflow of inflammatory factors such as interleukin-1β (IL-1β), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) during the onset of the disease. Other studies have found that the serum levels of IgG1, IgG2, IgG3, IgG4, IgGM, IgGA, IgGE, complement C3 and complement C4 are closely related to the pathogenesis of TS, and the abnormal humoral immune response mediated by food intolerance has an important impact on the pathogenesis of mental illness in children. The immune system plays a very complex role in TS. Based on this, we hypothesized that there may be differences in serum humoral immune effector levels between children with TS and healthy children, whether these differences are related to the consumption of certain allergenic foods or not, and so does Tuina spinal balancing can improve the clinical symptoms of children with TS by changing the levels of inflammatory and immune factors in peripheral serum. This study studied the peripheral mechanism of humoral immune effector mediated by Tourette syndrome and the intervention effect of Tuina through comprehensive scale analysis and advanced laboratory technology, which will provide a scientific theoretical basis and a safe and effective method for the treatment of multiple tics, and will have broad application prospects. conditions: Tourette Syndrome in Children conditions: Food Intolerance conditions: Inflammatory Response studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: According to the order of enrollment, the random number table method was used to divide the massage spinal manipulation+ placebo group (oral placebo, each dose: 50mg/time for 4-7 years old, 75mg/time for 7-12 years old, 100mg/time for 10-18 years old, 2 times/d), relaxation manipulation+ western medicine group (oral Typride tablets, each dose: 50mg/time for 4-7 years old, 75mg/time for 7-12 years old, 100mg/time for 10-18 years old, 2 times/d) for 2 consecutive weeks. Both groups were intervened for 2 courses. The observation time points were 2 weeks, 4 weeks, and 3 months before treatment and after treatment. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Spine manipulation; westren medicine measure: Change from Baseline in scores on Yale global Tic severity scale(YGTSS) at Week4 and Week8 measure: Change from Baseline in scores on TCM Syndrome Points at Week4 and Week8 measure: Change from Baseline in difference in the spacing of the lantoine side sex: ALL minimumAge: 4 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: First Affiliated Hospital of Zhejiang Chinese Medical University status: RECRUITING city: Hangzhou state: Zhejiang zip: 310006 country: China name: xiao Li, Doc. role: CONTACT phone: 0571-87072953 lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06379360 id: SZAMLLRM01 briefTitle: Maintenance Therapy of Hypomethylating Agent (HMA) in Favorable Risk Acute Myeloid Leukemia (AML) Patients overallStatus: RECRUITING date: 2020-11-01 date: 2024-05-01 date: 2028-12-31 date: 2024-04-23 date: 2024-04-24 name: The First Affiliated Hospital of Soochow University class: OTHER briefSummary: HMA maintenance therapy is expected to benefit overall survival (OS) and relapse free survival (RFS) in AML patients with favorable risk. conditions: Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Apply hypomethylating agent, azacitidine or decitabine as maintenance therapy. primaryPurpose: TREATMENT masking: NONE count: 77 type: ESTIMATED name: Hypomethylating agent, Azacitidine or Decitabine measure: Relapse free survival (RFS) measure: Overall survival (OS) measure: Cumulative incidence of relapse (CIR) sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Soochow University status: RECRUITING city: Suzhou state: Jiangsu zip: 215006 country: China name: Sheng-Li Xue, M.D. role: CONTACT phone: +86 512 6778 1139 email: slxue@suda.edu.cn lat: 31.30408 lon: 120.59538 hasResults: False

 nctId: NCT06379347 id: FZ 23/41 briefTitle: HOspitalized Patients and Clinical flUid Status, Assessment Using Point Of Care UltraSound acronym: HOCUS-POCUS overallStatus: RECRUITING date: 2024-02-28 date: 2025-03 date: 2025-03 date: 2024-04-23 date: 2024-04-23 name: Flevoziekenhuis class: OTHER briefSummary: Point of care ultrasound (POCUS) of the inferior vena cava (IVC) is a tool for assessing volume status through ultrasonography. Using a point of care ultrasound device, the physician can perform an ultrasound of the vena cava at the bedside. Previous research has demonstrated a correlation between right atrial pressure and the vena cava's diameter. Nonetheless, the majority of research has been conducted in critically ill populations to predict fluid responsiveness in patients with more complex hemodynamics. There is limited data available on the value of IVC ultrasound in the sub-acute setting on the regular ward for clinical decision-making regarding whether a patient is hypovolemic or hypervolemic. This study's objective is to assess the diagnostic utility of point-of-care ultrasonography of the IVC, by using a standardized methodology, performed by qualified ward physicians in a conventional nursing ward. conditions: Volume Status studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: POCUS perfomed on clinica indication measure: Volume status sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Flevoziekenhuis status: RECRUITING city: Almere country: Netherlands name: Koen de Heer, MD PhD role: CONTACT lat: 52.37535 lon: 5.25295 hasResults: False

 nctId: NCT06379334 id: I-22PJ911 briefTitle: Discovering Urinary Protein Biomarkers for Hepatocellular Carcinoma in Chronic Hepatitis B Population overallStatus: ACTIVE_NOT_RECRUITING date: 2020-12-06 date: 2024-12-06 date: 2026-12-06 date: 2024-04-23 date: 2024-04-23 name: Peking Union Medical College Hospital class: OTHER briefSummary: Chronic hepatitis B (CHB) can lead to hepatocellular carcinoma (HCC), imposing a significant health and economic burden globally. Early detection of hepatitis B virus-related HCC (HBV-HCC) in CHB with potential biomarkers has become a pressing and difficult challenge. Recent advancements in urinary proteomics offer a promising approach for HBV-HCC biomarker identification, utilizing Liquid chromatography with tandem mass spectrometry for urine proteome analysis. Differential analysis using limma in R software will uncover upregulated proteins in HBV-HCC. conditions: Hepatocellular Carcinoma conditions: Hepatitis B studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 180 type: ESTIMATED name: Urine test measure: upregulated proteins measure: downregulated proteins sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital city: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06379321 id: 24-362 briefTitle: A Retrospective/Prospective, Post-market Evaluation of Outcomes of the Triathlon Hinge Knee (THK) System acronym: Hinge overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2034-05-01 date: 2034-05-01 date: 2024-04-23 date: 2024-04-23 name: The Cleveland Clinic class: OTHER name: Stryker Orthopaedics briefSummary: This study is a prospectively and retrospectively enrolled, post-market, open-label, non-randomized, single institution evaluation of clinical outcomes of primary or revision knee surgery patients who meet the eligibility criteria and received devices from the Triathlon Hinge Knee System according to its indications for use (IFU).

Clinical evaluation for all cases will include data collection of patient demographics, surgical details, early postoperative status, functional and clinical outcomes, and survivorship at 1, 2, 6, and 10-years. conditions: Knee Arthropathy conditions: Recurrence conditions: Knee Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 200 type: ESTIMATED name: Triathlon Hinge Knee (THK) System measure: Survivorship sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Cleveland Clinic Florida city: Weston state: Florida zip: 33331 country: United States name: Kaitlin Bernabe role: CONTACT phone: 954-610-8016 email: BERNABK@ccf.org name: Jorge Manrique-Succar role: PRINCIPAL_INVESTIGATOR lat: 26.10037 lon: -80.39977 facility: Cleveland Clinic city: Cleveland state: Ohio zip: 44195 country: United States name: Laura Stiegel role: CONTACT phone: 216-442-5511 email: stiegel@ccf.org name: Alison Klika role: CONTACT phone: 216 444-4954 email: klikaa@ccf.org name: Matthew Deren, M.D. role: PRINCIPAL_INVESTIGATOR lat: 41.4995 lon: -81.69541 hasResults: False

 nctId: NCT06379308 id: IRBN552024/CHUSTE. briefTitle: Anterior Cruciate Ligament (ACL) Revision Surgery: French National Study overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2027-04 date: 2024-04-23 date: 2024-04-23 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER briefSummary: This is a national multicentric study led by the French Arthroscopy Society (SFA) evaluating clinical practice in anterior cruciate ligament (ACL) revision surgery (epidemiological data, morphological data, operative data, clinical and functional outcomes, and surgical complication rates). conditions: Anterior Cruciate Ligament Rupture studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: questionaries name: datas of medical record measure: Results of Functional score questionary Anterior Cruciate Ligament Return to Sport and Injury (ACL-RSI) measure: Results of Functional score questionary Tegner Activity Scale (TAS) measure: Results of Functional score questionary Simple Knee Value (SKV) measure: Results of Functional score questionary International Knee Documentation Commitee (IKDC) measure: Surgical complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Saint-Etienne city: Saint-Étienne country: France name: Thomas NERI, MD PhD role: CONTACT phone: (0)477120784 phoneExt: +33 email: thomas.neri@chu-st-etienne.fr name: Thomas NERI, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 45.43389 lon: 4.39 hasResults: False

 nctId: NCT06379295 id: CHUO-2024-05 briefTitle: Coronary Artery Calcification Assessed on PET/CT acronym: CALCOTEP overallStatus: NOT_YET_RECRUITING date: 2024-05-21 date: 2025-05-21 date: 2025-05-21 date: 2024-04-23 date: 2024-04-23 name: Centre Hospitalier Régional d'Orléans class: OTHER briefSummary: Calcification artery calcium (CAC) scoring is a valuable tool for determining the risk of major adverse cardiac events.

It was found that CAC can be quantitatively assessed, by manual scoring or using deep-learning, on low-dose non ECG-gated, contrast-enhanced or non-enhanced CT scans performed in association of PET acquisition, with a good agreement with standard scans.

The purpose of this study is to determine the impact of a systematic coronary artery calcification evaluation in patients undergoing 18F-FDG PET/CT imaging to improve primary prevention of cardiovascular diseases.

A visual CAC assessment will be made for each patient, dividing them into four groups: none, mild, moderate or heavy CAC. When possible, a CAC score will be computed.

Each patient will complete a questionnaire to collect risk factors, history of cardiovascular diseases and medications. conditions: Coronary Artery Disease conditions: Coronary Artery Calcification studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED name: Questionnaire measure: Prevalence of moderate CAC in participants without history of cardiac disease measure: Prevalence of coronary heart disease among participants measure: Correlation of CAC with the medical indication for PET imaging measure: Prevalence of CAC in young participants (< 45 years old) measure: Prevalence of moderate CAC in participants not taking low-cholesterol drug measure: Prevalence of no CAC in participants taking statins sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06379282 id: FHMS 21-22 263 EGA briefTitle: Investigating the Role of Energy Balance Modification on Health Responses in Chronic Lymphocytic Leukaemia acronym: HIT-CLL overallStatus: RECRUITING date: 2022-10-14 date: 2025-08-01 date: 2026-08-01 date: 2024-04-23 date: 2024-04-24 name: University of Surrey class: OTHER name: American Society of Hematology briefSummary: This randomised control clinical trial aims to investigate the effects of exercise training and diet on physical and functional fitness and immunological and metabolic changes in adults with chronic lymphocytic leukaemia. Investigators will randomise participants to either 12 weeks of supervised/semi-supervised exercise only, exercise + nutritional guidance, or no exercise. conditions: Chronic Lymphocytic Leukemia conditions: Frailty conditions: Muscle Function conditions: Immune Function conditions: Lipid Cell; Tumor studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Recruited participants will be randomised to either exercise only, exercise + nutritional guidance, or control for 12 weeks primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 132 type: ESTIMATED name: HIT name: EXE+ Nutritional Guidance measure: Change from baseline in absolute number of CD19+/CD5+ CLL cells at week 12 measure: Change from baseline in cardiorespiratory fitness (CRF: VO2peak) at week 12 measure: Frailty measure: Muscle Strength and Endurance measure: Muscle Health measure: Change in Quality of Life using the EORCT-QLQ-C30 measure: Change in muscle oxygen metabolism during a single bout of exercise measure: Change in B-CLL Cell Function measure: Change in systemic and cellular bioenergetics measure: Legacy Effect of Intervention on change in cardiorespiratory fitness (VO2peak) as measured by a cardiopulmonary exercise test measure: Legacy Effect of Intervention on absolute number of CD19+/CD5+ CLL cells sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Surrey status: RECRUITING city: Guildford zip: GU2 7WG country: United Kingdom name: David Bartlett, PhD role: CONTACT phone: 01483 683 45 email: d.bartlett@surrey.ac.uk lat: 51.23536 lon: -0.57427 hasResults: False

 nctId: NCT06379269 id: CMUH112-REC3-160 briefTitle: Effectiveness Verification of a Smartphone-based System for Assessment and Health Care on Myofascial Pain Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-06 date: 2024-12 date: 2024-04-23 date: 2024-04-24 name: China Medical University Hospital class: OTHER name: National Cheng Kung University name: National Science and Technology Council briefSummary: Myofascial pain syndrome (MPS) is the most common musculoskeletal pain disorder. The pain originates from myofascial trigger points (TrPs) in skeletal muscle. The muscle that presents with TrPs would be identified through clinical diagnosis and assessment, and further treatment would be designed according to the identified muscle.With the high penetration rate of smartphones, it would be convenient to utilize smartphones as the assistive technology in the assessment and intervention of MPS. The smartphone-based MPS assessment and care system could eliminate the restrictions of the epidemic, and provide an independent usage, precisely identifying muscle with TrPs and personalized care plan application. Therefore, the purpose of this study is to 1. develop a smartphone-based assessment and health care system for patients with myofascial pain syndrome. And to 2. verify the feasibility and validity of the system assessment function. And to 3. testify the effectiveness of the system health care functions for patient intervention. conditions: Myofascial Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: App healthcare name: Control measure: current pain visual analogue scale measure: functional questionnaire sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06379256 id: 202400364B0 briefTitle: Evaluation of Immune Responses and Outcomes in Patients With Hepatocellular Carcinoma Undergoing Radiotherapy overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2029-03-17 date: 2032-03-17 date: 2024-04-23 date: 2024-04-23 name: Chang Gung Memorial Hospital class: OTHER briefSummary: Radiation therapy (RT) is a highly effective modality for managing localized solid tumors and has become a fundamental component of treating unresectable hepatocellular carcinoma (HCC). Our previous preclinical investigation (Hsieh et al., Science Immunology 2022) revealed that RT can initiate immunogenic cell death and facilitate the cross-presentation of tumor antigens by antigen-presenting cells, thereby augmenting systemic anti-tumor T cell responses in murine tumor models. However, this immune response subsequent to irradiation has not been comprehensively evaluated in clinical trials involving HCC patients. Given that RT represents a standard therapeutic approach for unresectable HCC, our ongoing phase II non-randomized trial aims to prospectively assess immunological responses and dose-volumetric parameters, while identifying predictors of clinical outcomes in patients undergoing definitive RT for HCC. conditions: Hepatocellular Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Photon or proton 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: NCT06379243 id: KY-2023-008-02 briefTitle: Development and Validation of a Postoperative Re-fracture Risk Model for Osteoporotic Spinal Fractures overallStatus: RECRUITING date: 2023-12-01 date: 2026-12-31 date: 2027-12-31 date: 2024-04-23 date: 2024-04-23 name: The Seventh Affiliated Hospital of Sun Yat-sen University class: OTHER name: The Fourth Affiliated Hospital of Guangzhou Medical University name: Huizhou Municipal Central Hospital name: Dongguan Hospital of Traditional Chinese Medicine briefSummary: In this project, IDEAL-IQ technology and PDFF and R2\* image-based imaging methods are used to analyze the intrinsic relationship between preoperative vertebral bone marrow fat content, magnetic susceptibility properties of bone tissue and bone strength (bone volume and bone mass), to explore the mechanism of vertebral re-fracture after PVP / PKP, and to explore the imaging markers for the risk of postoperative vertebral re-fracture after PVP / PKP. To construct a precise and individualized risk assessment model of vertebral re-fracture after PVP/ PKP by combining clinical risk factors, preoperative quantitative MRI parameters (PDFF, R2\*) and imaging characteristics, so as to achieve the goal of objectively and accurately evaluating the risk of vertebral re-fracture at the early stage of the postoperative period (1 year). conditions: Osteoporosis Fracture conditions: Osteoporosis Vertebral conditions: Compression Fracture conditions: Perform PVP / PKP Treatment studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 560 type: ESTIMATED name: PVP/PKP measure: Non-operative vertebral re-fracture within 1 year after PVP / PKP measure: Visual Analog Score (VAS) at 1 year after PVP/ PKP measure: Oswestry Dysfunction Index (ODI) at 1 year after PVP/PKP sex: ALL minimumAge: 50 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Seventh Affiliated Hospital, Sun Yat-sen University status: RECRUITING city: Guangzhou state: Guangdong country: China name: Kuiqing Lu role: CONTACT phone: 0755-81207263 email: lukq@mail.sysu.edu.cn lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06379230 id: SH9H-2023-T378-1 briefTitle: A Retrospective Study on Epidemiological Characteristics of Chinese NF1 Patients in Real World (PROMISE) overallStatus: RECRUITING date: 2019-01-01 date: 2022-12-31 date: 2025-02-28 date: 2024-04-23 date: 2024-04-23 name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University class: OTHER briefSummary: Background/Rationale: Neurofibromatosis type 1 (NF1) affects about 1 in every 3000 people worldwide. Globally, 30\~50% NF1 patients will develop plexiform neurofibromas (PNs), which grow rapidly in early childhood and can cause disfigurement, motor dysfunction, pain, airway dysfunction, visual impairment and bladder and bowel dysfunction. This systemic disease imposes a heavy psychosomatic and financial burden on patients and their caregivers. In NF1 patients, the lifetime risk of MPNST developed from PN is 8% to 13%. The mean age for NF1-associated death was approximately 20 years lower than that for the general population. Limited epidemiological and clinical data of Chinese NF1 patients is available to date. And the treatment pattern of Chinese NF1-PN patients is also unknown.

Objectives and Hypotheses: It is a descriptive study without formal hypothesis. The primary objective of this study is determining the percentage of NF1 patients who develop PN. The secondary objectives of this study include describing the clinical characteristics, tumor progression and treatment pattern of NF1-PN. The exploratory objective is exploring the epidemiological characteristics of other NF1 manifestations.

Methods:

Study design: The study is a retrospective multi-center chart review study. Data Source(s): All the data will be collected by CRF from inpatient and outpatient electronic medical records in every study site from January 1, 2019 to December 31, 2022.

Study Population: Patients who attended the study sites between January 1, 2019 - December 31, 2022 and were diagnosed with NF1 were included in this study. Statistical Analysis: This study is purely descriptive without any formal hypotheses.

Missing data for baseline characteristics will be assessed and addressed as a categorical variable with a level for missingness. All reported measures will be summarized in the study tables. Point estimates and their 95% CIs will be presented in the final analyses. conditions: Neurofibromatosis 1 conditions: Plexiform Neurofibroma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 2000 type: ESTIMATED name: This study is purely descriptive study. measure: Determine the percentage of NF1 patients developed PN at the baseline. measure: Clinical characteristics of NF1-PN: measure: Tumor progression of NF1-PN measure: Treatment pattern of NF1-PN: measure: The exploratory endpoints: sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Xuanwu Hospital, Capital Medical University status: RECRUITING city: Beijing state: Beijing country: China name: Lei Zhang role: CONTACT phone: +86 13683139858 email: zhanglei@xwhosp.org lat: 39.9075 lon: 116.39723 facility: The First Affiliated Hospital of Guangxi Medical University status: RECRUITING city: Nanning state: Guangxi country: China name: Jiping Shi role: CONTACT phone: +86 17758670856 lat: 22.81667 lon: 108.31667 facility: The First Affiliated Hospital of Zhengzhou University status: RECRUITING city: Zhengzhou state: Henan country: China name: Minjing Chen role: CONTACT phone: +86 13673665337 email: 1916833431@qq.com lat: 34.75778 lon: 113.64861 facility: Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine status: ACTIVE_NOT_RECRUITING city: Shanghai state: Shanghai zip: 200011 country: China lat: 31.22222 lon: 121.45806 facility: West China Hospital, Sichuan University status: RECRUITING city: Chengdu state: Sichuan country: China name: Yang Xiao role: CONTACT phone: +86 18884266797 email: xiaoyang_angela@163.com lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06379217 id: CAAA617H12101 id: 2023-505655-43 type: EUDRACT_NUMBER briefTitle: NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer. overallStatus: NOT_YET_RECRUITING date: 2024-06-18 date: 2027-06-04 date: 2027-06-04 date: 2024-04-23 date: 2024-04-23 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: The purpose of this study is to evaluate the change in the expression of treatment targets on the surface of tumor cells (Prostate Specific Membrane Antigen (PSMA), Somatostatin Receptor 2 (SSTR2), and Gonadotropin Releasing Hormone Receptor (GRPR)) between the start and after the completion of radioligand therapy (RLT). Study will use radioligand imaging (RLI) to determine predominantly expressed target on the surface of tumor cells. Based on predominant expression of target, corresponding RLT targeting PSMA, SSTR2, or GRPR RLT will be given for up to 6 cycles every 6 weeks as intravenous (i.v.) injection in participants with metastatic neuroendocrine prostate cancer (mNEPC). conditions: Metastatic Neuroendocrine Prostate Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be assigned to a treatment arm based on their predominantly expressed target per PET images (based on central read):

* \[177Lu\]Lu-PSMA-617 will be assigned to those with predominant PSMA expression
* \[177Lu\]Lu-DOTA-TATE will be assigned to those with predominant SSTR2 expression
* \[177Lu\]Lu-NeoB will be assigned to those with predominant GRPR expression primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: [68Ga]Ga-PSMA-11 name: [68Ga]GA-DOTA-TATE name: [68Ga]Ga-NeoB name: [177Lu]Lu-PSMA-617 name: [177Lu]Lu-DOTA-TATE name: [177Lu]Lu-NeoB name: L-Lysine HCl-L-Arginine HCl, 2.5 %, name: Gonadotropin-releasing hormone (GnRH) analogues name: GnRH antagonists name: Antiemetics & antinauseants name: Metoclopramide measure: Number/extent of lesions with at least a moderate uptake of any of the Radioligand Imaging (RLI) measure: Percentage changes in qualitative PET parameters. measure: Overall Response Rate (ORR) measure: Disease Control Rate (DCR) measure: Duration of response (DOR) measure: Radiographic Progression-free Survival (rPFS) measure: Proportion of participants with a decline in PSA level measure: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) for Radioligand Therapy (RLT) measure: Dose modifications for [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB measure: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) for Radioligand Imaging (RLI) measure: Blood radioactivity concentration of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE, [177Lu]Lu-NeoB) measure: Blood mass concentration of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE, [177Lu]Lu-NeoB) measure: Observed maximum blood concentrations (Cmax) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB measure: Time of maximum blood concentration (Tmax) occurence of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB measure: Area under the blood concentration time curve (AUC) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB measure: Total systemic clerance (CL) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB measure: Volume of distribution during the terminal phase (Vz) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB measure: Terminal half-life (T^1/2) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB measure: Absorbed radiation doses of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB measure: Time Activity Curves (TACs) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06379204 id: No.2022026 briefTitle: A Study on the Intervention of Metabolic Syndrome Patients With Exercise Prescription Based on Ventilatory Threshold Using Cardiopulmonary Exercise Test overallStatus: COMPLETED date: 2022-11-04 date: 2023-08-30 date: 2023-09-19 date: 2024-04-23 date: 2024-04-26 name: Taiyuan Central Hospital of Shanxi Medical University class: OTHER briefSummary: Analyze the clinical intervention effects and differences of progressive precision exercise prescriptions formulated by two methods for determining exercise intensity on metabolic syndrome (MS). Compare the effects of the two on the cardiovascular endurance of the MS population and verify the effectiveness of individualized methods in reducing absolute exercise intensity for MS patients. conditions: Metabolic Syndrome X studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 52 type: ACTUAL name: the maximum physiological value standardized group name: the ventilatory threshold individualized group measure: Peak oxygen uptake sex: ALL minimumAge: 25 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taiyuan Cardiac Rehabilitation Center city: Taiyuan state: Shanxi zip: 030009 country: China lat: 37.86944 lon: 112.56028 hasResults: False

 nctId: NCT06379191 id: ZS-3411 briefTitle: The Efficacy of WeChat-based Multidisciplinary Full-course Nutritional Management Program overallStatus: COMPLETED date: 2023-02-01 date: 2023-10-30 date: 2023-10-30 date: 2024-04-23 date: 2024-04-23 name: Peking Union Medical College Hospital class: OTHER briefSummary: As the most malignant type of cancer in the female reproductive system, ovarian cancer (OC) has become the second leading cause of death among Chinese women. Chemotherapy is the main treatment for OC patients, and its numerous adverse effects can easily lead to malnutrition. It is difficult to centrally manage OC patients in the intervals between chemotherapy. The utility of WeChat, an effective and more cost-efficient mobile tool, in chronic disease management has been highlighted. conditions: Ovarian Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 78 type: ACTUAL name: Nutrition intervention model based on WeChat applets measure: patient-generated subjective global assessment (PG-SGA) measure: nutrition-related blood indices, such as total protein (g/L), albumin (g/L), prealbumin (g/L), and hemoglobin (g/L) measure: inflammation-related blood indices, such as leukocytes (10^9/L), lymphocytes (10^9/L), neutrophils (10^9/L), and platelets (10^9/L) measure: nutrition-inflammation composite indices, such as prognostic nutritional index (PNI) and systemic immunoinflammatory index (SII) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06379178 id: 6462e56fe8177 briefTitle: Effect of Oral Colostrum Applications Every 2 Hours and 4 Hours In Order to Achieve Trophic Feeding in Preterm Infants overallStatus: COMPLETED date: 2023-02-19 date: 2023-08-15 date: 2023-08-31 date: 2024-04-23 date: 2024-04-23 name: Gadjah Mada University class: OTHER briefSummary: The goal of this clinical trial is aims to evaluate the effects of applying colostrum orally every 4 and 2 hours in order to achieve trophic feeding in preterm infants. The main question it aims to answer is the optimal frequency of colostrum application that can be applied Participants will be divided by randomization using permutation blocks after meeting the inclusion and exclusion criteria and deemed eligible. These blocks were then randomized using computer software such as Microsoft Excel, determining the sequence for allocation to the control and intervention groups based on the randomization order from the permutation code, every 2 hours and every 4 hours. Researchers will investigate the effects of oropharyngeal colostrum application frequency, every 4 hours and every 2 hours, in order to achieve trophic feeding in preterm infants \<34 weeks gestational age. conditions: Trophic Feeding conditions: Very Low Birth Weight Baby conditions: Preterm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 47 type: ACTUAL name: Oral colostrum application 2 hours name: Oral colostrum application 4 hours measure: Days to Achieve Trophic Feeding sex: ALL maximumAge: 2 Days stdAges: CHILD facility: Neonatal Intensive Care Unit RSUP Dr. Sardjito city: Sleman state: Daerah Istimewa Yogyakarta zip: 55281 country: Indonesia lat: -7.71556 lon: 110.35556 hasResults: False

 nctId: NCT06379165 id: SYH9015-002 briefTitle: Efficacy and Safety Study of Meloxicam Nanocrystal Injection for the Treatment of Moderate to Severe Pain overallStatus: COMPLETED date: 2023-05-17 date: 2023-07-11 date: 2023-07-13 date: 2024-04-23 date: 2024-04-23 name: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of meloxicam nanocrystal injection in subjects with moderate to severe pain after abdominal surgery. conditions: Pain studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 192 type: ACTUAL name: Meloxicam Nanocrystal Injection name: Placebo measure: PID24 (Time Weighted Sum of Pain Intensity Difference Over 24 Hours Post-Dose) measure: TOTPAR (time-weighted sum of pain relief scores): TOTPAR12, TOTPAR18, TOTPAR24, TOTPAR48. measure: SPID2、SPID6、SPID12、SPID18、SPID18-24、SPID24-48、SPID42-48、SPID48 measure: Time to the first dose of the remedial analgesia measure: Number of times of remedial analgesia administered 0-24h and 24-48h after the first dose measure: Proportion of subjects requiring remedial analgesia measure: The total amount of remedial analgesia used 24 h and 48 h after the first dose measure: The subject's analgesic treatment satisfaction score (0-4 point categorical scale score) measure: The investigator's satisfaction score (0-4 point categorical scale score) for the subject's analgesic treatment sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Union Hospital of Tongji Medical College of Huazhong University of Science and Technology city: Wuhan country: China lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06379152 id: 2024-04-16 briefTitle: Effect of Bilirubin on Prognosis in Heart Failure With Preserved Ejection Fraction overallStatus: RECRUITING date: 2020-09-20 date: 2024-06-30 date: 2024-07-01 date: 2024-04-23 date: 2024-04-23 name: Chongqing Medical University class: OTHER briefSummary: Factors influencing the prognosis of patients with heart failure with preserved ejection fraction (HFpEF) have been extensively studied. Previous studies have found that elevated serum total bilirubin levels are associated with cardiac death, heart failure readmission, and all-cause mortality in patients with chronic heart failure. However, the relationship between direct bilirubin and prognosis in patients with HFpEF is unclear. conditions: Heart Failure With Preserved Ejection Fraction conditions: Prognathism studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED measure: The level of direct bilirubin measure: a composite of heart failure rehospitalization or all-cause mortality measure: heart failure rehospitalization measure: all-cause mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Chongqing Medical University status: RECRUITING city: Chongqing country: China name: Dongying Zhang, doctor role: CONTACT phone: +8613608398395 email: zdy.chris@qq.com lat: 29.56278 lon: 106.55278 hasResults: False

 nctId: NCT06379139 id: MALDINEY J'InvEst-I 2022 briefTitle: Dynamic Full-field Optical Coherence Tomography for Structural and Microbiological Characterization of Endotracheal Tube Biofilm in Critically Ill Patients acronym: BIOPAVIR2 overallStatus: RECRUITING date: 2024-03-01 date: 2025-03 date: 2025-03 date: 2024-04-23 date: 2024-04-23 name: Centre Hospitalier Universitaire Dijon class: OTHER briefSummary: Biofilm is a microstructure organised into aggregates of microbiological species within a polymeric matrix. As early as the 2000s, the Centers for Disease Control and Prevention (CDC) recognised the possible role of the biofilm lining endotracheal endotracheal tubes in the development of ventilator-associated pneumonia (VAP) , the most common infection in intensive care, with a high morbidity and mortality rate and a significant increase in hospital costs.

Targeting biofilm therefore now appears to be a new area of interest for limiting the risk of VAP, and this rationale has led to the development of an intraluminal for abrading biofilm deposited on the inside of the intubation probe

. Evaluation of this type of strategy nevertheless justifies the introduction of more precise methods for characterisation of the biofilm.

To this end, the investigator carried out an initial clinical study describing the biofilm on intubation probes, BIOPAVIR 1, showing the existence of several biofilm structures, each associated with a specific microbiological signature. Several limitations including a lack of power due to an insufficient number of patients and the use of number of patients, and the use of a confocal microscopy technique with poor axial without the possibility of acquiring metabolic images of the biofilm.

Based on the previous description of biofilm by optical coherence tomography (OCT), and a recent experience with an optimised form of high-resolution OCT, called full-field OCT, the investigator hypothesise that full-field OCT will allow more accurate characterisation of biofilm, due to its high spatial resolution and its potential ability to capture metabolic activity in the biofilm BIOPAVIR 2 proposes to use the performance of full-field OCT to better characterise the biofilm lining endotracheal tubes in patients undergoing mechanical ventilation in intensive care units. This project represents a first step towards understanding the link between the development of biofilm on intubation and the occurrence of VAP conditions: Healthcare Associated Infection conditions: Critically Ill conditions: Endotracheal Tube studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: •Dynamic Full-Field Optical Coherence Tomography analysis of endotracheal tube measure: Dynamic Full-Field Optical Coherence Tomography-based biofilm structure type measure: type of microbiological associated with each shape sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CH William Morey status: RECRUITING city: Chalon-sur-Saône country: France name: Thomas MALDINEY role: CONTACT email: thomas.maldiney@ch-chalon71.fr lat: 46.78333 lon: 4.85 facility: CHU Dijon Bourgogne status: RECRUITING city: Dijon country: France name: Jean Pierre QUENOT role: CONTACT email: jean-pierre.quenot@chu-dijon.fr lat: 47.31667 lon: 5.01667 hasResults: False

 nctId: NCT06379126 id: Yuting Li05 briefTitle: The Diagnostic and Prognostic Value of TAT, PIC, tPAI·C and TM in Sepsis-induced Coagulopathy overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2026-04-20 date: 2026-04-20 date: 2024-04-23 date: 2024-04-23 name: The First Hospital of Jilin University class: OTHER briefSummary: In order to evaluate the diagnostic and prognostic value of thrombin-antithrombin complex（TAT）, α2-plasmin inhibitor-plasmin complex（PIC）, tissue plasminogen activator-inhibitor complex（tPAI·C） and thrombomodulin（TM） in sepsis-induced coagulopathy(SIC), hospitalized patients with sepsis were prospectively included. Plasma TAT, PIC, tPAI·C,TM levels within 24 h after sepsis diagnosis were detected by MCL60 chemiluminescence analyzer. According to the SIC score (≥4), they were divided into SIC group and non-SIC group, and ROC curve analysis was performed according to the biomarker test results. conditions: Sepsis-induced Coagulopathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 210 type: ESTIMATED name: Test thrombin-antithrombin complex（TAT）, α2-plasmin inhibitor-plasmin complex（PIC）, tissue plasminogen activator-inhibitor complex（tPAI·C） and thrombomodulin（TM） measure: Thrombin-antithrombin complex（TAT）, α2-plasmin inhibitor-plasmin complex（PIC）, tissue plasminogen activator-inhibitor complex（tPAI·C） and thrombomodulin（TM） level sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06379113 id: 53211030-2 briefTitle: GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Cancer Patients overallStatus: RECRUITING date: 2022-07-13 date: 2025-03-30 date: 2025-03-30 date: 2024-04-23 date: 2024-04-23 name: Xiaojun Chen class: OTHER briefSummary: To investigate the efficacy of GnRHa plus letrozole in obese progestin-insensitive EEC patients. conditions: Endometrial Neoplasms conditions: Atypical Endometrial Hyperplasia conditions: Progesterone Resistance conditions: Obesity studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 29 type: ESTIMATED name: GnRH antagonist name: Letrozole 2.5mg measure: Complete response rates within 28 weeks of treatment measure: Adverse events measure: Time to achieve complete response measure: Relapse rates measure: Rates of fertility outcomes measure: Compliance sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Obstetrics and Gynecology Hospital, Fudan University status: RECRUITING city: Shanghai country: China name: Xiaojun Chen role: CONTACT phone: 862133189900 email: cxjlhjj@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06379100 id: KY20232388 briefTitle: Cerebellar iTBS Mode Transcranial Magnetic Stimulation for the Treatment of Alzheimer's Disease overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2024-08-25 date: 2024-09-25 date: 2024-04-23 date: 2024-04-23 name: Xijing Hospital class: OTHER briefSummary: Study the therapeutic effect and potential neural mechanisms of cerebellar iTBS mode transcranial magnetic stimulation on Alzheimer's disease patients through MRI and EEG. conditions: Transcranial Magnetic Stimulation conditions: Alzheimer Disease conditions: Magnetic Resonance Imaging conditions: Electroencephalogram studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Alzheimer's disease patients were enrolled by expert neurol ogists who were blinded to treatment allocation. rTMS sessions were performed by dedicated technicians. The Cognitive evaluations and analysis of neuro physiological data were performed by expert neurophysiologists blinded to treatment allocation. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 28 type: ESTIMATED name: transcranial magnetic stimulation measure: The changes in CDR（Clinical Dementia Rating） measure: The changes in MMSE(Mini Mental State Examination) measure: NPI (Neuropsychiatric Inventory) measure: ADL( Lawton-Brody Activities of Daily Living) measure: DST (Digital Span Test; Forward and Backward) measure: ADAS-cog（Alzheimer's disease assessment scale) measure: DMS(Delayed matching-to-sample task) measure: MEP（Motor evoked potential） measure: MRI measures measure: EEG（electroencephalogram） sex: ALL minimumAge: 45 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xijing Hospital of Air Force Military Medical University city: Xi'an state: Shaanxi zip: 710032 country: China name: Wen Jiang role: CONTACT phone: 13991905538 email: jiangwen@fmmu.edu.cn name: Xin Zhang role: CONTACT phone: 13154378732 email: zx312316@163.com lat: 34.25833 lon: 108.92861 hasResults: False

 nctId: NCT06379087 id: NEO-PIONEER briefTitle: Radiation Therapy Followed by Tislelizumab and Anlotinib Aeoadjuvant/Adjuvant Therapy for Stage II-IIIA NSCLC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2026-12-31 date: 2024-04-23 date: 2024-04-25 name: Ji Yongling class: OTHER briefSummary: This study is a single-center, prospective, single-arm exploratory clinical study of hypofractionated radiotherapy followed by tislelizumab and anlotinib neoadjuvant and adjuvant therapy. It is designed for patients with stage II-IIIA non-small cell lung cancer. The efficacy and safety of hypofractionated radiotherapy sequential tislelizumab and anlotinib in the neoadjuvant and adjuvant treatment of stage II-IIIA non-small cell lung cancer are observed. Finally, it provides new evidence-based medical evidence for the perioperative treatment of 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: 20 type: ESTIMATED name: Anlotinib Hydrochloride Capsule name: Tislelizumab Injection name: Hypofractionated Radiotherapy measure: 1-year EFS Rate measure: pCR Rate measure: MPR Rate measure: Adverse Events (AEs) according to CTCAE (V5.0) (Safety Evaluation) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06379074 id: 2022PMFMSE id: C53D23004250008 type: OTHER_GRANT domain: Italian Ministry of University and Research (MUR) briefTitle: Poor Sleep During Pregnancy as Risk Factor for Post-partum Stress and Mental Health acronym: MOTHERS overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2025-08-06 date: 2025-10-06 date: 2024-04-23 date: 2024-04-23 name: University of Rome G. Marconi class: OTHER name: University of Bologna name: University of the Italian Switzerland briefSummary: Improving maternal mental health is a worldwide health priority. Nevertheless, several scientific sources highlighted lack of empirical data which could drive clinical practice. The present project addresses psychobiological mechanisms leading to peripartum mental disorders. It focuses on one key risk factor for psychopathology, which is poor sleep continuity. The project aims to describe the link between maternal poor sleep quality and the cascade of events which may enhance vulnerability to stress and risk for mental disorders and to evaluate the efficacy of an online automated psychological prenatal intervention directed to sleep problems in preventing these negative outcomes. conditions: Postpartum Depression conditions: Insomnia conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will receive a personal e-mail address to access their reserved area of the study's website. Each e-mail address is created using the pre-defined pseudonymized code, which will be assigned to each participant after screening (participants with sleep difficulties will be randomly assigned a code for condition B1 or B2).

This procedure is designed to increase privacy protection, allow for matching of responses throughout study's phases, and blind outcome assessors to participants allocation.

The personal website areas include contents based on their group allocation:

* A: online questionnaire and sleep diaries;
* B1: online questionnaire and sleep diaries; placebo intervention's contents (videos and pdf);
* B2: online questionnaire and sleep diaries; intervention's contents (videos and pdf); weekly optional private chat with a clinician (a psychotherapist expert in CBT-I and insomnia during pregnancy). primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Each participant will be assigned an identification code (ID-code) randomly generated by a computer. The codes associated to participants in Group B will be randomly assigned to intervention (Group B2) or placebo (Group B1). E-mail addresses will be created for each participant using the ID-code to access the private area of the study website. The code will be associated with responses to online questionnaires, actigraphy recording, saliva samples and sleep diaries. whoMasked: OUTCOMES_ASSESSOR count: 114 type: ESTIMATED name: Improving sleep health and resilience during pregnancy name: Information on pregnancy-related issues measure: Stress reactivity measure: Sleep efficiency measure: Depressive symptoms measure: Insomnia symptoms measure: Anxiety symptoms measure: Valence of affective states measure: Arousal of affective states measure: Emotion regulation measure: Mothers' parenting stress measure: Partners' insomnia symptoms measure: Children sleep difficulties measure: Partners' sleep efficiency measure: Fathers' parenting stress measure: Daytime sleepiness sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Biomedical and Neuromotor Sciences, Physiology campus, University of Bologna, Bologna, Italy city: Bologna zip: 40126 country: Italy name: Viviana Lo Martire role: CONTACT email: viviana.lomartire2@unibo.it name: Debora Meneo, M.Sc role: CONTACT phone: 06377251 email: d.meneo@unimarconi.it name: Debora Meneo, M.Sc role: PRINCIPAL_INVESTIGATOR name: Elisabetta Baldi, M.Sc role: SUB_INVESTIGATOR name: Silvia Cerolini, PhD role: SUB_INVESTIGATOR name: Viviana Lo Martire, PhD role: SUB_INVESTIGATOR name: Giuliana Simonazzi, PhD role: SUB_INVESTIGATOR name: Sara Curati, B.Sc role: SUB_INVESTIGATOR name: Stefano Bastianini, PhD role: SUB_INVESTIGATOR name: Chiara Berteotti, PhD role: SUB_INVESTIGATOR name: Mauro Manconi, PhD role: SUB_INVESTIGATOR name: Giovanna Zoccoli, PhD role: SUB_INVESTIGATOR name: Francesca Gelfo, PhD role: SUB_INVESTIGATOR name: Chiara Baglioni, PhD role: PRINCIPAL_INVESTIGATOR name: Paola De Bartolo, PhD role: SUB_INVESTIGATOR lat: 44.49381 lon: 11.33875 hasResults: False

 nctId: NCT06379061 id: MM-01-24 briefTitle: Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2025-03-31 date: 2024-04-23 date: 2024-04-23 name: Beckman Coulter, Inc. class: INDUSTRY name: MeMed Diagnostics Ltd. briefSummary: The purpose of the pivotal study is to collect blood specimens and clinical data from pediatric (\>90 days old) and adult (≥18 years old) patients presenting with signs and symptoms suggestive of acute bacterial or viral infection. These samples will be used to establish the diagnostic performance of MeMed BV™ for differentiating bacterial from viral infection using method comparison and/or method concordance. conditions: Infection, Bacterial conditions: Infection Viral studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 400 type: ESTIMATED measure: Blood Specimen Collection sex: ALL minimumAge: 90 Days maximumAge: 89 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06379048 id: 2021.12.282 briefTitle: The Impact of Different Skin Suture Methods in Episiotomy Repair on Healing and Pain overallStatus: COMPLETED date: 2022-03-01 date: 2022-08-31 date: 2022-09-20 date: 2024-04-23 date: 2024-04-23 name: Başakşehir Çam & Sakura City Hospital class: OTHER_GOV briefSummary: Episiotomy is the intentional incision of the perineum during vaginal birth in order to accelerate the active phase of labor. This study aimed to compare various skin closure techniques in episiotomy repair. conditions: Labor; Prolonged, Second Stage conditions: Episiotomy Wound studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 132 type: ACTUAL name: Matress Suturing name: Primary Suturing name: Continuous Subcutaneous Suturing measure: Healing by Redness, Edema, Ecchymosis and Discharge (REEDA) Score measure: Pain by Visual Analog Scale (VAS) sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Cam and Sakura City Hospital city: Istanbul state: Basaksehir zip: 34494 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06379035 id: Protozoa in CRC patients briefTitle: Blastocystis and Cryptosporidium Infection in Colorectal Cancer Patients overallStatus: NOT_YET_RECRUITING date: 2024-11-01 date: 2025-11-01 date: 2025-12-31 date: 2024-04-23 date: 2024-04-23 name: Assiut University class: OTHER briefSummary: 1. Detect the prevelance of Blastocystis spp. and Cryptosporidium spp. among patients with colorectal cancer attending South Egypt Cancer Institute-Assiut University.
2. Detect the effect of Blastocystis and Cryptosporidium infection on various cytokines level in CRC patients that may be involved in the tumor progression. conditions: Blastocystis Infection conditions: Cryptosporidium Infection conditions: Colorectal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 54 type: ESTIMATED name: ELISA / PCR measure: Detect the prevelance of Blastocystis spp. and Cryptosporidium spp. among patients with colorectal cancer attending South Egypt Cancer Institute-Assiut University. measure: Detect the effect of Blastocystis and Cryptosporidium infection on various cytokines level in CRC patients that may be involved in the tumor progression. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06379022 id: AUTh-29/21-11-2018 briefTitle: Proteomic Analysis of Newly Restored Single Implants overallStatus: COMPLETED date: 2018-12-03 date: 2019-11-29 date: 2019-11-29 date: 2024-04-23 date: 2024-04-23 name: Aristotle University Of Thessaloniki class: OTHER name: Karolinska Institutet briefSummary: In 10 systemically healthy non-smokers, free of periodontitis, one newly restored implant (baseline-T0) and one corresponding tooth were followed over 12 months (T1). All implants were screw-retained, and platform-switched. Oral hygiene was closely monitored during the study. Probing pocket depth (PPD), attachment levels (CAL), bleeding and plaque indices and crevicular fluid were collected from an implant-site (PICF) and a tooth-site (GCF). Total proteomic profiles in PICF and GCF were investigated using label-free quantitative proteomics. conditions: Peri-Implantitis conditions: Peri-implant Mucositis conditions: Periodontal Diseases studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 10 type: ACTUAL name: Plaque control measure: Probing pocket depth measure: Protein expression measure: Recession measure: Bleeding upon probing measure: Inflammation index sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Dental School, Aristotle University city: Thessaloniki zip: 54124 country: Greece lat: 40.64361 lon: 22.93086 hasResults: False

 nctId: NCT06379009 id: 473076 briefTitle: Effect of Home-based Training Program for Kidney Transplant Recipients (HOMETRAIN-KTR) overallStatus: RECRUITING date: 2024-02-07 date: 2027-01-01 date: 2028-01-01 date: 2024-04-23 date: 2024-04-24 name: Oslo University Hospital class: OTHER name: South-Eastern Norway Regional Health Authority briefSummary: Does home-based training work in kidney transplant recipients with reduced physical function?

The goal of this clinical trial is to learn if home-based training works to better physical function in adult kidney transplant recipients. It will also learn about participants preoperative physical function. The main question it aim to answer is

* Does home-based training improves physical function in kidney transplant recipients.
* All the participants are assessed to have reduced physical function before the transplantation

Participants will:

* follow either a home-based training program or todays standard of physical activity after kidney transplantation
* the program starts 4 weeks after the transplantation and lasts for 12 weeks. A physiotherapist will help the participants in the beginning.
* the program consists of both cardio-training, strength-straining and optional activity
* the training group will be followed up every week by phone. Their activity will be documented via patients logs and heart rate monitor.
* the effect of the training will be evaluated one year after the transplantation conditions: Kidney Transplant; Complications conditions: Frailty conditions: Physical Disability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2 arms randomized control study. The intervention arm is exposed of a 12 week home-based training program. The control arm follow standard of care. primaryPurpose: TREATMENT masking: NONE maskingDescription: Both participants and investigators will know which arm the participants are randomized to. Training is not easy to mask count: 200 type: ESTIMATED name: Training measure: 6-minute walking distance test measure: Clinical Frailty Scale measure: Hand-grip strength measure: 30 seconds Sit-to-stand test measure: Bone density test measure: Bioelectrical impedance phase angle to measure muscle mass and strength. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Oslo University Hospital status: RECRUITING city: Oslo zip: 0372 country: Norway lat: 59.91273 lon: 10.74609 hasResults: False

 nctId: NCT06378996 id: S68535 briefTitle: Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring acronym: ALARM-PILOT overallStatus: RECRUITING date: 2024-05 date: 2024-09 date: 2024-10 date: 2024-04-23 date: 2024-04-23 name: Universitaire Ziekenhuizen KU Leuven class: OTHER briefSummary: Mitral valve prolapse (MVP) affects up to 3% of the general population and a small subset of patients is at risk for ventricular arrhythmias. This subgroup is referred to as AMVP (arrhythmic MVP) and was recently defined using the following criteria: (1) Presence of MVP), (2) Ventricular arrhythmia that is either frequent (≥5% total premature ventricular contraction (PVC) burden on Holter) or complex (non-sustained ventricular tachycardia (nsVT), ventricular tachycardia (VT), or ventricular fibrillation (VF)), and (3) The absence of any other well-defined arrhythmic substrate.

Currently, diagnosis is often based on repeated 24-hour Holter monitoring. However, the ventricular arrhythmia burden varies from day-to-day and long-term rhythm monitoring has shown in other pathologies to increase the diagnostic yield with up to 200% (from 22.5% on 24h to 75.3% on 14 days).

This pilot study aims to study the diagnostic yield of long-term rhythm monitoring in patients with MVP as well as the day-to-day variability of ventricular arrhythmias to facilitate power calculation for a future large-scale prospective registry. conditions: Mitral Valve Prolapse conditions: Ventricular Arrythmia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, single arm, interventional cohort study including 3 different patient cohorts:

* Patients with MVP (not previously known with AMVP) and mild to moderate mitral valve regurgitation
* Patients with AMVP and mild to moderate mitral valve regurgitation
* Patients with MVP and severe mitral valve regurgitation scheduled for surgical intervention primaryPurpose: DIAGNOSTIC masking: NONE count: 60 type: ESTIMATED name: 14-day rhythm monitoring measure: Time to arrhythmic mitral valve prolapse detection measure: Number of days with high PVC-burden ≥5% measure: Number of days with complex ventricular arrhythmia (nsVT, VT, or VF) measure: Day-to-day variation in percentage PVC burden measure: Association between percentage PVC burden and percentage of late gadolinium enhancement on cardiac MRI measure: Association between mean number of nsVT episodes per 24hours and percentage of late gadolinium enhancement on cardiac MRI measure: Association between percentage PVC burden and global longitudinal strain on transthoracic echocardiography measure: Association between mean number of nsVT episodes per 24hours and global longitudinal strain on transthoracic echocardiography 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: Bert Vandenberk, MD, PhD role: CONTACT email: bert.vandenberk@uzleuven.be name: Bert Vandenberk, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 50.87959 lon: 4.70093 hasResults: False

 nctId: NCT06378983 id: SYSKY-2023-1149-02 briefTitle: Clinical Trial of Microneedle Radiofrequency Combined With Oral Isotretinoin in Moderate to Severe Acne overallStatus: RECRUITING date: 2022-09-01 date: 2024-06-30 date: 2024-06-30 date: 2024-04-23 date: 2024-04-23 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: This study plans to select 100 AV patients and randomly divide them into two groups in a 1:1 ratio: the experimental group will be treated with MRF combined with oral isotretinoic acid for 8 consecutive weeks, with a total of 3 MRF treatments at weeks 1, 4, and 8. The control group received oral administration of isotretinoic acid alone for 8 weeks. The main observation indicators are the percentage of effective skin injury clearance achieved by subjects at week 20, as well as the change in ECCA acne scar score compared to baseline at week 20. I hope this study can clarify that the combination therapy of the two can achieve the effects of improving efficacy, shortening treatment course, reducing recurrence, not increasing adverse reactions, and reducing the risk of scar formation. conditions: Moderate to Severe Acne Vulgaris studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Oral isotretinoin name: Oral isotretinoin combined with microneedle radiofrequency therapy measure: Changes in ECCA acne scar score from baseline at week 20 measure: The percentage of effective skin lesion clearance rate in the 20th week sex: ALL minimumAge: 14 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Dermatology and Venereology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University. status: RECRUITING city: Guangzhou zip: 510030 country: China name: Sha Lu role: CONTACT phone: 13632383399 email: lush7@mail.sysu.edu.cn lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06378970 id: 22-1T/49 briefTitle: Audio Books Effects on Anxiety and Vital Sings overallStatus: COMPLETED date: 2022-04-15 date: 2022-07-15 date: 2022-07-15 date: 2024-04-23 date: 2024-04-23 name: Ege University class: OTHER briefSummary: Objectives: This study aimed to investigate the effect of audio book use on anxiety and vital signs in patients receiving non-invasive mechanical ventilation (NIMV) support.

Research Methodology/Design: It is an experimental-randomised controlled study. Settings: The study was carried out with patients hospitalised in the Chest Diseases Intensive Care Unit of a university hospital and NIMV support. The participants consisted of 60 people, 30 in the intervention group and 30 in the control group. Before starting the application in the intervention group, the book preferences of the patients were determined and the selected audio book was played to the patients with headphones via tablet/smartphone. No additional application was made to the control group.

Main Outcome Measures: Anxiety levels and vital signs in the intervention group were evaluated before, 15 minutes, 30 minutes and 30 minutes after the end of the intervention. In the control group, only routine care continued and anxiety levels, and vital signs were assessed simultaneously with the intervention group. conditions: Non-invasive Mechanical Ventilation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised Controlled primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ACTUAL name: Audio Book Application measure: Facial Anxiety Scale measure: Patient Follow-up Form measure: Audio Book Application Preference Form measure: Patient Information Form sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ege University city: Bornova state: İzmir zip: 35100 country: Turkey lat: 38.47921 lon: 27.2399 hasResults: False

 nctId: NCT06378957 id: IRB00436545 briefTitle: Behavioral Pharmacology of Orally Administered THC and D-limonene overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2027-07-01 date: 2027-12-31 date: 2024-04-23 date: 2024-04-23 name: Johns Hopkins University class: OTHER name: National Institutes of Health (NIH) briefSummary: The current clinical trial will investigate the effects of orally administered d-limonene (limonene), delta-9-tetrahydrocannabinol (THC) and the combination in healthy adult volunteers. conditions: Subjective Drug Effects conditions: THC conditions: D-limonene studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Within-subjects design where participants are randomly assigned to dose conditions primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: place controlled, double-blind whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 65 type: ESTIMATED name: D-Limonene name: Delta-9-THC name: Placebo measure: Subjective Drug Effect as assessed by Visual Analog Scale measure: Subjective Drug Liking as assessed by Visual Analog Scale measure: Subjective anxiety as assessed by Visual Analog Scale measure: Subjective hunger as assessed by Visual Analog Scale measure: Subjective paranoia as assessed by Visual Analog Scale sex: ALL minimumAge: 18 Years maximumAge: 55 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: NCT06378944 id: 61/23 briefTitle: Selective Sentinella Lymph Node Biopsy With Indocyanine Green in Patients With Breast Cancer acronym: INSEAN overallStatus: RECRUITING date: 2024-01-01 date: 2029-01-01 date: 2029-01-01 date: 2024-04-23 date: 2024-04-23 name: Omphis Foundation class: OTHER briefSummary: The current observational study aims to perform the sentinel lymph node in breast cancer in the usual way with technetium 99 and add a second tracer, indocyanine green. The objective is to evaluate the detection rate of the lymph node with indocyanine green compared to the usual technique. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 15000 type: ESTIMATED name: Application of green indocyanine colorant name: Technetium99 measure: Number of Sentinel lymph node detected. Scale of numbers measure: Number of possitive lymph nodes measure: surgery time in minutes sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sandra Lopez Gordo status: RECRUITING city: Cerdanyola Del Valles state: Barcelona zip: 08290 country: Spain name: Sandra Lopez gordo role: CONTACT phone: 660284047 email: sandra.lopezgordo@gmail.com lat: 41.49109 lon: 2.14079 hasResults: False

 nctId: NCT06378931 id: 2024HX161 briefTitle: Quality of Life Change in Patients Undergoing Parathyroidectomy With End-stage Renal Failure overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-12-30 date: 2025-12-30 date: 2024-04-23 date: 2024-04-23 name: Chunling Jiang class: OTHER briefSummary: The purpose of this study is to characterize the quality of life change in patients undergoing parathyroidectomy with secondary hyperparathyroidism due to end-stage renal failure. conditions: Secondary Hyperparathyroidism conditions: End Stage Renal Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Quality of life progression after parathyroidectomy measure: Measure quality of life scores change with respect to time measure: Measure anxiety and depression score change with respect to time measure: Measure bone pain scores change with respect to time measure: Length of hospital stay sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06378918 id: 2023-A02791-44 briefTitle: Comparison of the Effectiveness of the Simple Puncture Compared to the Incision of an Abscess on the piLOnidal Sinus acronym: PILO overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2025-04-15 date: 2027-04-15 date: 2024-04-23 date: 2024-04-23 name: University Hospital, Angers class: OTHER_GOV briefSummary: Pilonidal disease is a common disease characterized by the presence of abscess in the intergluteal groove. During periods of abscess, current recommendations are to make a simple incision with daily wicking of the abscess. Direct excision at this time is not recommended because there is a risk of incomplete excision. The principle of directed healing after incision of the abscess results in an average dressing period of 21 days. A definitive resection is recommended after 4 to 6 weeks, when healing has been achieved, in order to limit the risk of infectious recurrence.

An alternative has recently been proposed, consisting of a puncture of the abscess, aimed at emptying it under antibiotic coverage. The major advantage of this treatment is that patients no longer need general anesthesia to flatten the abscess. Although this technique is promising, it is currently not the subject of any published or ongoing randomized controlled study registered on Clinicaltrials.gov.

The research hypothesis is that the two techniques have the same results in terms of recurrence before definitive surgical treatment but that drainage puncture would imply a faster healing time, a lower cost of treatment, a quality of superior support, reduced support time and reduced work stoppage. conditions: Pilonidal Cyst studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 134 type: ESTIMATED name: puncture name: incision of the abscess measure: healing time measure: Effectiveness of the 2 procedures measure: Cost-utility analysis measure: Duration of nursing care measure: Duration of work stoppage measure: Returning to work measure: Quality of life measure: Healing after definitive resection sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06378905 id: 141/57 briefTitle: Cukurova Score Validation Study acronym: CUKUROVA overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-03 date: 2027-03 date: 2024-04-23 date: 2024-04-23 name: Cukurova University class: OTHER name: Muğla Sıtkı Koçman University name: Sakarya University name: Gazi University name: Ankara Etlik City Hospital name: Kayseri City Hospital name: Mersin University name: Selçuk University name: Bezmialem Vakif University name: Uludag University name: Mersin City Hospital name: Marmara University name: Prof. Dr. Cemil Tascıoglu City Hospital name: Ankara University name: Ege University name: Hacettepe University name: Akdeniz University name: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital name: Mustafa Kemal University name: Trakya University briefSummary: Despite significant advancements in imaging technologies, surgical techniques, chemotherapeutic regimens, and treatment strategies in recent years, ovarian cancer continues to remain the most deadly gynecological malignancy. Approximately 90% of ovarian cancers originate from the coelomic epithelium or modified mesothelial cells and are classified as epithelial ovarian cancers. The majority of patients with epithelial ovarian cancer (70-80%) present in advanced stages. The primary treatment for advanced-stage (stage 3-4) disease consists of primary cytoreductive surgery followed by adjuvant chemotherapy. Cytoreductive surgery aims to remove all visible tumor implants regardless of the extent of the disease and achieve no visible residual tumor (complete cytoreduction, R0) at the end of the surgery. In cases where R0 cannot be achieved (due to poor general condition and/or extensive tumor that cannot be completely excised surgically), the option of neoadjuvant chemotherapy followed by interval cytoreductive surgery is considered. Primary cytoreductive surgery is still the preferred option and is considered a quality indicator for centers performing advanced-stage ovarian cancer surgeries. Despite advancements in surgery, the decision for interval surgery following primary surgery or neoadjuvant chemotherapy is often based on the surgeon's experience, imaging results, and clinic preferences. Various methods and scores have been published and applied to predict which patients are suitable for primary surgery.

The Cukurova score developed in our clinic conceptualizes prioritizing surgical procedures using radiological imaging and diagnostic exploratory laparoscopy to achieve complete cytoreduction in harmony with the patient's clinical and performance status, rather than focusing solely on tumor burden. The score showed high success rates for complete cytoreduction and also was useful in terms of predicting the morbidity and mortality. However, the Cukurova score study was conducted in single center. Validation of scores in centers with different capacities is expected to facilitate their widespread use and acceptance. Therefore, in this study, the investigators plan to conduct a validation study of the score in a total of 20 centers in Turkey, including our center. This study aims to evaluate the validity of the Cukurova score in predicting outcomes of primary cytoreduction in advanced ovarian cancer patients and thus determining the decision for primary cytoreductive surgery or neoadjuvant chemotherapy followed by interval cytoreductive surgery. conditions: Epithelial Ovarian Cancer conditions: Primary Cytoreduction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 130 type: ESTIMATED measure: Rate of complete cytoreduction measure: Rate of postoperative 90-days mortality measure: Rate of postoperative morbidity sex: FEMALE minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cukurova University city: Adana zip: 01330 country: Turkey name: Ghanim Khatib, MD role: CONTACT phone: 03223386060 email: ghanim.khatib@gmail.com name: Ghanim Khatib, MD role: CONTACT phone: +903223386060 phoneExt: Khatib email: ghanim.khatib@gmail.com name: Ghanim Khatib, MD,Ass.Prof role: PRINCIPAL_INVESTIGATOR lat: 37.00167 lon: 35.32889 hasResults: False

 nctId: NCT06378892 id: CRO-2023-78 briefTitle: A Study to Evaluate the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib acronym: ALK-PPL overallStatus: RECRUITING date: 2024-03-15 date: 2028-05 date: 2028-05 date: 2024-04-23 date: 2024-04-23 name: Centro di Riferimento Oncologico - Aviano class: OTHER briefSummary: This study aims to evaluate the activity and safety of the combination of platinum-pemetrexed based chemotherapy plus Lorlatinib in ALK positive Non-Small Cell Lung Cancer (NSCLC) with exclusively extracranial disease progression on Lorlatinib. Platinum-pemetrexed based chemotherapy plus Lorlatinib will be administered for an induction phase of four cycles. Subsequently, patients with response or stability of disease at radiological assessment will start the maintenance phase with pemetrexed-Lorlatinib in 21-day cycles until progression, unacceptable toxicity, death, or withdrawal of consent. conditions: Non Small Cell Lung Cancer Metastatic conditions: ALK Gene Mutation studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Lorlatinib measure: Compare Progression Free Survival between patients treated with Pemetrexed (PT)/pem-based chemotherapy plus Lorlatinib after Lorlatinib versus retrospective data of 3,2 months for patients treated with PT/pem-based chemotherapy after Lorlatinib. measure: Intracranial Progression Free Survival (PFS) in patients treated with PT/pem-based chemotherapy plus Lorlatinib after Lorlatinib. measure: Overall survival (OS) in patients treated with PT/pem-based chemotherapy plus Lorlatinib after Lorlatinib progression measure: Describe the safety of PT/pem-based chemotherapy plus Lorlatinib combination sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centro di Riferimento Oncologico (CRO) IRCCS status: RECRUITING city: Aviano zip: 33081 country: Italy name: Alessandra Bearz role: CONTACT phone: 0434659294 email: abearz@cro.it lat: 46.07056 lon: 12.59472 facility: Azienda Ospedaliero-Universitaria Careggi Oncologia Medica status: NOT_YET_RECRUITING city: Firenze zip: 50134 country: Italy name: Lorenzo Antonuzzo role: CONTACT phone: 0557947298 email: antonuzzol@aou-careggi.toscana.it lat: 43.77925 lon: 11.24626 facility: Azienda USL Toscana Nord Ovest Oncologia Medica, Ospedale Versilia status: NOT_YET_RECRUITING city: Lido Di Camaiore zip: 55049 country: Italy name: Camerini Andrea role: CONTACT phone: 05846057282 email: andrea.camerini@uslnordovest.toscana.it lat: 43.90012 lon: 10.2269 facility: Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino amadori" status: NOT_YET_RECRUITING city: Meldola zip: 47014 country: Italy name: Delmonte Angelo role: CONTACT phone: 0543739100 email: angelo.delmonte@irst.emr.it lat: 44.12775 lon: 12.0626 facility: Fondazione IRCCS San Gerardo dei Tintori status: NOT_YET_RECRUITING city: Monza zip: 20900 country: Italy name: Cortinovis Diego Luigi role: CONTACT phone: 0392336040 email: diegoluigi.cortinovis@irccs-sangerardo.it lat: 45.58005 lon: 9.27246 facility: IOV Istituto Oncologico Veneto IRCCS status: NOT_YET_RECRUITING city: Padova zip: 35128 country: Italy name: Pasello Giulia role: CONTACT phone: 0498215608 email: giulia.pasello@iov.veneto.it lat: 45.40797 lon: 11.88586 facility: Azienda Ospedaliero-Universitaria di Parma status: NOT_YET_RECRUITING city: Parma zip: 43126 country: Italy name: Tiseo Marcello role: CONTACT phone: 0521702316 email: mtiseo@ao.pr.it lat: 44.79935 lon: 10.32618 facility: Azienda Ospedaliera di Perugia status: NOT_YET_RECRUITING city: Perugia zip: 06129 country: Italy name: Metro Giulio role: CONTACT phone: 0755783695 email: giulio.metro@ospedale.perugia.it lat: 43.1122 lon: 12.38878 facility: Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) status: NOT_YET_RECRUITING city: Udine zip: 33010 country: Italy name: Giacomo Pellizzari role: CONTACT phone: 0432552754 email: giacomo.pelizzari@asufc.sanita.fvg.it lat: 46.0693 lon: 13.23715 hasResults: False

 nctId: NCT06378879 id: 1073/1/3/26 briefTitle: Intermittent Boluses Versus Infusion of Propofol During Gastroscopy overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2025-04-30 date: 2025-07-30 date: 2024-04-23 date: 2024-04-23 name: Al-Balqa Applied University class: OTHER name: Luzmila Hospital briefSummary: It is unclear whether continuous infusion or intermittent bolus injection of propofol is better for achieving adequate sedation during a standard upper endoscopy. The study aimed to compare the efficacy and safety of continuous infusion and intermittent bolus injection of Propofol (Diprivan) during a standard upper endoscopy. In this prospective study, patients will be randomly assigned to undergo a standard upper endoscopy with either continuous infusion (CI group) or intermittent bolus injection (BI group) of Propofol (Diprivan) administered by an anesthesiologist. The primary outcome will be to assess the quality of sedation by the endoscopist (VAS). In addition to other sedation-related parameters that will include sedation induction time (minutes), total dose of propofol (mg), recovery time (minutes) using Aldrete score, any involuntary patient movement, and adverse events. conditions: Anesthesia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 100 type: ESTIMATED name: Propofol 100 MG in 10 ML Injection measure: Sedation induction time (minutes) measure: Total dose of propofol (mg) measure: Recovery time (minutes) measure: Involuntary movement measure: Quality of sedation measure: Adverse events sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06378866 id: MC230502 id: NCI-2024-02978 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-012176 type: OTHER domain: Mayo Clinic Institutional Review Board id: MC230502 type: OTHER domain: Mayo Clinic in Rochester briefTitle: Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial acronym: DIVINE overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2029-04-30 date: 2029-04-30 date: 2024-04-23 date: 2024-04-23 name: Mayo Clinic class: OTHER briefSummary: This phase II trial studies the effects of stereotactic body radiation therapy (SBRT) and the timing of treatment with androgen receptor pathway inhibitor (ARPI) plus androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate cancer that has spread from where it first started to other places in the body (metastatic), and that has come back after a period of improvement (recurrent). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Androgen can cause the growth of prostate cells. ADT lowers the amount of androgen made by the body. This may help stop the growth of tumor cells that need androgen to grow. Androgen receptor pathway inhibitors work by blocking the effects of androgen to stop the growth and spread of tumor cells. Giving SBRT alone with watchful waiting may be as effective in treating prostate cancer as giving SBRT together with ARPI and ADT. conditions: Recurrent Castration-Sensitive Prostate Carcinoma conditions: Stage IVB Prostate Cancer AJCC v8 conditions: Recurrent Prostate Cancer conditions: Castration-resistant Prostate Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Abiraterone name: Apalutamide name: Biospecimen Collection name: Bone Scan name: Computed Tomography name: Darolutamide name: Degarelix name: Enzalutamide name: Goserelin name: Histrelin name: Leuprolide name: Magnetic Resonance Imaging name: Patient Observation name: Positron Emission Tomography name: Prednisone name: Questionnaire Administration name: Relugolix name: Stereotactic Body Radiation Therapy name: Triptorelin measure: Modified radiographic progression-free survival (mrPFS) measure: Overall survival (OS) measure: Biologic progression-free survival (bPFS) measure: Time to local progression (TLP) measure: Time to distant progression (TDP) measure: Adverse event (AE) rate sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester 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: Jacob J. Orme, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06378853 id: 2023DZKY-049-01 briefTitle: Risk Factors of Postoperative Complications and Survival Rate in Pancreatic Ductal Adenocarcinoma Patients overallStatus: COMPLETED date: 2019-01-01 date: 2023-12-31 date: 2024-02-28 date: 2024-04-23 date: 2024-04-23 name: Jinling Hospital, China class: OTHER briefSummary: By evaluating the nutritional status of patients with pancreatic ductal adenocarcinoma (PDAC) admitted to Jinling Hospital, collecting relevant clinical data. we aim to conduct correlation analysis with patient clinical information, such as survival time, hospitalization time, nutritional status, hematological indicators, etc., in order to reveal the prognostic factors for overall survival and postoperative complications of PDAC patients. conditions: Pancreatic Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 548 type: ACTUAL name: no intervention measure: complications measure: overall survival measure: risk factors sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jinling Hospital city: Nanjing country: China lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06378840 id: KY2021-268-B briefTitle: the Predictive Value of Immune Cell in Locally Advanced Cervical Cancer overallStatus: RECRUITING date: 2022-01-01 date: 2024-12-30 date: 2024-12-30 date: 2024-04-23 date: 2024-04-23 name: RenJi Hospital class: OTHER briefSummary: To explore the predictive value of immune cells by single-cell sequencing on the outcome of locally advanced cervical cancer treated by concurrent chemoradiotherapy Followed by PD-1 inhibitor conditions: Locally Advanced Cervical Carcinoma conditions: Concurrent Chemoradiotherapy conditions: Immunotherapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Nab-paclitaxel/Platinum, Sintilimab measure: the change of immune cells in the blood after chemoradiotherapy and immunotherapy measure: the predictive value of the changed immune cell subtype in the blood on the side effect of immunotherapy measure: the predictive value of the changed immune cell subtype in the blood on the effect of chemoradiotherapy and immunotherapy measure: the change of immune cells in the tissue after chemoradiotherapy measure: the predictive value of the changed immune cell subtype in the tissue on the effect of chemoradiotherapy and immunotherapy measure: the predictive value of the changed immune cell subtype in the tumor microenvironment on the side effect of immunotherapy sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RenJi hospital status: RECRUITING city: Shanghai zip: 200127 country: China name: Haiyan Chen, Dr role: CONTACT phone: +862168383624 email: chenhaiyan@renji.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06378827 id: 418-1/2 briefTitle: Intraoperative Dexmedetomidine and Coronary Artery Bypass Graft Surgery overallStatus: RECRUITING date: 2024-04-03 date: 2024-07 date: 2024-10 date: 2024-04-23 date: 2024-04-23 name: University of Novi Sad class: OTHER briefSummary: This is a prospective randomized clinical trial designed to determine the effect of intraoperative dexmedetomidine administration on renal function after coronary artery bypass graft surgery. conditions: Acute Kidney Injury studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 100 type: ESTIMATED name: Dexmedetomidine measure: Indicator of renal function measure: An early biomarker of kidney injury measure: The change of inflammatory markers measure: Length of postoperative mechanical ventilation measure: Length of stay in the intensive care unit sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Novi Sad, Faculty of Medicine status: RECRUITING city: Novi Sad zip: 21000 country: Serbia name: Ranko Zdravkovic role: CONTACT phone: +381654674620 email: ranko.zdravkovic@mf.uns.ac.rs lat: 45.25167 lon: 19.83694 hasResults: False

 nctId: NCT06378814 id: IRAS N335444 briefTitle: Outcome of Selective & Nonselective Caries Removal in Permanent Teeth acronym: RCT-SNCR overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2030-04-30 date: 2024-04-23 date: 2024-04-29 name: King's College London class: OTHER name: Guy's and St Thomas' NHS Foundation Trust briefSummary: Patients presenting with deep decay within permanent teeth presents a common clinical challenge to dentists. The aim of this trial is to compare the success rate of the non-selective caries removal (NSCR) and selective caries removal (SCR) in managing deep caries, as both methods are commonly used in clinical practice.

This study will be a randomized controlled trial, with participants divided into two groups: NSCR group and SCR group. Participants of deep caries lesions (reaching more than two-thirds of dentin on periapical radiographs) Both groups will undergo either NSCR or SCR, followed by Partial Pulpotomy (PP) in cases with pulp exposure. Success rates will be assessed at follow-up visits scheduled 1, 3, and 5 years radiographs will be used to assess for pulp health(vitality).

The success rate of the two categories will be assessed using a scale that includes factors such as tooth vitality, caries recurrence, and clinical signs of pulpitis. The scale will be applied at follow-up visits. The trial will be conducted in post-graduate dental clinics at Guy's hospital.

Deep caries in permanent teeth is a common clinical problem that can lead to pulp exposure and subsequent restorative challenges. The aim of this study is to provide evidence-based guidance for clinicians in managing deep caries lesions, as both NSCR and SCR are commonly used in clinical practice. The results of this study will help clinicians to make informed decisions when choosing the appropriate treatment approach for their patients.

In conclusion, this trial aims to compare the success rate of NSCR and SCR in managing deep caries lesions in permanent teeth, as both methods are commonly used in clinical practice. The results of this study will provide valuable insights into the effectiveness of these two treatment approaches and will help clinicians to make informed decisions when choosing the appropriate treatment approaches. conditions: Deep Caries conditions: Carious Exposure of Pulp studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: two arms parallel randomized clinical trial primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 168 type: ESTIMATED name: Selective Caries Removal (No Pulp Exposure) name: Non-Selective Caries Removal (No Pulp exposure) name: Partial Pulpotomy (Pulp Exposed) measure: To compare the success rate of maintaining pulp vitality assessed by pulp sensibility test between Selective Caries Removal or Non- Selective Caries Removal techniques after one year of the intervention. measure: Periapical Health Assessment Using Periapical Index Score in Deep Caries Lesion Treatment measure: Quality of Life Assessment ( Using OHIP-14 questionnaire) in Deep Caries Lesion Treatment: A Comparative Study of Selective Caries Removal and Partial Pulpotomy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06378801 id: RADX-P-2408 briefTitle: Radicle Relaxation 24: A Study of Health and Wellness Products on Stress and Related Health Outcomes overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-29 date: 2024-05 date: 2024-08 date: 2024-04-22 date: 2024-04-24 name: Radicle Science class: INDUSTRY briefSummary: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on stress and related health outcomes conditions: Stress 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: The investigator is blinded to the participants' study product assignment. Participants are blinded to the study product they are assigned. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 500 type: ACTUAL name: Placebo Control Form 1 name: Relaxation Active Study Product 1.1 measure: Change in stress measure: Change in feelings of anxiety measure: Change in cognitive function measure: Change in mood (emotional distress-depression) measure: Minimal clinically important difference (MCID) in stress measure: Minimal clinically important difference (MCID) in feelings of anxiety measure: Minimal clinically important difference (MCID) in cognitive function measure: Minimal clinically important difference (MCID) in mood (emotional distress-depression) measure: Change in concentration of at-home (direct-to-consumer) specimen assays either saliva, blood or stool 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: NCT06378788 id: 2023/211 briefTitle: Muscle Architecture and Muscle Strength in Fibromyalgia overallStatus: RECRUITING date: 2024-02-01 date: 2024-04-30 date: 2024-06-30 date: 2024-04-22 date: 2024-04-25 name: Bezmialem Vakif University class: OTHER briefSummary: The goal of this observational study is to determine whether there is decrease in muscle mass and muscle strength in Fibromyalgia Syndrome (FMS) patients in comparison to controls. And to determine whether these parameters are correlated with clinical ones. Briefly the main questions investigators aims to answer are:

* Is there a significant difference in muscle morphology between FMS and controls?
* Is there a significant difference in muscle strength between FMS and controls?
* Is there a relationship between muscle thickness and pennation angle of the Quadriceps, gastrocnemius medialis, gastrocnemius lateralis and Tibialis anterior muscles and disease activity, pain and functionality?
* Is there a correlation between muscle strength in FMS and disease activity, pain and functionality? conditions: Fibromyalgia conditions: Sarcopenia conditions: Muscle Weakness studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 30 type: ESTIMATED name: Demographic information form name: widespread pain index (WPI) name: symptom severity scale (SSS) name: Fibromyalgia Impact Questionnaire (FIQ) name: Tender Point examination name: Muscle Architecture visualized with ultrasound name: Sarcopenia assessed by measuring isometric strengths of different parts of the body name: Timed Up & Go (TUG) measure: Quadriceps Femoris Vastus Lateralis Muscle Thickness measure: Quadriceps Femoris Vastus Lateralis Fascicle Length measure: Quadriceps Femoris Vastus Medialis Muscle Thickness measure: Quadriceps Femoris Vastus Medialis Fascicle Length measure: Quadriceps Femoris Rectus Femoris Muscle Thickness measure: Quadriceps Femoris Rectus Femoris Fascicle Length measure: Tibialis Anterior Muscle Thickness measure: Tibialis Anterior Muscle Fascicle Length measure: Gastrocnemius Muscle Vastus Medialis Muscle Thickness measure: Gastrocnemius Muscle Vastus Medialis Fascicle Length measure: Gastrocnemius Muscle Vastus Lateralis Muscle Thickness measure: Gastrocnemius Muscle Vastus Lateralis Fascicle Length measure: Cervical Muscle strength measure: Truncal Muscle strength measure: Shoulder Muscle strength measure: Hip Muscle strength measure: Knee Muscle strength measure: Ankle Muscle strength measure: Timed Up & Go (TUG) sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bezmialem Vakif University status: RECRUITING city: Istanbul state: Fatih zip: 34093 country: Turkey name: Mehmet Serkan Kılıçoğlu, Ass.Prof. role: CONTACT phone: +902124530453 email: drserkankilicoglu@yahoo.com name: Delal Ozturk, Res.Ass. role: CONTACT phone: +902124530453 email: drdelalozturk@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06378775 id: H23-03334 briefTitle: Robotically-assisted Minimally-invasive Direct Coronary Artery Bypass With Stenting, Randomized Against Coronary Artery Bypass Graft Surgery acronym: ROBOT RCT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2028-12-01 date: 2024-04-22 date: 2024-04-23 name: Cardiology Research UBC class: OTHER briefSummary: The study objective is to compare standard CABG to a hybrid revascularization strategy (RA-MIDCAB + PCI) in patients who have multi-vessel CAD and an indication for surgery, but who have a slightly higher risk of post-operative complications. conditions: Coronary Artery Disease conditions: Multivessel Coronary Artery Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Coronary Artery Bypass Graft name: Robotically-assisted minimally-invasive direct coronary artery bypass name: Percutaneous Coronary Intervention measure: Post-operative Length of Stay measure: Conversion to sternotomy / CABG measure: Intubation duration measure: ICU length of stay sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06378762 id: 6/2021 briefTitle: Interference of Endurance Training on Strength Development and Neuromuscular Adaptations overallStatus: ACTIVE_NOT_RECRUITING date: 2022-04-01 date: 2024-07-30 date: 2025-07-30 date: 2024-04-22 date: 2024-04-22 name: University of Lisbon class: OTHER name: Fundação para a Ciência e a Tecnologia briefSummary: This study aims to find out if performing combined strength and endurance exercise in the same program (called concurrent training-CT) leads to similar long-term improvements in neuromuscular function as doing each type of exercise separately. The main questions it seeks to answer are:

Does performing CT result in similar improvements in strength and power as doing just strength training? Does performing CT result in similar improvements in cardiorespiratory fitness as doing just endurance training? Are neuromuscular adaptations similar between CT and just strength training? Researchers will compare the results between three groups: the CT group, the endurance training group (E), and the strength training group (S) to answer these questions. conditions: Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 30 type: ACTUAL name: Endurance Exercise name: Strength Exercise name: Concurrent Exercise measure: Maximal Isometric Strength measure: Maximal Dynamic Strength measure: Surface EMG measure: H-reflex excitability measure: V-wave measure: Lower Body Muscle Power measure: Muscle architecture of the quadriceps femoris sex: MALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Faculdade de Motricidade Humana - Universidade de Lisboa city: Lisboa state: Cruz Quebrada - Dafundo zip: 1499-002 country: Portugal lat: 38.71667 lon: -9.13333 hasResults: False

 nctId: NCT06378749 id: 1R43CA275673 type: NIH link: https://reporter.nih.gov/quickSearch/1R43CA275673 briefTitle: Previvors Recharge: A Resilience Program for Cancer Previvors acronym: PreCharge overallStatus: RECRUITING date: 2024-04-11 date: 2024-07-31 date: 2024-07-31 date: 2024-04-22 date: 2024-04-24 name: Pro-Change Behavior Systems class: OTHER briefSummary: It is estimated that 1 in 279 people may be carriers of a Hereditary Cancer Syndromes (HCS), a cancer risk that is associated with germline mutations (inherited genetic mutations passed directly from a parent to a child that create a genetic predisposition to certain types of cancer). Individuals with an HCS who have never been diagnosed with cancer (Previvors) have up to an 80% lifetime risk of developing cancer and are at an increased risk of developing multiple primary cancers during their lifetime, often with onset at an early age. Previvors face multiple forms of adversity, including a multitude of annual cancer screenings and the uncertainty of not only their own health but the health of affected family members. This study will examine the acceptability and preliminary effects of PreCharge, a resilience-boosting solution specifically designed for Previvors and delivered primarily via bi-directional text messaging. PreCharge uses proven approaches to behavior change tailoring to increase resilience by promoting a positive mindset, strong social connections, and a deep sense of meaning and purpose while also proactively addressing scanxiety. Up to 150 Hereditary Cancer Previvors will be recruited for a 30-day pilot test. Participants will complete a baseline assessment, and then be provided with 30 days of access to the PreCharge program. At the end of the 30 days, they will be prompted to complete a follow-up assessment. Outcomes include 1) acceptability of the program, as evidenced by obtaining 75% endorsement that users would recommend the program to a fellow Previvor; (2) engagement as evidenced by continued receipt of text messages and one or more interactions with the online tools by at least 70% of participants; and (3) benefit from the program, evidenced by statistically significant pre-post improvement on the Connor Davidson Resilience Scale. conditions: Hereditary Cancer conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 150 type: ESTIMATED name: PreCharge measure: Connor Davidson Resilience Scale (CDRISC) measure: Cantril/Gallup Life Evaluation Index measure: Acceptance and Action Questionnaire (AAQII) measure: Patient Health Questionnaire-2 (PHQ-2) measure: Generalized Anxiety Disorder-2 (GAD-2) measure: Cancer Behavior Inventory (CBI-B V2.0-12) measure: Net Promoter Score (NPS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pro-Change Behavior Systems status: RECRUITING city: Narragansett state: Rhode Island zip: 02882 country: United States name: Kerry E Evers, PhD role: CONTACT phone: 401-360-2985 email: kevers@prochange.com name: Madison Gilmore role: CONTACT phone: 401-360-2988 email: mgilmore@prochange.com name: Kerry E Evers, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.4501 lon: -71.4495 hasResults: False

 nctId: NCT06378736 id: 21-1027 briefTitle: Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus overallStatus: RECRUITING date: 2024-01-22 date: 2026-03-23 date: 2026-03-23 date: 2024-04-22 date: 2024-04-29 name: Northwell Health class: OTHER briefSummary: Patients with systemic lupus erythematosus (SLE) often experience a frustrating decline of their cognitive skills that includes considerable problems in attention, learning, and memory. This lupus-related cognitive dysfunction (termed SLE-CD) is recognized as the most prevalent of the nineteen neuropsychiatric SLE syndromes, as it affects up to 80% of patients and can significantly decrease their quality of life. The goal is to have tools that can be used for diagnosis and for monitoring responses after targeted interventions and therapies. This study will focus on electroencephalographic (EEG) signals, which will be detected noninvasively from scalp placed surface electrodes while the subjects are in a state of wakeful rest. Our hypothesis is that a subset of brain oscillations known as theta and gamma, and their co-modulation or coupling will be disrupted in SLE patients. This research protocol will subject patients with systemic lupus erythematosus (SLE) to scalp electroencephalography (EEG), with the goal of determining whether specific EEG patterns ('theta-gamma coupling') appear abnormal during wakeful-rest periods of 20 minutes. The investigators are interested in using scalp EEG because it is a standard, safe and robust technique for monitoring the electrophysiological activity of neurons in the cerebral cortex. conditions: Systemic Lupus Erythematosus studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Electroencephalography (EEG) signals, which will be detected noninvasively from dry scalp surface electrodes while the subjects are in a state of wakeful rest. measure: A measure of the amount and relationship of theta and gamma waves in the EEG recording. The ability to perform the block building task and the ability to choose among unfolded three-dimensional objects. sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwell Health-Feinstein Insitute status: RECRUITING city: Manhasset state: New York zip: 11030 country: United States name: Bruce T Volpe, MD role: CONTACT phone: 516-562-3384 email: bvolpe1@northwell.edu name: Celina B. Fernandez, MS role: CONTACT phone: 5165623646 email: cfernandez14@northwell.edu lat: 40.79788 lon: -73.69957 hasResults: False

 nctId: NCT06378723 id: 2024/01/24 briefTitle: The Relationship Between Upper Extremity Functionality, Trunk Control and Balance in Children With Cerebral Palsy overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-01 date: 2024-04-15 date: 2024-04-16 date: 2024-04-22 date: 2024-04-23 name: Eastern Mediterranean University class: OTHER briefSummary: The aim of this study is to examine the relationship between trunk control, upper extremity functionality and balance in children with cerebral palsy and to compare this relationship with healthy sedentary children.This study is carried out through Eastern Mediterranean University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Pediatric Rehabilitation Unit. conditions: Cerebral Palsy conditions: Diplegic Cerebral Palsy conditions: Balance; Distorted studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 53 type: ACTUAL name: Balance Tests measure: trunk control measure: upper extremity functionality measure: balance measure: Weight and Height sex: ALL minimumAge: 8 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Eastern Mediterranean University city: Famagusta zip: 99628 country: Cyprus lat: 35.12054 lon: 33.93894 facility: Yeni Sihirli Eller Özel Eğitim ve Rehabilitasyon Merkezi city: Adana state: Çukurova zip: 01170 country: Turkey lat: 37.00167 lon: 35.32889 hasResults: False

 nctId: NCT06378710 id: 22-0219 briefTitle: Haemodynamic and Respiratory Effects of a Low Positive End Expiratory Pressure Associated With a Fluid Challenge in Knee-chest Position acronym: OPTIPEP overallStatus: RECRUITING date: 2023-01-20 date: 2025-01-20 date: 2025-01-30 date: 2024-04-22 date: 2024-04-22 name: University Hospital, Caen class: OTHER briefSummary: The genu pectoral position is a surgical position used for spine surgery. This surgical position will lead to physiological hemodynamic and respiratory changes during the procedure.

The knee-pectoral position notably induces an increase in CRF and improves pulmonary ventilation/perfusion ratios. On the other hand, it has been shown that it is accompanied by a reduction in cardiac output of approximately 15% Protective perioperative ventilation including a tidal volume between 6 and 8 ml/kg of theoretical ideal weight, PEEP and alveolar recruitment maneuvers is applied in the operating room to reduce postoperative pulmonary complications. The application of high PEEP and the performance of recruitment maneuvers induce arterial hypotension through changes in intra- and transpulmonary pressures. However, investigators hypothesize that the deleterious hemodynamic effects of PEEP seem to counterbalance its beneficial respiratory effects in this particular position.

The combination of the effects of the knee-pectoral position and protective ventilation could be potentiated and be the cause of the sometimes severe arterial hypotension observed in clinical practice. Since this position improves pulmonary ventilation perfusion ratios, the investigators hypothesized that a lower PEEP and the elimination of intraoperative recruitment maneuvers could be beneficial from a hemodynamic point of view without being deleterious in terms of perioperative pulmonary complications. An exploratory study was carried out at the CAEN University Hospital in 2021 under the name PEEP POSTURE (CLERS Agreement No. 2198 of February 17, 2021) on 90 patients aiming to collect hemodynamic and respiratory parameters in 3 surgical positions: supine decubitus, ventral decubitus , pectoral genu. No difference was found in the evolution of respiratory compliance. On the other hand, a significant drop in SBP, DBP and MAP in the pectoral position was shown compared to the supine group as well as greater vascular filling.

The investigators therefore hypothesize that a reduction in PEEP and optimization of vascular filling could help reduce the adverse effects on blood pressure linked to the surgical position. conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 84 type: ESTIMATED name: Optimized PEEP measure: Number of occurrences of a MAP sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CAEN University Hospital status: RECRUITING city: Caen country: France name: Mariam BOUTROS, MD role: CONTACT phone: 02.31.06.31.06 email: boutros-m@chu-caen.fr lat: 49.18585 lon: -0.35912 hasResults: False

 nctId: NCT06378697 id: AK111-303 briefTitle: A Phase III Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis overallStatus: RECRUITING date: 2023-11-10 date: 2025-02-28 date: 2026-04-30 date: 2024-04-22 date: 2024-04-22 name: Akeso class: INDUSTRY briefSummary: This is a randomized, double-blind, placebo-controlled, multi-center phase III clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with active ankylosing spondylitis. conditions: Ankylosing Spondylitis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 510 type: ESTIMATED name: AK111 name: Placebo+AK111 measure: the response rate of ASAS20 measure: The response rate of ASAS40 measure: The response rate of ASAS20 measure: The response rate of ASAS40 measure: The response rate of ASAS5/6 measure: Change from baseline on the ASDAS-CRP measure: Change from baseline on the SF-36 PCS measure: Change from baseline on the ASQoL scores measure: Treatment-emergent adverse events measure: Serious adverse events measure: Clinically significant examination results sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 1006-The First Affiliated Hospital of Bengbu Medical University status: RECRUITING city: Bengbu state: Anhui country: China lat: 32.94083 lon: 117.36083 facility: 1038-Anhui Provincial Hospital status: RECRUITING city: Hefei state: Anhui country: China lat: 31.86389 lon: 117.28083 facility: 1001-Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: 1002-Xuanwu Hospital Capital Medical University status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: 1042-Peking University Shougang Hospital status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: 1049-The First Affiliated Hospital of Xiamen University status: RECRUITING city: Xiamen state: Fujian country: China lat: 24.47979 lon: 118.08187 facility: 1027-Lanzhou University Second Hospital status: RECRUITING city: Lanzhou state: Gansu country: China lat: 36.05701 lon: 103.83987 facility: 1005-Nanfang Hospital status: RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: 1025-Guangzhou First People's Hospital status: RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: 1030-Jieyang People's Hospital status: RECRUITING city: Jieyang state: Guangdong country: China lat: 23.5418 lon: 116.36581 facility: 1008-The Seventh Affiliated Hospital, Sun Yat-sen University status: RECRUITING city: Shenzhen state: Guangdong country: China lat: 22.54554 lon: 114.0683 facility: 1026-Shenzhen People's Hospital status: RECRUITING city: Shenzhen state: Guangdong country: China lat: 22.54554 lon: 114.0683 facility: 1056-Zhongshan Traditional Chinese Medicine Hospital status: RECRUITING city: Zhongshan state: Guangdong country: China lat: 21.31992 lon: 110.5723 facility: 1024-Liuzhou People's Hospital status: RECRUITING city: Liuzhou state: Guangxi country: China facility: 1021-The People's Hospital of Guangxi Zhuang Autonomous Region status: RECRUITING city: Nanning state: Guangxi country: China lat: 22.81667 lon: 108.31667 facility: 1022-The First Affiliated Hospital of Hainan Medical University status: RECRUITING city: Haikou state: Hainan country: China lat: 20.04583 lon: 110.34167 facility: 1034-Affiliated Hospital of Hebei University status: RECRUITING city: Baoding state: Hebei country: China lat: 38.85111 lon: 115.49028 facility: 1012-Hebei Petro China Central Hospital status: RECRUITING city: Langfang state: Hebei country: China lat: 39.50972 lon: 116.69472 facility: 1029-Hebei General Hospital status: RECRUITING city: Shijiazhuang state: Hebei country: China lat: 38.04139 lon: 114.47861 facility: 1033-The First Hospital of Qiqihar status: RECRUITING city: Qiqihar state: Heilongjiang country: China lat: 47.34088 lon: 123.96045 facility: 1045-The First Affiliated Hospital of Henan University of Science and Technology status: RECRUITING city: Luoyang state: Henan country: China lat: 34.68361 lon: 112.45361 facility: 1053-Nanyang Central Hospital status: RECRUITING city: Nanyang state: Henan country: China lat: 32.99472 lon: 112.53278 facility: 1051-Shiyan People's Hospital status: RECRUITING city: Shiyan state: Hubei country: China lat: 32.6475 lon: 110.77806 facility: 1031-The First Affiliated Hospital of University of South China status: RECRUITING city: Hengyang state: Hunan country: China lat: 26.88946 lon: 112.61888 facility: 1032-Yueyang Central Hospital status: RECRUITING city: Yueyang state: Hunan country: China lat: 29.37455 lon: 113.09481 facility: 1011-Zhuzhou Central Hospital status: RECRUITING city: Zhuzhou state: Hunan country: China lat: 27.83333 lon: 113.15 facility: 1017-Changzhou NO.2 People's Hospital status: RECRUITING city: Changzhou state: Jiangsu country: China lat: 31.77359 lon: 119.95401 facility: 1037-The Second People's Hospital of Lianyungang status: RECRUITING city: Lianyungang state: Jiangsu country: China lat: 34.59845 lon: 119.21556 facility: 1004-Zhongda Hospital Southeast University status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: 1007-Nanjing Drum Tower Hospital status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: 1036-Jiangsu Province Hospital status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: 1018-Affiliated Hospital of Nantong University status: RECRUITING city: Nantong state: Jiangsu country: China lat: 32.03028 lon: 120.87472 facility: 1035-Wuxi People's Hospital status: RECRUITING city: Wuxi state: Jiangsu country: China lat: 31.56887 lon: 120.28857 facility: 1013-Xuzhou Central Hospital status: RECRUITING city: Xuzhou state: Jiangsu country: China lat: 34.18045 lon: 117.15707 facility: 1014-Affiliated Hospital of Jiangsu University status: RECRUITING city: Zhenjiang state: Jiangsu country: China lat: 32.21086 lon: 119.45508 facility: 1047-The First Affiliated Hospital of Gannan Medical College status: RECRUITING city: Ganzhou state: Jiangxi country: China facility: 1020-The Second Affiliated Hospital of Nanchang University status: RECRUITING city: Nanchang state: Jiangxi country: China lat: 28.68396 lon: 115.85306 facility: 1039-The First Affiliated Hospital of Nanchang University status: RECRUITING city: Nanchang state: Jiangxi country: China lat: 28.68396 lon: 115.85306 facility: 1046-Pingxiang People's Hospital status: RECRUITING city: Pingxiang state: Jiangxi country: China lat: 27.61672 lon: 113.85353 facility: 1044-Jilin Provincial People's Hospital status: RECRUITING city: Changchun state: Jilin country: China lat: 43.88 lon: 125.32278 facility: 1028- Jining First People's Hospital status: RECRUITING city: Jining state: Shandong country: China lat: 35.405 lon: 116.58139 facility: 1019-Linyi City People Hospital status: RECRUITING city: Linyi state: Shandong country: China lat: 35.06306 lon: 118.34278 facility: 1055-Weifang People's Hospital status: RECRUITING city: Weifang state: Shandong country: China lat: 36.71 lon: 119.10194 facility: 1016-Zaozhuang Municipal Hospital status: RECRUITING city: Zaozhuang state: Shandong country: China lat: 34.86472 lon: 117.55417 facility: 1054-Linfen Central Hospital status: RECRUITING city: Linfen state: Shanxi country: China lat: 36.08889 lon: 111.51889 facility: 1009-Second Hospital of Shanxi Medical University status: RECRUITING city: Taiyuan state: Shanxi country: China lat: 37.86944 lon: 112.56028 facility: 1043-Yuncheng Central Hospital status: RECRUITING city: Yuncheng state: Shanxi country: China lat: 35.02306 lon: 110.99278 facility: 1010-West China Hospital,Sichuan University status: RECRUITING city: Chengdu state: Sichuan country: China lat: 30.66667 lon: 104.06667 facility: 1048-Mianyang Central Hospital status: RECRUITING city: Mianyang state: Sichuan country: China lat: 31.46784 lon: 104.68168 facility: 1041-Affiliated Hospital of North Sichuan Medical College status: RECRUITING city: Nanchong state: Sichuan country: China lat: 30.79508 lon: 106.08473 facility: 1023-The People's Hospital of Xinjiang Uyghur Autonomous Region status: RECRUITING city: Urumqi state: Xinjiang country: China lat: 43.80096 lon: 87.60046 facility: 1040- Huzhou Third People's Hospital status: RECRUITING city: Huzhou state: Zhejiang country: China lat: 30.8703 lon: 120.0933 facility: 1015-Taizhou Hospital of Zhejiang Province status: RECRUITING city: Taizhou state: Zhejiang country: China lat: 32.49069 lon: 119.90812 facility: 1050-The First Affiliated Hospital of Wenzhou Medical University status: RECRUITING city: Wenzhou state: Zhejiang country: China lat: 27.99942 lon: 120.66682 hasResults: False

 nctId: NCT06378684 id: JW22105 briefTitle: To Evaluate the Safety and Pharmacokinetic Interactions in Healthy Volunteers overallStatus: COMPLETED date: 2023-09-10 date: 2023-12-23 date: 2024-01-13 date: 2024-04-22 date: 2024-04-22 name: JW Pharmaceutical class: INDUSTRY briefSummary: The objective is to evaluate the safety and Pharmacokinetic Interactions after adminitration drug(Treatment A or B or A+B) in Healthy Volunteers conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: NONE count: 48 type: ACTUAL name: Group 1: JW0104(Period 1), C2207(Period 2), JW0104 + C2207(Period 3) name: Group 2: JW0104 + C2207(Period 1), JW0104(Period 2), C2207(Period 3) name: Group 3: C2207(Period 1), JW0104 + C2207(Period 2), JW0104(Period 3) name: Group 4: JW0104(Period 1), JW0104 + C2207(Period 2), C2207(Period 3) name: Group 5: JW0104 + C2207(Period 1), C2207(Period 2), JW0104(Period 3) name: Group 6: C2207(Period 1), JW0104(Period 2), JW0104 + C2207(Period 3) measure: Cmax,ss measure: AUCτ,ss sex: ALL minimumAge: 19 Years maximumAge: 55 Years stdAges: ADULT facility: Clinical Trial Center, Severance Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06378671 id: ColdCough briefTitle: Single-center Clinical Study on the Safety and Effect of Bronchoscopic Cryotherapy in Patients With Chronic Cough acronym: ColdCough overallStatus: RECRUITING date: 2024-04 date: 2024-07 date: 2024-09 date: 2024-04-22 date: 2024-04-25 name: Guangzhou Medical University class: OTHER name: Ningbo SensCure Biotechnology Co., Ltd. briefSummary: Chronic cough is one of the most common complaints in respiratory specialty clinics, imposing significant economic burden on patients and severely affecting their quality of life. Currently, the pathogenesis of chronic refractory cough remains incompletely understood, and treatment remains a major challenge in clinical practice. Cryotherapy treatment via bronchoscopy has shown efficacy in certain airway diseases, but there is currently no research reporting its effects on chronic refractory cough.

The goal of this clinical trial is to learn if Cryotherapy treatment works to treat individuals with chronic cough. It will also learn about The safety and effectiveness of the cryotherapy treatment system produced by Ningbo SensCure Biotechnology Co., Ltd.. The main questions it aims to answer are:

* Does cryotherapy treatment lower the frequency and severity of cough and enhance quality of life?
* Will there be safety or operational performance issues when using this cryotherapy treatment system? Researchers will compare cryotherapy treatment with no treatment to determine if cryotherapy treatment is effective for treating chronic cough.

Participants will:

* Take routine bronchoscopy examination, lavage, and mucosal biopsy ,with/without cryotherapy treatment locally (around the left and right main bronchi, upper trachea, and carina)
* undergo a screening period of approximately 28 days. Follow-up visits and necessary examinations will be scheduled for the 3rd day after treatment initiation and at weeks 1, 2, 4, 8, and 12 thereafter.
* Monitor vital signs and clinical manifestations. conditions: Chronic Cough studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: a prospective, single-center, double-blind ,randomized controlled clinical trial primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: General treatment name: Cryotherapy Treatment measure: Device/Surgery-Related Serious Adverse Events measure: Device/Surgery Adverse Event Rate measure: Serious Adverse Event Rate measure: Device Defect Rate measure: Cough Visual Analogue Scale (VAS) measure: Cough frequency within 2 hours measure: Modified Cough Evaluation Tool (CET) measure: Leicester Cough Questionnaire (LCQ) measure: Tracheal Vibratory Cough Stimulation Test measure: Capsaicin Cough Stimulation Test measure: Performance evaluation of Cryotherapy Ablation Equipment measure: Performance evaluation of Cryotherapy Ablation Catheter sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Guangzhou Medical University status: RECRUITING city: Guangzhou state: Guangdong zip: 510163 country: China name: Shiyue Li role: CONTACT phone: +86 13902233925 email: lishiyue@gird.cn lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06378658 id: 22253 briefTitle: A Study to Learn About How Food and Esomeprazole Affect the Level of BAY2927088 in the Blood When Taken Together in Healthy Participants overallStatus: RECRUITING date: 2024-03-29 date: 2024-05-20 date: 2024-05-20 date: 2024-04-22 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 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.

The absorption of BAY2927088 into the blood is dependent on the amount of acid present in the stomach. Esomeprazole is a medicine which is used in the treatment of heartburn and excessive acid in the stomach. Both food and esomeprazole may change the amount of acid present in the stomach.

The main purpose of this study is to find out how food and esomeprazole may affect the absorption of BAY2927088 into the blood of healthy participants. For this, researchers will measure the levels of BAY2927088 in participants' blood when it is given with or without food as well as with or without esomeprazole. Researchers will then calculate the following:

* 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 4 treatment periods:

- Periods 1 to 3 (Day 1 to Day 9): All participants will take BAY2927088 with a low-fat meal, with a high-fat meal, and on an empty stomach, but in a different order, over the 3 study periods. Each period will last for 3 days and BAY2927088 will be given on the first day of each period.

On Day 9, participants will take esomeprazole on an empty stomach.

- Period 4 (Day 10 to Day 14): On Days 10 and 11, participants will take esomeprazole on an empty stomach. On Day 12, participants will take esomeprazole on an empty stomach. After 1 and a half hours, participants will take low-fat meal and BAY2927088.

On Day 13, participants will take esomeprazole on an empty stomach.

Participants will be in this study for about 8 weeks with 3 visits to the study clinic.

Participants will visit the study clinic:

* at least once, 2 to 28 days before the treatment starts, to confirm they can take part in this study
* once on the day before the treatment starts and will stay in the clinic until Day 14 of the treatment
* once, 7 to 10 days after last dose of BAY2927088, for a health check-up

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

* do 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 of whether 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: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 21 type: ESTIMATED name: BAY2927088 name: Esomeprazole name: Food measure: Cmax for BAY2927088 in plasma measure: AUC for BAY2927088 in plasma measure: Number of participants with treatment-emergent adverse events (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: NCT06378645 id: 2023-01682 briefTitle: Effect of Propofol vs. Sevoflurane on Erections During Narcosis In Transurethral Surgery acronym: PENIS overallStatus: RECRUITING date: 2024-02-01 date: 2026-12-01 date: 2026-12-01 date: 2024-04-22 date: 2024-04-22 name: Etienne Xavier Keller class: OTHER briefSummary: Penile erection is an unwanted event in transurethral (through the urethra) surgeries, which may be associated with adverse outcomes such as impaired access, prolonged operation time, the need to abort the operation, or the necessity for ancillary measures to achieve penile flaccidity, such as the injection of certain medications directly into the penis.

To reduce greenhouse gas emissions, the primary use of propofol instead of gaseous agents is being recommended for general anesthesia. Whether propofol may be associated with an increased or decreased rate of unwanted intraoperative penile erection compared to other anesthetic agents is not known. More generally, there are no high-quality studies available to evaluate the impact of the type of general anesthesia on the risk of unwanted penile erections during surgery.

This study aims to determine whether general anesthesia with propofol is more likely to cause intraoperative erections compared to sevoflurane during transurethral operations. conditions: Erection; Incomplete studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: The authorized study nurse will hand the upcoming envelope with the treatment allocation to the anesthesiologist. The patient and the urologists (who is measuring the outcome) will not know which form of general anesthesia will be performed. Herewith, blankets in the operating room will hide installations used by the anesthesiologists to prevent the urologists witnessing the assigned narcosis form. Before the surgical sign-out, while still scrubbed in and with the patient under anesthesia, the anesthesiologists will ask the urologists about the outcome questionnaire. Together, they will fill in the paper case report form (CRF). whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: General Anesthesia: Propofol name: General Anesthesia: Sevoflurane measure: Intraoperative Penile Erection measure: Prolongation of the surgery measure: Change in operative strategy measure: Adaptions of instruments or approaches measure: Altered operative outcome measure: Necessity for a drug application to decrease penile tumescence measure: Complications arisen sex: MALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Zurich status: RECRUITING city: Zürich zip: 8091 country: Switzerland name: Etienne X Keller, Ass Prof, MD role: CONTACT phone: +41 44 255 54 40 email: etiennexavier.keller@usz.ch lat: 47.36667 lon: 8.54999 hasResults: False

 nctId: NCT06378632 id: CLN0011 DETECT-HF briefTitle: AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM acronym: DETECT-HF overallStatus: RECRUITING date: 2022-02-11 date: 2024-07-15 date: 2024-12-01 date: 2024-04-22 date: 2024-04-22 name: Cordio Medical class: INDUSTRY briefSummary: Study Design:

This is an international, multicenter, observational, non-interventional, prospective, blinded, single-arm, two-period study, to collect patient utterances that will be retrospectively analyzed to determine the sensitivity and UPNR of the HearO system. conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Hearo App measure: Heart Failure Events (HFEs) sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eastern Shore Research Institute status: RECRUITING city: Fairhope state: Alabama zip: 36532 country: United States name: Jessica Huckleberry, SC role: CONTACT phone: 251-990-1920 email: jessicahuckleberry@yahoo.com name: Michael Pursley, MD role: PRINCIPAL_INVESTIGATOR lat: 30.52297 lon: -87.90333 facility: UC San Diego Health status: RECRUITING city: La Jolla state: California zip: 92037 country: United States name: Joshua Gillman, SC role: CONTACT phone: 858-246-2511 email: j1gillman@health.ucsd.edu name: Nicholas Wettersten, MD role: PRINCIPAL_INVESTIGATOR lat: 32.84727 lon: -117.2742 facility: VA Loma Linda Healthcare System status: RECRUITING city: Loma Linda state: California zip: 92357 country: United States name: Vicki Simpson, SC role: CONTACT phone: 909-593-6361 email: vicki.simpson@va.gov name: Jay Patel, MD role: PRINCIPAL_INVESTIGATOR lat: 34.04835 lon: -117.26115 facility: VA San Diego status: RECRUITING city: San Diego state: California zip: 92161 country: United States name: Jonathan Narita, SC role: CONTACT phone: 858-642-3512 email: jonathan.narita@va.gov name: Nancy Gardetto, MD role: PRINCIPAL_INVESTIGATOR lat: 32.71533 lon: -117.15726 facility: University of California, San Francisco status: RECRUITING city: San Francisco state: California zip: 94117 country: United States name: Priscilla Zhang, SC role: CONTACT phone: 415-514-7903 email: priscilla.zhang@ucsf.edu name: Liviu Klein, MD role: PRINCIPAL_INVESTIGATOR lat: 37.77493 lon: -122.41942 facility: Kaiser Permanente San Francisco status: RECRUITING city: San Francisco state: California zip: 94118 country: United States name: Priscilla Chung, SC role: CONTACT phone: 415-833-3480 email: priscilla.s.chung@kp.org name: Jana Svetlichanaya, MD role: PRINCIPAL_INVESTIGATOR lat: 37.77493 lon: -122.41942 facility: Nature Coast Clinical Research status: RECRUITING city: Crystal River state: Florida zip: 34429 country: United States name: Nina Smith, SC role: CONTACT phone: 352-563-1865 email: nsmith@encoredocs.com name: Susan Pasupuleti, MD role: PRINCIPAL_INVESTIGATOR lat: 28.90248 lon: -82.5926 facility: Jacksonville Center for Clinical Research status: RECRUITING city: Jacksonville state: Florida zip: 32216 country: United States name: Taylor Johnson, SC role: CONTACT phone: 904-730-0101 email: tjohnson@encoredocs.com name: Michael Koren, MD role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 facility: Amavita Clinical Research status: RECRUITING city: Miami state: Florida zip: 33137 country: United States name: Nereisy Alonso, SC role: CONTACT phone: 786-703-5941 email: researchadmin@amavita.health name: Pedro Martinez Clark, MD role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: Advance Medical Research Services Corp (AMRS) status: RECRUITING city: Miami state: Florida zip: 33173 country: United States name: Adam Rachid, SC role: CONTACT phone: 305-928-8845 email: arachid.amrs@gmail.com name: Yordan Orive Gomez, MD role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: Baptist Health (Miami Cardiac & Vascular Institute) status: RECRUITING city: Miami state: Florida zip: 33173 country: United States name: Margie Mckercher, SC role: CONTACT phone: 786-595-8075 email: margie.mchercher@baptisthealth.net name: Sandra Chaparro, MD role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: Comprehensive Medical & Research Center status: RECRUITING city: Plantation state: Florida zip: 33317 country: United States name: Wilmer Santiesteban Garcia, SC role: CONTACT phone: 954-368-3529 email: wsantiesteban@compmedical.net name: William Korey, MD role: PRINCIPAL_INVESTIGATOR lat: 26.13421 lon: -80.23184 facility: St. Johns Center for Clinical Research status: RECRUITING city: Saint Augustine state: Florida zip: 32086 country: United States name: Valerie Hayes, SC role: CONTACT phone: 904-209-0043 email: vhayes@encoredocs.com name: Ameeth Vedre, MD role: PRINCIPAL_INVESTIGATOR lat: 29.89469 lon: -81.31452 facility: Tampa General Hospital status: RECRUITING city: Tampa state: Florida zip: 33606 country: United States name: Kiria Almeida-Tamayo, SC role: CONTACT phone: 813-844-8058 email: kalmeidatamayo@tgh.org name: Debbie Hoffman, MD role: PRINCIPAL_INVESTIGATOR lat: 27.94752 lon: -82.45843 facility: West Georgia Cardiology status: RECRUITING city: Carrollton state: Georgia zip: 30117 country: United States name: Justina Okeke, SC role: CONTACT phone: 678-839-7285 email: justina.okeke@westgacardiology.com name: Charlie Rouse, MD role: PRINCIPAL_INVESTIGATOR lat: 33.58011 lon: -85.07661 facility: University of Chicago status: RECRUITING city: Chicago state: Illinois zip: 60637 country: United States name: Veronica Herzog, SC role: CONTACT phone: 773-834-9794 email: vherzog@bsd.uchicago.edu name: Gene Kim, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: Advocate Illinois Masonic Medical Center status: RECRUITING city: Chicago state: Illinois zip: 60657 country: United States name: Maci Eiber, SC role: CONTACT phone: 773-296-0969 email: maci.eiber@aah.org name: Sorin Danciu, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: Advocate Illinois Masonic Health Center status: RECRUITING city: Downers Grove state: Illinois zip: 60515 country: United States name: Debra Heidenreich, SC role: CONTACT phone: 630-352-2338 email: debra.heidenreich@aah.org name: Sorin Danciu, MD role: PRINCIPAL_INVESTIGATOR lat: 41.80892 lon: -88.01117 facility: Midwest Cardiovascular Center status: RECRUITING city: Naperville state: Illinois zip: 60540 country: United States name: Josilyn Klimek, SC role: CONTACT phone: 630-600-0730 email: josilyn.klimek@cardio.com name: Maria Rosa Costanzo, MD role: PRINCIPAL_INVESTIGATOR lat: 41.78586 lon: -88.14729 facility: Robert J. Dole VA Medical Center status: RECRUITING city: Wichita state: Kansas zip: 67218 country: United States name: Deborah Garner, sc role: CONTACT phone: 316-685-2221 phoneExt: 53352 email: deborah.garner@va.gov name: Freidy Eid, MD role: PRINCIPAL_INVESTIGATOR lat: 37.69224 lon: -97.33754 facility: St. Elizabeth Healthcare status: RECRUITING city: Edgewood state: Kentucky zip: 41017 country: United States name: Cynthia Mulcahy, SC role: CONTACT phone: 859-301-4046 email: cynthia.mulcahy@stelizabeth.com name: Haree Vongooru, MD role: PRINCIPAL_INVESTIGATOR lat: 39.01867 lon: -84.58189 facility: Cardiovascular Institute of the South status: RECRUITING city: Houma state: Louisiana zip: 70360 country: United States name: Kimberly Lirette, SC role: CONTACT phone: 985-873-5619 email: kimberly.lirette@cardio.com name: Peter Fail, MD role: PRINCIPAL_INVESTIGATOR lat: 29.59577 lon: -90.71953 facility: Cardiovascular Institute of the South status: RECRUITING city: Lafayette state: Louisiana zip: 70503 country: United States name: June Jones, SC role: CONTACT phone: 337-289-8429 email: june.jones@cardio.com name: Wade May, MD role: PRINCIPAL_INVESTIGATOR lat: 30.22409 lon: -92.01984 facility: University Medical Center New Orleans status: RECRUITING city: New Orleans state: Louisiana zip: 70112 country: United States name: Katasha Washington, SC role: CONTACT phone: 504-702-4704 email: katasha.washington@lcmchealth.org name: Frank Smart, MD role: PRINCIPAL_INVESTIGATOR lat: 29.95465 lon: -90.07507 facility: Nebraska Heart Center status: RECRUITING city: Lincoln state: Nebraska zip: 68526 country: United States name: Julie Potter, SC role: CONTACT phone: 402-328-3950 email: julie.potter@commonspirit.org name: Steven Krueger, MD role: PRINCIPAL_INVESTIGATOR lat: 40.8 lon: -96.66696 facility: VA Southern Nevada Healthcare System status: RECRUITING city: North Las Vegas state: Nevada zip: 89086 country: United States name: Rosalinda Cruz, SC role: CONTACT phone: 702-791-9000 phoneExt: 15575 email: Rosalinda.cruz@va.gov name: Marriyam Moten, MD role: PRINCIPAL_INVESTIGATOR lat: 36.19886 lon: -115.1175 facility: Mount Sinai Morningside status: RECRUITING city: New York state: New York zip: 10025 country: United States name: Kathy Idrissi, SC role: CONTACT phone: 646-561-1170 email: katharine.idrissi2@mountsinai.org name: Kiran Mahmood, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: The Mount Sinai Hospital status: RECRUITING city: New York state: New York zip: 10029 country: United States name: Lovelyne Julien, SC role: CONTACT phone: 212-241-1537 email: lovelyne.julien@mountsinai.org name: Anuradha Lala - Trindade, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: St. Francis Hospital status: RECRUITING city: Roslyn state: New York zip: 11576 country: United States name: Lyn Santiago, SC role: CONTACT phone: 516-562-6763 email: lyn.santiago@chsli.org name: Rita Jermyn, MD role: PRINCIPAL_INVESTIGATOR lat: 40.79982 lon: -73.65096 facility: Mission Hospital status: RECRUITING city: Asheville state: North Carolina zip: 28803 country: United States name: Josephine Purbrick, SC role: CONTACT phone: 828-412-9149 email: josephine.purbrick@sarahcannon.com name: Vinay Thohan, MD role: PRINCIPAL_INVESTIGATOR lat: 35.60095 lon: -82.55402 facility: Moses H. Cone Memorial Hospital status: RECRUITING city: Greensboro state: North Carolina zip: 27401 country: United States name: Michelle McCart, SC role: CONTACT phone: 336-832-3799 email: michelle.mccart@conehealth.com name: Daniel Bensimhon, MD role: PRINCIPAL_INVESTIGATOR lat: 36.07264 lon: -79.79198 facility: The Lindner Research Center at The Christ Hospital status: RECRUITING city: Cincinnati state: Ohio zip: 45219 country: United States name: Kathryn Gloria, SC role: CONTACT email: katherineaubre.glori@thechristhospital.com name: Eugene Chung, MD role: PRINCIPAL_INVESTIGATOR lat: 39.12713 lon: -84.51435 facility: Cleveland Clinic status: RECRUITING city: Cleveland state: Ohio zip: 44106 country: United States name: Savi Radesic role: CONTACT phone: 216-445-6916 email: radesis@ccf.org name: W.H. Wilson Tang, MD role: PRINCIPAL_INVESTIGATOR lat: 41.4995 lon: -81.69541 facility: The Ohio State University status: RECRUITING city: Columbus state: Ohio zip: 43210 country: United States name: Carina Pannelle role: CONTACT phone: 614-366-8650 email: carina.panelle@osumc.edu name: Rami Kahwash, MD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 facility: Vanderbilt University Medical Center status: RECRUITING city: Nashville state: Tennessee zip: 37232 country: United States name: Terry Weyand, SC role: CONTACT phone: 615-322-9349 email: terry.l.weyand@vumc.org name: JoAnn Lindenfeld, MD role: PRINCIPAL_INVESTIGATOR lat: 36.16589 lon: -86.78444 facility: Rio Grande Regional Hospital status: RECRUITING city: McAllen state: Texas zip: 78503 country: United States name: Dina Garcia, SC role: CONTACT phone: 956-632-6054 email: dina.garcia2@hcahealthcare.com name: Norman Ramirez, MD role: PRINCIPAL_INVESTIGATOR lat: 26.20341 lon: -98.23001 facility: Methodist Hospital of San Antonio status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States name: Maurene Cantu role: CONTACT phone: 210-218-4950 email: maurene.cantu@hcahealthcare.com name: Sachin Gupta, MD role: PRINCIPAL_INVESTIGATOR lat: 29.42412 lon: -98.49363 facility: University Hospital Samson Assuta Ashdod status: RECRUITING city: Ashdod country: Israel name: Sapir Swisa, SC role: CONTACT name: Alexander Goldman, MD role: PRINCIPAL_INVESTIGATOR lat: 31.79211 lon: 34.64967 facility: Assuta Be'er Sheva Medical Center status: RECRUITING city: Be'er Sheva country: Israel name: Alex Demitriev, SC role: CONTACT name: Amos Katz, MD role: PRINCIPAL_INVESTIGATOR lat: 31.25181 lon: 34.7913 facility: Rambam Medical Center status: RECRUITING city: Haifa country: Israel name: Ludmila Helmer, SC role: CONTACT phone: 972-4-7773475 name: Oren Caspi, MD role: PRINCIPAL_INVESTIGATOR lat: 32.81841 lon: 34.9885 facility: Shaare Zedek Medical Center status: RECRUITING city: Jerusalem country: Israel name: Hadas Barda, SC role: CONTACT phone: 972-2-6666769 name: Tal Hasin, MD role: PRINCIPAL_INVESTIGATOR lat: 31.76904 lon: 35.21633 facility: Galiee Medical Center status: RECRUITING city: Nahariya country: Israel name: Etti Lasri Kadosh, SC role: CONTACT phone: 972-4-9107747 name: Shaul Atar, MD role: PRINCIPAL_INVESTIGATOR lat: 33.00892 lon: 35.09814 facility: Tel Aviv Sourasky (Ichilov) Medical Center status: RECRUITING city: Tel Aviv country: Israel name: Tal Fux, SC role: CONTACT phone: 972-3-6972420 name: Michal Laufer Perl, MD role: PRINCIPAL_INVESTIGATOR lat: 32.08088 lon: 34.78057 facility: Poriya Medical Center status: RECRUITING city: Tiberias country: Israel name: Jannat Mukari, SC role: CONTACT phone: 972-4-6652201 name: Wadi Kinany, MD role: PRINCIPAL_INVESTIGATOR lat: 32.79221 lon: 35.53124 hasResults: False

 nctId: NCT06378619 id: CSAPG-50 briefTitle: Tapping Test and the Archimedean Spiral for the Differential Diagnosis of Tremor. Machine Learning Approach acronym: MATSEP overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-06 date: 2025-06 date: 2024-04-22 date: 2024-04-22 name: Consorci Sanitari de l'Alt Penedès i Garraf class: OTHER briefSummary: In clinical practice, it is sometimes difficult to establish whether a patient's tremor is due to Parkinson's disease or essential tremor. The distinction is crucial as the health implications differ significantly between the two conditions. Therefore, the present study aims to develop a diagnostic method based on machine learning techniques to help differentiate whether a patient's tremor is due to one condition or the other. To achieve this, 110 patients with tremor, correctly diagnosed with either Parkinson's disease or essential tremor, will participate. They will undergo two diagnostic tests (tapping test and Archimedean spiral) to capture data that can be processed using machine learning techniques. conditions: Tremor conditions: Essential Tremor conditions: Parkinson Disease studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 110 type: ESTIMATED name: Tapping Test name: Archimedes Spiral measure: Sensitivity measure: Specificity measure: Reliability sex: ALL minimumAge: 45 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Sant Camil-Consorci Sanitari Alt'Pènedes i Garraf city: Barcelona state: Cataluña zip: 08810 country: Spain name: José Luis Camacho, MD role: CONTACT phone: +34 938960025 email: jlcamacho@csapg.cat name: Noemí Casaponsa role: CONTACT phone: +34 938960025 phoneExt: 43197 email: recerca@csapg.cat name: José Luis Camacho, MD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06378606 id: P.T.REC/012/004907 briefTitle: Effect of Technology on Cognitive Function in Elderly acronym: cogntion overallStatus: RECRUITING date: 2023-07-01 date: 2024-06-01 date: 2024-06-01 date: 2024-04-22 date: 2024-04-22 name: Nourhan Hesham Ali class: OTHER name: Cairo University briefSummary: Cognitive technology therapies, including interactive video gaming, computer soft wares and mobile technology, have been used to implement cognitive training and rehabilitation programs. Potential advantages to using technology-based interventions include enhanced accessibility and cost-effectiveness, providing a user experience to be good communicator, immersive and comprehensive. conditions: Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The aim of study is to find the effects of screen based cognitive therapy on mild dementia in elderly . primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The aim of study is to find the effects of screen based cognitive therapy on mild dementia in elderly . whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: cognitive therapy measure: Cognitive functions assessment measure: Quality of life survey sex: ALL minimumAge: 65 Years maximumAge: 85 Years stdAges: OLDER_ADULT facility: Nour Ali status: RECRUITING city: Cairo state: Giza zip: 12511 country: Egypt name: Nour Ali, master role: CONTACT phone: 01156860154 email: nourheshame854@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06378593 id: 3HP-2827-102 briefTitle: A Study of 3HP-2827 in Treatment of Unresectable or Metastatic Solid Tumors With FGFR2 Alterations overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-03 date: 2028-06 date: 2024-04-22 date: 2024-04-22 name: 3H (Suzhou) Pharmaceuticals Co., Ltd. class: INDUSTRY briefSummary: The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment of unresectable or metastatic solid tumors with FGFR2 alterations. conditions: Solid Tumors With FGFR2 Alterations, Adult studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: 3HP-2827 measure: Dose Escalation Stage- incidence of adverse events (AEs) measure: Dose Escalation Stage- incidence of dose-limiting toxicities (DLTs) measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters measure: Dose Escalation Stage -determine the maximum tolerated dose (MTD) and/or the recommended dose (RD) for expansion stage or recommended Phase II dose (RP2D) of 3HP-2827 measure: Expansion stage -Objective response rate（ORR） measure: Maximum concentration (Cmax) during the dosing interval of 3HP-2827 and/or its major metabolites as monotherapy. measure: Time to maximum concentration (Tmax) of 3HP-2827 and/or its major metabolites as monotherapy. measure: Apparent clearance (CL/F) of 3HP-2827 and/or its major metabolites as monotherapy. measure: Area under the concentration-time curve (AUC) of 3HP-2827 and/or its major metabolites as monotherapy. measure: Terminal half life (t1/2) of 3HP-2827 and/or its major metabolites as monotherapy. measure: Apparent volume of distribution (Vz/F) of 3HP-2827 and/or its major metabolites as monotherapy. measure: Duration of Response (DOR) as assessed by RECIST v1.1 measure: Disease control rate (DCR) as assessed by RECIST v1.1 measure: Progression-free survival (PFS) as assessed by RECIST v1.1 measure: Overall survival (OS) measure: Dose escalation stage - Objective Response Rate (ORR) measure: Expansion Stage- incidence of adverse events (AEs) measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters measure: Expansion Stage -Changes in patient-reported outcomes as assessed by the European Organization for Research and Treatment of Cancer Core QoL Questionnaire (EORTC QLQ-C30) in patients with advanced solid tumors sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Cancer Hospital city: Beijing state: Beijing zip: 100142 country: China name: Lin Shen, MD role: CONTACT lat: 39.9075 lon: 116.39723 facility: ZhongShan Hospital city: Shanghai state: Shanghai zip: 200123 country: China name: Jia Fan, MD role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06378580 id: LGF22H160084 id: LGF22H160084 type: OTHER_GRANT domain: Zhejiang Provincial Basic Public Welfare Research Program briefTitle: The Prognostic Impact of Surufatinib for the Treatment of Advanced Pancreatic Ductal Adenocarcinoma overallStatus: COMPLETED date: 2022-07-01 date: 2023-07-01 date: 2024-04-01 date: 2024-04-22 date: 2024-04-22 name: Luo Cong class: OTHER briefSummary: Pancreatic ductal adenocarcinoma (PDAC) is a highly aggressive tumor with a poor prognosis, despite the emergence of chemotherapies, unmet medical needs and limited treatment options still exist for patients with metastatic PDAC (mPDAC). Surufatinib is a small-molecule tyrosine kinase inhibitor that targets vascular endothelial growth factor (VEGFR) 1, 2, 3, fibroblast growth factor receptor 1 (FGFR1), and colony stimulating factor 1 receptor (CSF-1R), and ex vivo experiments have demonstrated its effect on PC models.

A retrospective analysis of patients with PDAC who underwent surufatinib at Zhejiang Cancer Hospital (Hangzhou,China) from July 2022 to July 2023.The database was extracted from the preoperative demographics, blood markers, and surgical pathology information of patients undergoing surufatinib in the investigators' hospital. conditions: Pancreatic Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 72 type: ACTUAL name: Surufatinib combine immune checkpoint inhibitor name: AG/FOLFIRINOX measure: Median progression-free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhejiang Province Cancer Hospital city: Hangzhou state: Zhejiang zip: 310000 country: China lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06378567 id: HCD J8923 briefTitle: A Study to Assess the Effects of Dietary Supplement Drinks on Sleep, Stress and Mood overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-05 date: 2024-05 date: 2024-04-22 date: 2024-04-22 name: The Water Street Collective class: INDUSTRY name: British American Tobacco (Investments) Limited name: HCD Research briefSummary: A home placement, randomized, double blind, placebo-controlled, study to determine the effect of dietary liquid shot beverage products on self-reported measures of sleep, stress and mood on generally healthy participants with current self-reported mild/moderate sleep difficulties (but not clinical insomnia) and mild/moderate stress. conditions: Sleep conditions: Mood conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: Dietary supplement liquid shot beverage products measure: Sleep Disturbance measure: Sleep Impairment measure: Insomnia Severity measure: Restorative Sleep measure: Contentedness/Anxiety measure: Profile of Mood States (POMS) measure: Daily Sleep diary sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Sago Atlanta - The Palisades Complex city: Atlanta state: Georgia zip: 30328 country: United States name: Melissa Hall role: CONTACT phone: 770-396-8700 email: connect@sago.com lat: 33.749 lon: -84.38798 hasResults: False

 nctId: NCT06378554 id: IRB00111227 briefTitle: Cereset Research for Performance Improvement in a Hospital Nursing Unit overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2026-05 date: 2024-04-22 date: 2024-04-22 name: Wake Forest University Health Sciences class: OTHER name: Susanne Marcus Collins Foundation, Inc. briefSummary: The purpose of this study is to explore whether an implementation process composed of offering CR to staff in a single hospital nursing unit has any potential impact on unit-level quality measures post-implementation. conditions: Health Personnel conditions: Stress conditions: Anxiety conditions: Job Performance conditions: Insomnia conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ESTIMATED name: Cereset Research measure: Percent of ortho trauma unit staff who complete Cereset intervention sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wake Forest University Health Sciences city: Winston-Salem state: North Carolina zip: 27157 country: United States name: Dawn C Higgins role: CONTACT phone: 336-716-9447 email: dkellar@wakehealth.edu lat: 36.09986 lon: -80.24422 hasResults: False

 nctId: NCT06378541 id: SDR 21-267 briefTitle: Smartphone App Enhanced Facilitation Among Veterans in a Mental Health Inpatient Setting (Project HOPE) acronym: Project HOPE overallStatus: NOT_YET_RECRUITING date: 2024-11-01 date: 2028-10-31 date: 2028-10-31 date: 2024-04-22 date: 2024-04-22 name: VA Office of Research and Development class: FED briefSummary: This study will test whether a new intervention, Virtual Hope Box Enhanced Facilitation (VHB-EF), reduces suicide risk in Veterans after discharge from inpatient psychiatric hospitalization. Additionally, this study will also conduct interviews with Veterans and healthcare providers to explore barriers and facilitators to future adoption of the VHB-EF intervention in healthcare settings. conditions: Suicide Prevention conditions: Suicide Attempt conditions: Suicidal Ideation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 928 type: ESTIMATED name: Virtual Hope Box Enhanced Facilitation name: Enhanced Usual Care measure: Suicide attempts (measured by the Columbia Suicide Severity Rating Scale [C-SSRS] and medical chart review) measure: Suicidal ideation (measured by the Scale for Suicidal Ideation [SSI]) measure: Self-efficacy to resist a future suicide attempt (measured by the Self-Efficacy to Avoid Suicidal Action [SEASA] scale) measure: Ability to cope with stressful situations (measured by the Coping Self-Efficacy [CSE] scale) measure: Reasons to live (measured by the Brief Reasons for Living Inventory [BRFL]) measure: Depression symptoms (measured by the Patient Health Questionnaire [PHQ-9]) measure: Mental Health Treatment Utilization (measured by the Treatment Services Review [TSR]) measure: Demographics measure: Borderline personality disorder features (measured by the Personality Assessment Inventory-Borderline Features Scale [PAI-BOR]) measure: Alcohol misuse (measured by the Alcohol Use Identification Test [AUDIT]) measure: Drug use (measured by the Drug Abuse Screening Test [DAST-10]) measure: Anxiety (measured by the Generalized Anxiety Disorder 7 [GAD-7]) measure: Coping strategies (measured by the Brief-COPE scale) measure: Virtual Hope Box (VHB) frequency measure: VHB app beliefs, usage, and treatment satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VA Ann Arbor Healthcare System, Ann Arbor, MI city: Ann Arbor state: Michigan zip: 48105-2303 country: United States name: Fatima Makki, MPH MSW role: CONTACT phone: 734-845-3623 email: fatima.makki@va.gov name: Courtney L Bagge, PhD MA role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA city: Seattle state: Washington zip: 98108-1532 country: United States name: Mark Reger, PhD role: CONTACT phone: 253-583-3295 email: Mark.Reger@va.gov lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06378528 id: 2023-1706 id: Protocol Version Jan 2024 type: OTHER domain: UW Madison id: A538900 type: OTHER domain: UW Madison briefTitle: Ketamine-assisted Psychotherapy for Adolescent PTSD (KAP) overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-08 date: 2025-08 date: 2024-04-22 date: 2024-04-22 name: University of Wisconsin, Madison class: OTHER briefSummary: The objectives of this study are to investigate the feasibility, tolerability, and efficacy of repeated ketamine-assisted psychotherapy sessions in adolescents with severe posttraumatic stress disorder. The study will enroll adolescents with a current diagnosis of posttraumatic stress disorder (PTSD) to complete three intravenous ketamine administrations immediately prior to a psychotherapy session over the span of six weeks. All participants will complete an initial set of preparatory sessions, and each dosing session will be followed by three integration sessions. Finally, participants will complete 7 nights of at-home sleep recordings. The investigators hypothesize that this protocol will be well-tolerated by adolescents and that patients will experience decreases in PTSD symptom severity at follow-up. conditions: Posttraumatic Stress Disorder studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: single group, open label, pilot study primaryPurpose: TREATMENT masking: NONE count: 5 type: ESTIMATED name: Ketamine name: SmartSleep EEG recording headband measure: Summary of Adverse Events Attributable to Ketamine Administration measure: Number of Participants Adhering to the Study Protocol measure: Number of Visits Completed Throughout the Study Duration measure: Changes in PTSD symptom severity as measured by the Clinician Administered PTSD Scale Child/Adolescent Version (CAPS-CA) measure: Exploratory Measurements: Change waveform recorded with Philips SmartSleep headband, measured in Hz sex: ALL minimumAge: 15 Years maximumAge: 17 Years stdAges: CHILD facility: University of Wisconsin city: Madison state: Wisconsin zip: 53705 country: United States name: Sara Heyn, JD, PhD role: SUB_INVESTIGATOR name: Stephanie Jones, PhD role: SUB_INVESTIGATOR name: Steven Garlow, MD, PhD role: SUB_INVESTIGATOR name: Paul Hutson, PharmD role: SUB_INVESTIGATOR lat: 43.07305 lon: -89.40123 hasResults: False

 nctId: NCT06378515 id: Glymphactive briefTitle: Physical Activity, Sleep and Brain Health Based on the Glymphatic System overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-04 date: 2025-12 date: 2024-04-22 date: 2024-04-22 name: University of Valencia class: OTHER name: University of Oulu briefSummary: This study is aiming to analyze the impact of physical activity on neurohydrodynamics and glymphatic activity on young adults. This study is designed as a multicenter descriptive observational study with information collection at two different times: before performing a short exercise routine and during its performance using a wearable wireless device Glymphometer. conditions: Brain Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 77 type: ESTIMATED name: Physical activity, postural changes and cognitive tasks measure: Brain health measure: Physical activity (habitual) measure: Sleep duration measure: Sleep Quality measure: Chronotype measure: Self-reported health status measure: Other variables sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06378502 id: antibiotic-resistence briefTitle: The Effect of Different Antibiotic Protocols on Peri-implant Tissue Health overallStatus: NOT_YET_RECRUITING date: 2024-05-03 date: 2025-12-30 date: 2026-06-30 date: 2024-04-22 date: 2024-04-22 name: Universita degli Studi di Genova class: OTHER briefSummary: The aim of the present project (non-inferiority trial) is to evaluate the effect of different antibiotic strategies (long-span vs. short-span) for implant surgery on peri-implant tissue health, oral microbiome (included resistome) and salivary MiRNomics in healthy patients. conditions: Antibiotic studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Amoxicillin Short name: Amoxicillin Long measure: Mean peri-implant bone loss measure: Incidence of biological and technical complications at the implant site measure: implant survival rate measure: Antibiotic sensitivity measure: Peri-implant myco-, microbiome and resistome measure: Salivary miRNomics measure: Adverse reactions measure: Development of a 3D bone model measure: Plaque index (PI) measure: Bleeding on probing (BOP) measure: Peri-implant pocket probing depth (PPD) sex: ALL minimumAge: 35 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06378489 id: 2022-0346-01 briefTitle: The Use of Etonogestrel Contraceptive Implant as Treatment for Endometrial Hyperplasia Without Atypia: A Cohort Study overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-01-31 date: 2025-05-31 date: 2024-04-22 date: 2024-04-22 name: University of the Philippines class: OTHER name: Organon briefSummary: Endometrial hyperplasia without atypia is a condition in which the endometrium (the lining of the uterus) becomes abnormally thick. Although endometrial hyperplasia without atypia is not cancer, it can lead to endometrial cancer in 1-3% of women. This disease is treated by giving progestins. The optimal route, dosage and duration of progestin treatment for endometrial hyperplasia has not yet been determined until now. However, several publications have suggested the use of levonorgestrel releasing IUD as first-line treatment for endometrial hyperplasia without atypia. The other common medications used are the oral progestins medroxyprogesterone (MPA) and norethisterone acetate (NETA).

The etonogestrel implant (Implant NXT) has been approved for contraceptive use by the US FDA in 2006. The mchanism of action of the implant for contraception suggests a potential application for its use in the treatment on hyperplasia. Off-label use of the implant for adrnomyosis, endometriosis and chronic pelvic pain has already been described in various studies. However, its therapeutic effect on endometrial hyperplasia without atypia has not been studied yet. The researchers propose to use the etonogestrel implant (Implant NXT) as novel treatment for endometrial hyperplasia without atypia. The study aims to determine the rate of regression to normal endometrium among patients with endometrial hyperplasia without atypia at 3 and 6 months after insertion of the implant. conditions: Endometrial Hyperplasia Without Atypia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Etonogestrel implant measure: Rate of (resolution) regression to normal endometrium measure: Endometrial thickness (by ultrasound) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06378476 id: 855188 briefTitle: Supportive Understanding and Patient-centered Partnership for Optimizing Renal Treatment acronym: SUPPORT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2025-09 date: 2024-04-22 date: 2024-04-24 name: University of Pennsylvania class: OTHER briefSummary: Black and Hispanic people face higher risks of chronic kidney disease (CKD) but have unequal access to the highest-quality kidney care. Black adults with CKD face 1.5 times higher hospitalization risks than non-Black adults with CKD. Once reaching end stage kidney disease (ESKD), Black patients are half as likely to receive a transplant and are often excluded from home dialysis. Structural racism creates complex barriers to optimal CKD care, providing an explanation for these findings. The Penn Medicine IMPaCT Community Health Worker (CHW) program is a rigorously tested approach to employ people from local communities to dismantle structural racism within health care systems and improve outcomes for marginalized patients. This trial will innovate by training CHWs to focus specifically on CKD care for minoritized people. The investigators will also train primary care clinicians caring for CKD patients on how to provide trauma-informed care (TIC). The first aim is to determine the feasibility, acceptability, and reach of a clinic-level TIC training to address the needs and concerns of Black and other minoritized patients. The second aim will be to conduct a three arm trial comparing individuals in usual care to individuals randomized to either our tailored CHW intervention in conjunction with clinic-level TIC training or to clinic-level TIC intervention only. The investigators will examine whether patients in the intervention arms have greater improvements in quality of life (primary). The investigators will also explore the impact of the interventions on patient activation, hospitalizations, and ESKD treatment preferences. conditions: Chronic Kidney Diseases conditions: Racism, Systemic conditions: Trauma, Psychological studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: Research coordinators collecting baseline and outcomes data from participants will be blinded to arm. whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: IMPaCT Community Health Worker Program name: Trauma-Informed Care Training measure: Kidney Disease Quality of Life Instrument (KDQOL) measure: Patient Activation Measure measure: All-Cause Hospitalizations measure: Patient preferences for end-stage renal disease treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06378463 id: PSY-2324-S-0362 briefTitle: Cognitive Remediation and Transcranial Direct Current Stimulation in Severe Mental Illness (SMI) acronym: HEADDSET+ overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04 date: 2027-04 date: 2024-04-22 date: 2024-04-22 name: University of Groningen class: OTHER name: Stichting Cosis name: Lentis Psychiatric Institute name: GGZ Friesland briefSummary: Seven per cent of patients suffering from severe mental illness (SMI) need long-term intensive treatment and support in a clinical setting or sheltered living. These service users often experience problems on multiple domains, such as persistent complaints as a result of medication resistance, physical health problems and self-care, psychosocial and cognitive dysfunctioning. Cognitive remediation (CR) training is a type of training aimed at improving thinking abilities (cognitive functioning) and daily functioning. However, we don't yet know if CR training can also help people with SMI who need supported housing due to their severe cognitive and daily living problems. In this project, we are investigating whether we can improve daily functioning in this group by using a form of CR training that focuses on learning new cognitive skills and how to use these new skills in everyday life. Additionally, we are exploring whether combining CR training with mild brain stimulation (transcranial Direct Current Stimulation) can enhance the effects of CR training. conditions: Severe Mental Illness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a pragmatic triple-blinded, randomized, sham-controlled trial, following a non-concurrent multiple baseline design, with the participants serving as their own control. Participants will be randomized over two groups: CIRCuiTS +sham tDCS (group 1), or CIRCuiTS + active tDCS (group 2). The trial will start with a first measurement (T0), followed by a waiting period of 16 weeks and a second measurement (T1). The waiting period serves as the control condition (service users are their own control). Next, the participants will be allocated to 16-20 weeks of either CIRCuiTS + sham tDCS or CIRCuiTS + active tDCS. This period of 16-20 weeks is not fixed as it depends upon how fast participants go through the program. This is followed by a third measurement after treatment (T2). There will be a fourth measurement six months after the end of the intervention (T3). primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Participants will be randomly assigned to CR + sham tDCS (group 1) or CR + active tDCS (group 2) with a 1:1 allocation as per a computer-generated randomization plan using permuted blocks of random sizes. The block sizes will not be disclosed to ensure concealment. As such, both the researcher as the participant can stay blind to the tDCS treatment condition. Also, the assessors who will do neuropsychological tests are blind to the condition the participant is in and are blind to the type and aim of the treatment. After finishing measurement T2, the participants can indicate if they suspect to have experienced either the real or the sham tDCS treatment. The patients will be informed about the type of treatment they have received when all participants completed measurement T3. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 126 type: ESTIMATED name: Cognitive remediation + active tDCS name: Cognitive remediation + sham tDCS measure: Independent Living Skills Survey self- and observer-rated questionnaire (ILSS) measure: Goal Attainment Scale (GAS) measure: Controlled Oral World Association Task (COWAT) measure: Trail Making Test (TMT) measure: Digit span (forward & backward) measure: Wechsler Memory Scale - Visual Reproduction I and II measure: Stroop Color and Word Task (SCWT) measure: 15 Word Test (15-WT) measure: Behavioral Assessment of the Dysexecutive System (BADS) - Key Search task measure: Cognitive Failure Questionnaire (CFQ) measure: Self-Evaluation of Negative Symptoms (SNS) measure: DEX self/informant measure: General Self-Efficacy Scale (GSES) measure: Nurses' Observation Scale of Cognitive Abilities (NOSCA) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cosis city: Assen state: Drenthe zip: 9400 AE country: Netherlands name: Liesbeth Brand, MSc role: CONTACT phone: +31682079633 email: l.brand@cosis.nu lat: 52.99667 lon: 6.5625 facility: Lentis city: Zuidlaren state: Drenthe zip: 9470 AC country: Netherlands name: Lisette van der meer, PhD role: CONTACT phone: +31628259303 email: l.vandermeer@lentis.nl lat: 53.09417 lon: 6.68194 facility: GGZ Friesland city: Leeuwarden state: Friesland zip: 8932 PA country: Netherlands name: Sander De Vos, PhD role: CONTACT phone: +31 6 47368400 email: sander.de.vos@ggzfriesland.nl lat: 53.20139 lon: 5.80859 hasResults: False

 nctId: NCT06378450 id: 2022-23892-31512-2 briefTitle: Dose-Response Effects of Mindfulness Meditation overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-11-30 date: 2024-11-30 date: 2024-04-22 date: 2024-04-24 name: University of Melbourne class: OTHER briefSummary: The goal of this randomized controlled trial is to test for evidence of dose-response effects in a sample of healthy adults with little to no prior experience with meditation.

The main question it aims to answer is whether larger doses of mindfulness meditation yield greater positive changes in wellbeing than smaller doses.

Our hypotheses are that (1) larger doses of mindfulness training will yield significantly larger effects, and (2) different doses will be significantly associated with variation in participant engagement, with lower engagement associated with higher doses.

Researchers will compare each of three dose conditions, 10-min, 20-min, 30-min, against a minimal dose condition of 3-4 min.

Participants will take a 28-day mindfulness meditation course, with guided audio instructions provided daily throughout the intervention period (excluding one rest day per week). They will also be asked to respond to surveys before, during, and after the intervention. conditions: Well-Being, Psychological conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 860 type: ESTIMATED name: Mindfulness meditation guided practice measure: Psychological wellbeing measure: Psychological Distress measure: Anxiety measure: Depression measure: Nonattachment measure: Trait Mindfulness measure: Decentering measure: Equanimity measure: Repetitive Negative Thoughts measure: Emotional Regulation measure: Attentional Control measure: Emotional Reactivity measure: Social Anxiety measure: Sleep Quality measure: Momentary Mood measure: State Mindfulness measure: Attention measure: Decentering measure: Mindful Attitudes sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06378437 id: GLB-001-02 briefTitle: A Study of GLB-001 in Patients With Myeloid Malignancies overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2026-12-31 date: 2027-12-31 date: 2024-04-22 date: 2024-04-22 name: Hangzhou GluBio Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: Study GLB-001-02 is a phase 1, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of GLB-001 in study participants with relapsed or refractory or intolerant myeloid malignancies including polycythemia vera (PV), essential thrombocythemia (ET), myelofibrosis (MF), lower-risk myelodysplastic syndrome (LR-MDS), higher-risk myelodysplastic syndromes (HR-MDS), and acute myeloid leukemia (AML). This study consists of 3 parts, dose escalation (Phase 1a), dose exploration (Phase 1b) and dose expansion (Phase 1c). Dose escalation (Phase 1a) and dose exploration (Phase 1b) will evaluate the safety, tolerability, PK, PD and preliminary efficacy of GLB-001, administered orally, in study participants with PV/ET, or study participants with MF/LR-MDS/HR-MDS/AML, respectively. Dose expansion (Phase 1c) will be followed to determine the relationships among dose, exposure, toxicity, tolerability and clinical activity, to identify minimally active dose, and to select the recommended dose(s) for phase 2 study. Approximately 108 study participants may be enrolled in the study. conditions: Polycythemia Vera conditions: Essential Thrombocythemia conditions: Myelofibrosis conditions: Myelodysplastic Syndromes conditions: Acute Myeloid Leukemia conditions: Myeloid Malignancy studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 108 type: ESTIMATED name: GLB-001 measure: Dose-limiting Toxicity (DLT) measure: Maximum Tolerated Dose (MTD) measure: Recommended Expansion Doses (RED) measure: Incidence, Relatedness, Seriousness and Severity of Adverse Events (AEs) measure: Recommended Phase 2 Dose (RP2D) measure: Response Assessment in Study Participants With PV measure: Response Assessment in Study Participants With ET measure: Response Assessment in Study Participants With MF measure: Response Assessment in Study Participants With LR-MDS measure: Response Assessment in Study Participants With HR-MDS measure: Response Assessment in Study Participants With AML measure: GLB-001 and GLB-C183-A-2 (diastereoisomer of GLB-001) Pharmacokinetics after Single Administration - AUC0-last measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - AUC0-24 measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - AUC0-inf measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - Cmax measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - Tmax measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - T1/2 measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - Vz/F measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - CL/F measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - λz measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Tmax,ss measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Cav,ss measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Cmax,ss measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Cmin,ss measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - AUC0-tau measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration-AUC0-last measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - λz measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Vz/F measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - CLss/F measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - T1/2 measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Rac [AUC] measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Rac [Cmax] measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration-DF sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Henan Cancer Hospital city: Zhengzhou state: Henan zip: 450003 country: China name: Hu Zhou, MD role: CONTACT phone: 86-0371-65587320 lat: 34.75778 lon: 113.64861 facility: Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences city: Tianjin state: Tianjin zip: 300020 country: China name: Lei Zhang, MD role: CONTACT phone: 86-022-23909240 lat: 39.14222 lon: 117.17667 facility: The First Affilicated Hospital, Zhejiang University School of Medicine city: Hangzhou state: Zhejiang zip: 310003 country: China name: Hongyan Tong, MD role: CONTACT phone: 86-0571-87236114 lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06378424 id: 2023-6/6 briefTitle: The Effectiveness of Local Dry Cold, Hot and Vibration Applications in Peripheral Intravenous Catheterization overallStatus: COMPLETED date: 2023-03-22 date: 2023-03-22 date: 2023-08-23 date: 2024-04-22 date: 2024-04-22 name: Uludag University class: OTHER briefSummary: Aim: The aim of the present study was to examine the effect on venous dilation, procedure duration and pain severity of local hot, cold and vibration applications performed on the intervention area before peripheral intravenous catheterization in adults.

Methods: The study included 120 adults who were randomly selected between March and August 2023. One application group (n=30) received local hot application, one group (n=30) received local cold application, and one (n=30) received local vibration using the Buzzy® device. The applications, to the site of the peripheral intravenous catheterization, lasted one minute. The control group (n=30) the received standard peripheral intravenous catheterization application. The groups' venous dilation was assessed on the vein assessment scale and the level of pain felt during catheterization was assessed using a visual analog scale. conditions: Pain Management conditions: Emergency Unit conditions: Diarrhea conditions: Nausea conditions: Vomiting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ACTUAL name: Cold Application name: Heat Application name: Vibration Application measure: pain intensity in mm measure: venous dilation in score measure: procedure duration in sec measure: weight measure: height sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bursa Uludag University Hospital city: Bursa state: Nilüfer country: Turkey lat: 40.19559 lon: 29.06013 hasResults: False

 nctId: NCT06378411 id: P109 briefTitle: Development and Application of a Musical Game for Motor Rehabilitation overallStatus: RECRUITING date: 2024-04-04 date: 2024-07 date: 2024-10 date: 2024-04-22 date: 2024-04-22 name: Universidade da Madeira class: OTHER briefSummary: The aim of this study is to develop, adapt a musical game for residents of RAM, and evaluated the usability and correlation between this game with the improvement of motor coordination in short time. conditions: Health People conditions: Survivors of Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Music Game Intervention measure: Motor Coordination measure: Usability sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Universidade da Madeira status: RECRUITING city: Funchal country: Portugal name: Yasmim Moniz, Master role: CONTACT phone: +351 968412551 email: yasmimfernandes08@hotmail.com role: CONTACT email: yasmimfernandes08@hotmail.com lat: 32.66568 lon: -16.92547 hasResults: False

 nctId: NCT06378398 id: UMCC 2023.037 id: HUM00247729 type: OTHER domain: University of Michigan id: UMI23-13-01 type: OTHER domain: DCP Protocol Number id: 1UG1CA242632-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1UG1CA242632-01A1 briefTitle: A Trial of Omeprazole and Low Dose Aspirin to Identify Colorectal Biomarkers of Preventive Efficacy overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-08 date: 2024-08 date: 2024-04-22 date: 2024-04-22 name: University of Michigan Rogel Cancer Center class: OTHER name: National Cancer Institute (NCI) briefSummary: This trial will obtain biomarker data on the possible preventive effects of omeprazole and low-dose aspirin in colorectal tissue. Persons who have had 5 or more adenomas, 5 or more serrated polyps, or an incompletely removed adenoma or serrated polyp in the colon or rectum are potentially eligible. Before participating in the study, study staff will explain the study and review the consent form. If you are interested and provide consent, study staff will then confirm your eligibility. Once enrolled, participants will take two 20 mg omeprazole tablets and two 81 mg aspirin tablets each day before the first meal each day for 25-45 days.

The study does involve biopsies of the colorectal tissue before and after taking the study medications. The biopsies are samples of tissue, about the size of a grain of rice, that will be taken from the colon or rectum before and after taking the study medications. This is done during a usual, clinical colonoscopy exam and during one more limited exam, called flexible sigmoidoscopy, that is done for the research study. The flexible sigmoidoscopy requires less preparation. Which procedure comes first depends on what fits best with each participant's clinical scenario. Biopsies of both normal mucosa and polyps (if possible) are collected. conditions: Colorectal Neoplasia studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 24 type: ESTIMATED name: Omeprazole name: Aspirin measure: Identification of biomarkers for omeprazole/aspirin combination treatment in the human colorectum measure: Evaluation of gene expression changes sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Michigan Rogel Cancer Center city: Ann Arbor state: Michigan zip: 48109 country: United States name: Kirsten Tuck role: CONTACT phone: 734-763-1141 email: KLtuck@med.umich.edu name: Elena Stoffel, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 facility: Ohio State University Comprehensive Cancer Center city: Columbus state: Ohio zip: 43210 country: United States name: Kebire Gofar role: CONTACT email: Kebire.Gofar@osumc.edu name: Peter Stanich, MD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06378385 id: DevelopmentCEOAS briefTitle: Development and Content Validation of the Childhood Early Oral Aging Syndrome (CEOAS) Index for the Deciduous Dentition overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-31 date: 2024-12-20 date: 2024-04-22 date: 2024-04-25 name: University of Nove de Julho class: OTHER briefSummary: Premature, non-physiological tooth wear in childhood has numerous repercussions for oral health. This is a growing problem with multifactorial causes and associated with the current lifestyle. The aim of the present study was the development and determination of content validity of the Childhood Early Oral Aging Syndrome (CEOAS) index for the primary dentition as a diagnostic and epidemiological survey tool considering the current changes found in this population. conditions: Aging studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 6 type: ESTIMATED name: Childhood Early Oral Aging Syndrome index measure: Development of CEOAS index measure: Validation of CEOAS index sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universidade Metropolitana de Santos - UNIMES city: Santos state: São Paulo zip: 11045-002 country: Brazil lat: -23.96083 lon: -46.33361 hasResults: False

 nctId: NCT06378372 id: ETICA-ULE-064-2023 briefTitle: How Does Pianistic Musical Training Influence the Development of Alzheimer's Disease? overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-08-01 date: 2025-06-01 date: 2024-04-22 date: 2024-04-22 name: David Franco Castellanos class: OTHER name: Jesús Ángel Seco Calvo name: Javier Tejada Garcia briefSummary: The goal of this clinical trial is to learn about and describe how pianistic training influences the development of Alzheimer's disease.

The key question is: Can pianistic practice influence the development of Alzheimer's disease?

Participants will receive piano lessons for 4 weeks (20 sessions) and we will evaluate the evolution of the different parameters described by the tests carried out. conditions: Dementia of Alzheimer Type conditions: Dementia conditions: Dementia, Vascular conditions: Dementia, Mixed conditions: Dementia Frontal conditions: Dementia With Lewy Bodies conditions: Cognitive Decline conditions: Neurologic Disorder conditions: Neurologic Dysfunction conditions: Neurologic Deficits studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: An intervention based on teaching the piano in an individualized way primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 20 type: ESTIMATED name: Music therapy based on piano learning measure: State of global deterioration measure: Minimental Test measure: RDRS-2 Rapid Disability Assessment Scale measure: MONTREAL COGNITIVE ASSESSMENT (MOCA) measure: WAIS-IV measure: Behavioral disorders: BEHAVE-AD measure: NPI - CUMMINGS measure: Evaluation of the caregiver's burden (Zarit test) sex: ALL minimumAge: 50 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universidad de León city: León state: Castilla Y León zip: 24004 country: Spain lat: 42.60003 lon: -5.57032 hasResults: False

 nctId: NCT06378359 id: IDIM-2023-32364 briefTitle: Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients overallStatus: RECRUITING date: 2024-01-29 date: 2025-12-31 date: 2026-12-31 date: 2024-04-22 date: 2024-04-22 name: University of Minnesota class: OTHER briefSummary: The purpose of the study is to determine the effectiveness, safety, and health-care utilization and costs of a preoperative Staphylococcus aureus (SA) screening and decolonization bundle, (5 days of nasal mupirocin ointment, chlorhexidine gluconate (CHG) body wash, and CHG mouth rinse), in eradicating SA carriage compared to other SA decolonization approaches. The study will conduct a single center pilot trial to compare efficacy of different SA decolonization approaches in pre-surgical patients, in eradicating SA carriage, after obtaining informed consent.

The study will compare four different approaches, Arm 1) screen for SA carriage and using the three-drug decolonization bundle for 5 days among patients with SA colonization, non SA carriers in this arm will get two pre-op showers with CHG soap, Arm 2) all participants receive the three drug decolonization bundle, Arm 3) all receive pre-op nasal povidone iodine the day of surgery plus two pre-op showers with CHG soap, and Arm 4) all receive nasal alcohol gel the day of surgery plus two pre op showers with CHG soap.

The primary efficacy outcome will be eradication of SA colonization at all 5 body sites. Secondary outcomes will be SA surgical site infections (SSIs), all SSIs, and SA healthcare associated infections (HAIs). The study will also compare eradication of SA from each of the 5 body sites as a secondary outcome. conditions: Staphylococcus Aureus Colonization conditions: Surgical Site Infections conditions: Healthcare Associated Infections studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Screening and decolonization for SA carriers with the 3 drug bundle name: No screening for SA name: no screening name: Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening. name: Nasal alcohol gel on surgery day plus 2 CHG pre-op showers without screening measure: Efficacy in eradicating Staphylococcus aureus (SA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Minnesota Medical Center and Clinics status: RECRUITING city: Minneapolis state: Minnesota zip: 55414 country: United States name: Pragya Karki, MD role: CONTACT phone: 612-301-6316 email: pkarki@umn.edu lat: 44.97997 lon: -93.26384 hasResults: False

 nctId: NCT06378346 id: 2023-077 briefTitle: GU-01: Glycyrrhizin in Prostate Cancer acronym: GU-01 overallStatus: RECRUITING date: 2024-05 date: 2026-03 date: 2026-03 date: 2024-04-22 date: 2024-04-26 name: University of Illinois at Chicago class: OTHER briefSummary: This is a pilot, randomized, window-of-opportunity treatment trial in which participants with previously untreated prostate cancer (PCa) who are candidates for surgery (radical prostatectomy) conditions: Prostate Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Glycyrrhizin name: Glycyrrhizin name: Observation measure: Number of participants that have a change in prostate-specific antigen (PSA) before GLY administration measure: Number of participants that have a change in prostate-specific antigen (PSA) after GLY administration and prior to radical prostatectomy measure: The tolerability of GLY will be assessed by NCI Common Terminology Criteria for Adverse Events (AE) (NCI CTCAE) Version 5 (v5.0). measure: Assessment of plasma GLY levels after GLY administration measure: Assessment of blood sodium levels after GLY administration measure: Assessment of blood potassium after GLY administration measure: Assessment of serum creatinine after GLY administration measure: Assessment of serum testosterone levels after GLY administration measure: Assessment of serum dehydroepiandrosterone sulfate (DHEA-S) levels after GLY administration measure: Assessment of interleukin-1β (IL-1β) after GLY administration measure: Assessment of Tumor necrosis factor α (TNFα) after GLY administration measure: Assessment of interleukin 6 (IL-6) after GLY administration measure: Assessment of serum Vascular Endothelial Growth Factor (VEGF) after GLY administration measure: Assessment of Hepatocyte Growth Factor (HGF) after GLY measure: Assessment of Insulin-like Growth Factor-1 (IGF-1) after GLY measure: Evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires administered before GLY administration measure: Evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires administered after GLY administration measure: Gene expression analysis in tumor specimens obtained before administration of GLY measure: Number of patients with changes in gene expression analysis in tumor specimens obtained after administration of GLY sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Illinois status: RECRUITING city: Chicago state: Illinois zip: 60612 country: United States name: Natalie Reizine, MD role: CONTACT phone: 312-996-1581 email: nreizi2@uic.edu name: Omer Qazi, MBBS role: CONTACT phone: 312-413-1069 email: omerqazi@uic.edu lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06378333 id: 2024-01-023 briefTitle: Incidence, Clinical Characteristics and Outcomes of Unstable Angina in the contempoRary Area. acronym: ICAR overallStatus: COMPLETED date: 2022-11-27 date: 2024-01-27 date: 2024-04-15 date: 2024-04-22 date: 2024-04-22 name: University Hospital, Montpellier class: OTHER briefSummary: The study aims to evaluate clinical characteristics and prognostic of a contemporary population of patients with UA defined using T hs-cTn measurements The study includes all patients admitted in 2 French university centers with the confirmed diagnostic of UA defined with clinical ischemic symptoms and T hs-cTn concentrations \< 99 percentile (undetectable: \<5ng/l or non-elevated: \<14ng/l), or ≥ 99 percentile but mildly elevated (14-50ng/l) .The primary end-point included major events at 1-year follow-up (total mortality, new ACS, hospitalization for cardiac causes). conditions: Unstable Angina studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 210 type: ACTUAL name: patients who underwent coronary angiography measure: Hospitalisation for of unstable Angina sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital of Montpellier city: Montpellier zip: 34295 country: France lat: 43.61092 lon: 3.87723 hasResults: False

 nctId: NCT06378320 id: STUDY20240287 briefTitle: eHealth for Breastfeeding Support - the HOTSPOT Trial overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-06-01 date: 2024-04-22 date: 2024-04-22 name: University Hospitals Cleveland Medical Center class: OTHER briefSummary: This is a voluntary research study to test use of a phone app that is intended to support breastfeeding specifically for African American and Black people. This is called a "pilot" study because the app is still in development. The goal of this research is to see if mothers use the app more when they receive text "nudges" to look at it compared to not getting those "nudges". The research project is being conducted by Lydia Furman MD.

The purpose of the app (which is currently in clickable "wireframe" status, a "pre" app phase) is to support and promote breastfeeding specifically for mothers and fathers/partners who are African American or Black. Other breastfeeding apps have pictures mainly of White or Asian mothers and information that is not oriented toward African American mothers. This app aims to provide accurate and needed breastfeeding information that is culturally attuned.

Up to 24 participants will be enrolled at UHCMC, including up to 20 mothers. Other participants will include up to 4 African American or Black fathers/partners whose partners are interested in breastfeeding. conditions: Breast Feeding studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This will be a prospective randomized two arm study for expectant women and a prospective randomized two arm study for fathers/partners. All participants receive access to the wireframe app. Maternal participants will be randomized to nudge or no nudge via text with those in the app "nudge" group receiving questions weekly prior to delivery and biweekly (every 2 weeks) after delivery through 3 months postpartum. The purpose of these "nudges" is to assess whether participants are more likely to access and benefit from the app if they are encouraged to explore it. Father/partner participants will also be randomized to either a nudge or no nudge group with those in the "nudge" group receiving questions weekly for the first two months and then biweekly (every 2 weeks) for another two months. primaryPurpose: OTHER masking: NONE count: 24 type: ESTIMATED name: App access and Text message name: App access only measure: Maternal participants app usability score measure: Father/partner participants app usability score measure: Maternal participants app engagement score measure: Father/partner participants app engagement score measure: Maternal participants breastfeeding knowledge at enrollment measure: Maternal participants breastfeeding knowledge after app exposure measure: Father/partner participants breastfeeding knowledge at enrollment measure: Father/partner participants breastfeeding knowledge after app exposure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ahuja Rainbow Center for Women and Children city: Cleveland state: Ohio zip: 44103 country: United States lat: 41.4995 lon: -81.69541 facility: Passages, Inc. city: Cleveland state: Ohio zip: 44103 country: United States name: Lydia Furman MD role: CONTACT phone: 216-675-6691 email: lydia.furman@uhhospitals.org lat: 41.4995 lon: -81.69541 facility: University Hospital MacDonald Women's Hospital city: Cleveland state: Ohio zip: 44106 country: United States lat: 41.4995 lon: -81.69541 hasResults: False

 nctId: NCT06378307 id: CHUBX2022-06 briefTitle: A Transferability Study on the Conditions for a Successful Inclusive Education acronym: TIAP overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-06-30 date: 2025-06-30 date: 2024-04-22 date: 2024-04-22 name: University Hospital, Bordeaux class: OTHER briefSummary: The investigators are conducting a realist evaluation study with a multi-case and qualitative design. The study aims to identify the conditions that promote successful students with disabilities inclusive education at school. This study is nested in the TIAP research (Research to explore the conditions transfer of innovations in the field of disability, with a view to developing a transfer framework). conditions: Inclusive Education studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 114 type: ESTIMATED measure: Effect of inclusive education on children with disabilities autonomy and social participation at school measure: Effect of inclusive education on children with disabilities autonomy and social participation in their proximal living environment (leisures participation) measure: Effect of inclusive education on social participation of families with children with disabilities sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06378294 id: UHACoruna briefTitle: Locoregional Control With Radiotherapy of Breast Cancer Patients With MACrometastases Treated With MAstectomy (MACMA) acronym: MACMA overallStatus: RECRUITING date: 2021-04-20 date: 2024-12-31 date: 2029-12-31 date: 2024-04-22 date: 2024-04-25 name: University Hospital A Coruña class: OTHER name: Complejo Hospitalario Universitario de Pontevedra name: Complejo Hospitalario Universitario de Vigo name: Complejo Hospitalario Universitario de Santiago name: Hospital Universitario Lucus Augusti name: Complexo Hospitalario de Ourense briefSummary: Sentinel lymph node biopsy (SLNB) is the standard procedure to stage the axilla in clinically node-negative invasive breast cancer (IBC) patients undergoing upfront surgery.

The ACOSOG-Z0011 and the AMAROS trial demonstrated that SLNB with or without radiotherapy provided equivalent local control and survival to axillary lymph node dissection (ALND) in early-stage breast cancer patients with 1 or 2 positive SLNs. However, the ACOSOG-Z0011 trial did not included patients treated with mastectomy, and the AMAROS trial only included 17% of mastectomy patients.

The investigators conduct an observational cohort study of early stage breast cancer patients receiving upfront mastectomy with 1 or 2 macrometastases after SLNB. The study aim to demonstrate a 5-year disease-free survival of not less than 80% when ALND is omitted and replaced by axillary radiotherapy, and determine the axillary recurrence rate. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Mastectomy measure: Disease-free survival measure: Axillary recurrence rate measure: Overall survival sex: FEMALE minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario Ferrol status: RECRUITING city: Ferrol state: A Coruña zip: 15402 country: Spain name: EULALIA VIVES role: CONTACT email: Eulalia.Vives.Rodriguez@sergas.es name: EULALIA VIVES role: PRINCIPAL_INVESTIGATOR name: MANUEL DÍAZ role: SUB_INVESTIGATOR lat: 43.4896 lon: -8.21942 facility: Hospital Universitario Santiago de Compostela status: RECRUITING city: Santiago De Compostela state: A Coruña zip: 15706 country: Spain name: MARÍA EFIGENIA ARIAS role: CONTACT email: efi.arias@yahoo.com name: MARÍA EFIGENIA ARIAS role: PRINCIPAL_INVESTIGATOR lat: 42.88052 lon: -8.54569 facility: Hospital Universitario Vigo status: RECRUITING city: Vigo state: Pontevedra zip: 36214 country: Spain name: GONZALO DE CASTRO role: CONTACT email: gonzalo.jose.de.castro.parga@sergas.es name: GONZALO DE CASTRO role: PRINCIPAL_INVESTIGATOR name: GEORGINA FREIRÍA role: SUB_INVESTIGATOR lat: 42.23282 lon: -8.72264 facility: Hospital Universitario A Coruña status: RECRUITING city: A Coruña zip: 15006 country: Spain name: ALBERTO BOUZÓN role: CONTACT phone: +34690103810 email: dr.alberto@aecirujanos.es name: BENIGNO ACEA role: CONTACT phone: +34650482409 email: benigno.acea.nebril@sergas.es name: MARÍA ALEJANDRA GARCÍA role: SUB_INVESTIGATOR name: ALBERTO BOUZÓN role: PRINCIPAL_INVESTIGATOR name: BENIGNO ACEA role: PRINCIPAL_INVESTIGATOR lat: 43.37135 lon: -8.396 facility: Hospital Universitario Lugo status: RECRUITING city: Lugo zip: 27003 country: Spain name: LAURA MUÍÑOS role: CONTACT email: laura.muiños.ruano@sergas.es name: LAURA MUÍÑOS role: PRINCIPAL_INVESTIGATOR name: PATRICIA VÁZQUEZ role: SUB_INVESTIGATOR lat: 43.00992 lon: -7.55602 facility: Hospital Universitario Ourense status: RECRUITING city: Orense zip: 32005 country: Spain name: MANUEL GARCÍA role: CONTACT email: Manuel.Garcia.Garcia2@sergas.es name: MANUEL GARCÍA role: PRINCIPAL_INVESTIGATOR lat: 42.33669 lon: -7.86407 facility: Hospital Universitario Pontevedra status: RECRUITING city: Pontevedra zip: 36071 country: Spain name: MARÍA TERESA FERNÁNDEZ role: CONTACT email: terefez@yahoo.es name: MARÍA TERESA FERNÁNDEZ role: PRINCIPAL_INVESTIGATOR lat: 42.431 lon: -8.64435 hasResults: False

 nctId: NCT06378281 id: CRSK-3_221381 briefTitle: Testing a New Method to Improve Informed Consent in Prison Research acronym: Spark BATIR overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2025-09-30 date: 2024-04-22 date: 2024-04-24 name: Stéphanie Baggio class: OTHER name: University of Bern name: Leiden University name: School of Health Sciences Fribourg name: University Hospital, Geneva briefSummary: Understanding of informed consent is often limited in prison, due to unique challenges faced by detained people. This study will test a modified "teach-to-goal" informed consent process compared to standard procedures. Conducted within a larger study on psychiatric outcomes, it aims to enhance ethical practices for vulnerable populations. conditions: ADHD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Modified teach-to-goal informed consent measure: Understanding of the informed consent (binary) measure: Understanding of the informed consent (continuous) measure: Evaluation of the informed consent sex: MALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Geneva University Hospitals city: Geneva zip: 1211 country: Switzerland name: Stéphanie Baggio, Prof. role: CONTACT phone: +41316846774 email: stephanie.baggio@unibe.ch lat: 46.20222 lon: 6.14569 hasResults: False

 nctId: NCT06378268 id: 05/24/DD-BVMD briefTitle: PPOS vs GnRH Antagonist in Ovarian Stimulation (ProGanOS Study) acronym: ProGanOS overallStatus: RECRUITING date: 2024-04-24 date: 2025-12-31 date: 2026-09-30 date: 2024-04-22 date: 2024-04-26 name: Mỹ Đức Hospital class: OTHER briefSummary: This non-inferiority randomized controlled trial will be conducted at My Duc Hospital, Ho Chi Minh City, Vietnam.

This study compares the effectiveness of Progestin-Primed Ovarian stimulation versus GnRH protocol for ovarian stimulation in IVF treatment. Participants will be randomly assigned in a 1:1 ratio to receive Progestins or GnRH antagonists. conditions: Progestins Primed Ovarian Stimulation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 626 type: ESTIMATED name: Dydrogesterone 10 mg name: Cetrorelix 0.25 mg measure: Ongoing pregnancy measure: The incidence of premature LH surge measure: The incidence of premature progesterone elevation measure: Number of oocytes retrieved measure: Number of mature oocytes measure: Number of day 3 embryos measure: Number of day 5 embryos measure: Number of good quality day 3 embryos measure: Number of good quality day 5 embryos measure: Number of frozen embryos measure: Incidence of Ovarian hyperstimulation syndrome measure: Positive ß-hCG test measure: Clinical pregnancy measure: Ectopic pregnancy measure: Early miscarriage <12 weeks measure: Late miscariage 12-< 22 weeks measure: Live birth rate measure: Gestational age at birth measure: Mode of delivery measure: Birth weight measure: Very low birth weight measure: Low birth weight measure: High birth weight measure: Very high birth weight measure: Preterm birth measure: Gestational diabetes mellitus measure: Hypertensive disorders of pregnancy measure: Maternal mortality measure: Major congenital abnormalities measure: NICU admission measure: Reason for NICU admission measure: Neonatal mortality sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: My Duc Hospital status: RECRUITING city: Ho Chi Minh City zip: 70000 country: Vietnam name: Tuong M Ho, MD role: CONTACT phone: +84 90 3633377 email: tuongho.ivfmd@gmail.com lat: 10.82302 lon: 106.62965 hasResults: False

 nctId: NCT06378255 id: PKUSSNCT-23A04 id: PKUSSIRB-202393160 type: OTHER domain: Ethics Committee of PKUSH of Stomatology id: Z221100007422088 type: OTHER_GRANT domain: The SFP for clinical CDTT in capital briefTitle: Clinical Evaluation of Polycation-based New Dental Desensitizer on Dentin Hypersensitivity overallStatus: RECRUITING date: 2024-03-20 date: 2025-06-30 date: 2025-09-01 date: 2024-04-22 date: 2024-04-22 name: Peking University Hospital of Stomatology class: OTHER briefSummary: Evaluate the safety and clinical efficacy of new dental desensitizers in the treatment of dentin sensitivity, including the relief of sensitivity symptoms and the duration of efficacy. conditions: Dentin Sensitivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Polycation-based new dentinal desensitizer name: GLUMA desensitizer measure: Improvement of dentin sensitivity induced by probe pressure stimulation measure: Improvement of dentin sensitivity induced by air temperature stimulation sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University School and Hospital of Stomatology status: RECRUITING city: Beijing state: Beijing zip: 100081 country: China name: Qianqian Wang role: CONTACT phone: +86-10-62173403 email: wangqian0213@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06378242 id: RC48-C029 briefTitle: To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2 overallStatus: NOT_YET_RECRUITING date: 2024-04-23 date: 2029-03-15 date: 2029-12-31 date: 2024-04-22 date: 2024-04-22 name: RemeGen Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of intravesical instiliations of Disitamab Vedotin in patients with high-risk non-muscular invasive bladder cancer (NMIBC) that express HER2 conditions: High-risk Non-muscle Invasive Bladder Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Disitamab Vedotin for injection measure: Incidence of dose-limiting toxicity(DLT) (Phase I) measure: Incidence of Adverse event (Phase I) measure: Recommended Phase II Dose(RP2D) measure: Maximum Tolerated Dosage(MTD) measure: Disease-free survival (DFS) rates measure: Duration of response (DOR) measure: Disitamab Vedotin anti-drug antibody (ADA) measure: PK of enfortumab vedotin: Maximum concentration (Cmax) measure: PK of enfortumab vedotin: Trough concentration (Ctrough) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen Memorial Hospital,SunYat-sen University city: Guangzhou state: Guangdong country: China name: Tianxin Lin, Ph.D role: CONTACT lat: 23.11667 lon: 113.25 facility: Hunan Cancer hospital city: Changsha state: Hunan country: China name: Shusuan Jiang, M.D role: CONTACT lat: 28.19874 lon: 112.97087 facility: The first affiliated hospital with nanjing medical universtity city: Nanjing state: Jiangsu country: China name: qiang Lv, M.D role: CONTACT lat: 32.06167 lon: 118.77778 facility: Shandong Cancer hospital & Institute city: Jinan state: Shangdong country: China name: Jiasheng Bian, M.D role: CONTACT name: Yuping Sun role: SUB_INVESTIGATOR lat: 36.66833 lon: 116.99722 facility: The first affiliated hospital withXi'an Jiao Tong Universtity city: Xi'an state: Shanxi country: China name: Lei Li, M.D role: CONTACT lat: 34.25833 lon: 108.92861 hasResults: False

 nctId: NCT06378229 id: ONZ-2023-0157 id: 2022-501857-35-00 type: CTIS briefTitle: Psilocybin for Hospitalized Patients With Treatment-resistant Depression acronym: PSIHOS-D overallStatus: RECRUITING date: 2024-04 date: 2026-03 date: 2026-12-31 date: 2024-04-22 date: 2024-04-25 name: University Hospital, Ghent class: OTHER name: Filament Health briefSummary: The purpose of this study is to determine the safety and feasibility of performing psilocybin-assisted psychotherapy in patients hospitalized for treatment-resistant depression. conditions: Treatment Resistant Depression studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open label feasibility study primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Psilocybin measure: Incidence and type of Treatment-Emergent Adverse Events measure: Columbia-Suicide Severity Rating Scale (C-SSRS) measure: Recruitment and retention rates. measure: Qualitative data from the semi-structured interviews with the subjects and their partners. measure: Montgomery Asberg Depression Rating Scale (MADRS) measure: Quick Inventory of Depressive Symptomatology - Self Rated (QIDS-SR) measure: State-Trait Anxiety Inventory (STAI) measure: World Health Organization Quality of Life Inventory-Brief subscale (WHOQOL-BREF) measure: Maudsley 3-item Visual Analogue Scale (M3VAS) measure: Subjective Emotional Health Visual Analogue Scale (SEHVAS) measure: revised Dyadic Adjustment Scale (RDAS) measure: Zarit Burden Interview - Short Form (Zarit-12 Burden Scale) measure: Client Experiencing Scale (EXP) measure: Mystical Experience Questionnaire (MEQ) measure: Working Alliance Inventory - Short Revised (WAI-SR) measure: Semi-structured interviews. measure: EEG: sensor level analysis (power) and source level analysis (functional connectivity through amplitude envelope correlation), both in resting state and during an emotional paradigm. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ghent University Hospital status: RECRUITING city: Gent state: Oost-Vlaanderen zip: 9000 country: Belgium name: Cisse Geleyn, dr. role: CONTACT phone: +3293328742 email: cisse.geleyn@uzgent.be name: Gilbert Lemmens, prof. dr. role: PRINCIPAL_INVESTIGATOR lat: 51.05 lon: 3.71667 hasResults: False

 nctId: NCT06378216 id: MEDEA 975 briefTitle: Myotonic Dystrophy Type 1 Congenital and Juvenile Form: From Diagnosis to Rehabilitation [MDCJ-NeuBeRe] acronym: MDCJ-NeuBeRe overallStatus: RECRUITING date: 2022-09-15 date: 2024-03-18 date: 2024-12-30 date: 2024-04-22 date: 2024-04-22 name: IRCCS Eugenio Medea class: OTHER briefSummary: The rationale of the study is to collect structured data in the neuropsychological, clinical neuroradiologic and neurorehabilitation fields in children/young people affected by congenital and juvenile myotonic dystrophy. Children affected by the congenital form (CDM1) present important brain alterations present since birth while, on the contrary, patients with the adult form of DM1 often present a degenerative, slowly progressive neurocognitive picture. Promising therapies that aim to correct the molecular mechanism underlying the symptoms of adult forms of DM1 are under development, but their potential role at the level of the nervous system and in particular in forms of CDM1 (which appears to be a distinct disorder of neuronal development) is also to be clarified.

To this end, a better definition of neurocognitive profiles and their evolution is essential for the purposes of evaluating the effectiveness of experimental therapies. conditions: Myotonic Dystrophy 1 studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 30 type: ESTIMATED name: neurocognitive evaluations measure: Motor function evaluation by Muscular Impairment Rating Scale measure: cognitive evaluation by Wechsler Intelligence scale measure: cognitive evaluation by Raven Matrices measure: cognitive evaluation by Continous Performance Test 3 measure: cognitive evaluation by Trail Making Test A-B measure: cognitive evaluation by Digit Span and CORSI Test measure: cognitive evaluation by Rey Figure test measure: clinical evaluation by Epworth Sleepiness Scale measure: cognitive evaluation by Wisconsin Card Sorting Test measure: cognitive evaluation by Tower of London test measure: cognitive and behavioral evaluation by Minnesota Multiphasic Personality Inventory measure: cognitive and behavioral evaluation by Vineland Adaptive Behavior Scales sex: ALL minimumAge: 1 Year maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: Maria Grazia D'Angelo status: RECRUITING city: Bosisio Parini state: Lecco zip: 23842 country: Italy name: Maria Grazia D'Angelo role: CONTACT phone: +39031 877870 email: grazia.dangelo@lanostrafamiglia.it lat: 45.80075 lon: 9.29 hasResults: False

 nctId: NCT06378203 id: MEDEA 1013 briefTitle: Rehabilitation in Muscular Dystrophies From the Hospital Facility to the Home: Pilot Project [RIMUDI] acronym: RIMUDI overallStatus: RECRUITING date: 2023-12-15 date: 2024-12-15 date: 2025-04-15 date: 2024-04-22 date: 2024-04-22 name: IRCCS Eugenio Medea class: OTHER briefSummary: Until twenty years ago physical exercise in muscular dystrophies was considered harmful to the muscle cells, inducing an acceleration of cell necrosis. In fact, it is now certain and validated that an active lifestyle and the practice of controlled and regular physical activity are to be considered therapeutic in neuromuscular pathologies with the aim of optimizing muscular and cardio-respiratory function and preventing atrophy In particular, it seems that the optimal care is extensive and can be carried out in a safe and controlled manner even at home.

It is well documented that exercise has beneficial effects on muscle with increased strength and muscular endurance. conditions: Muscular Dystrophies conditions: Limb Girdle Muscular Dystrophy conditions: Facio-Scapulo-Humeral Dystrophy conditions: Becker Muscular Dystrophy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Each patient will carry out a series of evaluation and training sessions (15 sessions) with a physiotherapist for the drafting of a personalized treatment plan which will subsequently be carried out "independently" at domicile.

The home therapeutic proposal will include the use of the tele-rehabilitation system with virtual reality Home Kit - Virtual Reality Rehabilitation System (VRRS KHYMEIA) which allows to perform personalized games at home primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: tele-rehabilitation system with virtual reality Home Kit - Virtual Reality Rehabilitation System (VRRS KHYMEIA) measure: 6 minute walk test (6MWT) measure: Motor Function Measure scale (MFM) measure: Performance of Upper Limb (PUL) measure: Time up and go (TUG) measure: Modification of fatigue and quality of life scales from T0 to T6 measure: Short Form 36 (SF36) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Scientific Institute IRCCS Eugenio Medea status: RECRUITING city: Bosisio Parini state: Lecco zip: 23842 country: Italy name: Maria G D'Angelo, MD role: CONTACT phone: 031877111 phoneExt: +39 email: grazia.dangelo@lanostrafamiglia.it lat: 45.80075 lon: 9.29 hasResults: False

 nctId: NCT06378190 id: TranspoCART19 briefTitle: Treatment of Relapsed or Refractory B-cell Lymphoma With Chimeric Antigen Receptor (CAR) T-cell Therapy Produced by a New Technology acronym: TranspoCART19 overallStatus: RECRUITING date: 2024-03-11 date: 2027-04 date: 2028-10 date: 2024-04-22 date: 2024-04-22 name: Instituto de Investigación Biomédica de Salamanca class: OTHER name: Spanish Clinical Research Network - SCReN name: Fundación Canaria de Investigación Sanitaria name: Fundación para la Investigación Biomédica del Hospital 12 de Octubre briefSummary: The goal of this clinical trial is to to evaluate the safety and efficacy of TranspoCART19 in patients with relapsed/refractory B-lymphoma. The main questions it aims to answer are:

Maximum tolerated dose (MTD) Response rates Participants will be treated with the investigational medicinal product and will be followed for 36 months. conditions: Refractory B-Cell Lymphoma conditions: B-cell Lymphoma Recurrent studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Phase I/II, pilot, open, national, prospective, multicentre, non-randomised primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: CAR-T cells therapy measure: Maximum tolerated dose (MTD) measure: Efficiency measure: Procedure-related mortality (PRM) measure: Toxicity assessment measure: Response (overall and complete) measure: Duration of response measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Perceived general well-being measure: Molecular and cell biology exploratory objectives: Response dynamics measure: Molecular and cell biology exploratory objectives: Response dynamics measure: Molecular and cell biology exploratory objectives: Response dynamics measure: Molecular and cell biology exploratory objectives: In vivo survival of TranspoCART19 cells in peripheral blood measure: Molecular and cell biology exploratory objectives: Analysis of molecular markers which are possibly related to the tumor response to TranspoCART19 cells measure: Molecular and cell biology exploratory objectives: Evaluation of serum biomarkers of toxicity induced by TranspoCART19 cells (cytokine release syndrome and neurotoxicity) measure: Molecular and cell biology exploratory objectives: Epigenetic studies on mononuclear bone marrow cells. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institut Català d'Oncologia Hospital status: NOT_YET_RECRUITING city: Hospitalet de Llobregat state: Barcelona country: Spain name: Esperanza López-Franco, PhD role: CONTACT phone: 923291200 phoneExt: 55779 email: uicec.coordinacion@ibsal.es name: Alberto Musetti role: CONTACT lat: 41.35967 lon: 2.10028 facility: Virgen de la Arrixaca University Hospital status: NOT_YET_RECRUITING city: El Palmar state: Mur country: Spain name: Esperanza López-Franco, PhD role: CONTACT phone: 923291200 phoneExt: 55779 email: uicec.coordinacion@ibsal.es name: Joaquín Gómez-Espuch role: CONTACT lat: 37.93939 lon: -1.16095 facility: Clínica Universidad de Navarra status: RECRUITING city: Pamplona state: Navarra zip: 31008 country: Spain name: Esperanza López-Franco, PhD role: CONTACT phone: 923291200 phoneExt: 55779 email: uicec.coordinacion@ibsal.es name: Carlos Grande role: CONTACT lat: 42.81687 lon: -1.64323 facility: University Hospital of Navarra status: NOT_YET_RECRUITING city: Pamplona state: Navarra country: Spain name: Esperanza López-Franco role: CONTACT phone: 923291200 phoneExt: 55779 email: uicec.coordinacion@ibsal.es name: María Carmen Mateos-Rodríguez role: CONTACT lat: 42.81687 lon: -1.64323 facility: Hospital Clínic status: NOT_YET_RECRUITING city: Barcelona country: Spain name: Esperanza López-Franco, PhD role: CONTACT phone: 923291200 phoneExt: 55779 email: uicec.coordinacion@ibsal.es name: Valentín Ortiz-Maldonado role: CONTACT lat: 41.38879 lon: 2.15899 facility: Fundación Jiménez Díaz Hospital status: NOT_YET_RECRUITING city: Madrid country: Spain name: Esperanza López-Franco role: CONTACT phone: 923291200 phoneExt: 55779 email: uicec.coordinacion@ibsal.es name: Javier Cornago-Navascués role: CONTACT lat: 40.4165 lon: -3.70256 facility: Salamanca University Health Care Complex status: RECRUITING city: Salamanca zip: 37007 country: Spain name: Esperanza López-Franco, PhD role: CONTACT phone: 923291200 phoneExt: 55779 email: uicec.coordinacion@ibsal.es name: Lucía López-Corral, PhD role: CONTACT lat: 40.96882 lon: -5.66388 facility: Virgen del Rocio Hospital status: NOT_YET_RECRUITING city: Sevilla country: Spain name: Esperanza López-Franco, PhD role: CONTACT phone: 923291200 phoneExt: 55779 email: uicec.coordinacion@ibsal.es name: José Antonio Pérez-Simón role: CONTACT lat: 37.38283 lon: -5.97317 hasResults: False

 nctId: NCT06378177 id: LVGN6051-0402-HNSCC briefTitle: A Study of LVGN6051 Combination Therapy in Patient With Head and Neck Squamous Cell Carcinoma (HNSCC) overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2027-10-31 date: 2027-10-31 date: 2024-04-22 date: 2024-04-26 name: Lyvgen Biopharma Holdings Limited class: INDUSTRY briefSummary: The purpose of this study is to assess the safety and efficacy of LVGN6051 (4-1BB agonistic antibody) combined with toripalimab (anti-PD-1 antibody) and paclitaxel (anti-tubulin chemotherapy) in patients with recurrent/metastatic head and neck squamous cell carcinoma who rapidly progress from previous neoadjuvant, curative, or adjuvant platinum-containing therapy, or who are currently contraindicated for platinum-containing treatment. conditions: Head and Neck Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: This is a multicenter, open-labeled, single-arm Phase 2 clinical study.This study comprises two parts. Part 1 (Safety Run-in Phase) is designed to confirm the dose of combination therapy in Part 2. primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: LVGN6051 Monoclonal Antibody Injection name: toripalimab Injection name: Paclitaxel injection measure: to determine treatment-related adverse events (TRAEs, the safety and tolerability of two preset dose levels ) measure: to determine objective response rate (ORR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui Cancer Hospital city: Hefei state: Anhui zip: 230000 country: China name: Jin Gao role: CONTACT phone: +86 15395005376 email: gj11667@126.com lat: 31.86389 lon: 117.28083 facility: Beijing Cancer Hospital city: Beijing state: Beijing zip: 100142 country: China name: Yan Sun role: CONTACT phone: +86 13671370026 email: 13671370026@139.com lat: 39.9075 lon: 116.39723 facility: Beijing Tongren Hospital Affiliated to Capital Medical University city: Beijing state: Beijing zip: 100730 country: China name: Shurong Zhang role: CONTACT phone: +86 13501085646 email: 13501085646@163.com lat: 39.9075 lon: 116.39723 facility: Fujian cancer hospital city: Fuzhou state: Fujian zip: 350014 country: China name: Sufang Qiu role: CONTACT phone: +86 13609589163 email: sfqiu@126.com lat: 26.06139 lon: 119.30611 facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University city: Guangzhou state: Guangdong zip: 510120 country: China name: Xiaoming Huang role: CONTACT phone: +86 13602808820 email: xiaoming.huang@126.com lat: 23.11667 lon: 113.25 facility: Guangxi Medical University Cancer Hospital city: Nanning state: Guangxi zip: 530021 country: China name: Song Qu role: CONTACT phone: +86 13607887386 email: 13607887386@163.com lat: 22.81667 lon: 108.31667 facility: Henan cancer hospital city: Zhengzhou state: Henan zip: 450008 country: China name: Hui Wu role: CONTACT phone: +86 13503716710 email: wuhui7008@126.com lat: 34.75778 lon: 113.64861 facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430000 country: China name: Kunyu Yang role: CONTACT phone: +86 13995595360 email: yangky71@aliyun.com lat: 30.58333 lon: 114.26667 facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430030 country: China name: Guangyuan Hu role: CONTACT phone: +86 13886000095 email: h.g.y.121@163.com lat: 30.58333 lon: 114.26667 facility: Xiangya Hospital Central South University city: Changsha state: Hunan zip: 410008 country: China name: Liangfang Shen role: CONTACT phone: +86 13975805137 email: slf1688@sina.com lat: 28.19874 lon: 112.97087 facility: The Second Xiangya Hospital, Central South University city: Changsha state: Hunan zip: 410011 country: China name: Ping Liu role: CONTACT phone: +86 15084987287 email: cyril0820@sina.com lat: 28.19874 lon: 112.97087 facility: Hunan Cancer Hospital city: Changsha state: Hunan zip: 410031 country: China name: Yaqian Han role: CONTACT phone: +86 18673176667 email: hanyaqiancs@163.com lat: 28.19874 lon: 112.97087 facility: Hunan Cancer Hospital city: Changsha state: Hunan zip: 410031 country: China name: Jinguan Lin role: CONTACT phone: +86 13307318568 email: xjl5027@easthospital.com lat: 28.19874 lon: 112.97087 facility: Liaoning cancer hospital city: Shenyang state: Liaoning zip: 110042 country: China name: Xia Li role: CONTACT phone: +86 189 0091 7377 email: lixiadoctor@163.com lat: 41.79222 lon: 123.43278 facility: Shanghai Oriental Hospital city: Shanghai state: Shanghai zip: 200123 country: China name: Ye Guo role: CONTACT phone: +86 13501678472 email: pattrickguo@gmail.com lat: 31.22222 lon: 121.45806 facility: West China Hospital of Sichuan University city: Chengdu state: Sichuan zip: 610041 country: China name: Lei Liu role: CONTACT phone: +86 18980606231 email: 32498600@qq.com lat: 30.66667 lon: 104.06667 facility: Zhejiang Cancer Hospital city: Hangzhou state: Zhejiang zip: 310022 country: China name: Meiyu Fang role: CONTACT phone: +86 13750851650 email: fangmy@zjcc.org.cn lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06378164 id: P0041406 briefTitle: The Effect of Combined Volitional and Reactive Step Training in Reducing Falls Risk in Older Fallers overallStatus: RECRUITING date: 2023-12-01 date: 2025-04 date: 2026-04 date: 2024-04-22 date: 2024-04-22 name: The Hong Kong Polytechnic University class: OTHER name: Chinese University of Hong Kong name: Neuroscience Research Australia name: The University of New South Wales briefSummary: To examine the immediate and sustained effect of a 4-week combined volitional and reactive step training on fall risks in community-dwelling older fallers. conditions: Older Adults With a History of Falls studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 98 type: ESTIMATED name: Exercise name: Active Control measure: Choice Stepping Reaction Times measure: Spring Scale Test measure: Mini Balance Evaluation System Test measure: Motor Control Test measure: Falls Efficacy Scale - International measure: Trail-Making Test measure: Programme Adherence measure: Prospective Falls measure: Adverse Events sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: The Hong Kong Polytechnic University status: RECRUITING city: Hong Kong country: Hong Kong name: Freddy Man Hin LAM, PhD role: CONTACT phone: 27666720 email: freddy-mh.lam@polyu.edu.hk name: Freddy Man Hin LAM role: CONTACT name: Freddy Man Hin LAM, PhD role: PRINCIPAL_INVESTIGATOR lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06378151 id: 2023P002243 briefTitle: Time-limited Trials in the Emergency Department overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-02-28 date: 2025-09-30 date: 2024-04-22 date: 2024-04-22 name: Brigham and Women's Hospital class: OTHER briefSummary: A randomized controlled trial of a structured conversation between clinicians and patients/surrogates to facilitate shared decision-making for intensive care use in seriously ill older adults being admitted to the intensive care unit from the emergency department. conditions: Emergencies studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Clinician-level randomization primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: TLT training measure: Time to complete TLT conversations measure: Patient-reported acceptability of TLT conversations measure: Intervention fidelity measure: Clinician-reported feasibility measure: Clinician-reported satisfaction measure: EHR documentation by inpatient clinicians measure: Heard and understood measure: Patient-reported end-of-life quality of communication measure: Decisional regret scale measure: The number of days to the first family meeting in ICU measure: ICU length of stay (LOS) measure: Hospital LOS measure: The number of family meetings measure: ICU procedures (e.g., CPR, pressors, etc.) measure: ICU mortality measure: Patterns of hospital disposition measure: Rate of hospice utilization sex: ALL 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: NCT06378138 id: ICP-CL-01203 briefTitle: ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2030-11-25 date: 2031-07-25 date: 2024-04-22 date: 2024-04-22 name: Beijing InnoCare Pharma Tech Co., Ltd. class: INDUSTRY briefSummary: Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma conditions: Hematologic Malignancies studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 226 type: ESTIMATED name: ICP-248 name: Orelabrutinib measure: Adverse events (AEs) and serious adverse events (SAEs) evaluation according to CTCAE V5.0 or iwCLL 2018 criteria measure: Changes from baseline in pulse. measure: Changes from baseline in blood pressure. measure: Changes from baseline in ECG QRS interval. measure: Changes from baseline in ECG QT interval. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Anhui Medical University city: Hefei state: Anhui zip: 230022 country: China name: Jian Ge role: CONTACT lat: 31.86389 lon: 117.28083 facility: Peking University Third Hospital city: Beijing state: Beijing zip: 100191 country: China name: Hongmei Jing role: CONTACT lat: 39.9075 lon: 116.39723 facility: The First Affiliated Hospital of Chongqing Medical University city: Chongqing state: Chongqing zip: 400016 country: China name: Xiaoqiong Tang role: CONTACT lat: 29.56278 lon: 106.55278 facility: Xinqiao Hospital, the Second Affiliated Hospital of Army Military Medical University city: Chongqing state: Chongqing zip: 400037 country: China name: Xixi Xiang role: CONTACT lat: 29.56278 lon: 106.55278 facility: Fujian Medical University Union Hospital city: Fuzhou state: Fujian zip: 350001 country: China name: Zhenshu Xu role: CONTACT lat: 26.06139 lon: 119.30611 facility: The First Affiliated Hospital of Xiamen University city: Xiamen state: Fujian zip: 361003 country: China name: Bing Xu role: CONTACT lat: 24.47979 lon: 118.08187 facility: Sun Yat-sen University Cancer Center city: Guangzhou state: Guangdong zip: 510055 country: China name: Yang Liang role: CONTACT lat: 23.11667 lon: 113.25 facility: The Fourth Hospital of Hebei Medical University city: Shijiazhuang state: Hebei zip: 050010 country: China name: Lihong Liu role: CONTACT lat: 38.04139 lon: 114.47861 facility: Nanyang City Center Hospital city: Nanyang state: Henan zip: 473005 country: China name: Chao Li role: CONTACT lat: 32.99472 lon: 112.53278 facility: Henan Provincial People's Hospital city: Zhengzhou state: Henan zip: 463599 country: China name: Zunmin Zhu role: CONTACT lat: 34.75778 lon: 113.64861 facility: Henan Cancer Hospital city: Zhenzhou state: Henan zip: 450003 country: China name: Keshu Zhou role: CONTACT lat: 32.28034 lon: 119.16999 facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430011 country: China name: Xiaoxi Zhou role: CONTACT lat: 30.58333 lon: 114.26667 facility: Union Hospital Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430022 country: China name: Guohui Cui role: CONTACT lat: 30.58333 lon: 114.26667 facility: The Second Xiangya Hospital, Central South University city: Changsha state: Hunan zip: 410012 country: China name: Hongling Peng role: CONTACT lat: 28.19874 lon: 112.97087 facility: Hunan Cancer Hospital city: Changsha state: Hunan zip: 410031 country: China name: Fang Zhou role: CONTACT lat: 28.19874 lon: 112.97087 facility: Jiangsu Province Hospital city: Nanjing state: Jiangsu zip: 210029 country: China name: Wei Xu role: CONTACT lat: 32.06167 lon: 118.77778 facility: The First Affiliated Hospital of Nanchang University city: Nanchang state: Jiangxi zip: 330006 country: China name: Fei Li role: CONTACT lat: 28.68396 lon: 115.85306 facility: Bethune First Hospital of Jilin University city: Changchun state: Jilin zip: 130061 country: China name: Ou Bai role: CONTACT lat: 43.88 lon: 125.32278 facility: The Second Hospital of Dalian Medical University city: Dalian state: Liaoning zip: 116023 country: China name: Xiuhua Sun role: CONTACT lat: 38.91222 lon: 121.60222 facility: Shengjing Hospital affiliated to China Medical University city: Shenyang state: Liaoning zip: Liaoning country: China name: Aijun Liao role: CONTACT lat: 41.79222 lon: 123.43278 facility: Shandong Cancer Hospital city: Jinan state: Shandong zip: 250117 country: China name: Ji Ma role: CONTACT lat: 36.66833 lon: 116.99722 facility: Linyi City Cancer Hospital city: Linyi state: Shandong zip: 276002 country: China name: Meifang Zheng role: CONTACT lat: 35.06306 lon: 118.34278 facility: Huashan Hospital city: Shanghai state: Shanghai zip: 200040 country: China name: Tong Chen role: CONTACT lat: 31.22222 lon: 121.45806 facility: The Second Affiliated Hospital of Xi'an Jiaotong University city: Xi'an state: Shanxi zip: 710004 country: China name: Jianli Wang role: CONTACT lat: 34.25833 lon: 108.92861 facility: Sichuan Provincial People's Hospital city: Chengdu state: Sichuan zip: 610072 country: China name: Xiaobing Huang role: CONTACT lat: 30.66667 lon: 104.06667 facility: Yibin Second People's Hospital city: Yibin state: Sichuan zip: 644002 country: China name: Shihua Huang role: CONTACT lat: 28.76667 lon: 104.62383 facility: Tianjin Medical University Cancer Institute and Hospital city: Tianjin state: Tianjin zip: 300181 country: China name: Lihua Qiu role: CONTACT lat: 39.14222 lon: 117.17667 facility: The Affiliated Cancer Hospital of Xinjiang Medical University city: Urumqi state: Xinjiang Uygur Autonomous Region zip: 830000 country: China name: Shujuan Wen role: CONTACT lat: 43.80096 lon: 87.60046 facility: The First Affiliated Hospital of Kunming Medical University city: Kunming state: Yunnan zip: 650032 country: China name: Mingxia Shi role: CONTACT lat: 25.03889 lon: 102.71833 facility: The First Affiliated Hospital of Zhejiang University School of Medicine city: Hangzhou state: Zhejiang zip: 310003 country: China name: Wenjuan Yu role: CONTACT lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06378125 id: CIR-NA I briefTitle: Evaluation of Safety and Pharmacokinetics of Oral Controlled-ileal-release Nicotinic Acid (CIR-NA) Compared to Immediate-release Nicotinic Acid and Placebo in Healthy Subjects and Subjects With Prediabetes overallStatus: RECRUITING date: 2022-12-19 date: 2024-12-31 date: 2025-06-01 date: 2024-04-22 date: 2024-04-22 name: University Hospital Schleswig-Holstein class: OTHER briefSummary: A double-blind, randomised, placebo-controlled, single-ascending and multiple-ascending dose trial to evaluate the safety and pharmacokinetics of oral controlled-ileal-release nicotinic acid (CIR-NA) compared to immediate-release nicotinic acid and placebo in healthy subjects and subjects with prediabetes. conditions: Safety Issues conditions: Pharmacokinetic studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: DOUBLE maskingDescription: Double (Participant, Investigator) whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: controlled-ileal-release nicotinic acid (SAD/ MAD/MD) single- and multiple-ascending dose (SAD/MAD) or multiple dose (MD) name: immediate-release nicotinic acid (SAD) name: Placebo controlled-ileal-release nicotinic acid (SAD/MAD) name: Placebo immediate-release nicotinic acid (SAD) measure: Treatment-Emergent Adverse Events [Safety and Tolerability] measure: Treatment-Emergent Serious Adverse Events [Safety and Tolerability] measure: Haemoglobin measure: White blood cells measure: Blood creatinine measure: Blood urea measure: Blood uric acid measure: Glomerular filtration rate measure: Blood ALT measure: Blood AST measure: Blood GGT sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Center Schleswig-Holstein, Campus Kiel status: RECRUITING city: Kiel state: Schleswig-Holstein zip: 24105 country: Germany name: Corinna Geisler, PhD role: CONTACT phone: +4943150022243 email: studien.nutrisys.kiel@uksh.de lat: 54.32133 lon: 10.13489 hasResults: False

 nctId: NCT06378112 id: 2734/CEIH/2022 briefTitle: Extraction Socket Augmentation. A Clinical Study acronym: GTO overallStatus: RECRUITING date: 2022-05-20 date: 2025-01-15 date: 2025-12-30 date: 2024-04-22 date: 2024-04-22 name: Universidad de Granada class: OTHER briefSummary: Extraction socket preservation is defined as alveolar ridge preservation within the bone envelope remaining after tooth extraction, meanwhile ridge augmentation is defined as increasing the volume of alveolar ridge beyond the bony envelope at the time of tooth extraction. It is recommended to use in cases where extraction socket anatomy is intact. In contrast definition "extraction socket augmentation" defines alveolar ridge restoration when bony walls of the socket are partly or completely lost. In the case of severe loss (\> 50%) of the buccal bone plate, preservation of hard tissue with a prolonged healing time before implant placement has been suggested.

The null hypothesis of this experimental work states that: (i) the two different bone graft materials gained the same amount of bone following horizontal ridge augmentation procedure; (i) the two different bone graft materials exhibit similar histological and histomorphometric results Therefore, the main purpose of the current study is to compare two different biomaterials using guided bone regeneration procedures in the ridge preservation/ augmentation (hard-tissue preservation). conditions: Edentulous Alveolar Ridge With Labial Resorption studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: * Group 1 (test group): Guided bone regeneration procedure with GTO® as bone graft and soft collagenated cortical membrane (OsteoBiol® Lamina; Tecnoss srl) as graft stabilizer.
* Group 2 (control): Guided bone regeneration procedure with Apatos Mix® cortico-cancellous heterologous bone mix (OsteoBiol®; Tecnoss srl) as bone graft and soft collagenated cortical membrane (OsteoBiol® Lamina; Tecnoss srl) as graft stabilizer. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: GTO® measure: Dimensional bone changes sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dental School status: RECRUITING city: Granada zip: E18071 country: Spain name: Manuel Toledano, Professor role: CONTACT email: toledano@ugr.es name: Raquel Osorio role: CONTACT email: rosorio@ugr.es name: Manuel Toledano, Professor role: PRINCIPAL_INVESTIGATOR name: Raquel Osorio, Professor role: SUB_INVESTIGATOR name: Cristina Vallecillo, PhD role: SUB_INVESTIGATOR name: Marta Vallecillo-Rivas, PhD role: SUB_INVESTIGATOR name: Manuel Toledano-Osorio, PhD role: SUB_INVESTIGATOR lat: 37.18817 lon: -3.60667 hasResults: False

 nctId: NCT06378099 id: InFaPro briefTitle: Evaluation of the Effect of Consensual Pharmaceutical Indication Protocols for the Treatment of Minor Ailments acronym: InFaPro overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-02 date: 2025-08 date: 2024-04-22 date: 2024-04-25 name: Universidad de Antioquia class: OTHER name: Farmacias Pasteur briefSummary: Minor ailments are non-serious, short-term health problems, not related to the patient's pathologies or to the desired or undesired effects of the medications they are taking. Pharmaceutical indication is the service provided in response to a patient's request, who comes to the pharmacy asking for a medication recommendation for a health problem; for this purpose, over-the-counter medications are used, which are pharmacological agents that can be acquired without a prescription. The practice of pharmaceutical indication turns self-medication into a safe and responsible practice, but it requires agreed-upon protocols. conditions: Community Pharmacy Services studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: An exploratory clinical trial with a baseline reference period of parallel groups will be conducted. The study will take place over a period of 10 months, during which 5 MA will be analyzed, and for each of them, patients will be followed up on days 3 to 5, and 7 to 10 post-care (intervention). Drugstores and drugstores/pharmacies (groups) will be randomized in a 1:1 ratio to enroll in the intervention group or the control group. primaryPurpose: OTHER masking: NONE maskingDescription: Blinding of the participants and the pharmacists involved in the care is not possible due to the nature of the intervention. count: 800 type: ESTIMATED name: Patient guided and followed by the pharmacist measure: Resolution time of the MA and the frequency of referral to a physician. measure: Characterization of the population visiting drugstore or drugstore/pharmacy measure: Identification of the presence and classification of the MA measure: Need to acquire an OTC medication to treat the MA sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06378086 id: TEO-PAS-2302 briefTitle: RHA® Redensity With New Anesthetic Agent Perioral Rhytids (PAS) overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-02 date: 2025-05 date: 2024-04-22 date: 2024-04-22 name: Teoxane SA class: INDUSTRY briefSummary: This is a randomized, controlled, double-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA® Redensity with new anesthetic agent is non-inferior to RHA® Redensity with lidocaine in terms of injection site pain felt by the subject during injection.

At screening, the Principal Investigator (PI) evaluated subjects' perioral rhytid severity (using the Perioral Rhytid Severity Rating Scale; PR-SRS) to confirm eligibility and to establish a pre-treatment score for assessing aesthetic improvement.

At Visit 1, RHA® Redensity with new anesthetic agent was administered in a random sequence (first or second injection) and side of the mouth (left or right) and RHA® Redensity with lidocaine was administered to the other side. Study subjects and the PI injecting study devices were blinded.

Immediately after injection of an upper perioral quadrant, subjects rated the injection site pain experienced during injection using a 100 mm Visual Analog Scale (VAS). Injection site pain in each side of the mouth was also assessed at 15, 30, 45 and 60 minutes after injection of the upper quadrant.

Safety evaluation consisted of AE assessments, a 30-day CTR (Common Treatment Response) diary and a follow-up call performed by the study site at 72 hours after injection.

Subjects attended Visit 2 (30 days post-injection) where effectiveness and safety assessments were conducted.

Subjects who presented with an unresolved clinically significant device related AE at Visit 2 received a optional follow-up phone call no later than 30 days after Visit 2.

If the clinically significant AE remained unresolved, the Investigator requested that the subject attended the optional in-clinic follow-up visit (i.e., Visit 3) within 5 working days. Follow-up of the clinically significant AE continued until the AE was resolved or the TI determines that additional follow-up was not necessary. conditions: Pain conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Split-face design primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: RHA® Redensity with new anesthetic agent name: RHA® Redensity with lidocaine measure: Non-inferiority of RHA® Redensity with new anesthetic agent versus RHA® Redensity with lidocaine in terms of reducing pain during device injection into the upper perioral rhytids. measure: Difference between RHA® Redensity with new anesthetic agent versus RHA® Redensity with lidocaine in term of reducing pain at 15, 30, 45 and 60 minutes post-injection in each side of the mouth. sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: United States, New York city: New York state: New York zip: 10028 country: United States role: CONTACT phone: 212-472-2900 lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06378073 id: DPT/Batch-Fall19/557 briefTitle: Effects of Chest Physiotherapy Exercise in Prevention of Pre and Post Operative Complications By Cardiac Surgery overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-05 date: 2024-06-01 date: 2024-09-01 date: 2024-04-22 date: 2024-04-22 name: Superior University class: OTHER briefSummary: "A randomized control trial will be conducted among 189 patients who have undergone cardiac surgery in past. The participants for this research will be patients of Pakistan Institute of Cardiology, University of Lahore Teaching Hospital, Azra Naheed Medical College and Bahria International Hospital. The chest physiotherapy technique will be applied on 2 controlled groups.

In 94 patients the effects of chest physiotherapy will be checked post - operatively and the effects will be checked on other half pre - operatively. The data will be gathered on practical performance and treatment based along with questionnaire. The data collected will then be analyzed using SPSS" conditions: Surgery-Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 189 type: ACTUAL name: Incentive Spirometer name: Numeric Pain Rating Scale measure: Incentive Spirometer measure: Incentive Spirometer sex: ALL minimumAge: 48 Years maximumAge: 88 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azra Naheed Medical College, Superior University city: Lahore state: Punjab country: Pakistan lat: 31.558 lon: 74.35071 facility: Bahria Hospital city: Lahore state: Punjab country: Pakistan lat: 31.558 lon: 74.35071 facility: Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University city: Lahore state: Punjab country: Pakistan lat: 31.558 lon: 74.35071 facility: The University of Lahore Teaching Hospital city: Lahore state: Punjab country: Pakistan lat: 31.558 lon: 74.35071 facility: Punjab Institute of Cardiology Hospital city: Lahore country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06378060 id: KM04 briefTitle: Clinical Study on Modified Allogeneic Hematopoietic Stem Cell Transplantation Regimen for Severe Aplastic Anemia overallStatus: RECRUITING date: 2024-03-01 date: 2026-04-01 date: 2027-04-01 date: 2024-04-22 date: 2024-04-22 name: Hematology department of the 920th hospital class: OTHER briefSummary: The aim of this study was to evaluate the safety and efficacy of a modified allogeneic hematopoietic stem cell transplantation regimen for aplastic anemia. conditions: Severe Aplastic Anemia studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Modified transplantation system measure: overall survival (OS) measure: Acute graft-versus-host disease incidence measure: Transplantation-related motality measure: Chronic graft-versus-host disease incidence measure: incidence of Intensive fungal disease measure: EB virus reactivation rate measure: CMV reactivation rate sex: ALL minimumAge: 3 Years maximumAge: 65 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 PI sanbin, Doctor role: CONTACT phone: 0871-64774206 email: Wangsanbin2022@126.com lat: 25.03889 lon: 102.71833 hasResults: False

 nctId: NCT06378047 id: MCC-22325 briefTitle: Irreversible Electroporation & Pembro Immunotherapy in Locally Advanced Pancreatic Cancer overallStatus: RECRUITING date: 2024-04-10 date: 2027-04 date: 2027-04 date: 2024-04-22 date: 2024-04-22 name: H. Lee Moffitt Cancer Center and Research Institute class: OTHER name: Angiodynamics, Inc. briefSummary: This study aims to determine the safety and tolerability of combining sequential therapy of Irreversible Electroporation (IRE) and Immunotherapy (IO) for patients with locally advanced unresectable pancreas cancer following first-line treatment with chemotherapy and ablative stereotactic magnetic resonance image-guided adaptive radiation therapy (A-SMART). conditions: Pancreatic Cancer conditions: Locally Advanced Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 3 type: ESTIMATED name: Pembrolizumab name: Irreversible Electroporation measure: Safety and Tolerability measure: Progression-Free Survival (PFS) measure: Overall Survival (OS) measure: Objective Response Rate (ORR) 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: Alicia Chin role: CONTACT phone: 813-745-4673 email: Alicia.Chin@moffitt.org name: Victoria Kryliouk role: CONTACT email: Victoria.Kryliouk@moffitt.org name: Mokenge Malafa, MD role: PRINCIPAL_INVESTIGATOR name: Mohammed Al-Jumayli, MD role: SUB_INVESTIGATOR name: Junsung Choi, MD role: SUB_INVESTIGATOR name: James Costello, MD, PhD role: SUB_INVESTIGATOR name: Aamir Dam, MD role: SUB_INVESTIGATOR name: Jason Denbo, MD role: SUB_INVESTIGATOR name: Sophie Dessureault, MD, PhD role: SUB_INVESTIGATOR name: Martine Extermann, MD, PhD role: SUB_INVESTIGATOR name: Jessica Frakes, MD role: SUB_INVESTIGATOR name: Pamela Hodul, MD role: SUB_INVESTIGATOR name: Sarah Hoffe, MD role: SUB_INVESTIGATOR name: Dae Won Kim, MD role: SUB_INVESTIGATOR name: Richard Kim, MD role: SUB_INVESTIGATOR name: Bela Kis, MD, PhD role: SUB_INVESTIGATOR name: Allan Lima Pereira, MD, PhD role: SUB_INVESTIGATOR name: Shaffer Mok, MD role: SUB_INVESTIGATOR name: Russell Palm, MD role: SUB_INVESTIGATOR name: Jose Pimiento, MD role: SUB_INVESTIGATOR name: Paulo Rodriguez, PhD role: SUB_INVESTIGATOR name: Christine Sam, MD role: SUB_INVESTIGATOR name: Andrew Sinnamon, MD role: SUB_INVESTIGATOR name: Amalia Stefanou, MD role: SUB_INVESTIGATOR name: Jonathan Strosberg, MD role: SUB_INVESTIGATOR lat: 27.94752 lon: -82.45843 hasResults: False

 nctId: NCT06378034 id: 2023-A01926-39 briefTitle: Effect of Lactium on Sleep Disorders in Healthy Volunteers With Persistent Subclinical Insomnia overallStatus: NOT_YET_RECRUITING date: 2024-06-10 date: 2024-07-15 date: 2026-09-30 date: 2024-04-22 date: 2024-04-22 name: Ingredia S.A. class: INDUSTRY briefSummary: The main objective will be to assess the effect of Lactium® on sleep efficiency in volunteers presented with persistent subclinical insomnia. conditions: Sleep Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: Lactium name: Placebo measure: Sleep efficiency measure: Sleep diary measure: Insomnia Severity Index measure: PSQI measure: Sleep quality by cctigraphy sex: ALL minimumAge: 25 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06378021 id: Calcium chloride in CABG briefTitle: Role of Calcium Chloride Injection in Alleviating Atrial Fibrillation Post CABG overallStatus: RECRUITING date: 2024-03-14 date: 2025-03 date: 2025-04 date: 2024-04-22 date: 2024-04-22 name: Helwan University class: OTHER briefSummary: This study hypothesize that injecting calcium chloride (CaCl2) into the major atrial ganglionated plexus (GPs) during on pump Coronary artery bypass graft (CABG) can reduce the incidence of Post operative Atrial fibrillation in the first 7 days after surgery.The study is designed to be prospective interventional study two armed RCT for on pump CABG patient.

The intervention arm will be injected with Calcium chloride in the four major atrial ganglionic plexus The control arm will be injected with sodium chloride to determine the effect of Calcium chloride on Post CABG Atrial fibrillation conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: Calcium Chloride name: Sodium Chloride 0.9% Inj measure: Change in number of patients who developed Atrial fibrillation measure: Change in length of hospital stay sex: ALL minimumAge: 18 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ain shams university status: RECRUITING city: Cairo state: Abassia Cairo zip: 02 country: Egypt name: Mohamed A Gamal, Ass prof role: CONTACT phone: 010080827060 phoneExt: 02 name: Abdelhameed I Ebid, Prof role: PRINCIPAL_INVESTIGATOR lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06378008 id: 300100 briefTitle: A Clinical Study to Evaluate the Anti-Sensitivity Effect of a Calcium Sodium Phosphosilicate Toothpaste in a Population of Dentin Hypersensitivity Sufferers overallStatus: RECRUITING date: 2024-04-16 date: 2024-09-13 date: 2024-09-13 date: 2024-04-22 date: 2024-04-22 name: HALEON class: INDUSTRY briefSummary: The aim of this study is to confirm the clinical dentin hypersensitivity (DH) efficacy of a 5 percent (%) calcium sodium phosphosilicate (CSPS) toothpaste. conditions: Dentin Sensitivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 234 type: ESTIMATED name: CSPS 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 Days 3, 7, 14 and 28 measure: Change from Baseline in Tactile Threshold at Days 3, 7, 14 and 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, Question 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: All Sum Research status: RECRUITING city: Mississauga state: Ontario zip: L5N 6J2 country: Canada name: C R Goyal, Dr role: CONTACT lat: 43.5789 lon: -79.6583 hasResults: False

 nctId: NCT06377995 id: OST1_013 briefTitle: Effectiveness of an Intervention Plan Aimed at the Diaphragm in Chronic Non-specific Neck Pain overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2024-12-31 date: 2024-12-31 date: 2024-04-22 date: 2024-04-22 name: Escola Superior de Tecnologia da Saúde do Porto class: OTHER briefSummary: The aim of this study is to analyse the effectiveness of an intervention plan targeting the diaphragm, namely stretching technique, neuromuscular diaphragm and phrenic centre inhibition, in the treatment of chronic non-specific neck pain. conditions: Chronic Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Placebo technique name: Diaphragm protocol measure: Change in the intensity of pain in the cervical spine after applying the diaphragm intervention plan measure: Changes in range of motion after applying the diaphragm targeted protocol measure: Changes in pain level one week after the intervention measure: Changes in range of motion one week later sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Escola Superior de Saúde do Porto city: Porto zip: 4200-072 country: Portugal name: Natália MO Campelo, PhD role: CONTACT phone: +35122 206 1000 email: nmc.ess.ipp@gmail.com name: Natália MO Campelo, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.14961 lon: -8.61099 hasResults: False

 nctId: NCT06377982 id: SCCP001 briefTitle: Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-09 date: 2026-12 date: 2024-04-22 date: 2024-04-22 name: StemCyte Taiwan Co., Ltd. class: INDUSTRY briefSummary: A phase I, randomized, double-blind, placebo-controlled clinical study to assess the safety and efficacy of allogeneic human umbilical cord blood infusion in children with cerebral palsy conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 12 type: ESTIMATED name: hUCB measure: safety-TEAE sex: ALL minimumAge: 1 Year maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06377969 id: 75269 briefTitle: Prospective Evaluation of Effectiveness and Safety of Closed-Loop Spinal Cord Stimulation in Treating Patients With Chronic Pelvic Pain overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-12-31 date: 2027-06-30 date: 2024-04-22 date: 2024-04-26 name: Stanford University class: OTHER briefSummary: Spinal cord stimulation (SCS) is an effective treatment for patients with chronic pelvic pain. The investigators will evaluate how safe and effective closed-loop spinal cord stimulation is in treating these patients; closed-loop spinal cord stimulation is a more novel method in delivering spinal cord stimulation that controls energy output of the device based on real-time feedback on how the device is stimulating the spinal cord. conditions: Chronic Pelvic Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pilot prospective single arm interventional study primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: ECAP (Evoked Compound Action Potential)-controlled Closed-Loop Spinal Cord Stimulation measure: Change in Pain Intensity measure: Change in Disability measure: Patient Global Impression Change measure: Change in Quality of Life measure: Change in Pain Catastrophizing Scale measure: Change in sleep quality measure: Change in Social Functioning sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06377956 id: XRGao briefTitle: The Associations Between Gut Length, Gut Microbiota and Food Assimilation overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-06-01 date: 2025-06-01 date: 2024-04-22 date: 2024-04-22 name: Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences class: OTHER briefSummary: The purpose of this observational study is to explore the correlation between human gut length and food absorption rates. This will include characterization of gut length, total food intake energy, fecal calories, urinary calories, body composition, food intake behavior, genetics and gut microbiota in the small intestine. Researchers expect to recruit up to 100 healthy volunteers. conditions: Gut Length conditions: Food Assimilation Efficiency studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Observation without intervention measure: Gut length measure: Energy intake measure: Fecal calorie measure: Urine calorie measure: Weight measure: Height measure: Waist circumferences measure: Hip circumferences measure: Bone mass measure: Fat mass measure: Fat free mass measure: Blood pressure measure: Heart rate measure: Resting energy expenditure measure: Thermic effect of food measure: Body shape measure: Microbiome measure: Metabolites measure: Gut transit time measure: Food macronutrient content measure: Feces macronutrient content measure: Total daily water volume measure: Total daily urine volume measure: Physical activity measure: Bristol Stool Scale sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Shenzhen Institute of Advanced Technology city: Shenzhen state: Guangdong zip: 518055 country: China name: John R Speakman, PhD role: CONTACT phone: 13466654659 email: j.speakman@abdn.ac.uk lat: 22.54554 lon: 114.0683 hasResults: False

 nctId: NCT06377943 id: SIAT-IRB-240415-H0718 briefTitle: The Interaction Between Resting Metabolic Rate, Physical Activity and Thyroid Hormone in Females overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-31 date: 2024-10-31 date: 2024-04-22 date: 2024-04-22 name: Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences class: OTHER briefSummary: This Study is focused on the interaction between resting metabolic rate (RMR), physical activity (PA), and thyroid hormones (TH). TH controls almost all the cell activities of the body so, it is known as one of the major regulatory hormones. This is the reason for individuals who suffer from thyroid disorders show abnormal metabolism. Recently it was suggested that interindividual variations in thyroid hormone levels also influence daily physical activity. conditions: Thyroid conditions: Physical Activities conditions: Resting Energy Expenditure studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Body weight measure: Height measure: Waist and Hip circumferences measure: Fat mass measure: Far free mass measure: Bone mass measure: Resting Metabolism measure: Physical activity measure: Thyroid hormone measure: Total energy expenditure sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06377930 id: RAP-219-FOS-201 briefTitle: Study Evaluating the Safety and Efficacy of RAP-219 in Adult Participants With Refractory Focal Epilepsy overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-03-01 date: 2025-06-01 date: 2024-04-22 date: 2024-04-26 name: Rapport Therapeutics Inc. class: INDUSTRY briefSummary: This is a clinical research study for an investigational drug called RAP-219 in patients with Refractory Focal Epilepsy. This study is being conducted to determine if RAP-219 works and is safe in patients with Refractory Focal Epilepsy. conditions: Focal Onset Seizures studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: RAP-219 measure: Efficacy in reducing frequency of RNS-recorded long episodes in participants with FOS measure: Measurement of estimated electrographic seizure frequency from available RNS-recorded episodes measure: Measurement of Clinical Seizure Frequency measure: Change in seizure severity measure: Global Impression of Change measure: Pharmacokinetic parameters sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06377917 id: 2304-BRG-057-JF briefTitle: Investigating Micro-Manipulation Procedures for Assisted Hatching Timing acronym: IMPACT overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2026-05 date: 2024-04-22 date: 2024-04-22 name: Reproductive Medicine Associates of New Jersey class: OTHER briefSummary: This study aims to assess the clinical significance of cleavage stage (Day 3) assisted hatching compared to assisted hatching at the blastocyst stage (Day 5,6,7) of embryo development at the time of trophectoderm (TE) biopsy for patients undergoing in vitro fertilization (IVF) and preimplantation genetic testing for aneuploidy (PGT-A) for treatment of their infertility. conditions: Infertility studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: Laser Assisted Hatching measure: Blastulation Rate measure: Embryo morphologic grade measure: Timing of blastulation measure: Aneuploidy rate measure: Positive pregnancy rate measure: Sustained implantation rate measure: Pregnancy loss rate measure: Live birth rate sex: FEMALE minimumAge: 18 Years maximumAge: 42 Years stdAges: ADULT facility: Reproductive Medicine Associates of New Jersey city: Marlton state: New Jersey zip: 08053 country: United States name: Christine V Whitehead, MS, BSN, RN role: CONTACT phone: 973-656-2841 email: clinicalresearchteam@ivirma.com name: Caroline Zuckerman, BS, RN role: CONTACT phone: 19736562841 email: clinicalresearchteam@ivirma.com name: Jason Fransiak, MD role: PRINCIPAL_INVESTIGATOR name: Kevin Lambrese, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.89122 lon: -74.92183 hasResults: False

 nctId: NCT06377904 id: 2023-A02125-40 briefTitle: Clinical and Therapeutic Characteristics of Geriatric Patients Hospitalized for Heart Failure (AGING HF Study (AGe and Heart Failure IN Geriatrics)) acronym: AGING HF overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2028-04 date: 2024-04-22 date: 2024-04-22 name: Gérond'if class: OTHER briefSummary: This retrospective (between April 2020 and December 2023) then prospective (between January 2024 and August 2026), non-interventional cohort study has as its main objective to evaluate the clinical and therapeutic characteristics of patients aged 75 and over hospitalized in geriatrics for heart failure and also to evaluate the clinical characteristics and triggering factor(s) of acute heart failure. conditions: Patients Hospitalized in Geriatrics for Heart Failure conditions: Patients Aged 75 and Over studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 810 type: ESTIMATED measure: Evaluate the clinical and therapeutic characteristics of elderly patients hospitalized in geriatrics for heart failure measure: Factors associated with patients hospitalization or rehospitalization sex: ALL minimumAge: 75 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06377891 id: TDK-2024-13563 briefTitle: The Effect of Emotional Resilience Training on Fear of Birth and Depression in Primiparous Pregnant Women overallStatus: ENROLLING_BY_INVITATION date: 2024-04-16 date: 2024-10-30 date: 2024-12-30 date: 2024-04-22 date: 2024-04-22 name: Ataturk University class: OTHER name: Atatürk University briefSummary: Although birth has a great place in a woman's life, factors such as the woman's education level, personal experiences, social support status, whether the pregnancy is planned or not, the family's attitude towards pregnancy, and socioeconomic status increase the burden of pregnancy and can create a stressful situation for the woman. While the pain that may be experienced during birth, thoughts about the baby's health and postpartum baby care further increase this fear, primiparous women who will give birth for the first time experience many emotions that they cannot define and cannot predict the situations they will encounter during birth. The most important situation that will cause pain during birth is fear. So much so that fear of birth may cause women to avoid pregnancy and increase optional abortions.In particular, fear of birth may increase cesarean delivery rates and also lead to negative maternal outcomes such as poor mental health after birth. Fear experienced during the antenatal period can lead to difficult births, mother-baby attachment problems, and depression. While fear of birth causes depression and anxiety disorders in the postpartum period, it is stated that depression experienced during pregnancy may increase the fear of birth, or fear of birth may be a hidden symptom of depression. It is noted that emotional regulation skills and resilience in pregnant women can be effective strategies in minimizing and managing fear, anxiety, stress, and anxiety. Emotional resilience is defined as the style of coping with stress, the ability to repair oneself, the ability to recover from adverse events quickly, and the state of adapting to a new environment. In particular, individuals with high emotional resilience can protect their physical and mental health and increase their life satisfaction by reducing the negative consequences they experience. With the emotional resilience training given during pregnancy, pregnant women's stress, fear, and anxiety will be reduced, and they will be able to cope better with the difficulties they experience. This research will be conducted to examine the effect of emotional resilience training given to primiparous pregnant women on fear of childbirth and depression. conditions: Fear of Childbirth conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Emotional Resilience training measure: The effect of emotional resilience on fear of birth and depression in primiparous pregnant women. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bayburt State Hospital city: Bayburt zip: 69000 country: Turkey lat: 40.25631 lon: 40.22289 hasResults: False

 nctId: NCT06377878 id: Pro00008369 briefTitle: The Preeclampsia Registry acronym: TPR overallStatus: RECRUITING date: 2013-09-01 date: 2040-05 date: 2040-05 date: 2024-04-22 date: 2024-04-22 name: Preeclampsia Foundation class: OTHER briefSummary: The purpose of The Preeclampsia Registry is to collect and store medical and other information from women who have been medically diagnosed with preeclampsia or a related hypertensive (high blood pressure) disorder of pregnancy such as eclampsia or HELLP syndrome, their family members, and women who have not had preeclampsia to serve as controls. Information from participants will be used for medical research to try to understand why preeclampsia occurs, how to predict it better, and to develop experimental clinical trials of new treatments. The Registry will consist of a web-based survey and mechanism for collecting and reviewing medical records. This data will be utilized for immediate investigator-driven cross-sectional research projects (after proposal review by the Registry's scientific advisory board and as directed by the PI). Participants may also choose to be contacted regarding possible participation in future studies, about providing a biospecimen, as well as investigator-driven clinical trials. The Registry is anticipated to exist long-term and to serve as a foundation of participants from which to draw for studies of preeclampsia, anticipated to evolve as our scientific understanding of preeclampsia evolves. conditions: Preeclampsia conditions: Eclampsia conditions: HELLP Syndrome conditions: Toxemia conditions: Hypertensive Disorder of Pregnancy studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 20000 type: ESTIMATED measure: Self Reported Diagnosis of Preeclampsia and Hypertensive Disorders of Pregnancy Confirmed by Medical Records sex: ALL minimumAge: 13 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Preeclampsia Foundation status: RECRUITING city: Melbourne state: Florida zip: 32940 country: United States name: VeeAnn Argyle role: CONTACT phone: 321-421-6957 email: Registry@preeclampsia.org name: Eleni Z Tsigas, BA role: PRINCIPAL_INVESTIGATOR name: Hilary Gammill, MD role: SUB_INVESTIGATOR name: James Roberts, MD role: SUB_INVESTIGATOR lat: 28.08363 lon: -80.60811 hasResults: False

 nctId: NCT06377865 id: endocrine dis & B thalassemia briefTitle: Thyroid Function , HbA1c in Relation to Ferritin Level in Adullt Patient e B Thalassemia overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-11-01 date: 2026-05-01 date: 2024-04-22 date: 2024-04-22 name: Assiut University class: OTHER briefSummary: to evaluate thyroid function ,HbA1C,\&lipid profile in thalassemic patient to correlate thyroid function , Hba1c , lipid profile e ferritin level in thalassemic patient conditions: B Thalassemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 72 type: ESTIMATED measure: Thyroid function ,Hba1c in relation to ferritin level in adult patients with beta thalassemia sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06377852 id: Pro00075309 briefTitle: The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study overallStatus: NOT_YET_RECRUITING date: 2024-10-28 date: 2028-08-31 date: 2028-09-01 date: 2024-04-22 date: 2024-04-22 name: American Society of Clinical Oncology class: OTHER name: Patient-Centered Outcomes Research Institute briefSummary: The purpose of this study is to generate evidence on an alternative dosing strategy for CDK4/6 inhibitors to help more patients with MBC (age ≥ 65 years) tolerate side effects and stay on treatment longer, to derive the most clinical benefit from these drugs.

The primary objective of the CDK Study is to compare TTD on the approved dosing for palbociclib (125 mg orally daily on days 1-21 of 28-day cycle) or ribociclib (600 mg orally daily on days 1-21 of 28-day cycle) vs. TTD using titrated dosing approach with the same schedule but starting at a lower dose of palbociclib (100 mg or 75 mg) or ribociclib (400 mg or 200 mg) and escalating the dose if well-tolerated in combination with provider/patient choice endocrine therapy (AI or fulvestrant) in patients age 65 or older with HR+/HER2- MBC. The secondary and exploratory objectives will generate evidence needed to personalize treatment decisions by comparing patient-centric secondary outcomes and evaluating baseline factors.

Together with their treating physician, participants will choose the CDK4/6 inhibitor (palbociclib or ribociclib) and which endocrine therapy (aromatase inhibitor or fulvestrant) of their choice but will be randomized to either Arm 1 (indicated dosing) or Arm 2 (titrated dosing). conditions: Metastatic Breast Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 500 patients will be enrolled, 250 per arm (Arm 1 being indicated dose, Arm 2 being titrated dose). primaryPurpose: TREATMENT masking: NONE count: 500 type: ESTIMATED name: Palbociclib name: Ribociclib measure: Time to Treatment Discontinuation (TTD) measure: Toxicity (grade 3-4 AEs) measure: Event-Free survival (EFS) measure: Quality of life assessed by patient reported outcomes measure: Time to dose reduction and escalation measure: Reason for not escalating measure: Treatment received (missed doses, cumulative dose, etc.) measure: Healthcare utilization (ED visits, hospital admissions, etc.) measure: Body Mass Index sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06377839 id: N-20230048 briefTitle: Pain After Removal of Mandibular Third Molars With or Without Advanced Platelet-rich Fibrin overallStatus: RECRUITING date: 2024-01-10 date: 2024-04-17 date: 2025-12-01 date: 2024-04-22 date: 2024-04-22 name: Aalborg University Hospital class: OTHER name: Aalborg University briefSummary: Pain is the most common complication following surgical removal of an impacted mandibular third molar. Several risk factors may increase the intensity and duration of pain following removal of mandibular third molars. Acute postoperative pain can transcript into postoperative chronic pain without an explainable reason or a specific risk factor. The use of advanced platelet-rich fibrin in the extraction socket following surgical removal of mandibular third molar have diminished the intensity and duration of acute postoperative pain and facilitated improved wound healing. The objective of the present study is therefore to identified specific risk factors and predictors for developing postoperative chronic pain following surgical removal of mandibular third molars with or without advanced platelet-rich fibrin applied in the extraction socket using epigenetic modulation. conditions: Pain Syndrome studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: Advanced platelet-rich fibrin in the ekstraction socket measure: Assessment of postoperative pain by using Visual Analoque scale measure: Assessment of quality of life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Oral and Maxillofacial surgery, Aalborg University Hospital status: RECRUITING city: Aalborg state: Nordjylland zip: 9000 country: Denmark name: Thomas Starch-Jensen, Professor role: CONTACT phone: +45 23266370 email: thomas.jensen@rn.dk lat: 57.048 lon: 9.9187 hasResults: False

 nctId: NCT06377826 id: RCRAHS-ISB/REC/MS-PT/01813 briefTitle: Comparison of Aerobic and Resistance Training on Exercise Capacity, Depression and Quality of Life in Hypothyroidism. overallStatus: RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-06-01 date: 2024-04-22 date: 2024-04-22 name: Riphah International University class: OTHER briefSummary: the study will show the effects of aerobic and resistance training on exercise capacity, depression and quality of life in patients with hypothyroidism. The evaluation of TSH level before and after the exercise sessions will provide valuable data. conditions: Comparison of Aerobic Exercise and Resistance Training studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 66 type: ESTIMATED name: aerobic exercises name: resistance training name: medication measure: 6 Minute Walk Test measure: The Beck Depression Inventory Scale measure: SF- 36 SF-36 sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT facility: Abbottabad medical complex status: RECRUITING city: Abbottābād state: Khyber Pakhtunkhwa zip: 21300 country: Pakistan name: saira jahan, MS role: CONTACT phone: 031591289095 email: saira.jahan@riphah.edu.pk name: Usama Iqbal role: PRINCIPAL_INVESTIGATOR lat: 34.1463 lon: 73.21168 hasResults: False

 nctId: NCT06377813 id: REC/RCR& AHS/23/01100/Maryam briefTitle: Combined Mode-Kinetic Chain Exercise With and Without Core Stability Exercises on Patients With Knee Osteoarthritis overallStatus: RECRUITING date: 2023-11-20 date: 2024-06-01 date: 2024-06-01 date: 2024-04-22 date: 2024-04-22 name: Riphah International University class: OTHER briefSummary: The goal of this \[type of study: Randomized control trial\] is to \[ see the effects of Combined Mode Kinetic Chain Exercises along with or without core stability exercises on pain, range of motion and disability \] in \[ in patients with Knee Osteoarthritis\].The main question it aims to answer is:

Wether core stability exercises is effective if performed along with Combined chain kinetic exercises to improves the condition of Knee Osteoarthritis? Group A will receive Core Stability Exercises along with Combined Chain Kinetic Exercises and Group B will receive combined Chain Kinetic Exercises. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Assignment primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: Mode-Kinetic Chain Exercise With Core Stability Exercises name: Mode-Kinetic Chain Exercise measure: Numeric pain rating scale measure: Kellgren and Lawrence system for classification of Osteoarthritis measure: Knee Injury and Osteoarthritic outcome score (KOOS) measure: Goniometer sex: ALL minimumAge: 40 Years maximumAge: 70 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 name: Maryam Maqsood, DPT role: CONTACT phone: 03314815652 email: mail.maryam70@gmail.com lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06377800 id: REC 01801 Kainat Fatima briefTitle: Effects Of Navicular Mobilization In Patients With Planter Fasciitis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-07 date: 2024-04-22 date: 2024-04-22 name: Riphah International University class: OTHER briefSummary: The significance of studying the effects of navicular mobilization in patients suffering from plantar fasciitis lies in its potential to provide valuable insights into non-invasive treatment approaches for a common and debilitating foot condition such as flat foot. Understanding how this therapy impacts navicular height, pain and disability of the foot can lead to improved clinical outcomes and a better understanding of the biomechanical factors contributing to plantar fasciitis. Ultimately, this research may help refine treatment strategies and enhance the quality of life for individuals suffering from this condition conditions: Plantar Fascitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: navicular mobilization along conventional therapy. name: conventional therapy measure: Numeric Pain Rating Scale measure: (Foot Function Index) measure: Navicular drop test measure: Foot print analysis sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: DHQ Hospital city: Faisalābad state: Punjab country: Pakistan name: Maria Khalid, MSOMPT role: CONTACT phone: 03315369768 email: maria.khalid@riphah.edu.pk name: Kainat Fatima, MSOMPT* role: CONTACT name: Kainat Fatima, MSOMPT* role: PRINCIPAL_INVESTIGATOR lat: 31.41554 lon: 73.08969 hasResults: False

 nctId: NCT06377787 id: REC 01732 Aneeqa Zaheer briefTitle: Effects of ELDOA in Patients With Cervicogenic Headache overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-07 date: 2024-04-22 date: 2024-04-22 name: Riphah International University class: OTHER briefSummary: The aim of our study is to determine the effect of ELDOA in relieving pain, improving ROM and functional disability in patients with cervicogenic headache. This study will add to the growing body of knowledge that if this technique yields comparable outcomes, it would be the alternative therapy. Moreover, it would add to the society as no literature is available on the effect of ELDOA technique in the management of Cervicogenic headache. conditions: Cervicogenic Headache studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: ELDOA and conventional therapy name: conventional therapy measure: (Numeric Pain Rating Scale). measure: NDI (U) (Neck Disability Index) measure: Inclinometer sex: ALL minimumAge: 30 Years maximumAge: 45 Years stdAges: ADULT facility: Alkhidmat Raazi Hospital CBR Town city: Islamabad state: Punjab zip: 46000 country: Pakistan name: Maria Khalid, MSOMPT role: CONTACT phone: 03315369768 email: maria.khalid@riphah.edu.pk name: Aneeqa Zaheer, MSOMPT* role: CONTACT name: Aneeqa Zaheer, MSOMPT* role: PRINCIPAL_INVESTIGATOR lat: 33.72148 lon: 73.04329 hasResults: False

 nctId: NCT06377774 id: NFEC-2024-096 briefTitle: To Optimize Therapeutic Procedures of DPMAS in ACLF Patients: a Prospective, Sigle Arm and Multicenter Study overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-03-30 date: 2026-02-01 date: 2024-04-22 date: 2024-04-22 name: Nanfang Hospital, Southern Medical University class: OTHER briefSummary: Acute-on-chronic liver failure (ACLF) is a life-threaten syndrome carrying high-short-term mortality raging 40% to 60% within 90 days in patients with chronic liver disease. Double plasma molecular adsorption system (DPMAS) is one of the available artificial liver support systems, which combines plasma filtration and two specific adsorption membranes dedicating to remove bilirubin and the middle molecular toxins respectively. The efficiency of DMPAS treatment in liver failure patients remains controversial. Previous study indicate that liver failure patients with DPMAS therapy improve the short-term mortality and prevent the diseases progression within 28 days (PADSTONE Study). Thus, this single-arm, multicenter and prospective study is to further validate and optimize the therapeutic procedures of DPMAS therapy in ACLF patients. conditions: Acute-On-Chronic Liver Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED name: No intervention in this study measure: 28-day transplantation-free mortality measure: The disease progression rate measure: the 90-day transplantation-free mortality measure: the disease progression sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06377761 id: BF-2022-121 briefTitle: Study on Heart Failure With Preserved Ejection Fraction With Qishen Granules overallStatus: RECRUITING date: 2023-05-01 date: 2024-12-31 date: 2025-12-31 date: 2024-04-22 date: 2024-04-22 name: Guangdong Provincial Hospital of Traditional Chinese Medicine class: OTHER briefSummary: With the cardiopulmonary exercise testing as the primary outcome, the study aims to evaluate the efficacy of Qishen Granules on cardiac function, quality of life and biomarker level of patients with heart failure with preserved ejection fraction (HFpEF), which will provide evidence for the treatment of HFpEF with traditional Chinese medicine. conditions: Heart Failure With Preserved Ejection Fraction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Random parallel grouping primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Qishen Granules name: Placebo measure: Changes in peak oxygen uptake within the average minute (PeakVO2) compared to baseline on day 90 measure: Changes in Mitral valve diastolic blood flow velocity (E) and Mitral annulus lateral and septal motion velocity (e') compared to baseline on day 90 measure: Changes in E/e' ratio compared to baseline on day 90 measure: Changes in Left Atrial Volume index (LAVI) compared to baseline on day 90 measure: Changes in Left ventricular mass index (LVMI) compared to baseline on day 90 measure: Changes in Score of Kansas City Cardiomyopathy Questionnaire (KCCQ) compared to baseline on day 90 measure: Changes in blood N terminal pro B type natriuretic peptide(NT-proBNP) compared to baseline on day 90 measure: Changes in blood Growth STimulation expressed gene 2(ST2) compared to baseline on day 90 measure: Changes in blood urea compared to baseline on day 90 measure: Changes in blood creatinine compared to baseline on day 90 measure: Changes in Aspartate aminotransferase(AST) compared to baseline on day 90 measure: Changes in Alanine aminotransferase(ALT) compared to baseline on day 90 measure: Number of participants with treatment-related adverse events sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Provincial Hospital of Chinese Medicine status: RECRUITING city: Guangzhou state: Guangdong zip: 510120 country: China name: Lei Wang, M.D role: CONTACT phone: 8620-81887233-32801 email: Dr.wanglei@139.com lat: 23.11667 lon: 113.25 facility: WangLei status: RECRUITING city: Guangzhou state: Guangdong zip: 510120 country: China name: Lei Wang, doctorate role: CONTACT phone: +8613724078381 email: Dr.wanglei@139.com name: Shuai Mao, doctorate role: CONTACT phone: 86-20-81887233-32801 email: maoshuaitcm@163.com lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06377748 id: 2023/02 briefTitle: The Effect of Facilitated-tucking and ShotBlocker on Pain Caused by Vaccination in Healthy Infants overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-30 date: 2024-07-30 date: 2024-04-22 date: 2024-04-22 name: Istanbul Medeniyet University class: OTHER briefSummary: This study will be investigated the effects of facilitated tucking, ShotBlocker and combined facilitated tucking and ShotBlocker methods on procedural pain, crying time and duration of the procedure during Hepatitis B vaccine administration in healthy term infants. conditions: Procedural Pain conditions: Pain, Acute conditions: Nursing Caries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be assigned to experimental and control groups using block randomization method. Birth weight (2500-3000 g, 3001-3500 g, 3501 g and above), gender (male and female) and mode of delivery (vaginal and cesarean section) variables will be used for block randomization. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Using the block randomization technique, participants will be divided into 4 groups. A web-based randomization list creation tool will be used to create the blocked randomization list. Control and intervention groups will be coded as A, B, C and D using the sealed envelope method. Randomization information will be kept from the researcher involved in data collection until data collection begins. The researcher will learn which group each baby is in just before the application (researcher blinding).

Parents will know which group the baby is in within the scope of the research. By the nature of the sample group, babies are blind.

Research data will be entered into the computer database by coding the group name as A, B, C and D, and statistical analysis will be performed using this coding (statistician blinding). whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 144 type: ESTIMATED name: Facilitated tucking position name: ShotBlocker name: Combined facilitated tucking and ShotBlocker measure: Neonatal Infant Pain Scale measure: Crying time during the procedure measure: Procedure time sex: ALL minimumAge: 38 Weeks maximumAge: 42 Weeks stdAges: CHILD facility: Istanbul Medeniyet University city: Istanbul state: Kadıköy zip: 34720 country: Turkey name: Aynur Aytekin Özdemir, PhD role: CONTACT lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06377735 id: CHEST-001 briefTitle: BAI-BACE for Advanced Lung Squamous Cell Carcinoma overallStatus: RECRUITING date: 2024-05-01 date: 2025-12-30 date: 2026-12-30 date: 2024-04-22 date: 2024-04-24 name: Sun Yat-sen University class: OTHER briefSummary: Bronchial arterial infusion plus bronchial arterial chemoembolization (BAI-BACE) has been reported as non-first-line therapy to treat lung cancer in many hospitals in China. BAI, which uses chemotherapeutic drugs directly injected into the tumor and achieved a high concentration in a short time to kill the tumor. Then BACE could seal off the tumor vessels. In this study, we aim to describe the efficacy and safety of BAI-BACE as non-first-line for advanced lung squamous cell carcinoma. conditions: Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Bronchial arterial infusion, bronchial arterial chemoembolization (BACE-BAI) procedure was performed as follows: Bronchial arteriography was performed to find tumor-feeding artery. After the catheter had been inserted into the tumor-feeding artery, paclitaxel (300 mg) was infused slowly at least 30 min. BAI (bronchial arterial infusion) chemotherapy was followed by BACE (Drug-eluting beads bronchial arterial chemoembolization); the CalliSpheres loaded with cis-platinum (30 mg) were infused into the tumor-feeding arteries until stasis or near-stasis of blood flow in the vessel was observed. primaryPurpose: TREATMENT masking: NONE count: 85 type: ESTIMATED name: BAI-BACE measure: Progression-Free-Survival (PFS) measure: Overall survival (OS) measure: Objective response rate (ORR) measure: Adverse events sex: ALL minimumAge: 18 Years maximumAge: 80 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: NCT06377722 id: CABOPRE briefTitle: Cabozantinib Treatment Prior to Cytoreductive Nephrectomy in Patients With Advanced or Metastatic Renal Cells Cancer overallStatus: TERMINATED date: 2018-11-01 date: 2022-08-09 date: 2022-08-09 date: 2024-04-22 date: 2024-04-26 name: Fundacion Oncosur class: NETWORK briefSummary: Phase II, multicenter, national, uncontrolled, multicenter, uncontrolled, phase II clinical trial for the evaluation of cabozantinib treatment prior to cytoreductive nephrectomy in patients with advanced or metastatic renal cell cancer candidates for primary tumor cytoreductive nephrectomy (NC). conditions: Renal Cell Carcinoma Metastatic conditions: Renal Cell Carcinoma Stage IV conditions: Renal Cell Carcinoma Stage III studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 18 type: ACTUAL name: Cabozantinib measure: Radiological response rate prior to cytoreductive nephrectomy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario Central de Asturias city: Oviedo state: Asturias country: Spain lat: 43.36029 lon: -5.84476 facility: Institut Català d'Oncologia. Idibell city: L'Hospitalet de Llobregat state: Barcelona country: Spain lat: 41.35967 lon: 2.10028 facility: Hospital Universitario de Valdecilla city: Santander state: Cantabria country: Spain lat: 43.46472 lon: -3.80444 facility: Hospital Univeristario 12 de Octubre city: Madrid zip: 28041 country: Spain lat: 40.4165 lon: -3.70256 facility: Centro Oncológico Clara Campal - HM CIOCC city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: Hospital Universitario La Paz city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Ramón y Cajal city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Severo Ochoa city: Madrid country: Spain lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06377709 id: 24CP001 briefTitle: A Mixed-methods Acceptability Study of ProACTive™ to Help Burns Patients Adjust to Changes to Appearance overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2024-12 date: 2024-04-22 date: 2024-04-24 name: Nottingham University Hospitals NHS Trust class: OTHER briefSummary: This mixed-methods acceptability study aims to investigate whether an early acceptance and commitment therapy (ACT) based intervention called ProACTive™, aimed at supporting burns patients' adjustment to a changed appearance and preventing distress, is acceptable. This will be measured by descriptive data, questionnaire data and semi-structured interviews.

Preliminary data on the potential clinical effectiveness of the intervention will also be gathered. This will be measured by scores on standardised questionnaires. conditions: Burn Injuries conditions: Burns conditions: Emotional Distress conditions: Adjustment studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 15 type: ESTIMATED name: ProACTive™ measure: Body Esteem Scale for Adolescents and Adults - Appearance subscale (BESAA-A) measure: Positive and Negative Affect Schedule (PANAS-GEN) measure: Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT) measure: Self-Compassion Scale - Short Form (SCS-SF) measure: Helpful Aspects of Therapy Form (HAT) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06377696 id: MC230713 id: NCI-2024-02980 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: MC230713 type: OTHER domain: Mayo Clinic in Rochester id: 23-005512 type: OTHER domain: Mayo Clinic Institutional Review Board briefTitle: Remote Cognitive Assessment Battery and Wearable Device Monitoring Platform While Assessing the Impact of Metformin in Patients With History of Cranial Radiation Therapy overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04-30 date: 2027-04-30 date: 2024-04-22 date: 2024-04-26 name: Mayo Clinic class: OTHER briefSummary: This phase III trial evaluates whether patient care can be done remotely for patients having cranial (skull) radiation or who have previously had cranial radiation. In addition, this trial compares study outcomes between patients who get metformin and those who do not. Cranial radiation, an essential component of brain tumor treatment, can result in significant negative effects on cognitive (the ability to clearly think, learn, and remember) function. Wearable devices have been used in the field of neurology for seizure detection and assessment of patients with movement disorders. Wearable device technology has also been implemented for remote monitoring of cancer patients and for cancer clinical trials. Metformin is the active ingredient in a drug used to treat type 2 diabetes mellitus (a condition in which the body cannot control the level of sugar in the blood). It is also being studied in the treatment of cancer. Use of metformin may reduce risk of cognitive decline following radiation therapy within the skull (intracranial). These effects may be further strengthen by addition of device-based physical activity promotion. Mayo Test Drive is a web-based platform for remote self-administered cognitive assessment. Using Mayo Test Drive may help determine whether patient care can be done remotely, while simultaneously evaluating benefits of health promotion through use of a wearable watch device and metformin in preventing radiation-related cognitive decline. conditions: Malignant Brain Neoplasm studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 100 type: ESTIMATED name: Best Practice name: Medical Device Usage and Evaluation name: Metformin name: Neurocognitive Assessment name: Questionnaire Administration measure: Compliance of patients who complete the testing schedule for the cognitive assessments (Feasibility) measure: Overall completion rates and compliance (Feasibility) measure: Overall satisfaction measure: Adherence (Feasibility) measure: Neurocognitive scores measure: Incidence of adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester 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: Ugur T. Sener, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06377683 id: XMYY-2023KY122 briefTitle: Clinical Evaluation of 177Lu-DansyI-PSMA (LNC1011) in Patients With Metastatic Castration-Resistant Prostate Cancer overallStatus: RECRUITING date: 2024-04-05 date: 2025-12-30 date: 2026-12-30 date: 2024-04-22 date: 2024-04-22 name: The First Affiliated Hospital of Xiamen University class: OTHER briefSummary: Ten to 20% of patients with prostate cancer (PC) experience progression in their disease, even after undergoing pharmaceutical or surgical castration, leading to metastatic CRPC (mCRPC). Prostate-specific membrane antigen (PSMA) is a membrane-bound glycoprotein mostly specific to the prostate. While PSMA is expressed at low levels in normal prostate, this expression increased by 100-1000-fold in PC, which makes it a favorable target for therapy. This study was designed to evaluate the safety, tolerability, and maximum tolerated dose of a long-lasting radiolabeled ligand 177Lu-Dansyl-PSMA in mCRPC patients. conditions: Metastatic Castration-resistant Prostate Cancer, mCRPC studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: classic 3+3 dose escalation primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: 177Lu-Dansyl-PSMA radioligand therapy measure: Incidence of treatment-related adverse events (safety and tolerability) measure: To determine the maximum tolerated dose (MTD) measure: Dosimetry sex: MALE minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Xiamen University status: RECRUITING city: Xiamen state: Fujian zip: 361003 country: China name: Haojun Chen, MD, PhD role: CONTACT phone: +8618659285282 email: leochen0821@foxmail.com name: Hao Fu, MD, PhD role: CONTACT phone: +8615959230059 email: fuhaonuclear@163.com name: Haojun Chen, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Hao Fu, MD, PhD role: SUB_INVESTIGATOR lat: 24.47979 lon: 118.08187 hasResults: False

 nctId: NCT06377670 id: 38RC24.0012 briefTitle: Study of Functional and Aesthetic Outcomes After Wassel IV Thumb Duplication Surgery in Pediatric Population, With a Follow-up of at Least One Year overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2024-05-06 date: 2024-05-15 date: 2024-04-22 date: 2024-04-22 name: University Hospital, Grenoble class: OTHER briefSummary: The purpose of this study is to evaluate the functional and aesthetic outcomes in children with Wassel IV thumb duplication conditions: Wassel IV Thumb Duplication studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 30 type: ESTIMATED name: Wassel IV Thumb Duplication Surgery measure: Functional and Aesthetic Outcomes measure: Comparison of Surgical Techniques measure: Efficacy of Skin Flap Types measure: Immobilization Method Analysis measure: Preoperative Angle Decision Model sex: ALL minimumAge: 1 Year maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06377657 id: DONT4GET briefTitle: Oxidative and Antioxidant Indices to HIIT and Aloe Vera Supplementation in Patients With T2DM overallStatus: COMPLETED date: 2022-01-15 date: 2023-06-21 date: 2024-02-19 date: 2024-04-22 date: 2024-04-22 name: University of Nis class: OTHER briefSummary: Diabetes is a prevalent metabolic disease that leads to increased blood sugar levels due to insulin shortage or resistance. Type 2 diabetes is often linked to obesity, which can increase insulin resistance. Meteorin-like protein (METRNL) is a new secreted protein that affects insulin sensitivity and has been found to be negatively related to serum glucose levels in people with diabetes.

Oxidative stress in diabetics can stimulate the production of inflammatory mediators, increasing the activity of the antioxidant system. Aloe vera, a widely used plant, has been used for treating diabetes, wound healing, tumors, and inflammatory bowel disease. It has anti-inflammatory, antioxidant, neuroprotective, antidepressant, and memory-enhancing effects.

Exercise can improve diabetic patients' conditions by increasing the expression of GLUT4 protein and skeletal muscle. High-intensity interval training has been shown to increase the expression of the METORIN gene in human subjects and decrease MDA in type 2 diabetic patients. However, no studies have examined the simultaneous effect of exercise and Aloe vera on diabetes indicators.

The present study aims to investigate the response of METRNL and some oxidative and antioxidant plasma indicators to high-intensity interval training and Aloe vera supplementation in type 2 diabetic men. The findings indicate that exercise and consumption of plants with anti-inflammatory and antioxidant properties can be effective in modulating the pathological effects of diabetes and increasing insulin sensitivity. conditions: Diabetes Type 2 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The participants were blinded for the supplementation. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 44 type: ACTUAL name: Exercise name: Aloe vera measure: METRNL - Meteorin Like, Glial Cell Differentiation Regulator measure: Glutathione peroxidase (GPx) measure: Serum superoxide dismutase (SOD) measure: Total antioxidant blood capacity (TAD) measure: Plasma malondialdehyde (MDA) sex: MALE minimumAge: 25 Years maximumAge: 40 Years stdAges: ADULT facility: Department of Sport Physiology, Faculty of Sport and Physical education, Islamic Azad University of Ayatollah Amoli, Amol, Iran city: Amol country: Iran, Islamic Republic of lat: 36.46961 lon: 52.35072 hasResults: False

 nctId: NCT06377644 id: DPT/Batch-Fall19/560 briefTitle: Comparing the Efficacy of KT vs DN With Conventional Treatment for Improving QOL and Alleviating Pain in Frozen Shoulder overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-01 date: 2024-05-01 date: 2024-07-05 date: 2024-04-22 date: 2024-04-22 name: Superior University class: OTHER briefSummary: "Randomized control trial is our study design, we will make 2 groups group A ( 15 patients of frozen shoulder) and Group B (15 patients of frozen shoulder). we will apply interventions by this way For group A KT (kinesiology taping) will be applied on frozen shoulder patients by a professional physiotherapist or certified physiotherapist according to their pain pattern in muscles (supraspinatus, infraspinatus, teres minor, deltoid, subscapularis) with conventional physiotherapy of frozen shoulder also continues on 15 patients (group A). KT will apply twice a week for 8 weeks. We can check the results of our intervention every week by using variable tools or outcome measures, measuring pain by VAD (visual analog scale) and quality of life in the frozen shoulder by SPADI (shoulder pain and disability index) every week. And for group B Dry needling with conventional physical therapy. conditions: Frozen Shoulder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ACTUAL name: Kinesio taping name: Dry Needling measure: VAS measure: SPADI sex: ALL minimumAge: 35 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pain away Physical Therapy city: Lahore state: Punjab country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06377631 id: FATHIS+ briefTitle: Effect of Multi-ingredient on Visceral Adiposity & Non-alcoholic Fatty Liver Disease in Postmenopausal Women With Abdominal Obesity acronym: FATHIS+ overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-22 date: 2024-04-25 name: Fundació Eurecat class: OTHER name: Centre de Diagnosi per la Imatge name: Instituto de Investigación Biomédica de Girona (IDIBGI) name: Laboratorio de Referencia de Cataluña briefSummary: This study aims to evaluate the effect of daily intake of a specific combination of different natural histidine-related amino acids in combination with dietary recommendations, in the reduction of visceral fat, as well as their associated comorbidities, in postmenopausal women with abdominal obesity. conditions: Visceral Obesity conditions: Non-alcoholic Fatty Liver conditions: Postmenopausal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Multi-ingredient of L-histidine, L-serine, L-carnosine and N-Acetylcysteine name: Placebo measure: Change in Visceral Adiposity measure: Height (cm) measure: Age measure: Ethnicity measure: Change in Body Weight (kg) measure: Change in Body Mass Index (BMI) (Kg/m^2) measure: Change in Neck circumference (cm) measure: Change in Arm circumference (cm) measure: Change in Waist circumference (cm) measure: Change in Hip circumference (cm) measure: Change in Conicity Index measure: Change in Waist-to-Hip ratio measure: Change in Lipid Accumulation Product (LAP) measure: Change in Systolic Blood Pressure (mm Hg) measure: Change in Diastolic Blood Pressure (mm Hg) measure: Change in heart rate (bpm) measure: Change in serum glucose levels (mg/dL) measure: Change in serum total cholesterol (mg/dL) measure: Change in serum high-density lipoprotein cholesterol (HDL-C,mg/dL) measure: Change in serum low-density lipoprotein cholesterol (LDL-C, mg/dL) measure: Change in serum triglycerides (TG, mg/dL) measure: Change in serum alanine aminotransferase (ALT, U/L) measure: Change in serum aspartate aminotransferase (AST, U/L) measure: Change in serum gamma glutamyl transferase (GGT, U/L) measure: Change in serum insulin levels (mU/L) measure: Change in serum leptin levels (pg/mL) measure: Change in serum adiponectin levels (ng/mL) measure: Change in Adiponectin/Leptin ratio (numerical ratio) measure: Change in serum Monocyte chemoattractant protein-1 (MCP-1) levels (pg/mL) measure: Change in plasma tumor necrosis factor alpha (TNF-alpha) levels (pg/mL) measure: Change in plasma Interleukin 6 (IL-6) levels (pg/mL) measure: Change in plasma Interleukin 10 (IL-10) levels (pg/mL) measure: Change in plasma Intercellular Adhesion Molecule 1 (ICAM-1) levels (ng/mL) measure: Change in plasma Cluster of Differentiation 14 (CD14) levels (pg/mL) measure: Change in plasma oxidized low density lipoproteins (LDLox) levels (mU/L) measure: Change in serum C-Reactive protein levels (mg/L) measure: Change in Histidine levels in blood (umol/L) measure: Change in Acylcarnitine levels in blood (umol/L) measure: Change in 17-beta-estradiol (E2) levels in blood (pg/mL) measure: Change in Follicle-stimulating hormone (FSH) levels in blood (mU/mL) measure: Change in Homeostatic Model Assessment from Insulin Resistance Index (HOMA-IR) measure: Change in Fatty Liver Index (FLI) measure: Change in Triglyceride glucose index (TyG) measure: Change in Plasma atherogenic index measure: Change in lipidomic profile measure: Change in intestinal microbiota composition measure: Change in the expression of lipid-metabolism genes in PBMC measure: Change in Dietary habits measure: Change in Physical activity measure: Concomitant medication measure: Consumption of dietary supplements measure: Change in the Supraclavicular skin temperature measure: Change in postmenopausal symptoms measure: Adverse events sex: FEMALE minimumAge: 50 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anna Crescenti city: Reus state: Catalonia. Spain zip: 43204 country: Spain name: Anna Crescenti, PhD role: CONTACT phone: 977770958 email: anna.crescenti@eurecat.org lat: 41.15612 lon: 1.10687 hasResults: False

 nctId: NCT06377618 id: DPT/Batch-Fall19/556 briefTitle: Comparison Of Resistance Training And Core Strengthening Exercises Vitamin D In Postmenopausal Women With Low Back Pain overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-15 date: 2024-05-20 date: 2024-06-20 date: 2024-04-22 date: 2024-04-22 name: Superior University class: OTHER briefSummary: This study aims to evaluate the effectiveness of resistance training, core strengthening exercises, and vitamin D supplementation in reducing low back pain (LBP) among postmenopausal women. conditions: Menopausal conditions: Pain, Low Back studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 36 type: ACTUAL name: Resistance Training and Core Strengthening Exercises Group name: Resistance Training and Core Strengthening Exercises Group Plus Vitamin D Supplementation measure: Visual Analog Scale (VAS) measure: Oswestry Disability Index (ODI) sex: FEMALE minimumAge: 50 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azra Naheed Medical College, Superior University city: Lahore state: Punjab country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06377605 id: MD-15-2024 briefTitle: The Efficacy of Thoracic Erector Spinae Plane Block For Perioperative Analgesia in Laparoscopic Bariatric Surgery for Super Obese Patients: Randomized Controlled Trial. overallStatus: RECRUITING date: 2023-03-10 date: 2024-06-30 date: 2024-08-30 date: 2024-04-22 date: 2024-04-22 name: Amany Ahmed Eissa class: OTHER briefSummary: The epidemic of overweight and obesity presents a major challenge to chronic disease prevention and health across the life course around the world. \[1\] Bariatric surgery has proved to be an efficient intervention in the management of obesity. As a result, the number of post-bariatric surgery patients in the population is growing \[2\].

Postoperative analgesia presents various challenges in vulnerable patient groups suffering from obesity. With the high potential risk of respiratory depression and postoperative pulmonary complications associated with opioid use, such as atelectasis and pneumonia, the availability of other pain management modalities is essential \[14\].

Ultrasound-guided erector spinae plane block (ESPB) is a regional anesthesia technique where local anesthetic agent is injected deep to the erector spinae muscle to fascial plane and allowed to diffuse caudally and cranially. It is supposed to provide both visceral and somatic abdominal analgesia \[3\].

ESPB is effective, easy to perform, and can be performed in a short time. \[4\] It has been shown efficacy in different conditions such as thoracic surgery, trauma, cardiac surgery, breast surgery, and abdominal surgery \[5\]. However, the main concern with the ESPB block is feasibility together with the potency of the block in challenging populations, such as patients suffering from obesity.

Peripheral nerve blocks in the obese may pose challenges, like difficulties in proper patient positioning and landmark identification. However, Ultrasound guidance may help overcome many difficulties in regional techniques. But as expected, targets are more deeply situated in obese patients and the ultrasound beams are attenuated as they travel a greater distance through tissue layers. Additionally, when crossing a tissue boundary, a portion is reflected back to the transducer creating artifacts like speckling and clutter which are particular problems in the obese patient. \[15\] Few studies examined the use of ESPB in bariatric surgery \[3,6,7\], all indicating potential benefits of the technique in terms of opioid sparing and pain control. To date, the efficacy of ESPB has not been examined in superobese patient.

So we aim to compare the perioperative analgesic effect of bilateral ultrasound-guided ESPB with controls, Local bupivacaine infiltration to the trocar sites, in super obese patients undergoing bariatric surgery We hypothesis that ESBP provides good applicable modality of perioperative analgesia for superobese patients undergoing bariatric surgeries. conditions: Erector Spinae Plane Block conditions: Super Obese Patients conditions: Bariatric Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled trial- single blinded primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Computer-generated sequence will be used for randomization and opaque envelopes will be used for concealment. whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: ESPB name: local anaesthetic infiltration name: midazolam and lidocaine name: Bupivacain measure: Total opioid consumption measure: VAS score during first 24 hour postoperative sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Kasr Al Ainy Hospitals status: RECRUITING city: Cairo country: Egypt name: amany ahmea eissa, lecturer role: CONTACT phone: 01001807207 email: amany.eissa@kasralainy.edu.eg name: marwa saeed zayed, ass. professor role: CONTACT phone: 01003347560 email: marwa.zayed@kasralainy.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06377592 id: G22396 briefTitle: Development and Accuracy Evaluation of Gram Staining Analysis AI overallStatus: RECRUITING date: 2023-05-10 date: 2027-03-31 date: 2027-03-31 date: 2024-04-22 date: 2024-04-22 name: GramEye class: INDUSTRY briefSummary: The investigators use Gram-stained specimens provided from clinical settings to develop and evaluate the accuracy of Gram staining analysis AI conditions: Bacterial Infections studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 18000 type: ESTIMATED name: Sample collection without intervention measure: Advanced level of blood culture Gram stain analysis AI accuracy measure: Ordinary level of blood culture Gram stain analysis AI accuracy sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Osaka University Hospital status: RECRUITING city: Suita state: Osaka zip: 5650871 country: Japan name: Go Yamamoto role: CONTACT lat: 34.76143 lon: 135.51567 hasResults: False

 nctId: NCT06377579 id: FILObsLAM_IVOOBS briefTitle: OBServatory of Compassionate Use of IVOsidenib in France for Patients With Acute Myeloid Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-12-15 date: 2025-03-15 date: 2024-04-22 date: 2024-04-22 name: French Innovative Leukemia Organisation class: OTHER name: Acute Leukemia French Association briefSummary: Mutations in IDH genes are found in numerous cancers and more specifically in acute myeloid leukemia (AML). These mutations target specific amino acids, at positions 140 or 172 of IDH2, and 132 of IDH1. Mutant IDH proteins acquire an abnormal enzymatic activity allowing them to convert α-ketoglutarate (αKG) into D-2 hydroxyglutarate (D-2HG), an oncometabolite which massively accumulates in IDH-mutated cells. At high levels, D-2HG behaves as a competitive inhibitor of αKG and affects the activity of Fe(II)/αKG-dependent dioxygenases. This enzymatic family is involved in a broad spectrum of pathways such as demethylation of histone (JHDM histone demethylases) or DNA (methylcytosine hydroxylases of the TET family). As a result, IDH-mutated cells show altered survival, motility, invasiveness and cell differentiation. In AML, IDH1 mutations might be present in 10-15% at diagnosis

Ivosidenib (IVO) a first-in-class, oral, irreversible inhibitor of mutant IDH1 has shown clinical activity as a single agent in studies involving patients with IDH1 mutated relapsed or refractory (R/R) AML (DiNardo et al. 2018) and in front line settings (Montesinos et al. 2022). In phase II clinical trials, IVO yielded 30-35% of complete response rates both in frontline and R/R settings, with long lasting responses. Based on these results, the FDA (Food and Drug Agency) gave its approval for newly-diagnosed AML IDH1mut patients who are ≥ 75 years old or who have comorbidities and in R/R. However, European Medicines Agency (EMA)'s did not approved IVO due to lack of evidences to support the application. Agios Netherlands B.V. (the company that previously own the drug before Servier Laboratories) withdrew its EMA application. Nevertheless, IVO has been available in France through a compassionate use program (CUP), since February 2020 for R/R patients and March 2022 for first line treatment.

In this multicentric retrospective study, we aim to evaluate the efficacy and safety of Ivo in two cohorts of IDH1mut AML patients treated within the CUP. The first cohort will concern patients treated in first line setting and the second cohort those treated in R/R disease. Our results might provide new insights regarding IVO in real life settings and support signs of efficacy. This could provide new data for the haematologist community and for another appliance to grant EMA approval of IVO in the setting of R/R IDH1mut AML. conditions: AML, Adult studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 250 type: ESTIMATED measure: characterize the Overall survival (OS) in the both cohort : 1st line and Relapsed/Refractory (R/R) measure: characterize the composite response rate (CRc) at any time during follow-up, for the both cohort : 1st line and Relapsed/Refractory (R/R) measure: characterize the Event Free Survival (EFS) in both cohorts : 1st line and Relapsed/Refractory (R/R) measure: characterize the incidence and relatedness of serious adverse events (SAE), for patients treated by Ivosidenib, for both cohorts : 1st line and Relapsed/Refractory (R/R) measure: describe the management of treatment by Ivosidenib in both cohorts : 1st line and Relapsed/Refractory (R/R) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amiens CHU city: Amiens country: France lat: 49.9 lon: 2.3 facility: Angers CHU city: Angers country: France lat: 47.46667 lon: -0.55 facility: Bayonne CH city: Bayonne country: France lat: 43.48333 lon: -1.48333 facility: Besançon CHU city: Besançon country: France lat: 47.24878 lon: 6.01815 facility: CHU Estaing city: Clermont-Ferrand country: France lat: 45.77966 lon: 3.08628 facility: Créteil CHU HENRI MONDOR city: Créteil country: France lat: 48.78333 lon: 2.46667 facility: Grenoble CHU city: Grenoble country: France lat: 45.16667 lon: 5.71667 facility: Le Mans CH city: Le Mans country: France lat: 48.0 lon: 0.2 facility: Lyon sud CHU city: Lyon country: France lat: 45.74848 lon: 4.84669 facility: Marseille IPC city: Marseille country: France lat: 43.29551 lon: 5.38958 facility: Meaux CH de l'Est francilien city: Meaux country: France lat: 48.96014 lon: 2.87885 facility: Montpellier - Chu Saint Eloi city: Montpellier country: France lat: 43.61092 lon: 3.87723 facility: Nantes CHU city: Nantes country: France lat: 47.21725 lon: -1.55336 facility: Nice CHU city: Nice country: France lat: 43.70313 lon: 7.26608 facility: Orléans CHU city: Orléans zip: 45000 country: France lat: 47.90289 lon: 1.90389 facility: Paris Saint Louis city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Bordeaux CHU city: Pessac country: France lat: 44.81011 lon: -0.64129 facility: ICANS - Institut de cancérologie de strasbourg europe city: Strasbourg country: France lat: 48.58392 lon: 7.74553 facility: Toulouse - IUCT Oncopole - Service d'Hématologie city: Toulouse country: France lat: 43.60426 lon: 1.44367 hasResults: False

 nctId: NCT06377566 id: 24-039 briefTitle: A Study of BV-AVD in People With Bulky Hodgkin Lymphoma overallStatus: RECRUITING date: 2024-04-17 date: 2027-04 date: 2027-04 date: 2024-04-22 date: 2024-04-22 name: Memorial Sloan Kettering Cancer Center class: OTHER name: Seagen Inc. briefSummary: The purpose of this study is to test whether BV-AVD is an effective treatment in people with early stage, bulky Hodgkin lymphoma that was recently diagnosed and who have not yet received any treatments for their disease.

BV is a type of drug called an antibody-drug conjugate (ADC). ADCs are a substance made up of a monoclonal antibody chemically linked to a drug. Antibodies are proteins made by the immune system to fight infections and other possible harms to the body. The monoclonal antibody binds to specific proteins or receptors found on certain types of cells, including cancer cells. The linked drug enters these cells and kills them without harming other cells. Researchers think BV may be an effective treatment for this type of cancer because the drug targets cells that have CD30, which play a role in cancer cell growth. By destroying these cells, BV may help slow or stop the growth of the cancer. AVD (doxorubicin, vinblastine, and dacarbazine) is a treatment regimen that works by stopping the growth of cancer cells, either by killing the cells or by stopping them from dividing. The researchers think that BV in combination with AVD may work better than AVD alone to slow or stop the growth of the cancer. conditions: Hodgkin Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a multicenter, investigator-initiated, single-arm phase II trial. primaryPurpose: TREATMENT masking: NONE count: 71 type: ESTIMATED name: Brentuximab vedotin name: Doxorubicin name: Vinblastine name: Dacarbazine name: Pembrolizumab name: Gemcitabine name: Vinorelbine name: FDG-PET/CT scan measure: progression-free survival measure: overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Miami status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33136 country: United States name: Craig Moskowitz, MD role: CONTACT phone: 305-243-5302 lat: 25.77427 lon: -80.19366 facility: Memorial Sloan Kettering Basking Ridge (All Protocol Activities) status: RECRUITING city: Basking Ridge state: New Jersey zip: 07920 country: United States name: Robert Stuver, MD role: CONTACT phone: 646-608-4308 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: Robert Stuver, MD role: CONTACT phone: 646-608-4308 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: Robert Stuver, MD role: CONTACT phone: 646-608-4308 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: Robert Stuver, MD role: CONTACT phone: 646-608-4308 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: Robert Stuver, MD role: CONTACT phone: 646-608-4308 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: Robert Stuver, MD role: CONTACT phone: 646-608-4308 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: Robert Stuver, MD role: CONTACT phone: 646-608-4308 lat: 40.70038 lon: -73.59291 hasResults: False

 nctId: NCT06377553 id: 2023P000955 briefTitle: PET/MRI for Evaluation of Endometriosis overallStatus: NOT_YET_RECRUITING date: 2024-05-03 date: 2026-05-03 date: 2026-05-03 date: 2024-04-22 date: 2024-04-22 name: Massachusetts General Hospital class: OTHER briefSummary: This study aims to determine if PET/MRI can detect endometriosis and potentially improve upon currently available non-invasive diagnostic capabilities. Specifically, the authors will investigate the ability of PET/MRI to detect and quantify endometriosis, as well as differentiate among subcategories such as inflammatory peritoneal lesions, fibrotic deep infiltrating endometriosis lesions (DIE), and ovarian endometriomas. The authors will compare \[68Ga\]CBP8 or \[18F\]-FAPI-74 PET/MRI imaging versus the current gold standard diagnostic methods, including laparoscopic surgery, clinical follow-up, and follow-up imaging. conditions: Endometriosis conditions: Endometrioma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Radiotracer Injection name: Imaging name: Rectal Ultrasound Gel Injection measure: Diagnostic Accuracy of PET/MR in Preoperative Endometriosis Detection measure: Diagnostic Performance of PET/MRI vs. Conventional Imaging measure: Impact of [18F]-FAPI-74 and [68Ga]CBP8 PET/MRI on Diagnosis and Management in Endometriosis measure: Correlation of Pre-Treatment PET Uptake and Post-Treatment Response in Endometriosis sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School city: Charlestown state: Massachusetts zip: 02129 country: United States name: Onforio Catalano, MD, Ph.D role: CONTACT phone: 617-724-4030 email: ocatalano@mgh.harvard.edu name: Diandrea Galloway role: CONTACT phone: 617-643-1407 email: dgalloway@mgh.harvard.edu lat: 42.37787 lon: -71.062 hasResults: False

 nctId: NCT06377540 id: 2022LS174 briefTitle: MT2022-60: Ph 2 Study of Pembro+ BEAM With ASCT for Relapsed Hodgkin Lymphoma overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2026-09-01 date: 2027-09-01 date: 2024-04-22 date: 2024-04-22 name: Masonic Cancer Center, University of Minnesota class: OTHER briefSummary: This is a Phase 2 single arm study to evaluate efficacy and safety of Pembrolizumab before with BEAM ASCT followed by Pembrolizumab maintenance for 1 year. Patients will receive 200 mg Pembrolizumab Q3week starting at day - 28 before stem cell transplant until 1 year after autologous stem cell transplant. conditions: Autologous Stem Cell Transplant conditions: Classic Hodgkin Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: Pembrolizumab name: Autologous stem cell transplant name: Carmustine name: Etoposide name: Cytarabine name: Melphalan measure: Progression free survival (PFS) measure: Overall survival (OS) measure: Progression-free survival (PFS) measure: Non-relapse mortality (NRM) measure: Overall Survival (OS) measure: Rate of Complete Metabolic Response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06377527 id: 2023-0945 id: NCI-2024-03342 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Establishing a Tumor Registry of Patients With Mesonephric-like Adenocarcinoma (MLA) overallStatus: NOT_YET_RECRUITING date: 2024-10-31 date: 2035-12-28 date: 2037-12-28 date: 2024-04-22 date: 2024-04-22 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To develop a database of medical information about patients with MLA in an effort to increase our understanding of the characteristics of MLA, which is the rarest form of endometrial carcinoma. conditions: Mesonephric-like Adenocarcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 2000 type: ESTIMATED measure: Tumor Registry 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: Jeffrey How, MD role: CONTACT name: Jeffrey How, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06377514 id: PCOL109PHNG briefTitle: Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-10-31 date: 2025-10-31 date: 2024-04-22 date: 2024-04-22 name: Johnson & Johnson Surgical Vision, Inc. class: INDUSTRY briefSummary: Prospective, multicenter, bilateral, interventional, controlled, masked (sponsor, subjects, and evaluators), randomized clinical trial. conditions: Cataracts studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: Test IOL Model DEN00V name: Control IOL Model DCB00 measure: Monocular photopic DCIVA (first eyes) at 66 cm measure: Monocular Depth of Focus measure: Monocular Photopic BCDVA at 4m measure: Monocular Photopic DCVA at 100 cm measure: Monocular photopic DCNVA at 40 cm (first eyes) sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06377501 id: 804687 briefTitle: Feasibility of a Whole-Food, Plant-Based Diet for Patients With Low-Risk Chronic Lymphocytic Leukemia (CLL) overallStatus: RECRUITING date: 2023-03-07 date: 2024-07-01 date: 2024-07 date: 2024-04-22 date: 2024-04-22 name: University of California, San Diego class: OTHER briefSummary: This study will evaluate the feasibility of an 8-week vegan whole-food, plant-based dietary intervention in subjects with low risk CLL who are undergoing observation. Over the course of 8 weeks, participants will attend weekly group cooking classes via Zoom lead by a RD. Participants will also attend weekly individual meetings with a health coaches to assist with adherence to the dietary intervention. conditions: Chronic Lymphocytic Leukemia Stage A(0) studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: Whole-food, plant-based diet measure: Adherence to the Dietary Intervention measure: Satisfaction with the Dietary Intervention measure: Cooking Class Adherence measure: Recruitment measure: Retention measure: White blood cell count measure: Absolute lymphocyte count measure: Anthropometric Measures (height, weight, body mass index) measure: Anthropometric Measures (waist circumference) measure: Biomarkers of cardiometabolic health (complete metabolic panel) measure: Biomarkers of cardiometabolic health (hemoglobin A1c) measure: Biomarkers of cardiometabolic health (cholesterol and triglycerides) measure: Concentration of vitamin B12 measure: Concentration of vitamin B9 measure: Concentration of iron measure: Concentration of ferritin measure: Blood pressure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UC San Diego status: RECRUITING city: San Diego state: California zip: 92093 country: United States name: Ariel Portera, DO role: CONTACT phone: 858-249-6896 email: aportera@health.ucsd.edu lat: 32.71533 lon: -117.15726 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-02-23 uploadDate: 2024-04-17T18:09 filename: ICF_000.pdf size: 514422 hasResults: False

 nctId: NCT06377488 id: CR-6542 briefTitle: Evaluation of the Clinical Performance of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-06-24 date: 2024-06-24 date: 2024-04-22 date: 2024-04-22 name: Johnson & Johnson Vision Care, Inc. class: INDUSTRY briefSummary: This will be an open-label, 3-visit, single-arm, dispensing clinical trial to evaluate visual acuity. conditions: Visual Acuity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 155 type: ESTIMATED name: JJVC Investigational Multifocal Toric Contact Lens manufactured in Senofilcon A (C3) material with UV blocker / HEV filter measure: High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuities at distance 4m measure: High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuities at intermediate distance 64cm measure: High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuities at near distance 40cm measure: Subjective Vision CLUE Scores measure: Rotational Stability measure: Absolute Rotation Error measure: Incidence of Unacceptable Lens Fit measure: Slit Lamp Findings measure: Subjective Handling Scores measure: Subjective Comfort Scores measure: Subjective Vision Scores measure: Lens Fit Success sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dr. James Weber & Associates, PA - City Square Blvd city: Jacksonville state: Florida zip: 32218 country: United States lat: 30.33218 lon: -81.65565 facility: Stam & Associates Eye Care city: Jacksonville state: Florida zip: 32256 country: United States lat: 30.33218 lon: -81.65565 facility: Omega Vision Center city: Longwood state: Florida zip: 32779 country: United States lat: 28.70305 lon: -81.3384 facility: Maitland Vision Center - North Orlando Ave city: Maitland state: Florida zip: 32751 country: United States lat: 28.62778 lon: -81.36312 facility: Mid-State Eye city: Clinton state: Illinois zip: 61727 country: United States lat: 40.15365 lon: -88.96453 facility: Kannarr Eye Care city: Pittsburg state: Kansas zip: 66762 country: United States lat: 37.41088 lon: -94.70496 facility: Birmingham Vision Care city: Bloomfield Hills state: Michigan zip: 48301 country: United States lat: 42.58364 lon: -83.24549 facility: Center for Ophthalmic and Vision Research/Eye Associates of New York city: Manhattan state: New York zip: 10022 country: United States lat: 40.78343 lon: -73.96625 facility: Sacco Eye Group city: Vestal state: New York zip: 13850 country: United States lat: 42.08507 lon: -76.05381 facility: ProCare Vision Centers city: Granville state: Ohio zip: 43023 country: United States lat: 40.06812 lon: -82.5196 facility: Luxe Vision and Optical city: Powell state: Ohio zip: 43065 country: United States lat: 40.15784 lon: -83.07519 facility: Dr. David W. Ferris & Associates city: Warwick state: Rhode Island zip: 02888 country: United States lat: 41.7001 lon: -71.41617 facility: Optometry Group, LLC city: Memphis state: Tennessee zip: 38111 country: United States lat: 35.14953 lon: -90.04898 facility: Tyler Eye Associates city: Tyler state: Texas zip: 75703 country: United States lat: 32.35126 lon: -95.30106 facility: New River Vision Care city: Oak Hill state: West Virginia zip: 25901 country: United States lat: 37.97233 lon: -81.14871 hasResults: False

 nctId: NCT06377475 id: 2024-00148 id: 2024-00148 type: REGISTRY domain: EKNZ briefTitle: Fabrication and Insertion of Michigan Splints by Dental Students overallStatus: ENROLLING_BY_INVITATION date: 2024-03-08 date: 2024-05 date: 2025-12 date: 2024-04-22 date: 2024-04-22 name: Juliana Marotti Großhausen class: OTHER briefSummary: The aim of this study is to investigate the potential effects of different jaw relation determination (KRB) techniques on the fabrication of Michigan splints, in particular by comparing conventional methods with a wax plate and the use of an anterior jig. All materials and methods for the fabrication of the Michigan splint are already part of the curriculum of the Clinic for Dental Prosthodontics for first-year Master-students. Therefore, we intend to conduct a retrospective study (for the 2023 cohort) and a prospective analysis of the data (for the 2024 and 2025 cohorts). Questionnaires, models and intraoral scans will be used to evaluate the efficacy and precision of the different KRB methods as well as the fabrication process of the Michigan splint. conditions: Impression Technic, Dental conditions: Jaw Relationship conditions: Bruxism studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 73 type: ESTIMATED name: Jaw relation name: Questionnaire measure: Wax vs JIG Registration measure: Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZB city: Basel zip: 4058 country: Switzerland lat: 47.55839 lon: 7.57327 hasResults: False

 nctId: NCT06377462 id: VEXAS-Registry briefTitle: Multicenter, Interdisciplinary National VEXAS Registry With Accompanying Biomaterial Collection overallStatus: RECRUITING date: 2024-03-13 date: 2029-12-31 date: 2030-12-31 date: 2024-04-22 date: 2024-04-22 name: Technische Universität Dresden class: OTHER name: Bristol-Myers Squibb name: University Hospital Munich briefSummary: The aim is rapid collection of real-life data on the epidemiology, treatment and disease course in patients with VEXAS syndrome during routine clinical practice and collect biomaterials to evaluate genotype-phenotype associations, determine optimal treatment schedule, identify diagnostic features and biomarkers conditions: VEXAS Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: Collection of epidemiological data on VEXAS measure: Collection and monitoring of initial disease manifestations measure: Documentation of the treatment approaches and therapy sequences measure: Analysis of clinical-relevant clinical endpoints measure: Describe disease cluster measure: Laboratory diagnostics measure: Correlation clinical endpoints with treatment approaches measure: Quality of life data (QoL), fatigue questionnaire (Facit-F) measure: Accompanying translational research measure: Collection of Biospecimens sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitätsklinikum Carl Gustav Carus status: RECRUITING city: Dresden zip: 01307 country: Germany name: Katja Sockel, Dr. med. role: CONTACT lat: 51.05089 lon: 13.73832 hasResults: False

 nctId: NCT06377449 id: UIL-CSP-18052023 briefTitle: Influence of Lung Ultrasonography on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-05-15 date: 2026-01-01 date: 2024-04-22 date: 2024-04-22 name: Saint Petersburg State University, Russia class: OTHER briefSummary: The goal of this interventional is to assess advantages of the ultrasound examination of the lungs in the early postoperative period in cardiac surgical patients after heart surgeries requiring cardiopulmonary bypass. Evaluation of pulmonary complications and outcomes during mid-term follow-up, as well as comparison of ultrasound examination and traditional roentgenologic methods (X-ray examination and CT of the chest) will be performed. The main question\[s\] it aims to answer are:

* Is ultrasound examination of the lungs a more specific and sensitive method in identification of early postoperative pulmonary complications after on-pump cardiac surgical procedures, in comparison with traditional X-ray methods.
* Does early identification of interstitial pulmonary edema (based on number of visualised B-lines in the early postoperative period), influences mid-term outcomes in this cohort of patients Participants will undergo ultrasound examination of the lungs on postoperative day 1, 3, 5 and 7 after heart surgery. Based on ultrasound findings and degree of interstitial pulmonary edema, medical (diuretics, anti-inflammatory, e.t.c) therapy will be modified.

Researchers will compare this group of patients with control group, in which ultrasound examination will be performed in the same time frames, but no changes in medical management based on ultrasound findings will be made to see if timely administered medical therapy, based on ultrasound findings, can significantly improve symptoms, hospital lengths of stay and outcomes of this patients. conditions: Ischemic Heart Disease conditions: Aortic Stenosis, Severe conditions: Aortic Insufficiency conditions: Mitral Stenosis conditions: Mitral Insufficiency conditions: Mitral Stenosis With Insufficiency conditions: Tricuspid Insufficiency conditions: Ascending Aortic Aneurysm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, randomized, single-center study with 2 groups of patients (investigating and control arms) primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 186 type: ESTIMATED name: Ultrasound examination of the lungs measure: The number of participants with interstitial pulmonary edema at the day of hospital discharge, according to ultrasound lung examination measure: Postoperative pulmonary complications measure: Cumulative dosage of diuretics measure: Number of nights at home after hospital discharge sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Saint Petersburg State University Clinic city: Saint Petersburg zip: 190020 country: Russian Federation name: Sergei M Efremov, MD, PhD role: CONTACT phone: +79137946090 email: sergefremov@mail.ru lat: 59.93863 lon: 30.31413 hasResults: False

 nctId: NCT06377436 id: PRAISE briefTitle: Prevention of Disability in the Frail Elderly Person Through an Innovative Customised and Multidimensional Training Programme acronym: PRAISE overallStatus: RECRUITING date: 2023-03-20 date: 2024-12-31 date: 2024-12-31 date: 2024-04-22 date: 2024-04-22 name: University of Milan class: OTHER briefSummary: The goal of this clinical trial is to implement a personalized training program to prevent functional decline in frail subjects but not yet disable. The purpose of the project is to test the training in a subject at particularly high risk of entering the disabled condition. A total of 80 frail subjects, divide the participants into two groups "Divida Senso Group" (experimental group) and "Standard of care Group" (Control group) will be recruited.

The expected outcome is to slow down a functional decline not only in isolation in the domains trained by the program. conditions: Frailty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 80 type: ESTIMATED name: Experimental training measure: Changes in the Functional decline measure: Intrinsic Capacity (IC) measure: Intreaction between IC and cardiac autonomic control (CAC) sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Gabriella CERRI status: RECRUITING city: Milano zip: 20100 country: Italy name: Gabriella GC CERRI, Full Professor role: CONTACT phone: +393402527675 email: gabriella.cerri@unimi.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06377423 id: A54678775 briefTitle: Comparison Between Direct Composite and Indirect Ceramic Laminate Veneers in Multiple Diastema Closure Cases overallStatus: COMPLETED date: 2021-08-01 date: 2024-01-01 date: 2024-01-10 date: 2024-04-22 date: 2024-04-22 name: Prince Sattam Bin Abdulaziz University class: OTHER briefSummary: Thus, the present study aimed to evaluate the longevity of direct composite compared to indirect ceramic laminate veneers in multiple diastema closure cases using USPHS criteria. The formulated null hypothesis was that there is no significant difference in the clinical performance of direct composite and indirect ceramic laminate veneers in multiple diastema closure cases over two years. conditions: Dental Leakage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 28 type: ACTUAL name: Direct technique name: Indirect technique measure: Percentage % of patients with marginal staining sex: ALL minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: Ali Elkaffas city: Al Kharj country: Saudi Arabia lat: 24.15541 lon: 47.33457 hasResults: False

 nctId: NCT06377410 id: FF-2023-433 briefTitle: Efficacy & Safety of Dry Powder Ivy Extract (Syrup Prospan) Versus NAC Among COPD Patients acronym: SyProNAC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-11-30 date: 2026-11-30 date: 2024-04-22 date: 2024-04-22 name: National University of Malaysia class: OTHER briefSummary: As the third global leading cause of death, Chronic Obstructive Pulmonary Disease (COPD) affects more than 300 million people worldwide. These patients suffer from 0.5-3.5 exacerbations per year on average. Each exacerbations dampened their health status as well as quality of life, not to mention a great burden to our healthcare system. Those partially treated or prolonged exacerbations would subsequently lead to unfavorable disease progression. Hence a holistic approach in managing each exacerbations is very crucial.

Mucus hypersecretion in COPD patients plays a pivotal role in acute exacerbations and associated with unfavorable outcomes. These exacerbations comes with sputum increment as much as its purulence. Mucolytics are believed to to ease patient to expectorate and benefits them from tip into an exacerbations or even the consequent hospitalisation.

Mucolytics work by reducing sputum viscosity hence improved its expectoration. N-acetylcysteine (NAC) is a mucolytic with antioxidant and anti-inflammatory properties, commonly used in practice among COPD patients. Meanwhile, Syrup Prospan is ivy leaf preparations, obtained as extracts from leaves of the plant Hedera helix L. It is widely used over-the-counter cough remedy containing saponins which are believed to have expectorant properties. Studies show evidence of antispasmodic, bonchodilating, anti-inflammatory and antitussive properties and its usage is authorised by the European Medicines Agency . conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Syrup Prospan name: N-Acetylcysteine measure: To assess cough symptoms and its impact on daily activities using Cough and Sputum Assessment Questionnaire (CASA-Q); scores for each domain range from 0 to 100, with higher scores indicating fewer/less severe symptoms and less impact. measure: to determine change of Quality of Life using McGill COPD Quality of Life Questionnaire, scores ranged from 0 to 100, with higher scores indicating a better quality of life. measure: to determine change of Forced Expiratory Volume at 1second (FEV1); in litres/minute using spirometry measure: to determine change of Forced Vital Capacity in litres/minute using spirometry measure: to determine adverse effects of Syrup Prospan (in %) measure: to determine adverse effects of N-Acetylcysteine (in %) measure: To assess satisfaction of treatment using the 5 point Likert Scale (1- Not Satisfied, 5 - Most Satisfied) sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National University of Malaysia city: Cheras state: Kuala Lumpur zip: 56000 country: Malaysia name: Mohamed Faisal Abdul Hamid, MBBS (IIUM) role: CONTACT phone: 0391455555 email: faisal.hamid@ppukm.ukm.edu.my lat: 3.05 lon: 101.76667 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2024-02-01 uploadDate: 2024-04-08T19:34 filename: Prot_SAP_ICF_000.pdf size: 1474657 hasResults: False

 nctId: NCT06377397 id: IIRPIG-2023-0000070 briefTitle: Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates acronym: SAUNA overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-04-15 date: 2028-04-14 date: 2024-04-22 date: 2024-04-22 name: Indian Council of Medical Research class: OTHER_GOV name: Lady Hardinge Medical College name: King George's Medical University name: Indira Gandhi Institute of Child Health name: Institute of Obstetrics and Gynecology name: Government Medical College, Chandigarh name: Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak name: Government Medical College, Aurangabad name: King Edward Memorial Hospital, Mumbai briefSummary: Preterm infants are born at less than 37 weeks of pregnancy. Sometimes a break or tear in the fluid filled bag that surrounds and protects the infant during pregnancy leads to an untimely birth. This state puts the infant at risk of serious condition called sepsis. Sepsis is a condition in which body responds inappropriately to an infection. Sepsis may progress to septic shock which can result in the loss of life. Doctors give antibiotics to treat sepsis.

The goal of this research study is to find out:

1. Among neonates at risk of early-onset neonatal sepsis, whether a policy of administering antibiotics selectively to a subset of at-risk infants who later develop signs of sepsis is not inferior to administering antibiotics to all at-risk infants in the 1st week of life.
2. To find out if infants receiving selective antibiotics (as above) compared to those receiving antibiotics from birth (as above) require fewer antibiotic courses of 48 hours duration or more in the 1st week of life.
3. To find out whether infants receiving selective antibiotics (as above) compared to those receiving antibiotics from birth (as above) are significantly different with respect to a wide range of secondary outcomes (listed under "Outcomes"). conditions: Sepsis conditions: PROM, Preterm (Pregnancy) conditions: Early-Onset Neonatal Sepsis conditions: Preterm Premature Rupture of Membrane conditions: Preterm Birth studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Neonates will be randomized to 1 of the following groups:

1. Group 1: Intervention group (Selective antibiotic group)
2. Group 2: Comparison group (Universal antibiotic group) primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Project staff, nurses and resident doctors looking after the neonate will not be blinded. The assessment of the primary outcome will be performed by a blinded adjudicator, who is not involved in the recruitment and monitoring of subjects. A part of the case report form (CRF) containing relevant details of all episodes of sickness in the 1st week of life will be detached from the main form and will be sent to the blinded adjudicator. This part will be linked to the main form only by a unique identification number. No patient identifiers or allocation group will be mentioned on the part sent to the blinded adjudicator. whoMasked: OUTCOMES_ASSESSOR count: 1500 type: ESTIMATED name: Antibiotics measure: Composite of all-cause mortality and/or any episode of culture-positive sepsis and/or severe sepsis* within the 1st 7 days after randomization measure: Need for intravenous antibiotics for ≥ 48 hours within the 1st 7 days after randomization measure: All-cause Mortality within 1st 7 days after randomization measure: Blood culture-positive sepsis of any severity within 1st 7 days after randomization measure: Episode of severe sepsis within 1st 7 days after randomization measure: Composite of mortality/blood culture positive sepsis/severe sepsis within 1st 72 hours after randomization measure: Individual components of composite outcome within 1st 72 hours after randomization measure: Composite of mortality/blood culture positive sepsis/severe sepsis during hospital stay measure: Individual components of composite outcome during hospital stay measure: Necrotizing enterocolitis, stage II-III by modified Bell's staging criteria during hospital stay measure: Composite of mortality/blood culture positive sepsis/severe sepsis during 1st 30 days after randomization measure: Individual components of composite outcome during 1st 30 days measure: Necrotizing enterocolitis, stage II-III by modified Bell's staging criteria measure: Sepsis-related mortality within 1st 72 hours after randomization measure: Sepsis-related mortality within 7 day after randomization measure: Sepsis-related mortality during hospital stay after randomization measure: Sepsis-related mortality during 1st 30 days after randomization measure: Clinical sepsis within 1st 72 hours after randomization measure: Clinical sepsis within 7 days after randomization measure: Clinical sepsis during hospital stay measure: Clinical sepsis within 1st 30 days after randomization measure: Episode of Probable EONS within 72 hours after randomization measure: Episode of Probable EONS within 7 days after randomization measure: Episode of asymptomatic proven EONS within 72 hours after randomization measure: Need for sepsis workup during 1st 72 hours after randomization measure: Need for sepsis workup during 1st 7 days after randomization measure: Need for sepsis workup during 1st 30 days after randomization measure: Need for sepsis workup during hospital stay measure: Cumulative duration of antibiotic therapy during 1st 7 days after randomization measure: Cumulative duration of antibiotic therapy during 1st 72 hrs after randomization measure: Cumulative duration of antibiotic therapy during hospital stay measure: Duration of hospitalization measure: Episodes of healthcare associated infection during hospital stay. measure: Adverse effects until day 30 after randomization measure: Serious adverse effects until day 30 after randomization sex: ALL minimumAge: 0 Hours maximumAge: 4 Hours stdAges: CHILD facility: Post Graduate Institute of Medical Education and Research (PGIMER) city: Chandigarh zip: 160012 country: India lat: 30.73629 lon: 76.7884 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-04-02 uploadDate: 2024-04-02T01:02 filename: Prot_SAP_000.pdf size: 213987 hasResults: False

 nctId: NCT06377384 id: DHP-33-FLIGHT briefTitle: FLIGHT Study for Childhood Chronic Illness overallStatus: RECRUITING date: 2022-04-20 date: 2025-09 date: 2025-09 date: 2024-04-22 date: 2024-04-23 name: Documenting Hope Project class: OTHER briefSummary: The FLIGHT study is an open-label, single-arm, pilot and feasibility study of a personalized and multimodality intervention focusing upon modifiable lifestyle factors, environmental modifications, and transdisciplinary clinical care for children with chronic illness. A mixed methods outcomes evaluation will be performed. The primary goal of this study is to evaluate the most feasible and promising strategies to inform a more streamlined and scalable intervention in the future. Up to 14 participants may be enrolled, but fewer are expected to achieve the primary goal of the study. conditions: Chronic Illnesses, Multiple studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 14 type: ESTIMATED name: FLIGHT Intervention measure: Total Load Index (TLI) measure: Child Health Inventory for Resilience and Prevention (CHIRP) measure: Children's Sleep Habits Questionnaire (CSHQ) measure: Vineland Adaptive Behavior Scale measure: Sensory Profile 2 measure: Quick Environmental Exposure and Sensitivity Inventory (QEESI) measure: Hayward Environmental Illness Severity Scale measure: Parenting Stress Index, 4th edition (PSI-4) measure: Beck Anxiety Inventory (BAI) sex: ALL minimumAge: 2 Years maximumAge: 15 Years stdAges: CHILD facility: Epidemic Answers status: RECRUITING city: Windsor state: Connecticut zip: 06095 country: United States name: Study Coordinator role: CONTACT phone: 833-935-5543 email: info@epidemicanswers.org lat: 41.8526 lon: -72.6437 hasResults: False

 nctId: NCT06377371 id: 23-03025815 briefTitle: Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-01 date: 2025-01 date: 2024-04-22 date: 2024-04-22 name: Weill Medical College of Cornell University class: OTHER name: Curium US LLC briefSummary: The study team hypothesizes that it is feasible to intraoperatively detect tumor following \[CU64\]DOTATATE injection using the gamma probe device. conditions: Meningioma studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Brain Imaging with [Cu64]DOTATATE name: Radio-guided Surgery With Neoprobe Utilization measure: Preoperative [Cu64]DOTATATE PET SUV measure: 1st Post-operative [Cu64]DOTATATE PET SUV measure: 2nd Post-operative [Cu64]DOTATATE PET SUV measure: MRI Size Measurements measure: GTR vs STR Assessment measure: MRI Progression Assessment measure: Target Lesion Neoprobe Count measure: Subtotal Neoprobe Count measure: Reference Background Neoprobe Count measure: SSTR2 expression measure: WHO grade measure: Ki67 Proliferation Index measure: ER/PR expression sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: New York-Presbyterian/Weill Cornell Medical Center city: New York state: New York zip: 10021 country: United States lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06377358 id: CEEAH CA31 briefTitle: Study of Lipolysis of Visceral Reserve Fat Using Tecar Therapy. overallStatus: COMPLETED date: 2022-05-09 date: 2022-07-25 date: 2023-06-22 date: 2024-04-22 date: 2024-04-22 name: CAPENERGY MEDICAL, SL class: INDUSTRY name: University of Malaga name: Alfonso X El Sabio University briefSummary: The Scope of this study is to assess the visceral and subcutaneous fat loss in patients having Tecar (Radiofrequency) Therapy and its effects on other anthropometric variables, adipokines and inflammation.

20 obese patients will be treated with Tecar Therapy (Radiofrequency). Each patient will have 4 active, automatic plates placed on the abdomen (200 cm2 per plate), two on the right side of the midline and two on the left side. Energy will be applied for 50 minutes, controlling the temperature. Subsequently, 15 minutes of Capacitive and Resistive manual electrodes will be applied to the abdomen, simultaneously, 20 minutes of Lymphatic Drainage placing one active plate in the foot and the other in the lumbo-dorsal area. Patients will be informed that they will only feel comfortable warmth. Five sessions will be applied from Monday to Friday resting Saturday and Sunday, for 2 weeks. Total 10 sessions.

Subcutaneous and visceral fat will be measured by MRI. Anthropometric variables (Body Mass Index, Waist to Hip ratio and skinfold) will be also measured.

Metabolic and inflammatory effects of the RF treatment will be evaluated measuring adipokines (Leptin, adiponectin and resistin) as well as citokines (IL-6, TNF-a and C reactive Protein).

Results will be analyzed using the SPSS statistics package. A Kolmogorov-Smirnov test will be applied, if the data behaves normally, parametric tests will be applied. If not, non-parametric tests will be performed. The differences between proportions will be analyzed using Fischer's exact test. The differences between the medians will be assessed using the Student's t-test for paired samples and independent samples. conditions: Obesity, Visceral conditions: Obesity; Endocrine studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Tecar Theraty was applied to 20 obese patients in order to assess the effect on the body fat loss, serum adipocytokines and imflammation. It was an interventional study in one group of patients. No controls. No masking. primaryPurpose: TREATMENT masking: NONE count: 20 type: ACTUAL name: Tecar Therapy measure: Visceral fat loss (cm3) measure: Visceral fat loss (g) measure: Subcutaneous fat loss (cm3) measure: Subcutaneous fat loss (g) measure: Tumor Necrosis Factor alfa measure: Interleukin 6 levels measure: C reactive Protein levels measure: Leptin levels measure: Adiponectin levels measure: Resistin levels measure: Total cholesterol changes measure: Total triglycerides changes measure: LDL Cholesterol changes measure: HDL Cholesterol changes measure: Glucose measure: Body Mass Index loss measure: Waist to Hip Index loss measure: Skinfold Thickness (cm) sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Inneo Terapia Despi city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2022-02-01 uploadDate: 2024-03-21T05:39 filename: Prot_SAP_000.pdf size: 597014 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2022-02-01 uploadDate: 2024-04-11T07:17 filename: ICF_001.pdf size: 543945 hasResults: False

 nctId: NCT06377345 id: 202312-00011 briefTitle: Remote Patient Monitoring Solution for Chronic Respiratory Disease Management overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-12-31 date: 2025-03-30 date: 2024-04-22 date: 2024-04-22 name: SingHealth Polyclinics class: OTHER briefSummary: Aim: To evaluate the use of AeviceMD Monitoring System (AeviceMD) asthma in reducing acute exacerbation.

Methodology: Using a randomized controlled trial design, this project aims evaluate the effectiveness of AeviceMD in improving patients' outcomes in terms of reducing exacerbation, healthcare utilization, improving quality of life, self-efficacy, and cost effectiveness. Paediatric patients above age 7 and adults will be recruited. The data follow-up period is 3 months. It will also evaluate the usability of the device from both patients' and clinicians' perspective. 180 patients (124 adults, 56 pediatrics) and 120 clinicians will be recruited.

Importance of study: This study will evaluate if the AeviceMD can help improve disease management and reduce recurrence of asthma exacerbation.

Potential benefits and risk: AeviceMD allows for remote monitoring and tracking of patients' lung sounds, which could be used by patients to monitor their lung condition and prevent an episode of exacerbation or worsening exacerbations culminating in an admission which who further utilize already limited healthcare resources. An exacerbation is an episode of severe shortness of breath, cough, and chest tightening which warrants a visit to a healthcare institution. Through self-monitoring, patients can be empowered to self-manage their asthma, with aid of the asthma action plan which is given to all patients with asthma. AeviceMD can also help provide clinicians with patients' objective lung data. In the primary care setting, care is also fragmented as patients are often followed-up by a different doctor or healthcare providers. Clinicians have no objective data to track patients, and is dependent on patients' self-report and possible recall bias. There is no expected risk with the use of the device. conditions: Asthma conditions: Asthma Attack conditions: Asthma in Children conditions: Asthma Acute conditions: Asthma Chronic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A two-group randomized controlled trial (RCT) design will be used. The control group will receive the usual care, and the intervention group will receive the Aevice device on top of usual care. Outcomes will be measured at baseline, week 4, and week 12. This is to evaluate the long-term impacts of the Aevice device. Clinicians who have interacted with participants using Aevice will also be invited to participate in an interview and clinician perception survey. A convenience sampling will be used for the recruitment of clinicians. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The outcomes assessor will not be aware of the participants' group whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: AeviceMD device name: Standard care measure: Rescue therapy measure: Dose of oral Prednisolone use measure: Visit to hospital emergency department measure: Hospitalisation measure: Euro Quality of Life 5 dimensions (EQ5D) measure: Asthma quality of life questionnaire (AQLQ) measure: Pediatric asthma quality of life questionnaire (PAQLQ) measure: Self-efficacy measure: Usability measure: Heart rate measure: Respiratory rate measure: Wheeze detection trend measure: Medication log measure: Duration of device usage measure: Payment sex: ALL minimumAge: 7 Years maximumAge: 90 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06377332 id: X23-0330 briefTitle: Biomarkers of Dementia in Chronic Sleep and Breathing Disorders acronym: ORACLE overallStatus: RECRUITING date: 2023-12-01 date: 2025-07-01 date: 2025-07-01 date: 2024-04-22 date: 2024-04-22 name: Woolcock Institute of Medical Research class: OTHER briefSummary: Chronic obstructive pulmonary disease (COPD), obstructive sleep apnoea (OSA) and overlap syndrome are associated with obstructions in breathing and disturbed sleep.

Chronic breathing disruptions and poor sleep may lead to cognitive impairment and brain changes linked with early neurodegenerative processes. As such, identifying early markers of cognitive impairment and dementia risk in individuals with chronic respiratory and sleep breathing disorders is crucial for understanding how these diseases may contribute to accelerated brain ageing. This study will comprehensively measure sleep, lung function, cognitive performance and blood-based markers of dementia risk and inflammation. The investigators will use innovative technologies to identify biomarkers of cognitive impairment and dementia risk in people with chronic sleep and breathing disorders. The investigators will also investigate the relationships between disrupted sleep and abnormal breathing and the brain. This research may also inform future early interventions to improve cognition and brain health in chronic sleep and respiratory disease. conditions: COPD conditions: Overlap Syndrome conditions: OSA studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 104 type: ESTIMATED name: High density electroencephalogram (HdEEG) name: Functional near infrared spectroscopy (fNIRS) name: Magnetic resonance imaging (MRI) name: Blood collection name: Neuropsychological battery name: Questionnaires name: Pulmonary Function Test (PFT) name: Cognitive Assessment name: Polysomnogram (PSG) measure: Scores on the Montreal Cognitive Assessment (MoCA) neuropsychological assessment for dementia risk. measure: Blood levels of amyloid beta (Aβ40/Aβ42 ratio). measure: Absolute Electroencephalographic (EEG) Power During Non-Rapid Eye Movement (NREM) Sleep. measure: Brain tissue oxygenation during cognitive tasks and sleep. measure: Hypoxemia as measured by pulse oximetry. measure: Sleep Fragmentation measure: Assessment of premorbid functioning and preinjury through the Test of Premorbid Functioning (TOPF). measure: Assessment of verbal learning and memory through the Rey Auditory Verbal Learning Test (RAVLT). measure: Assessment of mild forms of cognitive dysfunction through Delis Kaplan Executive Functioning System (D-CEFS) neuropsychological assessment. measure: Assessment of speed of processing and executive functioning through the Trail Making Test (TMT). measure: Assessment of verbal fluency through the Controlled Oral Word Association Test (COWAT). measure: Assessment of attention, perceptual speed, motor speed and visual scanning through the Symbol Digits Modalities Test (SDMT). measure: Blood levels of fibrinogen. measure: Blood levels of clusterin. measure: Blood levels of 8-isoprostane measure: Blood levels of C-reactive protein (CRP) measure: Blood levels of erythrocyte sedimentation rate (ESR). measure: Blood levels of plasma tau. measure: Blood levels of neurofilament light chain (NFL). measure: Blood levels of Glial fibrillary acidic protein (GFAP). measure: Blood levels of Apolipoprotein E gene (APOE-4). measure: Blood levels of interleukin-8 (IL-8). measure: Blood levels of interleukin-6 (IL-6). measure: Blood levels of tumor necrosis factor alpha (TNFα). measure: Blood levels of amyloid beta (Aβ40/Aβ42 ratio). measure: Scores on the Montreal Cognitive Assessment (MoCA) neuropsychological assessment for dementia risk. measure: Brain structure: cortical thickness and volumetric brain maps measure: Brain structure: diffusion-weighted imaging measure: Brain function: resting-state BOLD fMRI measure: Brain pathology: T1-weighted, T2-weighted, diffusion-weighted imaging, and FLAIR measure: Assessment of sensorimotor function and comprehension through the Motor Screening Task (MOT) of CANTAB. measure: Assessment of processing and psychomotor speed through the Reaction Time (RTI) test of CANTAB. measure: Assessment of working memory and strategy through the Spatial Working Memory (SWM) test of CANTAB. measure: Assessment of visual episodic memory through the Paired Associate Learning (PAL) test of CANTAB. measure: Sleep Spindles During Non-Rapid Eye Movement (NREM) Sleep measure: Traditional sleep staging. measure: Absolute Electroencephalography (EEG) Power During Rapid Eye Movement (REM) Sleep. measure: Obstructive sleep apnoea (OSA) severity metrics measure: Lung function as measured by clinical pulmonary function tests (PFT) sex: ALL minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Woolcock Institute of Medical Research status: RECRUITING city: Sydney state: New South Wales zip: 2113 country: Australia name: Angela D'Rozario, PhD role: CONTACT phone: 02 9850 3246 email: angela.drozario@mq.edu.au name: Laura Harris, MScMed role: CONTACT phone: 02 9805 3194 email: laura.harris@woolcock.org.au lat: -33.86785 lon: 151.20732 hasResults: False

 nctId: NCT06377319 id: 101080905 briefTitle: Decision Support System for Diagnosis and Progression of Heart Failure acronym: STRATIFYHF overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-07-31 date: 2027-07-31 date: 2024-04-22 date: 2024-04-23 name: Coventry University class: OTHER name: Newcastle University name: University of Cambridge name: University of Novi Sad name: University of Florence name: University of Regensburg name: Utrecht University name: Servicio Madrileño de Salud, Madrid, Spain briefSummary: Heart failure (HF) is a complex clinical syndrome associated with impaired heart function, poor quality of life for patients and high healthcare costs. Accurate risk stratification and early diagnosis in HF are challenging as signs and symptoms are non-specific. Here the investigators propose to address this global challenge by developing novel analytic methods for HF (STRATIFYHF). A prospective clinical study will collect patient-specific data related to medical history, a physical examination for signs and symptoms, blood tests including natriuretic peptides, an electrocardiogram (ECG), an echocardiogram (ultrasound of the heart), cardiovascular magnetic resonance imaging (MRI), demographic, socio-economic and lifestyle data along with novel technologies (cardiac output response to stress (CORS) test and voice recognition biomarkers) from individuals at-risk of developing HF and those with a confirmed diagnosis of HF. STRATIFYHF will use these data to support clinical validation of an artificial intelligence (AI)-driven decision support system (DSS) and mobile application for risk prediction, diagnosis, and progression of HF to enhance patients' quality of life and lead to more cost-effective health care. conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1600 type: ESTIMATED name: Cardiac Output Response to Stress (CORS) test measure: Diagnostic accuracy of the DSS measure: Demographic and clinical predictors of risk, diagnosis, and progression of heart failure. sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06377306 id: MC study briefTitle: Identifying Periods of High Training Load Considering the Menstrual Cycle Phases in Elite and Non-elite Female Athletes overallStatus: RECRUITING date: 2023-11-05 date: 2026-01-30 date: 2027-01-30 date: 2024-04-22 date: 2024-04-22 name: Wingate Institute class: OTHER name: Weizmann Institute of Science name: Kaplan Medical Center name: Ministry of Innovation, Science and Technology of Israel briefSummary: Despite a rise in the number of women participating in competitive sports, there remains a gender gap within sport and exercise science literature. Studying females involves potential "noise" through the change in hormone concentrations during the different phases of the female menstrual cycle (MC) which can potentially affect physiological parameters, thereby making study design and interpretation of findings difficult. Longitudinal data on the acute and chronic combined effects of training load and MC phases on circulating female hormones in elite and non-elite female athletes is lacking.

The investigators aim to characterize and track the potential effects of training load and MC phases on performance, anthropometric measures, sport emotions, intestinal microbiome, serum metabolites and injury prevalence in elite and non-elite female athletes.

200 competitive premenopausal female athletes will be recruited. In a longitudinal observational design, each participant will be followed for 1 year, and tested at three time points. At each point, data will be collected on two occasions reflecting distinct phases of the MC.

Finding the possible relationship between the MC phases, training load and performance or specific bio-markers for training load are of utmost importance and can assist professionals to identify periods of high load and over-training, thus preventing injuries and training adjustment. conditions: Menstrual Cycle conditions: Athletes conditions: Physical Activity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Effect of training loads and sport performance level on health and sport performance measure: Stool Microbiome measure: Serum metabolomics measure: VO2max measure: Countermovement jump measure: Flexibility measure: Grip Strength measure: Lower leg Strength measure: Blood tests measure: Knee valgus measure: Anthropometric (Height) measure: Psychological questionnaire (Positive-Affect Negative-Affect scale - PANAS) measure: Anthropometric (Weight) measure: Percentage body fat (%) measure: Psychological questionnaire (The Sport Emotion Questionnaire (SEQ) sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Wingate Institute status: RECRUITING city: Netanya country: Israel name: Yotam Shribman, B.Sc role: CONTACT phone: +972-54-5723401 email: research@wingate.org.il lat: 32.33291 lon: 34.85992 hasResults: False

 nctId: NCT06377293 id: FEMH-IRB-TSAI2024 briefTitle: Effect of Dialysis-specific Therapeutic Diet on Biochemical Parameters in Dialysis Patients overallStatus: NOT_YET_RECRUITING date: 2024-11 date: 2025-12 date: 2029-06 date: 2024-04-22 date: 2024-04-23 name: Far Eastern Memorial Hospital class: OTHER briefSummary: In patients with kidney failure, disturbances in bone turnover, mineral metabolism, vascular calcification, uremia, inflammation, immunity, nutrition, and gut microbial metabolites are frequent. Unhealthy diet causes altered mineral metabolism, elevated uremic toxin level, immune dysregulation, inflammation, protein-energy wasting and dysbiosis. The investigators hypothesize that therapeutic diet intervention reverses these uremic complications and thereby reduces cardiovascular risk in patients with kidney failure. In this study, the investigators crafted 4-week dialysis-specific therapeutic diet to illustrate the clinical implications of therapeutic diet for dialysis patients. conditions: End-Stage Kidney Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: A randomized, active-controlled trial with cross-over design primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Laboratory technicians who assess the study outcomes will be masked whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Dialysis-specific therapeutic diet measure: Concentrations of intact fibroblast growth factor 23 (pg/mL) measure: Concentrations of C-terminal fibroblast growth factor 23 (RU/mL) measure: Concentrations of phosphate (mg/dL) measure: Concentrations of calcium (mg/dL) measure: Concentrations of intact parathyroid hormone (pg/mL) measure: Concentrations of bone-specific alkaline phosphatase (μg/L) measure: Concentrations of procollagen-type 1 N-terminal-propeptide (P1NP) (ng/mL) measure: Concentrations of tartrate resistance acid phosphatase-5b (TRACP-5b) (mIU/ml) measure: Concentrations of alkaline phosphatase (ALP) (IU/L) measure: Concentrations of free indoxyl sulfate (mg/L) measure: Concentrations of free p-cresol sulfate (mg/L) measure: Concentrations of pre-albumin (g/dL) measure: Concentrations of albumin (g/dL) measure: Concentrations of C-reactive protein (mg/dL) measure: Absolute number (per μl blood) of CD4+ (cluster of differentiation 4) T cells measure: Absolute number (per μl blood) of CD8+ (cluster of differentiation 8) T cells measure: Absolute number (per μl blood) of monocytes measure: Concentrations of fetuin-A (μg/ml) measure: Concentrations of trimethylamine-N-oxide (TMAO) (μM) sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06377280 id: NAV-0011 briefTitle: En Evaluation of Navina Mini, a New Low-volume Transanal Irrigation Device. overallStatus: RECRUITING date: 2024-01-18 date: 2024-10 date: 2024-12 date: 2024-04-22 date: 2024-04-22 name: Wellspect HealthCare class: INDUSTRY briefSummary: This is an un-controlled, prospective, multi center, post market clinical follow-up investigation that will enroll male and female subjects in need of bowel management with low-volume transanal irrigation (TAI) as judged by the investigator. A total of 40 investigational subjects in need of low-volume TAI will be recruited from 2-3 sites in Sweden and will be treated with Navina Mini as per product intended purpose and per instruction of use during a period of four weeks.

Participating subjects will perform three visits during the clinical investigation and will be followed for a total of four weeks. The first visit, Visit 1, will be performed at the investigational clinic to assess eligibility, collect demographics, baseline data and instruct how to use the device. Visit 2 will be performed after two weeks of treatment through telephone contact. The final visit, Visit 3, will be performed after additional two weeks of treatment, and can be performed either at the investigational clinic or through telephone contact. conditions: Bowel Dysfunction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Navina Mini measure: Patient satisfaction measure: Assessment of clinical benefit measure: Ease of handling measure: Safety Outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Skåne University Hospital status: RECRUITING city: Malmö country: Sweden name: Louis Banka Johnson, MD role: CONTACT phone: +4640336557 email: louis_banka.johnson@med.lu.se name: Sara Strandberg role: CONTACT phone: +4640336377 email: sara.strandberg@skane.se lat: 55.60587 lon: 13.00073 hasResults: False

 nctId: NCT06377267 id: ESR-20-21103 briefTitle: Status of HRD That Lead to a Benefit From Olaparib in Combination With Bevacizumab (STROBE Trial) acronym: STROBE overallStatus: RECRUITING date: 2024-02-06 date: 2024-04 date: 2025-09 date: 2024-04-22 date: 2024-04-22 name: Vall d'Hebron Institute of Oncology class: OTHER briefSummary: Background:

The study aims to address the challenge of accurately identifying patients with ovarian cancer who would benefit from poly-ADP ribose inhibitors (PARPi) as first-line maintenance therapy. While BRCA1/2-mutated epithelial ovarian cancer (EOC) patients have shown significant benefits from PARPi treatment, the efficacy in homologous recombination deficient (HRD) patients remains inconclusive. Current assays used to estimate HR status do not effectively differentiate between patients who benefit most from PARPi and those who do not, making it inefficient to treat all patients. There is a need for a more accurate HR status testing method to optimize PARPi benefit. This study aims to assess the performance of the VHIO-CARD-300 test in determining HR status compared to SOPHiA DDM™ Dx HRD Solution.

Summary:

The study is a prospective, non-randomized trial designed to evaluate the concordance of the VHIO-CARD-300 test in establishing HR status compared to SOPHiA DDM™ Dx HRD Solution. Additionally, it aims to assess the association between HRD status determined by the VHIO-CARD-300 test and treatment efficacy. Patients with advanced FIGO stage III-IV high grade serous or endometrioid ovarian, fallopian tube, or peritoneal cancer will be invited to participate. Those eligible will undergo testing with both VHIO-CARD-300 and SOPHiA DDM™ Dx HRD Solution. Patients classified as HRD positive will receive olaparib in combination with bevacizumab, while others will receive bevacizumab alone. Treatment will be administered according to approved doses, with follow-up evaluations conducted until RECIST progression. conditions: Ovarian Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Bevacizumab name: Olaparib measure: Concordance in HRD status identification between VHIO-CARD-300 test and SOPHiA DDM™ Dx HRD Solution measure: Performance Assessment of VHIO-CARD-300 Test for HR Status Identification measure: Association Between VHIO-CARD-300 Test Groups and Efficacy Outcomes(i.e., HRD positive and HRD negative) and efficacy outcomes. measure: Analysis of Progression-Free Survival (PFS) and Overall Survival (OS) in Discrepant HRD Cases measure: Safety and Tolerability of Olaparib Plus Bevacizumab measure: To evaluate the failure rate for the VHIOCARD-300 test and SOPHiA DD Dx HRD Solution. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vall d'Hebron Institute of Oncology status: RECRUITING city: Barcelona country: Spain name: Ana Oaknin role: CONTACT lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06377254 id: BB/X015173/1 briefTitle: Multi-organ Responses to CHronic Physical Activity and INactivity acronym: CHAIN overallStatus: RECRUITING date: 2024-03-12 date: 2027-12-17 date: 2028-10-31 date: 2024-04-22 date: 2024-04-22 name: University of Nottingham class: OTHER name: Biotechnology and Biological Sciences Research Council briefSummary: Life expectancy has been increasing for the last 150 years, but the maintenance of health has not kept pace with increased lifespan, and on average, UK adults spend the last decade of life in poor-health, with major consequences for society and the individual.

Persistent physical inactivity is thought to be a key contributing factor to the risk of poor health and functional decline occurring in middle-aged and older adults. It is therefore concerning that most middle-aged adults spend \>8hrs/day being sedentary, with average step count of 3000-4000 steps/day.

To be able to holistically assess the effectiveness of future strategies to address age-related decline in health, and devise public health messages to help individuals reach older age in better health, it is essential that the complex physiological effects that activity and inactivity have across biological systems are characterised.

The goal of this intervention study is to compare the impact of physical activity and inactivity on body functioning. Twenty moderately active participants will decrease their physical activity for six months to match the average amount carried out by middle-aged people in the UK. They will then undertake 3-months of reconditioning training to restore their fitness. In addition, twenty sedentary participants will increase their physical activity to UK recommended levels for six months.

Before and at points during the intervention period, participants will be asked to make some measurements at home and attend the University of Nottingham to have multiple assessments made. These include;

* fitness, muscle strength and function tests,
* completion of questionnaires and computer-based brain puzzles
* having muscle and fat tissue biopsies and blood samples taken.
* The study also involves having MRI scans.

This 5-year study will commence in January 2024, with participant recruitment starting in March 2024 and finishing in May 2027. conditions: Sedentary Behavior conditions: Metabolic Syndrome conditions: Age-related Cognitive Decline conditions: Age-Related Sarcopenia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Non-randomised, parallel design lifestyle intervention primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Those undertaking analysis of biological samples and MRI data will be masked as to the group the participant is allocated to. whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Decreased Physical Activity name: Increased Physical activity measure: Change in Cardiorespiratory fitness (VO2 max) measure: Change in Isometric leg strength measure: Change in time to leg fatigue measure: Change in incremental area under the curve (iAUC) for blood glucose concentration measure: Change in iAUC for serum insulin concentration measure: Change in fasting glucose oxidation rate measure: Change in 'fed' glucose oxidation rate measure: Change in Short Form Health Survey (SF36) Questionnaire aggregated normalised 'physical' score measure: Change in Short Form Health Survey (SF36) Questionnaire aggregated and normalised 'mental' score measure: Change in World Health Organisation Quality of Life (WHOQoL) score measure: Change in Pittsburgh Sleep Quality Index (PSQI) measure: Change in Stroop test; % Accuracy measure: Change in Stroop test; reaction time measure: Change in four-choice reaction time test; % Accuracy measure: Change in four-choice reaction time test; reaction time measure: Change in card sort test; % Accuracy measure: Change in card sort test; reaction time measure: Change in Logical reasoning test; % accuracy measure: Change in Logical reasoning test; reaction time measure: Change in serial subtractions test; number of responses in 2 minutes measure: Change in Corsi blocks test; score measure: Change in Muscle protein synthesis rate measure: Change in Muscle protein breakdown rate measure: Change in whole body fat volumes measure: Change in liver fat volumes measure: Change in thigh muscle fat volumes measure: Change in whole body muscle volumes measure: Change in muscle phosphocreatine synthesis rate measure: Change in cerebral volume measure: Change in cortical thickness measure: Change in plasma metabolome measure: Fasting blood lipid concentration measure: Fasting blood lipid concentration measure: Fasting blood lipid concentration measure: Fasting blood lipid concentration measure: Fasting blood lipid concentration measure: liver function test: alanine transaminase (ALT) measure: liver function test: alanine transaminase (ALT) measure: liver function test: alanine transaminase (ALT) measure: liver function test: alanine transaminase (ALT) measure: liver function test: alanine transaminase (ALT) measure: liver function test: aspartate aminotransferase (AST) measure: liver function test: aspartate aminotransferase (AST) measure: liver function test: aspartate aminotransferase (AST) measure: liver function test: aspartate aminotransferase (AST) measure: liver function test: aspartate aminotransferase (AST) measure: liver function test: Bilirubin measure: liver function test: Bilirubin measure: liver function test: Bilirubin measure: liver function test: Bilirubin measure: liver function test: Bilirubin measure: liver function test: Albumin measure: liver function test: Albumin measure: liver function test: Albumin measure: liver function test: Albumin measure: liver function test: Albumin measure: liver function test: Gamma glutamyl transferase (GGT) measure: liver function test: Gamma glutamyl transferase (GGT) measure: liver function test: Gamma glutamyl transferase (GGT) measure: liver function test: Gamma glutamyl transferase (GGT) measure: liver function test: Gamma glutamyl transferase (GGT) measure: Blood Haemoglobin concentration measure: Blood Haemoglobin concentration measure: Blood Haemoglobin concentration measure: Blood Haemoglobin concentration measure: Blood Haemoglobin concentration sex: ALL minimumAge: 55 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: David Greenfield Human Physiology Unit status: RECRUITING city: Nottingham state: Notts zip: NG72UH country: United Kingdom name: Sara Brown role: CONTACT phone: +44(0)115 8230434 email: sara.brown@nottingham.ac.uk name: Joanne Mallinson, PhD role: CONTACT phone: +44(0)1158230434 email: joanne.mallinson@nottingham.ac.uk name: Paul Greenhaff, PhD role: PRINCIPAL_INVESTIGATOR name: Liz Simpson, PhD role: SUB_INVESTIGATOR name: Joanne Mallinson, PhD role: SUB_INVESTIGATOR name: Abhishek Sheth, MD role: SUB_INVESTIGATOR name: Penny Gowland, PhD role: SUB_INVESTIGATOR name: Sue Francis, PhD role: SUB_INVESTIGATOR name: Rosemary Nicholls, PhD role: SUB_INVESTIGATOR name: Aline Nixon role: SUB_INVESTIGATOR name: Sara Brown role: SUB_INVESTIGATOR name: Donald Peden, PhD role: SUB_INVESTIGATOR lat: 52.9536 lon: -1.15047 hasResults: False

 nctId: NCT06377241 id: 2023-1436 id: A536000 type: OTHER domain: UW Madison id: SMPH/OPHTHAL&VIS SCI/GEN type: OTHER domain: UW Madison id: Protocol Version 2/23/2024 type: OTHER domain: UW Madison briefTitle: ScentAware and OCT in MCI vs HC overallStatus: RECRUITING date: 2024-04-15 date: 2024-06 date: 2024-06 date: 2024-04-22 date: 2024-04-22 name: University of Wisconsin, Madison class: OTHER briefSummary: The goal of this clinical trial is to learn whether a new smell test works as well as the standard clinical smell test, if there is a link between sense of smell and variations in the retina, and if these results could be used as a way to identify early stages of Alzheimer's disease. The main questions it aims to answer are:

* Whether the test is as effective and reliable as the standard test
* Whether there is a link between the results of the smell test and the structure of the back of the eye

Participants will:

* complete a short questionnaire
* have pictures of the inside of their eyes taken
* perform two smell tests conditions: Alzheimer Disease, Early Onset studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: ScentAware name: UPSIT measure: Compare test scores of ScentAware olfactory test to the scores of the University of Pennsylvania Smell Identification Test (UPSIT) olfactory test in a clinical setting measure: Compare ScentAware test results conducted with support from clinical staff to the test results when ScentAware test was self-administered independently measure: Compare UPSIT test results conducted with support from clinical staff to the test results when ScentAware test was self-administered independently measure: Compare baseline ScentAware test scores between cohorts measure: Compare baseline UPSIT test scores between cohorts measure: Compare baseline ScentAware test scores to the retinal nerve fiber layer (RNFL) thickness measure: Compare baseline UPSIT test scores to the retinal nerve fiber layer (RNFL) thickness measure: Compare baseline ScentAware test scores to the ganglion cell layer (GCL) thickness measure: Compare baseline UPSIT test scores to the ganglion cell layer (GCL) thickness sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Wisconsin status: RECRUITING city: Madison state: Wisconsin zip: 53705 country: United States name: Amy Remm role: CONTACT phone: 608-262-3377 email: amy.remm@wisc.edu lat: 43.07305 lon: -89.40123 hasResults: False

 nctId: NCT06377228 id: TAK-007-1001 briefTitle: A Study of TAK-007 in Adults With Refractory Lupus Nephritis (LN) overallStatus: NOT_YET_RECRUITING date: 2024-11-01 date: 2029-04-23 date: 2029-04-23 date: 2024-04-22 date: 2024-04-22 name: Takeda class: INDUSTRY briefSummary: The main aim of the study is to learn how well adults with refractory lupus nephritis (LN) tolerate TAK-007 and to check for side effects (adverse events).

Other aims are to learn how effective treatment with TAK-007 is in adults with refractory LN, what effects TAK-007 has on the human body, and whether participants will produce antibodies against TAK-007. conditions: Refractory Lupus Nephritis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: TAK-007 name: Chemotherapy Agents measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) measure: Number of Participants With Dose Limiting Toxicities (DLTs) measure: Cmax: Maximum Observed Plasma Concentration for TAK-007 measure: Tmax: Time to Reach the Cmax for TAK-007 measure: Tlast: Time of Last Measurable Concentration Above the Lower Limit of Quantitation for TAK-007 measure: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-007 measure: Change From Baseline in CD19+ B Cell Counts measure: Duration of B Cell Depletion measure: Change From Baseline in Plasma Cytokine Levels measure: Change From Baseline in Physician's Global Assessment (PGA) Score measure: Percentage of Participants Achieving a Reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Relative to Baseline measure: Percentage of Participants Achieving Complete Renal Response (CRR) measure: Time to CRR measure: Duration of CRR measure: Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) measure: Time to LLDAS measure: Duration of LLDAS measure: Percentage of Participants Meeting the Definition of Remission in SLE (DORIS) Criteria measure: Time to DORIS Remission measure: Duration of DORIS Remission measure: Change From Baseline in Anti-Double Stranded Deoxyribonucleic Acid (dsDNA) Levels measure: Change From Baseline in Antinuclear Antibody (ANA) Levels measure: Change From Baseline in Proteinuria Levels measure: Change From Baseline in Creatinine Levels measure: Change From Baseline in eGFR measure: Change From Baseline in Complement (C3, C4) Levels measure: Percentage of Participants With Antidrug Antibodies Categorized as Anti-Human Leukocyte Antigen (HLA) and Anti- Chimeric Antigen Receptor (CAR) measure: Percentage of Participants With Replication Competent Retrovirus (RCR) in Blood sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States name: Site Contact role: CONTACT phone: 888-229-3065 email: madisonj@med.umich.edu name: Jacqueline Madison role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 facility: University of Rochester city: Rochester state: New York zip: 14642 country: United States name: Site Contact role: CONTACT phone: 585-486-0901 email: christopher_palma@urmc.rochester.edu name: Christopher Palma role: PRINCIPAL_INVESTIGATOR lat: 43.15478 lon: -77.61556 facility: UT Health Houston city: Houston state: Texas zip: 77030 country: United States name: Site Contact role: CONTACT phone: 713-486-3100 email: Meera.g.subash@uth.tmc.edu name: Meera Subash role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06377215 id: Pro00041729 id: R01DC020514 type: NIH link: https://reporter.nih.gov/quickSearch/R01DC020514 briefTitle: Understanding Aided Speech Perception in Noise overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2028-03-01 date: 2028-03-01 date: 2024-04-22 date: 2024-04-22 name: University of South Florida class: OTHER name: National Institute on Deafness and Other Communication Disorders (NIDCD) briefSummary: The overarching hypothesis to be evaluated using this protocol is that age-related hearing loss (ARHL) leads to shifts in the functional spatial boundaries between segregated and integrated auditory streams, and that hearing aid intervention that relies on directional processing schemes is most effective for those that have the poorest spatial sensitivity. One key component of the research design is to measure both behavioral and neurophysiological indices of an individual's spatial segregation boundary. The second key component is to measure the cost or benefit associated with hearing aid intervention in older hearing-impaired listeners. The final component is to relate cost and benefit of hearing aid intervention to spatial sensitivity measures that might predict the efficacy of clinical intervention. conditions: Hearing Impairment, Sensorineural conditions: Spatial Perception conditions: Aging conditions: Hearing Aids studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 121 type: ESTIMATED name: Open-source master hearing aid measure: Digit Identification measure: Neural Segregation measure: Minimum Audible Angle (MAA) measure: Speech Localization Error measure: Fixed Spatial Release from Masking measure: Pure-tone Air Threshold (PTac) measure: Bone Conduction Threshold (PTbc) measure: Wideband Tympanometry (Equivalent Ear Canal Volume) measure: Wideband Tympanometry (Static Peak Pressure) measure: Wideband Tympanometry (Resonant Frequency) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: USF Research Park BPB, 3802 Spectrum Boulevard, Suite 210C city: Tampa state: Florida zip: 33612 country: United States name: Erol Ozmeral, Ph.D. role: CONTACT phone: 813-974-9778 email: eozmeral@usf.edu name: Carrie Secor, Au.D. role: CONTACT phone: 813-974-4148 email: csecor@usf.edu name: Erol Ozmeral, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 27.94752 lon: -82.45843 hasResults: False

 nctId: NCT06377202 id: SynKIR-110 LTFU briefTitle: Long-Term Follow-Up Safety Study of Subjects Treated With SynKIR-110 in Cancer Studies overallStatus: RECRUITING date: 2023-11-15 date: 2038-12-15 date: 2038-12-15 date: 2024-04-22 date: 2024-04-24 name: Verismo Therapeutics class: INDUSTRY briefSummary: The primary objective of this study is to evaluate the long-term safety of SynKIR- 110 administered to adult subjects with solid tumors expressing mesothelin. conditions: Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Number of subjects with treatment related adverse events as assessed by CTCAE v5.0 measure: Number of subjects with persistence of SynKIR-110 modified cells measure: Number of subjects with potential/suspected RCL 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: Katie Elkins role: CONTACT phone: 215-615-6740 email: katie.elkins@pennmedicine.upenn.edu name: Janos Tanyi, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06377189 id: 2023-01910 briefTitle: Psychiatric Consultation-Liaison Intervention in Primary Care: A Pilot Study acronym: PLIMeC-P overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-01 date: 2025-12-01 date: 2024-04-22 date: 2024-04-22 name: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland class: OTHER name: Neuchâtel Psychiatry Centre (CNP) name: University of Lausanne Hospitals briefSummary: The pilot study on the impact of a Psychiatric Consultation-Liaison Intervention in Primary Care Medical Consultations in French-speaking Switzerland (PLIMeC-P), is a mixed method randomized controlled trial. The investigated health-related intervention is a brief Consultation-Liaison (CL) psychiatry intervention in primary care.

Primary Care Physicians (PCPs) have a key role in preventing, detecting, and managing mental disorders. Therefore, the optimization of both the quality of their interventions and their cooperation with psychiatric and psychological care networks are important challenges. It is well demonstrated that multidisciplinary interventions improve the efficacy of mental health care, CL psychiatry being one such type of intervention. Therefore, community CL-psychiatry, for example in private primary care group practices, are rare. The impact of such community, primary care CL-psychiatry interventions, should be investigated.

The mixed methods randomized controlled trial PLIMeC study will examine the impact of a CL-psychiatric intervention in primary care settings, for newly reported mental illness, versus a Treatment As Usual (TAU) control arm. The intervention consists of a CL-psychiatric intervention into private medical practices, provided to patients suffering from mental health problems, a group of patients generally under-treated. The CL-psychiatrist will receive and discuss PCPs' referrals for patients with mental distress, who don't have a psychiatric follow-up. After a brief intervention (1-4 sessions), feedback conjoint (PCP-psychiatrist) session will be organized, to complete the intervention and provide proposals.

The pilot study (PLIMeC-P) will determine whether the main planned study (PLIMeC) is feasible and practicable. It will be conducted on two sites, the Neuchâtel Psychiatry Centre (CNP) and the North-west Adult Psychiatry Service (SPANO), Department of Psychiatry of CHUV, Yverdon. For the pilot study (PLIMeC-P), 15 eligible participants are expected for each group, 30 participants in total. They will be recruited in three private primary care group practices. After eligibility and randomization 15 participants will be included for the intervention arm (brief CL-psychiatric intervention) and 15 for the control arm (TAU). The expected number of participants for the main trial (PLIMeC) will be estimated through analysis of the initial results of the PLIMeC-P. conditions: Mental Health Issue conditions: Depression/Anxiety conditions: Quality of Life conditions: Psychosomatic Disorders conditions: Patients Lived Experiences conditions: Doctor-Patient Relation conditions: Collaboration studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In order to answer the research question of the PLIMeC-P (pilot study), aiming to determine the feasibility and practicability of the main PLIMeC study, in the initial phase, the statistical procedures will be limited to questions of practicability and quality.

For the main PLIMeC study we will use a mixed method approach, combining various data collection and analysis methods (qualitative and quantitative). Quantitative methods will be used to obtain a breadth of understanding of the phenomenon of interest, and qualitative methods will be used to explore and obtain depth of this understanding. More specifically, the combination of methods will be used for complementarity, using qualitative data to examine how the participants, patients and healthcare providers, experience this specific CL-psychiatric intervention and quantitative methods to examine the impact of such an intervention on patients. In data analysis, the priority among the two methods will be equal. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 30 type: ESTIMATED name: Intervention arm - Consultation-Liaison (CL) brief psychiatric intervention in primary care settings name: Control Arm - Treatment As Usual (TAU) measure: Evaluate the feasibility of the main PLIMeC study measure: Mental health - psychiatric symptoms measure: Mental health - Quality of life measure: Mental health - Self-report questionnaire measure: The lived experience of the participants measure: The lived experience of the implicated clinicians measure: Healthcare system complexity - Quantitative assessment measure: Healthcare system complexity - qualitative assessment measure: Access to mental healthcare sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center for Primary Care and Public Health (Unisanté) - Sponsorship / Not recruiting site city: Lausanne state: Vaud zip: 1010 country: Switzerland lat: 46.516 lon: 6.63282 facility: Service de psychiatrie de l'adulte nord ouest (SPANO) Département de psychiatrie - CHUV (DP-CHUV) city: Yverdon-les-Bains state: Vaud zip: 1400 country: Switzerland name: Julien Elowe, MD role: CONTACT phone: 0041 21 314 54 38 email: Julien.Elowe@chuv.ch name: Julien Elowe, MD role: PRINCIPAL_INVESTIGATOR name: Gerrit Weber, MD role: SUB_INVESTIGATOR lat: 46.77852 lon: 6.64115 facility: Centre Neuchâtelois de Psychiatrie (CNP) city: Neuchâtel zip: 2000 country: Switzerland name: Stéphane Saillant, PD role: CONTACT phone: 0041 32 755 15 15 email: stephane.saillant@cnp.ch name: Stéphane Saillant, PD role: PRINCIPAL_INVESTIGATOR name: Julie Gavin-Ramain, PhD role: SUB_INVESTIGATOR lat: 46.99179 lon: 6.931 hasResults: False

 nctId: NCT06377176 id: NTUNHSEN briefTitle: Postpartum Massage Therapy for Women and Infants: The Effect on Maternal Depression, Stress, Fatigue and Infant Temperament overallStatus: COMPLETED date: 2021-06-16 date: 2021-10-03 date: 2021-10-03 date: 2024-04-22 date: 2024-04-22 name: National Taipei University of Nursing and Health Sciences class: OTHER briefSummary: Mother and infant massage, a type of complementary therapy, possesses the capacity to ameliorate maternal depression, stress, fatigue, and also infant temperaments and convert them into more manageable ones. The objective of this study was to determine the effect of mother and infant massage therapy on maternal depression, stress, fatigue, and infant temperament. In this quasi-experimental study, a total of 102 participants were allocated into two groups based on a pretest and posttest. During a period of five weeks, the experimental groups were subjected to ten massages per week, twice every week. On the data, a generalized estimating equation (GEE) was implemented. This study's hypothesis was an improvement in maternal depression, stress, fatigue, and infant temperament. conditions: Postpartum Depression studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A quasi-experimental design was utilized in this investigation; it comprised a pre-test and a post-test administered to two distinct groups. The intervention group was subjected to pre-testing before receiving the intervention, and after the intervention, mother and infant massage treatment was delivered to the intervention group. Post-testing was performed on both groups, with the control group receiving mother and infant massage. primaryPurpose: TREATMENT masking: NONE count: 102 type: ACTUAL name: Massage therapy measure: Depression measure: Stress measure: Fatigue measure: Infant temperament sex: ALL minimumAge: 1 Month maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Community Health Center city: Sleman state: Yogyakarta zip: 55584 country: Indonesia lat: -7.71556 lon: 110.35556 hasResults: False

 nctId: NCT06377163 id: acquired pneumonia in children briefTitle: Bacterial Pathogens Associated With Community-acquired Pneumonia in Children overallStatus: COMPLETED date: 2021-01-01 date: 2021-08-31 date: 2021-08-31 date: 2024-04-22 date: 2024-04-22 name: Delta University for Science and Technology class: OTHER briefSummary: Pediatric community acquired pneumonia (CAP) is one of the most common reasons for hospital admission, there is no reliable way of distinguishing the causative organism based on clinical features.

This study examined common pathogens of community-acquired pneumonia from 28 days up to 10 years in Dakahlia Governorate. conditions: Children Pneumonia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ACTUAL measure: Complete blood count measure: C-reactive protein (CRP) measure: Blood culture and sensitivity on admission measure: Gastric lavage culture or sputum culture on admission sex: ALL minimumAge: 28 Days maximumAge: 10 Years stdAges: CHILD facility: Amira Hussin Mohammed city: Gamasa zip: 35712 country: Egypt lat: 31.44112 lon: 31.53675 hasResults: False

 nctId: NCT06377150 id: ABCA4-1382022BO2 briefTitle: Stargardt Disease in Childhood overallStatus: COMPLETED date: 2022-04-01 date: 2024-03-31 date: 2024-03-31 date: 2024-04-22 date: 2024-04-22 name: University Hospital Tuebingen class: OTHER briefSummary: Retrospective chart review study to elucidate the phenotype and genotype of children with ABCA4-associated Stargardt disease. conditions: Stargardt Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 39 type: ACTUAL measure: Best Corrected Visual Acuity (BCVA) measure: Visual Field (VF) measure: Fundus Photography (FP) measure: Fundus Autofluorescence (AF) measure: Optical Coherence Tomography (OCT) measure: Full-Field Electroretinography (ff-ERG) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Tuebingen city: Tuebingen state: Baden-Wuerttemberg, Germany zip: 72076 country: Germany lat: 48.52266 lon: 9.05222 hasResults: False

 nctId: NCT06377137 id: University of the Porto briefTitle: High-intensity Small-sided Soccer Games for Cardiometabolic Health in Adolescents With Metabolic Dysfunction overallStatus: COMPLETED date: 2023-03-10 date: 2023-04-10 date: 2023-09-01 date: 2024-04-22 date: 2024-04-22 name: Universidade do Porto class: OTHER briefSummary: Pediatric obesity is considered one of the most important public health problems worldwide due to its high prevalence and associated comorbidities. Physical exercise has been shown to have an important role in the treatment of obesity and associated cardiometabolic dysfunction. Small-sided soccer games (SSSG) have been explored as a promising way of increasing physical exercise due to its benefits on cardiometabolic health and high degree of enjoyment, which favors long-term adherence.

The objective of this research is to determine the effects of a 16-week high-intensity SSSG-based exercise intervention on cardiometabolic risk factors, physical fitness, adherence to 24-hour movement patterns, enjoyment and adherence to the intervention in adolescents with metabolic dysfunction and compare them to the effects of a traditional soccer intervention.

The investigators hypothesize that high-intensity SSSG are more effective in improving the obesity-related cardiometabolic risk profile in adolescents with cardiometabolic dysfunction compared to traditional soccer training.

A parallel 3-arm randomized controlled trial will be conducted in adolescents with overweight and metabolic dysfunction between 11 and 15 years of age. The inclusion criteria are: (i) age between 11-15 years at the time of intervention start; (ii) overweight or obesity (BMI\> 85th percentile); (iii) Abdominal obesity ≥90th percentile as assessed by waist circumference or a waist-to-height ratio ≥ 0.5; (iv) willing to participate in the study regardless of possible group allocation; (v) informed consent given by participant and legal representatives. Exclusion criteria: (i) health condition not compatible with participation in physical exercise; (ii) history of recent musculoskeletal injury hindering exercise participation; (iii) concurrent participation in a structured weight loss or exercise program.

Those eligible to participate in the study will be randomly assigned to one of three groups: i) SSSG group, ii) traditional soccer play group (TSG), or, iii) non-exercise intervention control group (CG). Participants in both exercise intervention groups will undergo a 16-week intervention. The SSSG group will participate in a high-intensity small-sided soccer games training, while the TSG will undergo a technical and tactical skills training program and traditional soccer training. The CG participants will continue with regular school physical education classes without any additional intervention. Before and after the intervention, all participants will be assessed for cardiometabolic and hepatic biochemical markers, physical fitness, anthropometry and body composition, blood pressure, objective daily physical activity and sleep quality, and perceived enjoyment of participation in SSSG and TSG. The primary outcomes of the study will be waist circumference and cardiorespiratory fitness.

The study protocol was approved by the Ethics Committee of the Faculty of Sport of the University of Porto and by the Scientific Ethics Committee of the Adventist University of Chile. conditions: Obesity, Adolescent conditions: Metabolic Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 51 type: ACTUAL name: Small-sided soccer games groups (SSSG) name: Traditional soccer training groups (TSG) measure: Waist circumference measure: Cardiorespiratory fitness measure: Variation in fasting blood glucose concentration (mg/dL) measure: Variation in serum insulin concentration (mU/L) measure: Variation in HOMA-IR measure: Variation in glycosylated hemoglobin concentration (mg/dL) measure: Variation in high-density lipoprotein cholesterol concentration (mg/dL) measure: Variation in low-density lipoprotein cholesterol concentration (mg/dL) measure: Variation in total cholesterol concentration (mg/dL) measure: Variation in blood triglycerides concentration (mg/dL) measure: Variation in blood Alanine aminotransferase concentration (U/L) measure: Variation in blood Aspartate aminotransferase concentration (U/L) measure: Variation in blood Gamma glutamyl transferase concentration (U/L) measure: 6-minute walk test measure: Hand grip strength measure: Lower limb strength measure: Body composition measure: Body mass index measure: Neck circumference measure: Blood Pressure (mmHg) measure: Physical activity measure: Sleep quality measure: Perceived enjoyment of physical activity sex: MALE minimumAge: 11 Years maximumAge: 15 Years stdAges: CHILD facility: Faculty of Sport of the University of Porto city: Porto zip: 4200-450 country: Portugal lat: 41.14961 lon: -8.61099 hasResults: False

 nctId: NCT06377124 id: UW21-507 briefTitle: A Smart Self-Management Support Programme (3S) to Improve Quality of Life in Lung Cancer Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2026-03-31 date: 2026-06-30 date: 2024-04-22 date: 2024-04-22 name: The University of Hong Kong class: OTHER name: Queen Mary Hospital, Hong Kong name: The Queen Elizabeth Hospital name: United Christian Hospital briefSummary: Lung cancers patients often experience multiple symptoms (e.g. fatigue, dyspnea, distress, depression, sleep disturbance). The current study attempts to explore the efficacy of the Smart Self-Management Support Programme (3S) in improving quality of life of patients using self-management support programme with mobile devices. conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The 3S intervention includes an individual session, messaging and phone contact related to lung cancer self-management, and hotline services.

The general health information includes an individual session, messaging and phone contact related to general health information, and hotline services. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: The outcome assessor was not aware of which groups the patients belonged to. whoMasked: OUTCOMES_ASSESSOR count: 320 type: ESTIMATED name: 3S intervention name: GH information measure: Change in health-related quality of life measure: Change in health-related quality of life measure: Change in patient activation measure: Change in general self-efficacy measure: Change in acceptance of illness measure: Change in physical activity level measure: Change in diet habit measure: Change in smoking and drinking habits measure: Change in health status measure: Change in anxiety symptoms of patients measure: Change in depression symptoms of patients measure: Change in social and family support measure: Change in adherence to agreed preset health-related goals measure: Change in symptom severity measure: Change in functional exercise capacity measure: Change in lower limb strength measure: Change in hand grip strength measure: Change in flexibility measure: Change in balance measure: Change in body composition measure: Change in objective physical activity level measure: Change in objective sleep quality measure: Change in burden of family caregivers (For FCGs) measure: Change in quality of life of family caregivers (For FCGs) measure: Change in anxiety symptoms of family caregivers (For FCGs) measure: Change in depression symptoms of family caregivers (For FCGs) sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Queen Mary Hospital city: Hong Kong country: Hong Kong name: Agnes YK Lai, PhD role: CONTACT phone: 3970-2903 email: ayklai@hkmu.edu.hk name: Agnes Yuen Kwan Lai, PhD role: PRINCIPAL_INVESTIGATOR lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06377111 id: PANTHEON-IO briefTitle: A Study to Test the Benefit of Vitamin B5 in Patients With Melanoma overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-05 date: 2024-04-22 date: 2024-04-22 name: University Health Network, Toronto class: OTHER briefSummary: This study is open to patients with a type of cancer called melanoma. Patients can join the study if their tumor cannot be removed by surgery or has spread to other organs, and are planned to receive immunotherapy as treatment for their cancer. This study is looking at whether taking calcium pantothenate supplement (a type of Vitamin B5) can increase its levels in the blood and have an effect in the immune system, when its used in combination with the immunotherapy. conditions: Melanoma (Skin) studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: C-PAN name: Nivolumab name: Ipilimumab measure: To determine if the dose of 2000 mg daily of pantothenic acid achieves an increase in plasmatic concentration of pantothenic acid by at least a 50% between baseline and week 9, in 9 or more of the patients treated with combined ICI. measure: Evaluate the overall response rate (ORR) of the enrolled cohort. measure: Evaluate the progression free survival (PFS) of the enrolled cohort. measure: Incidence of immune-related colitis. measure: Correlation between baseline intestinal microbiome composition to the development of immune-related colitis. measure: Correlation between the early changes in composition of intestinal microbiome and the development of immune-related colitis. measure: The incidence of treatment-related adverse events. measure: The incidence of treatment-related adverse events measure: Correlation between change in plasmatic pantothenic acid level between baseline and at first day of ICI, and ORR. measure: Correlation between change in pantothenic acid plasmatic level in mcMol/L between baseline and first day of ICI, and ORR by RECIST and iRECIST. measure: Correlation between change in plasmatic pantothenic acid level between baseline and week 9 assessment, and immune profiling. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Health Network- Princess Margaret Cancer Centre city: Toronto state: Ontario zip: M5G 2M9 country: Canada name: Minge Xu role: CONTACT phone: 416-946-4501 phoneExt: 7754 email: minge.xu@uhn.ca name: Samuel Saibil role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06377098 id: UAB-300010901 id: UAB Dixon Endowed Ch/3102800 type: OTHER_GRANT domain: UAB Dixon Endowed Chair briefTitle: Intrapartum Sildenafil in Laboring Mothers acronym: PRISM overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-31 date: 2028-01-31 date: 2024-04-22 date: 2024-04-22 name: University of Alabama at Birmingham class: OTHER name: University Teaching Hospital, Lusaka, Zambia name: Egerton University name: Cameroon Baptist Convention Health briefSummary: The goal of this feasibility pilot clinical trial is to learn if sildenafil citrate 50mg orally, up to three times during labor, can be appropriately administered, with limited clinical side effects, to laboring mothers to determine feasibility across a spectrum of available healthcare resources.

The main questions it aims to answer are:

* What are the fetal heart rate monitoring practices in a low-resource setting?
* What are the indications for operative delivery in a low-resource?
* What is the rate of relevant primary and secondary outcomes to possibly target in a large RCT of intrapartum sildenafil?
* What is the limited effect size of sildenafil citrate on maternal and neonatal outcomes in a low-resource setting?

Researchers will compare the administration of sildenafil citrate 50 mg orally to a placebo (a look-alike substance that contains no drug) to see if procedures are feasible, the drug is tolerated, the target outcomes are achievable, and effect size is as expected.

Participants will:

* Take Sildenafil 50 mg/placebo every eight hours or a placebo every eight hours for up to 24 hours during labor
* Have the (mothers \& babies) medical charts reviewed for outcomes, including fetal distress, operative delivery, maternal side effects, neonatal bag \& mask ventilation, Apgar scores, and seizures.
* Have a neonatal neurological assessment prior to discharge
* Have phone call assessments for re-hospitalization or mortality 7 days post-delivery
* Receive child development assessments at 1 year, 2 years and 3 years of age by the Ages and Stages Questionnaire administered via a telephone call

The results of this feasibility pilot trial will be used to inform the design and conduct of a large pragmatic randomized controlled trial to determine if sildenafil citrate, compared to placebo, will decrease fetal distress and perinatal asphyxia. conditions: Neonatal Asphyxia conditions: Intrapartum Fetal Distress conditions: Development, Infant conditions: Intrapartum Asphyxia studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double blinded, placebo-controlled, 1:1 parallel allocation, randomized feasibility trial primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The only person who will be unmasked will be the pharmacist who will dispense the study medication--either sildenafil 50mg or identical placebo whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1000 type: ESTIMATED name: Sildenafil 50 mg Oral Tablet name: Placebo Oral Tablet measure: Percentage of perinatal mortality measure: Percentage of operative delivery measure: Indication for operative delivery measure: Percentage of mothers who received fetal heart rate monitoring measure: Indication for fetal heart rate monitoring measure: Apgar Score measure: Percentage of use of bag and mask ventilation in neonates measure: Percentage of neonates with neonatal encephalopathy measure: Percentage of neonates with neonatal encephalopathy measure: Percentage of neonates with hypoxemia measure: Percentage of infants with neonatal hypoxic-ischemic encephalopathy measure: Percentage of neonatal ICU admissions measure: Percentage of maternal rehospitalization measure: Percentage of neonatal rehospitalization measure: Infant/child developmental assessment sex: ALL minimumAge: 0 Days maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Cameroon Baptist Convention Health Services city: Douala country: Cameroon name: Pius Tih Muffih, PhD role: CONTACT phone: 677764781 email: piustih@cbchealthservices.org name: Rahel Kyeng Mbah role: CONTACT phone: 370 371378 email: kyeng2003@yahoo.co.uk name: Akila Subramaniam, MD role: PRINCIPAL_INVESTIGATOR name: Pius Tih Miffih, PhD role: SUB_INVESTIGATOR lat: 4.04827 lon: 9.70428 facility: Egerton University/Nakuru County Referral Hospital city: Nakuru country: Kenya name: Amos Otara, MD role: CONTACT phone: 254 7222 7470 email: amosotara@yahoo.com name: Elizabeth G Kibaru, MbchB, Mmed role: CONTACT phone: 072 942 394 email: ekibaru@egerton.ac.ke name: Nora Switchenko, MD role: PRINCIPAL_INVESTIGATOR name: Amos Otara, MD role: SUB_INVESTIGATOR lat: -0.28333 lon: 36.06667 facility: University Teaching Hospital city: Lusaka country: Zambia name: Elwyn Chomba, MD role: CONTACT phone: 0211 254 655 email: elwynchomba@gmail.com name: Musaku Mwenechanya, MD role: CONTACT phone: +260966722966 email: mmusaku@gmail.com name: Elwyn Chomba, MD role: PRINCIPAL_INVESTIGATOR name: Musaku Mwenechanya, MD role: SUB_INVESTIGATOR lat: -15.40669 lon: 28.28713 hasResults: False

 nctId: NCT06377085 id: 809325 briefTitle: Repurposing 5-Azacytidine for the Treatment of Muscle Contractures in Children With Cerebral Palsy overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-05 date: 2024-04-22 date: 2024-04-22 name: Shirley Ryan AbilityLab class: OTHER name: Rady Children's Hospital, San Diego briefSummary: In this controlled dose-escalation study, we will study the initial safety, biological properties, and potential efficacy of 5-azacytidine (AZA). Our overarching aspiration is for AZA to evolve into an approved pharmacological treatment, fostering muscle growth and enhancing body movement, ultimately contributing to an improved quality of life in children with CP.

The main questions this study aims to answer are:

1. What is the optimal dose of AZA injection that can be used safely in children with CP?
2. Can the optimal safe dose of AZA improve the function of muscle-generating stem cells in children with CP?

Each participant will have up to five research visits over the course of the study duration, in which they will participate in: blood draws, pregnancy test(s) (if applicable), medical assessments, and a muscle biopsy during a surgery for muscle contractures.

Researchers will compare participants with four different dosages of AZA injections to those with four different dosages of placebo injections. A placebo is a look-alike substance that contains no active drug. They will see if a single injection of AZA at a standard concentration currently approved by the FDA to treat myelodysplastic syndromes, can also safely improve muscle growth and function in children with CP. conditions: Cerebral Palsy conditions: Contracture studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: For this Phase 1 trial, we will conduct a dose-escalation study in children having CP who receive 5-Azacytidine (AZA) via a single subcutaneous (SQ) injection two weeks before their surgery, already scheduled to release their contractures. We will use a "3 + 3" dose-escalation design where decisions are based on the rate of toxicity at the current dose level independently from prior dose levels. The primary goal of this study is to determine a Maximum Tolerated Dose (MTD), which will be the highest dose level at which less or equal of 33% of patients experience Dose-Limiting Toxicity (DLT). primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 27 type: ESTIMATED name: Placebo for the AZA 10mg/m^2 name: Placebo for the AZA 20mg/m^2 name: Placebo for the AZA 35mg/m^2 name: Placebo for the AZA 75mg/m^2 name: 5-Azacytidine 10mg/m^2 name: 5-Azacytidine 20mg/m^2 name: 5-Azacytidine 35mg/m^2 name: 5-Azacytidine 75mg/m^2 measure: Dose-limiting toxicity (DLT). measure: Satellite Cell Fusion Index. measure: DNA methylation quantification in Satellite Cells and Blood Mononucleated Cells. measure: DNA methylation profiling in Satellite Cells. measure: Chromatin immunoprecipitation sequencing (ChIP-seq), and assay for transposase-accessible chromatin sequencing (ATAC-seq) sex: ALL minimumAge: 2 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06377072 id: SHPL-W036-301 briefTitle: Efficacy and Safety of Shenqi Sherong Pill in Participants With Cervical Spondylotic Myelopathy overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-11 date: 2026-03 date: 2024-04-22 date: 2024-04-22 name: Shanghai Hutchison Pharmaceuticals Limited class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of Shenqi Sherong Pill in participants with Mild or Moderate Cervical Spondylotic Myelopathy (qi deficiency, blood stasis and kidney deficiency type) which based on placebo-control, providing a basis for drug registration. conditions: Cervical Spondylotic Myelopathy studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 428 type: ESTIMATED name: Shenqi Sherong Pill name: Placebo measure: Change in Modified Japanese Orthopaedic Association (mJOA) score measure: Change in mJOA score measure: Change in sensation of mJOA score measure: Changes in pain or stiffness score for neck and shoulder measure: Change in chest tightness score measure: Changes in hand and arm numbness scores measure: Change in numbness (or pain) scores from the chest to the toes measure: Change in Motor dysfunction of the upper extremities of mJOA score measure: Proportion of participants with at least 1 grade decline in Nurick grades measure: Change in Traditional Chinese medicine (TCM) syndrome integrality measure: Change in TCM syndrome score measure: Serious adverse events measure: Adverse events measure: Vital sign (systolic and diastolic blood pressure after 10-minute rest) measure: Vital sign (body temperature) measure: Vital sign (respiration) measure: Vital sign (heart rate） measure: Laboratory test indicator (blood routine) measure: Laboratory test indicator (liver function) measure: Laboratory test indicator (kidney function) measure: Laboratory test indicator (fasting glucose) measure: Laboratory test indicator (urine routine and urinary sediment count) measure: Laboratory test indicator (stool routine and occult blood) measure: Electrocardiogram(ECG) QT Interval measure: ECG QTc Interval measure: ECG QRS Interval measure: ECG PR Interval measure: Pathological sign (Hoffmann sign) measure: Pathological sign (Babinski sign) measure: Concomitant medication sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06377059 id: 2024-RH-phase1-WARD briefTitle: Early Detection of Complications During Immunotherapy for Haematological Malignancy overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-07-01 date: 2027-07-01 date: 2024-04-22 date: 2024-04-22 name: Rigshospitalet, Denmark class: OTHER briefSummary: Aims

* To identify patients that should remain admitted in hospital for more intense surveillance because of high risk for development of clinical complications
* Expand the understanding of the interactions between physiology and immunology for the design of future projects and general knowledge Hypothesis Development of a risk model based on a combination of physiological and immunological parameters can contribute to early detection of patients at risk for clinical complications after anti-cancer treatment. conditions: Hematologic Cancer conditions: CRS - Cytokine Release Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: WARD measure: CRS measure: Immune response measure: severe physiological deviations measure: clinical complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06377046 id: NL86643.068.24 briefTitle: Accelerated Pacing in Patients Undergoing Pace-and-ablate Strategy With LBBAP: a Randomized Controlled Pilot Trial acronym: PACE-AF overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-11 date: 2026-05 date: 2024-04-22 date: 2024-04-22 name: Maastricht University Medical Center class: OTHER briefSummary: The goal of this clinical trial is to determine the effect of accelerated pacing (pacemaker lower rate programmed to 80bpm) compared to pacing at the standard programmed lower rate of 60bpm in symptomatic atrial fibrillation patients undergoing pace-and-ablate strategy with LBBAP.

The main question it aims to answer is:

- To determine the effect of accelerated pacing on health-related quality of life compared to the current standard of care.

Secondary questions it aims to answer are:

* To study the acute hemodynamic effect of different (accelerated) pacing rates on pulmonary capillary wedge pressure, cardiac output and arterial blood pressure among atrial fibrillation patients undergoing pace-and-ablate strategy.
* To study the long-term effects (at 6 months) of accelerated pacing compared to the current standard of care among atrial fibrillation patients undergoing pace-and-ablate strategy on:
* NT pro BNP levels
* device detected atrial fibrillation burden and daily activity
* echocardiographic measurements (LVEF, left ventricular ejection fraction; LVEDD, left ventricular end- diastolic diameter; LVESD, left ventricular end-systolic diameter; LAVI left atrial volume index; diastolic parameters; strain conditions: Atrial Fibrillation conditions: Permanent Atrial Fibrillation conditions: Persistent Atrial Fibrillation conditions: Pacemaker DDD conditions: Paroxysmal Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, single center, prospective, single blinded, parallel group, pilot-trial. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: Accelerated pacing name: Current standard of care measure: The effect of accelerated pacing (lower programmed rate of 80 bpm) compared to pacing at the standard programmed rate of 60 bpm on health-related quality of life (HRQoL) in symptomatic AF patients undergoing pace-and-ablate strategy with LBBAP. measure: The acute hemodynamic effects of different (accelerated) pacing rates on pulmonary capillary wedge pressure (PCWP). measure: The acute hemodynamic effects of different (accelerated) pacing rates on cardiac output (CO). measure: The acute hemodynamic effects of different (accelerated) pacing rates on arterial blood pressure. measure: The long-term effects of accelerated pacing on health-related quality of life based on the 36-item short form health survey (SF-36) among AF patients undergoing pace-and-ablate strategy. measure: The long-term effects of accelerated pacing on NTproBNP levels among AF patients undergoing pace-and-ablate strategy. measure: The long-term effects of accelerated pacing on device detected AF burden among AF patients undergoing pace-and-ablate strategy. measure: The long-term effects of accelerated pacing on device detected daily activity among AF patients undergoing pace-and-ablate strategy. measure: The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy. measure: The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy. measure: The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy. measure: The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy. measure: The long-term effects of accelerated pacing on echocardiographic changes among AF patients undergoing pace-and-ablate strategy. measure: Palpitations experienced as a result of (accelerated) pacing. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06377033 id: 10877980 briefTitle: Using the EHR to Advance Genomic Medicine Across a Diverse Health System overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-31 date: 2027-06-30 date: 2024-04-22 date: 2024-04-22 name: University of Pennsylvania class: OTHER briefSummary: Given the expansion of indications for genetic testing and our understanding of conditions for which the results change medical management, it is imperative to consider novel ways to deliver care beyond the traditional genetic counseling visit, which are both amenable to large-scale implementation and sustainable. The investigators propose an entirely new approach for the implementation of genomic medicine, supported by the leadership of Penn Medicine, investigating the use of non-geneticist clinician and patient nudges in the delivery of genomic medicine through a pragmatic randomized clinical trial, addressing NHGRI priorities. Our application is highly conceptually and technically innovative, building upon expertise and infrastructure already in place.

Innovative qualities of our proposal include: 1) Cutting edge EHR infrastructure already built to support genomic medicine (e.g., partnering with multiple commercial genetic testing laboratories for direct test ordering and results reporting in the EHR); 2) Automated EHR-based direct ordering or referring by specialist clinicians (i.e., use of replicable modules that enable specialist clinicians to order genetic testing through Epic Smartsets, including all needed components, such as populated gene lists, smartphrases, genetic testing, informational websites and acknowledgement e-forms for patient signature); 3) EHR algorithms for accurate patient identification (i.e., electronic phenotype algorithms to identify eligible patients, none of which currently have phenotype algorithms present in PheKB; 4) Behavioral economics-informed implementation science methods: This trial will be the first to evaluate implementation strategies informed by behavioral economics, directed at clinicians and/or patients, for increasing the use of genetic testing; further it will be the first study in this area to test two forms of defaults as a potential local adaptation to facilitate implementation (ordering vs. referring); and 5) Dissemination: In addition to standard dissemination modalities,PheKB95, GitHub and Epic Community Library, the investigators propose to disseminate via AnVIL (NHGRI's Genomic Data Science Analysis, Visualization, and Informatics Lab-Space). Our results will represent an entirely new paradigm for the provision of genomic medicine for patients in whom the results of genetic testing change medical management. conditions: Genetic Predisposition conditions: Paraganglioma conditions: Pheochromocytoma conditions: ALS conditions: Parkinson Disease conditions: Polyneuropathies conditions: Frontotemporal Dementia conditions: Alzheimer Disease conditions: Cardiomyopathy Non-ischemic conditions: Thoracic Aortic Aneurysm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1000 type: ESTIMATED name: Behavioral nudge measure: Rate of Genetic Testing measure: Rate of Genetic Test Orders/Referrals measure: Rate of Patient Engagement measure: Rate of Pathogenic variants and VUS measure: Rate of Clinician actions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06377020 id: 23-2490 briefTitle: Prevention and Choice for Type 2 acronym: PACT2 overallStatus: RECRUITING date: 2024-04-10 date: 2024-10-23 date: 2024-10-30 date: 2024-04-22 date: 2024-04-22 name: University of Colorado, Denver class: OTHER name: American Diabetes Association name: High Plains Research Network briefSummary: People living with prediabetes are advised to lose weight to prevent development of type 2 diabetes by participating in intensive lifestyle interventions (ILI's), such as PreventT2. The PreventT2 program focuses on a low-calorie diet for weight loss. However, many people find it difficult to stick to a low-calorie diet over the long-term. The identification of novel, effective and individualized dietary strategies to produce long-term weight loss is critically important in diabetes prevention. An ILI based on PreventT2 which considers individual preferences, allowing participants to choose among a variety of diets, may result in greater adherence to the diet than a standard PreventT2 intervention. ILIs also need to be available to individuals in a wide range of communities, including Americans living in rural communities, who experience higher rates of obesity and chronic disease, yet have less access to medical care, including programs for diabetes prevention. The investigators plan to develop and carry out a 16-week pilot and feasibility study of a group-based ILI program based on PreventT2 plus choice of dietary strategy (Prevention and Choice for Type2 , PACT2) delivered via videoconference to adults with prediabetes living in rural communities. Successful completion of this project will result in the refinement of an ILI that incorporates personal preferences and is tailored to individuals at high risk for type 2 diabetes living in rural areas where access to such interventions is limited. conditions: PreDiabetes studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a single group pilot and feasibility study primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: PACT2 measure: Body weight measure: Blood pressure measure: Physical activity measure: Energy intake measure: HbA1c measure: 24 hr glucose levels measure: Dietary adherence sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado Anschutz Medical Campus status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Elizabeth Thomas, MD role: CONTACT phone: 303-808-2622 email: elizabeth.thomas@cuanschutz.edu lat: 39.72943 lon: -104.83192 hasResults: False

 nctId: NCT06377007 id: WU66290 id: WU66290 type: OTHER_GRANT domain: Walailak individual grant briefTitle: Refractive Outcomes and Ocular Biometry of Two Swept-Source Optical Coherence Tomography-Based Biometers With Segmental or Equivalent Refractive Indices (ORION) acronym: ORION overallStatus: RECRUITING date: 2024-01-01 date: 2025-07-30 date: 2025-12-30 date: 2024-04-22 date: 2024-04-26 name: Walailak University class: OTHER briefSummary: Cataract surgery represents a common surgical intervention, encompassing the extraction of the opaque natural crystalline lens, followed by the substitution with an artificial intraocular lens (IOL). To ascertain an IOL possessing optimal power, antecedent to the surgery, preoperative evaluations are conducted through the utilization of a biometric devices. Diverse categories of these instruments are accessible, each harnessing distinct optical methodologies or mathematical algorithms to ascertain the most fitting IOL power. The principal objective of this study was to evaluate the ocular biometry and the predictive precision outcome of a biometer that uses standard keratometry to the prediction accuracy of another biometer that uses Total Keratometry. conditions: Cataract studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 142 type: ESTIMATED name: IOLMaster 700 (Carl Zeiss Meditec AG) name: Argos (Alcon Laboratories, Inc.) measure: Mean absolute prediction error measure: Proportion of eyes with an absolute prediction error equal to or less than 0.25 sex: ALL minimumAge: 50 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Walailak University status: RECRUITING city: Nakhon Si Thammarat zip: 80160 country: Thailand name: Jakkrit.ju Juhong, MD. role: CONTACT phone: 0816773406 email: jakkrit.ju@wu.ac.th lat: 8.43333 lon: 99.96667 hasResults: False

 nctId: NCT06376994 id: IRB00407311 id: 1U24HL169566-01 type: NIH link: https://reporter.nih.gov/quickSearch/1U24HL169566-01 briefTitle: Multi-Center Clean Air Randomized Controlled Trial in COPD acronym: Clean Air overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2027-09 date: 2028-09 date: 2024-04-22 date: 2024-04-22 name: JHSPH Center for Clinical Trials class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: This is a multi-center randomized, sham-controlled clinical trial to determine the effectiveness of an air cleaner intervention aimed at improving indoor air quality on reducing COPD exacerbation risk and improving quality of life, functional status, rescue medication use. conditions: Chronic Obstructive Pulmonary Disease (COPD) studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 770 type: ESTIMATED name: Air cleaner name: Sham air cleaner measure: St. George's Respiratory Questionnaire (SGRQ) sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins city: Baltimore state: Maryland zip: 21224 country: United States name: Wendy Lorizio role: CONTACT phone: 410-510-2449 email: wlorizi1@jhmi.edu name: Maggie Maly role: CONTACT phone: 410-550-9527 email: mmaly1@jhmi.edu lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06376981 id: CHD23_0025 briefTitle: Hyaluronic Acid in Shoulder Tendinopathy acronym: ACCTE overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-08 date: 2026-11 date: 2024-04-22 date: 2024-04-22 name: Centre Hospitalier Departemental Vendee class: OTHER briefSummary: Multicentric, randomised study to compare the effectiveness on activity pain at 3 months of corticosteroid injection associated with hyaluronic acid with corticosteroids injection alone in patients with tendinopathy of the supraspinatus with clinical reevaluation at one, three and six months. conditions: Shoulder Tendinitis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 132 type: ESTIMATED name: Hyaluronic acid injection name: Corticosteroid injection name: Placebo injection measure: Visual analog scale pain on activity ranging from 0 to 100 mm at month 3. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHD Vendée city: La Roche-sur-Yon country: France name: Céline COZIC, Dr role: PRINCIPAL_INVESTIGATOR lat: 46.66667 lon: -1.43333 facility: CHU Nantes city: Nantes country: France name: Christelle DARRIEUTORT-LAFFITE, Dr role: PRINCIPAL_INVESTIGATOR lat: 47.21725 lon: -1.55336 hasResults: False

 nctId: NCT06376968 id: BA-G-H-1604 briefTitle: Prospective, Multicentre, Randomized, Controlled, Cross-over Study on the Safety and Performance of the Biologic Fusion Option of DialogiQ Compared to Haemodialysis Without Biologic Fusion in Hypotension Prone Patients on Maintenance Haemodialysis overallStatus: RECRUITING date: 2024-04-22 date: 2025-07 date: 2025-08 date: 2024-04-22 date: 2024-04-29 name: B.Braun Avitum AG class: INDUSTRY briefSummary: The goal of this prospective, randomized, controlled, cross-over, multicentric study is to demonstrate the safety of bioLogic Fusion in patients on chronic haemodialysis or hemodiafiltration prone to hypotensive episodes. The main question it aims to answer is:

• Which is the number and percentage of individual sessions with reached prescribed post-dialysis body weight in the prescribed treatment time in each single session in hypotensive-prone patients on high-flux haemodialysis or hemodiafiltration within each patient with treatments performed with DialogiQ with (treatment A) or without (treatment B) the bioLogic Fusion option activated? Participants will in addition to their routine dialysis treatment undergo 2 physical examinations and regularly answer questionnaires.

A crossover design is used to compare treatments with or without the BioLogic Fusion function activated. conditions: Renal Dialysis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: BioLogic Fusion measure: Post-dialysis body weight sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Policlinico S. Orsola - Malpighi - UOC Nefrologia, Dialisi e Ipertensione status: RECRUITING city: Bologna state: Emilia Romagna zip: 40138 country: Italy name: Annalisa Zucchelli, Prof. role: CONTACT name: Annalisa Zucchelli, Prof. role: PRINCIPAL_INVESTIGATOR lat: 44.49381 lon: 11.33875 hasResults: False

 nctId: NCT06376955 id: IRB00014233-1 briefTitle: High Intensity Interval Versus Focused Ultrasound on Insulin Resistance in Diabetics With Abdominal Obesity acronym: diabetic overallStatus: NOT_YET_RECRUITING date: 2024-04-16 date: 2024-08-30 date: 2024-08-30 date: 2024-04-22 date: 2024-04-22 name: Badr University class: OTHER briefSummary: Obesity and diabetes share a common insulin resistance pathway and contribute to chronic hyperglycemia. Both high-intensity interval exercise (HIIE) and focused ultrasound (FUS) have been explored in the context of managing insulin resistance in diabetic individuals with abdominal obesity, though they operate through different mechanisms and have different implications. conditions: Insulin Resistance conditions: Abdominal Obesity conditions: Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: High intensity interval exercise name: Focused ultrasound measure: Body mass index measure: Waist circumference measure: Skin fold measure: Value of HbA1c and HOMA-IR hormone sex: FEMALE minimumAge: 25 Years maximumAge: 35 Years stdAges: ADULT hasResults: False

 nctId: NCT06376942 id: Int/IEC/2024/SPL-5 briefTitle: A RCT to Compare the Effectiveness of Nebulized Anticholinergics for Cough Suppression During Flexible Bronchoscopy acronym: NAFCOF overallStatus: NOT_YET_RECRUITING date: 2024-04-24 date: 2025-04-25 date: 2025-06-15 date: 2024-04-22 date: 2024-04-22 name: Post Graduate Institute of Medical Education and Research, Chandigarh class: OTHER briefSummary: No study has examined the role of inhaled glycopyrrolate on mucus secretion. We hypothesize that nebulized glycopyrrolate will improve bronchoscopy procedure by effectively suppressing airway mucus secretion, thereby decreasing cough, and thus improving patient comfort during bronchoscopy. In this study, we aim to compare the efficacy of nebulized glycopyrrolate versus nebulized ipratropium in suppression of cough during flexible bronchoscopy. conditions: Subjects Undergoing Flexible Bronchoscopy studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1050 type: ESTIMATED name: Glycopyrronium name: Ipratropium name: Saline measure: Cough count measure: Operator-estimated airway secretion measure: Operator-rated secretions on a visual analogue scale (VAS) measure: Operator-rated cough intensity on a visual analogue scale (VAS) measure: Patient-rated comfort on a visual analogue scale (VAS) measure: Adverse reactions sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bronchoscopy suite, PGIMER city: Chandigarh zip: 160012 country: India lat: 30.73629 lon: 76.7884 hasResults: False

 nctId: NCT06376929 id: oralcarbohydrateinpediatric briefTitle: Oral Carbohydrates in Pediatric Surgery and Random Blood Glucose Level overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-08 date: 2024-09 date: 2024-04-22 date: 2024-04-25 name: Cairo University class: OTHER briefSummary: The correlation between preoperative oral carbohydrate intake and intraoperative random blood sugar and also the effect on postoperative nausea and vomiting. conditions: Postoperative Nausea and Vomiting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: randomized controlled primaryPurpose: SCREENING masking: NONE count: 120 type: ESTIMATED name: oral carbohydrate containing fluid measure: Mean values of Intraoperative random blood sugar in mg/dl sex: ALL minimumAge: 3 Years maximumAge: 9 Years stdAges: CHILD hasResults: False

 nctId: NCT06376916 id: IRB00110863 briefTitle: Comparing Magnesium 2g Versus 4g Versus Placebo in the Incidence of Treating AFF RVR acronym: ATRIUM overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2026-12 date: 2024-04-22 date: 2024-04-24 name: Aurora Health Care class: OTHER briefSummary: The purpose of this prospective, randomized, double-blinded study is to further evaluate the safety and efficacy of varying doses of intravenous magnesium in the treatment of AFF RVR. conditions: Tachycardia Atrial conditions: Atrial Fibrillation conditions: Atrial Flutter With Rapid Ventricular Response studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 153 type: ESTIMATED name: Magnesium Sulfate 2 G name: Magnesium Sulfate 4 G name: Saline measure: Ventricular rate control measure: Time to achieve goal HR (heart rate) measure: Rate of conversion measure: Incidence of hypotension measure: Change in heart rate measure: Clinical need for rescue medication administration measure: Adverse effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Advocate Christ Medical Center Emergency Department (ACMC ED) city: Oak Lawn state: Illinois zip: 60453 country: United States name: Marc McDowell, PharmD role: CONTACT phone: 708-684-6230 email: marc.mcdowell@aah.org lat: 41.71087 lon: -87.75811 hasResults: False

 nctId: NCT06376903 id: P.T.REC/012/004860 briefTitle: Effect of Pilates Exercises on Stress Urinary Incontinence in Posmenopausal Women overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-08-20 date: 2024-09-20 date: 2024-04-22 date: 2024-04-22 name: Cairo University class: OTHER briefSummary: • This study will be conducted to determine the effect of pilates exercises on stress urinary incontinence in postmenopausal women conditions: Urinary Stress Incontinence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Pilates exercise - pelvic floor exercise - home advices measure: • Revised urinary incontinence scale measure: • Quality of Life Questionnaire (QOL) for stress urinary incontinence sex: FEMALE minimumAge: 50 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06376890 id: Chile24 briefTitle: Effects of Chili Pepper on Inflammation and Glycemic Control in Southern New Mexico overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-05 date: 2025-07 date: 2024-04-19 date: 2024-04-19 name: New Mexico State University class: OTHER briefSummary: Diabetes is a major health epidemic facing the United States and New Mexico. Currently, 11.6% of the US population (38.4 million) has diabetes, and 38.0% of US adults have prediabetes. It is estimated that around 70% of prediabetics will develop diabetes in their lifetime. In New Mexico, 48% of adults are at least prediabetic, and 12% of adults in southern New Mexico adults have diabetes. Moreover, major health disparities challenge the southern New Mexico region. Type 2 diabetes mellitus (T2DM) is generally linked with chronic inflammation, obesity, insulin resistance, and ultimately insulin dependence via pancreatic β-cell failure. Lessening pathological inflammation, a critically important factor that contributes to diabetes, can improve the disease. Furthermore, 89.8% of diabetics in the US are overweight or obese, this is a major risk for prediabetes and T2DM, as it causes insulin resistance and pancreatic β-cell dysfunction, Weight loss in people with T2DM and prediabetes has been demonstrated to affect glycemic control and metabolic parameters significantly. The purpose of this proposed study is to explore and establish the beneficial effects of 10 weeks of powdered chili pepper consumption on several parameters related to diabetes and prediabetes. This research will demonstrate how powdered chili pepper consumption can improve systemic inflammation, glycemic control, and body composition, and will provide valuable preliminary data for future funding to further examine these effects in Type 2 diabetics. This research is innovative because chili peppers are an already widely accepted food in Southern New Mexico. Demonstrating the beneficial improvements in diabetes-related markers using a popular food in the area may help to establish better treatments and protocols for an area that has health disparities. The first aim is to establish if 10 weeks of powdered red or green chili pepper consumption can significantly improve markers of inflammation, inflammatory capacity, and antioxidant capacity. The second aim is to establish if 10 weeks of powdered red or green chili pepper ingestion has a significant effect on resting blood glucose and insulin levels, connecting peptide (C-peptide) levels, and Homeostatic Model Assessment for Insulin Resistance (HOMA-IR). The third aim is to determine whether powdered chili pepper consumption for 10 weeks improves resting body composition and metabolic rate. This research is innovative because chili peppers are an already widely accepted food in Southern New Mexico. Demonstrating the beneficial improvements in diabetes-related markers using a popular food in the area may help to establish better treatments and protocols for an area with health disparities. Overall, this study will provide valuable insight and background knowledge for the use of chili peppers for the treatment of prediabetes and the prevention of diabetes progression. conditions: Prediabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A 3x2 model with 2 intervention groups (green and red chili) and a control group, and pre and post-intervention measures will be taken. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Only the primary investigator will know the intervention assigned to the participants. whoMasked: PARTICIPANT count: 21 type: ESTIMATED name: Red chili peppers name: Green Chili Pepper name: Placebo measure: Concentration of resting and fasted blood glucose measured in mg/dl measure: Concentration of resting and fasted insulin measured in pmol/L measure: Concentration of circulating C-reactive protein reported as mg/dl. measure: Concentration of circulating interleukin (IL)-1 beta reported as pg/ml. measure: Concentration of circulating interleukin-6 (IL-6) reported as pg/ml. measure: Concentration of circulating interleukin tumor necrosis factor (TNF)-alpha reported as pg/ml. measure: Concentration of circulating superoxide dismutase (SOD) reported as ng/ml. measure: Concentration of circulating glutathione peroxidase reported as pg/ml. measure: Body composition measured as total fat mass and total fat free mass reported in kg. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06376877 id: 2024P000900 briefTitle: Connectomic Targeted TMS Target for Refractory Anxiety acronym: ConTRA overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2028-08-01 date: 2029-02-01 date: 2024-04-19 date: 2024-04-19 name: Brigham and Women's Hospital class: OTHER briefSummary: We will perform a randomized sham-controlled trial of aiTBS to an anxiosomatic circuit in patients with anxiety-related disorders (i.e., panic disorder, generalized anxiety disorder, social anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder). 80 participants with an anxiety-related disorder (defined below) will receive 50 active or sham TMS treatments over 5 days (following the SAINT protocol, which is FDA-cleared for MDD. The primary outcome will be the BAI, with a modified recall window to reflect the short treatment interval. Participants randomized to sham will be offered an open-label crossover extension. conditions: Anxiety Disorders conditions: Mental Disorder conditions: Psychiatric Disorder studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Nonresponders may have the option for open label active treatment. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Transcranial magnetic stimulation name: Sham transcranial magnetic stimulation measure: Beck Anxiety Inventory (BAI) measure: Inventory of Depression and Anxiety Symptoms-II measure: Hierarchical Taxonomy of Psychopathology (HiTOP)-Self Report, Distress, Fear, and Mania subfactors measure: State-Trait Anxiety Inventory measure: Penn State Worry Questionnaire (PSWQ) measure: Mood/Anxiety Symptoms Questionnaire: Anxious Arousal (MASQ:AA) measure: Anxiety Sensitivity Index (ASI) measure: Intolerance of Uncertainty Scale (IUS) measure: Beck Depression Inventory (BDI) measure: TCI-R140 (Temperament and character inventory, revised 140-question format) measure: Emotional Conflict Resolution Task measure: Laboratory Fear Extinction Paradigm sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emma Jones city: Boston state: Massachusetts zip: 02115 country: United States name: Emma Jones role: CONTACT email: bwhtmsanxiety@mgb.org lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06376864 id: RC- FNRA-IG /20-21/SOSC/01 briefTitle: Physical Activity Intervention Effects on Executive Function, Physical Activity and Sedentary Behaviour in Children overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-01 date: 2024-06-30 date: 2024-07-30 date: 2024-04-19 date: 2024-04-19 name: Hong Kong Baptist University class: OTHER briefSummary: The current study aims to implement the Activity Breaks intervention and evaluate its effectiveness on outcome measures of executive function (EF), physical activity (PA), and sedentary behaviour (SB) in school children. conditions: Child Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 450 type: ACTUAL name: Activity Breaks measure: Executive function measure: Psychological capacities measure: Working memory measure: Attention measure: Physical activity (min/week) measure: Sedentary behavior (hour) measure: Body weight (kg) measure: Height (cm) sex: ALL minimumAge: 8 Years maximumAge: 12 Years stdAges: CHILD facility: Department of Sport, Physical Education, and Health, Hong Kong Bapist University city: Kowloon Tong country: Hong Kong lat: 22.33312 lon: 114.17969 hasResults: False

 nctId: NCT06376851 id: CP-910-001 briefTitle: AI DErived Plaque Quantification: CCTA and AI-QCPA for Determining Effective CAD Management acronym: DECIDE overallStatus: ENROLLING_BY_INVITATION date: 2024-03-27 date: 2026-03-27 date: 2030-03-27 date: 2024-04-19 date: 2024-04-19 name: HeartFlow, Inc. class: INDUSTRY briefSummary: The objective of HeartFlow's DECIDE Registry is to collect observational data about the management of patients before and after HeartFlow Artificial Intelligence-Quantitative Coronary Plaque Analysis (AI-QCPA). conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 10000 type: ESTIMATED name: AI-enabled quantitative coronary plaque analysis (AI-QCPA) measure: Primary Endpoint measure: Change in LDL levels measure: Change in HbA1c levels measure: Changes in Non HDL levels measure: Changes in HDL levels measure: Changes in TG levels measure: Changes in weight measure: Reclassification rate of medical management (across the groups) measure: Rates of referral to invasive coronary angiography and coronary revascularization (PCI+CABG) measure: Number of CV hospitalizations measure: Number of MACE (CV-related death, MI, or CAD hospitalization) measure: Timing of referral to other provider(s) for management measure: Timing of lab orders (Group 1 vs. Group 2) measure: Change in Lp(a) (Group 2) measure: Change in Lp(a) (Group 4 compared to Group 1) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Moses Cone Memorial Hospital city: Greensboro state: North Carolina zip: 27401 country: United States lat: 36.07264 lon: -79.79198 hasResults: False

 nctId: NCT06376838 id: DLV-001-02 briefTitle: To Prove the Non-inferiority of DLMR01 by Evaluating the Injecting Efficacy and Safety DLMR01 and Control for Patients in Crow's Feet acronym: dermal filler overallStatus: COMPLETED date: 2020-07-07 date: 2021-10-15 date: 2023-05-04 date: 2024-04-19 date: 2024-04-19 name: DEXLEVO class: INDUSTRY briefSummary: This clinical study is a confirmatory clinical study to prove that the test device, DLMR01, is non-inferior to the control device, Rejuran®, in terms of temporary wrinkle improvement effect on crow's feet and safety. After applying DLMR01, a test device, and Rejuran®, a control device, respectively to wrinkles around the eyes, randomization to compare and evaluate the temporary wrinkle improvement effect and safety of the two clinical study medical devices, subject-evaluator blinding, pair matching, It was designed as a comparative clinical study. conditions: Crow's Feet Lines studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 218 type: ACTUAL name: DLMR01 name: Rejuran measure: Crow's Feet Grading Scale by independent evaluators after 12 weeks of using measure: (1) The improvement rate of wrinkles evaluated using the Crow's Feet Grading Scale measure: (2) The improvement rate of wrinkles assessed using the Crow's Feet Grading Scale by independent evaluators after 2 weeks and 4 weeks of using the medical device both during rest and when smiling was evaluated. sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chung-ang University Hospital city: Seoul state: Dongjak-gu zip: 06973 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06376825 id: CSV202401 briefTitle: The Efficacy and Acceptability of an Internet-Based Self-Help Program to Reduce Burnout overallStatus: RECRUITING date: 2024-04-15 date: 2024-06-15 date: 2024-06-15 date: 2024-04-19 date: 2024-04-19 name: Ahmet Nalbant class: OTHER briefSummary: The goal of this clinical trial is to determine whether an internet-based self-help program reduces burnout in teachers. The study will also evaluate the program's acceptability which means assessing the extent to which users complete the program and find it useful. The main questions it aims to answer are:

* Does the program reduce the level of burnout in teachers?
* Does the program contribute to an increased sense of meaning for teachers?
* How much of the program do teachers finish? conditions: Burnout, Professional studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The study will be a concurrent multiple-baseline single-case experimental study with participiants randomized to baseline durations. primaryPurpose: TREATMENT masking: NONE maskingDescription: In this study participants will be randomized to different baseline durations and randomization will be done by one of the investigators who are blind to participants assessments. count: 25 type: ESTIMATED name: MyLife: An internet-based self-help program to reduce burnout measure: Burnout Assessment Tool measure: Valued Living Questionnaire measure: Acceptance and Action Questionnaire-2 measure: System Usability Scale measure: Attendance rate measure: Daily measures sex: ALL minimumAge: 22 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CanSagligi Foundation Center for Contextual Behavioral Science status: RECRUITING city: Istanbul country: Turkey name: Eda Aksoy role: CONTACT phone: +90(216) 269 66 11 email: eda.aksoy@cansagligivakfi.org name: Ahmet Nalbant, MD role: PRINCIPAL_INVESTIGATOR name: Havvanur Uysal Akdemir, MS role: SUB_INVESTIGATOR name: Edanur Gürbüz, BA role: SUB_INVESTIGATOR name: Meryem Gökçe Yavuz, BA role: SUB_INVESTIGATOR name: Kaasım Fatih Yavuz, MD role: SUB_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06376812 id: 23-0320 briefTitle: No Time to Pause: Physical Activity to Improve Health of Midlife Hispanic Women overallStatus: NOT_YET_RECRUITING date: 2026-05 date: 2029-01 date: 2029-01 date: 2024-04-19 date: 2024-04-19 name: The University of Texas Medical Branch, Galveston class: OTHER briefSummary: This study will test the effects of a physical activity intervention among midlife Hispanic women. conditions: Elevated Blood Pressure conditions: Perimenopause studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 40 type: ESTIMATED name: Physical activity intervention measure: Days the activity monitor was worn measure: Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months measure: Physical activity as measured by minutes of moderate-vigorous intensity physical activity at 6 months measure: Physical activity as measured by minutes of moderate intensity physical activity at 6 months measure: Physical activity as measured by minutes of moderate intensity physical activity at 6 months measure: Physical activity as measured by minutes of vigorous intensity physical activity at 6 months measure: Physical activity as measured by minutes of vigorous intensity physical activity at 6 months measure: Physical activity as measured by minutes of light intensity physical activity at 6 months measure: Physical activity as measured by minutes of light intensity physical activity at 6 months measure: Physical activity as measured by minutes of total physical activity at 6 months measure: Physical activity as measured by minutes of total physical activity at 6 months measure: Systolic blood pressure measure: Systolic blood pressure measure: Diastolic blood pressure measure: Diastolic blood pressure measure: Abdominal circumference measure: Abdominal circumference measure: Body mass index measure: Body mass index sex: FEMALE minimumAge: 45 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06376799 id: 38RC23.0437 id: 2024-A00485-42 type: OTHER domain: ID RCB briefTitle: Which Health-care Professional(s) to Talk About Advance Care Planning ? acronym: QPSPAS overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-11-01 date: 2024-11-02 date: 2024-04-19 date: 2024-04-19 name: University Hospital, Grenoble class: OTHER briefSummary: The goal of this descriptive observational study is to evaluate the preference of French adult patients followed in the context of a oncological disease, regarding the choice of the preferred healthcare professional to discuss advance care planning.

To this end, voluntary participants will be asked to indicate their preferences by answering a self-questionnaire available in electronic or paper format. conditions: Advance Care Planning conditions: Patient Preference studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 240 type: ESTIMATED name: Self-questionnaire measure: Determining the healthcare professional preferred by cancer patients to talk about advance care planning measure: Determining cancer patients' second choice of healthcare professional to talk about advance care planning measure: Evaluation of patient preferences regarding advance care planning, concerning the form, the moment it should be carried out, whether or not they wish to be accompanied by a relative, and the benefit of systematization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06376786 id: ItaliTTP briefTitle: Italian iTTP Registry overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2030-05-31 date: 2030-05-31 date: 2024-04-19 date: 2024-04-19 name: Fondazione Luigi Villa class: OTHER briefSummary: ItaliTTP is an observational, prospective, single-arm, national, multicenter, non-pharmacological cohort study aimed at better defining and understanding the natural history, disease severity, and clinical outcomes of patients with immune-mediated thrombotic thrombocytopenic purpura (iTTP) in Italy.

A minimum of 132 consecutive patients with acute iTTP (first event or relapse) will be enrolled for 3 years, with the possibility of extension, with a follow-up period of 3 years. conditions: TTP - Thrombotic Thrombocytopenic Purpura studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 132 type: ESTIMATED measure: Age at onset measure: Sex measure: Birth Country/Region measure: Race measure: Blood group measure: BMI measure: Proportion of patients with comorbidities, including: autoimmune diseases, cancer, HIV infection, hypertension, type 2 diabetes, hypercholesterolemia, cardiovascular disease, chronic renal failure, liver disease, depression. measure: Proportion of acute iTTP episodes preceded by potential triggering factors including: infections, pregnancy, surgery, psychological trauma, vaccination, drugs measure: Incidence, type and severity of clinical manifestations, including: bleeding, cardiovascular, neurological, renal and systemic signs and symptoms measure: Platelet count lactate dehydrogenase (LDH), total and indirect bilirubin, liver transaminases, creatinine, troponin measure: Hemoglobin lactate dehydrogenase (LDH), total and indirect bilirubin, liver transaminases, creatinine, troponin measure: Lactate dehydrogenase (LDH) lactate dehydrogenase (LDH), total and indirect bilirubin, liver transaminases, creatinine, troponin measure: Creatinine lactate dehydrogenase (LDH), total and indirect bilirubin, liver transaminases, creatinine, troponin measure: Cardiac troponin measure: ADAMTS13 activity measure: Anti-ADAMTS13 antibodies measure: Number of daily therapeutic plasma exchange procedures measure: Proportion of acute iTTP patients treated with rituximab measure: Proportion of acute iTTP patients treated with immunosuppressors other than steroids and rituximab measure: Proportion of iTTP patients treated with caplacizumab measure: Incidence, type and severity of TTP-related drugs adverse events measure: Proportion of iTTP patients achieving clinical remission measure: Proportion of iTTP patients refractory to acute iTTP treatment measure: Proportion of iTTP patients experiencing complications during hospitalization, including: bleeding, thrombosis, neurological, renal, cardiac complications measure: Proportion of iTTP patients experiencing clinical exacerbation measure: Proportion of iTTP patients achieving ADAMTS13 remission measure: Time to clinical response measure: Time to clinical remission measure: Time to ADAMTS13 remission measure: Proportion of iTTP patients with a clinical relapse measure: Proportion of iTTP patients with an ADAMTS13 relapse measure: Time to clinical relapse measure: Time to ADAMTS13 relapse measure: Incidence, type and severity of pregnancy complications in iTTP pregnant women measure: iTTP incidence in Italy sex: ALL minimumAge: 12 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06376773 id: 2022KY123 briefTitle: Neoadjuvant Treatment Based on Gastric Cancer Molecular Subtyping. overallStatus: COMPLETED date: 2022-06-01 date: 2023-07-01 date: 2023-11-30 date: 2024-04-19 date: 2024-04-19 name: Fujian Medical University class: OTHER briefSummary: Extensive research employing diverse omics methodologies has unveiled a varied landscape of gastric cancer (GC). Recent progress in next-generation sequencing and other genomic technologies has facilitated a more intricate exploration of GC at the molecular level. This study aimed to identify the most effective drug therapeutics for patients with the mesenchymal subtype of gastric cancer.Based on RNA-seq transcriptome, 234 patients were divided into four molecular subtypes: mesenchymal, immunogenic, metabolic, and classic.Our analysis has revealed that, for neoadjuvant therapy in advanced gastric cancer (AGC), the mesenchymal subtype stands out as the ideal patient population benefiting from Apatinib, without a concurrent increase in postoperative complications. conditions: Advanced Gastric Cancer conditions: Neoadjuvant Therapy conditions: Multi-omics Analysis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 234 type: ACTUAL name: combination chemotherapy with Apatinib or Camrelizumab measure: overall survival measure: objective response rate sex: ALL minimumAge: 18 Years maximumAge: 80 Years 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: NCT06376760 id: KY2024-091-02 briefTitle: Changes in Intravenous Anesthetic Drug Dosage in Insomnia Patients Undergoing Digestive Endoscopy overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-03-31 date: 2027-03-31 date: 2024-04-19 date: 2024-04-19 name: Beijing Tiantan Hospital class: OTHER briefSummary: To compare the dosage requirement of intravenous anesthetics during digestive endoscopy between patients with insomnia and those with normal sleep pattern. conditions: Insomnia conditions: Digestive Endoscopy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3360 type: ESTIMATED name: No interventions, it is a observational study measure: The total consumption of intravenous anesthetic drug measure: The dosage of intravenous anesthetic drug for successful insertion of digestive endoscope measure: The occurrence of the respiratory and cardiovascular adverse events measure: The occurrence of the other adverse events measure: The incidence of intraoperative recall or awareness measure: The recovery time measure: Duration of patients' PACU stay measure: The ease of operation at this level of sedation evaluated by the gastroenterologists measure: The satisfaction degree of anesthesia effect evaluated by the gastroenterologists measure: Patients' satisfaction measure: Patients' willingness sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: Beijing Tiantan Hospital city: Beijing state: Beijing zip: 100070 country: China name: Fang Luo, M.D. role: CONTACT phone: 13611326978 email: 13611326978@163.com name: Fang Luo, M.D. role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06376747 id: KDAR- PBM 2024 briefTitle: The Influence of Blood Sampling Technique on the Total Amount of Blood Collected for Laboratory Testing Critically Ill Pediatric Patients acronym: PEDPBM overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2025-08-31 date: 2024-04-19 date: 2024-04-19 name: Brno University Hospital class: OTHER briefSummary: The aim of this prospective randomized study is to evaluate blood loss caused by laboratory blood draws in patients in the paediatric ICU (Intensive Care Unit) of a tertiary hospital among two groups of patients with established long-term or mid-term intravenous access. In the first group, patients will undergo blood draws using the standard method. In the second group of patients, blood draws will be performed using a closed system. conditions: Iatrogenic Anaemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: SINGLE maskingDescription: Patients will be randomized into two groups: a group with standard blood sampling technique and a group with closed technique blood sampling by using randomizing software. whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: In line sampling name: Standard blood sampling technique measure: Average amount of blood collected for laboratory diagnostic purposes measure: Cumulative amount of blood drawn per day of ICU hospitalization measure: Absolute amount of blood drawn and blood used for laboratory testing measure: Trend of haemoglobin decline over time measure: Incidence of anaemia measure: Incidence of anaemia up to transfusion trigger measure: Frequency of blood product transfusions and their quantity measure: Type and frequency of laboratory tests measure: Incidence of coagulopathy measure: Incidence of catheter-related complications measure: Time to catheter replacement in case of catheter exchange sex: ALL minimumAge: 1 Month maximumAge: 19 Years stdAges: CHILD stdAges: ADULT facility: KDAR - department of pediatrics anesthesia and resuscitation city: Brno zip: 62500 country: Czechia lat: 49.19522 lon: 16.60796 hasResults: False

 nctId: NCT06376734 id: 2024p000528 briefTitle: Search for Novel Transcranial Magnetic Stimulation (TMS) Targets for Mental Illness acronym: Searchlight overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2029-06-01 date: 2030-06-01 date: 2024-04-19 date: 2024-04-19 name: Brigham and Women's Hospital class: OTHER name: National Institutes of Health (NIH) briefSummary: Participants will receive Transcranial Magnetic Stimulation (TMS) at a random location in the left prefrontal cortex, excluding sites that are potentially unsafe. Extensive behavioral testing will be conducted to determine which behaviors are modulated by stimulating which circuits. conditions: Major Depressive Disorder conditions: Obsessive-Compulsive Disorder conditions: Schizophrenia conditions: Generalized Anxiety Disorder conditions: Mood Disorders conditions: Psychiatric Disorder conditions: Mental Disorder conditions: Depression, Anxiety studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Double-blind, randomized controlled crossover trial. Participants will be stimulated at a random location in the prefrontal cortex, which will be mapped to its underlying brain network to determine which network was stimulated. primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: All participants will receive real open-label TMS, so there will be no conventional masking. However, participants and investigators will be blinded to which network is being stimulated. count: 180 type: ESTIMATED name: TMS measure: Clustering of multiple behavioral measures sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06376721 id: TREC2024-KY016 briefTitle: Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma overallStatus: RECRUITING date: 2024-04-14 date: 2026-10-31 date: 2027-10-31 date: 2024-04-19 date: 2024-04-19 name: Beijing Tongren Hospital class: OTHER briefSummary: The patients diagnosed with relapsed/refractory or advanced NK/T-cell Lymphoma (r/r NKTCL) were selected as the research objects. To explore effective and safe treatment for advanced or r/r NKTCL, the combination of PI3K-δ inhibitor Linperlisib with PD-1 blockade Camrelizumab and anti-metabolic agent Pegaspargase was applied for the treatment. conditions: Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type conditions: T-lymphoblastic Lymphoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Treatment with linperlisib in combination with camrelizumab and pegaspargase for advanced or relapsed/refractory ENKTCL patients primaryPurpose: TREATMENT masking: NONE count: 43 type: ESTIMATED name: Linperlisib name: Camrelizumab name: Pegaspargase name: Dexamethasone measure: The best objective response rate（ORR） over 6 treatment cycles measure: Objective Response Rate（ORR） measure: Complete Response （CR） measure: Progression Free Survival (PFS) measure: Overall Survival (OS) measure: Disease Control Rate（DCR） measure: Drug safety sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Liang Wang status: RECRUITING city: Beijing state: Beijing country: China name: Liang Wang, M.D. role: CONTACT phone: +8615001108693 email: wangliangtrhos@126.com name: Liang Wang, M.D. role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06376708 id: 3-3-13 briefTitle: Comparison Between PEEK With Platelet-rich Fibrin and PEEK Alone in Maxillary Sinus Augmentation overallStatus: COMPLETED date: 2022-09-01 date: 2023-03-01 date: 2023-07-01 date: 2024-04-19 date: 2024-04-19 name: Cairo University class: OTHER briefSummary: comparison between the resulted bone during maxillary sinus elevation by PEEK with and without platelet rich fibrin conditions: Maxillary Sinus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: use of platelet rich fibrin after maxillary sinus elevation using PEEK primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 24 type: ACTUAL name: platelet rich fibrin name: Polyether ether ketone measure: Bone quantity measure: Bone quality sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of Dentistry Cairo University city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06376695 id: RADX-P-2407 briefTitle: Radicle GI Health 24: A Study of Health and Wellness Products on GI Health and Related Health Outcomes overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-19 date: 2024-06 date: 2024-10 date: 2024-04-19 date: 2024-04-23 name: Radicle Science class: INDUSTRY briefSummary: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI health and related health outcomes conditions: Abdominal Pain conditions: GI Disorders conditions: Digestion 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: The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 500 type: ACTUAL name: Radicle GI Health Placebo Control Form 1 name: Radicle GI Health Active Study Product 1.1 Usage measure: Change in GI (Gastrointestinal) Health (1) measure: Change in GI (Gastrointestinal) Health (2) measure: Change in GI (Gastrointestinal) Health (3) measure: Change in GI (Gastrointestinal) Health (4) measure: Change in GI (Gastrointestinal) Health (5) measure: Change in GI (Gastrointestinal) Health (6) measure: Change in feelings of anxiety measure: Change in GI-related Quality of Life (QOL) measure: Change in mood (emotional distress-depression) measure: Minimal clinically important difference (MCID) in GI Health (1) measure: Minimal clinically important difference (MCID) in GI Health (2) measure: Minimal clinically important difference (MCID) in GI Health (3) measure: Minimal clinically important difference (MCID) in GI Health (4) measure: Minimal clinically important difference (MCID) in GI Health (5) measure: Minimal clinically important difference (MCID) in GI Health (6) measure: Minimal clinically important difference (MCID) in feelings of anxiety measure: Minimal clinically important difference (MCID) in GI-related QOL measure: Minimal clinically important difference (MCID) in mood (emotional distress-depression) measure: Change in concentration of at-home (direct-to-consumer) specimen assays either saliva, blood or stool 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: NCT06376682 id: CA-BO-CIP-0060 briefTitle: EPIBONE Study: a Prospective Study on Feasibility, Safety and Accuracy acronym: EPIBONE overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2024-12-31 date: 2025-02-28 date: 2024-04-19 date: 2024-04-19 name: Quantum Surgical class: INDUSTRY briefSummary: Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for bone percutaneous procedures. conditions: Bone Metastases conditions: Fractures, Bone conditions: Bone Tumor studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The Epione device is an image-guided robotized device that assists the physician during CT-guided procedures. primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: CT-guided bone percutaneous procedure measure: Successful instrument insertion with the EPIONE device. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06376669 id: J2421 id: IRB00427823 type: OTHER domain: JHM IRB briefTitle: Stereotactic Body Proton Therapy for Treatment of Primary Renal Cell Carcinoma acronym: SPARE overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-06 date: 2030-08 date: 2024-04-19 date: 2024-04-19 name: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins class: OTHER briefSummary: This study examines the impact of proton based stereotactic radiation therapy (SBRT) on kidney function as well as other oncologic outcomes including local control, locoregional and systemic failure, progression free and overall survival. conditions: Renal Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Proton Stereotactic Body Radiation therapy (SBRT) measure: Change in kidney function after PROTON-BASED SBRT treatment as assessed by serum creatine levels measure: Change in kidney function after PROTON-BASED SBRT treatment as assessed by estimated glomerular rate (eGFR) values measure: Number of PROTON-BASED SBRT treatment Adverse Events measure: Local progression of disease after PROTON-BASED SBRT treatment as assessed by size or appearance of lesions measure: Systemic progression of disease after PROTON-BASED SBRT treatment as assessed by appearance of lesions measure: Time to locoregional progression measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06376656 id: LRGS/1/2019/SYUC/02/1 briefTitle: Successful Aging and Age-related Decline acronym: MyAgeWell overallStatus: RECRUITING date: 2022-05-20 date: 2029-05 date: 2030-05 date: 2024-04-19 date: 2024-04-19 name: Sunway University class: OTHER briefSummary: Recent studies have shown promising cognitive and physical interventions aimed at slowing down ageing-related declines in quality of life, but they lack strong ecological validity (brief durations, unrealistic goals, no real-world application) and has yet to show robust evidence that such interventions are stable and suitable in the long-term. The investigators aim to examine whether these interventions can, over four years, significantly slow down the normal rate of ageing-related decline. conditions: Aging conditions: Elderly conditions: Cognitive Decline conditions: Physical Decline conditions: Intervention Study studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A cohort of older Malaysian adults will be recruited and assigned to one of the groups, either cognitive stimulation, physical activity, combined cognitive stimulation and physical activity, or non-intervention control. primaryPurpose: PREVENTION masking: NONE count: 400 type: ESTIMATED name: Cognitive stimulation name: Physical activity measure: Changes in cognitive scores measure: Changes in electroencephalogram (EEG) measure: Changes in structural magnetic resonance imaging (MRI) measure: Cost-benefit analysis of intervention measure: Changes in levels of human salivary lactoferrin measure: Changes in levels of human salivary C-reactive proteins measure: Changes in salivary telomere length measure: Changes in depression scores measure: Changes in anxiety scores sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sunway University status: RECRUITING city: Petaling Jaya state: Selangor zip: 47500 country: Malaysia name: Michael J Jenkins, PhD role: CONTACT phone: +60374918622 phoneExt: 7183 email: michaeljj@sunway.edu.my lat: 3.10726 lon: 101.60671 hasResults: False

 nctId: NCT06376643 id: InterFACE-AR briefTitle: Augmented Reality to Support Cardiopulmonary Resuscitation overallStatus: NOT_YET_RECRUITING date: 2024-11-01 date: 2025-10-31 date: 2025-10-31 date: 2024-04-19 date: 2024-04-19 name: Johan Siebert, MD class: OTHER name: Geneva Children's Hospital, Geneva, Switzerland name: Alberta Children's Hospital, Calgary, Canada briefSummary: A prospective, multicenter, randomized clinical trial in two tertiary pediatric emergency department. It will assess, amongst pediatric healthcare teams, whether the use of augmented reality supportive devices improves adherence to American Heart Association (AHA) advanced life support guidelines and performance, while reducing medication errors, when compared to groups using the AHA pocket reference card (control) during standardized, simulation-based, pediatric in-hospital cardiac arrest (IHCA) scenarios. Seventy participants will be randomized. The primary endpoint is the time to first dose of epinephrine. conditions: Cardiopulmonary Arrest conditions: Resuscitation conditions: Pediatric studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Open-label, prospective, multicenter, cluster randomized controlled clinical trial primaryPurpose: OTHER masking: SINGLE maskingDescription: It will not be possible to blind study participants to study arm allocation due to the nature of the intervention(s), but they will be blinded to study objectives. The statistician will be blinded regarding the allocation of participants to the study arms for results analysis. whoMasked: OUTCOMES_ASSESSOR count: 70 type: ESTIMATED name: Augmented reality supportive tool name: Conventional method (AHA pocket reference card) measure: Time to first dose of epinephrine measure: Time to initiation of cardiopulmonary resuscitation measure: Time to defibrillation measure: Time to delivery of epinephrine measure: Time to delivery of amiodarone measure: Time to secure definitive airway measure: Medication dosage errors measure: Types of Medication Errors measure: Frequency of Medication Errors measure: Frequency of pauses in cardiopulmonary resuscitation measure: Duration of pauses in cardiopulmonary resuscitation measure: Causes of pauses in cardiopulmonary resuscitation measure: Cardiopulmonary resuscitation quality: Percentage of overall excellent cardiopulmonary resuscitation measure: Cardiopulmonary resuscitation quality: Chest compression fraction measure: Cardiopulmonary resuscitation quality: Peri-shock pause duration measure: Provider workload (NASA-TLX) measure: User Experience Questionnaire (UEQ) measure: System Usability Scale (SUS) measure: Unified Theory of Acceptance and Use of Technology questionnaire (UTAUT) measure: State-Trait Anxiety Inventory (STAI) form Y-1 sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alberta Children's Hospital city: Calgary state: Alberta zip: AB T3B 6A8, country: Canada name: Adam Cheng, Prof role: CONTACT phone: 403 955 2633 email: chenger@me.com name: Jennifer Davidson, RN BSc role: CONTACT email: Jennifer.Davidson@albertahealthservices.ca name: Kangsoo Kim, Ass Prof role: SUB_INVESTIGATOR name: Yiqun Lin, PhD role: SUB_INVESTIGATOR lat: 51.05011 lon: -114.08529 facility: Geneva Children's Hospital, Geneva University Hospitals city: Geneva zip: 1205 country: Switzerland name: Johan N Siebert, MD, PD role: CONTACT phone: 795534072 phoneExt: +41 email: Johan.Siebert@hcuge.ch name: Delphine Courvoisier, Prof role: SUB_INVESTIGATOR name: Frederic Ehrler, PhD role: SUB_INVESTIGATOR lat: 46.20222 lon: 6.14569 hasResults: False

 nctId: NCT06376630 id: 298-2024 briefTitle: Study of Microvascular Dysfunction, CFR and Cardioprotective Effect of Early Administration of Esmolol in MI acronym: ESMO-VASCMI overallStatus: RECRUITING date: 2024-01-29 date: 2029-01-29 date: 2030-01-29 date: 2024-04-19 date: 2024-04-19 name: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation class: OTHER_GOV briefSummary: Study rationale: to evaluate clinical and prognostic relevance of microvascular dysfunction, coronary flow reserve and cardioprotective effects of iv administration of esmolol in patients with myocardial infarction.

First substudy is an open randomized trial evaluating the efficacy and safety of early intravenous administration of esmolol in patients with acute ST-segment elevation myocardial infarction (MI) and relative contraindications to administration of other intravenous β1-adrenergic blocker (metoprolol etс.). Сomparison group will include patients who have not received intravenous β1-adrenergic blocker. Secondary outcome in this substudy is the degree of microvascular obstruction and infarct size according to MRI with gadolinium delayed enhancement.

Second substudy examines the quantitative parameters of coronary physiology in patients with MI and multivessel disease. Changes of coronary physiology measurements over time ((iFR, Pd/Pa, FFR, delta FFR, gradient FFR per time unit (dFFR(t)/dt), pullback pressure gradient (PPG)) measured in the infarct-related artery and in non-infarct-related arteries with diameter stenosis of 50-85% immediately after the completion of a primary percutaneous coronary intervention and during a second hospitalization (30-45 days after STEMI) will be evaluated. The comparison changes of coronary physiology over time with presence of an MVO and infarct size determined by MRI. The model of calculating coronary flow reserve (CFR) based on tridimensional reconstruction of coronary arteries and coronary physiology parameters as measured during coronary angiography will be developed. The influence of coronary physiology parameters measured after complete myocardial revascularization by PCI, and derived CFR in patients with MI on long-term clinical outcomes will be evaluated, based on prospective data collection.

Primary composite outcome in all substudies will be the sum of adverse cardiac outcomes (congestive heart failure, episodes of recurrent congestive heart failure worsening resulting in hospitalizations, cardiac mortality, MI recurrences, unstable angina, urgent myocardial revascularization) within \> 12 months post-infarction.

Secondary composite outcome in all substudies is the degree of microvascular obstruction and infarct size evaluated by MRI with gadolinium delayed enhancement. conditions: Myocardial Infarction conditions: Coronary Stenosis conditions: Coronary Microvascular Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 300 pts with MI are to be enrolled. Among them 100 pts with STEMI will be included into the substudy evaluating cardioprotective effects of early iv administration of esmolol. They will be randomized 1:1 by in arms receiving esmolol or no IV beta-blockers. In the esmolol arm the infusion will begin immediately on admission. 200 pts with MI and multivessel disease with non-IRA lesions of 50-85% diameter stenosis will be included into another substudy investigating coronary physiology. All patients will undergo PCI with IRA stenting. 50 stable patients will undergo invasive measurements of coronary physiology. Those will also undergo cardiac MRI. Other 150 pts will not undergo invasive measurements of coronary physiology during initial hospitalization. Pts in both groups will be hospitalized again in 30-40 days after MI. They will undergo stress SPECT or stress echocardiography. All patients will undergo a follow-up coronary angiography with invasive measurement of coronary physiology. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: envelopes whoMasked: INVESTIGATOR count: 300 type: ESTIMATED name: Esmolol Hcl 10Mg/Ml Inj measure: Composite of adverse cardiac outcomes measure: Degree of microvascular obstruction measure: Infarct size sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NMRCCardiologyRu status: RECRUITING city: Moscow country: Russian Federation name: Andrey Komarov, PhD role: SUB_INVESTIGATOR name: Tatiana Sukhinina, PhD role: SUB_INVESTIGATOR name: Mariy Terenicheva, PhD role: SUB_INVESTIGATOR name: Olga Stukalova, PhD role: SUB_INVESTIGATOR name: Sergey Ternovoy, Academic role: SUB_INVESTIGATOR name: Goar Arutiunian, PhD role: SUB_INVESTIGATOR name: Evgeniy Merkulov, PhD role: SUB_INVESTIGATOR name: Viktor Shitov, MD role: SUB_INVESTIGATOR name: Marina Saidova, PhD role: SUB_INVESTIGATOR name: Aleksey Ansheles, PhD role: SUB_INVESTIGATOR name: Vladimir Sergienko, PhD role: SUB_INVESTIGATOR lat: 55.75222 lon: 37.61556 hasResults: False

 nctId: NCT06376617 id: MS.24.03.2743 briefTitle: Pattern Of Isolated Fungi From Bronchoalveolar Lavage Among Patients With Bronchial Asthma overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2025-04-20 date: 2025-05-20 date: 2024-04-19 date: 2024-04-19 name: Mansoura University class: OTHER briefSummary: This study is to assess the pattern of isolated fungi from the respiratory air way (bronchial tree) from bronchoalvealar lavage (BAL) in asthmatic patients with uncontrolled or difficult to treat asthma conditions: Bronchial Asthma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: BAL will stained by fungal staining with lactophenol stain as well as culture on Sabouraud dextrose agar. primaryPurpose: DIAGNOSTIC masking: NONE count: 60 type: ESTIMATED name: fibroptic bronchoscopy measure: assess the pattern of isolated fungi from the respiratory air way (bronchial tree) from bronchoalvealar lavage (BAL) in asthmatic patients with uncontrolled or difficult to treat asthma sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06376604 id: LNT55 briefTitle: Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies overallStatus: RECRUITING date: 2021-09-08 date: 2025-09-01 date: 2025-12-30 date: 2024-04-19 date: 2024-04-19 name: L-Nutra Inc class: INDUSTRY name: University of Tennessee Medical Center briefSummary: This study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies. conditions: Cancer, Ovarian conditions: Chemotherapy Effect conditions: Calorie Deficiency conditions: Fasting, Intermittent studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: Outcomes Assessor count: 30 type: ESTIMATED name: Fasting Mimicking Diet name: Chemotherapy measure: Quality of life by National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Ovarian Cancer Symptom Index (NFOSI-18) questionnaire measure: Rate of Adherence measure: Change in Body Weight measure: Change in Body Composition measure: Change in HbA1c measure: Change in Insulin Like Growth Factor 1 (IGF-1) Concentration measure: Change in Fasting Insulin Concentration measure: Change in Fasting Glucose Concentration measure: Change in High-sensitivity C reactive protein Concentration measure: Change in Leptin Concentration measure: Change in planned chemotherapy regimen measure: Number of Hospitalization Days measure: Rate of Chemotherapy Side Effects sex: FEMALE minimumAge: 35 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Tennessee Medical Center status: RECRUITING city: Knoxville state: Tennessee zip: 37920 country: United States name: Jonathan D Boone, MD role: CONTACT phone: 865-305-5622 email: jboone@utmck.edu lat: 35.96064 lon: -83.92074 hasResults: False

 nctId: NCT06376591 id: LUMHS/B12/Temp/12.04.2024 briefTitle: Assessing the Efficacy of Different Carrier Systems in Oral Vitamin B12 Supplementation in Healthy Adults With B12 Deficiency overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-07-31 date: 2024-08-31 date: 2024-04-19 date: 2024-04-19 name: Liaquat University of Medical & Health Sciences class: OTHER briefSummary: Vitamin B12, a vital nutrient, plays a crucial role in red blood cell formation, neurological function, and DNA synthesis. Deficiency in B12 can lead to anemia, neurological symptoms such as tingling or numbness, and cognitive impairment. Oral B12 supplementation serves as an effective strategy to address B12 deficiency, especially for individuals with limited dietary intake or absorption issues. Regular B12 supplementation can help restore body B12 levels, alleviate deficiency-related symptoms, and support overall health and well-being. conditions: Vitamin B 12 Deficiency studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Oral Vitamin B12 supplement name: Control group measure: Supplementation effect on circulatory vitamin B12 levels measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Liaquat University of Medical and Health Sciences city: Jamshoro zip: 76090 country: Pakistan name: Dr. Ikram Ujjan, MBBS, PhD role: CONTACT phone: 03000506955 email: ikramujjan@lumhs.edu.pk lat: 25.43773 lon: 68.28522 hasResults: False

 nctId: NCT06376578 id: 245256 briefTitle: Exercise Interventions for Improving Health in Breast Cancer Survivors overallStatus: COMPLETED date: 2018-09-05 date: 2020-01-30 date: 2020-01-30 date: 2024-04-19 date: 2024-04-19 name: University of Bath class: OTHER briefSummary: Supervised, prescribed exercise has positive effects on body composition, physical functioning, psychological wellbeing and quality of life for patients after breast cancer treatment. However, exercise interventions are often time consuming, commonly take place at a health or fitness facility, and usually require a trained professional to be present. Cost-effective, enjoyable and practical approaches, that can be adopted at home or in local surroundings are needed. For example, an alternative approach is using an electronic physical activity tracking wristwatch to help patients engage with exercise or physical activity. Research demonstrates the importance of structured and supervised exercise for breast cancer survivors. However, it is not known whether other approaches (e.g. home-based exercise and physical activity) alongside the use of personalised technology-enabled feedback, can cause similar improvements to health when compared to structured exercise. The overall aim of this study is to determine whether cardiorespiratory fitness is changed by a technology enabled, remotely delivered exercise intervention and to determine whether this change is similar to the change caused by a partly supervised, prescribed exercise intervention. This study will also determine the influence of both interventions on physical functioning, body composition and blood pressure. conditions: Breast Cancer Female studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ACTUAL name: Exercise intervention name: Polar A380 wristwatch physical activity tracker measure: Change in VO2max (maximum oxygen uptake) measure: Change in Body composition measure: Change in physical functioning measure: Change in Psychological measures measure: Change in immune profiles and function sex: FEMALE minimumAge: 35 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Bath city: Bath zip: BA2 7AY country: United Kingdom lat: 51.3751 lon: -2.36172 hasResults: False

 nctId: NCT06376565 id: 22-000647 id: NCI-2024-02090 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: R01CA271034 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA271034 briefTitle: Improving Colonoscopy Surveillance for Patients With High Risk Colon Polyps overallStatus: NOT_YET_RECRUITING date: 2024-05-05 date: 2027-03-31 date: 2028-03 date: 2024-04-19 date: 2024-04-24 name: Jonsson Comprehensive Cancer Center class: OTHER name: National Cancer Institute (NCI) briefSummary: This clinical trial tests a multilevel intervention at the clinic, provider and patient levels, to improve colonoscopy surveillance in patients with high risk colon polyps. Colorectal cancer (CRC) is a common and deadly disease that is largely preventable through the detection and removal of colorectal polyps. One million Americans are diagnosed with high risk polyps of the colon or rectum annually and are at increased risk for CRC; however, uptake of recommended repeat colonoscopy in 3 years to reduce CRC risk is low in this group. This multilevel intervention may work to improve timely colonoscopy screening for patients with high risk colon polyps. conditions: Colorectal Carcinoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 1680 type: ESTIMATED name: Best Practice name: Communication Intervention name: Communication Intervention name: Communication Intervention name: Interview name: Interview measure: Stakeholder perspectives on the multilevel intervention (Aim 1) measure: Completion of surveillance colonoscopy (Aim 2) measure: Implementation quality (Aim 3a) measure: Cost effectiveness (Aim 3b) measure: Time from high risk neoplasia (HRN) diagnosis to colonoscopy (Aim 2) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: UCLA / Jonsson Comprehensive Cancer Center city: Los Angeles state: California zip: 90095 country: United States name: Folasade P. May role: CONTACT phone: 617-620-7806 email: FMAY@MEDNET.UCLA.EDU name: Folasade P. May role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06376552 id: AI4Cardio briefTitle: Artificial Intelligence for the Prioritization of Genetic Background in Brugada Syndrome acronym: AI4Cardio overallStatus: COMPLETED date: 2018-12-19 date: 2022-06-06 date: 2022-06-06 date: 2024-04-19 date: 2024-04-19 name: IRCCS San Raffaele class: OTHER briefSummary: Brugada Syndrome (BS) is an inherited heart condition that can cause sudden cardiac arrest in young individuals. It's diagnosed through specific changes seen on an electrocardiogram (ECG). Currently, the only treatment option is a cardioverter defibrillator (ICD). Despite advances, much about BS remains unclear, including its genetic basis. This study aims to use advanced genetic sequencing and artificial intelligence to uncover new genetic factors contributing to BS. By understanding these factors better, we hope to improve risk assessment and treatment for affected individuals. conditions: Brugada Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 200 type: ACTUAL measure: New candidate genes, likely associated with Brugada Syndrome using an AI based approach. measure: Identification of genetic risk factors associated with the worse phenotype. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS San Raffaele city: Milan zip: 20132 country: Italy lat: 45.46427 lon: 9.18951 facility: Milano-Bicocca University city: Milan country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06376539 id: CEAVEC: 111/2024/Oss/IOR briefTitle: Functional Recovery of Patients Undergoing Resection and Reconstruction of the Lower Limbs for Bone Tumor. acronym: FISIO-ONCO overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-05 date: 2025-04 date: 2024-04-19 date: 2024-04-19 name: Istituto Ortopedico Rizzoli class: OTHER briefSummary: The aim of the present study is to describe the course of functional recovery of patients with musculoskeletal tumours and undergone resection and reconstruction operations of lower limbs in the first six months post-surgery, differentiating them on the basis of the anatomical level involved. conditions: Bone Neoplasm conditions: Rehabilitation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED measure: Toronto Extremity Salvage Score (TESS) measure: Toronto Extremity Salvage Score (TESS) measure: Range of motion (ROM) measure: Rang of motion - 2 (ROM) measure: Number of participants able to walk measure: Time Up and Go -2 (TUG) measure: Time Up and Go (TUG) measure: Muscle Strength measure: Muscle Strength-2 measure: Number of day from surgery to first walking sex: ALL minimumAge: 12 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06376526 id: 20230236 briefTitle: IMMUNOPLANT for Newly Diagnosed Multiple Myeloma acronym: IMMUNOPLANT overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2027-06-30 date: 2029-06-30 date: 2024-04-19 date: 2024-04-19 name: Dickran Kazandjian, MD class: OTHER name: Regeneron Pharmaceuticals briefSummary: The purpose of this study is to determine whether Linvoseltamab therapy in patients with newly diagnosed multiple myeloma will convert the disease status from minimal residual disease (MRD)-positive to MRD-negative, and increase the length of time that the disease is controlled. The researchers also want to find out the effects (good and bad) that Linvoseltamab has on participants and the condition. conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: Linvoseltamab measure: Minimal Residual Disease (MRD) Negativity Rate measure: Sustained MRD-Negativity Rate measure: Progression-Free Survival (PFS) measure: Overall Survival measure: Number of Participants Experiencing Treatment-Related Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Miami city: Miami state: Florida zip: 33136 country: United States name: Dickran Kazandjian, MD role: CONTACT phone: 305-243-5001 email: dkazandjian@miami.edu name: Dickran Kazandjian, MD role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 hasResults: False

 nctId: NCT06376513 id: 69HCL24_0031 briefTitle: Evaluation of Penile Prosthesis Pump Manipulation acronym: ECM3P overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-12-01 date: 2025-12-01 date: 2024-04-19 date: 2024-04-19 name: Hospices Civils de Lyon class: OTHER briefSummary: Erectile dysfunction is a highly prevalent pathology. When oral or injectable pharmacological treatments prove ineffective, the treatment of choice is penile prosthesis which provides the possibility of sexual activity with penetration.

Unfortunately, current prostheses are difficult (or even impossible) to manipulate for some patients. Many patients underutilize their device due to difficulties in using the pump related to mechanical issues (difficult grip, lack of strength, etc.) or sensory issues (altered proprioception, etc.), resulting in an inability to achieve rigidity that allows optimal satisfaction for the patient and/or partners.

These difficulties correspond to a significant portion of dissatisfaction among patients with penile prostheses.

Actually, no study has evaluated patients' ability to manipulate the pump of their penile prosthesis, as well as the association between these manipulation abilities, the rigidity of erections with a penile prosthesis, and patient and partner sexual satisfaction.

In this descriptive study, the primary outcome is to describe the manipulation abilities of patients with penile prostheses during follow-up consultations after prosthesis implantation.

The secondary outcomes are to estimate the association of various markers related to penile prosthesis manipulation (overall hand grip strength, pinch grip strength, proprioception, and discrimination) with

* Rigidity of erections with penile prosthesis
* Patient's sexual satisfaction
* Partner's sexual satisfaction
* Satisfaction related to pump manipulation conditions: Penile Prosthesis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 60 type: ESTIMATED name: Evaluation measure: Describing the manipulation abilities of patients with penile prosthesis : overall hand grip strength measure: Describing the manipulation abilities of patients with penile prosthesis : pinch grip strength measure: Describing the manipulation abilities of patients with penile prosthesis : proprioception measure: Describing the manipulation abilities of patients with penile prosthesis :discrimination measure: Describing the manipulation abilities of patients with penile prosthesis :upper limb function for activities of daily living measure: Correlation of manipulation parameters (main outcome) with rigidity of erections measure: Correlation of manipulation parameters (main outcome) with patient's sexual satisfaction modified EDITS measure: Correlation of manipulation parameters (main outcome) with patient's sexual satisfaction QoLSPP measure: Correlation of manipulation parameters (main outcome) with partner's sexual satisfaction measure: Correlation of manipulation parameters (main outcome) with satisfaction related to pump manipulation (self-made questionnaire) sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Urology, Lyon Sud Hospital, city: Pierre-Bénite zip: 69310 country: France name: Nicolas MOREL role: CONTACT phone: + 33 4 72 6788 37 email: nicolas.morel-journel@chu-lyon.fr name: Clément PARAT role: CONTACT phone: + 33 4 72 6788 37 email: clement.parat@chu-lyon.fr lat: 45.7009 lon: 4.82511 hasResults: False

 nctId: NCT06376500 id: HSEARS20240223001 briefTitle: Effects of tDCS for Enhancing Cognitive Function in Individuals With Persistent Post-Concussion Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-08 date: 2028-02 date: 2024-04-19 date: 2024-04-19 name: The Hong Kong Polytechnic University class: OTHER briefSummary: Globally, 10 million new traumatic brain injury (TBI) cases are estimated annually, with mild traumatic brain injury (mTBI) accounting for 75-90% of all TBI cases. It is estimated that 40-80% of individuals with mTBI may experience the post-concussion syndrome (PCS), which is characterized by a range of physical, cognitive, and emotional symptoms. Although the underlying basis of cognitive dysfunction of patients with persistent PCS remains to be clarified, converging evidence shows that the clinical symptoms is underpinned by abnormal neural information processing as a result of axonal injury due to mTBI. Recent studies have demonstrated abnormalities in both structural and functional cortical connectivity, and a loss of cortical excitability-inhibitory (E/I) balance after TBI. Yet, there is no consensus for treating chronic symptoms of concussion, and PCS remains a chronic and highly disabling condition. One potential treatment option is transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique that has been shown to modify behavior by enhancing connectivity between targeted brain areas. However, research on the therapeutic effect of tDCS on PCS symptoms is limited, and the neurologic mechanisms underlying its effects are not well understood. The proposed study aims to address these knowledge gaps by examining the effects of tDCS on the central nervous system function in patients with PCS, with a specific focus on functional cortical connectivity and cognitive functions such as processing speed and executive function. The study also aims to add value to existing evidence by potentially opening new directions for designing intervention programs for the treatment of PCS after mTBI. conditions: Transcranial Direct Current Stimulation conditions: Post-Concussion Syndrome conditions: Functional Magnetic Resonance Imaging conditions: Magnetic Resonance Spectroscopy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: tDCS with cognitive training programme measure: Executive function measure: Change in CANTAB® cognitive test - Reaction Time (RTI) measure: Change in CANTAB® cognitive test - Multitasking Test (MTT) measure: Change in CANTAB® cognitive test - Spatial Working Memory (SWM) measure: Exploratory mediator - default mode network (DMN) activation measure: Exploratory mediator - excitability-inhibitory (E/I) ratio sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Hong Kong Polytechnic University city: Hung Hom state: Kowloon country: Hong Kong lat: 22.30715 lon: 114.18532 hasResults: False

 nctId: NCT06376487 id: 75202423.2.0000.0071 briefTitle: Pulmonary Aeration and Muscle Thickening Fraction: Association of Electrical Impedance Tomography and Ultrasound overallStatus: RECRUITING date: 2024-05-01 date: 2025-07-31 date: 2026-01-31 date: 2024-04-19 date: 2024-04-19 name: Hospital Israelita Albert Einstein class: OTHER name: Fundação de Amparo à Pesquisa do Estado de São Paulo name: Feculdade de Medicina da Universidade de Sao Paulo - Brasil briefSummary: The goal of this prospective clinical study is to evaluate the effect of different High Flow Nasal Cannula (HFNC) flow rates on diaphragm, rectoabdominal, and oblique thickening fraction, and to determine whether this effect depends on the action of HFNC flow rates on Functional Residual Capacity (FRC) in Infants under 2 years of age with a diagnosis of bronchiolitis and indication for use of HFNC. The main question\[s\] it aims to answer are:

* If the thickening fraction of the abdominal muscle and diaphragm will change at the different flow rates evaluated
* If the end-expiration lung impedance (EELZ) will change at the different flow rates evaluated

The belt will be installed around the chest before the start of the change in flow rates and monitoring with Electrical Impedance Tomography (EIT) will be initiated. Patients will be positioned in dorsal decubitus elevated 10 to 20 degrees and monitoring will be performed continuously during all flow rate variations and also during the ultrasound performance.

Four different randomized flow rates will be used for evaluation: 2.0 liter.Kg-1.min-1, 1.5 liter.Kg-1.min-1, 1.0 liter.Kg-1.min-1, 0.5 liter.Kg-1.min-1. At the end of the randomized order evaluation the infant will remain in the flow of 0.5 liter.Kg-1.min-1 for 5 minutes and then return to the flow of 2.0 liter.Kg-1.min-1. The EIT parameters, ultrasound assessment, and clinical variables will be collected at the end of the 5-minute stay in each lane.

The randomization of the order of application of the phases will be carried out in blocks, so that the homogeneity of the sequences is maintained even if the collection is interrupted before reaching the total number of individuals. The blocks will be of size two and four and the test and production lists will be generated with the help of the R packages. conditions: Bronchiolitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A prospective clinical study to evaluated four different flow rate in infants with bronchiolitis using high flow nasal cannula primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: Patient will not know the flow rate sequence used during the assessment count: 82 type: ESTIMATED name: Flow rate evaluation measure: diaphragm thickening fraction measure: abdominal muscle thickening fraction measure: EELZ (end-expiration lung impedance) sex: ALL maximumAge: 24 Months stdAges: CHILD facility: Hospital Israelita Albert Eisntein status: RECRUITING city: São Paulo zip: 05653000 country: Brazil name: Milena S Nascimento role: CONTACT phone: 55 11 984520061 email: milena.nascimento@einstein.br lat: -23.5475 lon: -46.63611 hasResults: False

 nctId: NCT06376474 id: HM005PS1S06 briefTitle: To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Liver Damage overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-19 date: 2024-04-19 name: Ganzhou Hemay Pharmaceutical Co., Ltd class: INDUSTRY briefSummary: The purpose of this study was to evaluate the pharmacokinetics of Hemay 005 tablets in subjects with mild, moderate liver impairment and normal liver function, and to provide a basis for the formulation of clinical medication regimens for patients with liver impairment. conditions: Psoriasis studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Hemay005 measure: Relevant pharmacokinetic parameters，Peak Plasma Concentration（Cmax） measure: Relevant pharmacokinetic parameters，Area under the plasma concentration versus time curve（AUC0-t） measure: Relevant pharmacokinetic parameters，Area under the curve from time 0 extrapolated to infinite time (AUC0-inf) measure: Relevant pharmacokinetic parameters，half-life (T1/2) measure: Relevant pharmacokinetic parameters，clearance (CL/F) measure: Relevant pharmacokinetic parameters，volume of distribution (Vz/F) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06376461 id: 333874 briefTitle: Prospective, Multicentre Study to Validate the GastroIntestinal Dysfunction Score (GIDS) and Describe Prevalence, Outcomes, and Management of Phosphate Disorders in Intensive Care Patients acronym: GUTPHOS overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-07 date: 2024-12 date: 2024-04-19 date: 2024-04-22 name: University Hospitals of North Midlands NHS Trust class: OTHER briefSummary: Part A Multiple organ dysfunction syndrome is one of the main problems in critically ill patients. Several organ dysfunctions are routinely and systematically monitored in patients admitted to intensive care units. Gastrointestinal dysfunction is currently not included in multiple organ dysfunction scores and lacks a standardised approach. At the same time, investigators earlier studies have shown that gastrointestinal dysfunction plays an essential role in the course of illness in intensive care patients. A tool for measuring dysfunction is needed to enable future studies on interventions to improve gastrointestinal function. The GIDS (GastroIntestinal Dysfunction Score) combines different clinical signs and symptoms commonly observed and documented in patients in the ICU into a scoring system, allowing distinguishing between different grades of severity of dysfunction. The investigators will only use observations documented during the patient's stay in the intensive care unit without additional measurements and calculate gastrointestinal (GIDS) and other organ dysfunction scores.

Part B Phosphate is an electrolyte commonly measured and often corrected, while the indications and clear guidance for correction are insufficiently studied. The results of this study will assist in specifying indications for the correction of phosphate levels better and refine the management strategies in the future. Only phosphate levels measured as part of routine care will be documented, no additional samples for study purposes will be taken, and the study will not influence the treatment of phosphate disorders. conditions: Gastrointestinal Dysfunction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Data collection measure: 28 day outcome measure: 90 day outcome measure: ICU length of stay measure: ICU length of stay measure: Hospital length of stay measure: Hospital length of stay measure: Free of organ support sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospitals of North Midlands NHS Trust city: Stoke-on-Trent country: United Kingdom lat: 53.00415 lon: -2.18538 hasResults: False

 nctId: NCT06376448 id: cc-obs-01 briefTitle: An Observational Study Using Novel Questionnaire to Characterize Cough Phenotypes in Patients With Chronic Cough overallStatus: RECRUITING date: 2022-10-24 date: 2024-10-04 date: 2025-02-10 date: 2024-04-19 date: 2024-04-19 name: Hull University Teaching Hospitals NHS Trust class: OTHER_GOV briefSummary: Cough has previously been described by the type of cough you have ie such as wet, dry, and chesty, and also by its features such as how often you are coughing its,intensity, and severity, but never has the varying patterns of cough been studied in any detail and it could be that the pattern of the cough is closely related to patient-perceived intensity, frequency and most importantly severity. Cough is a symptom and like any other symptom (such as pain) the severity of it can only be gauged by the patient experiencing it.

We have created a one-page brand newl questionnaire that shows 4 distinct cough patterns that we believe exist and an empty field designed so that patients can record a pattern of cough they experience which is not already a choice on the questionnaire. The questionnaire also records patients' experience of how frequent, and intense, the cough is, and how it disrupts their lives, on a 1-10 scale (Visual analogue scale), the sum of these scores is collated and this gives us a severity score. The first phase of the project is to determine whether 30 Chronic cough patients understand the questionnaire, and are able to complete it with little direction, and if the cough patterns we identified encompassed all pattern types. second part of the study is to look at how repeatable the questionnaire is when completed over a 6 week period. conditions: Chronic Cough studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED measure: The primary objective of the study is to characterize and identify the different patterns of cough in chronic cough patients measure: measure of cough severity measure: describe any correlation between severity of cough and cough pattern measure: reproducibility of questionnnare sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Redspiratory Medicine, First Floor, Daisy Building, Castle Hill Hospital status: RECRUITING city: Cottingham state: East Yorkshiure zip: HU16 5JQ country: United Kingdom name: Caroline Wright role: CONTACT phone: 01482624067 email: c.wright@hull.ac.uk name: Rachel H Thompson, Bsc role: CONTACT phone: 01482 461800 phoneExt: Thompson email: r.h.thompson@hull.ac.uk name: Caroline Wright, Bsc role: PRINCIPAL_INVESTIGATOR lat: 52.50243 lon: -0.7554 hasResults: False

 nctId: NCT06376435 id: HBHQ-CTIT-RWS briefTitle: A Multicentre Real-world Study of Heptapopal Ethanolamine Tablets in Concurrent/Sequential Radioimmunoinduced Thrombocytopenia overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2026-07-01 date: 2026-07-01 date: 2024-04-19 date: 2024-04-19 name: Hebei Medical University Fourth Hospital class: OTHER briefSummary: The objective of this study was to observe and evaluate the efficacy and safety of hexapopal ethanolamine tablets in the treatment of synchronous/sequential radioimmunoinduced thrombocytopenia in the real world.

The subjects of this study were patients with solid malignant tumors who had received radioimmunoinduced thrombocytopenia.

This study will retrospectively and prospectively collect real-world data related to investigational drugs, and will observe 500 patients to observe the diagnosis and treatment pattern of radiochemo-induced thrombocytopenia. The study included a screening period (no more than one week) and a treatment period (at least two cycles).Participants meeting protocol inclusion criteria were defined as having platelet values \< 100×109/L during radioimmunotherapy. conditions: Cancer, Therapy-Related studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Herombopag Olamine Tablets measure: The proportion of patients recovered to 100×109/L measure: The proportion of patients recovered to 75×109/L measure: Time for platelet recovery to 100×109/L measure: Proportion of patients with treatment delay or dose reduction measure: TRAE sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06376422 id: EU-CT-2023-508271-36-00 briefTitle: Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss overallStatus: RECRUITING date: 2024-05-01 date: 2029-04-30 date: 2031-04-30 date: 2024-04-19 date: 2024-04-19 name: Privatpraxis für Knie- und Schulterchirurgie class: OTHER briefSummary: The goal of this clinical trial is to learn if partial meniscal replacement can prevent or postpone total meniscal replacement, in adult patients (female/male) with partial meniscal loss. The main questions it aims to answer are:

* Can partial meniscal replacement improve knee function?
* Can partial meniscal replacement prevent/postpone total meniscal replacement/knee prothesis? Researchers will compare the results of the operated group with patients not willing to be operated but with partial meniscal loss to see if the operation improves knee function.

Participants will be operated and have to attend follow-up visits with MRI after 6 months up to 5 years after surgery. conditions: Meniscus Lesion studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE maskingDescription: no masking, patient decides which group count: 40 type: ESTIMATED name: Spongioflex® name: non-operated measure: To evaluate efficacy of the procedure measure: Improvement of International Knee Documentation Committee (IKDC) score (between 0 and 100, the higher the better) measure: Improvement of Knee Injury and Osteoarthritis Outcome Score (KOOS) score (between 0 and 100, the higher the better) measure: Improvement of Visual Analogue Scale (VAS) Pain Score (between 0 and 10, the lower the better) measure: Safety of the patient (adverse events (AE) and serious adverse events (SAE)) measure: Efficacy of the procedure, progression to osteoarthrosis measure: Menuiscus size measure: extrusion of meniscus measure: Size of meniscal extrusion measure: Patient satisfaction sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Privatpraxis für Knie und Schulterchirurgie status: RECRUITING city: Dortmund zip: 44137 country: Germany name: Sven Behrendt, MD role: CONTACT phone: +49231 8626064 email: praxis@dr-sven-behrendt.de name: Sven Behrendt, MD role: PRINCIPAL_INVESTIGATOR lat: 51.51494 lon: 7.466 hasResults: False

 nctId: NCT06376409 id: NW-HGN-02 briefTitle: Prospective Study of Nutraceutical Supplements to Support Hair Growth in Females overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2025-04-01 date: 2025-06-01 date: 2024-04-19 date: 2024-04-23 name: Nutraceutical Wellness Inc. class: INDUSTRY briefSummary: A single site open label interventional study evaluating currently marketed hair supplements targeting the underlying root causes of thinning hair. conditions: Hair Thinning studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single Group Assignment 6-month, single-center, prospective interventional study primaryPurpose: TREATMENT masking: NONE count: 180 type: ESTIMATED name: Nutrafol Women's Hair Growth Supplement name: Nutrafol Women's Balance Hair Growth Supplement name: Nutrafol Women's Vegan Hair Growth Supplement name: Nutrafol Women's Postpartum Hair Growth Supplement measure: The percent change in hair growth rate at Day 180 relative to baseline (Day 0) measure: The percent change in hair growth rate at Day 90 relative to baseline (Day 0) measure: The change in total hair count, terminal hairs, vellus hairs, anagen, and telogen hairs compared to baseline at 90 days measure: The change in total hair count, terminal hairs, vellus hairs, anagen, and telogen hairs compared to baseline at 180 days measure: The change in terminal to vellus ratio measure: The change in terminal to vellus ratio measure: The change in anagen to telogen ratio measure: The change in anagen to telogen ratio measure: The change in average number of hairs per follicular unit measure: The change in average number of hairs per follicular unit measure: The change in total hair width per cm2 measure: The change in total hair width per cm2 measure: The change in mean inter-follicular distance measure: The change in mean inter-follicular distance measure: Subjective assessments of change measured with Consumer Perception Questionnaire at 90 days measure: Subjective assessments of change measured with Consumer Perception Questionnaire at 180 days sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Integrative Skin Science and Research city: Sacramento state: California zip: 95815 country: United States name: Nasima Afzal role: CONTACT phone: 916-750-2463 lat: 38.58157 lon: -121.4944 hasResults: False

 nctId: NCT06376396 id: 101103306 briefTitle: Assessment of Combined Praziquantel and Albendazole vs Albendazole Alone to Treat Active Parenchymal Neurocysticercosis acronym: NeuroSolve overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2026-12 date: 2024-04-19 date: 2024-04-23 name: R-Evolution Worldwide S.r.l. Impresa Sociale class: OTHER name: Muhimbili University of Health and Allied Sciences name: National Institute for Medical Research, Tanzania name: Sokoine University of Agriculture name: University of Zambia name: University Ghent briefSummary: The goal of this clinical trial is to compare the combination albendazole and praziquantel versus albendazole alone in patients affected by neurocysticercosis. conditions: Neurocysticercosis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: albendazole and praziquantel name: Albendazole measure: Cyst resolution or reduction in both study arms measure: Seizures frequency measure: Quality of Life questionnaire measure: Headache measure: Serological test results correlation with neuroimaging results sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06376383 id: TETT-RHG id: 110500 type: OTHER domain: The Central Denmark Region Committees on Health Research Ethics briefTitle: Tonsillectomy vs. Tonsillotomy in Adults With Obstructive Sleep Apnea overallStatus: NOT_YET_RECRUITING date: 2025-01 date: 2026-12 date: 2027-09 date: 2024-04-19 date: 2024-04-19 name: University of Aarhus class: OTHER briefSummary: The primary purpose of this randomized controlled trial s to investigate whether surgical reduction of palatine tonsils (tonsillotomy) is a superior treatment compared to complete surgical removal of palatine tonsils (tonsillectomy) in adults patients with obstructive sleep apnea and concomitant enlarged tonsils in regards of perioperative and postoperative morbidity. conditions: Obstructive Sleep Apnea conditions: Tonsillar Hypertrophy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 464 type: ESTIMATED name: Tonsillectomy name: Tonsillotomy measure: Postoperative hemorrhage measure: Postoperative pain measure: Recovery time - Sick leave measure: Morbidity measure: AHI measure: DISE - VOTE sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06376370 id: 16.04.24/2 briefTitle: The Effect of a Computer-Assisted Rehabilitation Program on Epilepsy Patient overallStatus: ENROLLING_BY_INVITATION date: 2024-04-26 date: 2024-06-10 date: 2024-07-28 date: 2024-04-19 date: 2024-04-19 name: Selcuk University class: OTHER briefSummary: The aim of this study is to examine the effects of the RehaCom Computer-Assisted Rehabilitation Program Applied to Epilepsy Patients on Self-Management, Cognitive Function and Quality of Life. conditions: Epilepsy conditions: Computer-assisted Cognitive Rehabilitation conditions: Quality of Life studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: INVESTIGATOR count: 50 type: ESTIMATED name: Application of computer-assisted cognitive rehabilitation program measure: Mini Mental State Test measure: Epilepsy Quality of Life Scale measure: MOXO Test measure: Epilepsy Self-Management Scale sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: ülkü Saygili Düzova city: Selçuklu state: Konya country: Turkey lat: 37.8842 lon: 32.49222 hasResults: False

 nctId: NCT06376357 id: 16.04.24/1 briefTitle: The Effect of Foot Massage With Roles on Cancer Patients overallStatus: ENROLLING_BY_INVITATION date: 2024-04-27 date: 2024-06-15 date: 2024-07-30 date: 2024-04-19 date: 2024-04-19 name: Selcuk University class: OTHER briefSummary: It was aimed to examine the roles in the management of treatment-related peripheral neuropathy in cancer patients receiving taxane-based chemotherapy and the effect of foot massage on neuropathy and quality of life. conditions: Breast Neoplasms conditions: Over Cancer conditions: Foot Massage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: INVESTIGATOR count: 54 type: ESTIMATED name: Foot Massage with roller measure: EORTC QLQ C-30 Quality of Life Scale measure: CIPN20 Neuropathy Scale measure: One Leg Standing Test measure: Brief Pain Inventory BPI measure: Pain Threshold Assessment Test measure: Two Point Discrimination sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ülkü Saygili Düzova city: Selçuklu state: Konya country: Turkey lat: 37.8842 lon: 32.49222 hasResults: False

 nctId: NCT06376344 id: 16.04.24 briefTitle: The Effect of Tennis Ball on Balance and Quality of Life in Cancer Patients With Neuropathy. overallStatus: ENROLLING_BY_INVITATION date: 2024-04-28 date: 2024-06-10 date: 2024-07-10 date: 2024-04-19 date: 2024-04-19 name: Selcuk University class: OTHER briefSummary: This research; It was aimed to evaluate the effect of myofascial release using a tennis ball on balance and quality of life in cancer patients who developed peripheral neuropathy. conditions: Cancer conditions: Neuropathy conditions: Therapy-Associated Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: INVESTIGATOR count: 50 type: ESTIMATED name: myofascial release with tennis ball measure: EORTC QLQ C-30- CIPN20 Scale measure: One Leg Standing Test measure: Lateral Reach Test measure: Pain Assessment measure: Pressure Pain Threshold Assessment measure: Two Point Discrimination sex: ALL minimumAge: 25 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ülkü Saygili Düzova city: Selçuklu state: Konya country: Turkey lat: 37.8842 lon: 32.49222 hasResults: False

 nctId: NCT06376331 id: ADHD20240403 briefTitle: Washed Microbiota Transplantation for Attention-deficit/Hyperactivity Disorder overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2027-06-01 date: 2027-07-01 date: 2024-04-19 date: 2024-04-24 name: The Second Hospital of Nanjing Medical University class: OTHER name: SIR RUN RUN hospital of Nanjing Medical University briefSummary: Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder characterized by inattention and hyperactivity-impulsivity. ADHD is often accompanied by oppositional defiant disorder and sleep disturbance, and can increase the risk of other psychiatric disorders, functional impairment in academic and occupational performance. Recently, gut microbiota has been implicated in the ADHD via gut-brain axis. In this study, investigators aimed to evaluate the efficacy of WMT for core ADHD symptoms and its comorbidities using specialized questionnaires for ADHD and investigate the underlying mechanism. conditions: Attention-deficit/Hyperactivity Disorder studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: washed microbiota transplantation measure: change of Swanson, Nolan and Pelham-IV (SNAP-IV). measure: change of Chinese version of the Conners abbreviated symptom questionnaire (C-ASQ). measure: change of the Sleep Disturbance Scale for Children (SDSC). measure: change of the Gastrointestinal Symptom Rating Scale (GSRS) . measure: the difference of the gut microbe composition between children with ADHD and healthy children by sequencing faecal metagenome. measure: the difference of the serum neurotransmitters between children with ADHD and healthy children measure: intestinal barrier sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD facility: Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University city: Nanjing state: Jiangsu country: China name: Faming Zhang, PhD role: CONTACT phone: 086-025-58509883 email: fzhang@njmu.edu.cn lat: 32.06167 lon: 118.77778 facility: SIR RUN RUN hospital of Nanjing Medical University city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06376318 id: 19-138 briefTitle: Shock and Acute Conditions OutcOmes Platform acronym: ShockCO-OP overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2025-07-01 date: 2026-01-01 date: 2024-04-19 date: 2024-04-19 name: Saint-Louis Hospital, Paris, France class: OTHER name: University of Helsinki name: University of Ottawa name: University of Leipzig name: University of Nancy name: McGill University name: Mayo Clinic name: University of Paris 5 - Rene Descartes name: University of Toronto briefSummary: In-hospital mortality of patients admitted in the intensive care unit (ICU) for circulatory shock remains high (between 20 and 40%).

Currently, there are no markers that allow us to classify patients with circulatory shock at higher risk of early and late bad outcomes, or who may better respond to a specific intervention.

To understand the contribution of biological heterogeneity to circulatory shock independently from its etiology, the ShockCO-OP Research Program aims to use clustering approaches to re-analyze existing clinical and molecular data from several large European and North American prospective cohorts and clinical trials.

This will enable an improvement in risk prediction and a better patient selection in future clinical trials to assess a personalized therapy (i.e., prospective enrollment based on a biological/molecular signature). conditions: Circulatory Shock conditions: Sepsis conditions: Cardiogenic Shock conditions: Major Trauma conditions: Surgical Shock studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 1000 type: ESTIMATED name: Inotrope name: Mechanical circulatory support name: anti-bodies measure: Mortality rate measure: Mortality rate measure: Renal replacement therapy use rate measure: Mechanical circulatory support use rate measure: Vasopressors and inotropes-free days sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St Michael's Hospital city: Toronto state: Ontario zip: M5B 1W8 country: Canada lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06376305 id: 176786 briefTitle: EndoBarrier in Obstructive Sleep Apnoea Study acronym: End-OSA overallStatus: COMPLETED date: 2016-03 date: 2019-12 date: 2019-12 date: 2024-04-19 date: 2024-04-19 name: Dr Bob Ryder class: OTHER name: Association of British Clinical Diabetologists briefSummary: Obstructive sleep apnoea (OSA) is a common condition in which the upper airways (windpipe) collapse repeatedly during sleep, blocking the flow of air into the lungs. It is characterized by repetitive pauses in breathing during sleep, despite the effort to breathe, and is associated with a reduction in the amount of oxygen in the blood (oxygen saturation). People with OSA are at risk of heart disease, high blood pressure, stroke, depression, and premature death. OSA is usually treated using a continuous positive airway pressure (CPAP) machine. This involves the patient wearing a face mask during sleep which is connected to the machine which supplies a constant steam of air to help keep the airways open. This improves the symptoms and hopefully the long-term outlook, but it is an uncomfortable solution. OSA is associated with obesity and weight loss can improve or even cure it. Treatment with EndoBarrier (placement of a thin flexible tube that is placed inside your intestine creating a physical barrier between the intestinal wall and the food so less can be absorbed) can be associated with significant weight loss and can improve blood sugar control in patients with type 2 diabetes related to their weight (diabesity). This study aims to find out if EndoBarrier treatment can improve OSA in patients with diabesity to the extent that some patients no longer require their CPAP machine treatment. conditions: Type 2 Diabetes conditions: Obstructive Sleep Apnoea conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ACTUAL name: EndoBarrier measure: Requirement for continuous positive airway pressure (CPAP) treatment will be assessed by sleep studies at screening and then every 3 months, up to 24 months measure: Apnea-hypopnea index (AHI) is measured by sleep studies at screening and then every 3 months, up to 24 months measure: Obstructive sleep apnoea (OSA) symptoms are measured by sleep studies at screening, and then every 3 months, up to 24 months measure: Continuous positive airway pressure (CPAP) pressures are measured by sleep studies at screening, and then every 3 months, up to 24 months measure: Glycated haemoglobin measured by blood test (HbA1c) at screening, baseline, and then every 3 months, up to 24 months measure: Fasting plasma glucose is measured by blood test(fasting plasma glucose) at baseline, and then at 12 and 24 months measure: Weight and Body mass index (BMI) is measured by checking weight in kilograms as well as height (in metres) ( weight and height will be combined to report BMI in kg/m^2) at screening, baseline, and then every 3 months, up to 24 months measure: Composite scores of NAFLD severity derived from the blood measurements of Alanine Aminotransferase in U/L, Aspartate Aminotransferase in U/L, platelets in x10^9/L and serum albumin in g/L as well as age in years and BMI measure: Circulating free testosterone, fasting insulin and C-Peptide are measured by blood tests at baseline, and then at 3, 12 and 24 months measure: Blood pressure is measured by checking blood pressure at sitting at screening, baseline, and then every 3 months, up to 24 months measure: Diabetes treatment including need for insulin is measured at baseline, and then every 3 months, up to 24 months21 and 24 months measure: Quality of life scores is measured by EQ-5D questionnaire at baseline and then at 6, 12 and 24 months sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City Hospital city: Birmingham zip: B18 7QH country: United Kingdom lat: 52.48142 lon: -1.89983 hasResults: False

 nctId: NCT06376292 id: Y⒛24-0106 briefTitle: A Prospective Study of Whole-Brain RT Combined With Thiotepa Sheath Injection Combined With Systemic Therapy for the Primary Disease in the Treatment of Meningeal Metastases in Solid Tumors overallStatus: RECRUITING date: 2024-02-01 date: 2026-02-01 date: 2026-02-01 date: 2024-04-19 date: 2024-04-19 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: The goal of this prospective, single-arm exploratory clinical study is to explore the safty and efficacy of whole-brain radiotherapy combined with Thiotepa sheath injection combined With Systemic Therapy for the Primary Disease in the Treatment of Meningeal Metastases in Solid Tumors

How works well was the combined therapy？ How safe was combined therapy？ Participants will receive whole brain radiotherapy combined with intrathecal injection of Thiotepa twice a week for a total of 4 weeks. Evaluate the efficacy and safety every 2 cycles.

Researchers will evaluate whether this combination treatment is safe and whether it is more effective than previous studies. conditions: Solid Tumor Leptomeningeal Metastasis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Participants will receive a comprehensive treatment plan consisting mainly of whole brain 30Gy/10F radiotherapy combined with intrathecal injection of Thiotepa twice a week for a total of 4 weeks. primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Intrathecal Injection of Thiotepa+Radiation+Systemic Treatment of Primary Diseases measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] measure: OS measure: 3-month PFS measure: 6-month PFS measure: 1-year PFS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Zhejiang University status: RECRUITING city: Hangzhou state: Zhejiang zip: 310000 country: China name: Ting Zhang, Prof. role: CONTACT phone: +8615157125533 email: zezht@zju.edu.cn lat: 30.29365 lon: 120.16142 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-03-12 uploadDate: 2024-03-13T09:04 filename: Prot_000.pdf size: 320618 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-03-12 uploadDate: 2024-03-13T09:05 filename: ICF_001.pdf size: 156721 hasResults: False

 nctId: NCT06376279 id: 2008/351-31 briefTitle: Genetic Diagnosis in Inborn Errors of Metabolism overallStatus: ENROLLING_BY_INVITATION date: 2008-04-29 date: 2030-12-31 date: 2030-12-31 date: 2024-04-19 date: 2024-04-19 name: Region Stockholm class: OTHER_GOV name: Karolinska Institutet briefSummary: Inborn Errors of metabolism comprise a large number of rare conditions with a collective incidence of around 1/2000 newborns. Many disorders are treatable provided that a correct diagnosis can be established in time, and for many diseases novel therapies are being developed. Without treatment, many of the conditions result in early death or severe irreversible handicaps.

The Centre for Inherited Metabolic Diseases, CMMS at Karolinska university hospital, is an integrated expert center where clinical specialists work closely together with experts in laboratory medicine, combining clinical genetics, clinical chemistry, pediatrics, neurology, and endocrinology. The center serves the whole Swedish population with diagnostics and expert advice on IEM and has a broad arsenal of biochemical investigations designed to detect defects in intermediary metabolism. conditions: Metabolic Disease conditions: Mitochondrial Diseases conditions: Epilepsy in Children conditions: Epilepsy conditions: LHON conditions: Motor Neuron Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 1000 type: ESTIMATED name: IEM-EP measure: Genetic variant identification using NGS for diagnosis sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06376266 id: 202305083RSC briefTitle: Assessment of the Intervention Effectiveness of Branched-chain Amino Acids(BCAA) Combined With Medium-chain Fatty Acid(MCFA) Products in Sarcopenia Among Middle-aged and Elderly Individuals overallStatus: RECRUITING date: 2023-10-01 date: 2023-12-29 date: 2024-09-30 date: 2024-04-19 date: 2024-04-19 name: National Taiwan University Hospital class: OTHER briefSummary: Taiwan entered an aging society in 2018 and is expected to transition into a super-aged society by 2025. With the increasing elderly population, age-related diseases pose urgent challenges to modern society. According to the Ministry of Health and Welfare's National Health Statistics in 2018, the prevalence of sarcopenia in Taiwan among individuals aged 65 and older is 23.6% for males and 18.6% for females. Sarcopenia, characterized by the loss of skeletal muscle mass due to aging, coupled with decreased muscle strength and/or reduced physical performance, poses a significant risk for disability, decreased quality of life, and increased mortality.

Existing research indicates that appropriate nutrition and exercise can slow the onset of sarcopenia and even increase muscle mass to reverse its effects. This study is an interventional clinical trial recruiting middle-aged and elderly patients with sarcopenia or pre-sarcopenia. The intervention involves a combination of branched-chain amino acids and medium-chain triglyceride products, and the study aims to assess the effectiveness of this intervention for sarcopenia in middle-aged and elderly individuals. conditions: Sarcopenia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: nutritional supplements measure: the scale of sarcopenia measure: the scale of sarcopenia measure: the scale of sarcopenia sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Geriatrics and Gerontology, National Taiwan University Hospital status: RECRUITING city: Taipei zip: 100 country: Taiwan name: Ding-cheng Chan, DR role: CONTACT phone: +886-2-23123456 phoneExt: 67095 email: dingchengchan@ntu.edu.tw lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06376253 id: CGIZ943A12101 id: 2023-507674-41-00 type: OTHER domain: CTIS briefTitle: A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers overallStatus: NOT_YET_RECRUITING date: 2024-09-06 date: 2030-08-30 date: 2030-08-30 date: 2024-04-19 date: 2024-04-19 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-EVS459 and the safety and imaging properties of \[68Ga\]Ga-EVS459 in patients aged ≥ 18 years with advanced high-grade serous ovarian cancer (OC) or locally advanced unresectable or metastatic non-squamous non-small cell lung carcinoma (non-sq. NSCLC). conditions: Ovarian Cancer conditions: Lung Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 96 type: ESTIMATED name: [68Ga]Ga-EVS459 name: [177Lu]Lu-EVS459 measure: Number of participants with dose limiting toxicities of [177Lu]Lu-EVS459 measure: Incidence and severity of adverse events and serious adverse events of [177Lu]Lu- EVS459 measure: Dose modifications for [177Lu]Lu- EVS459 measure: Dose intensity for [177Lu]Lu- EVS459 measure: Overall response rate (ORR) measure: Duration of Response (DOR) measure: Disease control rate (DCR) measure: Progression free survival (PFS) measure: Area Under the Curve (AUC) of [177Lu]Lu-EVS459 measure: Total body clearance of [177Lu[Lu-EVS459 measure: Observed maximum plasma concentration (Cmax) of [177Lu]Lu-EVS459 measure: Volume of distribution during the terminal phase following intravenous elimination (Vz) of [177Lu]Lu-EVS459 measure: Terminal elimination half-life (T1/2) of [177Lu]Lu-EVS459 measure: Urinary excretion of radioactivity expressed as a percentage of injected activity (%IA) measure: Renal clearance of [177Lu]Lu- EVS459 measure: Absorbed dose of [177Lu]Lu- EVS459 measure: Time-activity curves (TACs) related to [177Lu]Lu-EVS459 uptake in organs and tumor lesions measure: Incidence and severity of adverse events and serious adverse events of [68Ga]Ga-EVS459 measure: Visual and quantitative assessment of [68Ga]Ga-EVS459 uptake in normal tissues and tumor lesions over time sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06376240 id: NL85203.068.23 briefTitle: The Effect of Pyridoxamine Supplementation on Microvascular Function in Type 2 Diabetes acronym: PYRAMID overallStatus: RECRUITING date: 2024-03-21 date: 2025-12-31 date: 2025-12-31 date: 2024-04-19 date: 2024-04-19 name: Maastricht University Medical Center class: OTHER name: Diabetes Fonds briefSummary: Patients with type 2 diabetes have an increased risk of developing vascular complications. Microvascular dysfunction might be caused by the increased production of methylglyoxal under hyperglycaemic conditions. Methylglyoxal is a by-product of glycolysis and forms advanced glycation endproducts (AGEs) on proteins and DNA, thereby disrupting their function. Preventing methylglyoxal accumulation and AGEs formation may offer a therapeutic option for treating microvascular complications in diabetics. Pyridoxamine is a vitamin B6 vitamer that scavenges methylglyoxal and thereby inhibits the formation of AGEs. In this study, the researchers investigate whether pyridoxamine supplementation in type 2 diabetes improves microvascular function in the eye, kidney and skin, and reduces markers of endothelial dysfunction and glycation. conditions: Type 2 Diabetes conditions: Microvascular Function conditions: Retinopathy, Diabetic conditions: Nephropathy, Diabetic conditions: Neuropathy, Diabetic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Pyridoxamine 300mg per day name: Placebo 300mg placebo per day measure: Central retinal artery equivalent of the eye measure: eGFR measure: Microvascular function in skin measure: Markers of endothelial function and glycation in blood plasma. measure: Advanced glycation end products in skin measure: Advanced glycation end products in blood plasma and urine measure: Adipokines and inflammatory markers in blood plasma measure: Methylglyoxal, glyoxal and 3-deoxyglucose in blood plasma. measure: Markers of dicarbonyl stress and oxidative stress in urine measure: Glucose metabolism measure: Liver fat measure: Systolic and diastolic blood pressure measure: Microvascular function eye measure: Urinary albumin sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Academic Hospital Maastricht status: RECRUITING city: Maastricht zip: 6229 HX country: Netherlands name: CTCM Clinical Trial Center Maastricht role: CONTACT phone: + 31 (0) 43 387 20 40 email: secretariaat.ctcm@mumc.nl lat: 50.84833 lon: 5.68889 hasResults: False

 nctId: NCT06376227 id: jamesdukeryan briefTitle: Robotic-Assisted or Laparoscopic Radical Resection for Rectal Cancer With or Without Left Colic Artery Preservation overallStatus: COMPLETED date: 2020-04-01 date: 2023-05-31 date: 2023-12-28 date: 2024-04-19 date: 2024-04-22 name: Northern Jiangsu People's Hospital class: OTHER briefSummary: Brief Summary

Background The preservation of the left colic artery (LCA) during rectal cancer resection remains a topic of controversy, and there is a notable absence of robust evidence regarding the outcomes associated with LCA preservation. And the advantages of robotic-assisted laparoscopy (RAL) surgery in rectal resection remain uncertain. The objective of this study was to assess the influence of LCA preservation surgery and RAL surgery on intraoperative and postoperative complications of rectal cancer resection.

Methods Participants who underwent laparoscopic (LSC) or RAL with or without LCA preservation resection for rectal cancer between April 2020 and May 2023 were retrospectively assessed. The patients were categorized into two groups: low ligation (LL) which with preservation of LCA and high ligation (HL) which without preservation of LCA. A one-to-one propensity score-matched analysis was performed to decrease confounding. The primary outcome was operative findings, operative morbidity, and postoperative genitourinary function. conditions: Rectal Cancer conditions: Left Colic Artery Stenosis (Diagnosis) conditions: Robotic Assisted Laparoscopic Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1164 type: ACTUAL name: with or without Left Colic Artery Preservation measure: The incidence of anastomotic leakage in postoperative patients with or without left colic artery preservation. measure: The genitourinary function of the patients after the radical resection with or without left colic artery preservation. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northern Jiangsu People's Hospital Affiliated to Yangzhou University, General Surgery Institute of Yangzhou, Yangzhou University , Yangzhou city: Yangzhou state: Jiangsu zip: 225001 country: China lat: 32.39722 lon: 119.43583 hasResults: False

 nctId: NCT06376214 id: 2024-02 briefTitle: Daratumumab for Patients With Light Chain Amyloidosis overallStatus: RECRUITING date: 2023-01-01 date: 2025-12-31 date: 2026-12-31 date: 2024-04-19 date: 2024-04-19 name: Nanjing University School of Medicine class: OTHER briefSummary: This is a prospective, single-center study exploratory clinical trial, aim to exploring the efficacy and safety of daratumumab in patients with AL amyloidosis, patients were divided into three groups: one group received long-term treatment with daratumumab based regimen, and the other group received autologous stem cell transplantation after two standard treatment courses with daratumumab based regimen, and the third group consists of newly diagnosed stage IIIb AL amyloidosis patients who plan to receive DPD treatment. The purpose of this study is to observe the efficacy and safety of Daratumumab, in the treatment of newly diagnosed systemic AL amyloidosis. conditions: Light Chain (AL) Amyloidosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Dratumumab / Hyaluronidase Injection [Darzalex Faspro] name: Pomalidomide 4 MG name: autologous stem cell transplantation (ASCT) measure: Hematological complete response rate measure: Organ response rate measure: Time to Next Treatment measure: Progression-free survival measure: Overall survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Clinical Research Center for Kidney Diseases, Jinling Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210016 country: China name: Xianghua Huang, MD role: CONTACT phone: 02580862351 email: hxhszb@163.com lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06376201 id: NFEC-2024-018 briefTitle: A Clinical Study on the Efficacy and Safety of ABCD in the Treatment of Patients With Invasive Fungal Disease overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-02 date: 2025-09 date: 2024-04-19 date: 2024-04-19 name: Nanfang Hospital, Southern Medical University class: OTHER briefSummary: This study is a prospective, multicenter, single-arm study, that aims to evaluate the efficacy and safety of amphotericin B cholesterol-sulfate complex (ABCD) for injection in the first-line treatment of patients with invasive fungal diseases, hoping to provide a reference for the clinical treatment of invasive fungal diseases. Patients with hematologic diseases who meet the criteria for inclusion and discharge with febrile neutropenia and suspected fungal infection were treated with ABCD antifungal therapy for 14 days while receiving treatment for underlying diseases, and the response rate of treatment was observed. conditions: Invasive Fungal Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 125 type: ESTIMATED name: Amphotericin B cholesterol-sulfate complex for injection measure: Treatment is effective measure: Incidence of the single index in the five criteria of treatment success measure: Completion rate of ABCD treatment for at least 14 days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06376188 id: 1582/2021 SimCom briefTitle: Improving Breaking Bad News in Pediatrics by Simulated Communication acronym: SimCom overallStatus: COMPLETED date: 2021-09-01 date: 2022-08-31 date: 2022-09-30 date: 2024-04-19 date: 2024-04-19 name: Medical University of Vienna class: OTHER briefSummary: Breaking bad news, especially a death notice, is an essential part of the medical profes-sional communication. Being inadequately trained in those skills this may result in un-pleasant psychosocial consequences for everyone involved.

This prospective, single-center, randomized controlled trial evaluated the delivery of a death notice to simulation parents out of the perspective of these parents (professional actors), the participants (students) and by video analysis. The simulation patient has prior unexpectedly died during a simulated resuscitation. The intervention group broke the bad news after receiving a short communication conditions: Communication conditions: End of Life conditions: Pediatric ALL studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 46 type: ACTUAL name: communication training measure: score by simulation parents measure: score by participants measure: score of video analysis sex: ALL minimumAge: 18 Years maximumAge: 75 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: NCT06376175 id: LL-016 briefTitle: Task Atlas: Study to Develop a Task Atlas of Brain Recruitment During a Digital Game-based Program overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-08-31 date: 2024-08-31 date: 2024-04-19 date: 2024-04-19 name: Lumos Labs, Inc. class: INDUSTRY briefSummary: Healthy volunteers ages 25-40 from the general US population who meet the eligibility criteria and are enrolled will (a) play Lumosity games at least 20 times each in under 60 days and (b) then complete one session of task-based functional magnetic resonance imaging (fMRI) while playing Lumosity games. conditions: Healthy Adults studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: BOLD response during gameplay measure: Responder rates measure: Structural MRI volumetrics: Volume measure: Structural MRI volumetrics: Cortical thickness measure: Structural MRI volumetrics: Brain-Predicted Age Difference measure: Behavior response: Game score measure: BAMS-7 (Brief Attention and Mood Scale of 7 Items) measure: VGPQ (Video Game Playing Questionnaire) sex: ALL minimumAge: 25 Years maximumAge: 40 Years stdAges: ADULT facility: UC Davis Imaging Research Center (IRC) city: Sacramento state: California zip: 95817 country: United States name: Kevin Madore, PhD role: CONTACT lat: 38.58157 lon: -121.4944 hasResults: False

 nctId: NCT06376162 id: ITCC-101/APAL2020K id: 2023-505262-28-00 type: CTIS briefTitle: Ziftomenib in Combination With Chemotherapy for Children With Relapsed/Refractory Acute Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-08 date: 2027-08 date: 2024-04-19 date: 2024-04-19 name: LLS PedAL Initiative, LLC class: OTHER name: Kura Oncology briefSummary: The primary objective of the study is to determine the recommended phase 2 dose (RP2D) of ziftomenib in combination with chemotherapy (FLA) in children with relapsed or refractory KMT2A-r, NUP98-r, or NPM1-m acute leukemia based on safety and pharmacokinetics (PK). conditions: Relapsed/Refractory KMT2A-r Acute Leukemia conditions: Relapsed/Refractory NUP98-r Acute Leukemia conditions: Relapsed/Refractory NPM1-m Acute Leukemia studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Ziftomenib name: Cytarabine name: Fludarabine measure: Number of Participants Who Experience a Dose-limiting Toxicity (DLT) measure: Area Under the Plasma Concentration-time Curve (AUC) of Ziftomenib measure: Number of Participants Who Experience an Adverse Event (AE) measure: Number of AEs by Severity measure: Maximum Observed Plasma Concentration (Cmax) of Ziftomenib measure: Minimum Observed Plasma Concentration (Cmin) of Ziftomenib measure: Time to Cmax (Tmax) measure: Truncated AUC (AUC0-t) of Ziftomenib in Combination with FLA Chemotherapy measure: Extrapolated AUC (AUC0-∞) of Ziftomenib in Combination with FLA Chemotherapy measure: Oral Plasma Clearance (CL/F) of Ziftomenib in Combination with FLA Chemotherapy measure: Volume of Distribution (Vz/F) of Ziftomenib in Combination with FLA Chemotherapy measure: Terminal Elimination Half-life (t1/2) of Ziftomenib in Combination with FLA Chemotherapy measure: HSCT Rate measure: Morphological Overall Response Rate (ORR) measure: Flow-based ORR measure: Flow-based Measurable Residual Disease (MRD) Negativity Rate measure: Duration of Response (DOR) measure: Event-free Survival (EFS) measure: Overall Survival (OS) measure: Cumulative Incidence of Relapse (CIR) sex: ALL minimumAge: 0 Years maximumAge: 21 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06376149 id: 124973 briefTitle: M3-JIA: Making Mindfulness Matter for Children With JIA acronym: M3-JIA overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-12 date: 2026-02 date: 2024-04-19 date: 2024-04-29 name: Lawson Health Research Institute class: OTHER name: Brain Canada briefSummary: The investigator will evaluate the efficacy of M3©, an intervention for patients with JIA and their caregivers. Children with Juvenile arthritis and their parents will attend an 8 week online program called Making Mindfulness Matter (M3). This is a facilitator-led program that integrates knowledge and skills related to mindfulness, social-emotional learning, neuroscience, and positive psychology to promote coping and resiliency for children and families in context of the challenges of pediatric chronic disease. The child program is designed for children 4-12 years of age, with each lesson including a variety of concrete ways to teach children skills based on their age/developmental level. conditions: Juvenile Idiopathic Arthritis conditions: Children conditions: Mental Health conditions: Mental Well-being studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The primary objective is to conduct a pilot RCT to evaluate the effectiveness of a live-online mindfulness-based family intervention program, Making Mindfulness Matter (M3©) for children with JIA and their caregiver(s).

Measures will be obtained via questionnaires at 3 time points: baseline, 9 weeks and 2 months post-intervention.

Additionally, at the start of each session, parents will complete a one-page semi-structured questionnaire evaluating treatment fidelity and at home utilization of M3© skills. At the end of each session, parent participants will complete a one-page structured questionnaire providing feedback on the session, and facilitators will complete the M3© Adherence Checklist, evaluating whether planned activities were completed, and any modifications made. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Participants will be blinded to their group assignment: all participants will be told that they will receive the intervention. Program facilitators will be blinded to participant group assignment order, since sessions for both study arms would run on a rolling basis. The statistician will also be blinded to the group assignment and order. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 74 type: ESTIMATED name: M3 Intervention group name: M3 Waitlist Group measure: conduct a pilot RCT to evaluate the effectiveness of a live-online mindfulness-based family intervention program, Making Mindfulness Matter (M3©) for children with JIA and their caregiver(s). measure: Effects of M3 on health related quality of life of children with JIA measure: Effects of M3 on health quality of life for parents measure: Does M3 have a positive effect on children's severity of JIA measure: Does M3 have a positive effect on children's executive function measure: Does M3 have a positive effect on parents' stress measure: Does M3 have a positive effect on parents' depression and anxiety measure: Does M3 have a positive effect on Child's' depression and anxiety measure: Does M3 have a positive effect on children's resiliency measure: Does M3 have a positive effect on parent resiliency sex: ALL minimumAge: 4 Years maximumAge: 12 Years stdAges: CHILD facility: McMaster Children's Hospital, city: Hamilton state: Ontario zip: L8N 3Z5 country: Canada name: Karen Beatie role: CONTACT phone: (905) 521-2100 email: beattik@mcmaster.ca name: Michelle Dr. Batthish role: CONTACT phone: (905) 521-2100 email: batthim@mcmaster.ca name: Michelle Batthish role: SUB_INVESTIGATOR lat: 43.25011 lon: -79.84963 facility: London Health Sciences Centre- Children's Hosptial city: London state: Ontario zip: N6J 4L8 country: Canada name: Sarah Wells role: CONTACT phone: 519-685-8500 phoneExt: 56816 email: sarah.wells@lhsc.on.ca name: Roberta Berard role: CONTACT phone: 519-685-8500 phoneExt: 52479 email: roberta.berard@lhsc.on.ca name: Roberta Berard, MD role: PRINCIPAL_INVESTIGATOR lat: 42.98339 lon: -81.23304 facility: Sickids city: Toronto state: Ontario zip: M5G 1E8 country: Canada name: Andrea Knight role: CONTACT phone: (416) 813-1500 email: andrea.knight@sickkids.ca name: Andrea Dr. Knight role: SUB_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06376136 id: BAT-8010+1006-001-CR briefTitle: An Evaluation of BAT 8010 for Injection in Combination With BAT 1006 in Locally Advanced or Metastatic Entities Safety, Tolerability, Pharmacokinetic Profile, and Initial Clinical Efficacy of the Tumor in Patients Multicenter, Open Phase Ib/IIa Clinical Study overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-05-24 date: 2026-12-09 date: 2024-04-19 date: 2024-04-19 name: Bio-Thera Solutions class: INDUSTRY briefSummary: This study is a multicenter, open, exploratory Phase Ib/IIa clinical trial in humans The combination of BAT8010 and BAT1006 was administered in patients with locally advanced or metastatic solid tumors(HER-2 expression, including IHC3+, IHC2+/FISH+, and IHC2+/FISH- patients)Tolerance and PK characteristics, to explore the maximum tolerated dose (MTD) and provide recommendations for subsequent clinical studies Recommended dose (RP2D) and rational administration regimen, and preliminary evaluation of antitumor efficacy. There are two main studies In the first stage, the "3+3" dose escalation rule is proposed to explore the safety and tolerance of the drug Sex; The second stage selects the appropriate dose and administration according to the preliminary safety and efficacy results of the previous stage The drug regimen and tumor species were expanded to further explore the combination of BAT8010 and BAT1006 for injection，The safety and clinical effectiveness of drug administration provided the basis for the follow-up clinical study. conditions: Advanced Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 108 type: ESTIMATED name: BAT8010 for Injection name: BAT1006 for Injection measure: Dose-limiting toxicity (DLT) measure: vital signs measure: Physical examination measure: Adverse events measure: Clinical laboratory tests measure: Number of participants with abnormal clinical auxiliary tests measure: Duration of Response(DOR) measure: Disease Control Rate (DCR) measure: Pharmacokinetic measure: Pharmacokinetic measure: Pharmacokinetic measure: Pharmacokinetic measure: Antibody measure: Antibody sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06376123 id: Nkangarli001 briefTitle: Nomogram for Prediction of Alveolo-arterial Gradient During One-lung Ventilation overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-09-01 date: 2024-09-15 date: 2024-04-19 date: 2024-04-19 name: Bezmialem Vakif University class: OTHER briefSummary: The cause of hypoxia during one-lung ventilation is a common anaesthetic problem seen during thoracic surgery and is associated with increased fraction of shunted blood. This shunt occurs because the lung not participating in respiration stops saturating the blood with oxygen. The importance of our study is to collect some of the patient's parameters on a nomogram in the preoperative period, to predict the shunt fraction that will occur during one-lung ventilation and to make preparations and interventions accordingly. conditions: One-lung Ventilation studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: Alveolo-arterial gradient measure: Alveolo-arterial gradient measure: Alveolo-arterial gradient change measure: Alveolo-arterial gradient change sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bezmialem Vakif University Dragos Hospital city: Istanbul state: Maltepe zip: 34844 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06376110 id: AviClear-001 briefTitle: Single-Blind Study Assessing the Use of a Topical Antioxidant With A Series of Laser Procedures to Reduce Sebum Production overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-15 date: 2025-04-15 date: 2024-04-19 date: 2024-04-19 name: Austin Institute for Clinical Research class: NETWORK name: SkinCeuticals briefSummary: This is a split-face, single-blind study assessing the use of an antioxidant serum with a series of acne laser treatments to reduce sebum production in healthy male and female subjects between the ages of 18 and 65 years, inclusive, with Fitzpatrick skin types I-VI. conditions: Acne studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 10 type: ESTIMATED name: Topical Antioxidant Serum name: AviClear Laser measure: Change in Product Tolerability measure: Change in Product Efficacy sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06376097 id: D5162R00036 briefTitle: Lung Cancer Screening Program Using Low-dose Tomography and Metabolomic Evaluation in a Public Service. overallStatus: RECRUITING date: 2023-04-19 date: 2025-01-30 date: 2025-01-30 date: 2024-04-19 date: 2024-04-19 name: AstraZeneca class: INDUSTRY briefSummary: Observational study that aims to evaluate the implementation of a lung cancer screening program in a smoker population included in a public heath service. conditions: Lung Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: Absolute number and frequency of false-negative lung nodules . measure: Assess adherence to smoking cessation treatment in active smokers who enter screening. measure: Assessment of morbidity and mortality in patients undergoing invasive procedures, whether diagnostic or therapeutic. measure: Cost comparasion of treating patients in metastatic setting vs. treating early-stage lung cancer patients, including all costs from the screening program. sex: ALL minimumAge: 45 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital das Clínicas da Faculdade de Medicina de Botucatu (HCFMB) status: RECRUITING city: Botucatu state: São Paulo zip: 18618-686 country: Brazil name: Erica Hasimoto role: CONTACT phone: (14) 99792-0222 email: ericanh80@hotmail.com lat: -22.88583 lon: -48.445 hasResults: False

 nctId: NCT06376084 id: D5161R00055 briefTitle: Osimertinib With Chemotherapy as First-line Therapy for EGFR Mutation-positive NSCLC acronym: FOREFRONT overallStatus: NOT_YET_RECRUITING date: 2024-07-24 date: 2028-02-28 date: 2028-02-28 date: 2024-04-19 date: 2024-04-19 name: AstraZeneca class: INDUSTRY briefSummary: To estimate parameters related to clinical outcomes in a real-world seeting, including investigator reported PFS and OS. conditions: Carcinoma, Non-Small-Cell Lung conditions: Lung Neoplasms conditions: Respiratory Tract Neoplasms conditions: Thoracic Neoplasms conditions: Neoplasms by Site conditions: Neoplasms conditions: Lung Diseases conditions: Respiratory Tract Diseases conditions: Carcinoma, Bronchogenic conditions: Bronchial Neoplasms studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 700 type: ESTIMATED measure: Real-World Progression Free Survival (rwPFS) measure: Chemotherapy regimen measure: Duration of chemotherapy (induction and maintenance cycles) measure: Response rate measure: Duration of response measure: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Chest Hospital city: Shanghai state: Shanghai zip: 200030 country: China name: Rong LI role: CONTACT phone: +8621-22200000-5451 email: lrw@hotmail.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06376071 id: fungal rhinosiusitis briefTitle: Sinonasal Risk Factors for Occurrence of Unilateral Versus Bilateral Allergic Fungal Rhinosinusitis . overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-06-30 date: 2024-04-19 date: 2024-04-19 name: Assiut University class: OTHER briefSummary: This study aims to assess Sinonasal risk factors for occurrence of unilateral versus bilateral allergic fungal rhino sinusitis regarding::

1. anatomical variations and correlate radiological finding with intraoperative finding.
2. other associated factors like demographic ,environmental, immunological and climatic risk factors . conditions: Allergic Fungal Rhinosinusitis studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 76 type: ESTIMATED name: functional endoscopic sinus surgery measure: Sinonasal risk factors for occurrence of unilateral versus bilateral allergic fungal rhinosinusitis sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06376058 id: 434/06-06-2022 briefTitle: Chloroprocaine 1% Versus Ropivacaine 0,75% During Cesarean Section acronym: annie-mariana overallStatus: RECRUITING date: 2024-01-10 date: 2026-01-10 date: 2026-01-10 date: 2024-04-19 date: 2024-04-19 name: Aretaieion University Hospital class: OTHER briefSummary: This will be a prospective randomized study, aiming at comparing an intrathecal fixed dose of chloroprocaine 1% versus an intrathecal fixed dose of ropivacaine 0.75% in elective cesarean sections conditions: Cesarean Section conditions: Local Anesthetic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Chloroprocaine 1% Injectable Solution name: Ropivacaine 0.75% Injectable Solution measure: Time from spinal anesthesia to T10 block (min) measure: Time from spinal anesthesia to T4 block (min) measure: Time of spinal anesthesia to Bromage =3 measure: level of sensory block every 3 min measure: level of sensory block every 15 min measure: highest level of sensory block measure: time from spinal anesthesia to highest level of sensory block measure: duration of sensory block measure: pain at surgical incision measure: pain at neonatal delivery measure: pain at peritoneal manipulation measure: pain at Post Anesthesia Care Unit (PACU) admission measure: pain at Post Anesthesia Care Unit (PACU) discharge measure: need for rescue analgesia intraoperatively measure: Bromage scale every 3 min after spinal anesthesia measure: Bromage scale every 15 min measure: duration of motor block measure: duration of staying in PACU measure: Neonatal Apgar score at 1 minute measure: Neonatal Apgar score at 5 minutes measure: neonatal blood gases measure: incidence of neonatal acidosis measure: incidence of hypotension measure: incidence of bradycardia measure: need for vasoconstrictor measure: need for atropine measure: incidence of nausea/vomiting measure: incidence of dizziness measure: incidence of drowsiness measure: incidence of discomfort measure: incidence of shivering measure: need for rescue analgesia in PACU measure: time from spinal anesthesia to rescue analgesia in PACU measure: incidence of neurological symptoms during hospital stay measure: incidence of neurological symptoms 2 months after the operation measure: incidence of low back pain measure: time from spinal anesthesia to mobilization measure: mother's satisfaction from anesthesia measure: gynecologist's satisfaction sex: FEMALE minimumAge: 18 Years maximumAge: 48 Years stdAges: ADULT facility: Aretaieion University Hospital status: RECRUITING city: Athens zip: 11528 country: Greece name: Kassiani Theodoraki, PhD, DESA role: CONTACT phone: 6974634162 email: ktheodoraki@hotmail.com name: Marianna Mavromati, MD role: CONTACT email: marimavr14@gmail.com lat: 37.97945 lon: 23.71622 hasResults: False

 nctId: NCT06376045 id: 20220093 briefTitle: A Phase 2, Dose Ranging Study Assessing Rocatinlimab in Moderate-to-severe Asthma overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2026-08-10 date: 2026-10-02 date: 2024-04-19 date: 2024-04-19 name: Amgen class: INDUSTRY briefSummary: The primary objective of this study is to describe the efficacy of rocatinlimab in reducing asthma exacerbations. conditions: Asthma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 428 type: ESTIMATED name: Rocatinlimab name: Placebo measure: Annualized Asthma Exacerbation Rate (AAER) During the Blinded Treatment Period measure: Change From Baseline in Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1) measure: Annualized Rate of Composite Endpoint for Exacerbations (CompEx) Events During the Blinded Treatment Period measure: Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score at Week 48 measure: Change From Baseline in Pre-BD FEV1 measure: Change From Baseline in Asthma Symptom Diary (ASD) Score measure: Number of Participant Achieving ACQ-6 Response at Week 48 measure: Change From Baseline in ACQ-6 measure: Change From Baseline in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ (S)) Self-Administered Score measure: Number of Participants Achieving AQLQ (S) Response at Week 48 measure: Annualized Rate of Asthma Exacerbation Leading to Hospitalization or Emergency Room Visits During the Blinded Treatment Period measure: Time to First Asthma Exacerbation Event measure: Time to First CompEx Event measure: Number of Participants with a CompEx Event During the Double Blinded Treatment Period measure: Annualized Rate of CompEx Events measure: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels measure: Serum Rocatinlimab Concentrations measure: Trough Concentration (Ctrough) of Rocatinlimab measure: Number of Participants with Treatment-emergent Adverse Events measure: Number of Participants with Serious Adverse Events measure: Number of Participants with Anti-rocatinlimab Antibody Formation sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06376032 id: Akili-068 briefTitle: EndeavorOTC® Research Study in College Students overallStatus: RECRUITING date: 2024-01-10 date: 2025-12-31 date: 2025-12-31 date: 2024-04-19 date: 2024-04-23 name: Akili Interactive Labs, Inc. class: INDUSTRY name: Landmark College name: Villa Maria College briefSummary: The objective of this study is to evaluate the impact of a digital therapeutic (EndeavorOTC®, also known as AKL-T01A) on clinical symptoms of executive and cognitive functioning in a real-world sample of university students. This study aims to answer whether EndeavorOTC represents a useful intervention for targeting broad cognitive and emotional health among university students. conditions: Attention conditions: Cognition conditions: University Students studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Eligible students will be randomized\* to two cohorts: the first will receive immediate access to AKL-T01, and the second will complete weekly online surveys and receive access to AKL-T01 after the first group has completed the recommended 6 weeks of use. Regardless of group assignment, all participants will receive full 12-weeks of access to AKL-T01 during the course of the study.

\*Depending on enrollment numbers for a given semester (e.g., if \<100 students are enrolled and the study is underpowered to conduct between-group comparisons), all participants may be assigned to receive treatment immediately (i.e., single-arm design) and primary study hypotheses may be evaluated according to within-person changes in outcomes. primaryPurpose: OTHER masking: NONE count: 500 type: ESTIMATED name: EndeavorOTC® measure: Computerized Adaptive Test, Mental Health (CAT-MH®) measure: PROMIS Cognitive Function v2.0 - Short Form measure: PROMIS Satisfaction with Participation in Discretionary Social Activities (v1.0) measure: General Academic Self-Efficacy scale (GASE) measure: Mental Health Quality of Life Scale (MHQoL) measure: Adult ADHD Self-Report Scale (ASRS) measure: Patient Health Questionnaire-4 (PHQ-4) measure: System Usability Scale (SUS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Villa Maria College status: RECRUITING city: Cheektowaga state: New York zip: 14225 country: United States name: Laura Pietak role: CONTACT phone: 716-961-2869 email: lpietak@villa.edu lat: 42.90339 lon: -78.75475 facility: Landmark College status: RECRUITING city: Putney state: Vermont zip: 05346 country: United States name: Rick Bryck, PhD role: CONTACT phone: 802-387-6306 email: rickbryck@landmark.edu lat: 42.9748 lon: -72.52176 hasResults: False

 nctId: NCT06376019 id: FDASU-RecID11352 briefTitle: Occlusion and Disocclusion Time in Immediately Loaded Overdentures Supported by Two Splinted Versus Non Splinted Interforaminal Implants overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2024-08-15 date: 2024-09-15 date: 2024-04-19 date: 2024-04-19 name: Ain Shams University class: OTHER briefSummary: complete denture wearers struggle to eat well with their dentures due to poor denture retention, stability, and occlusal disharmony. So, the current study protocol aims to compare the occlusion/ disocclusion time in immediately loaded implant retained overdentures supported by two interforaminal implants; splinted versus non splinted dental implants compared to the conventional complete denture. conditions: Edentulous Jaw studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: parallel assignment of the participants in ratio 1:1:1 will take place. For allocation concealment, opaque sealed envelopes will be used. primaryPurpose: TREATMENT masking: NONE maskingDescription: the statistician will be the only one to be blinded count: 27 type: ESTIMATED name: solitary Implant loading with ball attachment name: splinted Implant loading with intra oral welding name: complete denture measure: Assessment of occlusion/disocclusion time sex: ALL minimumAge: 50 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Dentistry Ain Shams University city: Cairo zip: 11361 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06376006 id: 1798538 briefTitle: Evaluating Learning Curves and Competence in Colorectal Endoscopic Mucosal Resection Among Advanced Endoscopy Trainees acronym: EMR-STAT overallStatus: ACTIVE_NOT_RECRUITING date: 2022-05-11 date: 2024-04-01 date: 2024-12-01 date: 2024-04-19 date: 2024-04-24 name: AdventHealth class: OTHER name: Duke University name: University of South Florida name: Stony Brook University name: Atrium Medical Center name: Hofstra University name: Long Island Jewish Medical Center name: Vanderbilt University name: Yale University name: Columbia University name: Geisinger Clinic name: Unity Health Toronto name: University of Virginia name: Baylor University name: University of Kentucky name: Cedars-Sinai Medical Center name: University of Chicago name: University of California, Irvine name: University of Alabama at Birmingham name: Beth Israel Deaconess Medical Center briefSummary: Quality improvement project with the aim to use a standardized assessment tool (EMR-STAT) to establish learning curves and competence thresholds for key cognitive and technical colorectal EMR core skills among advanced endoscopy trainees (AETs). conditions: Competence conditions: Assessment, Self studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 42 type: ESTIMATED name: EMR STAT - Survey measure: Primary Endpoint sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AdventHealth Orlando city: Orlando state: Florida zip: 32804 country: United States lat: 28.53834 lon: -81.37924 hasResults: False

 nctId: NCT06375993 id: ADI-202300103 briefTitle: A Phase 1 Study of ADI-001 in Lupus Nephritis overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-12 date: 2027-12 date: 2024-04-19 date: 2024-04-19 name: Adicet Bio, Inc class: INDUSTRY briefSummary: ADI-202300103 is a phase 1 multicenter, open label, dose finding and dose expansion safety/efficacy study in patients with lupus nephritis. The study will consist of different periods including screening, lymphodepletion, treatment, and follow-up conditions: Lupus Nephritis conditions: Autoimmune Diseases studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: 3+3 Dose Escalation Design primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: ADI-001 name: Fludarabine name: Cyclophosphamide measure: The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort measure: Proportion of treatment emergent and treatment related adverse events sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06375980 id: ANKARA_OR_MP briefTitle: Intraoperative Mechanical Power and Ventilation-Associated Lung Injury: Assessing Complications overallStatus: COMPLETED date: 2022-04-01 date: 2022-12-31 date: 2022-12-31 date: 2024-04-19 date: 2024-04-19 name: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital class: OTHER briefSummary: This study investigates the relationship between intraoperative mechanical power and postoperative pulmonary complications in patients undergoing major abdominal surgery. We record mechanical ventilation parameters and surgical characteristics, assessing the incidence of pulmonary complications within 24 hours postoperatively conditions: Lung Injury conditions: Pulmonary Complication studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 207 type: ACTUAL name: Intraoperative Mechanical Ventilation Strategies measure: Relationship between mechanical power and postoperative pulmonary complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Oncology Training and Research Hospital city: Ankara zip: 06200 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06375967 id: CARPEGIEM briefTitle: EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial) acronym: CARPEGIEM overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2027-06 date: 2024-04-19 date: 2024-04-19 name: Hospital Universitari de Bellvitge class: OTHER name: Hospital Clínico Universitario de Valencia name: Hospital General Universitario de Alicante name: Hospital Mutua de Terrassa name: Hospital Universitario Ramon y Cajal name: Hospital General Universitario de Castellón name: Complejo Hospitalario de Navarra name: University Hospital Virgen de las Nieves name: Hospital de Sant Pau name: University of Salamanca name: Complejo Hospitalario Universitario de Santiago name: Complejo Hospitalario Universitario de Vigo briefSummary: The aim of the study is to evaluate technical, clinical and safety outcomes of lumen-apposing metal stent (LAMS) with a coaxial double-pigtail plastic stent (DPS) in EUS-guided choledochoduodenostomies vs cholcystogastrostomy for the management of malignant biliary obstruction in palliative patients. conditions: Malignant Biliary Obstruction conditions: Biliary Tract Neoplasms conditions: Pancreatic Cancer Non-resectable studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 128 type: ESTIMATED name: Endoscopic biliary drainage name: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS) name: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS) measure: SAFETY (ADVERSE EVENTS) measure: Recurrent biliary obstruction measure: CLINICAL SUCCESS measure: TECHNICAL SUCCESS measure: BILIARY REINTERVENTIONS (BRI) measure: HOSPITAL STAY measure: MORTALITY measure: COST ANALYSIS sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitari de Bellvitge city: L'Hospitalet De Llobregat state: Barcelona, Catalonia zip: 08907 country: Spain name: Joan B Gornals, PhD role: CONTACT phone: +34 93 260 76 82 phoneExt: 2624 email: jgornals@bellvitgehospital.cat name: Julia Escuer Turu, MD role: CONTACT phone: +34 618 27 28 24 email: jescuer@bellvitgehospital.cat name: Maria Puigcerver Mas, MD role: SUB_INVESTIGATOR name: Sandra Maisterra, MD role: SUB_INVESTIGATOR name: Albert Garcia-Sumalla, MD role: SUB_INVESTIGATOR name: Julio G Velasquez-Rodriguez, MD role: SUB_INVESTIGATOR name: Daniel Luna-Rodriguez, MD role: SUB_INVESTIGATOR name: Carme Loras, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Charly Guarner Argente, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Juan J Vila, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Jose R Aparicio, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Jose Lariño, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Rafa Pedraza, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Antonio Rodriguez D'Jesus, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Alberto Alvarez, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Vicente Sanchiz, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.35967 lon: 2.10028 hasResults: False

 nctId: NCT06375954 id: CARPEDIEM-2 briefTitle: EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-06-01 date: 2027-05-01 date: 2024-04-19 date: 2024-04-19 name: Hospital Universitari de Bellvitge class: OTHER name: Hospital Mutua de Terrassa name: Hospital Clínico Universitario de Valencia name: Hospital General Universitario de Alicante name: Hospital Universitario Ramon y Cajal name: Hospital General Universitario de Castellón name: Hospital Álvaro Cunqueiro name: Complejo Hospitalario Universitario de Santiago name: University Hospital Virgen de las Nieves name: Complejo Hospitalario de Navarra name: Hospital de Sant Pau name: University of Salamanca briefSummary: The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and chemotherapy start in patients with borderline distal malignant biliary obstruction. conditions: Malignant Biliary Obstruction conditions: Pancreatic Cancer conditions: Biliary Tract Neoplasms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 96 type: ESTIMATED name: Endoscopic biliary drainage name: Self-expandable metallic stent (SEMS) name: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS) measure: Delay in days between endoscopic biliary drainage and chemotherapy treatment start measure: Technical success measure: Clinical success measure: AE - biliary drainage measure: AE - surgery measure: Delay in days between endoscopic biliary drainage and cephalic duodenopancreatectomy (CDP) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitari de Bellvitge city: L'Hospitalet de Llobregat state: Barcelona zip: 08907 country: Spain name: Joan B Gornals, MD, PhD role: CONTACT phone: + 34 93 260 7682 phoneExt: 2624 email: jgornals@bellvitgehospital.cat name: Maria Puigcerver-Mas, MD role: CONTACT phone: +34 687332007 email: mariapuigcervermas@gmail.com name: Julia Escuer, MD role: SUB_INVESTIGATOR name: Sandra Maisterra, MD role: SUB_INVESTIGATOR name: Julio G Velasquez-Rodriguez, MD role: SUB_INVESTIGATOR name: Albert Garcia-Sumalla, MD role: SUB_INVESTIGATOR name: Daniel Luna-Rodriguez, MD role: SUB_INVESTIGATOR name: Berta Laquente, MD, PhD role: SUB_INVESTIGATOR name: Juli Busquets, MD, PhD role: SUB_INVESTIGATOR name: Carme Loras, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Juan J Vila, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Jose Lariño, MD, PhD role: PRINCIPAL_INVESTIGATOR name: VIcente Sanchiz, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Jose R Aparicio, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Eduardo Redondo, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Charly Guarner-Argente, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Antonio Rodriguez D'Jesus, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Alberto Alvarez, MD, pHD role: PRINCIPAL_INVESTIGATOR lat: 41.35967 lon: 2.10028 hasResults: False

 nctId: NCT06375941 id: ProStars briefTitle: Prospective Observational Study of Localized Angiosarcoma of Any Site: ProStars acronym: ProStars overallStatus: RECRUITING date: 2024-03-29 date: 2029-04-01 date: 2034-04-01 date: 2024-04-19 date: 2024-04-19 name: Italian Sarcoma Group class: NETWORK briefSummary: This study will be a multi-institutional, prospective, observational study of patients with localized primary AS of any site within ISG and RTR centers. Patients will be treated according to clinical practice of the center and according to ISG clinical recommendations on localized AS. conditions: Angiosarcoma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Observational measure: Demographic characteristics measure: General characteristics measure: Cancer data measure: Origin of Tumor measure: Tumor characteristics measure: Tumor size measure: Tumor aspects measure: Pathological characteristics measure: Tumor phenotype measure: Molecular characteristics sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Istituto Nazionale Tumori - Milano status: RECRUITING city: Milano zip: 20133 country: Italy name: Palassini Elena role: CONTACT lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06375928 id: CARPEDIEM-1 briefTitle: EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction in Resectable Disease (CARPEDIEM-1 Trial) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-02-01 date: 2026-05-01 date: 2024-04-19 date: 2024-04-19 name: Hospital Universitari de Bellvitge class: OTHER name: Hospital Mutua de Terrassa name: Hospital Clínico Universitario de Valencia name: Hospital General Universitario de Alicante name: Hospital Universitario Ramon y Cajal name: Hospital General Universitario de Castellón name: Hospital Álvaro Cunqueiro name: Complejo Hospitalario Universitario de Santiago name: University Hospital Virgen de las Nieves name: Complejo Hospitalario de Navarra name: Hospital de Sant Pau name: University of Salamanca briefSummary: The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and surgery in patients with resectable distal malignant biliary obstruction. conditions: Malignant Biliary Obstruction conditions: Pancreatic Cancer Resectable conditions: Biliary Tract Neoplasms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 44 type: ESTIMATED name: Endoscopic biliary drainage name: Self-expandable metallic stent (SEMS) name: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS) measure: Delay in days between endoscopic biliary drainage and cephalic duodenopancreatectomy (CDP) measure: Technical success measure: Clinical success measure: AE - biliary drainage measure: AE - surgery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitari de Bellvitge city: L'Hospitalet de Llobregat state: Barcelona, Catalonia zip: 08907 country: Spain name: Joan B Gornals, MD, PhD role: CONTACT phone: +34 93 260 76 82 phoneExt: 2624 email: jgornals@bellvitgehospital.cat name: Maria Puigcerver-Mas, MD role: CONTACT phone: +34 687332007 email: mariapuigcervermas@gmail.com name: Julia Escuer-Turu, MD role: SUB_INVESTIGATOR name: Daniel Luna Rodriguez, MD role: SUB_INVESTIGATOR name: Albert Sumalla, MD role: SUB_INVESTIGATOR name: Berta Laquente, MD, PhD role: SUB_INVESTIGATOR name: Juli Busquets, MD, PhD role: SUB_INVESTIGATOR name: Julio Velasquez Rodriguez, MD role: SUB_INVESTIGATOR name: Sandra Maisterra, MD role: SUB_INVESTIGATOR name: Carme Loras, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Charly Guarner Argente, MD, PHD role: PRINCIPAL_INVESTIGATOR name: Jose Lariño, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Rafael Pedraza, MD role: PRINCIPAL_INVESTIGATOR name: Jose Ramon Aparicio, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Vicente Sanchiz, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Eduardo Redondo, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Juan J Vila, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.35967 lon: 2.10028 hasResults: False

 nctId: NCT06375915 id: PM-CARE id: PNRR-MAD-2022-12375905 type: OTHER_GRANT domain: Italian Ministry of Health briefTitle: Precision Medicine in Patients With Unresectable CholAngiocarcinoma: RadioEmbolization and Combined Biological Therapy acronym: PM-CARE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-01 date: 2026-01 date: 2024-04-19 date: 2024-04-19 name: Francesco De Cobelli class: OTHER name: Cardarelli Hospital name: A.O. Ospedale Papa Giovanni XXIII name: AOU Pisana, Pisa, Italy briefSummary: Underlying disease mechanisms are fundamental for correct treatment selection and patient management in highly invasive and debilitating non-transmissible diseases. Even though overall disease burden of cancer may have decreased due to a higher degree of awareness, the availability of high-quality healthcare and early diagnosis may become challenging in certain neoplasms. Cholangiocarcinoma is usually diagnosed at advanced stages due to non-specific presentation and is frequently refractory to chemotherapy, causing a massive impact on patients and their families. Surgery is currently the only curative treatment but is available to only approximately 30% of patients. The combination of interventional- and immune-oncology to standard of care creates the perfect substrate for synergistic mechanisms to fight tumor growth; in situ cell death following transarterial embolization(TARE) elicits immune mediated response, inflammatory response and biomarkers of oxidative stress and increases antigen presenting T-cells which an anti-anti progam death ligand (PD-L)1 can bind to; standard of care can then add on with its known effects.The rationale of a combined- locoregional and systemic - treatment lies in the synergistic effects of each of the treatments. conditions: Intrahepatic Cholangiocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: radioembolization with Y-90 name: Durvalumab name: Cisplatin name: Gemcitabine measure: Overall response rate (ORR) measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 measure: Median progression free survival measure: Overall response rate measure: Overall response rate measure: Overall response rate measure: Overall response rate measure: Tumor circulating markers tumor tissue-based markers tumor circulating markers tumor tissue-based markers measure: Tumor circulating markers measure: Tumor tissue based evaluation measure: Tumor tissue-based markers tumor tissue-based markers tumor circulating markers tumor tissue-based markers measure: Tumor tissue-based markers tumor tissue-based markers tumor circulating markers tumor tissue-based markers measure: Tumor tissue-based markers tumor circulating markers tumor tissue-based markers measure: Tumor tissue-based markers tumor circulating markers tumor tissue-based markers measure: Tumor tissue-based markers tumor circulating markers tumor tissue-based markers measure: Tumor tissue-based markers tumor circulating markers tumor tissue-based markers measure: Quantitative imaging based biomarkers measure: Quantitative biomarkers measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Radiology, IRCCS Ospedale San Raffaele city: Milano zip: 20132 country: Italy name: Francesco De Cobelli, MD role: CONTACT phone: +39022643 phoneExt: 2529 email: decobelli.francesco@hsr.it name: Stephanie Steidler, PhD role: CONTACT phone: +39022643 phoneExt: 6111 email: steidler.stephanie@hsr.it name: Francesco De Cobelli, MD role: PRINCIPAL_INVESTIGATOR name: Francesca Ratti, MD role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06375902 id: 2022289RNA briefTitle: The Fragility of Metaphors (FraMe): Learning, Loosing, and How to Train Them acronym: FRAME overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-10 date: 2025-10 date: 2024-04-19 date: 2024-04-19 name: IRCCS San Raffaele class: OTHER briefSummary: Tracking down the difficulties in metaphor comprehension experienced by individuals with schizophrenia across different metaphor types and exploring the neurological correlates via EEG recording technique conditions: Schizophrenia; Psychosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 64 type: ESTIMATED name: PragmaCom measure: Tracking down the difficulties in metaphor comprehension via a behavioural task measure: Tracking down the difficulties in metaphor comprehension via task during electrophysiological recording measure: Evaluation of psychopathology measure: Evaluation of cognition measure: Evaluation of Theory of Mind measure: Evaluation of functioning measure: Evaluate the efficacy of a rehabilitative training in restoring metaphor comprehension ability sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06375889 id: 69HCL24_0250 id: 2024-A00796-41 type: OTHER domain: ID-RCB briefTitle: Platelet Activation in Delayed Cerebral Ischemia Secondary to Aneurysmal Subarachnoid Hemorrhage acronym: APICRASH overallStatus: NOT_YET_RECRUITING date: 2024-05-13 date: 2025-06-13 date: 2025-06-13 date: 2024-04-19 date: 2024-04-19 name: Hospices Civils de Lyon class: OTHER briefSummary: Aneurysmal subarachnoid haemorrhage is a complex pathology, the pathophysiology of which is still imperfectly understood. Its morbidity and mortality remain significant. In addition to the damage sustained by the brain in the immediate aftermath of aneurysmal rupture, which is inaccessible to life-saving treatment, a significant proportion of lesions occur at a distance from the initial event. Delayed cerebral ischaemia is one of the most morbid complications. It combines an inflammatory pattern with vascular dysfunction and neuronal excitotoxicity, leading to avoidable secondary neuronal loss.

Vascular dysfunction is mediated by a loss of homeostasis between endothelial cells and figurative blood cells, including platelets. However, the interrelationship between these elements and the precise chronology of the dysfunction remain imperfectly described to date.

It therefore seems appropriate to propose temporal monitoring of platelet activation kinetics over time, combined with concomitant collection of markers of endothelial damage, in order to clarify the vascular chronobiology of this pathology. conditions: Aneuvrysmal Subarachnoid Hemorrhage conditions: Delayed Cerebral Ischemia conditions: Endotheliopathy conditions: Platelets Kinetic studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: blood test measure: The difference in the percentage of platelets expressing P-selectin, reflecting their irreversible activation. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anaesthesiology and Intensive Care medicine department, Pierre Wertheimer hospital city: Bron state: Auvergne-Rhône-Alpes zip: 69005 country: France name: Nicolas Chardon, MD;Msc role: CONTACT phone: 683396245 phoneExt: 33 email: nicolas.chardon@chu-lyon.fr name: Nicolas Chardon, MD;msc role: PRINCIPAL_INVESTIGATOR lat: 45.73333 lon: 4.91667 facility: Neurovascular intensive care unit department, Pierre Wertheimer hospital city: Bron state: Auvergnes-Rhones-Alpes zip: 69005 country: France name: Nicolas Chardon, MD;Msc role: CONTACT phone: 683396245 phoneExt: 33 email: nicolas.chardon@chu-lyon.fr name: Nicolas Chardon, MD;Msc role: PRINCIPAL_INVESTIGATOR lat: 45.73333 lon: 4.91667 hasResults: False

 nctId: NCT06375876 id: 2000034173 id: 15JOVW-22-GG-04755-STOP type: OTHER_GRANT domain: Office on Violence Against Women (OVW) briefTitle: Single Session Intervention to Promote Hope overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-19 date: 2024-04-26 name: Yale University class: OTHER name: Office on Violence Against Women (OVW) briefSummary: The purpose of this study is to develop a brief, self-guided single-session intervention (SSI) that targets the development of, or increase in, hope, and pilot test it for the primary outcomes of feasibility, acceptability/likeability, safety, and changes in hope, and the secondary outcomes of self-worth, empowerment, and emotional wellbeing among women experiencing intimate partner violence (IPV). The study will be conducted in 2 stages: intervention development (Intervention Development Stage), and pilot testing the intervention (Pilot Stage). The focus of this registration is the Pilot Stage. conditions: Domestic Violence studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 65 type: ESTIMATED name: Single-session intervention (SSI) measure: Feasibility assessed by percent enrolled measure: Feasibility assessed by time to complete measure: Feasibility assessed by post-intervention survey/process supplement measure: Acceptability/likability assessed using the Program Feeback Scale measure: Safety assessed using end of study survey measure: Change in Hope assessed using Herth Hope Index measure: Change in Hope assessed using Trait Hope Scale measure: Change in Hope assessed using Beck Hopelessness Scale (single item) measure: Change in Self-worth measure: Change in Empowerment assessed using The Personal Progress Scale-Revised (PPS-R) measure: Change in Emotional wellbeing measured by the Patient Health Questionnaire-2 (PHQ-2) measure: Change in Emotional wellbeing measured by the State Joy Scale sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Consultation Center at Yale city: New Haven state: Connecticut zip: 06511 country: United States name: Ashley Clayton role: CONTACT phone: 203-623-9830 email: ashley.clayton@yale.edu lat: 41.30815 lon: -72.92816 hasResults: False

 nctId: NCT06375863 id: 44-2023 briefTitle: QT Changes in Geriatric Patients: a Comparison of Spinal and General Anesthesia overallStatus: COMPLETED date: 2023-03-29 date: 2023-05-29 date: 2023-05-29 date: 2024-04-19 date: 2024-04-19 name: Haseki Training and Research Hospital class: OTHER briefSummary: QT interval, defined as the time between the beginning of the QRS complex and the end of the T wave in electrocardiography (ECG), is an indicator of depolarization and repolarization of the myocardium.11 Prolongation of the heart rate corrected QT (QTc) interval reflects electrical instability of ventricles and is associated with life-threatening ventricular arrhythmias, including torsade de pointes, ventricular fibrillation and sudden cardiac death.

Spinal anesthesia can cause profound prolongation of the QTc interval due to disparity between lumbar and thoracic sympathetic activity following subarachnoid block. Meanwhile inhalational anesthetics, sevoflurane, isoflurane, and desflurane are known to prolong QTc interval and intravenous anesthetics such as propofol, thiopental, etomidate and ketamin can also cause remarkable prolongation of the QTc interval. Moreover laryngoscopy and intubation may contribute to prolongation of the QTc interval because of the sympathetic stimulation.

Over the years it has been occurred an increase in the proportion of elderly population requiring surgical anesthesia. The incidence of ventricular arrhythmias increases in advancing age even in the absence of underlying heart disease and elderly patients have reduced physiological functions and poor tolerance to anesthesia. However the choice of anesthesia type is critical in this population.

To the best of knowledge, there was no published study to compare spinal anesthesia and inhalational anesthesia in elderly patients with regard to the QT interval changes. Investigators aimed to investigate the effects of spinal anesthesia on QT, QTc intervals and to compare general anesthesia with sevofluran in elderly patients. conditions: Anesthesia, Spinal conditions: Sevoflurane conditions: Long QT Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 58 type: ACTUAL name: QT and QTc interval measure: QTc interval measure: QT sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Health Science University, Haseki Training and Research Hospital city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06375850 id: Effects of topical sesame oil briefTitle: Effects of Topical Sesame Oil in the Prevention of Peripheral Venous Catheter Phlebitis: Clinical Trial. overallStatus: RECRUITING date: 2022-06-05 date: 2025-02-11 date: 2025-05-11 date: 2024-04-19 date: 2024-04-19 name: Hospital Universitario Marqués de Valdecilla class: OTHER briefSummary: Cancer is a disease that, despite having a higher cure rate, is currently on the rise, with an increase in the number of diagnoses.

For the treatment of these patients a venous access is required, which in the first treatments is of peripheral insertion. These peripheral venous catheter in combination with the highly aggressive treatments for the veins are the cause of the appearance of chemical phlebitis.

Phlebitis is an inflammation caused by a combination of factors, whether chemical, perfusion of irritating medication; mechanical, due to the puncture site, type and fixation of the catheter and infectious, caused by the colonization of pathogenic agents whose origin is the skin and that migrate inward.

Phlebitis involves an injury to the wall of the vein, and consequently, the patient will also be at risk of thrombus formation, which in turn leads to thrombophlebitis, deep vein thrombosis or pulmonary embolism.

The existence of phlebitis involves intense and constant pain, with increased sensitivity and a sensation of heat and swelling.

With the use of topical sesame oil, and thanks to its anti-inflammatory properties, the investigators intend to study whether it is effective in preventing the appearance of phlebitis. conditions: Phlebitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 300 type: ESTIMATED name: Sesame oil name: Saline solution measure: Number of phlebitis in oncology patients with peripheral catheter to whom sesame oil is applied topically measure: Other adverse effects that appear in relation to the topical application of sesame oil in patients with peripheral catheters sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario Marqués de Valdecilla status: RECRUITING city: Santander state: Cantabria zip: 39008 country: Spain name: Virginia Meneses Campos role: CONTACT phone: +34942202520 email: virginia.meneses@scsalud.es name: Virginia Meneses Campos role: PRINCIPAL_INVESTIGATOR lat: 43.46472 lon: -3.80444 hasResults: False

 nctId: NCT06375837 id: bioactive-NCCLs briefTitle: Comparative Evaluation of an Alkasite-based Restorative Material and Two Different Resin Composites overallStatus: RECRUITING date: 2024-04-15 date: 2024-06-15 date: 2026-06-15 date: 2024-04-19 date: 2024-04-19 name: Hacettepe University class: OTHER briefSummary: The clinical performance of an an alkasite-based restorative material and two different resin composites will be evaluated and compared in non-carious cervical lesions. After recruiting participants with at least three non-carious cervical lesions, all restorations will be placed by a single clinician. Lesions will be divided in three groups: an alkasite-based restorative material (Cention N, Ivoclar Vivadent, Schaan, Liechtenstein (CN)), hybrid resin composite (Gradia Direct Anterior, GC, Tokyo, Japan (GD)) and a highly filled flowable resin composite ((G-aenial Universal Flo, GC, Tokyo, Japan (GF)). All restorative procedures will be conducted according to manufacturers' instructions. Restorations will be scored using FDI criteria. Descriptive statistics will be performed using chi-square tests. conditions: Tooth Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 33 type: ESTIMATED name: an alkasite-based restorative material name: hybrid resin composite name: a highly filled flowable resin composite measure: Clinical performances of different restorative systems according to FDI criteria (Esthetic properties) measure: Clinical performances of different restorative systems according to FDI criteria (Functional properties) measure: Clinical performances of different restorative systems according to FDI criteria (Biological properties) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hacettepe University status: RECRUITING city: Ankara country: Turkey name: Fatma Oz role: CONTACT lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06375824 id: TCM for Pre-COPD briefTitle: Bufei Recipe Reduces the Incidence Rate of COPD overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04-30 date: 2027-10-31 date: 2024-04-19 date: 2024-04-19 name: Henan University of Traditional Chinese Medicine class: OTHER name: West China Hospital name: The First Affiliated Hospital of Zhejiang Chinese Medical University briefSummary: Establish early TCM prevention and treatment program to reduce the incidence rate of COPD. conditions: Preserved Ratio Impaired Spirometry studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 1100 type: ESTIMATED name: Bufei Recipe name: Bufei Recipe placebo measure: Incidence rate of COPD measure: FVC measure: FEV1 measure: FEV1% pred measure: FEV1/FVC measure: IPAG-Q measure: LFQ measure: COPD-PS measure: CAT measure: SF-36 measure: Clinical symptoms measure: Biochemical indicators sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06375811 id: 2000027121_temp briefTitle: Pre-IVF Treatment With a GnRH Antagonist in Women With endometriosis_temp acronym: PREGnant overallStatus: RECRUITING date: 2024-03-16 date: 2026-06-30 date: 2026-06-30 date: 2024-04-19 date: 2024-04-23 name: Yale University class: OTHER name: University of Colorado, Denver name: Northwestern University name: University of North Carolina name: Duke University name: Johns Hopkins University briefSummary: A Phase 3 clinical trial of oral GnRH antagonist pre-treatment for women with endometriosis who are undergoing IVF, with a primary outcome of live birth rate. The investigators' central hypothesis is that in infertile woman with endometriosis undergoing in vitro fertilization-embryo transfer (IVF-ET), live birth rates will improve in those pretreated with GnRH antagonist compared to those not pretreated with GnRH antagonist. conditions: Infertility conditions: Endometriosis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Half of the subjects (200, randomized or not randomized) will receive elagolix 200mg twice a day (BID) and the other half of subjects will receive placebo BID or SOC IVF (200, placebo or SOC IVF). Elagolix or placebo will be taken for a minimum of 60 days before IVF cycle start. For convenience of IVF cycle scheduling, participants may receive up to an additional 14 days of intervention (elagolix or placebo) beyond the minimum 60 days of pre-IVF treatment, such that the last dose of study intervention (elagolix or placebo) is received no more than 24 hours before start of IVF treatment protocol. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: For participants who agree to be randomized, a computer-generated randomization list will be created by the PREGnant Data Coordinating Center (DCC) and randomization will be performed prior to the first dose of elagolix. Randomization will have random sizes (2, 4, or 6) of blocks and be stratified by site, i.e. whole blocks are assigned to sites. The randomization list will not be available to any person involved in the conduct and evaluation of the trial until the trial is complete and database is declared clean and is released by the DCC. Likewise, treatment allocation information will not be accessible to investigators (except for serious safety concerns), trial staff at the site or central laboratory personnel during the trial. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 288 type: ESTIMATED name: Elagolix 200 MG name: Placebo or SOC IVF measure: Live birth rate measure: Fertilization rate measure: Number of embryos transferred measure: Implantation rate measure: Biochemical pregnancy rate measure: Clinical pregnancy rate measure: Miscarriage rate measure: Overall pregnancy complication rate measure: Gestation age at delivery measure: Infant birth weight sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: University of Colorado Department of Obstetrics & Gynecology status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Katherine Kuhn role: CONTACT phone: 303-724-5276 email: katherine.kuhn@cuanschutz.edu name: Nanette Santoro role: PRINCIPAL_INVESTIGATOR lat: 39.72943 lon: -104.83192 facility: Yale School of Medicine Dept.of Ob/Gyn & Reproductive Sciences status: RECRUITING city: New Haven state: Connecticut zip: 06520 country: United States name: Michele Frank role: CONTACT phone: 203-785-6949 email: michele.frank@yale.edu name: Hugn Taylor role: PRINCIPAL_INVESTIGATOR lat: 41.30815 lon: -72.92816 facility: Northwestern University Department of Obstetrics and Gynecology status: RECRUITING city: Chicago state: Illinois zip: 60611 country: United States name: Jessica Almgren-Bell role: CONTACT phone: 312-503-4118 email: jessica.almgrenbell@nm.org name: Emily Jungheim role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: Johns Hopkins, Division of Reproductive Science and Women's Health Research status: RECRUITING city: Baltimore state: Maryland zip: 21205 country: United States name: Gaelle Massoud, role: CONTACT phone: 410-583-2763 email: gmassou1@jhmi.edu name: James Segars role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 facility: Duke Fertility status: RECRUITING city: Morrisville state: North Carolina zip: 27560 country: United States name: Tifani Panek role: CONTACT phone: 773-706-4202 email: tifani.panek@duke.edu name: Steven Young role: PRINCIPAL_INVESTIGATOR lat: 35.82348 lon: -78.82556 hasResults: False

 nctId: NCT06375798 id: 2020137 briefTitle: Clinical Study of Breast Conserving Surgery Combined With Intraoperative Radiotherapy for Early Breast Cancer overallStatus: RECRUITING date: 2020-11-19 date: 2026-11-19 date: 2026-11-19 date: 2024-04-19 date: 2024-04-19 name: Hebei Medical University Fourth Hospital class: OTHER briefSummary: A Single-center, open, prospective study，for analyzing the local recurrence rate, the incidence of incision complications and the aesthetic effect of intraoperative radiotherapy in early breast cancer patients after breast-conserving surgery. conditions: Breast Cancer conditions: HER2-negative Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 620 type: ESTIMATED name: radiotherapy measure: LRFS sex: FEMALE minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Fourth Hospital of Hebei Medical University status: RECRUITING city: Shijiazhuang state: Hebei country: China name: qimei wang, attending role: CONTACT phone: 18633051639 email: maggie92320@hotmail.com lat: 38.04139 lon: 114.47861 hasResults: False

 nctId: NCT06375785 id: LSVT-BIG vs Otago briefTitle: Two Different Exercise Methods in Geriatrics overallStatus: COMPLETED date: 2023-03-01 date: 2023-06-01 date: 2024-03-01 date: 2024-04-19 date: 2024-04-23 name: Halic University class: OTHER name: Fenerbahce University name: Istanbul Galata University name: Biruni University briefSummary: The aim of the study is to compare slow rhythmic exercises with large amplitude exercises in elderly people conditions: Elderly People conditions: Nursing Homes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 70 type: ACTUAL name: Otago-based (slow rhythmic) exercise group name: LSVT BIG-based (large amplitude) exercise group measure: Timed Up &Go Test measure: Performanz Balance System measure: Functional Reaching Test measure: Six Minute Walking Test measure: Tinetti Balance and Gait Assessment measure: Activity-Specific Balance and Confidence Scale measure: Five Times Sit to Stand measure: Montreal Cognitive Assessment Test measure: KATZ Activities of Daily Living Scale measure: Clinical Frailty Scale sex: ALL minimumAge: 65 Years maximumAge: 80 Years stdAges: OLDER_ADULT facility: Haliç University city: Istanbul state: Eyüpsultan country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06375772 id: 2-DG-02 briefTitle: A Controlled Human Rhinovirus Infection Study of 2-Deoxy-D-Glucose in Healthy Adults overallStatus: RECRUITING date: 2024-04-02 date: 2024-08-31 date: 2024-12-31 date: 2024-04-19 date: 2024-04-19 name: G.ST Antivirals GmbH class: INDUSTRY briefSummary: 2-DG-02 is a randomized, placebo-controlled, double-blind Phase 2 study to investigate the efficacy and safety of 2-Deoxy-D-Glucose as a pre-exposure prophylaxis using the rhinovirus challenge model in healthy study participants. conditions: Acute Nasopharyngitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 128 type: ESTIMATED name: 2-Deoxy-D-glucose name: Placebo measure: The difference in the rate of rhinovirus-associated illness between 2-DG and placebo measure: Number of infected subjects measure: Difference in percent of infected subjects measure: Difference in percent of days virus positive measure: Difference in peak nasal virus load measure: Difference in AUC nasal virus load measure: Difference in Total Jackson Symptom Score measure: Duration of illness measure: Difference in percent of days Jackson Symptom Score positive measure: Difference in Peak Jackson Symptom Score measure: Difference in peak total WURSS-21 measure: Difference in AUC total WURSS-21 measure: Occurrence of adverse events (AEs) and adverse drug-reactions (ADRs) measure: Biodistribution of multiple doses of 2-DG in plasma samples measure: Biodistribution of multiple doses of 2-DG in nasal wash samples sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: Centre for Human Drug Research status: RECRUITING city: Leiden zip: 2333 country: Netherlands name: Ingrid de Visser- Kamerling, PhD role: CONTACT phone: +31 71 5246400 email: clintrials@chdr.nl lat: 52.15833 lon: 4.49306 hasResults: False

 nctId: NCT06375759 id: XWSSB briefTitle: Subarachnoid-Subarachnoid (S-S) Bypass Versus Adhesion Lysis in Spinal Arachnoiditis and Syringomyelia overallStatus: RECRUITING date: 2024-04 date: 2025-04 date: 2027-04 date: 2024-04-19 date: 2024-04-19 name: Xuanwu Hospital, Beijing class: OTHER briefSummary: To determine whether Subarachnoid-Subarachnoid (S-S) Bypass results in better patient outcomes with fewer complications and improved quality of life compared to intradural adhesion lysis in individuals with Spinal Arachnoiditis and Syringomyelia. conditions: Syringomyelia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Subarachnoid-Subarachnoid (S-S) Bypass name: Intradural Adhesion Lysis measure: complication measure: improvement or resolution of the syrinx, measure: ASIA score measure: Klekamp and Sammi syringomyelia scale measure: modified Japanese Orthopaedic Association Scores (mJOA) measure: xuanwu syringomyelia scale sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fengzeng Jian status: RECRUITING city: Beijing state: Beijing zip: 100053 country: China name: Yuan Chenghua role: CONTACT email: yuanchenghua@ccmu.edu.cn name: Jian Fengzeng role: CONTACT email: jianfengzeng@xwh.ccmu.edu.cn name: jian guan, dr role: SUB_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06375746 id: 0091-22-WOMC briefTitle: The Impact of a Customized Informative Video Prior to Induction of Labor on Anxiety Relieve - a Randomized Controlled Trial overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-01 date: 2024-08-31 date: 2024-04-19 date: 2024-04-19 name: Wolfson Medical Center class: OTHER_GOV briefSummary: To determine whether watching a personalized video prior to medically indicated labor induction among term parturients reduces anxiety levels according to the STAI questionnaire, compared to a standard counselling. conditions: Induction of Labor Affected Fetus / Newborn studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 180 type: ESTIMATED name: Personalized video measure: STAI questionnaire score measure: satisfaction questionnaire sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06375733 id: GFH009X1202 briefTitle: A Study of GFH009 in Combination With Zanubrutinib in Subjects With Relapsed or Refractory DLBCL overallStatus: RECRUITING date: 2024-03-20 date: 2026-12-31 date: 2026-12-31 date: 2024-04-19 date: 2024-04-19 name: Zhejiang Genfleet Therapeutics Co., Ltd. class: INDUSTRY briefSummary: This is a multicentre, open-label phase Ib/II study. The purpose of the study is to assess the safety and efficacy of GFH009 in combination with Zanubrutinib in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) conditions: Large B-cell Lymphoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 51 type: ESTIMATED name: GFH009 name: Zanubrutinib name: GFH009 name: Zanubrutinib measure: Phase Ib: adverse events(AEs) measure: Phase II: ORR sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangxi Medical University Cancer Hospital&Guangxi Cancer Institute status: RECRUITING city: Nanning country: China name: Cen Hong role: CONTACT lat: 22.81667 lon: 108.31667 facility: Affiliated Cancer Hospital of Zhengzhou University Henan Cancer Hospital status: RECRUITING city: Zhengzhou country: China name: Keshu Zhou role: CONTACT lat: 34.75778 lon: 113.64861 hasResults: False

 nctId: NCT06375720 id: FujianUTCM-2 briefTitle: Efficacy of Different Doses of Tai Chi Chuan on Cognitive Function in Persons With Mild Cognitive Impairment overallStatus: NOT_YET_RECRUITING date: 2024-05-05 date: 2025-06-15 date: 2025-12-15 date: 2024-04-19 date: 2024-04-19 name: Lidian Chen class: OTHER name: Peking University Third Hospital briefSummary: To determine the relationship between the effects of different frequencies and duration of Tai Chi Chuan in dose parameters to improve cognitive function in elderly persons with mild cognitive impairment. conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 350 type: ESTIMATED name: Lower frequency, shorter period of Tai Chi Chuan name: Higher frequency, shorter period of Tai Chi Chuan name: Lower frequency, longer period of Tai Chi Chuan name: Higher frequency, longer period of Tai Chi Chuan name: Standard Health Education measure: Montreal Cognitive Assessment measure: Montreal Cognitive Assessment measure: Wechsler Memory Scale measure: Digit Symbol Substitution Test measure: Trial Making Test part B measure: Stroop Color Word Test measure: Boston Naming Test measure: Rey-Osterrieth Complex Graphics Test measure: Rey Auditory Verbal Learning Test measure: The Pittsburgh Sleep Quality Index (PSQI) measure: 12-Item Short Form Health Survey measure: Blood glucose metabolism index measure: Blood lipid metabolism index measure: functional Magnetic Resonance Imaging measure: Electroencephalogram measure: Heart rate variability measure: Gut microflora sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06375707 id: HERO-KC23 briefTitle: Efficacy and Safety of Ribociclib in Combination With NSAI Versus Physician's Choice of Chemotherapy Sequential Endocrine Therapy in HR+/HER2- Advanced Breast Cancer overallStatus: RECRUITING date: 2024-01-09 date: 2025-11 date: 2025-12 date: 2024-04-19 date: 2024-04-19 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER name: Zhejiang Cancer Hospital briefSummary: Evaluate the efficacy and safety of Ribociclib in combination with NSAI versus physician's choice of chemotherapy sequential endocrine therapy in HR+/HER2- advanced breast cancer. conditions: Advanced Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 144 type: ESTIMATED name: physician's choice of chemotherapy sequential Ribociclib combined with NSAI±OFS name: Ribociclib combined with NSAI±OFS measure: Progression Free Survival measure: Progression Free Survival2 measure: Time to treatment failure measure: Overall response rate (ORR) measure: Overall survival(OS) measure: Time To Response (TTR) measure: Clinical benefit rate(CBR) measure: Change from baseline in the global health status/QOL scale score by using FACT-B questionnaire measure: Frequency/severity of adverse events, lab abnormalities sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jiangsu Provincial People's Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210000 country: China name: Wei Li, Ph.D role: CONTACT phone: 025-68306360 email: real.lw@163.com name: Wei Li, Ph.D role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06375694 id: IRB00025485 briefTitle: Probiotic Effect on Dietary Nitrate to Plasma Nitrite Production ( OPEDNPN ) acronym: OPEDNPN overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-05 date: 2025-05 date: 2024-04-19 date: 2024-04-19 name: Wake Forest University class: OTHER name: University of South Florida briefSummary: Nitric Oxide (NO) is an important molecule that is produced naturally in the body and that helps maintain healthy blood flow. Low availability of NO contributes to many diseases while administration of NO is therapeutic.

In addition to being made naturally in the body, NO can be obtained through the diet via the Nitrate-Nitrite-NO cycle. Nitrate, which is abundant in green leafy vegetables and beetroot juice, is partially converted to nitrite by oral bacteria. The nitrate and nitrite are taken up into the blood and nitrite is converted into NO. Remaining nitrate in the blood is taken back up into the mouth by salivary glands and the cycle continues. Emerging studies suggest that the Nitrate-Nitrite-NO cycle may contribute to cardiovascular health. In addition, there have been many studies where dietary nitrate is given to increase NO and treat various conditions.

The current study rests on the premise that the quality of the oral microbiome plays a major role in the Nitrate-Nitrite-NO cycle and hence cardiovascular health and the efficacy of dietary nitrate interventions. Investigators have begun to identify oral bacterial species that are effective nitrite producers as well as though that are nitrite depleters (those that interfere with nitrite production from nitrate).

In laboratory experiments, certain bacterial species have been shown to block nitrate to nitrite conversion by other oral bacteria. These nitrite depleting species are found in a commercially available oral probiotic designed to improve oral health. The purpose of this study is to examine if use of the probiotic negatively affects the Nitrate-Nitrite-NO cycle. Nitrate to Nitrite conversion will be assessed by measuring plasma levels of nitrite before and after consumption of nitrate-rich beetroot juice. Dietary nitrate to plasma nitrite conversion will assessed at baseline and after one week of consumption of the probiotic or a placebo (follow-up). The primary hypothesis of this study is that participants that consume the probiotic will have lower nitrate to nitrite conversion at follow-up compared to baseline and that there will be no significant change in nitrate to nitrite conversion between baseline and follow-up for participants who consume the placebo.

While this study does not aim to treat any specific disease, it is intended to elucidate a basic physiological function that may be relevant to cardiovascular health and certain NO-based therapeutics. conditions: Hypertension conditions: Cardiovascular Diseases conditions: Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized into two groups with one group receiving the oral probiotic and the other receiving the placebo. Each group will take their intervention 2X a day for 7 days. primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Participants will not know which group they are in. The lozenges will be distributed in unmarked bottles whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: Herbiotics Oral + Ent Probiotic measure: Dietary Nitrate Conversion to Plasma Nitrite measure: Percentage Lactobaciluus sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06375681 id: 2019-1378: R01 id: 1R01AG076157-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01AG076157-01 id: A487400 type: OTHER domain: UW Madison briefTitle: Effectiveness of Cognitive Training in Older and Younger Adults overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-01 date: 2028-01 date: 2024-04-19 date: 2024-04-19 name: University of Wisconsin, Madison class: OTHER name: National Institute on Aging (NIA) briefSummary: The proposed study will enroll 1600 participants to examine the effectiveness of cognitive training. Participants will be randomized into different experimental groups and can expect to participate for up to 15 hours of research over 4 to 8 weeks. conditions: Cognitive Change studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: Following Pre-testing, participants randomly assigned into the full study will be further randomly assigned to a total of 9 unique experimental conditions for the full 2x2x2+1 factorial design.

The full description of the study's 9 arms will be registered after data collection is completed to preserve the scientific integrity of the study. primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: All researchers that have contact with participants will be unaware of the tested hypothesis of the study.

Participants will be unaware of the experimental conditions.

Researchers and participants will be unaware (blinded) to the game conditions assigned to the participant, except for researchers in charge of supervising the training part of the study who will be aware what training the participant is undergoing.

More information on how this was achieved will be registered after data collection is completed to preserve the scientific integrity of the study. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 1600 type: ESTIMATED name: Visual and / or Auditory Cognitive Tasks (1) name: Visual and / or Auditory Cognitive Tasks (2) measure: Change in the difference between the proportion of hits minus false alarms for a given level of the N-back task measure: Change in the proportion of correctly reported sequences in the Corsi Complex task measure: Change in the proportion of correctly reported number and letter sets in the Letter-Number task measure: Change in the difference of response time and accuracy in switch trials minus non-switch trials in the Task Switching Task measure: Change in the difference of response time in (i) switch trials minus non-switch trials and (ii) congruent minus incongruent trials in the Flanker Task measure: Change in the proportion of correctly identified targets in the mixed condition of the Cancellation task measure: Change in the proportion of correct responses on the Useful Field of View (UFOV) Task measure: Change in the proportion of correct responses on the Multiple Object Tracking (MOT) Task measure: Change in the response time and percentage of correct responses in the Mental Rotation Task measure: Change in the percentage of correct responses in the Paper Folding task measure: Change in the sum of correctly solved items in Raven's Advanced Progressive Matrices task measure: Change in the sum of correctly solved items in the UC Matrix Reasoning task measure: Change in the percentage of accuracy in the Shipley Institute of Living Scale measure: Change in the percentage of accuracy in the Mill-Hill Vocabulary Scale measure: Big-5-Inventory 10-item version (BFI-10) Score measure: Behavioral Inhibition/Activation System (BIS/BAS) Score measure: Grit and Conscientiousness Score measure: Meta-Cognition Score measure: Theories of Intelligence - Mindset (Fixed vs Growth) Score measure: Schutte self-report emotional intelligence test (SSEIT) Score measure: Work and Family Orientation (WOFO) Score measure: Brief Pittsburgh Sleep Quality Index (B-PSQI) Score measure: Participant Experience Measure 1 measure: Participant Experience Measure 2 measure: Participant Experience Measure 3 measure: Participant Experience Measure 4 measure: Participant Experience Measure 5 sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, Riverside city: Riverside state: California zip: 92521 country: United States name: Aaron Seitz, PhD role: CONTACT phone: 951-827-6422 email: aseitz@ucr.edu lat: 33.95335 lon: -117.39616 facility: Northeastern University city: Boston state: Massachusetts zip: 02115 country: United States name: Susanne Jaeggi, PhD role: CONTACT phone: 617-373-3653 email: s.jaeggi@northeastern.edu lat: 42.35843 lon: -71.05977 facility: University of Wisconsin - Madison city: Madison state: Wisconsin zip: 53706 country: United States name: C. Shawn Green, PhD role: CONTACT phone: 608-263-4868 email: cshawn.green@wisc.edu lat: 43.07305 lon: -89.40123 hasResults: False

 nctId: NCT06375668 id: CT/NB/140/2020/PR-MS briefTitle: The Effect of the Probiotic Strains on Bone Mineral Density in Postmenopausal Women overallStatus: ACTIVE_NOT_RECRUITING date: 2022-03-15 date: 2024-01-15 date: 2024-06-15 date: 2024-04-19 date: 2024-04-24 name: Nordic Biotic Sp. z o.o. class: INDUSTRY briefSummary: Osteoporosis is a systemic condition characterized by low bone mass and altered bone tissue microarchitecture, with the resulting greater bone fragility leading to fractures. Osteoporosis develops as a result of genetic and environmental factors, with the patient's lifestyle playing an important role. Recent years saw an emergence of reports on the significance of the intestinal microbiota in the development of osteoporosis, thus new ways of modifying the composition and activity of microbiota have been sought, and the potential role of probiotics has been considered. Probiotics are defined as live microorganisms, which-when administered at appropriate doses-are beneficial to the host's health. Probiotics both modify the gut microbiota composition and directly affect the human body. Recently published clinical studies demonstrated that probiotics may facilitate osteoporosis treatment and prevention. The current randomized double-blind placebo-controlled study will assess the effect of a dietary intervention via oral supplementation of Lactobacillus plantarum and Lactobacillus paracasei in a population of Polish postmenopausal women on their bone mineral density assessed via bone densitometry-derived T-scores of the lumbar segment of the spine (L1-L4). Study subjects will take the provided probiotic formulation/placebo orally once daily for 12 months. conditions: Osteoporosis, Postmenopausal conditions: Bone Density, Low studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 170 type: ACTUAL name: Probiotic name: Placebo measure: The effect of intervention on bone mineral density measure: Changes in the level of calcium measure: Changes in the level of phosphorus measure: Changes in the level of alkaline phosphatase measure: Changes in the level of vitamin D measure: Changes in the level of C-reactive protein measure: Changes in Body Mass Index (BMI) measure: Changes in type of stools measure: Changes in the number of bowel movements measure: Changes in severity of abdominal pain measure: Changes in severity of bloating measure: Occurrence of adverse events measure: Satisfaction with the intervention sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Private Specialist Practice city: Bytom zip: 41-902 country: Poland lat: 50.34802 lon: 18.93282 facility: Specialist Practice city: Katowice zip: 40-750 country: Poland lat: 50.25841 lon: 19.02754 facility: Clinical Research Center city: Poznań zip: 60-773 country: Poland lat: 52.40692 lon: 16.92993 hasResults: False

 nctId: NCT06375655 id: STUDY20240085 briefTitle: Texting to Promote Breastfeeding (TOPS) overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2025-07-31 date: 2025-07-31 date: 2024-04-19 date: 2024-04-24 name: Lydia Furman class: OTHER briefSummary: The purpose of the study is to see if a program of text messages that support and promote breastfeeding for expecting and delivered African-American/Black women (called TEAM2BF), as compared to a national maternal health texting program (called Text4baby), can result in more women being able to breastfeed their infant. Because breastfeeding is healthy for mothers and babies, and because fewer African-American/Black women decide to breastfeed and continue breastfeeding than many other racial and ethnic groups, researchers like us are trying to figure out ways to be supportive to African-American/Black mothers who might be interested in breastfeeding. The investigators will enroll up to 80 mothers and their infants at UHCMC. conditions: Increased Breastfeeding studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 80 type: ESTIMATED name: Team2BF name: Text4baby measure: Percentage of participants who do not opt out of receipt of text messages measure: Percentage of participants who said texts were helpful as measured by questionnaire measure: Percentage of participants who would refer a friend/family to the texting program measure: Percentage of participants who are exclusively breastfeeding at 2 months postpartum as measured by participant report/chart review measure: Percentage of participants who are exclusively breastfeeding as measured by participant report/chart review measure: Percentage of participants who are partially breastfeeding as measured by participant report/chart review sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ahuja Rainbow Center for Women and Children city: Cleveland state: Ohio zip: 44103 country: United States name: Lydia Furman, MD role: CONTACT phone: 216-675-6691 email: lydia.furman@uhhospitals.org lat: 41.4995 lon: -81.69541 hasResults: False

 nctId: NCT06375642 id: SHR1316-HMPL012-HAIC-01 briefTitle: A Single Arm, Single Centered Phase II Trial on the Combination of Adebrelimab, Surufatinib and Irinotecan Liposome-based HAIC in Advanced iCC overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2025-08-31 date: 2026-08-31 date: 2024-04-19 date: 2024-04-19 name: Tianjin Medical University Cancer Institute and Hospital class: OTHER briefSummary: Southeast Asia and China have the highest incidence of intrahepatic cholangiocarcinoma worldwide, with limited treatment options and large unmet medical needs.

Hepatic arterial infusion chemotherapy (HAIC) has gradually emerged as a promising treatment option for patients with hepatocellular carcinoma (HCC). Increasing evidence suggests that infusion of HAIC, which maintains high local concentrations of toxic agents in tumors without embolism, provides a significant survival benefit for patients with advanced HCC and is well-tolerated. However, there is limited evidence for the efficacy of HAIC for intrahepatic cholangiocarcinoma.

Irinotecan liposome (nal-IRI) is a concentrate of an infusion solution containing 5 mg/ml irinotecan trihydrate (irinotecan sucrose salt) active substance, which is encapsulated in liposomes and prevents premature conversion of the drug to SN-38 in the liver. Liposomal irinotecan prolongs the circulation time of the drug in the plasma of patients and prolongs the tumor exposure of the drug compared to conventional irinotecan.Nal-IRI based protocol has shown positive results in the phase III trial of pancreatic carcinoma.

Adebrelima(SHR-1316) is a recombinant humanized IgG4 antibody that binds efficiently and specifically to human and cynomolgus programmed cell death ligand 1 (PD-L1, CD274, or B7-H1), a cell surface molecule that plays an important role in T cell immune function, and stimulates IFN-γ secretion from mixed lymphocyte reactions (MLRs) of dendritic cells (DCs) and CD4 + T cells.

Surufatinib is a multiple kinase inhibitor targeting VEGFR 1-3, FGFR1 and CSF1R.

This study aims to evaluate the efficacy and safety of irinotecan liposome-based hepatic arterial infusion chemotherapy combined with adebrelimab and surufatinib in the treatment of intrahepatic cholangiocarcinoma, which may bring significant clinical benefit to the iCC patients with new treatment options. conditions: Intrahepatic Cholangiocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Adebrelimab measure: Objective Response Rate measure: Disease Control Rate measure: Overall Survival measure: Progress-Free Survival measure: Incidence and severity of AE and SAE measure: Dose suspension rate caused by adverse events measure: dose termination rate caused by adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Cancer Hospital Airport Hospital city: Tianjin state: Tianjin zip: 300308 country: China lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06375629 id: EDAP TMS briefTitle: ES-HIFU, Prospective Data Collection of Patients Treated With Partial Gland HIFU Ablation for Prostate Cancer acronym: ES-HIFU overallStatus: RECRUITING date: 2023-04-20 date: 2027-04-20 date: 2027-04-20 date: 2024-04-19 date: 2024-04-19 name: EDAP TMS S.A. class: INDUSTRY briefSummary: The objective of this study is to evaluate the clinical effectiveness and safety of treatment of prostate cancer in patients who have received a focal HIFU treatment using the Focal One medical device. conditions: Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: FocalOne measure: Evaluation of adverse events measure: Evaluation of quality of life measure: Evaluation of urinary incontinence measure: Erectile function assessment measure: Urinary Symptoms sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario Puerta del Mar status: RECRUITING city: Cadiz zip: 21 11009 country: Spain name: Cristina Salvatierra Pérez, Doctor role: CONTACT phone: +34 956 00 21 00 email: cris_salvatierra86@hotmail.com lat: 36.52672 lon: -6.2891 facility: Hospital General Universitario Gregorio Marañón C/ Doctor Esquerdo status: RECRUITING city: Madrid zip: 46 28007 country: Spain name: Carlos Hernández Fernández, Doctor role: CONTACT phone: +34 912 05 38 54 email: carlos.hernandez@salud.madrid.org lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Central De Asturias status: RECRUITING city: Oviedo zip: 33011 country: Spain name: Jorge Garcia Rodriguez, Doctor role: CONTACT phone: +34 985 10 80 00 email: garciajorge70@gmail.com lat: 43.36029 lon: -5.84476 facility: Hospital Universitario Marqués De Valdecilla status: RECRUITING city: Santander zip: 39008 country: Spain name: Mario Dominguez Esteban role: CONTACT phone: +34 942 42 06 26 email: mariodominguezesteban@gmail.com lat: 43.46472 lon: -3.80444 facility: Hospital Consorcio General Universitario de Valencia status: RECRUITING city: Valencia zip: 46014 country: Spain name: Emilio Mr López Alcina, Doctor role: CONTACT phone: +34 960 64 00 78 email: e.lopezalcina@gmail.com lat: 39.46975 lon: -0.37739 hasResults: False

 nctId: NCT06375616 id: KY2024-023 briefTitle: Comparison of Nafamostat and Unfractionated Heparin in RRT for Sepsis Associated AKI overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-04-19 date: 2024-04-19 name: Shen Lei class: OTHER briefSummary: The goal of this clinical trial is to compare the safety and efficacy of nafamostat mesylate (NM) and unfractionated heparin (UFH) in the process of renal replacement therapy (RRT) for patients suffering from sepsis associated acute kidney injury (SA-AKI). The main questions it aims to answer are:

The impact of NM and UFH on platelet count in septic patients undergoing RRT treatment.

The satisfaction with anticoagulation of NM and UFH in septic patients undergoing RRT treatment.

The 28-day all-cause mortality rate of septic patients undergoing RRT treatment with NM and UFH.

Researchers will use NM or UFH as anticoagulation during RRT in SA-AKI patients, assessing effects on platelet count, anticoagulation satisfaction, and mortality.

Participants will receive NM or UFH as anticoagulation during RRT for a minimum of 7 days. Bleeding symptoms, platelet count and coagulation function will be monitored daily. Platelet changes during the 7-day treatment period and survival status at 28 days post-treatment will be recorded. conditions: Sepsis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 156 type: ESTIMATED name: Nafamostat Mesylate name: Unfractionated Heparin measure: Platelet decline rate measure: Satisfaction of filter anticoagulation measure: All-cause mortality at 28 days sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Huashan Hospital, Fudan University city: Shanghai state: Shanghai country: China name: Lei Shen, MD role: CONTACT phone: 86-021-52887920 email: sh_leisen@126.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06375603 id: SMARTALPHA-NERVEBLOX-1001 briefTitle: Nerve and Plane Block Data Collection Study for the Development of Artificial Intelligence-assisted Software overallStatus: COMPLETED date: 2022-12-01 date: 2023-05-01 date: 2023-05-01 date: 2024-04-19 date: 2024-04-19 name: Smart Alfa Teknoloji San. ve Tic. A.S. class: INDUSTRY name: Ankara University briefSummary: The primary objective of this observational study is to acquire ultrasound images (raw data) from nerve and plane block regions to develop artificial intelligence-guided nerve block software (Nerveblox). The study aims to acquire raw ultrasound video from 200 volunteers' planned nerve and plane block regions. These participants will undergo ultrasound scans administered by expert clinicians proficient in these techniques in their clinical practice. The data collection devices utilized in this study are FDA-cleared general-purpose ultrasound devices. conditions: Ultrasound Imaging of Anatomical Structures conditions: Nerve Block studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ACTUAL name: Ultrasound scans measure: Assessment of image quality sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara University School of Medicine city: Ankara zip: 06230 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06375590 id: 2024-NavIIcusp briefTitle: NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2026-05-01 date: 2024-04-19 date: 2024-04-19 name: Didier TCHETCHE class: OTHER name: Abbott briefSummary: The aim of this prospective registry is to evaluate the clinical impact of the new Navitor prosthesis (Abbott, Minneapolis, MN, USA) in BAV and evaluate both the main sizing methods (the classical annular or the supra-annular with ICD measurement at 4 mm above the virtual basal ring). conditions: Bicuspid Aortic Valve studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Transcatheter Aortic Valve Implantation measure: 30-day device success (Rate) measure: 1 year at least moderate bioprosthetic valve deterioration measure: 1 year severe patient-prosthesis mismatch measure: 30 days and 1 year all-cause and cardiovascular mortality measure: 30 days and 1 year stroke sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinique Pasteur city: Toulouse state: Occitanie zip: 31076 country: France name: Didier Tchétché, MD role: CONTACT name: Didier Tchétché role: PRINCIPAL_INVESTIGATOR name: Chiara De Biase, MD, PhD role: SUB_INVESTIGATOR lat: 43.60426 lon: 1.44367 hasResults: False

 nctId: NCT06375577 id: LMS-24-Dean-1 briefTitle: Speed of Absorption overallStatus: RECRUITING date: 2024-06 date: 2025-04 date: 2025-04 date: 2024-04-19 date: 2024-04-22 name: Lancaster University class: OTHER briefSummary: The purpose of this study is to look at how fast commercially available supplements containing carbohydrate can get into the bloodstream. If carbohydrate, in the form of glucose, gets into the blood faster, this can provide an instant energy source and help fuel the body during exercise. We will be testing three supplements, namely Voom Pocket Rocket, SIS Go Isotonic Energy Gel, and Maurten Gel 160. Each participant will complete all three conditions, consuming one of each supplement at random per condition. The study requires participation from male runners, cyclists and triathletes who are aged between 18-35.

Each visit will take approximately 1 hour and 30 minutes, and three experimental visits per participant. The study will involve frequent blood sampling and the continuous monitoring of gas exchange (oxygen/carbon dioxide). Blood sampling via cannulation will be used to analyse the lactate, glucose, and insulin content of the blood. Gas exchange will measure the oxygen breathed in and carbon dioxide breathed out throughout the study.

The investigators plan to carry out the study on 16 participants who will be a mix of male runners, cyclists and triathletes. conditions: Healthy conditions: Nutrition, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This will be a double-blind randomised crossover design. There will be 1 group of participants who will complete all three conditions at random:

Condition 1 - consume Voom Pocket Rocket. Condition 2 - consume SIS Isotonic Energy Gel. Condition 3 - consume Maurten Gel 160.

All participants will undergo the same measures - blood sampling for blood glucose, blood lactate, and insulin, and monitoring of gas exchange during each study visit. primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: Both the participants and investigators will be blinded to what supplement they are consuming on each visit. Each supplement will taste the same, and be placed into identical packaging, and be randomly labelled (e.g., A, B, C). This will be done to avoid potential bias. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 16 type: ESTIMATED name: 45 grams Voom Pocket Rocket Electro Energy name: 45 grams SIS Go Isotonic Energy Gel name: 45 grams Maurten Gel 160 measure: Blood Glucose measure: Blood Lactate measure: Insulin measure: Gas Exchange sex: MALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Lancaster University status: RECRUITING city: Lancaster state: Lancashire zip: LA1 4AT country: United Kingdom lat: 54.04649 lon: -2.79988 hasResults: False

 nctId: NCT06375564 id: XMYY-2020KY067-05 briefTitle: Clinical Evaluation of 177Lu-AB-3PRGD2 in Various Solid Tumors With Integrin αvβ3 Positive Expression overallStatus: RECRUITING date: 2024-05-01 date: 2025-12-30 date: 2026-12-30 date: 2024-04-19 date: 2024-04-23 name: The First Affiliated Hospital of Xiamen University class: OTHER briefSummary: This is an open-label, non-controlled, non-randomized study to assess the therapeutic efficacy of 177Lu-AB-3PRGD2 in patients with various solid tumors who will undergo radioligand therapy using 177Lu-AB-3PRGD. conditions: Refractory Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: 177Lu-AB-3PRGD2 radioligand therapy measure: Objective response rate (ORR) measure: Incidence of treatment-related adverse events (safety and tolerability) sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Xiamen University status: RECRUITING city: Xiamen state: Fujian zip: 361003 country: China name: Haojun Chen role: CONTACT phone: +8618659285282 email: leochen0821@foxmail.com name: Hao Fu, MD, PhD role: CONTACT phone: +8615959230059 email: fuhaonuclear@163.com name: Haojun Chen, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Hao Fu, MD, PhD role: SUB_INVESTIGATOR lat: 24.47979 lon: 118.08187 hasResults: False

 nctId: NCT06375551 id: 1171-0623 id: K01MH128761 type: NIH link: https://reporter.nih.gov/quickSearch/K01MH128761 briefTitle: K-ORCA: Testing a Decision Support Tool and Group Process for Selecting Interventions acronym: K-ORCA overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2027-07-31 date: 2027-07-31 date: 2024-04-19 date: 2024-04-19 name: Chestnut Health Systems class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: This proposal responds to NIMH Objective 4.2.c to develop "decision-support tools and technologies that increase the effectiveness and continuous improvement of mental health interventions" by leveraging the Family First Prevention Services Act (FFPSA) policy opportunity. First, a web-based platform to host (a) a decision-support tool and (b) automated facilitation for group decisions with the tool will be developed with state partners' feedback. Next, decision makers leading their states' FFPSA quality improvement efforts will be engaged to pilot a decision-support intervention comprised of the tool and live or automated facilitation, and to evaluate the implementation quality of evidence-based programs adopted with the decision-support intervention. conditions: Child Abuse conditions: Decision Making conditions: Child Welfare conditions: Decision Making, Shared conditions: Decision Support Technique conditions: Social Facilitation conditions: Implementation Science conditions: Policy conditions: Organizations conditions: Consensus conditions: Mental Health conditions: Family studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 80 type: ESTIMATED name: Optimizing Responses with Collaborative Assessments-Automated (ORCA-A) name: Optimizing Responses with Collaborative Assessments-Live (ORCA-L) measure: Mean changes in decision assumptions, decision goals Pre and Immediately Post-intervention measure: Mean changes in decision experience quality pre-post intervention measure: Mean changes in decision commitment pre-post intervention measure: Mean changes in perceived potential community health impact pre-post intervention measure: Descriptive changes in ordinal intervention rankings assisted (with ORCA) compared to unassisted (no ORCA) measure: Qualitatively described rationale for program adoption from pre-post intervention measure: Descriptive, mean group-level changes in perceived feasibility of intervention Pre-post intervention measure: Descriptive, mean group-level changes in perceived acceptability of intervention for implementation measure: Descriptive, mean group-level changes in perceived appropriateness of intervention for implementation measure: Descriptive differences in implementation process fidelity (activities completed) for interventions adopted with ORCA measure: Descriptive differences in implementation process fidelity (timing) for interventions adopted with ORCA measure: Qualitative changes in decision reasoning pre- post-intervention measure: Qualitative changes in decision goals pre- post-intervention measure: Qualitative changes in decision consensus pre- post-intervention measure: Time to adoption or re-adoption of interventions with ORCA sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06375538 id: B2022-527 briefTitle: Ultrasound Evaluations of Diaphragm and Intercostal Muscle to Predict the Failure of High-Flow Nasal Cannula Therapy overallStatus: RECRUITING date: 2022-10-21 date: 2025-08-31 date: 2025-12-31 date: 2024-04-19 date: 2024-04-19 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: The study aims to predict the failure of High-flow Nasal Cannula oxygenation therapy by ultrasound evaluation of diaphragm and intercostal muscle contraction during the first 24 hours. conditions: High-flow Nasal Cannula conditions: Ultrasound Evaluation conditions: Diaphragm and Intercostal Muscle studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Ultrasound evaluation of diaphragm measure: Ultrasound evaluation of intercostal muscle movement index measure: The patient's condition deteriorated and required noninvasive or intubated invasive mechanical ventilation. measure: ICU stay measure: Hospital stay measure: all cause mortality measure: Oxygen saturation measure: respiratory rate measure: oxygen concentration measure: flow velocity of HFNC measure: VT measure: duration on HFNC sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Zhongshan Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200032 country: China name: Wei Wu role: CONTACT phone: 13817976707 email: wu.wei1@zs-hospital.sh.cn lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06375525 id: SHEBA-15-2635-SMC briefTitle: Clinical Trial: The Efficacy of Janssen's Icon Application (App) in Improving Adherence to Treatment With Stimulant Medications in Children With Attention Deficit/Hyperactivity Disorder acronym: App ADHD overallStatus: COMPLETED date: 2015-11 date: 2017-08 date: 2017-08 date: 2024-04-19 date: 2024-04-19 name: Prof. Doron Gothelf MD class: OTHER_GOV briefSummary: The overarching aim of the study is to assess the efficacy of Janssen's icon Application (App), a digital tool designed to improve adherence to medication treatment in children with ADHD.

Our specific hypotheses are:

1. In children receiving medication for ADHD those provided with the App tool will be more adherent to treatment than children treated as usual (i.e., not provided with the App tool).
2. Adherent patients will show greater improvement of ADHD symptoms and related dysfunction. conditions: Children Aged 6-18 Years With the Diagnosis of ADHD studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 39 type: ACTUAL name: Janssen's icon Application (App) measure: Attention Module of the Kiddie-SADS questionniare measure: MINI-KID measure: ADHD-Rating Scale Questionnaire (ADHD-RS) measure: Clinical Global Impression Scale (CGI) measure: the Barkley Side Effects Rating Scale measure: Drug accountability by reviewing the completed medication logs sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: ADHD Medical Clinic, Child and Adolescent Psychiatry Unit, Sheba Medical Center city: Ramat-Gan country: Israel lat: 32.08227 lon: 34.81065 hasResults: False

 nctId: NCT06375512 id: IN001001 briefTitle: A Study to Describe the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-12 date: 2026-06 date: 2024-04-19 date: 2024-04-19 name: Shenzhen Shenxin Biotechnology Co., Ltd class: INDUSTRY briefSummary: The study will evaluate the safety, tolerability, and immunogenicity (your immune system's reaction) of the study vaccine called Herpes Zoster IN001 mRNA Vaccine (IN001) in healthy participants who are between 50 and 69 years of age 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: 150 type: ESTIMATED name: HZ Vaccine (IN001) name: Placebo name: Shingrix measure: Percentage of Participants Reporting Solicited Local Reactions measure: Percentage of Participants Reporting Solicited Systemic Reactions measure: Percentage of Participants With Unsolicited Adverse Events (AEs) measure: Percentage of Participants With Any Medically Attended AEs (MAAEs) measure: Percentage of Participants With Any Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), AEs Leading to Vaccine Discontinuation, and AEs Leading to Study Withdrawal measure: Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) measure: Change from Baseline in Geometric Mean Fold Rise (GMFR) of Anti-gE Antibodies as Measured by ELISA measure: Proportion of Participants with Vaccine Response in Anti-gE Antibodies as Measured by ELISA measure: Geometric Mean Titer (GMT) of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay measure: Change from Baseline in GMFR of Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay measure: Proportion of Participants with Vaccine Response in Anti-VZV Neutralizing Antibodies as Measured by Neutralization Assay measure: gE-specific T Cell Response (IFN-γ and IL-4 Secreting T Cells) as Measured by Enzyme-Linked Immunospot (ELISpot) measure: Frequencies of gE-specific CD4+ and CD8+ T Cells Expressing Activation Markers (i.e., IFN-γ, IL-2, TNFα, CD40L) as Measured by Intracellular Cytokine Staining (ICS) sex: ALL minimumAge: 50 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06375499 id: LT2769-004 briefTitle: Comparison of the Performance and Safety of T2769 Versus Hylo-Forte® in the Treatment of Moderate to Severe Dry Eye Syndrome. overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2025-04-28 date: 2025-04-28 date: 2024-04-19 date: 2024-04-19 name: Laboratoires Thea class: INDUSTRY briefSummary: The objective is to demonstrate the non-inferiority of T2769 compared to Hylo-Forte® in terms of the change from baseline (D1) in total ocular surface staining score assessed on Oxford 0-15 scale, in the study eye at the D36 visit.

The investigation is defined as a post-market stage. The clinical investigation design is confirmatory. conditions: Dry Eye Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 74 type: ESTIMATED name: T2769 name: Hylo-Forte® measure: To demonstrate the non-inferiority of T2769 compared to Hylo-Forte® in terms of total ocular surface staining (Oxford score). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06375486 id: AK112-IIT-TianjinCIH-LHK briefTitle: Ivonescimab Combined With HAIC for the Treatment of Unresectable Hepatocellular Carcinoma（uHCC）. overallStatus: RECRUITING date: 2024-03-14 date: 2025-03-14 date: 2026-06-15 date: 2024-04-19 date: 2024-04-19 name: Tianjin Medical University Cancer Institute and Hospital class: OTHER briefSummary: This study is a single-center, open-label Phase II clinical trial, aiming to enroll approximately 30 unresectable BCLC stage B or C hepatocellular carcinoma (HCC) patients from China. The primary objective is to evaluate the safety and efficacy of AK112 (a dual-specific antibody against PD-1/VEGF) in combination with hepatic arterial infusion chemotherapy (HAIC) for the treatment of unresectable hepatocellular carcinoma.

All enrolled subjects will receive AK112 (20mg/kg Q3W) combined with HAIC (utilizing the FOLFOX chemotherapy regimen) until the investigator determines no further clinical benefit (based on RECIST v1.1 imaging evaluation and clinical assessment), intolerable toxicity, completion of 24 months of treatment, or meeting other criteria for treatment discontinuation as outlined in the protocol, whichever occurs first. conditions: Hepatocellular Carcinoma Non-resectable conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Ivonescimab（AK112，a PD-1/VEGF bispecific antibody） measure: Overall response rate (ORR) measure: Progress Free Survival （PFS） measure: Overall survival (OS) measure: Adverse Events（AEs） sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Cancer Hospital Airport Hospital status: RECRUITING city: Tianjin state: Tianjin zip: 300308 country: China name: Huikai Li, Doctor role: CONTACT phone: 18622228639 email: tjchlhk@126.com name: Yang Liu, MD role: CONTACT phone: 17694950696 email: tjchlhk@126.com lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06375473 id: MA-PC-RWS-011 briefTitle: Treatment of Irinotecan Hydrochloride Liposome Injection II in China: a Real World Study of Pancreatic Cancer Patients acronym: MA-PC-RWS-011 overallStatus: NOT_YET_RECRUITING date: 2024-04-19 date: 2027-04-19 date: 2027-04-19 date: 2024-04-19 date: 2024-04-19 name: Peking Union Medical College Hospital class: OTHER briefSummary: This study is a multi-center observational study.The start time for data collection is May 1, 2024. Patients' baseline and treatment data will be collected under informed concent. The purpose of this case registry study was to evaluate the safety and efficacy of irinotecan hydrochloride liposome injection II based therapy in Chinese patients with pancreatic cancer in the real world by collecting, understanding, and analyzing the etiology, clinical features, treatment pattern, treatment outcomes, and pharmacoeconomics changes in pancreatic cancer patients receiving this regimen. conditions: Pancreatic Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED name: Irinotecan liposome II combination therapy regimen measure: rwTEAE measure: OS measure: PFS measure: ORR measure: TTP measure: DCR sex: ALL minimumAge: 18 Years maximumAge: 100 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: NCT06375460 id: STUDY24020141 id: 1R01DK137803-01A1 type: OTHER_GRANT domain: NIDDK briefTitle: Real-time Engagement for Learning to Effectively Control Type 2 Diabetes acronym: REFLECT2D overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2028-06-01 date: 2029-06-30 date: 2024-04-19 date: 2024-04-19 name: University of Pittsburgh class: OTHER name: Dartmouth College name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) name: University of Michigan name: San Diego State University briefSummary: This is a clinical trial that includes a run-in period, a 90 day micro-randomized trial, and a 90-day observational period. The goal of this study is to evaluate whether providing paired real time glycemic and health behavior data in a smartphone app leads to better glycemic control among adolescents and young adults with T2D. Glycemic control will be monitored using Continuous Glucose Monitors (CGM), and health behavior data will be collected via a Fitbit activity tracker and a research app (Healthmine). Participants will be prompted to view and reflect on glycemic trends and health behavior data (Fitbit data, logging of diet and medication adherence) during the 90-day micro-randomized trial period, then observed for ongoing use of the Healthmine app and engagement with CGM in the following 90-day observation period. conditions: Diabetes Mellitus, Type 2 conditions: Lifestyle conditions: Hyperglycemia conditions: Physical Inactivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Subjects will wear a continuous glucose monitor and activity watch for study duration. Subjects will be micro-randomized once daily for 90 days to receive app prompts regarding nutrition or physical activity. primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Focused App Prompt name: No App Prompt measure: Glucose time above 180mg/dL measure: Mean daily glucose measure: Maximum daily glucose measure: Minimum daily glucose measure: Glucose coefficient of variability measure: Mean amplitude of glycemic excursions measure: Hemoglobin A1c measure: Fasting glucose measure: Objective physical activity (step count) measure: Objective physical activity (moderate-vigorous physical activity) measure: Self-reported physical activity measure: Diet quality measure: Capability measure: Healthmine app use measure: Continuous glucose monitor use use measure: Motivation to engage in diabetes self-management measure: Body Mass Index (BMI) measure: Diabetes distress measure: Diabetes family support and conflict sex: ALL minimumAge: 16 Years maximumAge: 24 Years stdAges: CHILD stdAges: ADULT facility: Children's Hospital of Pittsburgh city: Pittsburgh state: Pennsylvania zip: 15224 country: United States lat: 40.44062 lon: -79.99589 hasResults: False

 nctId: NCT06375447 id: Insomnia briefTitle: Intelligent Diagnosis and Treatment Model for Insomnia Disorder overallStatus: RECRUITING date: 2022-12-01 date: 2025-10-31 date: 2025-12-31 date: 2024-04-19 date: 2024-04-19 name: Xuanwu Hospital, Beijing class: OTHER name: West China Hospital name: Beijing Tiantan Hospital name: Ningcheng Center Hospital name: Second Affiliated Hospital of Soochow University briefSummary: To establish a multicenter, multi-dimensional cohort on insomnia disorder and to develop an intelligent model for the diagnosis and treatment of insomnia disorder. conditions: Insomnia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 16000 type: ESTIMATED name: Routine clinical treatment measure: The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of Epworth Sleepiness Scale (ESS) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of sleep onset latency from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of wake after sleep onset from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of terminal wakefulness from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of sleep efficiency from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of total sleep time from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of time in bed from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of Insomnia severity index (ISI) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of Short Form 36 (SF-36) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of PHQ-15 total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of PDQ-D-5 total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of SHAPS total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. measure: The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xuanwu Hospital, Capital Medical University status: RECRUITING city: Beijing zip: 100053 country: China name: Hongxing Wang, MD & PhD role: CONTACT phone: 01083198650 email: wanghongxing@xwh.ccmu.edu.cn lat: 39.9075 lon: 116.39723 facility: Beijing Tiantan Hospital, Capital Medical University status: RECRUITING city: Beijing zip: 100070 country: China name: Yi Zhang, MD & PhD role: CONTACT phone: 15801203052 email: ttyyzy@126.com lat: 39.9075 lon: 116.39723 facility: The First Bethune Hospital of Jilin University status: NOT_YET_RECRUITING city: Changchun country: China name: Zan Wang, MD & PhD role: CONTACT lat: 43.88 lon: 125.32278 facility: West China Hospital, Sichuan University status: RECRUITING city: Chengdu zip: 610041 country: China name: Lan Zhang, MD & PhD role: CONTACT phone: 18980601706 email: Zhanglan102@126.com lat: 30.66667 lon: 104.06667 facility: The Second Affiliated Hospital of Soochow University status: NOT_YET_RECRUITING city: Suzhou country: China name: Hua Hu, MD & PhD role: CONTACT phone: 051268282030 email: sz_huhua@126.com lat: 31.30408 lon: 120.59538 hasResults: False

 nctId: NCT06375434 id: 20240101-01 briefTitle: Correlation Between Gut Microbiota and Radiosensitivity of Rectal Cancer acronym: GMRSC-LARC overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-08-15 date: 2024-08-31 date: 2024-04-19 date: 2024-04-19 name: Jing-kun Liu class: OTHER briefSummary: The purpose of this process is to clarify the characteristics of gut microbiota changes in patients with locally advanced rectal cancer undergoing preoperative neoadjuvant treatment, and to identify key bacterial species closely related to sensitivity to radiotherapy. This aims to elucidate the mechanism linking gut microbiome dysbiosis with radiotherapy sensitivity, thereby providing new combined treatment strategies to enhance the efficacy of radiotherapy. conditions: Locally Advanced Rectal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: No intervention measure: Diameter of tumor measure: Change in Gut Microbiota Composition measure: Change in Plasma metabolites measure: Five-year survival rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06375421 id: GR018280 briefTitle: Pilot and Feasibility of MEMI for Chronic Traumatic Brain Injury overallStatus: ENROLLING_BY_INVITATION date: 2024-04-03 date: 2024-12-31 date: 2024-12-31 date: 2024-04-19 date: 2024-04-19 name: Vanderbilt University Medical Center class: OTHER briefSummary: This is a pilot and feasibility study for a mobile phone-delivered intervention for memory, called MEMI (memory ecological momentary intervention), that was designed to support adults with chronic traumatic brain injury with their memory. The goal of the study is to examine the feasibility and acceptability of MEMI and to assess preliminary efficacy as to whether technology-delivered spaced memory retrieval opportunities improve memory in people with and without a history of chronic traumatic brain injury. conditions: Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The order of conditions and the order of word list presentation will be counterbalanced. The order of condition/word list combination will be pre-determined, and participants will be assigned to the next available combination based on when they join the study (i.e., a counterbalanced within-person crossover design). primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: MEMI (Memory Ecological Momentary Intervention) Spaced Retrieval name: Blocked Retrieval measure: Acceptability measure: Feasibility (Engagement) measure: Free Recall of Word Forms measure: Cued Recall of Word Forms measure: Cued Recall of Word Meanings measure: Number of Spatial Contexts sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Vanderbilt University Medical Center city: Nashville state: Tennessee zip: 37203 country: United States lat: 36.16589 lon: -86.78444 hasResults: False

 nctId: NCT06375408 id: KS2022212 briefTitle: Transcranial Alternating Current Stimulation Prevents Delirium in Patients With Subarachnoid Hemorrhage acronym: TACS overallStatus: RECRUITING date: 2024-03-24 date: 2026-02-24 date: 2026-03-24 date: 2024-04-19 date: 2024-04-19 name: Xuanwu Hospital, Beijing class: OTHER briefSummary: The goal of this clinical trial is to learn about using the latest transcranial alternating current stimulation (tACS) to reduce the incidence of delirium in patients with subarachnoid hemorrhage. The main question it aims to answer is:

• To evaluate the effect of tACS on reducing delirium in patients with subarachnoid hemorrhage.

Participants will treated with real tACS or sham tACS. Researchers will mainly compare the two groups to see if patients' delirium will reduce by using tACS. conditions: Subarachnoid Hemorrhage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: The random number table method was used for randomization, and the envelope method was used for randomization. The random serial number was stored in an airtight envelope, an envelope was opened when a patient was admitted. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 74 type: ESTIMATED name: Real transcranial alternating electrical stimulation name: Sham transcranial alternating electrical stimulation measure: Incidence of delirium measure: Sleep quality score measure: Anxiety score measure: Duration of delirium measure: Cognitive function score sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xuanwu Hospital Capital Medical University status: RECRUITING city: Beijing state: Beijing zip: 100053 country: China name: Jun Wang role: CONTACT phone: 18612583695 email: wangj229@126.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06375395 id: Memory Updating Tasks briefTitle: Boosting The Intervention Effect of Negative Memory Through tACS Stimulation overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-12-15 date: 2024-12-31 date: 2024-04-19 date: 2024-04-19 name: Xuanwu Hospital, Beijing class: OTHER name: Beijing Normal University briefSummary: The objectives of this study include: 1) investigating the impact of negative memory substitution on an individual's other intellectual memories (i.e., neutral memories) and the underlying neurocognitive mechanisms; 2) investigating the memory enhancement effect resulting from retrieval practice associated with memory substitution intervention along with an examination of the neurocognitive mechanisms responsible for this enhancement. conditions: Seizures 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: Active tACS Device name: Sham tACS Device measure: Negative memory retention measure: The negative emotional intensity of negative memory measure: The retention of associated neutral memories as assesses by the proportions of responses of correctly choosing picture category of B picture (A-Bneu) in last A-B paired associate memory test measure: The negative emotional intensity of neutral memory sex: ALL minimumAge: 14 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06375382 id: ZYS2024-01 briefTitle: Effects of Acupuncture on Abdominal Pain-related Intestinal Flora in Patients With Crohn's Disease overallStatus: COMPLETED date: 2015-03-01 date: 2023-12-31 date: 2024-03-31 date: 2024-04-19 date: 2024-04-19 name: Shanghai Institute of Acupuncture, Moxibustion and Meridian class: OTHER briefSummary: Crohn's disease is an intestinal inflammatory disease, causing abdominal pain, diarrhea and other symptoms. The intestinal flora disorder is closely related to the occurrence and development of Crohn's disease. Acupuncture can induce remission of Crohn's disease during mild to moderate active period, improve clinical symptoms such as abdominal pain. This study is to screen the intestinal bacteria related to abdominal pain in CD, and explore the effects of acupuncture on the intestinal flora related to abdominal pain in CD patients. conditions: Crohn Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 64 type: ACTUAL name: acupuncture name: Sham acupuncture measure: Abdominal pain remission rate measure: Crohn's disease activity index （CDAI） measure: Hospital anxiety and depression scale (HADS) measure: Inflammatory bowel disease questionnaire (IBDQ) measure: Safety evaluation (number of participants with abnormal routine blood tests) measure: Safety evaluation (number of participants with abnormal Liver function tests) measure: Safety evaluation (number of participants with abnormal Renal function tests) measure: Gut microbiota composition structure and function measure: Correlation between changes in relative abundance of gut microbes and abdominal pain 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: NCT06375369 id: Pro00127121 briefTitle: Digital Health Pathway for Children With Medical Complexity Requiring Tracheostomy acronym: DECIDE-T overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-19 date: 2024-04-23 name: University of Alberta class: OTHER name: Alberta Innovates Health Solutions briefSummary: The DECIDE-T project is developing a standardized clinical pathway specifically for pediatric patients who require tracheostomy with or without long-term ventilation (tracheostomy/LTV). These patients represent a small portion of Alberta's population but account for over 50% of pediatric patients hospitalized for more than 180 days. The pathway will include a hospital-to-home directive that incorporates digital health solutions to provide support to families, caregivers, and healthcare professionals. Digital supports will include a Connect Care pathway, resources for informed decision-making, educational modules, high-fidelity simulations for family and caregiver education, an online parental resource center, and access to peer support within the hospital and community, as well as a post-discharge telehealth program.

The goal of the DECIDE-T project is to reduce hospital stays and associated costs for children requiring tracheostomy/LTV, as well as to decrease mental distress and burnout experienced by their caregivers and families. conditions: Tracheostomy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 180 type: ESTIMATED name: Digital health pathway for children with medical complexity requiring tracheostomy (DECIDE-T) measure: Hospital length of stay measure: ICU length of stay measure: ICU readmission measure: Mortality measure: Decannulation measure: Duration of tracheostomy measure: Tracheostomy adverse events measure: Hospital cost measure: Hospital readmission measure: Net-monetary benefit of DECIDE-T measure: Caregivers mental stress sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Alberta Children's Hospital city: Calgary state: Alberta country: Canada name: Karen Kam, MD role: CONTACT email: karen.kam@albertahealthservices.ca name: Karen Kam, MD role: PRINCIPAL_INVESTIGATOR lat: 51.05011 lon: -114.08529 facility: Stollery Children's Hospital city: Edmonton state: Alberta country: Canada name: Michael van Manen, MD role: CONTACT email: michaelv@ualberta.ca name: Michael van Manen, MD role: PRINCIPAL_INVESTIGATOR lat: 53.55014 lon: -113.46871 hasResults: False

 nctId: NCT06375356 id: 75119 briefTitle: Stronger: Muscle Strengthening for Menopause overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2026-08 date: 2026-08 date: 2024-04-19 date: 2024-04-19 name: Stanford University class: OTHER briefSummary: Menopause is a period of time with increased risk for muscle and bone loss. Very few people strength train regularly at least 2 times per week, and commonly reported barriers include inadequate time and resources, worries of safety, inadequate knowledge base of what moves to do and how to do them. Menopause-aged women may report unique barriers - or perceived facilitators - to strength training. This pilot study will develop and test the feasibility and acceptability of an at-home, band-based, expert-supported strength training intervention. conditions: Resistance Training studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: Resistance Training measure: number of strength exercises the participant logged over the intervention measure: Liking of the intervention measure: Number of participants completing post 3 month measure / those randomized and consented measure: Change in total seconds a participant can remain in a wall sit measure: Change in number of full body weight squats in 60 seconds sex: FEMALE minimumAge: 35 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford University School of Medicine city: Stanford state: California zip: 94305-7240 country: United States lat: 37.42411 lon: -122.16608 hasResults: False

 nctId: NCT06375343 id: SOPH240-0923/I briefTitle: Study to Evaluating PRO-240 Ophthalmic Solution Compared to Optive® overallStatus: NOT_YET_RECRUITING date: 2024-10-30 date: 2024-10-30 date: 2025-06 date: 2024-04-19 date: 2024-04-19 name: Laboratorios Sophia S.A de C.V. class: INDUSTRY briefSummary: This is a phase I clinical study to evaluating safety and tolerability of PRO-240 ophthalmic solution through the incidence of unexpected adverse events, as well as through changes in Best Corrected Visual Acuity (BCVA), and the incidence of stinging after its administration, compared to Optive®. conditions: Dry Eye Disease conditions: Dry Eye Sensation conditions: Ocular Surface Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase I, controlled, comparative, single-blind, single-center, comparative clinical trial. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: PRO-240 name: Optive® measure: Incidence of unexpected adverse events related to the interventions measure: Changes in the Ocular Comfort Index score measure: Adherence to treatment (adherence) Adherence to treatment (adherence) measure: Changes in Best Corrected Visual Acuity (BCVA) measure: Changes in tear film breakup time measure: Changes in intraocular pressure (IOP) measure: Changes in the integrity of the ocular surface (fluorescein staining) measure: Changes in lissamine green staining of the conjunctival surface sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06375330 id: Poli.01 briefTitle: Clinical Efficacy of Polynucleotides TMJ Injections Compared to Physiotherapy. overallStatus: COMPLETED date: 2023-04-18 date: 2024-01-08 date: 2024-04-08 date: 2024-04-19 date: 2024-04-19 name: Sidoti & Tartaglia Srl class: OTHER briefSummary: The main objective of the present study is the evaluation of the clinical efficacy of the intra-articular administration of polynucleotides in association with hyaluronic acid in the improvement of the subjective and objective manifestations of arthrosis of the temporomandibular joint compared to normal clinical management which involves Physiotherapy. conditions: TMJ Disease conditions: TMJ Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: PoliArt measure: Maximum mouth opening measure: Lateral movements improvements measure: Pain assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UOC di Chirurgia Maxillo-Facciale e Odontostomatologia della Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico city: Milan state: MI zip: 20122 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06375317 id: HCC-HAIC-001 briefTitle: HAIC Combined With PD-L1 Plus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma After Immunotherapy Failure overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2026-04-30 date: 2026-10-30 date: 2024-04-19 date: 2024-04-19 name: Yehua Shen class: OTHER briefSummary: For patients with advanced liver cancer who have progressed after first-line targeted and immunotherapy , there is currently no standard treatment regimen for second-line therapy. this study aims to explore the efficacy and safety of HAIC combined with PD-L1 and Regorafenib in patients with advanced liver cancer who have failed immunotherapy, not only providing new treatment options for second-line therapy of liver cancer, but also laying the foundation for research on the combination of HAIC and PD-L1 inhibitors plus Regorafenib, which has significant scientific research significance and clinical value. conditions: HCC - Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: PD-L1 inhibitor: Adebrelimab Injection；Regorafenib Tablets measure: Objective Response Rate measure: Disease Control Rate (DCR) measure: Progression-Free Survival (PFS) measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06375304 id: MP-37-2024-10384 briefTitle: The Antiretroviral Speed Access Program Switch (ASAP-Switch) Study overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-06-01 date: 2027-05-01 date: 2024-04-19 date: 2024-04-19 name: McGill University Health Centre/Research Institute of the McGill University Health Centre class: OTHER briefSummary: This project builds on our experience with the ASAP Study (McGill University Health Centre research ethics board: MP-37-2020-4911). The goal of this study is to better understand the experience of migrant people with Human Immunodeficiency Virus (HIV) of having their treatment switched to Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). In other words, the investigators want to evaluate how feasible and acceptable this switch is, and how participants will take B/F/TAF (fidelity) and remain on it. The investigators also want to know more about migrant people with HIV's experience of care; namely, how often they see their HIV specialist or other healthcare professionals, and their healthcare coverage (the type of insurance that they have). conditions: HIV Infections studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: B/F/TAF measure: Feasibility of the switch measure: Acceptability measure: acceptability of the regimen measure: Acceptability of the intervention measure: Fidelity measure: ART initiation (HIV care cascade milestones) measure: Viral suppression (HIV care cascade milestones) measure: Retention in HIV care (HIV care cascade milestones) measure: consultations at the study site (Nature of clinical pathways) measure: consultations at other care centres or organizations (Nature of clinical pathways) measure: healthcare coverage sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Institute of the McGill University Health Centre city: Montréal state: Quebec zip: H4A3T2 country: Canada name: Bertrand Lebouché, MD, PhD role: CONTACT phone: +1-514-843-2090 email: bertrand.lebouche@mcgill.ca name: Ashkan Baradaran, MD, MSc role: CONTACT phone: +1 514-863-4468 email: ashkan.baradaran@muhc.mcgill.ca lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06375291 id: MersinTRHpregcts briefTitle: Pregnancy-Related Carpal Tunnel Syndrome Treatment overallStatus: COMPLETED date: 2021-01-01 date: 2023-12-31 date: 2024-03-31 date: 2024-04-19 date: 2024-04-22 name: Mersin Training and Research Hospital class: OTHER_GOV briefSummary: The current retrospective study aimed to compare the effectiveness of local steroid injection plus splinting with that of local steroid injection or splinting alone. To assess the primary outcome, The Boston Carpal Tunnel Symptom Severity Scale was used. The secondary aim was the efficacy of the treatment on the patient's function severity and depression assessed by The Boston Carpal Tunnel Symptom Function Scale Edinburgh Depression Scale. conditions: Carpal Tunnel Syndrome Pregnancy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 45 type: ACTUAL name: splint /steroid injection/both measure: Symptom severity measure: function severity measure: pregnancy and postpartum depression sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Suna Aşkın Turan city: Mersin state: Yenişehir zip: 33020 country: Turkey lat: 36.79526 lon: 34.61792 hasResults: False

 nctId: NCT06375278 id: DC019586 id: 5R44DC019586 type: NIH link: https://reporter.nih.gov/quickSearch/5R44DC019586 briefTitle: Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-12-31 date: 2026-03-31 date: 2024-04-19 date: 2024-04-19 name: Restorear Devices LLC class: INDUSTRY name: University of Miami name: National Institute on Deafness and Other Communication Disorders (NIDCD) briefSummary: The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia for preservation of residual hearing in cochlear implant surgery. The main questions the trial aims to answer are:

1. Is mild therapeutic hypothermia safe for use during cochlear implantation?
2. Is mild therapeutic hypothermia effective at preserving residual hearing after cochlear implantation?

Participants will receive mild therapeutic hypothermia therapy during cochlear implant surgery. Researchers will compare results from those receiving the therapy to those from a control group (individuals receiving no therapy). conditions: Cochlear Implants conditions: Cochlear Implantation conditions: Hearing Loss studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: Intra-Ear Canal Cooling Catheter name: Intra-Ear Canal Cooling Catheter (Sham) measure: Cochlear Implant (CI) Device Performance Following Hypothermia Treatment measure: Residual Hearing measure: Electrophysiological Impedance measure: Electrically Evoked Compound Action Potential (ECAP) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Miami city: Miami state: Florida zip: 33136 country: United States lat: 25.77427 lon: -80.19366 hasResults: False

 nctId: NCT06375265 id: 2024P000780-1 briefTitle: Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients acronym: SLEEP-BOOST overallStatus: NOT_YET_RECRUITING date: 2024-10-31 date: 2026-05-31 date: 2026-08-31 date: 2024-04-19 date: 2024-04-19 name: Massachusetts General Hospital class: OTHER briefSummary: The Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST) is a pilot randomized, controlled, singled-blinded (participant) trial in major orthopedic joint surgery patients that will build on a previously clinically tested cognitive behavioral therapy for insomnia (CBT-I) mobile application paired with a wearable device (wrist actigraphy). conditions: Insomnia conditions: Postoperative Delirium conditions: Delayed Neurocognitive Recovery conditions: Postoperative Neurocognitive Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) name: Sleep Health Education measure: Adherence measure: Insomnia Severity measure: Sleep Diary Completion measure: Homework Completion measure: Utility measure: Satisfaction with intervention measure: Cognition measure: Pain severity measure: Mood measure: Anxiety measure: Function measure: Postoperative Delirium Incidence measure: Postoperative Delirium Severity measure: Delayed Neurocognitive Recovery measure: Postoperative Neurocognitive Disorders (NCD) measure: Sleep Efficiency measure: Circadian Rest-Activity Rhythms sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02114 country: United States lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06375252 id: sbughfyaseminozkan1985 briefTitle: Evaluation of Central Jugular Vein Catheter Lumen Holder Design and Ergonomic Use acronym: CJVClumen overallStatus: NOT_YET_RECRUITING date: 2024-04-19 date: 2024-05-16 date: 2024-05-30 date: 2024-04-19 date: 2024-04-19 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: The aim of this study was to evaluate the design and ergonomic use of central jugular vein catheter lumen holder. conditions: Central Venous Catheterization studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 40 type: ESTIMATED name: Central Jugular Vein Catheter Lumen Holder Apparatus measure: demographic information measure: comfort effect sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06375239 id: RTx-VRAI-NHS01 briefTitle: Observational Study to Assess Endpoint Operational Feasibility & Measurement Properties in Retinitis Pigmentosa Patients overallStatus: RECRUITING date: 2024-04-05 date: 2026-04-30 date: 2026-04-30 date: 2024-04-19 date: 2024-04-19 name: Ray Therapeutics, Inc. class: INDUSTRY name: The Vision Research and Assessment Institute (VRAI) briefSummary: RayTx established The Vision Research and Assessment Institute (VRAI) with the express purpose of serving as a testing facility for efficacy endpoints for patients with Low Vision. The mission of the VRAI is to enable the highest quality, standardized efficacy testing of patients with visual impairment to be performed by expert clinicians in an optimized environment. The proposed assessments or testing modalities to be evaluated in this non-interventional study are published in some capacity, and some of these publications already include patients with severe-to-profound vision loss from retinitis pigmentosa and other inherited retinal diseases. conditions: Retinitis Pigmentosa studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: Operational feasibility of testing severe to profound vision impaired patients with RP on a battery of visual assessments measure: To quantify patient-based measurement properties of each test modality (for the purposes of endpoint qualification) measure: To quantify assessor-based measurement properties of each test modality (for the purposes of endpoint qualification) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vision Research and Assessment Institute status: RECRUITING city: Irvine state: California zip: 92612 country: United States name: Shawn Yu, OD role: CONTACT phone: 949-264-3793 email: info@vr-ai.com lat: 33.66946 lon: -117.82311 hasResults: False

 nctId: NCT06375226 id: 2023.17 id: 2023.0871 type: OTHER domain: METC Amsterdam UMC briefTitle: Autism and Attachment. An Explorative Study of Attachment Styles in Autistic Adults. acronym: ASDA overallStatus: RECRUITING date: 2024-03-01 date: 2025-04-01 date: 2025-04-01 date: 2024-04-19 date: 2024-04-23 name: Parnassia Groep class: OTHER briefSummary: The present study examines the relationship between attachment and autism spectrum disorder (ASD) in adults. conditions: Autism Spectrum Disorder studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED measure: The Social Responsiveness Scale - Adult version (SRS-A) measure: The Attachment Styles Questionnaire (ASQ) measure: Experiences in Close Relationships - Revised questionnaire (ECR-r) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ParnassiaGroep Antes status: RECRUITING city: Rotterdam state: Zuid-Holland zip: 3083 AK country: Netherlands name: Stephanie Bohnen, MSc role: CONTACT phone: +31653386139 email: s.bohnen@anteszorg.nl name: Richard Vuijk, Dr. role: CONTACT phone: +31883585428 email: r.vuijk@anteszorg.nl lat: 51.9225 lon: 4.47917 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-10-19 uploadDate: 2024-03-29T08:28 filename: Prot_SAP_000.pdf size: 287252 hasResults: False

 nctId: NCT06375213 id: 425/66 briefTitle: Investigating Neurocognitive Disorders Epidemiology acronym: INDE overallStatus: RECRUITING date: 2023-08-24 date: 2035-08-24 date: 2035-08-24 date: 2024-04-19 date: 2024-04-22 name: King Chulalongkorn Memorial Hospital class: OTHER name: Health Systems Research Institute,Thailand briefSummary: This is a prospective cohort study with the main purpose of predicting progression neurocognitive disorders in Thai population. The main predictor variables to be evaluated are plasma phosphorylated tau (p-tau) level and cognitive test scores, which will be combined using statistical/computational modeling. Additionally, it seeks to evaluate biomarkers for diagnosing disease pathologies, understand their correlation with clinical outcomes, and explore the socioeconomic impact of neurocognitive disorders. The study invites both participants for biospecimen collection, structured interviews, and cognitive examinations and schedules follow-up visits annually or biennially. conditions: Dementia conditions: Cognitive Decline conditions: Alzheimer Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 990 type: ESTIMATED name: Plasma tau phosphorylated at Thr217 name: Neurocognitive examination measure: Progression to dementia measure: Changes in Sum of Boxes of the Clinical Dementia Rating Scale measure: Changes in the Montreal Cognitive Assessment measure: Changes in the Montreal Cognitive Assessment - Memory Index Score measure: Changes in the Mini Mental State Examination measure: Changes in the Wechsler Memory Scale - Fourth Edition (WMS-IV) Visual Reproduction Scaled Score measure: Changes in the Wechsler Memory Scale - Fourth Edition (WMS-IV) Logical Memory Scaled Score measure: Changes in the Wechsler Memory Scale - Fourth Edition (WMS-IV) Verbal Paired Associates Scaled Score measure: Biological diagnosis of Alzheimer's disease measure: Biological staging of Alzheimer's disease measure: Quantitative amyloid PET uptake. measure: Quantitative tau PET uptake in various cortical regions. measure: Future diagnosis of Alzheimer's disease dementia. measure: Quality of life (WHOQOL-BREF) measure: Quality of life (EQ-5D-5L) measure: Number of modifiable risk factors sex: ALL minimumAge: 35 Years stdAges: ADULT stdAges: OLDER_ADULT facility: King Chulalongkorn Memorial Hospital status: RECRUITING city: Pathum Wan state: Bangkok zip: 10330 country: Thailand name: Adipa Chongsuksantikul, D.Eng. role: CONTACT phone: +66 (0)84 1134443 email: adipar@gmail.com lat: 13.73649 lon: 100.5239 hasResults: False

 nctId: NCT06375200 id: ONZ-2024-0066 briefTitle: Healthcare for Men With Suicidal Thoughts: Needs Assessment acronym: KUJK2NEEDS overallStatus: RECRUITING date: 2024-04-25 date: 2024-07-01 date: 2024-10-10 date: 2024-04-19 date: 2024-04-29 name: University Ghent class: OTHER briefSummary: The aim of the current project is twofold, namely

1. To gain insight into needs related to help-seeking among men with (previous) suicidal thoughts (STUDY 1). More specifically, this study examines help-seeking behaviour, possible barriers to seeking help and needs with regard to existing tools and health care among men who had suicidal thoughts. In other words, is there a difference in help-seeking behaviour between men and women with suicidal thoughts in the past and what factors contribute to this difference? More specifically:

   1. To what extent do men with suicidal thoughts in the past recognize their need for help, compared to women with suicidal thoughts in the past?
   2. What barriers and needs do men with suicidal thoughts in the past experience towards seeking help, compared to women with suicidal thoughts in the past?
   3. What barriers and needs do men with suicidal thoughts in the past experience to remain engaged in help, compared to women with suicidal thoughts in the past?
2. To map out needs of healthcare providers in working with men with suicidal thoughts and/or behaviour (STUDY 2). More specifically, how do healthcare providers experience working with men who are feeling suicidal and what are their experienced barriers and needs. Two main research questions were formulated:

   1. How do health care providers experience working with men (in comparison to women or people of other genders) who are feeling suicidal?
   2. What needs and barriers do health care providers experience when working with men (in comparison to women or people of other genders) who are feeling suicidal? conditions: Suicide Prevention conditions: Help-Seeking Behavior conditions: Men studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 586 type: ESTIMATED measure: STUDY 1: Help-seeking behavior measure: STUDY 1: Experienced need measure: STUDY 1: Emotional Openness measure: STUDY 1: Barriers measure: STUDY 1: Self-reliance measure: STUDY 1: Stigma measure: STUDY 1: needs of individuals with suicidal ideation measure: STUDY 2: needs of healthcare providers measure: STUDY 1: Socio-demographic characteristics measure: STUDY 1: Suicidality measure: STUDY 2: socio-demographic variables measure: STUDY 2: Professional experience with men with suicidal thoughts sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Flemish Centre of Expertise in Suicide Prevention, Ghent University status: RECRUITING city: Ghent zip: 9000 country: Belgium name: Eva De Jaegere, MSc role: CONTACT phone: +3293320775 email: eva.dejaegere@ugent.be lat: 51.05 lon: 3.71667 hasResults: False

 nctId: NCT06375187 id: GC203 TIL-ST-Ⅰ briefTitle: Engineering Tumor Infiltrating Lymphocytes Injection (GC203 TIL) for the Treatment of Advanced Malignant Solid Tumors acronym: KUNLUN-001 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-11-01 date: 2027-05-01 date: 2024-04-19 date: 2024-04-23 name: Shanghai Juncell Therapeutics class: INDUSTRY briefSummary: A clinical trial to assess the safety and efficacy of engineered Tumor Infiltrating Lymphocytes (TIL) for the treatment of Advanced Malignant Solid Tumors conditions: Solid Tumor conditions: Gynecologic Cancer conditions: Breast Cancer conditions: Gastrointestinal Cancer conditions: Lung Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: Engineering Tumor Infiltrating Lymphocytes measure: Maximal Tolerance Dose measure: Dose Limiting Toxicity measure: Adverse Events measure: Objective Response Rate measure: Duration of Response measure: Disease Control Rate measure: Progression-Free Survival measure: Overall Survival measure: Quality of Life Assessment sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06375174 id: NSISTRCR_2202 briefTitle: PRECISE (PERFUSION IMAGING TO IDENTIFY POSTERIOR CIRCULATION CANDIDATES FOR THROMBECTOMY) acronym: SWISS-PRECISE overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-09 date: 2026-02-28 date: 2026-02-28 date: 2024-04-19 date: 2024-04-19 name: Dr. med. Carlo Cereda class: OTHER_GOV briefSummary: We hypothesize that patients with a favorable Critical Area Perfusion Score (CAPS≤3) on cerebral perfusion imaging will have a favorable response to revascularization by thrombectomy and that patients with a CAPS\>3 will not conditions: Posterior Circulation Acute Ischemic Stroke Due to Large Vessel Occlusion of the Vertebral or Basilar Artery Needing Endovascular Thrombectomy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Thrombectomy measure: mRS score sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Neurocenter of Southern Switzerland, Ospedale Civico city: Lugano state: Ticino zip: CH-6900 country: Switzerland lat: 46.01008 lon: 8.96004 hasResults: False

 nctId: NCT06375161 id: CD19-CN-A6 briefTitle: Anti-CD19-CAR-T Cells in Relapsed/Refractory B-cell Tumor Patients. overallStatus: RECRUITING date: 2023-12-11 date: 2025-12-10 date: 2039-12-10 date: 2024-04-19 date: 2024-04-19 name: Shanghai Tongji Hospital, Tongji University School of Medicine class: OTHER briefSummary: This study is a single-center, open-label, single-dose clinical trial of anti-CD19-CAR-T cell therapy in relapsed/refractory B-cell tumor patients after Qinglin pre-treatment.

In this study phase, a traditional "3+3" trial design is employed for dose escalation. conditions: B Cell Malignancies studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: anti-CD19-CAR-T cells measure: Incidence of dose-limiting toxicity sex: ALL minimumAge: 18 Weeks maximumAge: 70 Weeks stdAges: CHILD facility: Shanghai Tongji Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200333 country: China name: Aibin Liang role: CONTACT phone: +8618601670600 email: lab7182@tongji.edu.cn name: Ping LI role: CONTACT phone: +86 135 6418 1131 email: lilyforever@126.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06375148 id: Yan2024-0052 briefTitle: A Questionnaire Survey on Cognition of Enteral Nutrition Implementation in Patients Requiring Mechanical Ventilation in Prone Position overallStatus: ENROLLING_BY_INVITATION date: 2024-03-20 date: 2024-05-30 date: 2024-06-30 date: 2024-04-19 date: 2024-04-19 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: Prone ventilation is an important treatment for respiratory failure with intractable hypoxia, and the Corona Virus Disease 2019(COVID-19 ) outbreak has further elevated the status of prone ventilation. Early enteral nutrition (EN) is also recognised as an important measure to improve the prognosis of critically ill patients. However, the administration of enteral nutrition during prone position is still quite controversial. In this paper, we analysed the tolerance and safety of enteral nutrition in the prone position by reviewing studies before and after the COVID-19 outbreak. Key strategies to improve the tolerability of enteral nutrition in the prone position are also summarised and discussed. conditions: Enteral Nutrition conditions: Prone Position studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED name: Enteral nutrition measure: A questionnaire survey on cognition of enteral nutrition implementation in patients requiring mechanical ventilation in prone position sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Zhejiang University School of Medicine city: Zhenjiang country: China lat: 32.21086 lon: 119.45508 hasResults: False

 nctId: NCT06375135 id: R1MD017205 briefTitle: mHealth + e-Navigator Stepped Care on ART Adherence in Latino MSM acronym: Project STEP overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-03-31 date: 2027-03-31 date: 2024-04-19 date: 2024-04-19 name: Florida International University class: OTHER name: Ann & Robert H Lurie Children's Hospital of Chicago name: Care Resource Community Health Centers briefSummary: The goal of this study is to evaluate the efficacy of stepped care strategies to improve ART adherence among adult Latino MSM with HIV using a sequential, multiple assignment, randomized trial (SMART). The trial will compare a stepped care strategy of delivering TXTXT ("Treatment Text") first and stepping up to remote patient navigation for non-responders vs. a stepped care strategy of delivering TXTXT + e-Navigation first and stepping up to EMA-supported e-Navigation for non-responders. Both TXTXT and the foundations of the e-Navigation interventions are CDC evidence-based interventions (EBI). We propose to use a SMART design which explicitly allows building, testing, and optimizing stepped care strategies without compromising rigor or randomization. We propose three specific aims:

Aim 1. Compare the immediate (6-month) and sustained (9- and 12-month) efficacy of two static (non-stepped) treatment regimens (TXTXT alone vs. TXTXT + e-Navigation) on ART adherence and viral suppression among Latino MSM with HIV. Hypothesis 1a. TXTXT + e-Navigation will be more efficacious than TXTXT alone. Aim 2. Compare the immediate (6-month) and sustained (9- and 12-month) efficacy of two stepped care strategies (TXTXT with added e-Navigation for non-responders vs. TXTXT + e-Navigation with added EMA support for non-responders) on ART adherence and viral suppression among Latino MSM with HIV. Hypothesis 2a: TXTXT + e-Navigation with added EMA support for non-responders at the 3-month follow-up will be more efficacious than TXTXT with added e-Navigation for non-responders at the 3-month follow-up. Aim 3. Identify baseline and time-varying moderators on the association between stepped care strategy and ART adherence and viral suppression among Latino MSM with HIV. Hypotheses 3a-c: TXTXT with added e-Navigation for non-responders will be less efficacious than TXTXT + e-Navigation with added EMA support for non-responders for individuals who are: (a) older at baseline, or report (b) substance use, or (c) symptoms of depression between baseline and the 3-month follow-up. conditions: ART Adherence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: We will enroll 250 adults Latino MSM with HIV with suboptimal ART adherence and randomize (1:1) into two arms: TXTXT (n=125) or TXTXT + e-Navigation (n=125). Those in Arm 1 who continue to have suboptimal adherence (\<90% pills taken) at 3-months will be re-randomized (1:1) to continue TXTXT or add e-Navigation; those in Arm 2 who have suboptimal adherence will be re-randomized (1:1) to continue TXTXT + e-Navigation or add EMA support. At 6-months, the intervention arms will cease to receive any intervention components and be followed for an additional 6-months. primaryPurpose: TREATMENT masking: NONE count: 250 type: ESTIMATED name: TXTXT name: e-Navigation name: Ecological Momentary Assessment (EMA) supported e-Navigation. measure: ART adherence measure: HIV viral load sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Care Resource Community Health Centers, Inc., d/b/a CARE RESOURCE city: Miami state: Florida zip: 331370000 country: United States name: Sheryl J Zayas, MD role: CONTACT phone: 305-576-1234 email: szayas@careresource.org name: Sheryl J Zayas, MD role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 hasResults: False

 nctId: NCT06375122 id: 10001951 id: 001951-C briefTitle: Natural History Study of Kaposi Sarcoma overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2034-12-31 date: 2036-12-31 date: 2024-04-19 date: 2024-04-26 name: National Cancer Institute (NCI) class: NIH briefSummary: Background:

Kaposi sarcoma (KS) is a type of tumor caused by the Kaposi sarcoma herpesvirus. KS usually affects the skin, but lesions can also appear in the lymph nodes, lungs and digestive tract. KS is most common in people with compromised immunity, but it also appears in otherwise healthy people. Researchers want to understand more about how KS develops, why it may recur, and how it affects the immune system and organs.

Objective:

To learn more about the natural history of KS.

Eligibility:

People aged 18 years and older with KS.

Design:

Participants will be screened. They will have a physical exam with blood tests. They will have an imaging scan. They may need a new biopsy: Tissue samples may be cut from their tumor. Their ability to perform normal activities will be assessed.

Participants will visit the clinic to have their KS evaluated. In addition to the imaging scans and other tests performed during screening, procedures may include:

Eye exam.

Ultrasound exam of the heart (electrocardiogram).

Collection of saliva and urine samples.

Biopsies of the skin or lymph nodes.

Swabs of the anus and cervix.

Photographs of skin lesions.

Removal of fluid samples from the space around the lungs, intestine, or heart.

The evaluation visit will be repeated 5 more times over 18 months and then yearly for up to 10 years.

Participants will follow their standard treatment for KS during the study. conditions: Kaposi Sarcoma conditions: HIV studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED measure: To characterize the natural history of KS, including presentation, manifestation, and proportion of participants with KS with remission and recurrence by epidemiologic subtype measure: To evaluate differences in rates of KS recurrence by HIV status and CD4 T cell count measure: To evaluate the emergence of KSHV-associated inflammatory syndromes in the natural history of KS 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 email: ncimo_referrals@mail.nih.gov lat: 38.98067 lon: -77.10026 hasResults: False

 nctId: NCT06375109 id: BJXK-2023-KY-53 id: NeoSCLC-001 type: OTHER domain: Beijing Chest Hospital, Capital Medical University briefTitle: PD-L1/PD-1 Inhibitors Plus Chemotherapy Versus Chemotherapy Alone for the Neoadjuvant Treatment of Limited-stage SCLC acronym: NeoSCLC-001 overallStatus: NOT_YET_RECRUITING date: 2024-04-16 date: 2027-04-15 date: 2029-04-15 date: 2024-04-19 date: 2024-04-19 name: Beijing Chest Hospital, Capital Medical University class: OTHER briefSummary: This is an open-label, non-randomized, controlled, single-center, phase II study to compare the efficacy and safety of neoadjuvant PD-L1/PD-1 inhibitor + chemotherapy (carboplatin/cisplatin + etoposide) with chemotherapy (carboplatin/cisplatin + etoposide) alone followed by radical surgery and adjuvant treatment as perioperative therapy in patients with limited-stage SCLC. conditions: Limited-stage Small-cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Tislelizumab name: Carboplatin injection name: Cisplatin injection name: Etoposide injection measure: Pathologic Complete Response (pCR) Rate measure: Major Pathologic Response (MPR) Rate measure: Event-Free Survival (EFS) measure: Overall Survival (OS) measure: Objective response rate (ORR) measure: Safety: frequency of severe adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06375096 id: Graves' disease briefTitle: Bone Mineral Density in Children With Graves' Disease overallStatus: NOT_YET_RECRUITING date: 2024-06-25 date: 2025-06-25 date: 2025-06-25 date: 2024-04-19 date: 2024-04-19 name: Assiut University class: OTHER briefSummary: to evaluate bone mineral density in children with graves' disease conditions: Bone Density, Low conditions: Bone Mineral Density in Children With Graves' Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: evaluate bone mineral density measure: bone mineral density sex: ALL minimumAge: 2 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06375083 id: 23-1231 briefTitle: Computerized Cognitive Behavioral Therapies for Suicide Prevention and Depression overallStatus: RECRUITING date: 2024-03-20 date: 2024-12-30 date: 2024-12-30 date: 2024-04-19 date: 2024-04-19 name: VA Eastern Colorado Health Care System class: FED briefSummary: This study plans to learn more about the use of one of two self-guided online cognitive behavioral therapy courses. One is focused on symptoms of depression and one is focused on history of suicidal thoughts and behaviors. conditions: Suicide conditions: Depression studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Cognitive Behavioral Therapy for Suicide Prevention (cCBT-SP) and Cognitive Behavioral Therapy for Depression (cCBT-D) primaryPurpose: TREATMENT masking: NONE count: 472 type: ESTIMATED name: Cognitive Behavioral Therapy measure: Client Satisfaction Questionnaire measure: Internet Evaluation and Utility Questionnaire measure: Internet Impact and Effectiveness Questionnaire measure: Narrative Evaluation of Intervention Interview measure: Recruitment Rate measure: Completion of intervention measure: Beck Scale for Suicide Ideation measure: Patient Health Questionnaire-9 measure: Posttraumatic Stress Disorder Checklist-5 measure: Generalized Anxiety Disorder-7 measure: Computerized Adaptive Testing - Suicide Scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eastern Colorado Health Care System status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Lisa A Brenner, PhD role: CONTACT phone: 720-723-6488 email: Lisa.Brenner@va.gov name: Kelly A Stearns-Yoder, MA role: CONTACT phone: 720-723-6477 email: Kelly.Stearns@va.gov lat: 39.72943 lon: -104.83192 hasResults: False

 nctId: NCT06375070 id: RMeng1 briefTitle: Anticoagulants for PFO Patients overallStatus: COMPLETED date: 2016-08 date: 2022-08 date: 2022-08 date: 2024-04-19 date: 2024-04-19 name: Xuanwu Hospital, Beijing class: OTHER briefSummary: Patients who underwent both bubble transcranial Doppler (bubble-TCD) and transoesophageal echocardiography (TEE) at our institution were consecutively enrolled in this real-world case-control study from August 2016 through August 2023. The patients were categorized into three groups based on the degree of the shunt observed: mild (3-9 bubbles), moderate (10-30bubbles), and severe (more than 30 bubbles). In cases with mild-shunt (small-size) PFO, post-procedural anticoagulation or PFO closure was administered. Subsequent to the interventions, the follow-up encompassed the recording of migraine remission, recurrent neurological incidents, instances of major bleeding, and mortality. conditions: Patent Foramen Ovale studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 277 type: ACTUAL name: PFO closure name: anticoagulant measure: whether occur recurrent stroke or migraine relief sex: ALL minimumAge: 16 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06375057 id: asiamkfv49wurfpylld2m6g7cr4kz6 briefTitle: Relationship Between Acute Phase Markers and Post-operative Pain in Laparoscopic Cholecystectomy: An Observational Study overallStatus: RECRUITING date: 2023-03-03 date: 2024-02-26 date: 2025-12-31 date: 2024-04-19 date: 2024-04-19 name: University of Roma La Sapienza class: OTHER briefSummary: Many patients undergoing laparoscopic cholecystectomy are prone to developing acute and chronic post-operative pain.

The aim of the study is to show a possible correlation between pain and acute phase proteins in order to:

* predict the severity of pain;
* select most suitable pain relief therapy for the patient. conditions: Post Operative Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 54 type: ESTIMATED name: laparoscopic cholecystectomy measure: Relationship Between Post-operative Pain and C Reactive Protein (CRP) in Laparoscopic Cholecystectomy measure: Relationship Between Post-operative Pain and D-dimer in Laparoscopic Cholecystectomy measure: Relationship Between Post-operative Pain and Fibrinogen in Laparoscopic Cholecystectomy measure: Relationship Between Post-operative Pain and white blood cell count in Laparoscopic Cholecystectomy measure: Relationship Between Post-operative Pain and Neutrophil to Lymphocyte Ratio (NLR) in Laparoscopic Cholecystectomy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Augusto Lauro status: RECRUITING city: Roma zip: 000186 country: Italy name: Augusto Lauro role: CONTACT phone: +39 388 8663 879 email: augusto.lauro@uniroma1.it lat: 41.89193 lon: 12.51133 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-03-03 uploadDate: 2024-04-16T07:17 filename: Prot_SAP_000.pdf size: 179155 hasResults: False

 nctId: NCT06375044 id: SIM0500-101 briefTitle: Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2026-06-30 date: 2028-12-30 date: 2024-04-19 date: 2024-04-19 name: Jiangsu Simcere Pharmaceutical Co., Ltd. class: INDUSTRY name: Shanghai Xianxiang Medical Technology Co., Ltd. briefSummary: This is an open-label, multicenter phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0500 in adult participants with Relapsed or Refractory Multiple Myeloma(RRMM). The trial is consisted of two parts, Part 1 (dose escalation) and Part 2 (dose optimization). In both parts, SIM0500 will be administered until disease progression, intolerable toxicity, withdraw of consent or end of trial. conditions: Relapsed or Refractory Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: SIM0500 measure: Dose-limiting toxicity (DLT) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences city: Tianjin state: Tianjin zip: 300000 country: China name: Yan Xu role: CONTACT email: xuyan1@ihcams.ac.cn lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06375031 id: HR011408-103 briefTitle: Comparison of HR011408 and NovoRapid® in Subjects With Diabetics overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-07-01 date: 2024-07-15 date: 2024-04-19 date: 2024-04-19 name: Jiangsu HengRui Medicine Co., Ltd. class: INDUSTRY briefSummary: The objective of the study is to compare the pharmacokinetics and pharmacodynamics between HR011408 and NovoRapid® in Subjects with Diabetics. conditions: Diabetes studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The study was designed as a multi-center, randomized, double-blind, three-cycle crossover, positive drug control (NovoRapid ®) To compare the pharmacokinetics, pharmacodynamics, safety, and tolerability of a single injection of HR011408 or NovoRapid ® before or after a standard meal test in patients with type 1 or type 2 diabetes. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: HR011408 injection; HR011408 injection Placebo name: NovoRapid®; HR011408 injection Placebo name: HR011408 injection Placebo; HR011408 injection measure: Area under the serum concentration-time curve of insulin aspart measure: Area under the serum concentration-time curve of insulin aspart measure: Plasma glucose concentration measure: Number of subjects with adverse events and severity of adverse events sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: The Second Hospital of Anhui Medical University city: Hefei state: Anhui zip: 230601 country: China name: 230601 Pan, Doctor role: CONTACT phone: 0551-65997421 email: ptr1968@163.com name: Wei Hu, Doctor role: CONTACT phone: 0551-65997421 email: ayefygcp@163.com lat: 31.86389 lon: 117.28083 hasResults: False

 nctId: NCT06375018 id: OST1_011 briefTitle: Effect of the Diaphragm Stretching Technique on Nonspecific Low Back Pain overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-19 date: 2024-04-19 name: Escola Superior de Tecnologia da Saúde do Porto class: OTHER briefSummary: This study aims to analyze the efficacy of diaphragm stretching technique on symptomatology in young adults with nonspecific low back pain. conditions: Nonspecific Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Placebo Technique name: Diaphragm Stretching measure: Change in level of inspiratory capacity immediately after intervention measure: Change in the level of disability derived from low back pain immediately after the intervention measure: Change in the level of functionality of the lumbar spine immediately after the intervention sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Escola Superior de Saúde do Porto city: Porto zip: 4200-072 country: Portugal lat: 41.14961 lon: -8.61099 hasResults: False

 nctId: NCT06375005 id: 2024-0381 briefTitle: Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-08-01 date: 2026-12-31 date: 2024-04-19 date: 2024-04-19 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: This study is a prospective, open-label, randomized, controlled, multi-center clinical trial. The aim of this study is to investigate the efficacy and safety of Telitacicept in adults with early diffuse cutaneous systemic sclerosis (dcSSc), with Mycophenolate Mofetil (MMF) administered as a background treatment. conditions: Diffuse Cutaneous Systemic Sclerosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 38 type: ESTIMATED name: Telitacicept name: Mycophenolate Mofetil measure: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 48 measure: Percentage of Participants With Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24 measure: Percentage of Participants Who Improved in Modified Rodnan Skin Score (mRSS) by ≥20%, ≥40%, ≥60% From Baseline to Week 24 and Week 48 measure: American College of Rheumatology Composite Response Index for Systemic Sclerosis (ACR-CRISS) and Revised ACR-CRISS at Week 24 and 48 measure: Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted at Week 24 and Week 48 measure: Change From Baseline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) Percent Predicted (Corrected For Hemoglobin) at Week 24 and Week 48 measure: Change From Baseline in Patient's Global Assessment at Week 24 and Week 48 measure: Change From Baseline in Physician's Global Assessment at Week 24 and Week 48 measure: Change From Baseline in Short Form-36 (SF-36) Questionnaire at Week 24 and Week 48 measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24 and Week 48 measure: Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI) at Week 24 and Week 48 measure: Change From Baseline in Tender Joint Counts at Week 24 and Week 48 measure: Change From Baseline in Swollen Joint Counts at Week 24 and Week 48 measure: Change From Baseline in Digital Ulcer Counts at Week 24 and Week 48 sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affiliated Hospital of Yangzhou University city: Yangzhou state: Jiangsu zip: 225009 country: China lat: 32.39722 lon: 119.43583 facility: Huashan Hospital of Fudan University city: Shanghai state: Shanghai zip: 200433 country: China lat: 31.22222 lon: 121.45806 facility: Hangzhou First People's Hospital city: Hangzhou state: Zhejiang zip: 310006 country: China lat: 30.29365 lon: 120.16142 facility: Sir Run Run Shaw Hospital, Zhejiang University School Of Medicine city: Hangzhou state: Zhejiang zip: 310016 country: China lat: 30.29365 lon: 120.16142 facility: The Second Affiliated Hospital of Zhejiang University School of Medicine city: Hangzhou state: Zhejiang zip: 310016 country: China name: Jing Xue, PhD role: CONTACT phone: 86-13858121751 email: jingxue@zju.edu.cn lat: 30.29365 lon: 120.16142 facility: Changxing People's Hospital city: Huzhou state: Zhejiang zip: 313100 country: China lat: 30.8703 lon: 120.0933 facility: The First Hospital of Jiaxing city: Jiaxing state: Zhejiang zip: 314000 country: China lat: 30.7522 lon: 120.75 facility: Ningbo First Hospital city: Ningbo state: Zhejiang zip: 315000 country: China lat: 29.87819 lon: 121.54945 facility: The First Affiliated Hospital of Wenzhou Medical University city: Wenzhou state: Zhejiang zip: 325000 country: China lat: 27.99942 lon: 120.66682 hasResults: False

 nctId: NCT06374992 id: Pro00114569 briefTitle: Family Involvement Hospital Ethnography overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-08 date: 2024-08 date: 2024-04-19 date: 2024-04-19 name: Duke University class: OTHER briefSummary: The goal of this observational study is to learn about the role of family members in caring for hospitalized older adults with cognitive impairment. The main questions it aims to answer are:

1. What features of the healthcare system facilitate or hinder family involvement in care from the perspective of patients, families, and healthcare workers?
2. How do hospital leaders understand the facilitators and barriers to family involvement?

Data collection will occur via semi-structure interviews, direct observation, and artifact analysis. conditions: Dementia studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED measure: Faciltators and Barriers to Family Involvement in Care of Hospitalized Older Adults with Cognitive Impairment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06374979 id: 2024-0047 briefTitle: Efficacy and Safety of Ixekizumab in Patients With Refractory Guttate Psoriasis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2025-06 date: 2024-04-19 date: 2024-04-19 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: The goal of this clinical trial is to analyse efficacy and safety of ixekizumab in participants with refractory guttate psoriasis. The main question it aims to answer is:

What percentage of participants achieved more than 90% reduction from baseline in Psoriasis Area Index （PASI 90） after 12 weeks of ixekizumab treatment? Participants will receive a 12-week treatment of ixekizumab, with follow-up visits every 2 weeks during the treatment period. Keep a diary of their symptoms and Psoriasis Area Index. conditions: Guttate Psoriasis studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Ixekizumab measure: PASI 90 response measure: PGA 0/1 response measure: PASI 100 response measure: Relapse sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06374966 id: 2024-0246 briefTitle: Real-world Study of Efficacy and Safety of Zonisamide in add-on Therapy for Patients With Focal Epilepsy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-09 date: 2025-12 date: 2024-04-19 date: 2024-04-19 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER name: Hangzhou Children's Hospital name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine name: Jinhua Second Hospital name: Ningbo Medical Center Lihuili Hospital name: Ningbo Women & Children's Hospital name: Yuyao People's Hospital name: Huzhou Third People's Hospital name: The Second Affiliated Hospital of Jiaxing University name: Lishui Country People's Hospital briefSummary: Patients were first observed for a 4-week baseline period, which required no medication adjustments and a seizure frequency of greater than or equal to 2 times per 4-week . After the baseline observation period, if the patients met the criteria for enrolment and there were no contraindications, zonisamide was added as an additional therapeutic drug.Clinical data were collected before the initiation of treatment, at 1 month, 3 months and 6 months after taking zonisamide respectively, with regular review of blood tests and urinary ultrasound, and imaging and electrophysiological examinations according to the clinical needs of the patient's actual condition. conditions: Epilepsies, Partial studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: Zonisamide measure: Effective rate at 6 months of treatment measure: Effective rate at 3 months of treatment measure: Total time to treatment failure measure: Incidence of side effects sex: ALL minimumAge: 2 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Hangzhou Children's Hospital city: Hangzhou state: Zhejiang zip: 310005 country: China name: Zhanli Liu, doctorate role: CONTACT phone: 15968194368 email: liuzhanli@126.com lat: 30.29365 lon: 120.16142 facility: The Second Affiliated Hospital of Zhejiang University School of Medicine city: Hangzhou state: Zhejiang zip: 310009 country: China name: Shuang Wang, doctorate role: CONTACT phone: 13588817561 email: wangs77@zju.edu.cn lat: 30.29365 lon: 120.16142 facility: Huzhou Third People's Hospital city: Huzhou state: Zhejiang zip: 313002 country: China name: Changguo Zhang, doctorate role: CONTACT phone: 15957288075 email: zhangcg1981@163.com lat: 30.8703 lon: 120.0933 facility: Jiaxing Second hospital city: Jiaxing state: Zhejiang zip: 314099 country: China name: Xiaoxiang Yu, doctorate role: CONTACT phone: 13567340650 email: 43262048@qq.com lat: 30.7522 lon: 120.75 facility: Jinhua Second hospital city: Jinhua state: Zhejiang zip: 321016 country: China name: Suhong Ye, doctorate role: CONTACT phone: 13757990511 email: 1073774376@qq.com lat: 29.10678 lon: 119.64421 facility: The Fourth Affilicated Hospital of Zhejiang University School of Medicine city: Jinhua state: Zhejiang zip: 322099 country: China name: Jiajia Fang, doctorate role: CONTACT phone: 15215880868 email: fangjjiaj@zju.edu.cn lat: 29.10678 lon: 119.64421 facility: Lishui People's Hospital city: Lishui state: Zhejiang zip: 323050 country: China name: Likang Lan, doctorate role: CONTACT phone: 18957090351 email: lsllk67@163.com lat: 28.46042 lon: 119.91029 facility: Ningbo Women And Children's Hospital city: Ningbo state: Zhejiang zip: 315012 country: China name: Minghai Huang, doctorate role: CONTACT phone: 13605742462 email: hmhai432@126.com lat: 29.87819 lon: 121.54945 facility: Ningbo Medical center Lihuili hospital city: Ningbo state: Zhejiang zip: 315048 country: China name: Xiaoqin Fan, doctorate role: CONTACT phone: 13685739576 email: fanteacher@163.com lat: 29.87819 lon: 121.54945 facility: Yuyao People's hospital city: Yuyao state: Zhejiang zip: 315499 country: China lat: 30.05 lon: 121.14944 hasResults: False

 nctId: NCT06374953 id: 2024-0182 briefTitle: A Novel Viscoelastic Test Based on Ultrasonic Guided Wave for Identifying Hyperfibrinolysis Rapidly overallStatus: RECRUITING date: 2024-03-26 date: 2024-09-30 date: 2024-09-30 date: 2024-04-19 date: 2024-04-19 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: This study compares the results of the existing fibrinolysis monitoring technology to the Ultrasound-based viscoelastic hemostasis analysis, a new method, using small amount of extra blood obtained during routine blood draws in surgery patients. conditions: Hyperfibrinolysis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 140 type: ESTIMATED name: Ultrasound-based viscoelastic hemostasis analysis measure: Comparison of the novel viscoelastic hemostasis analysis results to TEG-LY30 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Zhejiang University anesthesiology department status: RECRUITING city: Hangzhou state: Zhejiang zip: 310009 country: China name: Fengjiang ZHANG role: CONTACT phone: +8613858007629 email: zrzfj@zju.eud.cn lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06374940 id: Lütfi Kırdar City Hospital briefTitle: Surgical Outcomes of Conventional Hysterectomy or Manipulator-assisted Abdominal Hysterectomy overallStatus: ENROLLING_BY_INVITATION date: 2024-04-17 date: 2024-05-17 date: 2024-05-18 date: 2024-04-19 date: 2024-04-19 name: Dr. Lutfi Kirdar Kartal Training and Research Hospital class: OTHER_GOV briefSummary: Objective: The comparison of surgical outcomes conventional hysterectomy and manipulator-assisted hysterectomy

Study design: Prospective randomized controlled trial. Allocation to either group occurred via computer-generated random numbers. Sequentially numbered, opaque envelopes were prepared according to randomization. The patients were unaware of whether they would undergo a conventional hysterectomy or manipulator-assisted abdominal hysterectomy for their surgical procedure. The research coordinator unveiled group assignments upon individual patient recruitment by opening the corresponding envelope.

Study population: Inclusion criteria were patients aged 40-70 years who underwent hysterectomy for benign gynecological indications.

Primary outcomes: (1) Operation Time.

Secondary outcomes: (1) Postoperative early pain (Visual Analog Score (VAS) at 6th and 24th hours of the surgery) (2) intraoperative complications, (3) postoperative complications conditions: Gynecologic Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 140 type: ESTIMATED name: Manipulator-assisted Abdominal Hysterectomy measure: Duration of the surgical procedure measure: Postoperative pain at 6th hours measure: Postoperative pain at 24th hours measure: intraoperative complications measure: Postoperative complications sex: FEMALE minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dr.Lütfi Kırdar City Hospital city: Istanbul zip: 34000 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06374927 id: PHRASE-2023 briefTitle: Personalised Health Cognitive Assistance for RehAbilitation SystEm (PHRASE): A Feasibility Study acronym: PHRASE-2023 overallStatus: RECRUITING date: 2024-04-25 date: 2024-10-01 date: 2024-10-30 date: 2024-04-19 date: 2024-04-23 name: Donders Centre for Neuroscience class: OTHER briefSummary: The incidence of cognitive and neuromotor impairment caused by strokes has become a growing challenge.

The patient's journey to recovery in the healthcare system involves multiple phases, spanning from initial hospitalization to in-patient and out-patient rehabilitation, finally leading to the patient's return to home. The access to stroke units and rehabilitation varies within Europe. Unfortunately, not everyone has access to rehabilitation programs, and the benefits derived from these programs often decline after hospital discharge.

Currently, the support of the patient is organized in a rather fragmented way, and informal care sometimes places a severe burden requiring dedicated support in the patient's social environment. The PHRASE project proposes to deploy rehabilitation technology such as the Rehabilitation Gaming System (RGS) to instil and support a virtuous cycle of stroke patients' recovery in the at-home setting. RGS is an effective advanced digital tool for rehabilitation programs that uses Augmented Reality (AR)- and Virtual Reality (VR)-based gamified training grounded on neuroscientiﬁc principles, that has been shown to promote cognitive and motor recovery after a stroke at the clinic and home.

There are many dedicated cognitive therapies, but most rehabilitation outcomes are mostly limited to the task trained and do not extend to day-to-day function or remain unconvincing. Based on recent literature, the PHRASE RGS-based system can provide an effective tool to address cognitive impairment using VR-based interventions. In a previous study, the neuropsychological test battery was compiled by the neuropsychologist and covered four cognitive domains: 1. basic attention, 2. memory (short-term memory), 3. visuospatial memory, and 4. executive function. All these functions were tested using VR-based tasks. The conclusion of this study confirms the possibility of addressing cognitive impairment effectively using VR-based interventions when properly mapped with clinical scales.

The validation of the PHRASE system with post-stroke patients is needed to strengthen its usefulness and effectiveness for cognitive rehabilitation at home. For this, a feasibility study will be conducted to measure its usability, adherence, acceptance, and the user's experience.

The investigators will also explore the effectiveness of the PHRASE system in improving cognitive function (attention, memory, executive function) after stroke.

Participants: stroke patients at different time points after stroke (acute, subacute, and chronic), aged over 18 years. The participants will integrate the PHRASE technology into their daily routines in parallel to their regular neurorehabilitation treatment for 6 weeks. conditions: Stroke studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Rehabilitation Gaming System (VR-based mobile application) measure: Usability measure: User experience measure: Adherence measure: Acceptance measure: The Montreal Cognitive Assessment (MoCA) measure: Fugl-Meyer Assessment of the sensorimotor function of the upper limb (FMA-UE) measure: Hamilton Depression Rating Scale (HDRS) measure: Fatigue Severity Scale (FSS) measure: Pain Visual Analogue Scale (VAS) measure: Barthel Index (BI) measure: EuroQol - 5 Dimension - 5 Level (EQ-5D-5L) measure: Modified Ashworth scale (MAS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre hospitalier universitaire de Limoges status: NOT_YET_RECRUITING city: Limoges zip: 87000 country: France name: Stephane Mandigout, Dr. role: CONTACT email: stephane.mandigout@unilim.fr lat: 45.83153 lon: 1.25781 facility: Cluj Rehabilitation Hospital status: NOT_YET_RECRUITING city: Cluj-Napoca state: Cluj zip: 400066 country: Romania name: Stefan Strilciuc, PhD. role: CONTACT email: stefan.strilciuc@genomics-center.ro lat: 46.76667 lon: 23.6 facility: Parc Sanitari Sant Joan de Déu status: RECRUITING city: Barcelona country: Spain name: Raffaele Fiorillo, Dr. role: CONTACT email: raffaele.fiorillo@sjd.es name: Raffaele Fiorillo role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: IRF La Salle status: NOT_YET_RECRUITING city: Madrid country: Spain name: Miguel Gómez Martínez, Dr. role: CONTACT email: miguel.gomez@lasallecampus.es name: Miguel Gómez Martínez, Dr. role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06374914 id: TUO-UR-23-05 briefTitle: Sequential Intravesical Gemcitabine and Docetaxel for Rescue Therapy in BCG Unresponsive Non-muscle Invasive Bladder Cancer Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-09 date: 2026-04-09 date: 2026-04-09 date: 2024-04-19 date: 2024-04-19 name: Dokuz Eylul University class: OTHER briefSummary: Studies in the literature are limited both throughout Turkey and in general. For this reason, as a result of the study that we will create, it will provide us with information for bladder protective treatments in patients who do not respond to BCG therapy in bladder cancer patients. conditions: Bladder Cancer conditions: BCG conditions: Gemcitabine conditions: Docetaxel conditions: Intravesical Instillation studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 120 type: ESTIMATED name: Intravesical Solution measure: Recurrence rate measure: Progression rate measure: Adverse effects of intravesical chemotherapy measure: Intravesical chemotherapy versus radical cystectomy measure: treatment change sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dokuz Eylul University Faculty of Medicine Department of Urology city: Izmir state: Other (Non U.s.) zip: 35330 country: Turkey name: Muhammed Selcuk Ozer, Medical Doctor role: CONTACT phone: +905543078941 email: mseljukozer@gmail.com name: Ozan Bozkurt, Professor role: CONTACT email: drozanbozkurt@gmail.com name: Ozan Bozkurt, Professor role: PRINCIPAL_INVESTIGATOR lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06374901 id: IRB-2024-311 briefTitle: Tislelizumab Combined With Neoadjuvant Chemotherapy Used in the Perioperative Treatment. overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2026-03-31 date: 2028-03-31 date: 2024-04-19 date: 2024-04-19 name: Xiangdong Cheng class: OTHER name: Liaoning Tumor Hospital & Institute name: Shanxi Province Cancer Hospital name: Sichuan Cancer Hospital and Research Institute name: The Second Affiliated Hospital of Harbin Medical University briefSummary: To evaluate the efficacy of Tislelizumab in combination with chemotherapy versus chemotherapy in neoadjuvant treatment of patients with MHC-II positive (IHC≥2+) and locally advanced gastric/gastroesophageal junction adenocarcinoma by evaluating the main pathologic response rate (MPR). conditions: Gastric Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 134 type: ESTIMATED name: Tislelizumab name: SOX/XELOX measure: MRP (Main pathological response) measure: pCR (pathologic complete response) measure: DFS (Disease free survival) measure: OS (Overall survival) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital) city: Hangzhou state: Zhejiang country: China lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06374888 id: CVL009-2002 briefTitle: Nilatinib Maleate Tablets Combined With Capecitabine in the Treatment of HER2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastases overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2026-09-30 date: 2027-07-30 date: 2024-04-19 date: 2024-04-19 name: Convalife (Shanghai) Co., Ltd. class: INDUSTRY briefSummary: To evaluate the efficacy of nilatinib maleate tablets combined with capecitabine in the treatment of HER2-positive advanced esophageal/esophagogastric junction/gastric adenocarcinoma with brain metastasis. conditions: Her2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastasis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Her2-positive advanced esophageal/esophagogastric junction/gastric adenocarcinoma with brain metastases primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: Neratinib maleate in combination with capecitabine measure: Objective response rates of the central nervous system as assessed by the Independent Imaging Evaluation Committee based on RECIST1.1 measure: Central nervous response rate measure: Objective response rates outside the central nervous system measure: Disease control rate measure: Duration of reaction measure: Clinical benefit rate measure: overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06374875 id: 24-213 briefTitle: Fibrosis Lessens After Metabolic Surgery acronym: FLAMES overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2029-05-31 date: 2029-12-31 date: 2024-04-19 date: 2024-04-19 name: Ali Aminian class: OTHER briefSummary: Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), a major global public health concern, is commonly associated with obesity, diabetes, and dyslipidemia. MASLD is currently the most common cause of chronic liver disease affecting about 80% of people with obesity, ranging from simple fat deposits in the liver to Metabolic Dysfunction-Associated Steatohepatitis (MASH), cellular injury, advanced fibrosis, cirrhosis, or hepatocellular carcinoma. Patients with MASH are also at risk for cardiovascular disease and mortality. There is no universally approved medication for MASH. Weight loss remains the cornerstone of MASH treatment.

Patients meeting the inclusion and exclusion criteria and who give informed consent will be enrolled in the trial and undergo the baseline liver biopsy (if none available). Approximately 120 patients with MASH and liver fibrosis (F1-F4 in baseline liver biopsy) will be randomized in a 1:1 ratio to metabolic surgery or medical treatment (incretin-based therapies ± other medical therapies for MASH) and followed for 2 years at which time a repeat liver biopsy will be performed for the assessment of the primary end point. conditions: Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) conditions: Non-Alcoholic Fatty Liver Disease conditions: Metabolic Dysfunction-Associated Steatohepatitis (MASH) conditions: Liver Fibrosis conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients will be randomized in a 1:1 ratio into 1 of the 2 arms using a computer-generated randomization plan, stratified to ensure that there are equal number of patients with/without T2DM and with/without F4 (cirrhosis) according to the baseline liver biopsy in each treatment group (surgical group vs non-surgical group). The participant sites are regrouped into three geographic regions. All patients in each region will be randomized separately to have equal number of patients with/without T2DM and with/without F4 in each treatment group in each region. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Patients and investigators will not be blinded to treatment assignment. The treatment assignment will remain unknown until the patient is randomized after meeting all eligibility requirements.

Pathologists who report the liver biopsies (to assess the primary end point of study) are blinded to treatment assignment whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Metabolic surgery name: Incretin-Based Therapy measure: Improvement of at least 1 fibrosis stage of the Kleiner fibrosis classification and no worsening of MASH in the repeat liver biopsy. measure: MASH resolution in the repeat liver biopsy measure: MASH resolution and fibrosis improvement in the repeat liver biopsy measure: Fibrosis progression in the repeat liver biopsy measure: Average Weight loss percentage measure: Disease-specific Quality of Life (QoL) measure: MASLD-related histopathologic end points measure: MASLD-related laboratory end points measure: MASLD-related liver scan end points measure: MASLD-related clinical end points measure: Achieved Weight-loss proportions measure: Weight change (kg) measure: BMI change (kg/m^2) measure: Excess weight loss, % measure: Change in waist circumference, cm measure: Systolic blood pressure trends, mmHg measure: Mean and change from baseline in lipid panel, mg/dl measure: Changes in glucose hemostasis markers measure: Percentage of patients with T2DM meeting predefined HbA1c targets measure: Changes in inflammatory markers, CRP mg/L measure: Change in cardiovascular and diabetes medications measure: SF-Bari Score measure: Quality of life end points measure: Safety end points sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Banner Health Center city: Phoenix state: Arizona zip: 85006 country: United States name: Farah Husain, MD role: CONTACT email: Farah.husain@bannerhealth.com lat: 33.44838 lon: -112.07404 facility: Indiana University city: Indianapolis state: Indiana zip: 46202 country: United States name: Dimitrios Stefanidis, MD, PhD role: CONTACT email: dstefanidis@iuhealth.org lat: 39.76838 lon: -86.15804 facility: Mayo Clinic city: Rochester state: Minnesota zip: 55905 country: United States name: Omar Ghanem, MD role: CONTACT email: ghanem.omar@mayo.edu lat: 44.02163 lon: -92.4699 facility: Cleveland Clinic city: Cleveland state: Ohio zip: 44195 country: United States name: Ali Aminian, MD role: CONTACT email: aminiaa@ccf.org lat: 41.4995 lon: -81.69541 facility: Hospital Alemão Oswaldo Cruz city: São Paulo country: Brazil name: Ricardo Cohen, MD role: CONTACT email: ricardo.cohen@haoc.com.br lat: -23.5475 lon: -46.63611 facility: McGill University city: Montréal country: Canada name: Amin Andalib, MDCM, MSc role: CONTACT email: amin.andalib@mcgill.ca lat: 45.50884 lon: -73.58781 facility: Turku University Hospital city: Turku country: Finland name: Paulina Salminen, MD, PhD role: CONTACT email: paulina.salminen@tyks.fi lat: 60.45148 lon: 22.26869 facility: Sri Aurobindo Institute of Medical Sciences city: Indore country: India lat: 22.71792 lon: 75.8333 facility: The Digestive Health Institute city: Mumbai country: India lat: 19.07283 lon: 72.88261 facility: University College Dublin city: Dublin country: Ireland name: Helen Heneghan, MB BCh BAO, PhD role: CONTACT email: helen.heneghan@ucd.ie lat: 53.33306 lon: -6.24889 facility: Università Cattolica del Sacro Cuore city: Milan country: Italy name: Geltrude Mingrone, M.D. PhD role: CONTACT email: geltrude.mingrone@unicatt.it lat: 45.46427 lon: 9.18951 facility: Sapienza Università di Roma city: Roma country: Italy name: Giovanni Casella, MD role: CONTACT email: giovanni.casella@uniroma1.it lat: 41.89193 lon: 12.51133 facility: Kuwait University city: Kuwait country: Kuwait lat: 29.36972 lon: 47.97833 facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador city: Mexico City country: Mexico name: Mauricio Sierra, MD role: CONTACT lat: 19.42847 lon: -99.12766 facility: Hospital Clínic Barcelona city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 facility: Linköping University city: Linköping country: Sweden lat: 58.41086 lon: 15.62157 facility: Örebro University city: Örebro country: Sweden name: Erik Stenberg, MD, PhD role: CONTACT email: erik.stenberg@regionorebrolan.se lat: 59.27412 lon: 15.2066 facility: Clarunis Universitäres city: Basel country: Switzerland name: Ralph Peterli, Dr. med role: CONTACT email: ralph.peterli@clarunis.ch lat: 47.55839 lon: 7.57327 facility: Hôpitaux universitaires de Genève city: Geneva country: Switzerland name: Minoa Jung, PD Dr. med. role: CONTACT email: minoa.jung@hcuge.ch lat: 46.20222 lon: 6.14569 facility: Nuffield Health Bristol Hospital city: Bristol country: United Kingdom name: Dimitri Pournaras, PhD role: CONTACT email: dpournaras@doctors.org.uk lat: 51.45523 lon: -2.59665 facility: King's College Hospital city: London country: United Kingdom name: Francesco Rubino, MD role: CONTACT email: francesco.rubino@kcl.ac.uk lat: 51.50853 lon: -0.12574 facility: Queen Mary University city: London country: United Kingdom name: William Alazawi, MB BChir PhD role: CONTACT email: w.alazawi@qmul.ac.uk lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06374862 id: PI2024_843_0008 briefTitle: Effects of Specific Thoracic Spine Mobilizations on Muscle Activity in a Healthy Volunteer Population acronym: RACHI-MOB overallStatus: RECRUITING date: 2024-03-28 date: 2025-10 date: 2025-10 date: 2024-04-19 date: 2024-04-19 name: Centre Hospitalier Universitaire, Amiens class: OTHER briefSummary: In this study, the investigators will examine the effect of manual therapy on the thoracic spine and its impact on the muscular strength gain of the thoracic extensors. Treatment with manual therapy, as described by Maitland, consists of a specific mobilization of the thoracic spine in the postero-anterior direction on the transverse and spiny processes of the thoracic vertebrae. To ensure the relevance of the measures, and to better control the occurrence of biases inherent to the practice of manual therapy, the investigators constituted three distinct groups: an intervention group, a control group and a group without intervention. In short, this methodology will allow us to explore in detail the effects of specific spinal mobilization on motor control, while taking into account placebo response elements and natural variations in the results conditions: Musculoskeletal Manipulations conditions: Range of Motion conditions: Muscle Strength conditions: Peripheral Joints in Upper Quarters studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 156 type: ESTIMATED name: mobilization name: no effect measure: electrical activity assessment of the spine extensor muscles using EMG sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Amiens Picardie status: RECRUITING city: Amiens state: Picardie zip: 80054 country: France name: Vicente BELTRAN AIBAR role: CONTACT phone: 03.22.45.59.92 email: BeltranAibar.Vicente@chu-amiens.fr name: François-Régis Sarhan role: SUB_INVESTIGATOR lat: 49.9 lon: 2.3 hasResults: False

 nctId: NCT06374849 id: PI2023_843_0173 briefTitle: Intraoperative Sufentanil and Chronic Postsurgical Pain in Non-major Scheduled Abdominal Surgery acronym: ISPAIN overallStatus: RECRUITING date: 2024-03-17 date: 2026-04 date: 2026-07 date: 2024-04-19 date: 2024-04-19 name: Centre Hospitalier Universitaire, Amiens class: OTHER briefSummary: Several risk factors for chronic postoperative pain have been identified. A series of studies have shown that administrating intraoperatively a high dose of Remifentanil is associated with an increased incidence of CPSP. These findings highlight a risk factor for CPSP that the anaesthetist can influence on, but they however remain limited to remifentanil. To this day, no study have attempted to evaluate the existence of such an association between the incidence of CPSP and the intraoperative administration of sufentanil doses. Improved knowledge of the long-term nociceptive impact of intraoperative sufentanil administration would enable better therapeutic adaptation according to each patient's risk.

In the field of CPSP, non-major abdominal surgeries remain poorly studied. This is due to their lower risk of CPSP than other surgeries such as orthopaedic, mammary or thoracic surgery. Nevertheless, they constitute a large number of daily surgical procedures. The estimated incidence of CPSP in non-major abdominal surgery appears in several studies to be between 15 and 20% The aim of this study is to evaluate the correlation between the intraoperative administration of sufentanil doses and the incidence of CPSP at 3 months in patients undergoing non-major scheduled abdominal surgery. conditions: Chronic Postsurgical Pain conditions: Chronic Pain conditions: Abdominal Surgery conditions: Sufentanil conditions: Risk Factors studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 855 type: ESTIMATED name: phone interview measure: Incidence of CPSP measure: Post-operative pain intensity measure: Post-operative pain intensity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Amiens-Picardie status: RECRUITING city: Amiens zip: 80054 country: France name: Paul TARPIN, MD role: CONTACT phone: 0322087980 email: Tarpin.Paul@chu-amiens.fr name: Ottilie Fumery, MD role: SUB_INVESTIGATOR name: Stephane BAR, Pr role: SUB_INVESTIGATOR name: Benjamin Mestan, MD role: SUB_INVESTIGATOR lat: 49.9 lon: 2.3 hasResults: False

 nctId: NCT06374836 id: nWMO 2024.040 briefTitle: The Contractile Response of the Thoracic Aorta to Vasoactive Substances acronym: AorticContract overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-08 date: 2024-12 date: 2024-04-19 date: 2024-04-24 name: Catharina Ziekenhuis Eindhoven class: OTHER name: Maastricht University briefSummary: Hypertension affects 32-35% of the global adult population. Despite many drugs being available hypertension is not controlled in 50% of the over 500 million treated people leaving patients with an elevated blood pressure for life.

In the development of isolated systolic hypertension, the aorta plays a pivotal role. With each heartbeat, the heart empties its stroke volume into the large arteries. These arteries, particularly the thoracic part of the aorta, temporarily distend to buffer the stroke volume and thereby dampen the pressure fluctuation: they have a Windkessel function. When this function is reduced (and arterial stiffness is increased), the heart needs to contract more forcefully during ejection, leading to isolated systolic hypertension.

Likely, the aorta is not just a passive structure (the aorta as an elastic 'bicycle tube'). Rather, the smooth muscle cells in the aorta wall can presumably actively change the aorta's dimension through vasoconstriction/-dilation. If this is the case, such vasoconstriction/-dilation will have direct consequences for the aorta's Windkessel function and, since this Windkessel function directly influences the blood pressure flucturation, also for hypertension and its progression. Therefore, the aim of this study is to quantify the thoracic aorta's ability to vasoconstrict, and to assess whether this contractility is related to specific predictors.

During the study we will measure in the operating room the thoracic descending and ascending aortic diameter with transoesopahgeal echocardiography (part of standard clinical care), before and after administration of vasoactive drugs (phenylephrine and norepinephrine; also part of standard clinical care). During these measurements we will simultanesouly measure peripheral arterial blood pressure and an electrocardiogram (ECG, to monitor sympathetic activity as estimated using heart rate variability analysis). Measurements will be performed at Catharina Hospital Eindhoven, the Netherlands (NL), where patients undergo elective cardiac surgery. Using the data obtained, we will 1) establish and quantify the in vivo contractility of the human thoracic aorta, and 2) study whether and to which extent potential predictors (age, sex, smoking status, antihypertensive medication use/class, mean arterial pressure, pulse pressure as an indirect measure of arterial stiffness, diabetes, chronic kidney disease, total cholesterol, and sympathetic activity) influence contractility conditions: Human Thoracic Aorta Contractility studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 98 type: ESTIMATED name: Phenylephrine measure: To establish and quantify the in vivo contractility of the human thoracic aorta measure: To quantify the magnitude of contractile response measure: To study whether and to which extent potential predictors influence contractility. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Catharina hospital city: Eindhoven state: Noord-Brabant zip: 5623 EJ country: Netherlands name: Frederique de Raat, Msc. role: CONTACT phone: +31615137244 email: frederique.d.raat@catharinaziekenhuis.nl name: Angélique Burmanje, Msc. role: CONTACT phone: +316 44 15 00 18 email: angelique.burmanje@catharinaziekenhuis.nl lat: 51.44083 lon: 5.47778 hasResults: False

 nctId: NCT06374823 id: IIT2023-020-002 briefTitle: Multiple Electrolytes Injection (II) and Normal Saline on Hyperchloremia in Severe Hemorrhagic Stroke acronym: MERIT overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-12 date: 2026-12 date: 2024-04-19 date: 2024-04-19 name: Capital Medical University class: OTHER briefSummary: Normal saline (0.9% sodium chloride), a classical crystalloid solution, is widely used to maintain fluid balance, volume resuscitation and dilute drugs during clinical practice. However, the chloride concentration of normal saline (154mmol/L) is much higher than human plasma, and a large amount of infusion may lead to iatrogenic hyperchloremia in ICU patients. In contrast, the concentrations of Multiple electrolytes II is more similar to those of plasma and is considered to be a better fluid choice than normal saline. conditions: Critical Care conditions: Hyperchloremia conditions: Hemorrhagic Stroke studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 342 type: ESTIMATED name: Multiple Electrolyte name: Normal Saline measure: Hyperchloremia measure: Hyperchloremia acidosis measure: Plasma osmolality measure: AKI measure: RRT measure: hospital length of stay measure: ICU length of stay measure: hospitalization expense sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Shijitan Hospital city: Beijing state: Beijing zip: 100038 country: China name: Jian-Xin Zhou, MD role: CONTACT phone: +8613801183875 email: zhoujx.cn@icloud.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06374810 id: CCB1 briefTitle: Does Conscious Connected Breathwork Reduce Symptoms of Anxiety? overallStatus: COMPLETED date: 2023-09-21 date: 2023-12-20 date: 2023-12-20 date: 2024-04-19 date: 2024-04-22 name: Richard Blake class: OTHER briefSummary: The goal of this clinical trial is to test whether conscious connected breathwork reduces symptoms of anxiety in people with mild to severe anxiety symptoms, as measured by the Zung Self Rating Anxiety Scale.

The main questions aims to answer:

1. Does conscious connected breathwork reduce symptoms of anxiety?
2. Does an increased frequency of self-practice lead to even greater reductions of anxiety symptoms.

there is a comparison group: Researchers will compare whether people doing the breathwork to see if \[insert effects\].

Participants will participate in 1, 90 minute breath workshop per week for 6 weeks. These sessions will be held on Zoom by 2 facilitators. Participants will also be given a 10 minute recording of a guided conscious connected breathwork session that they will be encouraged to complete daily. conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants were randomly assigned to either the breathwork group or they were told that they had been placed on a waitlist and that they would participate in the 2nd cohort, which would take place after the 1st 6-week program had been completed.

Participants in the breathwork groups were also given a 10 minute guided conscious connected breathwork recording. They were advised to do this daily to support the integration of their process. This was not mandatory. At the end of the study participants were asked how often they used the guided self-practice. The frequency of use of the self-practice was used a covariate. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants in group 2 were told that the trial was full but actually they were just placed in the placebo control group. whoMasked: PARTICIPANT count: 108 type: ACTUAL name: Conscious Connected Breathwork name: Placebo waitlist measure: Changes in anxiety symptoms sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CIIS city: San Francisco state: California zip: 94103 country: United States lat: 37.77493 lon: -122.41942 hasResults: False

 nctId: NCT06374797 id: CMZ-207 briefTitle: A Study of Auxora in Patients With AKI and Injurious Lung "Crosstalk" acronym: KOURAGE overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-08 date: 2025-08 date: 2024-04-19 date: 2024-04-19 name: CalciMedica, Inc. class: INDUSTRY briefSummary: Approximately 150 patients with acute kidney injury (AKI) associated with acute hypoxemic respiratory failure (AHRF) will be randomized at up to 40 sites. Patients will be randomly assigned to either Auxora or matching placebo. Study drug infusions will occur every 24 hours for five consecutive days for a total of five infusions. conditions: Acute Kidney Injury studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Auxora name: Placebo measure: Days alive, ventilator-free and kidney replacement therapy (KRT)-free from SFISD through Day 30 measure: Major adverse kidney event (MAKE) 90-1: ≥25% decline in estimated glomerular filtration rate (eGFR) from baseline, incident KRT, and all-cause mortality at 90 days measure: MAKE 90-2: ≥35% decline in eGFR from baseline, incident KRT, and all-cause mortality at 90 days measure: Proportion of patients alive at Day 30 measure: Proportion of patients alive at Day 90 measure: Days alive and ventilator-free from start of first infusion of study drug (SFISD) through Day 30 measure: Days alive and KRT-free from SFISD through Day 30 measure: Proportion of patients recovered from AHRF through Day 30 as categorized by an 8-point ordinal scale measure: Proportion of patients receiving KRT at Day 30 measure: Proportion of patients receiving KRT at Day 90 measure: Number of patients with treatment-related adverse events (TEAE) measure: Number of patients with grade 3 TEAEs measure: Days alive and not hospitalized through Day 30 measure: Proportion of patients re-hospitalized through Day 30 measure: Proportion of patients re-hospitalized through Day 90 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06374784 id: perio2023ARP briefTitle: Autogenous Demineralized Dentin Graft Combined With Injectable PRF + Metronidazole Versus Autogenous Demineralized Dentin Graft Combined With Injectable PRF Versus Autogenous Demineralized Dentin Graft Alone for Alveolar Ridge Preservation overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-10-20 date: 2024-11-20 date: 2024-04-19 date: 2024-04-23 name: Cairo University class: OTHER briefSummary: The aim of this trial is to compare the effect of autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazole (sticky demineralized tooth releasing metronidazole) versus autogenous demineralized dentin graft combined with injectable PRF (sticky demineralized tooth) versus autogenous demineralized dentin graft (ADDG) alone on alveolar ridge preservation after extraction of non restorable, infected single-rooted teeth conditions: Alveolar Bone Loss studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF loaded with metronidazole name: Alveolar ridge preservation using autogenous demineralized dentin graft combined with injectable PRF name: Alveolar ridge preservation using autogenous demineralized dentin graft alone measure: Alveolar ridge apico-coronal height change in mm measure: Alveolar ridge bucco-lingual width change in mm measure: Histological assessment sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Faculty of Dentistry city: Cairo country: Egypt name: Cairo University role: CONTACT lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06374771 id: MD-15-2022 briefTitle: Analgesic Effect of Melatonin and Vitamin C Administration, Alone or In Combination in Major Abdominal Surgery. overallStatus: NOT_YET_RECRUITING date: 2024-04-27 date: 2024-06-27 date: 2024-07-10 date: 2024-04-19 date: 2024-04-19 name: Cairo University class: OTHER name: Theodor Bilharz Research Institute briefSummary: The goal of this clinical trial is to compare the analgesic effect of melatonin, and vitamin C and their combination in patients aged 18-60 years old who will undergo major abdominal surgery with mid-line incision within an expected time of surgery from 3 to 5 hours e.g. radical cystectomy, radical prostatectomy, colectomy, sigmoidectomy, splenectomy, and CBD exploration through mid-line incision.

This study hypothesizes that using both vitamin C and melatonin together as adjuvants will cause:

* More reduction in total morphine consumption in the first 24 hours postoperatively
* More reduction of the incidence of chronic post-surgical pain, than using each adjuvant alone.

Participants will be allocated into three equal groups: Melatonin (M group) and vitamin C (V group), and Melatonin and vitamin C (VM group). Two hours before surgery all patients will receive the study drugs orally and will be continued for 3 days postoperative at the same time of the first administration; 10mg of melatonin for M group (Melatonin 10 mg - Puritan's Pride premium company), 1gm of vitamin C for V group (Sanso C 1000 mg - AUG pharma company), and 10mg of melatonin and 1gm of vitamin C for VM group.

Researchers will compare:

* The effect of melatonin, vitamin C, and their combination on postoperative opioid consumption
* The severity of postoperative pain, using the Numerical Rating Scale (NRS)
* Patients' satisfaction with a three-point scale
* The time of the first requirement for rescue analgesia
* The effect on the incidence of chronic post-surgical pain. conditions: Postoperative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Melatonin 10 MG name: Vitamin C measure: Total morphine consumption measure: Numeric Rating Scale measure: Richmond Agitation Sedation Scale measure: Time to first analgesic request measure: chronic post-surgical pain measure: patient satisfaction using Likert three-point scale measure: systolic blood pressure measure: Heart rate measure: Intra-operative mean consumption of sevoflurane per hour. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine - Cairo University city: Cairo state: Manial zip: 11553 country: Egypt name: Waleed Hamimy, MD role: CONTACT phone: 01150377770 phoneExt: +2 email: hamimy2002@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06374758 id: MU-2096449 briefTitle: Accelerated ART Initiation for PWHIV Who Are Out of Care acronym: ACCELERATE overallStatus: RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-11-01 date: 2024-04-19 date: 2024-04-19 name: University of Missouri-Columbia class: OTHER name: Gilead Sciences briefSummary: The main purpose of the study is to evaluate the effectiveness, of the ACCELERATE model of care to achieve HIV viral suppression at Week 24. The study will also assess the acceptability, appropriateness, feasibility, and sustainability of the ACCELERATE model of care. The ACCELERATE model combines a standardized method for outreach, the use of telehealth for rapid access to an HIV care provider, a simplified pre-approved HIV regimen, a free 30-day medication starter supply, and re-linkage to medical care. conditions: HIV Infections conditions: ART conditions: Noncompliance, Patient studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 120 type: ESTIMATED name: The Accelerate model of care name: bictegravir/emtricitabine/tenofovir alafenamide 50/200/25 mg measure: The effectiveness of the ACCELERATE model of care to achieve HIV viral suppression at Week 24. measure: To study the change over time in the acceptability of the ACCELERATE model of care in patient and staff participants. measure: To study the change over time in appropriateness of the ACCELERATE model of care in patient and staff participants measure: To study the change over time in feasibility of the ACCELERATE model of care in patient and staff participants measure: To study the change over time in sustainability of the ACCELERATE model of care in patient and staff participants measure: Qualitative data measure: To evaluate the effectiveness of the intervention to achieve HIV viral suppression at week 48 using ACCELERATE model of care. measure: To assess change in patient experience (PROs) and satisfaction for participants using the ACCELERATE model of care measure: To assess change in health-related quality of life (HRQoL) measure: To measure the change in patients' satisfaction with the HIV treatment regimen B/F/TAF measure: To measure Retention in Care measure: To assess the adherence to the study treatment measure: To study the virologic response of using B/F/TAF as first line regimen in ACCELERATE model of care. measure: To study the immunologic response of using B/F/TAF as first line regimen in ACCELERATE model of care. measure: To assess staff impact of ACCELERATE model of care on staff satisfaction measure: To assess staff impact of ACCELERATE model of care on staff burnout sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Missouri-Columbia status: RECRUITING city: Columbia state: Missouri zip: 65212 country: United States name: Dima Dandachi, MD role: CONTACT phone: 573-884-8728 email: dandachid@health.missouri.edu lat: 38.95171 lon: -92.33407 hasResults: False

 nctId: NCT06374745 id: 2020-01307; mu24Kappos briefTitle: An Integrated Algorithm for Surgical Intervention in Chronic Lymphedema After Breast Cancer Treatment: The Basel Lymphedema Protocol overallStatus: RECRUITING date: 2015-01-02 date: 2024-12-30 date: 2024-12-30 date: 2024-04-19 date: 2024-04-19 name: University Hospital, Basel, Switzerland class: OTHER name: Sana Kliniken Düsseldorf GmbH briefSummary: The primary objective of the investigators is to develop an integrated algorithm for surgical treatment of chronic lymphedema after breast cancer surgery. This will be achieved by retrospectively analysing a subgroup of patients who had breast cancer-related surgery prior to lymphedema. conditions: Lymphedema conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 500 type: ESTIMATED measure: To design an integrated algorithm for surgical treatment of chronic lymphedema after breast cancer surgery. measure: Date of follow-up procedure measure: Follow-up and type of lymphedema surgery measure: Circumferences of the affected and unaffected side measure: Postoperative complications measure: Surgery duration. measure: Type of lymphedema surgery measure: Date of lymphedema surgery measure: Use of compression stockings measure: Number of lymphedema drainages per week measure: Stage of lymphedema measure: Duration of lymphedema measure: Location of lymphedema measure: Subsequent cancer treatment measure: Date of cancer related surgery measure: Tumor staging measure: Tumor location measure: BMI measure: Comorbidities measure: Age measure: Gender measure: Analysis of cohort subgroups: all patients who had surgery related to any kind of cancer prior to their lymphedema measure: Analysis of cohort subgroups: all patients who had surgery related to a specific kind of cancer prior to their lymphedema, e.g. vulvar, cervical or uterine cancer measure: Analysis of cohort subgroups: all patients who had no history of cancer and thus no cancer-related surgery in their medical history measure: Analysis of cohort subgroups: all patients with chronic lymphedema regardless of whether or not they have an oncological history measure: Analysis of cohort subgroups: all patients who underwent DIEP flap or TRAM flap or LDM flap or implant based breast reconstruction or BCS measure: Analysis of cohort subgroups: exploratory sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Basel status: RECRUITING city: Basel zip: 4031 country: Switzerland name: Elisabeth A Kappos, PD Dr. med. role: CONTACT phone: 0041 61 265 25 25 email: elisabeth.kappos@usb.ch name: Adriano Fabi, BMed role: CONTACT phone: 0041 79 888 12 51 email: adriano.fabi@uzh.ch lat: 47.55839 lon: 7.57327 hasResults: False

 nctId: NCT06374732 id: TY2024002 briefTitle: The Benefits of a High-intensity Interval Training Intervention Delivered in a School Setting Among Adolescents overallStatus: RECRUITING date: 2024-02-26 date: 2024-10-01 date: 2024-10-01 date: 2024-04-19 date: 2024-04-19 name: University of Exeter class: OTHER name: China Scholarship Council name: Ningbo University briefSummary: A 12-week school-based high-intensity interval training intervention, with 8 classes of year 7 students randomly allocated to either intervention or control group. The interval training sessions will last for 6 to 10 minutes and will be delivered 5 times per week. Outcome variables will be physical activity, body composition, cardiorespiratory fitness, muscular strength, bone health, executive function, mental wellbeing, and academic performance, which will be measured pre- and post-intervention and two months after the intervention has been completed. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 400 type: ESTIMATED name: High-intensity interval training name: Control group measure: Cardiorespiratory fitness measure: Muscular strength measure: Wellbeing measure: Enjoyment measure: Motivation measure: Affect measure: Academic performance measure: Height measure: Weight measure: BMI measure: Waist circumference measure: Body fat percentage measure: Physical activity measure: Bone health measure: Perceived physical ability measure: Flanker task measure: Visual 2-back task measure: Colour-shape switch task measure: Confounding variables measure: Interview sex: ALL minimumAge: 11 Years maximumAge: 13 Years stdAges: CHILD facility: University of Exeter status: RECRUITING city: Exeter state: Devon zip: EX1 2LU country: United Kingdom name: Yong Liu role: CONTACT phone: +447570013632 email: yl932@exeter.ac.uk role: CONTACT phoneExt: Liu email: yl932@exeter.ac.uk name: yong Liu role: PRINCIPAL_INVESTIGATOR lat: 50.7236 lon: -3.52751 hasResults: False

 nctId: NCT06374719 id: WiTNNess briefTitle: WiTNNess - TNNT1 Myopathy Natural History Study acronym: WiTNNess overallStatus: RECRUITING date: 2018-09-23 date: 2027-01-01 date: 2027-06-01 date: 2024-04-19 date: 2024-04-19 name: Clinic for Special Children class: OTHER briefSummary: WiTNNess is designed to accurately document the natural course and variation of muscle disease caused by pathogenic changes of the TNNT1 gene. The primary aim of the study is to specify meaningful outcome measures for future clinical trials. WiTNNess is open to children and adults worldwide. Participants can choose to include their information once (cross-sectional cohort) or every few months (prospective cohort). conditions: TNNT1-associated Myopathy conditions: Infantile-onset Nemaline Rod Myopathy conditions: Myopathies, Nemaline conditions: Myopathy conditions: Myopathy, Rod conditions: Myopathy; Hereditary conditions: Amish Nemaline Myopathy conditions: Nemaline Myopathy 5 conditions: NEM5 conditions: Genetic Muscle Disease conditions: Recessive Hereditary Disorder (Autosomal) conditions: ANM studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED measure: Event-free survival measure: Motor Milestones measure: Thriving sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Clinic for Special Children status: RECRUITING city: Strasburg state: Pennsylvania zip: 17579 country: United States name: Joelle FS Williamson, MPH role: CONTACT phone: 717-687-9407 email: jwilliamson@clinicforspecialchildren.org lat: 39.98316 lon: -76.18412 hasResults: False

 nctId: NCT06374706 id: 23-0129 briefTitle: Effects of End-Effector Type Rehabilitation Robots-Morning Walk on Symmetrical Walking Patterns in Individuals With Hemiparesis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-01 date: 2025-08-30 date: 2024-04-19 date: 2024-04-19 name: The University of Texas Medical Branch, Galveston class: OTHER briefSummary: In this study, our objective is to explore and evaluate interventions to improve the process of recovery following a stroke. The main focus is on enhancing symmetrical walking patterns in adults who have experienced neurological deficits due to a stroke. The primary tool will be an end-effector type rehabilitation robot, the Morning Walk®. This robot has been specifically designed to assist in enhancing symmetrical walking patterns for individuals recovering from a stroke Morning Walk® has received approval from the FDA, meaning it meets stringent safety and efficacy standards. conditions: Stroke conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Morning Walk training for stroke name: Morning Walk training for healthy measure: The Number of Participants with Kinematic representation of the temporal events during end-effector robot training measure: Muscle Activity in the lower extremities measure: Spatiotemporal Patterns of Walking, Speeds measure: Spatiotemporal Patterns of Walking, Parameters sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Texas Medical Branch city: Galveston state: Texas zip: 77555 country: United States name: Mansoo Ko, Ph.D. role: CONTACT phone: 409-772-9555 email: mako@utmb.edu name: Judith L Linton, MS role: CONTACT phone: 4092661767 email: jllinton@utmb.edu lat: 29.30135 lon: -94.7977 hasResults: False

 nctId: NCT06374693 id: STH22772 briefTitle: Investigating the Tolerability and Feasibility of Transcutaneous Vagus Nerve Stimulation Following Aneurysmal Subarachnoid Haemorrhage acronym: tVNS in aSAH overallStatus: NOT_YET_RECRUITING date: 2024-04-14 date: 2025-08 date: 2025-08 date: 2024-04-19 date: 2024-04-19 name: Sheffield Teaching Hospitals NHS Foundation Trust class: OTHER briefSummary: After a subarachnoid haemorrhage, complications are common and increase the overall rate of disability and death from the condition. Despite some advances in preventing, detecting and treating these complications, the rates of complications and associated risks remain high. Further research into ways to reduce complications of subarachnoid haemorrhage.

Transcutaneous vagus nerve stimulation (tVNS) is a technique where a small handheld device is attached to an earpiece which stimulates the nerves to the ear. This is given for short periods and may help improve blood flow and reduce inflammation in the brain. The intervention has been safely used and licensed in seizures, headache and severe depression.

This study will look to see if it is feasible and tolerable to have tVNS twice daily for 5 days after subarachnoid haemorrhage, and whether it can help reduce the risk of complications from subarachnoid haemorrhage.

The participant will be randomly allocated to receive either tVNS or a dummy intervention, known as sham.

The researchers will collect some personal and clinical details such as diagnosis, medications, age, blood test results, as well as some details about the subarachnoid haemorrhage.

The researchers will also complete brief questionnaires with the participant to assess symptoms. They will take measurements of heart rate, pupil response, and brain activity using a cap. The participant will then be randomly allocated to either receive the tVNS or sham intervention.

Next, the research team will apply the earpiece to their ear twice a day for 45 minutes, for a total of 5 days.

At the end of the 5-day study period, the intervention will be complete. The researchers will arrange a follow-up meeting on discharge and at 6 weeks, to assess the participants symptoms and recovery.

Previous studies have shown that tVNS is safe and well tolerated, including a recent review of tVNS studies which evaluated the side effects experienced by 1322 patients receiving tVNS.

The main side effects include localised tingling/numbness/pain/redness around the ear (17%), headaches (3%), dizziness (1%), facial droop (1%), nausea (1%), nasal discharge (2%). Rarely, palpitations or a slow heart rate may occur.

They will continue to receive full medical treatment and observation alongside the study. They are free to withdraw from this study if they find it too demanding on top of their other activities. conditions: Subarachnoid Haemorrhage From Cerebral Aneurism Rupture studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Transcutaneous Vagus Nerve Stimulation name: Sham Transcutaneous Vagus Nerve Stimulation measure: Monitor tolerability for tVNS measure: Assess study feasibility measure: Monitor safety criteria for tVNS measure: Rates of delayed cerebral ischaemia (DCI) measure: Inpatient mortality measure: Length of inpatient stay measure: Rates of inpatient complications measure: Modified rankin score measure: Barthel Index measure: Inflammatory markers measure: Headache scores measure: Cerebral functional near-infrared spectroscopy measure: Heart rate variability measure: Pupillary light reactivity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Sheffield city: Sheffield state: South Yorkshire zip: S10 2HQ country: United Kingdom name: Dr Ali Ali role: CONTACT phone: +4401142159114 email: Ali.ali@sheffield.ac.uk name: Mr Matthew Myers role: SUB_INVESTIGATOR lat: 53.38297 lon: -1.4659 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-12-16 uploadDate: 2024-01-12T08:49 filename: Prot_000.pdf size: 2294124 hasResults: False

 nctId: NCT06374680 id: C3 ectomy briefTitle: C3 Laminectomy With Cervical Laminoplasty overallStatus: WITHDRAWN date: 2017-03-20 date: 2021-12-31 date: 2021-12-31 date: 2024-04-19 date: 2024-04-22 name: Seoul National University Hospital class: OTHER briefSummary: 1. Background In cervical stenosis, cervical laminoplasty from the third to sixth cervical vertebrae is widely used. However, the muscles attached to the C2, which play an important role in the movement of our neck, are frequently damaged during the C3 laminoplasty. In contrast, cervical spine surgery through the removal of the C3 is thought to give less damage to the muscles attached to the C2.
2. Purpose The aim of this study was to compare the prospective randomized comparison of these two surgical methods.
3. Hypothesis There is no difference in the cervical length and overall cervical angle between 1 month, 3 months, 6 months, and 12 months postoperatively between C3 laminectomy with C4-6 laminoplasty and C3-6 laminoplasty. conditions: Neck Pain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 0 type: ACTUAL name: laminectomy at C3 level measure: neck pain sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Hospital city: Seoul zip: 110-744 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06374667 id: KY2024-071-02 briefTitle: The Efficacy and Safety of Y-3 Intracalvariosseous Injection Versus Intravenous Injection in the Treatment of Acute Large Hemispheric Infarction acronym: SOLUTION-2 overallStatus: RECRUITING date: 2024-04-22 date: 2025-09-15 date: 2026-03-15 date: 2024-04-18 date: 2024-04-26 name: yilong Wang class: OTHER briefSummary: A pilot study confirmed the feasibility and safety of neuroprotectant Y-3 intracalvariosseous(ICO) injection in patients with malignant middle cerebral artery infarction (mMCAI), showing a trend in improving 90-day functional scores compared to conventional treatment. The aim of this trial is to further investigate the efficacy and safety of ICO injection of Y-3 compared to intravenous injection in patients with acute large hemispheric infarction(LHI) who has contraindications of reperfusion therapy or have got poor reperfusion therapy outcomes. conditions: Stroke, Acute Ischemic conditions: Blood-Brain Barrier studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Y-3 ICO injection name: Y-3 intravenous injection name: Conventional treatment measure: 90-day favorable clinical outcome measure: Change of infarct volume from baseline to 8-day measure: Neurofunctional deficit defined as the National Institutes of Health Stroke Scale (NIHSS) . measure: Patients with symptoms improvement from baseline to 14-day measure: Rate of decompressive hemicraniectomy measure: Depression scale scores at 90-day measure: Proportion of combined adverse events at 90-day sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The first affiliated hospital of Wannan Medical College status: NOT_YET_RECRUITING city: Wuhu state: Anhui country: China name: Shoucai Zhao, MD role: CONTACT name: Zhenbao Li, MD role: CONTACT lat: 31.33728 lon: 118.37351 facility: Beijing Tiantan Hospital status: RECRUITING city: Beijing state: Beijing zip: 100050 country: China name: Yilong Wang, PhD，MD role: CONTACT email: yilong538@gmail.com lat: 39.9075 lon: 116.39723 facility: Tangshan Municipal Worker's Hospital status: NOT_YET_RECRUITING city: Tangshan state: Heibei country: China name: Jun Hong, MD role: CONTACT lat: 39.63333 lon: 118.18333 facility: Shaanxi Provincial People's Hospital status: NOT_YET_RECRUITING city: Xi'an state: Shaanxi country: China name: Wei Hu, MD role: CONTACT lat: 34.25833 lon: 108.92861 hasResults: False

 nctId: NCT06374654 id: 2023P003272 briefTitle: RCT of Home-based vs Formal Physical Therapy for Treatment of New Onset Non-insertional Achilles Tendinopathy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-18 date: 2024-04-18 name: Brigham and Women's Hospital class: OTHER briefSummary: The goal of this prospective randomized controlled trial is to compare the effectiveness of a home-based exercise protocol to formal physical therapy in patients who have been diagnosed with Achilles tendinopathy. The null hypothesis is that there will be no difference in the treatment outcomes between patients with Achilles tendinopathy who participate in a home-based program versus patients with Achilles tendinopathy who undergo formal physical therapy. Participants will be randomized to a 12-week home-based or formal physical therapy protocol and asked to complete brief outcomes surveys at their initial visit, and at 6 weeks, 12 weeks, 6 months, and 1 year after their initial visit. conditions: Achilles Tendinopathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: Home-based Exercise Protocol name: Formal Physical Therapy measure: Victorian Institute of Sports Assessment self-administered Achilles questionnaire (VISA-A) measure: PROMIS Pain Interference (4a) measure: PROMIS Pain Intensity (3a) measure: PROMIS Depression (4a) measure: Patient Acceptable Symptom State Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02130 country: United States lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06374641 id: 5514255 briefTitle: The Effects of a Novel Mitochondrial Substrate Supplement on Exercise Performance and Cognitive Function acronym: MCh1 overallStatus: RECRUITING date: 2024-03-26 date: 2025-04 date: 2025-08 date: 2024-04-18 date: 2024-04-18 name: University of Exeter class: OTHER name: Mitocholine Ltd name: Innovate UK briefSummary: The goal of this clinical trial is to compare the effects of taking a new supplement for 16 days on cognitive function and exercise performance, compared to a placebo (a supplement that looks and tastes the same, but doesn't have the same ingredients) in 40 healthy individuals - 20 young individuals (aged 18-30) and 20 older individuals (aged 50-65).

The main questions it aims to answer are:

* If taking the supplement for 16 days improves exercise performance, or the speed with which the body responds to the commencement of exercise.
* If taking the supplement improves cognitive function.

Participants will visit the lab on 5 separate occasions to:

* complete some cognitive tests
* complete exercise performance tests
* provide blood samples

All exercise tests will be on an exercise bike.

After 28 (or 46 for pre-menopausal females) days to make sure the supplement has left the body fully, participants will consume the opposite supplement and repeat the tests. conditions: Exercise Performance conditions: Cognitive Function studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Trials will be randomised and counterbalanced to remove any trial-order effect. primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: Partners Innovate UK and Mitocholine Ltd will also be masked. Masking will be performed by an individual outside of the research group. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Mitochondrial Substrate Supplement name: Placebo Supplement measure: Exercise Capacity measure: VO2 kinetic response to exercise measure: Cognitive Function (Stroop test) measure: Cognitive Function (decision reaction test) measure: Grip Strength measure: Capillary Blood Lactate measure: Questionnaire 1 measure: Questionnaire 2 measure: Venous Blood [Betaine] measure: Venous Blood [Choline] measure: Venous blood [S-Adenosyl methionine] measure: Venous blood [glucose]. measure: Venous blood [insulin]. measure: Venous blood [trimethylamine N-oxide]. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Richards Building St. Lukes Campus University of Exeter status: RECRUITING city: Exeter state: Devon zip: EX2 4TH country: United Kingdom name: Jimmy T Wangdi, PhD role: CONTACT phone: 01392 661000 email: j.Wangdi4@exeter.ac.uk name: Matthew I Black, PhD role: CONTACT email: M.I.Black@exeter.ac.uk lat: 50.7236 lon: -3.52751 hasResults: False

 nctId: NCT06374628 id: 0001 briefTitle: Pre-pectoral Tissue Expander and Acellular Dermal Matrix for a Two-stage Muscle Sparing Breast Reconstruction overallStatus: RECRUITING date: 2019-06-01 date: 2024-04-01 date: 2024-12-31 date: 2024-04-18 date: 2024-04-18 name: Rossella Elia, MD PhD class: OTHER briefSummary: The aim of the research is to evaluate clinical outcomes of a two stage muscle sparing prepectoral breast reconstruction using tissue expander (TE) entirely covered by an ADM. The authors aim to report surgical indications, technical tips, clinical and histological outcomes with the final objective of delineate a decision-making algorithm for immediate prosthetic breast reconstruction. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 44 type: ESTIMATED name: breast reconstruction measure: Patient satisfaction measure: Pain Evaluation measure: Complication rate sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: AOU Policlinico status: RECRUITING city: Bari state: BA country: Italy name: Rossella Elia role: CONTACT phone: 3409616476 email: rossellaelia4@gmail.com lat: 41.11148 lon: 16.8554 hasResults: False

 nctId: NCT06374615 id: 2024-07 briefTitle: Insights Into Tick-Borne Diseases: a Study From an Endemic Area of Northern Italy acronym: TICKTOC overallStatus: RECRUITING date: 2024-03-25 date: 2029-03 date: 2029-03 date: 2024-04-18 date: 2024-04-18 name: IRCCS Sacro Cuore Don Calabria di Negrar class: OTHER briefSummary: This is a monocentric, experimental, non-pharmacological and non-device no profit study.

The study is experimental because all the visits and blood withdrawals foreseen by the protocol do not fall within the normal clinical practice. conditions: Tick-Borne Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 384 type: ESTIMATED name: IgG and IgM search for specific Tick-Borne Patogens measure: Number of individuals diagnosed with Tick-Borne Diseases (TBD) over the total number of individuals who were bitten by a tick which carried an identified TBP. measure: Number of identified Tick-Borne Patogenees (TBPs) on the total number of analyzed ticks measure: Number of individuals who developed symptoms and were diagnosed for a TBP infection during the 12 weeks' follow-up period measure: Number of individuals who developed specific antibodies against a TBP after tick bite. measure: List of novel TBPs that were not previously found in the study areas. sex: ALL minimumAge: 8 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Sacro Cuore Don Calabria hospital status: RECRUITING city: Negrar state: Verona zip: 37024 country: Italy name: Andrea Tedesco role: CONTACT email: andrea.tedesco@sacrocuore.it name: Andrea Tedesco role: PRINCIPAL_INVESTIGATOR lat: 45.52918 lon: 10.93899 hasResults: False

 nctId: NCT06374602 id: 33 briefTitle: Efficacy of Pembrolizumab and Lenvatinib in Patients With Anaplastic Thyroid Cancer overallStatus: RECRUITING date: 2024-03-25 date: 2026-03-25 date: 2026-06-25 date: 2024-04-18 date: 2024-04-18 name: Saint Petersburg State University, Russia class: OTHER briefSummary: This pilot phase 2 study evaluate the effectiveness and safety of pembrolizumab and lenvatinib in patients with anaplastic thyroid cancer. Patients with anaplastic thyroid cancer who are treatment-naive (BRAF-negative) and who were previously treated with chemptherapy or targeted therapy are scheduled to undergo pembrolizumab and lenvatinib and evaluate the outcomes according to the primary and secondary endpoints. conditions: Anaplastic Thyroid Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Pembrolizumab + Lenvatinib measure: Objective response rate measure: Progression-Free Survival measure: Safety and Tolerability assessment (Incidence of Treatment-Emergent Adverse Events) measure: Overall survival measure: The assessment of conversion to resectability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Saint Petersburg State University Hospital status: RECRUITING city: Saint Petersburg zip: 190020 country: Russian Federation name: Ernest Dzhelialov role: CONTACT phone: +7(911)134-50-44 email: ernest.dzhelialov@gmail.com lat: 59.93863 lon: 30.31413 hasResults: False

 nctId: NCT06374589 id: 202303123 briefTitle: Closed-Loop O2 Use During High Flow Oxygen Treatment Of Critical Care Adult Patients (CLOUDHFOT) acronym: CLOUDHFOT overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-21 date: 2024-08-30 date: 2024-12-30 date: 2024-04-18 date: 2024-04-18 name: Başakşehir Çam & Sakura City Hospital class: OTHER_GOV name: Hamilton Medical AG briefSummary: High flow nasal oxygen therapy (HFNO) is an established modality in the supportive treatment of patients suffering from acute hypoxemic respiratory failure. The high humidified gas flow supports patient's work of breathing, reduces dead space ventilation, and improves functional residual capacity while using an unobtrusive patient's face interface \[Mauri et al, 2017; Möller et al, 2017\].

As hyperoxia is considered not desirable \[Barbateskovic et al, 2019\] during any oxygen therapy, the inspired O2 concentration is usually adapted to a pre-set SpO2 target-range of 92-96% in patients without hypercapnia risk, and of 88-92% if a risk of hypercapnia is present \[O'Driscoll et al, 2017; Beasley et al, 2015\]. In most institutions, the standard of care is to manually adapt the FiO2, although patients frequently have a SpO2 value outside the target range.

A new closed loop oxygen controller designed for HFNO was recently developed (Hamilton Medical, Bonaduz, Switzerland). The clinician sets SpO2 targets, and the software option adjusts FiO2 to keep SpO2 within the target ranges. The software option offers some alarms on low and high SpO2 and high FiO2. Given the capability, on the one hand, to quickly increase FiO2 in patients developing sudden and profound hypoxia, and, on the other hand, of automatically preventing hyperoxia in patients improving their oxygenation, such a system could be particularly useful in patients treated with HFNO.

A short-term (4 hours vs 4 hours) crossover study indicated that this technique improves the time spent within SpO2 pre-defined target for ICU patients receiving high-flow nasal oxygen therapy \[Roca et al, 2022\]. Due to its simplicity, HFNO is increasingly used outside the ICU during transport and in the Emergency Room (ER). This environment poses specific challenges, as patients may deteriorate very quickly and depending on patient's flow, healthcare providers can easily be overwhelmed. We thus propose to evaluate closed loop controlled HFNO in ER patients.

The hypothesis of the study is that closed loop oxygen control increases the time spent within clinically targeted SpO2 ranges and decreases the time spent outside clinical target SpO2 ranges as compared to manual oxygen control in ER patients treated with HFNO. conditions: Acute Hypoxemic Respiratory Failure conditions: Acute Hypercapnic Respiratory Failure conditions: Respiratory Depression conditions: Respiratory Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: Closed-loop FiO2 controller name: Conventional measure: Percentage of time spent in optimal SpO2 range measure: Percentage of time with SpO2 signal available measure: Percentage of time with SpO2 below target range measure: Percentage of time with SpO2 above target range measure: Percentage of time with SpO2 outside optimal range measure: Percentage of time with with FiO2 below 40% measure: Percentage of time with with FiO2 above 60% measure: Percentage of time with with FiO2 = 100% measure: Mean SpO2/FiO2 measure: Number of events with SpO2 below of target range (duration >10 s) measure: Number of events with SpO2 below of target range (duration >60 s) measure: Number of events with SpO2 below the predefined low SpO2 emergency limit measure: Number of events with SpO2 above the predefined low SpO2 emergency limit measure: Total oxygen use sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dr.Suat Seren Chest Diseasees Hospital city: Izmir zip: 35230 country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06374576 id: GCIEL briefTitle: Improving eHealth Literacy of Older Adults in Hong Kong overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-12 date: 2024-04-18 date: 2024-04-18 name: The University of Hong Kong class: OTHER name: Sino Group name: NG TENG FONG Charitable Foundation briefSummary: This study is an randomized controlled trial (RCT) study to examine the feasibility and effectiveness of a community-based health promotion education intervention for improving the eHealth literacy of older adults conditions: eHealth Literacy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 184 type: ESTIMATED name: Lecture on eHealth literacy name: Digital intervention on eHealth literacy name: Lecture on general health name: Digital intervention on general health measure: eHealth literacy measure: Health Knowledge Learning Intention measure: Online Health Information Seeking measure: Online Health Information Scanning measure: Health-promotion behaviors measure: Health Decision Change sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: The University of Hong Kong city: Hong Kong country: China name: Sophia SC Chan, PhD role: CONTACT phone: 85239176610 email: nssophia@hku.hk name: Sophia SC Chan, PhD role: PRINCIPAL_INVESTIGATOR lat: 22.39407 lon: 114.13737 hasResults: False

 nctId: NCT06374563 id: BUC-IACUC-221109-6 briefTitle: Tackling Pressure Ulcer Via Bee Venom Phonophoresis acronym: ulcer overallStatus: COMPLETED date: 2022-11-09 date: 2024-01-01 date: 2024-03-01 date: 2024-04-18 date: 2024-04-18 name: Badr University class: OTHER briefSummary: This study aimed to investigate the efficiency of topical Bee Venom gel versus phonophoresis of Bee Venom gel to accelerate healing of chronic pressure ulcer conditions: Bee Venom conditions: Pressure Ulcers conditions: Phonophoresis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ACTUAL name: group 1 received topical Bee venom gel name: Group 2: Phonophoresis of Bee Venom gel measure: wound surface area wound surface area measure: wound volume sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT facility: Badr University in Cairo city: Cairo zip: 11837 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06374550 id: 20231026 briefTitle: Jump Start on the Go: Improving Resiliency and the Social-Emotional Development of At-Risk Preschool Children overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-12-01 date: 2025-12-01 date: 2024-04-18 date: 2024-04-18 name: University of Miami class: OTHER briefSummary: The purpose of this study is to test the Jump Start on the Go (JS Go), an app-based program and see how helpful it is at improving resiliency and behavior support within childcare settings. conditions: Mental Health Wellness 1 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 250 type: ESTIMATED name: Jump Start on the Go name: Jump Start Plus Coronavirus Support measure: Change in classroom practices as measured by Health Environment Rating Scale measure: Change in child behaviors as measured by Devereux Early Childhood Assessments (DECA) measure: Change in child behaviors as measured by Strengths and Difficulties Questionnaire (SDQ) measure: Change in resiliency as measured by Brief Resiliency Coping Scale measure: Change in stress as measured by Childcare Worker Job Stress Index measure: Change in stress as measured by Everyday Stressors Index measure: Change in satisfaction as measured by Teacher Opinion and Satisfaction survey sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Miami city: Miami state: Florida zip: 33136 country: United States name: Ruby Natale, PhD, PsyD role: CONTACT phone: 305-243-4617 email: rnatale@med.miami.edy name: Ruby Natale, PhD, PsyD role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 hasResults: False

 nctId: NCT06374537 id: 2017-0784 briefTitle: Evaluate the Impact of Targeted Physical Activity on Clinically Debilitated Dialysis Patients. overallStatus: RECRUITING date: 2019-05-22 date: 2026-05-22 date: 2027-05 date: 2024-04-18 date: 2024-04-22 name: University of Illinois at Chicago class: OTHER briefSummary: This research is being done to better understand the impact of the use of a specific physical activity training program (GH Method) in dialysis/kidney disease patients. conditions: Frailty conditions: Pain, Chronic conditions: Dialysis; Complications conditions: Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Muscle Therapy measure: Rate at which subjects will see changes in their physical abilities. measure: Rate at which exercise will change body composition measure: Rate at which exercise will change handgrip strength. measure: Rate at which subjects enrolled in the exercise intervention will have an overall changed sense of well-being. measure: Rate at which subjects enrolled in the exercise intervention will have an overall changed in their quality of life. measure: Rate at which subjects enrolled in the exercise intervention will have an overall decreased change in depression. measure: Rate at which subjects enrolled in the exercise intervention will have an overall change in pain intensity. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Illinois at Chicago status: RECRUITING city: Chicago state: Illinois zip: 60612 country: United States name: Ilaria Santi role: CONTACT phone: 312-996-9594 email: isanti@uic.edu name: Natalie Isho role: CONTACT phone: 312-996-4708 email: nisho@uic.edu lat: 41.85003 lon: -87.65005 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-07-25 uploadDate: 2024-04-15T15:15 filename: Prot_SAP_000.pdf size: 1911663 hasResults: False

 nctId: NCT06374524 id: R24-03 briefTitle: Greater Occipital Nerve Block for Spontaneous Intracranial Hypotension overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2026-02-01 date: 2026-06-01 date: 2024-04-18 date: 2024-04-18 name: University Health Network, Toronto class: OTHER briefSummary: SIH is a debilitating neurological disorder caused by a cerebrospinal fluid leak, with an estimated incidence of 5 per 100,000 persons per year, of which mostly women between the ages of 35 years and 55 years (1). The typical presentation is moderate-to-severe orthostatic headache and several other possible neurological symptoms, that significantly impact patients' quality of life (2).

Treatment of SIH usually starts with conservative measures, consisting of strict supine bed rest, hydration, caffeine, and simple analgesics (3). The vast majority of patients will require invasive treatments for their CSF leak, such as epidural blood patches, fibrin glue patches, endovascular coiling, and/or surgical repair (4). These specialized treatments are only offered in tertiary care centers and require specialized personnel and resources, which implicates a certain waiting time for the patients before permanent treatment is offered (5). In the meantime, due to the lack of an effective and accessible alternative, patients continue to suffer.

The GONB has been reported as a simple, safe, and effective treatment to provide short-to-intermediate term relief of migraine (6), cervicogenic headache, cluster headache (7), occipital neuralgia, and more recently, post-dural puncture headaches (PDPH) (8). As the pathophysiology of intracranial hypotension caused by SIH or PDPH is very similar (9), it is stipulated that the effect of GONB will be similar for SIH patients. However, to date, no studies exploring the efficacy of GONB for SIH have been performed.

We propose to do a prospective observational study to explore the outcome of GONB for SIH. GONB can serve as a bridge therapy to control the debilitating headache of SIH while patients are awaiting permanent SIH treatment. Moreover, GONB can be performed by physicians of different specialties including neurology, which makes it an accessible treatment for all patients. Lastly, by offering better symptom control, this intervention could potentially restore patients' ability to work and reduce healthcare costs. conditions: Spontaneous Intracranial Hypotension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 34 type: ESTIMATED name: greater occipital nerve block measure: Change in headache intensity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06374511 id: NFEC-2023-546 briefTitle: Prospective Cohort Study of Complications and Outcomes in Cirrhosis overallStatus: RECRUITING date: 2024-01-01 date: 2024-04-04 date: 2025-12-31 date: 2024-04-18 date: 2024-04-18 name: Nanfang Hospital, Southern Medical University class: OTHER briefSummary: This is a multi-center, nested cohort study intended to investigate the prevalence, risk factors, and outcomes of complications in patients with acutely decompensated cirrhosis, especially focused on Cytomegalovirus (CMV) reactivation, bacterial infections, hepatic encephalopathy, and Hepatorenal syndrome. Patients diagnosed with acutely decompensated cirrhosis were enrolled. Upon enrollment, detailed baseline data were collected and samples were harvested. Complications were assessed during hospitalization. Post-discharge follow-up was conducted through telephonic interviews at Day 30 and Day 90. conditions: Decompensated Cirrhosis conditions: CMV Reactivation conditions: Overt Hepatic Encephalopathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 660 type: ESTIMATED name: Test for CMV reactivation measure: Incidence of CMV reactivation measure: Incidence of hepatic encephalopathy measure: Response to anti-CMV therapy measure: Response to treatment for hepatic encephalopathy (HE) measure: Survival sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong zip: 510515 country: China name: Jinjun Chen, PHD role: CONTACT phone: 86-18588531001 email: chjj@smu.edu.cn lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06374498 id: 2023P003247 briefTitle: Study to Determine the Clinical Significance of Intravascular OCT-NIRAF overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2026-04-30 date: 2027-04-30 date: 2024-04-18 date: 2024-04-18 name: Massachusetts General Hospital class: OTHER briefSummary: Patients undergoing coronary angiography for stable or acute coronary disease presentations and eligible for percutaneous coronary intervention (PCI) will be imaged with OCT-NIRAF at baseline and with CCTA 12 months apart to demonstrate that:

1. NIRAF coronary artery signal level (patient, artery, lesion basis) is correlated with the severity of coronary artery disease.
2. NIRAF coronary artery signal level is a predictor of plaque progression on a per patient, per artery, or per lesion basis. conditions: Cardiovascular Diseases conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 40 type: ESTIMATED name: OCT-NIRAF measure: Plaque size estimation using OCT-NIRAF measure: Plaque progression estimate using OCT-NIRAF sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02114 country: United States name: Nitasha Bhat, MD role: CONTACT phone: 617-724-4515 email: Tearneylabtrials@partners.org lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06374485 id: AU409-LEES-2021-03 briefTitle: Study of AU409 Capsule in Advanced Hepatocellular Carcinoma Patients Who Failed Standard Treatment overallStatus: RECRUITING date: 2024-04-12 date: 2026-02-28 date: 2026-08-28 date: 2024-04-18 date: 2024-04-18 name: Lee's Pharmaceutical Limited class: INDUSTRY briefSummary: This study is a Phase I, dose-escalation study of AU409 in advanced hepatocellular carcinoma patients who failed standard treatment. A '3+3' dose-escalation design will be utilized to gradually increase the dose of AU409, aiming to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor efficacy of multi-dose AU409 in patients with advanced HCC. conditions: Advanced Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: AU409 capsules measure: Dose Limiting Toxicity measure: Maximum Tolerated Dose measure: Recommended Phase 2 Dose measure: Objective Response Rate measure: Disease Control Rate measure: Duration of Response measure: Progression-free Survival measure: Overall Survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Clinical Oncology, Queen Mary Hospital status: RECRUITING city: Hong Kong country: China name: Chi Leung Chiang role: PRINCIPAL_INVESTIGATOR name: Albert Chan role: SUB_INVESTIGATOR name: Aya El HELALI role: SUB_INVESTIGATOR lat: 22.39407 lon: 114.13737 hasResults: False

 nctId: NCT06374472 id: IRB00001194 briefTitle: Surgical Treatment of Fractures of the Dorso-lombar Spine overallStatus: COMPLETED date: 2018-01-01 date: 2022-01-01 date: 2022-01-01 date: 2024-04-18 date: 2024-04-18 name: Ibn Jazzar Hospital class: OTHER briefSummary: Trauma to the thoracolumbar spine is responsible for potentially serious lesions, most often involving the functional prognosis in the short, medium and long term, and rare The frequency of these traumas is explained by falls from high places, especially during work accidents or suicide attempts, but also by the perpetual increase in accidents on public roads ly the vital prognosis conditions: Spine Fracture studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 80 type: ACTUAL name: Osteosynthesis measure: Age (in years) measure: Sex measure: Neurological status ( Frenkel classification) 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: NCT06374459 id: 24-x109 id: BC200714 type: OTHER_GRANT domain: Department of Defense briefTitle: Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2031-11-30 date: 2031-11-30 date: 2024-04-18 date: 2024-04-18 name: Washington University School of Medicine class: OTHER name: United States Department of Defense name: Aclaris Therapeutics, Inc. briefSummary: This is a phase Ib/II study evaluating the safety and efficacy of zunsemetinib (ATI-450) with capecitabine in patients with hormone receptor-positive and HER2-negative (HR+/HER2-) metastatic breast cancer (MBC). conditions: Hormone Receptor Positive HER-2 Negative Metastatic Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The Phase I portion of the study is sequential and patients will not be randomized and the Phase II portion is parallel and patients will be randomized. primaryPurpose: TREATMENT masking: NONE count: 138 type: ESTIMATED name: Zumsemetinib name: Capecitabine name: Zoledronic acid name: Denosumab measure: Number of participants with adverse events (Phase Ib only) measure: Recommended phase II dose of zunsemetinib (Phase Ib only) measure: Percent change in serum CTX (Phase II only) measure: Progression-free survival (PFS) (Phase II only) measure: Treatment-induced changes in DEXA BMD (g/cm^2) at hip and spine (Phase Ib only) measure: Treatment-induced changes in sCTX by clinical assay (Phase II only) measure: Objective response rate (ORR) (Phase II only) measure: Clinical benefit rate (Phase II only) measure: Overall survival (OS) (Phase II only) measure: Treatment-induced changes in DEXA BMD (g/cm^2) at hip and spine (Phase II only) measure: Treatment-induced changes in quality of life as measured by EORTC QLQ-C30 (Phase II only) measure: Treatment-induced changes in pain as measured by Brief Pain Inventory (BPI) (Phase II only) measure: Number of participants with adverse events (Phase II only) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Kansas Cancer Center city: Westwood state: Kansas zip: 66205 country: United States name: Qamar Khan, M.D. role: CONTACT phone: 913-588-1227 name: Qamar Khan, M.D. role: PRINCIPAL_INVESTIGATOR lat: 39.04056 lon: -94.6169 facility: Mayo Clinic city: Rochester state: Minnesota zip: 55905 country: United States name: Matthew Goetz, M.D. role: CONTACT phone: 507-284-2511 email: Goetz.Matthew@mayo.edu name: Matthew Goetz, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 facility: Washington University School of Medicine city: Saint Louis state: Missouri zip: 63110 country: United States name: Cynthia X Ma, M.D., Ph.D. role: CONTACT phone: 314-362-8903 email: cynthiaxma@wustl.edu name: Cynthia X Ma, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR name: Sheila Stewart, Ph.D. role: SUB_INVESTIGATOR name: Roberto Civitelli, M.D. role: SUB_INVESTIGATOR name: Jingqin (Rosy) Luo, Ph.D. role: SUB_INVESTIGATOR name: Foluso Ademuyiwa, M.D. role: SUB_INVESTIGATOR name: Nusayba Bagegni, M.D. role: SUB_INVESTIGATOR name: Ron Bose, M.D., Ph.D. role: SUB_INVESTIGATOR name: Andrew Davis, M.D. role: SUB_INVESTIGATOR name: Ashley Frith, M.D., Ph.D. role: SUB_INVESTIGATOR name: Faisal Fa'ak, M.D. role: SUB_INVESTIGATOR name: Lindsay Peterson, M.D. role: SUB_INVESTIGATOR name: Rama Suresh, M.D. role: SUB_INVESTIGATOR lat: 38.62727 lon: -90.19789 hasResults: False

 nctId: NCT06374446 id: 22-172 briefTitle: Effect of Virtual Reality in Patients With Long Covid-19 overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-06-15 date: 2024-06-30 date: 2024-04-18 date: 2024-04-18 name: Istinye University class: OTHER briefSummary: SARS-CoV-2 was first detected in Wuhan, Hubei Province, China, in late 2019. It is a highly contagious virus that has been reported to occur in humans and is said to cause pneumonia.

Covid-19 infection is transmitted through droplets during coughing and sneezing and through contact with the mouth, nose or eyes after contaminated hands. The most obvious symptoms of Covid-19 symptoms include cough, dyspnea and fever. Covid-19, which can also be seen asymptomatic, is in intensive care it may be severe enough to require hospitalization, cause multiple organ failure and even death it could be. Musculoskeletal symptoms such as fatigue, myalgia, and arthralgia are common with Covid-19 are the symptoms. The first case in Turkey was reported on March 11, 2020.

Long-term Covid or Chronic Post Covid Syndrome are multi-system syndromes that last more than 12 weeks and physical, cognitive, psychological, social and occupational domains. The most commonly reported long covid symptoms are; fatigue, shortness of breath, cough, joint pain, chest pain.

Virtual reality application provides its users with content created using computer technology. In a virtual environment with a high perception of reality, the aim is to enable mirror neuron activation, enabling the individual to interact with virtual objects and events with three-dimensional movements and to create the perception of doing all these in the real world.

Virtual reality for training, treatment, rehabilitation, analysis and testing purposes in healthcare can be used. It is possible to use virtual reality for different purposes, for treatment and rehabilitation. With virtual reality applications in treatment and rehabilitation processes It was stated that patient motivation will increase and patient fear and anxiety will decrease.

No study was found in the literature investigating the effect of virtual reality application on fatigue, functional capacity and respiratory function in long-term Covid-19 patients. The purpose of this study; To investigate the effect of virtual reality application on fatigue, functional level and respiratory function in long-term Covid-19 patients. conditions: COVID-19 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 56 type: ESTIMATED name: Classical Treatment name: Virtual Reality Combined with Classical Treatment name: Virtual Reality name: Control Group measure: Fatigue measure: Kinesiophobia measure: Evaluation of Respiratory Function measure: Shuttle Walking Test measure: Endurance Shuttle Walking Test measure: Sit and Reach Test measure: Peripheral Muscle Strength measure: The Nottingham Health Profile measure: Dyspnea measure: Energy Consumption measure: Posture Analysis measure: Covid-19 Yorkshire Performance measure: FACIT Fatigue Scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06374433 id: PREDICOM-01 briefTitle: Investigating the Plasticity of Human Predictive Coding Through Neuromodulation acronym: PREDICOM overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-12-31 date: 2024-04-18 date: 2024-04-18 name: Università Vita-Salute San Raffaele class: OTHER name: Alessia Santoni name: Sara Stottmeier name: Klara Hemmerich name: Giuseppe Di Dona name: Luigi Ferini-Strambi briefSummary: The hypothesis of the study is to investigate how different trm (tES) methods (transcranial Alternating Current Stimulation, tACS, and transcranial Random Noise Stimulation, tRNS) applied at different stimulation frequencies and networks can modulate the predictive mechanisms in human perception and cognition. This is an interventional, monocentric, cross-sectional randomized, single-blinded study on healthy adult volunteers, recruited through online advertisements, flyers and oral transmission. Volunteers will be recruited from the general population of young adults. conditions: Human Brain and Cognition studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 210 type: ESTIMATED name: Occipital tACS at IAF-2Hz name: Occipital tACS at IAF+2Hz name: Frontal tACS at 4-7 Hz name: Occipital tRNS name: Frontal tRNS name: Sham/placebo tACS name: Sham/placebo tRNS measure: Behavioral measures sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False

 nctId: NCT06374420 id: MD.21.11.564 briefTitle: Small Airway Disease And Bronchial Hyperreactivity In Patients With Post Acute Covid-19 Syndrome overallStatus: COMPLETED date: 2021-09-01 date: 2023-09-01 date: 2024-04-01 date: 2024-04-18 date: 2024-04-19 name: Mansoura University class: OTHER briefSummary: The aim of this work is to estimate the frequency of small airway disease and/or the bronchial hyperreactivity in follow up of postacute covid survivors. conditions: COVID-19 studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 100 type: ACTUAL measure: investigating pulmonary sequelae of covid-19. measure: investigating pulmonary sequelae of covid-19. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mansoura University city: Mansoura state: Dakhlia zip: 050 country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06374407 id: GT-001 briefTitle: The MIND-GUT Digital Pilot Intervention Study acronym: MINDGUT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-05 date: 2026-12 date: 2024-04-18 date: 2024-04-18 name: University of Skövde class: OTHER name: State University of New York - Downstate Medical Center name: Albert Einstein College of Medicine name: Göteborg University name: Uppsala University name: Kristianstad University name: University of Pavia name: The Food Scientist AB (Sweden) briefSummary: This 12-week pilot study aims to evaluate the feasibility and effectiveness of a dietary intervention targeting diet, obesity, mental health, and the gut microbiome in promoting weight loss and enhancing mental health among obese men and women aged 30-50. Participants, excluding those with specific medical conditions, will be randomly assigned to either an intervention or control group using a meal planning smartphone app. Clinical assessments will include anthropometry, mental health questionnaires, dietary recalls, and stool sample collections. The study's endpoints include program retention, adherence, changes in body weight, mental health, and gut microbiome diversity. Statistical analyses will evaluate intervention effects and the potential mediating roles of the gut microbiome. This pilot study has implications for health policies, public healthcare, digital health companies, and the biotech and pharmacology industries. Future plans involve a large-scale intervention study in multiple countries with ongoing collaborations. conditions: Obesity conditions: Depressive Symptoms conditions: Anxiety conditions: Stress conditions: Eating Habit conditions: Dysbiosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: We plan to randomly assign participants to either the intervention or control group. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Participants will be blinded to their group assignment and will use a smartphone app for meal planning. However, those in the intervention group may have some awareness of their assignment due to specific food choices. Meanwhile, the control group will have access to a variety of foods and recipes, maintaining blinding between the groups regarding their assigned diets, addressing a common challenge in diet intervention studies. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 126 type: ESTIMATED name: Dietary intervention based on the MIND diet measure: Program retention measure: Adherence measure: Acceptability measure: Study effectiveness: change in eating attitudes at follow-up measure: Study effectiveness: change in stress levels at follow-up measure: Study effectiveness: change in depression symptoms at follow-up measure: Study effectiveness: change in anxiety symtoms at follow-up measure: Study effectiveness: change in body weight at follow-up measure: Study effectiveness: change in % total fat mass at follow-up measure: Study effectiveness: change in % visceral fat mass at follow-up measure: Study effectiveness: change in waist circumference at follow-up measure: Study effectiveness: change in hip circumference at follow-up measure: Study effectiveness: change in microbiome variety at follow-up sex: ALL minimumAge: 30 Years maximumAge: 50 Years stdAges: ADULT facility: University of Skövde city: Skövde zip: 54128 country: Sweden name: Gianluca Tognon, PhD role: CONTACT lat: 58.39118 lon: 13.84506 hasResults: False

 nctId: NCT06374394 id: 217848 id: 2023-510196-59-00 type: OTHER domain: EU CTR Number briefTitle: A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a COVID-19 mRNA Vaccine in Adults Aged 50 Years and Above overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2024-12-03 date: 2025-05-20 date: 2024-04-18 date: 2024-04-18 name: GlaxoSmithKline class: INDUSTRY briefSummary: This study will assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when it is co-administered with a COVID-19 messenger ribonucleic acid (mRNA) vaccine (Omicron XBB.1.5), compared to administration of the vaccines separately in adults aged 50 years and above. conditions: Respiratory Syncytial Virus Infections studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE maskingDescription: Click here to enter text. count: 850 type: ESTIMATED name: RSVPreF3 OA investigational vaccine name: COVID-19 mRNA vaccine measure: RSV-A neutralization titers measure: RSV-B neutralization titers measure: SARS-CoV-2 Omicron XBB.1.5 neutralization titers against pseudovirus bearing S protein measure: RSV-A neutralization titers expressed as GMT measure: RSV-A neutralization titers expressed as Mean Geometric Increase (MGI) measure: RSV-A neutralization titers expressed as Seroresponse Rate (SRR) measure: Percentage of participants having RSV-A neutralizing titers >= assay cut-off value measure: RSV-B neutralization titers expressed as GMT measure: RSV-B neutralization titers expressed as MGI measure: RSV-B neutralization titers expressed as SRR measure: Percentage of participants having RSV-B neutralizing titers >= assay cut-off value measure: SARS-CoV-2 Omicron XBB.1.5 neutralization titers against the pseudovirus bearing S protein expressed as GMT measure: SARS-CoV-2 Omicron XBB.1.5 neutralization titers against the the pseudovirus bearing S protein expressed as MGI measure: Percentage of participants having SARS-CoV-2 Omicron XBB.1.5 neutralization titers >= assay cut-off value measure: Percentage of participants reporting each solicited administration site event measure: Percentage of participants reporting each solicited systemic event measure: Percentage of participants reporting unsolicited adverse events (AEs) measure: Percentage of participants reporting serious adverse events (SAEs) measure: Percentage of participants reporting potential immune-mediated diseases (pIMDs) sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GSK Investigational Site city: Coral Gables state: Florida zip: 33134 country: United States 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: Jeffrey B. Rosen role: PRINCIPAL_INVESTIGATOR lat: 25.72149 lon: -80.26838 facility: GSK Investigational Site city: Savannah state: Georgia zip: 31406 country: United States 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: Paul Bradley role: PRINCIPAL_INVESTIGATOR lat: 32.08354 lon: -81.09983 facility: GSK Investigational Site city: Evansville state: Indiana zip: 47714 country: United States 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: Hubert Sulit Reyes role: PRINCIPAL_INVESTIGATOR lat: 37.97476 lon: -87.55585 facility: GSK Investigational Site city: Omaha state: Nebraska zip: 68134 country: United States 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: Brandon James Essink role: PRINCIPAL_INVESTIGATOR lat: 41.25626 lon: -95.94043 facility: GSK Investigational Site city: Secaucus state: New Jersey zip: 07094 country: United States 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: Johnathan Blizzard role: PRINCIPAL_INVESTIGATOR lat: 40.78955 lon: -74.05653 facility: GSK Investigational Site city: Rochester state: New York zip: 14609 country: United States 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: Patrick Connors role: PRINCIPAL_INVESTIGATOR lat: 43.15478 lon: -77.61556 facility: GSK Investigational Site city: Winston-Salem state: North Carolina zip: 27103 country: United States 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: Jonathan Paul Wilson role: PRINCIPAL_INVESTIGATOR lat: 36.09986 lon: -80.24422 facility: GSK Investigational Site city: North Charleston state: South Carolina zip: 29405 country: United States 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: Kelly Morales role: PRINCIPAL_INVESTIGATOR lat: 32.85462 lon: -79.97481 facility: GSK Investigational Site city: Newport News state: Virginia zip: 23606 country: United States 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: George H Freeman role: PRINCIPAL_INVESTIGATOR lat: 37.08339 lon: -76.46965 facility: GSK Investigational Site city: Antwerpen zip: 2000 country: Belgium 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: Yven Van Herrewege role: PRINCIPAL_INVESTIGATOR lat: 51.21989 lon: 4.40346 facility: GSK Investigational Site city: Edegem zip: 2650 country: Belgium 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: Nikita Hanning role: PRINCIPAL_INVESTIGATOR lat: 51.15662 lon: 4.44504 facility: GSK Investigational Site city: Gent zip: 9000 country: Belgium 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: Isabel Leroux-Roels role: PRINCIPAL_INVESTIGATOR lat: 51.05 lon: 3.71667 facility: GSK Investigational Site city: Kluisbergen zip: 9690 country: Belgium 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: Klaas Vercruysse role: PRINCIPAL_INVESTIGATOR facility: GSK Investigational Site city: Mechelen zip: 2800 country: Belgium 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: Claudia Cornelis role: PRINCIPAL_INVESTIGATOR lat: 51.02574 lon: 4.47762 facility: GSK Investigational Site city: Breda zip: 4818 CK country: Netherlands 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: Simone van der Sar role: PRINCIPAL_INVESTIGATOR lat: 51.58656 lon: 4.77596 facility: GSK Investigational Site city: Enschede zip: 7512 KZ country: Netherlands 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: Paolo Zocca role: PRINCIPAL_INVESTIGATOR lat: 52.21833 lon: 6.89583 facility: GSK Investigational Site city: Utrecht zip: 3584 BA country: Netherlands 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: Marc Bonten role: PRINCIPAL_INVESTIGATOR lat: 52.09083 lon: 5.12222 facility: GSK Investigational Site city: Zutphen zip: 7207 AE country: Netherlands 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: Martijn Goosens role: PRINCIPAL_INVESTIGATOR lat: 52.13833 lon: 6.20139 facility: GSK Investigational Site city: Boadilla del Monte state: Madrid zip: 28660 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: Silvina Laura Natalini role: PRINCIPAL_INVESTIGATOR lat: 40.405 lon: -3.87835 facility: GSK Investigational Site city: Barcelona zip: 08023 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: Fernando Cereto Castro role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: GSK Investigational Site city: Barcelona zip: 08907 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: Cristina Masuet Aumatell role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: GSK Investigational Site city: Coruña zip: 15006 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: Maria Jose Pereira Rodriguez role: PRINCIPAL_INVESTIGATOR lat: 43.37135 lon: -8.396 facility: GSK Investigational Site city: Madrid zip: 28040 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: Helena Moza Moríñigo role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: GSK Investigational Site city: Madrid zip: 28041 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: Pablo Rojo Conejo role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: GSK Investigational Site city: Majadahonda zip: 28222 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: Jenry Borda Olivas role: PRINCIPAL_INVESTIGATOR lat: 40.47353 lon: -3.87182 hasResults: False

 nctId: NCT06374381 id: 854990 briefTitle: PEACE for ImPACT Study overallStatus: ENROLLING_BY_INVITATION date: 2023-12-01 date: 2027-11 date: 2027-11 date: 2024-04-18 date: 2024-04-18 name: University of Pennsylvania class: OTHER name: Institute of Education Sciences name: Michigan State University briefSummary: Investigators will test the impact of the PEACE implementation toolkit and determine the level of implementation support needed to improve early intervention providers use of caregiver coaching with families of young children with autism who receive early intervention services. The study will also assess caregiver and child outcomes for families receiving caregiver coaching and the cost effectiveness of the PEACE implementation toolkit. The investigators will enroll 200 early intervention providers, and 400 parent-child dyads. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcome assessors will be masked to randomization condition. whoMasked: OUTCOMES_ASSESSOR count: 600 type: ESTIMATED name: PEACE Online Resources name: PEACE Weekly Group Facilitation name: PEACE Weekly Individual Facilitation measure: Parent Empowerment and Coaching in Early Intervention (PEACE) Caregiver Coaching Fidelity Tool measure: Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO) measure: Autism Impact Measure (AIM) measure: Social Communication Checklist (SCC) measure: Confusion, Hubbub, and Order Scale (CHAOS) measure: Acceptability, Appropriateness, and Adoption measure measure: Qualitative Interview sex: ALL minimumAge: 12 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Center for Mental Health city: Philadelphia state: Pennsylvania zip: 19104 country: United States lat: 39.95233 lon: -75.16379 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-11-30 uploadDate: 2024-04-12T13:20 filename: Prot_SAP_000.pdf size: 508769 hasResults: False

 nctId: NCT06374368 id: JID-SURG briefTitle: Small Bowel Diversion overallStatus: ACTIVE_NOT_RECRUITING date: 2019-05-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-18 date: 2024-04-24 name: University of Ostrava class: OTHER name: Institute for Clinical and Experimental Medicine name: Vitkovice Hospital briefSummary: In an effort to replicate metabolic surgery's durable results in metabolic disease while minimizing its risks, two innovative methods has been created. Two surgical methods to create a bowel-to-bowel anastomosis, similar to the type used in current metabolic surgeries. It be to create a jejuno-ileal, side-to-side anastomosis and jejunocolic side-to-side anastomosis. The side-to-side jejuno-ileal anastomosis and side-to-side jejunocolic anastomosis provides two routes for ingested food. The new, shorter route has a malabsorptive effect similar to that seen in Roux en-Y gastric bypass (RYGB) and biliopancreatic diversion (BPD) - procedures which leads to weight loss. Additionally, delivery of non-absorbed macronutrients to the distal ileum, or transverse colon can enhance incretin effect and improve Type 2 Diabetes parameters. However, the native route is also preserved, which theoretically reduces the risk of malnutrition, diarrhea, and metabolic derangements seen in other metabolic surgeries.The side-to-side jejuno-ileal anastomosis was already tested in the Pilot Study of the GI Windows Self-Forming Magnetic (SFM) Anastomosis Device for Crea-tion of an Incisionless Small Bowel Bypass for Treatment of Obesity and Diabetes in year 2015 (15). The results of this study demonstrated the safety of this approach without seri-ous adverse events. This non-surgical approach resulted in Significant weight loss, favorable changes in insulin and incretin responses to a mixed meal and Significant improvement in A1C in T2DM (16).In summary, metabolic disease is a growing pandemic with suboptimal clinical solutions. The surgical side-to-side jejuno-ileal anastomosis and side-to-side jejuno-colic anastomosis without gastrectomy potentially represents a new class of therapy that may produce durable clinical results generally associated with surgery while minimizing its attendant risks. conditions: Obesity conditions: Type2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ACTUAL name: jejuno-ileal diversion name: jejuno-colic diversion measure: Total body weight loss measure: Glycated hemoglobin loss measure: Diabetes medication loss measure: Total cholesterol loss measure: Low density lipoprotein loss measure: High density lipoprotein loss measure: Leptin metabolism evaluation measure: Adiponectin metabolism evaluation measure: Change from baseline quality of life-Lite measure: Change from baseline quality of life - Sort Form Survey sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Ostrava, Faculty of Medicine city: Ostrava country: Czechia lat: 49.83465 lon: 18.28204 hasResults: False

 nctId: NCT06374355 id: Semibranch_Retro briefTitle: Semibranch Registry - Retrospective overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-04 date: 2030-10 date: 2024-04-18 date: 2024-04-22 name: University Hospital Muenster class: OTHER briefSummary: The goal of this registry is to evaluate the semibranch in branched endovascular arotic repair, which is a new tool in endovascular branched aortic repair. conditions: Aortic Aneurysm conditions: Endovascular Aortic Repair conditions: Stent-Graft Endoleak studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: Semibranch CMD branched aortic stentgraft measure: Freedom from target vessel instability measure: Mortality measure: Technical success measure: Morbidity measure: Freedom of Endoleak type I and III measure: Long term mortality measure: Branch patency sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Muenster University Hospital city: Münster country: Germany lat: 51.96236 lon: 7.62571 hasResults: False

 nctId: NCT06374342 id: SO01-TK-SUBSTITUTES briefTitle: BONE SUBSTITUTES OUTCOMES overallStatus: RECRUITING date: 2021-09-16 date: 2026-09-16 date: 2032-09-30 date: 2024-04-18 date: 2024-04-18 name: Teknimed class: INDUSTRY briefSummary: A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Bone Substitute range of products: CERAFORM, TRIHA+, NANOGEL, and all their private labels.

TEKNIMED bone substitutes 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, prospective observational study. Patients will be followed as per local standard medical care of the sites. conditions: Bone Resorption studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 425 type: ESTIMATED name: Bone defect name: Spine fusion name: Cage filling measure: Successful bone repair measure: Alleviation of Pain measure: Bone reconstruction measure: Well-being measure: Patient satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pôle Rachis Hôpital Privé d'Eure et Loir status: RECRUITING city: Mainvilliers state: Eure Et Loir zip: 28300 country: France name: Jean MEYBLUM, MD role: CONTACT email: jeanmeyblum@hotmail.com name: Jean MEYBLUM, MD role: PRINCIPAL_INVESTIGATOR lat: 48.45003 lon: 1.45607 facility: Hôpital Joseph Ducuing status: RECRUITING city: Toulouse state: Haute Garonne zip: 31000 country: France name: Gérard GIORDANO, MD role: CONTACT email: ortho.giordano@gmail.com name: Gérard GIORDANO, MD role: PRINCIPAL_INVESTIGATOR lat: 43.60426 lon: 1.44367 facility: Clinique Médipole Garonne status: RECRUITING city: Toulouse state: Haute Garonne zip: 31100 country: France name: Dominique VARDON, MD role: CONTACT email: dr-dominique.vardon@orange.fr name: Dominique VARDON, MD role: PRINCIPAL_INVESTIGATOR lat: 43.60426 lon: 1.44367 facility: CHRU Brabois status: RECRUITING city: Nancy state: Meurthe Et Moselle zip: 54000 country: France name: Didier MAINARD, MD role: CONTACT email: didier.mainard@univ-lorraine.fr name: Didier MAINARD, MD role: PRINCIPAL_INVESTIGATOR lat: 48.68439 lon: 6.18496 facility: Clinique du Pré status: RECRUITING city: Le Mans state: Sarthe zip: 72000 country: France name: Jean-Patrick RAKOVER, MD role: CONTACT phone: 02 43 77 54 21 email: jeanpatrickrakover@me.com name: Jean-Patrick RAKOVER, MD role: PRINCIPAL_INVESTIGATOR lat: 48.0 lon: 0.2 facility: OCM Klinik GmbH status: RECRUITING city: München state: Bavière zip: D-81369 country: Germany name: Markus SCHROEDEL, MD role: CONTACT email: Markus.schroedel@ocm-muenchen.de name: Markus SCHROEDEL, MD role: PRINCIPAL_INVESTIGATOR lat: 48.13743 lon: 11.57549 hasResults: False

 nctId: NCT06374329 id: S68717 briefTitle: Effect of Interceptive Strategies on the Clinical Outcome of Impacted Maxillary Permanent Canines acronym: RCTcanines2 overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2026-08-01 date: 2027-08-01 date: 2024-04-18 date: 2024-04-24 name: Universitaire Ziekenhuizen KU Leuven class: OTHER name: Karolinska Institutet name: University of Copenhagen name: Palacky University name: The University of Hong Kong briefSummary: Canine impaction is a sign of abnormal dental development with potentially far-reaching consequences (such as significant root resorption and loss of lateral incisors. This compromises both aesthetics and function of the teeth, making the prediction of canine tooth impaction increasingly important. Interceptive orthodontic measures, such as extraction of deciduous canines or molars or maxillary expansion aim to create extra space in the dental arch, allowing the canines to position themselves better and normalizing their eruption pattern.

This study corresponds to the second phase of an RCT, based on the results of the first phase, published in July 2023 (S59030) (Willems G, Butaye C, Raes M, Zong C, Begnoni G, Cadenas de Llano-Pérula M. Early prevention of maxillary canine impaction: a randomized clinical trial. Eur J Orthod. 31;45(4):359-369). The first phase compared the effect of 3 interceptive strategies (expansion, extraction and no intervention) on the position of impacted maxillary canines, finding that maxillary expansion provides the most improvement on impacted canine position. In second phase, 8-year-old patients without posterior crossbite and lack of space in the dental arch are randomized to treatment with 'slow maxillary expansion with removable plates' or 'no treatment'. These groups are additionally compared with patients with a crossbite and lack of space, which always receive expansion treatment. All selected patients will be followed up for at least 18 months. The primary endpoint is to investigate the effect of maxillary expansion with removable plates on the position of maxillary canines prone to impaction during early mixed dentition, assessed on panoramic X-rays. The secondary endpoint is the assessment of the need for additional orthodontic treatment. conditions: Tooth Impaction conditions: Canine Teeth studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 75 type: ESTIMATED name: Interceptive Slow Maxillary Expansion with removable plates measure: Position of the impacted maxillary canine towards the dental midline (3^ML). measure: Need for subsequent interventions (extraction of deciduous or permanent teeth, other orthodontic interventions, surgical exposure) sex: ALL minimumAge: 7 Years maximumAge: 10 Years stdAges: CHILD hasResults: False

 nctId: NCT06374316 id: 2302888 briefTitle: Air Purifiers in Classrooms for Infection Control - a Pilot Study overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-15 date: 2024-05-01 date: 2024-05-01 date: 2024-04-18 date: 2024-04-18 name: Norwegian Institute of Public Health class: OTHER_GOV name: SINTEF Health Research briefSummary: This study aims to investigate the acceptability and feasibility of deploying air purifiers equipped with HEPA (high-efficiency particulate air) filters in classrooms, to study air purifiers as an infection control measure. It will also evaluate the direct effect of air purifiers on air quality, comparing ceiling-mounted purifiers, portable purifiers and no purifier. conditions: Feasibility conditions: Acceptability studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: We will select schools for participation in arm 1 and 2, respectively, based on the feasibility of installing ceiling-mounted and placing portable air purifiers in each relevant classroom. In arm 3, all three classrooms will be equipped with both ceiling-mounted and portable air purifiers, as well as indoor air quality sensors.

For this arm, we will randomize the three classrooms to each of three weekly programs for the air purifiers;

Program 1) Week 1, 4, and 7: Ceiling-mounted ON, Week 2, 5, and 8: No purifier on, Week 3, 6, and 9: Portable ON. Program 2) Week 1, 4, and 7: Portable ON, Week 2, 5, and 8: Ceiling-mounted ON, Week 3, 6, and 9: No purifier on. Program 3) Week 1, 4, and 7: No purifier on Week 2, 5, and 8: Portable ON, Week 3, 6, and 9: Ceiling-mounted ON.

Each classroom will be assigned a computer-generated random number and will based on the ascending order of the random numbers be allocated to the three predetermined sequences of programs. primaryPurpose: OTHER masking: NONE count: 6 type: ACTUAL name: Ceiling-Mounted Air Purifiers name: Portable Air Purifiers name: Portable or Ceiling Mounted Air Purifiers measure: Effectiveness of air purifiers versus no air purifier on improving air quality in classrooms. measure: Effectiveness of ceiling mounted versus portable air purifier on improving air quality in classrooms. measure: Acceptability of having Air Purifiers in Classrooms measure: Untoward events when installing air purifiers in classrooms measure: Untoward events when running air purifiers in classrooms measure: How student absence data can be collected from existing school registration systems. measure: Response rate of class teachers to the study surveys. measure: Response rate of students/their guardians to study surveys. measure: Proportion of absence due to respiratory disease. measure: Absence frequency among students sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Norwegian Institute of Public Health city: Oslo country: Norway lat: 59.91273 lon: 10.74609 hasResults: False

 nctId: NCT06374303 id: CHRBSS 00001940 briefTitle: Novel Intervention to Improve Food Insecurity Among Individuals With Opioid Use Disorder: A Randomized Clinical Trial overallStatus: COMPLETED date: 2022-04-19 date: 2023-11-20 date: 2023-11-20 date: 2024-04-18 date: 2024-04-18 name: University of Vermont class: OTHER briefSummary: The adverse consequences of illicit opioid use (e.g., overdose, premature death) are the focus of intensive research efforts. However, other serious health problems among individuals with opioid use disorder (OUD) have received far less attention. Food insecurity (FI) is 4-7 times greater among individuals with OUD than the general population. In addition to the increased healthcare utilization and costs, poor health outcomes, and adverse social consequences associated with FI in the general population, patients with co-occurring FI and OUD are at increased risk for licit and illicit drug use, sexual and drug risk behaviors, infectious disease, and a two-fold greater odds of premature death.

In this randomized pilot study, we evaluated a novel, mail-based meal delivery intervention for improving household FI and other outcomes among individuals receiving methadone or buprenorphine maintenance for OUD.

Fifty adults with FI and OUD were randomized to one of two 12-week experimental conditions: Nutritional Education (NE) participants received brief education, a list of FI-related resources in their community, and assistance with contacting those resources. NE + Meal Delivery (NE+MD) participants received the same educational platform plus weekly meal deliveries using a commercial service that delivers premade, refrigerated meals directly to the participant's home.

The primary outcome of household FI was measured at monthly assessments using the USDA Household Food Security Survey. Secondary measures included depression symptoms (Beck Depression Inventory), quality of life (RAND-36 Quality of Life Survey), and drug use as measured by biochemical urinalysis.

The NE+MD intervention was associated with significant improvements in household FI, with fewer NE+MD participants meeting criteria for FI vs. NE participants at all three assessment timepoints (p's\<.05). Retention rates were similar between the two groups (88% and 84% for NE+MD and NE conditions, respectively; p=.68). Intervention acceptability was also high, with NE+MD participants rating the enjoyment and convenience of the meals at 81 and 93, respectively (range: 0-100).

Changes in FI status were also associated with improvements in other areas of functioning. NE+MD participants experienced reductions in depression symptomatology, with Beck Depression Inventory scores lower than intake at Weeks 4 and 8 (p's\<.05) and no changes among NE participants. NE+MD participants also experienced improvements on four of the eight subscales of the RAND-36 Quality of Life Health Survey (i.e., General Health, Bodily Pain, Mental Health, Role Emotional; p's\<.05), with no changes among NE participants.

This study represents the first effort to develop and evaluate a novel intervention to reduce FI and related problems among individuals with OUD. These pilot data support the feasibility, acceptability and initial efficacy of the NE+MD intervention for improving household FI, as well as provide exciting new preliminary evidence suggesting that FI may be linked to participants' mental and physical health. conditions: Food Security studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, parallel-groups pilot study primaryPurpose: TREATMENT masking: NONE count: 50 type: ACTUAL name: NE + Meal Delivery (NE+MD) intervention measure: Household food insecurity Survey sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Vermont city: Burlington state: Vermont zip: 05401 country: United States lat: 44.47588 lon: -73.21207 hasResults: False

 nctId: NCT06374290 id: HSC-MS-24-0024 briefTitle: Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-02-15 date: 2025-04-15 date: 2024-04-18 date: 2024-04-18 name: The University of Texas Health Science Center, Houston class: OTHER briefSummary: The purpose of this study is to assess the feasibility and safety of injectable naltrexone (NTX;380 mg) in conjunction with oral bupropion (BUP; 450 mg daily)NTX-BUP administration among individuals with schizophrenia spectrum disorders that smoke cigarettes and to evaluate change on smoking-related measures and symptoms of schizophrenia. conditions: Smoking Cessation studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: Naltrexone (Vivitrol) name: Bupropion measure: Feasibility as assessed by the percentage of participants that enroll in the study measure: Percentage of participants that complete 3 weeks of treatment measure: Safety as assessed by the percentage of participants that show no serious adverse events measure: Change in number of cigarettes smoked per day (CPD) measure: Change in smoking urges as assessed by the Questionnaire on Smoking Urges (QSU) measure: Reduction in number of cigarettes consumed when price is at 0 as assessed by the Cigarette Purchasing Task (CPT) measure: Change in psychiatric symptoms as assessed by the score on the Brief Psychiatric Rating Scale (BPRS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Texas health Science Center at Houston city: Houston state: Texas zip: 77030 country: United States name: Jin H Yoon, PhD role: CONTACT phone: 713-486-2800 email: jin.ho.yoon@uth.tmc.edu name: Jessica Vincent role: CONTACT phone: (713) 486-2645 email: Jessica.N.Vincent@uth.tmc.edu lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06374277 id: 23-09339-IAA briefTitle: Pharmacy-led Transitions of Care Intervention to Improve Medication Adherence acronym: MedAAAction overallStatus: RECRUITING date: 2024-04-06 date: 2027-09-30 date: 2028-01-31 date: 2024-04-18 date: 2024-04-25 name: University of Tennessee class: OTHER name: Sponsor GmbH briefSummary: Socioeconomically disadvantaged populations with multiple chronic conditions have high rates of nonadherence to essential chronic disease medications after hospital discharge. Medication nonadherence after hospital discharge is significantly associated with increased mortality and higher rates of readmissions and costs among these patients. Major patient-reported barriers to essential medication use after hospital discharge among low-income individuals are related to social determinants of health (SDOH) and include: 1) financial barriers , 2) transportation barriers, and 3) system-level barriers. Although, medication therapy management services are important during care transitions, these services have not proven effective in improving medication adherence after hospital discharge, highlighting a critical need for innovative interventions. The Medication Affordability, Accessibility, and Availability in Care Transitions (Med AAAction) Study will test the effectiveness of a pharmacy-led care transitions intervention versus usual care through a pragmatic randomized controlled trial of 388 Medicaid and uninsured hospital in-patients with MCC from three large healthcare systems in Tennessee. The intervention will involve: 1) medications with zero copay, 2) bedside delivery then home delivery of medications, and 3) care coordination provided by certified pharmacy technicians/health coaches to assist with medication access, medication reconciliation, and rapid and ongoing primary care follow-up. We will examine the impact of the intervention during 12 months on 1) medication adherence (primary outcome) and 2) rapid primary care follow-up, 30-day readmissions, hospitalizations and emergency department visits, and costs. We will conduct key informant interviews to understand patient experience with the acre received during and after care transitions. By examining effectiveness of the intervention on outcomes including medication adherence, health care utilization, costs, and patient experience, this study will provide valuable results to health systems, payers, and policymakers to assist in future implementation and sustainability of the intervention for socioeconomically disadvantaged populations. conditions: Diabetes conditions: Hypertension conditions: High Cholesterol/Hyperlipidemia conditions: Coronary Artery Disease conditions: Congestive Heart Failure conditions: Chronic Lung Disease conditions: Chronic Kidney Diseases conditions: Arrythmia conditions: Stroke conditions: Depression conditions: Anxiety conditions: Pulmonary Embolism conditions: Heart Attack studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Eligible patients who sign consent forms and complete baseline surveys will be randomized to the Med AAAction intervention group or the usual care in a 1:1 ratio, stratified by health system. The participants will be enrolled before hospital discharge. The Med AAAction intervention will include the following components: 1) medications with zero copay, 2) bedside delivery and subsequent home delivery of medications, and 3) care coordination provided by certified pharmacy technicians/health coaches to assist with medication access, medication reconciliation, and rapid and ongoing primary care follow-up after hospital discharge. The intervention will be provided for one-year. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 388 type: ESTIMATED name: Med AAAction intervention measure: Adherence to chronic disease medications measure: Health care utilization measure: Cost measure: Qualitative Evaluation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Tennessee Medical Center status: NOT_YET_RECRUITING city: Knoxville state: Tennessee zip: 37920 country: United States name: Shauntá M Chamberlin role: CONTACT phone: 865-305-5061 email: schamberlin@utmck.edu lat: 35.96064 lon: -83.92074 facility: University of Tennessee Health Science Center/Regional One Health status: RECRUITING city: Memphis state: Tennessee zip: 38103 country: United States name: Kay Ryan, PharmD role: CONTACT phone: 901-545-7840 email: kryan@regionalonehealth.org lat: 35.14953 lon: -90.04898 hasResults: False

 nctId: NCT06374264 id: NM100 briefTitle: Acceptability and Safety of MR-C-014 in Persons With Neuromyelitis Optica Spectrum Disorder acronym: aNiMatO overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2024-12-31 date: 2024-12-31 date: 2024-04-18 date: 2024-04-24 name: MedRhythms, Inc. class: INDUSTRY name: Alexion Pharmaceuticals, Inc. briefSummary: The purpose of this proof of concept study is to assess the acceptability and safety of MR-C-014 in persons with Neuromyelitis optica spectrum disorder (NMOSD) who have a gait deficit. conditions: Neuromyelitis Optica Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: MR-C-014 measure: Participant acceptability of MR-C-014 measure: Number of device-related adverse events (AEs) measure: 6-Minute Walk Test (6MWT) measure: Number of walks per week measure: Spatiotemporal symmetry of gait as measured by the MR-C-014 sensors measure: Spatiotemporal variability of gait as measured by the MR-C-014 sensors measure: Stride length as measured by the MR-C-014 sensors measure: Falls Efficacy Scale-International (FES-I) measure: Number of falls as recorded in Falls Diary measure: Multiple Sclerosis Walking Scale (MSWS-12) measure: Visual Analogue Scale (VAS) measure: Generalized Anxiety Disorder-7 (GAD-7) measure: 9 Hole Peg Test (9-HPT) measure: Symbol Digit Modalities Test (SDMT) measure: Fatigue Scale for Motor and Cognitive Functions (FSMC) measure: Expanded Disability Status Scale (EDSS) Ambulation Score measure: Activities-Specific Balance Confidence Scale (ABC) measure: Patient Experience and Satisfaction Survey sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02114 country: United States name: Eric Klawiter, MD role: CONTACT email: EKLAWITER@mgh.harvard.edu lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06374251 id: 0S-23-2 id: NCI-2023-08890 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 0S-23-2 type: OTHER domain: USC / Norris Comprehensive Cancer Center id: P30CA014089 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA014089 briefTitle: Narrative Medicine for Improving Well-Being in Patients With Gastrointestinal Cancers overallStatus: RECRUITING date: 2023-09-27 date: 2024-09-27 date: 2025-03-27 date: 2024-04-18 date: 2024-04-18 name: University of Southern California class: OTHER name: National Cancer Institute (NCI) briefSummary: This clinical trial assesses whether narrative medicine methods may improve the sense of well-being among gastrointestinal (GI) (digestive system) cancer patients. Narrative medicine is a clinical approach where providers can use a patient's own narrative (perspective) of their illness to promote healing and resilience. By applying narrative medicine's main tool, close reading, to clinical practice, clinicians learn to listen and attend to patients more deeply. This allows for freer communication and the creation of a healthcare encounter that centers on the psychological and emotional well being of the patient in addition to their medical conditions. Narrative medicine can include close reading, creative or reflective writing, and discussion. These methods may help patients with GI cancer to reflect on their life stories, both inside and outside of their illness experience, and help them gather skills to optimize their well-being. conditions: Malignant Digestive System Neoplasm studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 10 type: ESTIMATED name: Discussion name: Interview name: Survey Administration measure: Number of participants who complete the narrative medicine sessions measure: Change in well-being scores sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: USC / Norris Comprehensive Cancer Center status: RECRUITING city: Los Angeles state: California zip: 90033 country: United States name: Eve L. Makoff role: CONTACT phone: 323-865-3000 email: makoff@usc.edu name: Eve L. Makoff role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06374238 id: UG3HL165839 type: NIH link: https://reporter.nih.gov/quickSearch/UG3HL165839 id: UG3HL165839 type: NIH link: https://reporter.nih.gov/quickSearch/UG3HL165839 briefTitle: Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain acronym: PRESENCE overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2027-12 date: 2028-05 date: 2024-04-18 date: 2024-04-18 name: University of Pittsburgh class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The study, known as the Peer suppoRt for adolescents and Emerging adults with Sickle cell pain: promoting ENgagement in Cognitive behavioral thErapy (PRESENCE), aims to determine the effectiveness of digital CBT in reducing pain, opioid use, and healthcare utilization among AYAs with SCD. It also seeks to understand the role of personalized peer support in enhancing engagement and outcomes of digital CBT interventions.

By leveraging existing infrastructure for delivering virtual peer support interventions, tailored digital CBT programs for individuals with SCD, and partnerships with CBOs, the study aims to provide valuable insights into the feasibility and effectiveness of digital CBT as a pain management strategy for this vulnerable population. conditions: Pain conditions: Sickle Cell Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Three-arm, phase III randomized controlled effectiveness trial. Participants will be randomized 3:3:2 into (1) CBT + peer, (2) self-guided CBT, or (3) UC, stratified by site primaryPurpose: TREATMENT masking: NONE count: 470 type: ESTIMATED name: CBT+ Health coach name: CBT w/o Health Coach ( self-guided) name: Usual Care measure: Determine the effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs usual care (UC) to improve pain intensity for AYAs with SCD and chronic pain measure: Determine the effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs usual care (UC) to improve pain interference for AYAs with SCD and chronic pain measure: Determine the effectiveness of CBT+ peer vs. self-guided CBT to improve pain intensity for AYAs with SCD and chronic pain measure: Determine the effectiveness of CBT+ peer vs. self-guided CBT to improve pain interference for AYAs with SCD and chronic pain measure: Determine the sustained effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs UC to improve pain intensity for AYAs with SCD and chronic pain measure: Determine the sustained effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs UC to improve pain interference for AYAs with SCD and chronic pain measure: Determine the sustained effectiveness of CBT+ peer vs self-guided CBT to improve pain intensity of AYAs with SCD and chronic pain measure: Determine the sustained effectiveness of CBT+ peer vs self-guided CBT to improve pain interferences of AYAs with SCD and chronic pain sex: ALL minimumAge: 16 Years maximumAge: 30 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06374225 id: 23-0866 briefTitle: Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention acronym: SAVE-O2 AI overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12-31 date: 2026-05-01 date: 2024-04-18 date: 2024-04-18 name: University of Colorado, Denver class: OTHER name: United States Department of Defense name: O2matic ApS name: IDTS Medical, Inc. briefSummary: This study is a multicenter randomized controlled trial to determine the effectiveness of a closed loop/autonomous oxygen titration system (O2matic PRO100) to maintain normoxemia (goal range SpO2 90-96%, target 93%) during the first 72 hours of acute injury or illness, compared to standard provider-driven methods (manual titration with SpO2 target of 90-96%). conditions: Critical Illness conditions: Wounds and Injury conditions: Disease Attributes conditions: Pathologic Processes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Automated Titration (O2matic) measure: Proportion of time spent within the targeted normoxemia range measure: Amount of supplemental oxygen administered measure: Proportion of time spent in hypoxemia (SpO2<88%) measure: Proportion of time spent in hyperoxemia (SpO2 >96%) measure: Time to Room Air sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 facility: Oregon Health and Sciences University city: Portland state: Oregon zip: 97239 country: United States lat: 45.52345 lon: -122.67621 facility: Vanderbilt University Medical Center city: Nashville state: Tennessee zip: 37232 country: United States lat: 36.16589 lon: -86.78444 hasResults: False

 nctId: NCT06374212 id: 24-0191 briefTitle: Anifrolumab for Hidradenitis Suppurativa overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-12 date: 2024-04-18 date: 2024-04-18 name: University of North Carolina, Chapel Hill class: OTHER name: AstraZeneca briefSummary: This clinical trial aims to study if a drug called anifrolumab works to treat Hidradenitis Suppurativa (HS) as well as its effect in quality of life before and after treatment. Anifrolumab is a monoclonal antibody that inhibits several processes that have been shown to be involved in the development of HS.

The study lasts approximately 40 weeks separated into a screening, treatment, and follow-up phase. Researchers determine if it is safe for the you to receive the drug and if you are eligible for the study during Screening. If eligible for the study, the treatment phase lasts 24 weeks (or six months) with one follow-up visit 12 weeks after the last visit in the treatment phase.

During the treatment phase, participants will be asked to come to clinic every two weeks for the first month of treatment, and monthly thereafter for a total of eight treatment visits. Participants will be asked to:

* Complete questionnaires asking about the effect of HS in their daily lives and their perception of HS and treatment received.
* Receive related medical evaluation
* Receive the study drug intravenously
* Stay 20 minutes after the infusion for monitoring conditions: Hidradenitis Suppurativa conditions: Acne Inversa conditions: Hidradenitis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All study participants, if eligible, will receive the study drug (anifrolumab). primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Anifrolumab measure: Percentage of participants achieving at least a Hidradenitis Suppurativa Clinical Response score of 50 (HiSCR 50) at 12 weeks measure: Percentage of participants achieving a HiSCR 50 at 24 weeks measure: Percentage of participants who achieve a Hidradenitis Suppurativa Clinical Response score of 75 (HiSCR 75) at 12 weeks measure: Percentage of participants who achieve a HiSCR 75 at 24 weeks of treatment. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UNC Dermatology and Skin Cancer Center city: Chapel Hill state: North Carolina zip: 27516 country: United States name: Erika Hanami role: CONTACT phone: 984-974-3682 email: erika_hanami@med.unc.edu name: Christopher Sayed, MD role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False

 nctId: NCT06374199 id: 24-0181 briefTitle: Med-South Lifestyle Program for Pregnancy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-01 date: 2025-01 date: 2024-04-18 date: 2024-04-18 name: University of North Carolina, Chapel Hill class: OTHER briefSummary: Eating a Mediterranean-style diet during pregnancy improves pregnancy outcomes, yet most Americans who are pregnant do not follow this type of dietary pattern. There is increasing interest in Food is Medicine programs, which provides foods to patients to improve health outcomes - food provided in this context is called medically tailored meals. The research team at the UNC Center for Health Promotion and Disease Prevention is developing a Food is Medicine program to improve pregnancy outcomes and at this point the team is ready to test the program.

The purpose of this study is to assess the feasibility and acceptability of a Food is Medicine intervention when started during the first trimester of pregnancy. The eating pattern to be evaluated in this study is a Mediterranean-style dietary pattern adapted for the southern United States - thus, the program is called "Med-South." All who take part will receive Med-South dietary counseling. In addition, to help participants follow a Med-style dietary pattern, one group of study participants will receive extra virgin olive oil and nuts. The other group will receive extra virgin olive oil, nuts, and frozen meals (medically tailored meals) that align with the Med-South dietary pattern. Participants will be assigned at random (like flipping a coin) to one of these groups conditions: Pregnancy Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Standard 2 group parallel randomized trial study design. primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Med-South Lifestyle Intervention for Pregnancy--Arm 1 name: Med-South Lifestyle Intervention for Pregnancy--Arm 2 measure: Percent that would recommend this program to others who are pregnancy measure: Percent of participants who take part in the 10 study counseling sessions measure: Maternal diet quality measure: skin carotenoids sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Center for Health Promotion and Disease Prevention/UNC-Chapel Hill city: Chapel Hill state: North Carolina zip: 27599 country: United States lat: 35.9132 lon: -79.05584 hasResults: False

 nctId: NCT06374186 id: 2095072 id: 2095072 type: OTHER domain: UMKC IRB briefTitle: Continuous Glucose Monitoring, Contingency Management, and Motivational Interviewing for Patients With Type 2 Diabetes in Kansas City acronym: COMMITTED2-KC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2025-04-08 date: 2024-04-18 date: 2024-04-18 name: University of Missouri, Kansas City class: OTHER briefSummary: This study is evaluating a behavioral treatment program that uses diabetes coaching and financial rewards in addition to continuous glucose monitoring to improve diabetes management in adult patients with type 2 diabetes. This study will evaluate if this behavioral treatment program increases individual adherence to a diabetes treatment plan and improves blood sugar management. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized parallel-group pilot study of a combination intervention using Motivational Interviewing (MI) and Contingency Management (CM) for patients with T2DM. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Because this is a behavioral intervention, participant blinding is not possible. Randomization will occur after baseline assessment and participants will be instructed to not tell their provider their assigned condition. whoMasked: CARE_PROVIDER count: 40 type: ESTIMATED name: Behavioral Intervention with financial rewards and coaching name: Control measure: Time in target blood glucose range per CGM measure: Hemoglobin A1C measure: Diabetes Quality of Life Brief Inventory measure: Diabetes Distress Scale measure: PROMIS Medication Adherence Scale measure: Perceived Dietary Adherence Questionnaire measure: Motivation and Confidence Ruler sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Missouri - Kansas City School of Medicine city: Kansas City state: Missouri zip: 64108 country: United States name: Carrie R Kriz role: CONTACT phone: 816-512-7473 email: mckinleycr@umkc.edu name: Jared M Bruce, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.09973 lon: -94.57857 hasResults: False

 nctId: NCT06374173 id: TGI6-T1-01 briefTitle: A Phase 1 Study to Evaluate TGI-6 in Subjects With Locally Advanced/Metastatic Solid Tumors overallStatus: RECRUITING date: 2024-01-03 date: 2027-09 date: 2027-12 date: 2024-04-18 date: 2024-04-18 name: Hefei TG ImmunoPharma Co., Ltd. class: OTHER briefSummary: A Phase 1 Study to Evaluate TGI-6 in Subjects with Locally Advanced/Metastatic Solid Tumors conditions: Advanced or Metastatic Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 123 type: ESTIMATED name: TGI-6 Injection measure: Dose-limiting Toxicity (DLT) measure: Dose-Finding measure: Frequency and Severity of Adverse Events (AE) measure: Pharmacokinetics of TGI-6 measure: Pharmacokinetics of TGI-6 measure: Number of subjects with Anti-TGI-6 antibody positive measure: Objective 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 stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Cancer Hospital status: RECRUITING city: Beijing country: China name: Hang Zhou role: CONTACT email: hang.zhou@tgimmunopharma.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06374160 id: 70115371 briefTitle: Exercise in Patients With Advanced Non-small Cell Lung Cancer acronym: BREATH overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-08-31 date: 2024-04-18 date: 2024-04-18 name: University Hospital, Essen class: OTHER name: German Cancer Aid briefSummary: Lung cancer is one of the most common types of cancer in Germany, with 56,839 new cases and 45,072 deaths annually. Approximately 70% of patients with non-small cell lung cancer (NSCLC) are diagnosed at an advanced stage and suffer from comorbidities and symptoms such as fatigue, tiredness, and loss of strength. The standard first-line treatment for metastatic NSCLC includes platinum-based chemoimmunotherapy followed by immunotherapy maintenance. Exercise can have positive effects on symptoms such as shortness of breath, fatigue, quality of life, and physical fitness. However, there is a lack of current scientific evidence for the effectiveness of exercise in advanced lung cancer patients. No current trial investigated exercise in advanced NSCLC receiving immunotherapy so far.

The BREATH-study is a prospective 3-arm randomized controlled trial (RCT). In total, the investigators plan to recruit 104 patients. A 2:1:1 randomization will be performed with three study groups: a control group and two exercise therapy groups (strength+endurance exercise/only endurance exercise). One group receives individual endurance training and the other group a combination of individual endurance and strength training. Both treatment groups will be treated twice a week for 12 weeks. The control group will initially receive standard treatment without exercise for 12 weeks and will then be randomized into one of the other two study groups with exercise twice a week for 12 weeks. This approach allows for a sufficiently large sample for comparisons between exercise therapy and the control group, as well as between the two exercise therapy approaches.

The primary aim is to investigate the impact of exercise on V02peak. Secondarily endpoints aim to investigate changes in physical function, patient related outcomes and cardiac function before and after exercise. conditions: Advanced Lung Carcinoma conditions: First Line Treatment conditions: Second Line Treatment conditions: NSCLC Stage IV conditions: NSCLC Stage IIIB conditions: Palliative Treatment conditions: NSCLC Stage IIIC studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: BREATH is a prospective 3-arm 2:1:1 randomized controlled trial (RCT). The first arm represents the control group, which will receive the standard treatment for the first 12 weeks (recommendations for physical activity during cancer treatment). The other two arms represent the exercise groups, one group will receive individualized endurance training and the other group a combination of individualized endurance and strength training. All arms will be treated for 12 weeks. Afterwards, the patients in the control group are randomized to one of the other two study arms and then also treated twice for 12 weeks. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 104 type: ESTIMATED name: Exercise intervention measure: Maximum oxygen uptake (VO2 peak [ml/min/kg]) measure: Functional Assessment of Chronic Illness Therapy - Fatigue (FACT-F) measure: European Organisation for Research and Treatment of Cancer (EORTC QLQ C30) measure: European Organisation for Research and Treatment of Cancer Lung cancer module (EORTC-LC13) measure: Arterial blood pressure measure: Change in ECG measure: Adherence to exercise intervention measure: Drop-out rate measure: Recruitment rate measure: Serious Adverse Event/Adverse Events measure: Therapy response measure: Treatment Toxicity measure: Treatment scheme measure: NT-pro-BNP measure: High sensitive troponin I measure: Erythrocytes measure: Hemoglobin measure: Leukocytes measure: Lymphocytes measure: Neutrophils measure: CRP measure: CYRFRA 21-1 measure: Physical function (Hypothetical One-repetition maximum) measure: Blood gas analysis pH value measure: Blood gas analysis (PAO2) measure: Blood gas analysis (SaO2) measure: Blood gas analysis (PCO2) measure: Blood gas analysis (BE) measure: Blood gas analysis (HCO3) measure: Blood gas analysis (SBCe) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West German Cancer Center (Department of Palliative medicine and Department of Medical Oncology), University Hospital Essen city: Essen state: North Rhine-Westphalia zip: 45147 country: Germany name: Mitra Tewes, PD. Dr. role: CONTACT email: mitra.tewes@uk-essen.de name: Nico De Lazzari, M. Sc. role: CONTACT phone: +49 201 723-82035 email: nico.delazzari@uk-essen.de name: Mitra Tewes, PD. Dr. role: PRINCIPAL_INVESTIGATOR name: Marcel Wiesweg, PD. Dr. role: SUB_INVESTIGATOR name: Miriam Götte, PD. Dr. role: SUB_INVESTIGATOR name: Eva-Maria Hüßler, Dr. role: SUB_INVESTIGATOR name: Andreas Stang, Prof. Dr. role: SUB_INVESTIGATOR name: Matthias Totzeck, Prof. Dr. role: SUB_INVESTIGATOR lat: 51.45657 lon: 7.01228 hasResults: False

 nctId: NCT06374147 id: STUDY00004467 briefTitle: "Prapela® SVS Incubator Pad for Apnea of Prematurity acronym: Prapela AOP overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2026-06-01 date: 2026-12-31 date: 2024-04-18 date: 2024-04-18 name: Tufts Medical Center class: OTHER name: University of Alabama at Birmingham briefSummary: The study proposes to complete the development of and then establish the safety, efficacy, and clinical risk/benefit of a novel hospital incubator pad with stochastic vibrotactile stimulation (SVS) that will provide a complementary treatment and the first improvement in the clinical management of apnea of prematurity (AOP) in over 20 years. Currently, the only approved therapy for AOP is Caffeine Citrate. The SVS mattress pad can prove to be an effective, non-invasive adjunct to Caffeine Citrate for preterm infants with potential to shorten the need for respiratory support as well as overall shortened length of stay. conditions: Apnea of Prematurity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: SVS mattress measure: Reduce apnea events by 30% or more in the three days after study entry measure: Reduce the number of days caffeine citrate is used after study entry by 3 days or more measure: Reduce the number of days of respiratory support by 3 days or more sex: ALL minimumAge: 0 Days maximumAge: 3 Months stdAges: CHILD hasResults: False

 nctId: NCT06374134 id: STUDY00004835 briefTitle: The Impact of Community and Patient Engagement Practices on Vaccine Confidence in the United States overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-11 date: 2025-02 date: 2024-04-18 date: 2024-04-18 name: Tufts University class: OTHER name: Merck Sharp & Dohme LLC briefSummary: The primary objective of this study is to demonstrate an empirical relationship between community- engagement practices, and between patient-centric clinical trial design, execution and communication practices, and vaccine adoption experience.

Our hypothesis is that patient-centric clinical trial activity, and community engagement in late-stage clinical trials and early-stage commercialization, reduces vaccine hesitancy and increases vaccine confidence among health care providers overall and within diverse patient communities and ultimately drives faster vaccine adoption. conditions: Vaccine Hesitancy studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: RETROSPECTIVE count: 30 type: ESTIMATED name: Community Engagement Practice name: Patient-Centric Protocol Element measure: Units of Vaccine Dispensed sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06374121 id: POWER briefTitle: Kidney Perfusion With or Without Absorption acronym: POWER overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-06 date: 2024-04-18 date: 2024-04-18 name: Mario Negri Institute for Pharmacological Research class: OTHER briefSummary: In this single-center, pilot, prospective, randomized study, the investigators will compare the biochemical profiles of the perfusate and the functional parameters of five kidneys perfused with Integrated PerLife® system and "PerSorb ECOS-300CY ™" sorbent (adsorption groups) with the profiles of the perfusate and functional parameters of five matched kidneys perfused with Integrated PerLife® system only (non-adsorption group). Kidneys from marginal donors with a clinical indication to pre-transplant histological evaluation (donor \>70-years-old or aged 60 to 69 years but with hypertension, diabetes and/or clinical proteinuria) will be allocated to perfusion with or without adsorption using a 1:1 randomization ratio. When both donor kidneys will have a score from 0 to 4, the two kidneys will be used for two single transplants. When one kidney will have a score from 0 to 4 and the other kidney will have a score of 5 or more, and when both kidneys will have a score from 5 to 7, the two kidneys will be transplanted together into the same recipient. If one kidney will have a score from 5 to 7 and the other kidney will have a score of 8 or greater, the two kidneys will be discarded. With the use of the minimization method, the randomization will be planned in order to have the same number of single or dual transplants in the perfusion kidney groups with or without adsorption. Donor selection, kidney evaluation and allocation and recipient management will be based on per center practice. conditions: Kidney Replacement studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: To compare the biochemical profiles of the perfusate obtained from 5 kidneys treated with perfusion and concomitant adsorption, with that of the perfusate obtained from 5 kidneys treated with perfusion without adsorption. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: PerSorb cartridge (CytoSorbents Europe GmbH, Germany) name: PerLife PerKidney measure: Oxidative stress markers measure: Acute kidney injury markers measure: Inflammatory cytokine markers measure: Complement activation markers measure: Vascular resistances measure: Perfusate sample collection sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ASST - Papa Giovanni XXIII - U.O. Nefrologia e Dialisi/ Mario Negri Institute for Pharmacological Research - Clinical Research Center for Rare Diseases Aldo e Cele Daccò city: Bergamo state: BG zip: 24027 country: Italy lat: 45.69601 lon: 9.66721 hasResults: False

 nctId: NCT06374108 id: Neuro_Exercise briefTitle: Resistance Training and Corticospinal Excitability in Multiple Sclerosis acronym: NEXIMS overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2026-05-31 date: 2024-04-18 date: 2024-04-29 name: University of Aarhus class: OTHER name: Aarhus University Hospital name: University of Copenhagen briefSummary: The goal of the present study is to investigate effects of progressive resistance training on central nervous system functioning (corticospinal excitability (CSE)) and walking capacity in persons with multiple sclerosis (pwMS). A total of 54 pwMS will be enrolled and randomized into 1 of 3 groups: high dose resistant training (RT), low dose RT, and waitlist control. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: Progressive resistance training measure: MEP/Mmax ratio measure: Muscle strength measure: Voluntary activation I measure: Voluntary activation II measure: Force Steadiness measure: Rate of Force Developement measure: Ultrasound measure: Resting Motor Threshold (rMT) measure: Active Motor Threshold (aMT) measure: MEP latency (resting) measure: MEP latency (active) measure: MEP amplitude (resting) measure: MEP amplitude (active) measure: Short-interval intracortical Inhibition (SICI) measure: Intracortical facilitation (ICF) measure: Cortical Silent Period (CSP) measure: Central Motor Conduction Time (CMCT) measure: EEG-EMG coherence (0-1) measure: Timed 25 feet walk test (T25FWT) measure: 6-minute walk test (6MWT) measure: Six spot step test (SSST) measure: 5 sit-to-stand (5STS) measure: 9-step stair ascend (9SSA) measure: Patient determined disease steps (PDDS) measure: Multiple Sclerosis Walking Scale (MSWS) measure: Modified fatigue impact scale (MFIS) measure: MS impact scale (MSIS) measure: Falls-efficacy scale - international (FES-1) measure: The Physical Activity Enjoyment Scale (PACES) measure: Brief pain inventory (BPI) measure: Baecke physical activity measure: Accelerometry sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06374095 id: ONSET briefTitle: 1 vs 7 RATG Infusions in Renal Transplantation acronym: ONSET overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2025-06 date: 2024-04-18 date: 2024-04-18 name: Mario Negri Institute for Pharmacological Research class: OTHER briefSummary: This trial is to compare the risk/benefit profile over six-month follow-up of two induction immunosuppressive regimens based on one or seven low-dose perioperative RATG infusions on top of the same induction therapy with basiliximab and steroid (progressively tapered post-transplant) and maintenance therapy with calcineurin inhibitors and mycophenolate mofetil/mycophenolic acid in 75 recipients (25 Patients and 50 Reference-Patients) of a single or dual first kidney transplant from an ideal or marginal donor at a single Renal Transplant Center. conditions: Kidney Replacement studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 75 type: ESTIMATED name: RATG name: Basiliximab measure: Incidence of thrombocytopenia and/or leukopenia measure: Occurrence of anemia measure: Occurrence of viral infections measure: Occurrence of pneumonia measure: Occurrence of opportunistic infections measure: Occurrence of delayed graft function measure: Occurrence of allograft rejection measure: Occurrence of biopsy proven rejection measure: Survival measure: Platelet and WBC counts measure: Creatinine levels measure: Adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ASST HPG23 - Unità di Nefrologia city: Bergamo state: BG zip: 24127 country: Italy lat: 45.69601 lon: 9.66721 hasResults: False

 nctId: NCT06374082 id: HKWC-2024-179 briefTitle: Instant Messaging Reinforcement for Smoking Cessation Counseling Training overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-08 date: 2024-10 date: 2024-04-18 date: 2024-04-18 name: The University of Hong Kong class: OTHER briefSummary: This research aims to assess the impact of instant messaging reinforcement on the learning outcomes of smoking cessation counseling (SCC) training among master of nursing (MN) students at the University of Hong Kong. The hypotheses suggest that this reinforcement can enhance students' SCC knowledge and techniques, improve their perception of SCC, and increase their application of SCC in clinical work.

The study is a pragmatic randomized controlled trial (RCT) with a 1:1 allocation ratio, using WhatsApp Messenger (WhatsApp) messages for intervention and control groups. The intervention group receives messages related to SCC, while the control group receives generic mental health information. The subjects are MN students enrolled in the "Tobacco Dependency Nursing Intervention and Management" course.

The study uses various tools for measurement, including Ecological momentary assessment (EMA) and Providers Smoking Cessation Training Evaluation (ProSCiTE). The main outcome measures include SCC practice frequency, SCC knowledge score, SCC attitude score, and SCC practice score.

Data analysis will be performed in Statistical Package for the Social Sciences (SPSS), using descriptive statistics, intention-to-treat analysis, Chi-square and t-tests, Cohen's d for effect size, and linear mixed models. The expected results suggest that instant messaging reinforcement will enhance SCC knowledge, attitude, and practice among MN students. conditions: Smoking Cessation Counseling Ability conditions: Smoking Cessation Counseling Practice studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE maskingDescription: Double-blinding technique will be used to conceal the allocation. Participants will not know which group they are in as placebo messages will be introduced. Using a central allocation web-based-controlled randomization, outcome assessors and data analysts will be blind to group allocation, only the principal investigator will be aware of who belongs to the control and intervention groups. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: WhatsApp message measure: SCC practice measurement measure: SCC knowledge score measure: SCC attitude score measure: SCC practice score sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Hong KongLKS Faculty of Medicine city: Hong Kong zip: 00 country: Hong Kong name: Derek Yee Tak Cheung, PhD role: CONTACT phone: +852 3917 6652 email: derekcheung@hku.hk name: Derek Yee Tak Cheung, PhD role: PRINCIPAL_INVESTIGATOR name: Xiaoyun Xie, PhDcandidate role: SUB_INVESTIGATOR name: Guowen Zhang, DN student role: SUB_INVESTIGATOR name: Tzu Tsun Luk, PhD role: SUB_INVESTIGATOR name: Man Ping Wang, PhD role: SUB_INVESTIGATOR name: Siu Chee Chan, PhD role: SUB_INVESTIGATOR lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06374069 id: NL81887.058.23 briefTitle: Longevity Families of the Netherlands acronym: LOF-NL overallStatus: RECRUITING date: 2023-09-11 date: 2026-12 date: 2026-12 date: 2024-04-18 date: 2024-04-18 name: Leiden University Medical Center class: OTHER name: Jacobijn Gussekloo, Prof. dr. name: Simon P. Mooijaart, Prof. dr. briefSummary: The demographic life expectancy enhancement of the past 150 years imposes an urgent challenge in Western and economically growing societies to stimulate the healthy lifespan that is lagging behind. Families surviving into exceptionally high ages (longevity) in good physical and mental health illustrate that this is physiologically possible. Such families harbor cross generational socio-genetic mechanisms that mediate healthy aging and protection from (multi)morbidity.

The purpose of our research is: to identify gene variants associated with healthy aging and protection from (multi)morbidity; to study the social-, environment- and behavioral factors of familial longevity, their role in (multi-)morbidity and its interaction with the genetic component. conditions: Longevity conditions: Familial Longevity conditions: Extreme Longevity conditions: Aging studyType: OBSERVATIONAL observationalModel: FAMILY_BASED timePerspective: CROSS_SECTIONAL count: 600 type: ESTIMATED measure: Identifying the genetic variants of Familial Longevity measure: Studying the environmental factor of Familial Longevity through questionnaires and its interaction with the genetic component sex: ALL minimumAge: 75 Years stdAges: OLDER_ADULT facility: Leiden University Medical Center status: RECRUITING city: Leiden state: South Holland zip: 2333ZA country: Netherlands lat: 52.15833 lon: 4.49306 hasResults: False

 nctId: NCT06374056 id: 0458 briefTitle: Kintsugi Voice Device Pilot Study overallStatus: RECRUITING date: 2024-03-22 date: 2025-03-22 date: 2025-07-22 date: 2024-04-18 date: 2024-04-19 name: Kintsugi Mindful Wellness, Inc. class: INDUSTRY name: Sonar Strategies name: Vituity Psychiatry briefSummary: A prospective, single arm, non-randomized, pilot clinical validation study to evaluate the ability of the Kintsugi Voice Device (the Device) to aid clinical assessment for depression by comparing its output with a diagnosis made by a clinician using the Structured Clinical Interview for DSM-5 (SCID-5-CT) for up to 500 English speaking adult patients ages 22 and older living in the United States. Recruitment will occur for 1 year and participation will be for up to 2 weeks. conditions: Depression conditions: Depression Moderate conditions: Depression Severe conditions: Depression Mild studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Kintsugi Voice Device measure: Sensitivity and Specificity of Kintsugi Voice Device Relative to the SCID-5 measure: PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the SCID-5 measure: Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the Severity of the SCID-5-CT measure: Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the PHQ-9 sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kintsugi Mindful Wellness Inc. status: RECRUITING city: Berkeley state: California zip: 94707 country: United States name: Alexa A Mazur, BA role: CONTACT phone: 610-724-1431 email: alexa@kintsugihealth.com name: Victoria Graham, MS role: CONTACT email: victoria@kintsugihealth.com name: Albert Ihochi, MBA role: PRINCIPAL_INVESTIGATOR name: Prentice Tom, MD role: SUB_INVESTIGATOR lat: 37.87159 lon: -122.27275 hasResults: False

 nctId: NCT06374043 id: 2020/1002 briefTitle: Decentralized N=1 Study: A Feasible Approach to Evaluate Individual Therapy Response to Dapagliflozin. acronym: @HOME overallStatus: COMPLETED date: 2021-05-11 date: 2022-09-13 date: 2022-09-13 date: 2024-04-18 date: 2024-04-22 name: University Medical Center Groningen class: OTHER name: AstraZeneca briefSummary: Randomized placebo-controlled double-blind cross-over N=1 trial in adult male and female patients with UACR \>20 mg/g (2.26 mg/mmol) with type 2 diabetes treated in primary or secondary healthcare.

The goal of this clinical trial is to determine the individual response to the SGLT2 inhibitor dapagliflozin in urine albumin-to-creatinine ratio (UACR). Secondary objectives are to determine the individual response to dapagliflozin in systolic blood pressure, body weight, eGFR, and fasting plasma glucose.

Participants will collect all study data in the comfort of their own environments:

* First-morning void urine samples
* Capillary blood samples
* Blood pressure
* Body weight

Participants will be randomly assigned to a cross-over study consisting of two periods of 1-week treatment with dapagliflozin 10 mg/day and two periods of 1-week treatment with placebo in random order with a 1-week wash-out period between every treatment period to avoid cross-over effects. conditions: Diabetes Mellitus, Type 2 conditions: Diabetes Mellitus Type 2 With Proteinuria conditions: Diabetes Mellitus conditions: Diabetes conditions: Diabetes Complications conditions: Albuminuria conditions: Chronic Kidney Diseases conditions: Chronic Kidney Disease Due to Type 2 Diabetes Mellitus conditions: CKD conditions: Proteinuria studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized placebo-controlled double-blind cross-over trial with repeated administration (i.e., a series of N=1 trials). primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 20 type: ACTUAL name: Dapagliflozin 10mg Tab name: Placebo name: Withings BPM Connect name: Withings Body+ name: Hem-Col Capillary Blood Collection Device name: MEMS (Medication Electronic Monitoring System) Cap name: Questionnaire: participants' perspectives toward remote data collection measure: UACR response measure: Systolic blood pressure response measure: Body weight response measure: eGFR response measure: Fasting plasma glucose response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ziekenhuisgroep Twente city: Almelo country: Netherlands lat: 52.35667 lon: 6.6625 facility: University Medical Center Groningen city: Groningen country: Netherlands lat: 53.21917 lon: 6.56667 hasResults: False

 nctId: NCT06374030 id: EDSAM2024 briefTitle: Retrospective Study of Airway Management in Dutch ED's overallStatus: ACTIVE_NOT_RECRUITING date: 2019-01-01 date: 2023-12-31 date: 2024-12-31 date: 2024-04-18 date: 2024-04-18 name: Medical Centre Leeuwarden class: OTHER name: VieCuri Medical Centre name: Catharina Ziekenhuis Eindhoven name: Rijnstate Hospital name: Zuyderland Medical Centre briefSummary: Describing characteristics of the practice of airway management in Dutch emergency departments, including information about patient demographics, indications, performer characteristics, equipment and medication used and complications due to intubation. conditions: Endotracheal Intubation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED name: Endotracheal intubation measure: Different complications of endotracheal intubation measure: Intubator characteristics measure: Indication for intubation measure: Sedation agent used measure: Paralytic agent used measure: Sedative agent after intubation measure: Method of intubation measure: Patient characteristics sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Leeuwarden Medical Centre city: Leeuwarden zip: 8934AD country: Netherlands lat: 53.20139 lon: 5.80859 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-15 uploadDate: 2024-03-20T05:01 filename: Prot_SAP_000.pdf size: 247439 hasResults: False

 nctId: NCT06374017 id: N-258-2023 briefTitle: Evaluation of Lidocaine Spray Versus Dexmetomidine Spray on Stress Response overallStatus: RECRUITING date: 2023-09-20 date: 2024-04-30 date: 2024-05-10 date: 2024-04-18 date: 2024-04-18 name: Kasr El Aini Hospital class: OTHER briefSummary: Many studies discussed attenuating stress response by various measures but to the interest of our study , No one compared topical spray of both lidocaine and dexmedetomidine in attenuating the haemodynamic stress responses of laryngoscopy and endotracheal intubation, avoiding undesired systemic effects of drugs , conditions: To Measure Systolic Blood Pressure Postintubation studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Normal saline, Lidocaine, dexmetomidine measure: To measure systolic blood pressure immediately after intubation. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cairo University hospitals status: RECRUITING city: Cairo zip: 11559 country: Egypt name: Dina M Mohamed, MD role: CONTACT phone: 01005249134 phoneExt: MD email: Dinamahmoud@kasralainy.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06374004 id: HU-FTR-MC-01 briefTitle: The Effect of Thoracic Mobilization in Individuals With Subacromial Pain Syndrome overallStatus: ENROLLING_BY_INVITATION date: 2024-04-10 date: 2024-07-05 date: 2024-07-05 date: 2024-04-18 date: 2024-04-18 name: Hacettepe University class: OTHER briefSummary: The purpose of this study is to investigate the effect of six-week thoracic mobilization on pain intensity, muscle tone, functional and muscle activation in individuals with subacromial pain syndrome. conditions: Subacromial Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: One group received exercise therapy and the other group received manual therapy (thoracic mobilization) in addition to exercise therapy primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants will be randomly divided into two groups and participants will not know which group participants are in. whoMasked: PARTICIPANT count: 32 type: ESTIMATED name: Exercise Group name: Thoracic Mobilization Group measure: Electromyography (EMG) measure: Acromiohumeral Distance (AHD) measure: Muscle Tone measure: Functional Activity Level measure: Pain Intensity sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Hacettepe University, Faculty of Physical Therapy and Rehabilitation city: Ankara zip: 06100 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06373991 id: EDI-901-SLE01 briefTitle: A Study to Evaluate the Safety and Efficacy of ATHENA CAR-T in Subjects With Systemic Lupus Erythematosus overallStatus: RECRUITING date: 2024-04-24 date: 2027-04-30 date: 2027-04-30 date: 2024-04-18 date: 2024-04-29 name: EdiGene Inc. class: INDUSTRY name: The First Affiliated Hospital of Henan University of Science and Technology name: Changping Laboratory briefSummary: The goal of this clinical trial is to test ATHENA CAR-T injection in adults with moderate to severe Systemic Lupus Erythematosus. The main question it aims to answer is:

• To evaluate the safety and tolerability of ATHENA CAR-T.

After screening, participants will be subjected to lymphodepletion regimen. After recovery, participants will be injected with ATHENA CAR-T injection and followed up to 24 months. conditions: Lupus Erythematosus, Systemic studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: ATHENA CAR-T name: Fludarabine name: Cyclophosphamide measure: Dose Limiting Toxicity measure: Frequency of AEs, SAEs, lab abnormalities, AESIs measure: Efficacy: Percent of patients achieved SRI-4 measure: Efficacy: Patients SLEDAI-2000 change compared with baseline measure: Efficacy: Patients BILAG-2004 change compared with baseline measure: Efficacy: Percent of patients' PGA not worsen measure: Percent of patients responded by BILAG-2004 measure: Efficacy: Immunologic parameters measure: Efficacy: Immunologic parameters (cont) measure: PK characteristics measure: PK characteristics (cont) measure: PK characteristics (cont) measure: PD characteristics measure: PD characteristics (cont) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Henan University of Science and Technology status: RECRUITING city: Luoyang state: Henan zip: 471003 country: China name: Muchen Liu role: CONTACT phone: (86)-13663884080 lat: 34.68361 lon: 112.45361 hasResults: False

 nctId: NCT06373978 id: 24-307 briefTitle: NonNarcotic Pain Control in Percutaneous Needle Tenotomy of Elbow overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-12-01 date: 2024-04-18 date: 2024-04-18 name: The Cleveland Clinic class: OTHER briefSummary: This study is a double-blind, randomized controlled trial comparing the effectiveness of oral Diclofenac and Tramadol in reducing the consumption of narcotic pills (primary outcome) and minimizing patients\&#39; exposure to narcotics (secondary outcome) following an ultrasound-guided percutaneous needle tenotomy procedure on the lateral elbow.

The primary objective of this study is to illustrate a reduction in the consumption of narcotic pills following a percutaneous needle tenotomy procedure on the lateral elbow.

The secondary aim is to assess the proportion of patients who have been randomly assigned to Diclofenac and successfully refrain from using the Tramadol rescue medication, measured at the 10 day (+/- 4 days) postoperative mark.

The third objective is to uphold consistent early recovery outcomes as measured by the Patient-Rated Tennis Elbow Evaluation (PRTEE) and Quick Disability of Arm, Shoulder, and Hand (QuickDASH) scores after percutaneous needle tenotomy of the lateral elbow, while also investigating the relationship between resiliency and pain catastrophizing in relation to Tramadol usage and response to Diclofenac. conditions: Elbow Pain conditions: Chronic Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study will be a double-blind, randomized trial comparing a control group receiving the standard care narcotic Tramadol (50mg) to an experimental group receiving Diclofenac (50mg). primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 92 type: ESTIMATED name: Diclofenac name: Tramadol measure: Number of pills taken measure: Non narcotic use sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Cleveland Clinic Florida city: Coral Springs state: Florida zip: 33067 country: United States name: Jennifer Baldwin role: CONTACT phone: 216-390-5833 email: baldwij3@ccf.org name: Alison Klika role: CONTACT phone: 216 444-4954 email: klikaa@ccf.org name: Michael Dakkak, DO role: PRINCIPAL_INVESTIGATOR lat: 26.27119 lon: -80.2706 facility: The Cleveland Clinic Ohio city: Avon state: Ohio zip: 44011 country: United States name: Jennifer Baldwin role: CONTACT phone: 216-390-5833 email: baldwij3@ccf.org name: Jason Genin, DO role: SUB_INVESTIGATOR name: Vikas Patel, DO role: SUB_INVESTIGATOR lat: 41.45171 lon: -82.03542 hasResults: False

 nctId: NCT06373965 id: B2024-000 briefTitle: Integrated Online-to-offline (O2O) Model of Care for HIV Prevention and Treatment Among Transgender Women (CINTAI) overallStatus: NOT_YET_RECRUITING date: 2024-05-19 date: 2025-01-06 date: 2025-02-18 date: 2024-04-18 date: 2024-04-18 name: University of Connecticut class: OTHER name: University of Malaya briefSummary: The proposed research focuses on developing and testing a web-based platform, called Jom-TestPlus, that will incorporate HIV self-testing (HIVST) with real-time e-counseling (eHIVST) with online-to-offline (O2O) linkage to HIV prevention and treatment services while simultaneously co-addressing chemsex-related needs for transgender women (TGW) in Malaysia. This model represents a potentially impactful strategy for reaching marginalized populations, like TGW, and allows immediate engagement in the post-test linkage process to prevention or treatment services. conditions: HIV Prevention Program studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 50 type: ESTIMATED name: Online to offline counseling measure: HIVST uptake measure: Linkage to PrEP measure: Linkage to HIV treatment services sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre of Excellence For Research in AIDS (CERiA) city: Kuala Lumpur country: Malaysia lat: 3.1412 lon: 101.68653 hasResults: False

 nctId: NCT06373952 id: 23-08-658-910 briefTitle: Integrated Online-to-offline (O2O) Model of Care for HIV Prevention and Treatment Among Men Who Have Sex With Men acronym: CINTAI overallStatus: NOT_YET_RECRUITING date: 2024-05-19 date: 2025-01-06 date: 2025-02-18 date: 2024-04-18 date: 2024-04-22 name: University of Connecticut class: OTHER name: University of Malaya briefSummary: The proposed research focuses on developing and testing a web-based platform, called Jom-TestPlus, that will incorporate HIV self-testing (HIVST) with real-time e-counseling (eHIVST) with online-to-offline (O2O) linkage to HIV prevention and treatment services while simultaneously co-addressing chemsex-related needs for men who have sex with men (MSM) in Malaysia. This model represents a potentially impactful strategy for reaching marginalized populations, like MSM, and allows immediate engagement in the post-test linkage process to prevention or treatment services. conditions: HIV Prevention Program studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 78 type: ESTIMATED name: Online to offline counseling measure: HIVST uptake measure: Linkage to PrEP measure: Linkage to HIV treatment services sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre of Excellence For Research in AIDS (CERiA) city: Kuala Lumpur country: Malaysia lat: 3.1412 lon: 101.68653 hasResults: False

 nctId: NCT06373939 id: Pneumoscope study briefTitle: Performance and Safety of the Pneumoscope Device in Adults and Children overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-31 date: 2024-12-31 date: 2024-04-18 date: 2024-04-18 name: Pediatric Clinical Research Platform class: OTHER name: University Hospital, Geneva briefSummary: Respiratory diseases are associated with high morbidity and mortality worldwide. Proper diagnosis and risk assessment of these conditions are essential for optimal management. Clinicians use three particularly useful tools to identify these conditions when assessing the patient's status: the stethoscope, the pulse oximeter, and the thermometer. The Pneumoscope is an all-in-one device including a digital stethoscope, a pulse oximeter, and a thermometer. This study aims to assess the performance and safety of the Pneumoscope in recording respiratory sounds, body temperature, non-invasive blood oxygen saturation levels and heart rate in children and adults. conditions: Respiratory Diseases conditions: Pneumonia conditions: Asthma conditions: Cyanotic Heart Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This single center, open, non-controlled investigation will be conducted at one site; the University Hospitals of Geneva, Switzerland. This will be a non-inferiority study between Pneumoscope and CE marked comparable medical devices in children and adults. primaryPurpose: OTHER masking: NONE count: 225 type: ESTIMATED name: Digital lung auscultation name: Pulse oximetry measurement name: Non invasive body temperature measurement measure: Evaluation of Pneumoscope's built-in sensors measure: Collect audio records of lung sounds for AI models training and sensor calibration measure: Pulse oximetry measure: Body temperature sex: ALL minimumAge: 1 Year stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Geneva University Hospitals city: Geneva zip: 1205 country: Switzerland name: Alain Gervaix, Prof role: CONTACT phone: (0)22 372 45 55 phoneExt: +41 email: Alain.Gervaix@hcuge.ch name: Johan Siebert, MD role: CONTACT phone: (0)79 553 40 72 phoneExt: +41 email: Johan.Siebert@hcuge.ch name: Johan N Siebert, MD role: PRINCIPAL_INVESTIGATOR name: Laurence Lacroix-Duccardonnoy, MD role: SUB_INVESTIGATOR name: Isabelle Ruchonnet-Métrailler, MD role: SUB_INVESTIGATOR lat: 46.20222 lon: 6.14569 hasResults: False

 nctId: NCT06373926 id: PI2019_843_0010 briefTitle: Evaluation of Cell Membrane Expression of Annexin A2 on Monocytes by Flow Cytometry in Primary Antiphospholipid Syndrome acronym: MONOCYTAN overallStatus: RECRUITING date: 2023-03-28 date: 2025-03 date: 2025-03 date: 2024-04-18 date: 2024-04-18 name: Centre Hospitalier Universitaire, Amiens class: OTHER briefSummary: Annexin A2 (ANXA2), an endothelial cell receptor for plasminogen and tissue plasminogen activator, plays a pivotal role in regulation of fibrinolysis in vitro and in vivo and has been identified as a new autoantigen in antiphospholipid syndrome (APS). ANXA2 can exist as a monomer or a heterotetrameric complex with S100A10 protein. The aim of this study was to evaluate the cell membrane expression of ANXA2 on circulating monocytes in APS by flow cytometry. Several pathogenic mechanisms are involved in APS such as activation of endothelial cells, platelets and monocytes, inhibition of the natural anticoagulant protein C/protein S pathway, activation of the complement system and also impairment of fibrinolysis. Annexin A2 which hits binding partner S100A10, ANXA2 forms a cell surface complex that regulates generation of plasmin. ANXA2 is involved in the pathogenesis of APS-associated through several possible mechanisms. Human peripheral blood monocytes represent the major circulating ANXA2-expressing cell and ANXA2-mediated assembly of plasminogen and tissue activator of plasminogen (tPA) on monocyte/macrophages contributes to plasmin generation. Thus the investigators could suppose that decrease of cell membrane expression of ANXA2 on circulating monocytes represent a new pathogenic mechanism in APS. conditions: Antiphospholipid Syndrome studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 60 type: ESTIMATED name: blood withdrawal measure: Cell membrane expression rate of ANXA2 on circulating monocytes in APS measure: Cellular expression of ANXA2 and S100A10 in APS patients measure: cell membrane expression of ANXA2 and S100A10 in APS patients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Amiens status: RECRUITING city: Amiens zip: 80054 country: France name: Valéry SALLE, MD role: CONTACT phone: +33 3 22 66 82 30 email: salle.valery@chu-amiens.fr lat: 49.9 lon: 2.3 hasResults: False

 nctId: NCT06373913 id: MASP2NSRZL briefTitle: The Role of Proprotein-convertase-subtilisin/Kexin-type 9 in Kidney Damage in Nephrotic Syndrom acronym: PCSK9 overallStatus: RECRUITING date: 2023-06-01 date: 2027-07-30 date: 2028-07-30 date: 2024-04-18 date: 2024-04-18 name: Kolding Sygehus class: OTHER name: Odense University Hospital name: Vejle Hospital briefSummary: Nephrotic syndrome (NS) is characterized by gross proteinuria (\>3.5 g/day), hypoalbuminaemia, edema and often hyperlipidemia. Hyperlipidemia is correlated with increased morbidity and mortality.

The study aim is to investigate the role of the protein convertase subtilisin/kexin type 9 (PCSK9) in hyperlipidemia of NS, which has been suggested to play an important role. This is done by testing the following hypotheses:

1. PCSK9 is increased in patients with NS and hyperlipidemia compared to kidney-healthy controls
2. The level of PCSK9 in plasma correlates to the degree of proteinuria.
3. PCSK9 i increased in the kidney tissue of patients with NS

The study will compare plasma levels of PCSK9 in correlation with degree of protein in the urine between test persons with NS and kidney healthy controls. Furthermore the investigators will study the the degree of PCSK9 in the kidney in biopsies obtained from test persons with nephrotic syndrome and test persons without proteinuria. conditions: Hyperlipidemias conditions: Nephrotic Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 75 type: ESTIMATED measure: Plasma PCSK9 correlated to the degree of protein in the urine measure: Degree of PCSK9 in kidney tissue measure: Localization of PCSK9 in kidney tissue sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kolding Sygehus, Lillebælt Hospital status: RECRUITING city: Kolding zip: 6000 country: Denmark name: Rikke Z Langkilde, md, phd role: CONTACT phone: 004576362554 name: Anne D Thuesen, md, phd role: CONTACT phone: 004576360555 email: Anne.Daugaard.Thuesen2@rsyd.dk lat: 55.4904 lon: 9.47216 hasResults: False

 nctId: NCT06373900 id: IndusH briefTitle: Wound Closure After Total Knee Arthroplasty: Comparison of Polypropylene and Polyglactin 910 Suture. overallStatus: COMPLETED date: 2022-02-13 date: 2022-02-19 date: 2022-03-30 date: 2024-04-18 date: 2024-04-18 name: Indus Hospital and Health Network class: OTHER briefSummary: Comparison of wound complication and scar formation in patient undergone bilateral total knee replacement comparison between polypropylene and polyglactin 910 suture. patient randomised according to SNOS protocol into group A and B for their right and left knee closure with each suture. patient followed on 3rd, 7th, 15th and 30th post operative day for wound healing, wound dehiscence and scar formation. conditions: Wound Heal conditions: Wound Dehiscence conditions: Wound Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: SNOS protocol whoMasked: PARTICIPANT count: 40 type: ACTUAL name: wound closure measure: Wound characteristics and complications measure: Wound Infection Grade measure: Hollander Cosmetic Wound Evaluation Score sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Indus Hospital and Health Network city: Karachi state: Sindh zip: 74900 country: Pakistan lat: 24.8608 lon: 67.0104 typeAbbrev: Prot_SAP_ICF hasProtocol: True hasSap: True hasIcf: True label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form date: 2022-02-04 uploadDate: 2024-04-03T02:55 filename: Prot_SAP_ICF_000.pdf size: 130365 hasResults: False

 nctId: NCT06373887 id: 2023-09-005A briefTitle: The Efficacy of Weight-loss Diet Decision-making Based on Initial Gut Metabolic Modules (GMMs) overallStatus: RECRUITING date: 2024-04-10 date: 2024-11-29 date: 2024-12-31 date: 2024-04-18 date: 2024-04-18 name: Taipei Veterans General Hospital, Taiwan class: OTHER_GOV briefSummary: In recent years, the technology to detect the gut microbiome's function has become increasingly developed. GMMs are tools (GitHub - raeslab/GMMs: A manually curated database of human gut metabolic modules.) for describing metabolic pathways for linking microbial metabolic function to species associated with a single metabolite, helping to analyze the transcriptional characteristics and metabolic functions of each bacterium, and studying their role of the food chain in the ecosystem. According to our previous research, the group with good weight loss response (more than 10% body weight loss in 8 weeks) after low-carb diet intervention has higher Shannon's diversity and carbohydrate degradation activity test by GMMs, implying the deficiency of availability of energy sources may cause more weight changes.

Based on the above research, we designed a low-carb diet (rich in monounsaturated fatty acids) and a low-fat diet (whole grains) with the same calories as a means of weight loss. The primary purpose of this study is to evaluate the pre-GMM test for determines the weight loss benefit of the intervention diet. Furthermore, we try to found the possible mechanism of whether metabolites of microbiota (e.g. SCFA) could affect the immune cell change which modulates adipose tissue . conditions: Weight Loss studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: To compare the weight-loss efficacy of different carbohydrate degradation status under two different diet arm (low carbohydrate or low fat diet) to evaluate the benefits of initial gut microbiota profiling in precision weight loss dietary interventions. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE maskingDescription: Single-blinded count: 150 type: ESTIMATED name: plant-based Low carbohydrate diet name: plant-based Low low fat diet measure: Body weight loss/fat mass loss measure: microbiota change sex: ALL minimumAge: 20 Years maximumAge: 64 Years stdAges: ADULT facility: Taipei Veterans General Hospital status: RECRUITING city: Taipei state: Beitou District zip: 11217 country: Taiwan name: Chun-Ying Wu role: CONTACT phone: +886-28712121 phoneExt: 4190 email: chptaiwan07@gmail.com name: HSIAO-PING CHEN role: CONTACT phone: +886-28712121 phoneExt: 4190 email: chptaiwan07@gmail.com lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06373874 id: MCBU-SBF-YC-04 briefTitle: The Effect of High Reality Simulation Environment on the Skills of Midwifery Students, in Newborn Heel Blood Collection overallStatus: COMPLETED date: 2023-04-01 date: 2023-05-30 date: 2023-05-30 date: 2024-04-18 date: 2024-04-18 name: Celal Bayar University class: OTHER briefSummary: The researchers gave midwifery students theoretical training on how to take heel blood on a newborn model. Students were asked to take heel blood on the model in the high-reality simulation environment and simulation room. The student's ability to take heel blood before and after taking heel blood in a high-reality simulation environment or on a newborn model in a simulation environment, satisfaction with learning, anxiety and self-efficacy levels were compared. conditions: Students conditions: Educational Problems conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment experimental study with experimental and control group primaryPurpose: OTHER masking: NONE count: 92 type: ACTUAL name: Heel blood collection in a newborn simulation model measure: Skill checklist measure: State and Trait Anxiety Scales measure: Self-Efficacy Scale measure: Student Satisfaction and Self-Confidence in Learning Questionnaire sex: FEMALE minimumAge: 21 Years maximumAge: 32 Years stdAges: ADULT facility: Manisa Celal Bayar University Faculty of Health Sciences, Department of Midwifery city: Manisa zip: 45140 country: Turkey lat: 38.61202 lon: 27.42647 facility: Yonca çiçek okuyan city: Manisa zip: 45140 country: Turkey lat: 38.61202 lon: 27.42647 hasResults: False

 nctId: NCT06373861 id: 20-0482 briefTitle: Generating Advancements Through Longitudinal Analysis in X and Y Variations (GALAXY) acronym: GALAXY overallStatus: RECRUITING date: 2022-04-28 date: 2037-04 date: 2037-04 date: 2024-04-18 date: 2024-04-18 name: University of Colorado, Denver class: OTHER name: Children's Hospital Colorado briefSummary: GALAXY is a registry research study that plans to learn more about individuals with X\&Y variations (also called sex chromosome aneuploidies) through collecting information from medical records.This includes genetic tests, imaging, medications, and more for hundreds of patients seen at a number of clinics across the US. The purpose of the GALAXY Registry is to collect and store this information with the overall goal to improve health outcomes in individuals with X\&Y variations and the care they receive. conditions: Sex Chromosome Aneuploidy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 5000 type: ESTIMATED name: no intervention measure: Health Conditions measure: Prevalence of mental health diagnoses measure: Cardiometabolic diagnoses - prevalence of obesity measure: Cardiometabolic diagnoses - prevalence of dyslipidemia measure: Cardiometabolic diagnoses-prevalence of hypertension measure: Autoimmune diagnoses - prevalence of hypothyroidism and of hyperthyroidism measure: Autoimmune diagnoses - prevalence of diabetes sex: ALL minimumAge: 0 Days maximumAge: 100 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Children's Hospital Colorado status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Shanlee M Davis, MD, PhD role: CONTACT phone: 720-777-6073 email: shanlee.davis@childrenscolorado.org lat: 39.72943 lon: -104.83192 hasResults: False

 nctId: NCT06373848 id: 346 briefTitle: Comparison of Salivary Parameters in Patients Receiving CoQ10 and Vitamin E Supplementation overallStatus: ENROLLING_BY_INVITATION date: 2024-04-20 date: 2024-08-20 date: 2024-09-15 date: 2024-04-18 date: 2024-04-18 name: Islamic Azad University, Tehran class: OTHER briefSummary: Comparison of salivary markers in patients with Initial chronic periodontitis after non-surgical periodontal treatment with CoQ10 supplementation with vitamin E conditions: Periodontal Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment, Randomized, Double-blind, Controlled design. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The study was carried out utilizing a double-blind approach. In order to guarantee objectivity, all three groups - the Vitamin E group, the Coq10 group, and the control group - received medications that were indistinguishable in terms of appearance, packaging, and color. Additionally, to minimize any potential bias, a clinician who had no association with the research labeled the medications as A, B, and C (empty) based on their content, and then distributed them among the patients. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 85 type: ESTIMATED name: Receive 30 mg of Coq10 measure: Total Antioxidant capacity (TAC) of saliva measure: Bleeding on probing 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: NCT06373835 id: EMODEPSIDE_LAOS briefTitle: Efficacy and Safety of Emodepside in Adults Infected With Strongyloidiasis Stercoralis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-31 date: 2024-07-31 date: 2024-04-18 date: 2024-04-18 name: Swiss Tropical & Public Health Institute class: OTHER name: National Institute of Public Health, Vientiane, Laos briefSummary: Efficacy, safety and pharmacokinetics of ascending dosages of emodepside and in comparison to ivermectin against Strongyloidiasis stercoralis in adults: randomized stage II seamless adaptive controlled trials conditions: Strongyloides Stercoralis Infection conditions: Strongyloidiasis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 240 type: ESTIMATED name: Emodepside measure: Cure rate (CR) of emodepside against Strongyloides stercoralis measure: Safety and tolerability of the dose-dependent emodepside treatment regimes, and compared with ivermectin. measure: Geometric Mean Larvae Reduction Rate (LRR) of emodepside against Strongyloides stercoralis. measure: Exposure response of emodepside in adults measure: Cure rate (CR) and egg reduction rate (ERR) with other soil-transmitted helminths (STH) and trematodes sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06373822 id: 2024/18JAN/028 briefTitle: New Perspectives in Adenomyosis Pathogenesis With Epigenetic Analysis and miRNAs acronym: ADENO-MIRNA overallStatus: RECRUITING date: 2024-03-21 date: 2031-09 date: 2031-09 date: 2024-04-18 date: 2024-04-22 name: Université Catholique de Louvain class: OTHER briefSummary: Objectives:

To identify differentially expressed miRNAs in the blood of adenomyosis patients in view to develop new diagnostic methods

Hypotheses Circulating miRNAs may be abnormally expressed in patients suffering from adenomyosis and could be used to diagnose the disease

Study Design Blood samples will be collected from healthy subjects and adenomyosis patients and miRNAs will be isolated and analyzed to detect potential differences. conditions: Adenomyosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED name: Circulating-mirna measure: Circulating-miRNA as diagnostic biomarkers sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CUSL status: RECRUITING city: Brussel state: Woluwe-Saint-Lambert zip: 1200 country: Belgium name: Emilie Wacheul, MD role: CONTACT phone: 027645246 email: emilie.wacheul@uclouvain.be lat: 50.85045 lon: 4.34878 hasResults: False

 nctId: NCT06373809 id: PDSC1970222 briefTitle: Placenta Derived Stem Cells for Treating of Chronic Ulcers and Neuropathy acronym: PDSC overallStatus: COMPLETED date: 2021-10-08 date: 2024-03-31 date: 2024-03-31 date: 2024-04-18 date: 2024-04-18 name: Michael H Carstens class: OTHER name: Ministerio de Salud de Nicaragua name: Wake Forest Institute for Regenerative Medicine briefSummary: This is an initial dose escalation safety and exploratory efficacy study to treat two groups of subjects with critically sized diabetic wounds and diabetic neuropathy using placental-derived stem cells (PDSC) transplanted by injection into soft tissues of the lower limb. Its primary objective is safety assessment and its secondary objective is determining optimum PDSC safe dose. Group 1 will receive implantation of cells in the ulcer, in the ulcer bed, and along the distal arterial vessels that supply blood to the foot. Group 2 will follow the same protocol for the foot but will have an additional dose of cells implanted in the anterior and posterior compartments of the same leg to determine the impact on peripheral neuropathy. Dose escalation and safety will be documented. Exploratory measures of efficacy include: ulcer healing, hemodynamic and anatomical effects on the arteries of the foot, and changes in the sensory perceptions of the foot. conditions: Diabetic Foot conditions: Diabetic Neuropathies conditions: Diabetic Foot Ulcer studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective an open label primaryPurpose: TREATMENT masking: NONE count: 20 type: ACTUAL name: Transplantation of Placenta Derived Stem Cells measure: Foot Ulcer Healing measure: Fine Touch Sensation: Documenting diabetes-associated lower extremity pathophysiology changes. measure: Vibration: Documenting diabetes-associated lower extremity pathophysiology changes. sex: ALL minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Escuela Oscar Danilo Rosales Arguello (HEODRA) city: León state: Leon zip: 21000 country: Nicaragua lat: 12.43787 lon: -86.87804 facility: Hospital Escuela Cesar Amador Molina city: Matagalpa zip: 61000 country: Nicaragua lat: 12.92559 lon: -85.91747 hasResults: False

 nctId: NCT06373796 id: 2024-A00523-44 briefTitle: Ultrasound Index Fat Fraction acronym: FAT-PLUS overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-07 date: 2024-09 date: 2024-04-18 date: 2024-04-18 name: SuperSonic Imagine class: INDUSTRY briefSummary: The objective is to compare the ultrasound index fat fraction (FAT PLUS), derived from several ultrasound biomarkers, with the gold-standard imaging exam for liver fat content evaluation (MRI-PDFF) in patients to quantify the hepatic steatosis. conditions: Steatosis of Liver studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: Echographic scan measure: FAT PLUS sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06373783 id: 2023/05 briefTitle: Ultrasonographic Evaluation of the Connective Tissue Grafts Obtained With Two Different Methods in Root Coverage overallStatus: COMPLETED date: 2023-06-15 date: 2024-01-15 date: 2024-03-16 date: 2024-04-18 date: 2024-04-23 name: Pamukkale University class: OTHER briefSummary: Gingival recession is a clinical problem that increases with age and affects patient comfort. It is defined as the displacement of the gingival margin to a more apical position of the cementum-enamel border of the tooth.

Coronally advanced flap (CAF) or tunnel technique (TUN) with subepithelial connective tissue procedures have been reported to be the most predictable methods of single gingival recession treatments. The ultimate goal of these plastic periodontal surgical procedures is to close the exposed root surface and achieve optimum aesthetic results. The main indications for root coverage (RC) procedures are aesthetic concern, root hypersensitivity, prevention of cervical abrasion and root caries, improvement of restorative results, and facilitation of plaque control. The use of a subepithelial connective tissue graft (SCGT) combined with a coronally positioned flap is considered the gold standard by many authors for single gingival recession treatments.

De-epithelialization of free gingival grafts (DGG) has been proposed, especially when palatal tissue thickness is insufficient (≤2.5 mm) and larger graft size in the apico-coronal or mesio-distal directions is required. In this technique, the graft of the required width and length is separated from the lateral side of the palate, and then the 0.3-0.5 mm thick epithelial layer of the resulting graft is cut from the connective tissue layer.

Ultrasonography (USG) is based on the principle of recording data obtained as a result of ultrasound waves sent with the help of a probe hitting and reflecting on substances of different densities. This technique is widely used in medical practice. In dentistry, the USG method is used to measure the alveolar bone level and the dimensions of the periodontium to evaluate the gingival thickness. It also has functions to evaluate color power and color speed, as well as blood flow.

The study hypothesizes that combining SCGT and DGG with a coronally positioned flap could yield different clinical outcomes in patients with a single buccal gingival recession. This study aims to compare the clinical success of connective tissue grafts obtained by two different surgical methods in covering the root surface with ultrasonography (USG). conditions: Gingival Recession, Localized studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 20 type: ACTUAL name: subepithelial connective tissue graft name: de- epithelize gingival graft name: ultrasonography measure: tissue thickness measure: pulsatility index sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pamukkale University of the Dentistry city: Denizli zip: 20160 country: Turkey lat: 37.77417 lon: 29.0875 hasResults: False

 nctId: NCT06373770 id: MSRSW/Batch-Fall22/700 briefTitle: Effects of Ayres Sensory Integration Therapy Versus Conservative Treatment in Autism Spectrum overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-01 date: 2024-06-01 date: 2024-09-30 date: 2024-04-18 date: 2024-04-22 name: Superior University class: OTHER briefSummary: Effects of Ayres Sensory Integration Therapy Versus Conservative Treatment in Autism Spectrum conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ACTUAL name: Ayres sensory integration therapy name: Behaviour Therapy measure: sensory profile by winnie dunn sex: ALL minimumAge: 2 Years maximumAge: 8 Years stdAges: CHILD facility: RICCER Institute city: Faisalabad state: Punjab country: Pakistan lat: 31.41554 lon: 73.08969 hasResults: False

 nctId: NCT06373757 id: RECO6U/5-2023 briefTitle: Chitosan Nano-hydroxyapatite Hydrogel in Non-Surgical Treatment of Intrabony Defect overallStatus: COMPLETED date: 2023-03-01 date: 2023-09-01 date: 2023-09-01 date: 2024-04-18 date: 2024-04-18 name: October 6 University class: OTHER briefSummary: The aim of this study was to evaluate the clinical effect of Chitosan with nano-hydroxyapatite hydrogel in the treatment of periodontal intrabony defects. conditions: Chitosan conditions: Nano-hydroxyapatite Hydrogel conditions: Intrabony Defect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 24 type: ACTUAL name: Nano-HAP/Chitosan hydrogel measure: Gingival index measure: Plaque index measure: Clinical attachment level measure: Periodontal probing depth measure: Acrylic stent for pocket assessment sex: ALL minimumAge: 25 Years maximumAge: 55 Years stdAges: ADULT facility: October 6 University city: Giza zip: 12511 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06373744 id: SYSU-022 briefTitle: Metronomic Chemotherapy in a Real-world Population of Advanced Breast Cancer Patients overallStatus: COMPLETED date: 2023-01-01 date: 2024-01-01 date: 2024-01-01 date: 2024-04-18 date: 2024-04-18 name: Sun Yat-sen University class: OTHER briefSummary: The goal of this observational study is to learn about the effects of metronomic chemotherapy in advanced breast cancer patients. The main question it aims to answer is:

How effective is metronomic chemotherapy in advanced breast cancer? Specific benefit groups of metronomic chemotherapy. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 597 type: ACTUAL name: cyclophosphamide , methotrexate , vinorelbine ,capecitabine measure: Progression free survival measure: Overall Survival measure: Objective Response Rate measure: Disease Control Rate sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shusen Wang city: Guangzhou state: Gangdong country: China lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06373731 id: SPIAM-301 briefTitle: ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD) acronym: ReNEW overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-08 date: 2027-08 date: 2024-04-18 date: 2024-04-22 name: Stealth BioTherapeutics Inc. class: INDUSTRY briefSummary: The goal of this clinical trial is to evaluate the efficacy, safety and pharmacokinetics of elamipretide in subjects with dry age-related macular degeneration (AMD). The main questions it aims to answer are: what is the rate of change in the macular area of photoreceptor loss in subjects who receive a daily dose of elamipretide compared with those who receive a look-alike substance that contains no active drug, and what is the safety and tolerability of elamipretide daily subcutaneous injections. Participants will receive either once daily subcutaneous doses of 40mg elamipretide or placebo and the two treatment groups will be compared. conditions: Age-Related Macular Degeneration studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Subjects will be randomized (2:1) to once daily 40 mg SC of elamipretide or placebo for 96 weeks of treatment by a central randomization primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Trial personnel and subjects will be masked to treatment until the database is locked at the end of the trial, unless noted below. The Investigator will contact the Sponsor Medical Monitor prior to unmasking any subject's treatment sequence unless in the instance of a medical emergency. In case of an immediate medical emergency, or if directed by the Sponsor, and only if the information is required by the Investigator to manage a subject's AE, a subject's treatment assignment may be unmasked prematurely using the computerized system. The Sponsor must be notified as soon as possible regarding the reason for unmasking. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 360 type: ESTIMATED name: Elamipretide name: Placebo measure: Week 48 Rate of change in the macular area of photoreceptor loss measure: Week 72 Rate of change in the Macular area of photoreceptor loss measure: Week 96 Rate of change in the Macular area of photoreceptor loss measure: Proportion of subjects gaining ≥ 10 letters (2 lines) in Low Luminance Best-Corrected Visual Acuity (LL BCVA) measure: Proportion of subjects gaining ≥ 15 letters in Low Luminance Best-Corrected Visual Acuity (LL BCVA) sex: ALL minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06373718 id: IRB-74553 briefTitle: A Novel Use of a Sleep Intervention to Target the Emotion Regulation Brain Network to Treat Depression and Anxiety (R33 Phase) overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-06 date: 2027-06 date: 2024-04-18 date: 2024-04-18 name: Stanford University class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: This project is the second phase of a two-phased project investigating the impact of a proven sleep intervention, Cognitive Behavioral Therapy for Insomnia (CBT-I) on engagement of the emotion regulation brain network as a putative mechanistic target. conditions: Insomnia conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Enrolled participants will be randomized into either the Immediate Treatment group, or the Monitored Control group. Both study groups will receive CBT-I. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 150 type: ESTIMATED name: Cognitive Behavioral Therapy for Insomnia measure: Change in Emotion Regulation Network brain activation as assessed by functional magnetic resonance imaging measure: Change in Emotion Regulation Network brain connectivity as assessed by functional magnetic resonance imaging measure: Change in Beck Depression Inventory measure: Change in PSG Sleep Efficiency measure: Change in Columbia Suicide Severity Rating Scale measure: Change in Actigraph Sleep Onset Latency (SOL) as a Measure of Sleep Continuity measure: Change in Actigraph Number of Arousals as a Measure of Sleep Continuity measure: Change in Actigraph Wake After Sleep Onset (WASO) as a Measure of Sleep Continuity measure: Change in Actigraph Total Sleep Time (TST) as a Measure of Sleep Continuity measure: Change in Actigraph Sleep Efficiency (SE) as a Measure of Sleep Continuity measure: Change in PSG Sleep Onset Latency (SOL) as a Measure of Sleep Architecture measure: Change in PSG Number of Arousals as a Measure of Sleep Architecture measure: Change in PSG Wake After Sleep Onset (WASO) as a Measure of Sleep Architecture measure: Change in PSG Total Sleep Time (TST) as a Measure of Sleep Architecture measure: Change in PSG Sleep Efficiency (SE) as a Measure of Sleep Architecture measure: Change in Sleep Physiology measured by PSG measure: Change in Insomnia Severity Index (ISI) Scale Score measure: Change in 36-Item Short Form Survey (SF-36) Score measure: Change in Beck Anxiety Inventory measure: Change in Respiratory Sinus Arrhythmia (RSA)- measured by PSG sex: ALL minimumAge: 25 Years maximumAge: 60 Years stdAges: ADULT facility: Stanford University city: Palo Alto state: California zip: 94304 country: United States name: Pandora Lam role: CONTACT phone: 650-497-5130 email: pal217@stanford.edu name: Andrea Goldstein-Piekarski, PhD role: PRINCIPAL_INVESTIGATOR lat: 37.44188 lon: -122.14302 hasResults: False

 nctId: NCT06373705 id: 74566 id: 1R01HL173845 - 01 type: OTHER_GRANT domain: NIH briefTitle: Cardiac Simulator for Surgical Planning overallStatus: NOT_YET_RECRUITING date: 2026-04 date: 2029-04 date: 2029-04 date: 2024-04-18 date: 2024-04-22 name: Stanford University class: OTHER name: National Institutes of Health (NIH) briefSummary: The goal of this clinical trial is to learn if a computer software program (cardiac simulator) for surgical planning will lead to improvements in patient care by decreasing the incidence of unsuccessful interventions and reinterventions for pediatric patients with congenital heart disease. It is not a commercially available device to treat congenital heart disease in pediatric patients. The main aims are:

To provide safe pre-operative testing of surgical approaches with a computer model cardiac simulator.

To aid surgeons in envisioning different surgical approaches for each individual patient.

To bolster the standard of care surgical planning discussions which will be particularly useful for patients with unique, complex congenital heart disease.

Participants will:

Consent to being randomized with a 50% chance of receiving standard of care "on the fly" surgical planning discussion as is current practice or assisted surgical planning discussion with the aid of the computer software cardiac simulator.

Receive results of their computer simulated findings during their surgical planning discussion if they are in the cardiac simulator group. conditions: Congenital Heart Disease in Children studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1:1 randomization to either receive standard of care "on the fly" surgical planning discussion as is current practice or assisted surgical planning discussion with the aid of computer simulation. primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: After consent to participate in the study, patient will be entered into a random allocation sequence for standard of care (SOC) or cardiac simulator groups.

Patient and surgeon will both be notified which group they have been assigned to. count: 275 type: ESTIMATED name: Cardiac simulator measure: Mortality measure: Mortality measure: Number of cardioplegic arrest measure: Number of repair revisions needed measure: Time on cardiopulmonary bypass measure: Ventricular function measure: Ventricular function measure: Ventricular function measure: Valvular function measure: Valvular function measure: Valvular function measure: Number of days in hospital post-operation measure: Type of post-operative inotrope sex: ALL maximumAge: 17 Years stdAges: CHILD hasResults: False

 nctId: NCT06373692 id: TCM for Asthma Cohort briefTitle: REspiratory diSEAse cohoRt Studies of CHinese Medicine for Asthma (RESEARCH- Asthma) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-30 date: 2026-12-30 date: 2024-04-18 date: 2024-04-18 name: Henan University of Traditional Chinese Medicine class: OTHER name: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine name: Tianjin University of Traditional Chinese Medicine name: The Third Affiliated Hospital of Henan University of Traditional Chinese Medicine name: Hebei Provincial Hospital of Traditional Chinese Medicine name: Peking University People's Hospital name: The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine name: The First Affiliated Hospital of Zhengzhou University name: First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine name: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine briefSummary: The purpose of this study is to define the standard use of TCM treatment regimen as the TCM cohort group and the non-TCM cohort group of those who use conventional Western medicine treatment without the standard TCM treatment regimen through a multi-center, large-sample prospective cohort study design. To evaluate the clinical efficacy and safety of TCM treatment regimens in the treatment of bronchial asthma, and to provide high-quality evidence for the promotion and application of TCM syndrome differentiation treatment in bronchial asthma. conditions: Bronchial Asthma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1508 type: ESTIMATED measure: Asthma control rate measure: Number of exacerbations measure: Asthma exacerbation severity measure: Change in severity of chronic persistent disease measure: The dose used by glucocorticoids measure: Rapid-acting beta2 agonists use drugs and doses measure: Asthma Control Test (ACT) score measure: Asthma Control Questionnaire (ACQ) measure: Asthma Quality of Life Score (AQLQ) measure: Anxiety Self-Assessment Form (SAS) measure: Depression Self-Rating Scale (SDS) measure: Pulmonary function measure: Exhaled nitric oxide (FeNO) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine city: Zhengzhou state: Henan country: China name: Hai-bin Yu, Ph.D role: CONTACT phone: +86 13526671773 email: wwz1231125@163.com lat: 34.75778 lon: 113.64861 hasResults: False

 nctId: NCT06373679 id: Pro00125514 id: 1R01DA056445-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R01DA056445-01A1 briefTitle: Switch or Quit R01 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-05 date: 2027-05 date: 2024-04-18 date: 2024-04-18 name: Medical University of South Carolina class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: This study evaluates whether non-cigarette tobacco products (e-cigarettes) can help smokers quit smoking as compared to traditional quit methods (nicotine replacement therapy or varenicline/Chantix). Participants in this study will be randomly assigned to one of two groups, then will have a choice between the offered products of that group. Participants in the e-cigarette group will have a choice of e-cigarette brand and flavor. Participants in the medication group will have choice between nicotine replacement therapy (patches and lozenges) or varenicline, also known as Chantix. Participation will last 6 months and will include weekly phone calls for the initial 7-weeks plus a 11-week phone call and a 6-month follow-up visit. Participants will also complete electronic daily diaries during the first 7-weeks. conditions: Cigarette Smoking conditions: Smoking Behaviors studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 225 type: ESTIMATED name: Switching to E-Cigarette name: Switching using Medication measure: Biochemically-confirmed 7-day point prevalence abstinence from cigarettes on timeline followback measure: Greater than 50% reduction in cigarette smoking sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical Univeristy of South Carolina city: Charleston state: South Carolina zip: 29425 country: United States lat: 32.77657 lon: -79.93092 hasResults: False

 nctId: NCT06373666 id: SPZ4-02 briefTitle: A Study to Evaluate the Adjustment Function of a Modified Spatz3 Adjustable Balloon (Spatz4). overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2025-06 date: 2024-04-18 date: 2024-04-22 name: Spatz FGIA, Inc class: OTHER briefSummary: The purpose of this study is to evaluate the function of the adjustment procedure with the Spatz4 in subjects with a BMI ≥ 27. conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Spatz4 Adjustable Balloon System measure: Successful adjustment procedure at 16 ±2 weeks in > 85% of attempts. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06373653 id: SOPHMAN-0922/IV briefTitle: Study of Non-inferiority Between Manzanilla Sophia® and Meticel Ofteno® 0.5% for Providing a Soothing Sensation to the Eyes. overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2024-06-30 date: 2024-12-30 date: 2024-04-18 date: 2024-04-18 name: Laboratorios Sophia S.A de C.V. class: INDUSTRY briefSummary: This is a phase IV clinical study to demonstrate the non-inferiority of Manzanilla Sophia® compared to Meticel Ofteno® 0.5% in providing restful sensation to the eyes. This will be evaluated by measuring the incidence of unexpected adverse events related to the interventions, the incidence of conjunctival hyperemia and the incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI). conditions: Eye Strain conditions: Eye Strain of Both Eyes studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase IV non-inferiority, open-label, controlled, comparative, multicenter, clinical study. primaryPurpose: TREATMENT masking: NONE maskingDescription: Open-label, count: 100 type: ESTIMATED name: Manzanilla Sophia® name: Meticel Ofteno® measure: Analog visual eyestrain test score measure: Incidence of unexpected adverse events related to the interventions measure: Incidence of conjunctival hyperemia measure: Incidence of sensation of ocular dryness. measure: Incidence of ocular irritation measure: Incidence of sensation of (sleep-crust) measure: Incidence of sensation of comfort with the application, when applied by the Principal Investigator (PI) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06373640 id: RHM NEU0458 briefTitle: Haemoglobin And Vancomycin Pharmacokinetics in the Cerebrospinal Fluid Following Subarachnoid Haemorrhage acronym: HAPTO overallStatus: NOT_YET_RECRUITING date: 2024-11 date: 2027-03 date: 2028-01 date: 2024-04-18 date: 2024-04-18 name: University Hospital Southampton NHS Foundation Trust class: OTHER briefSummary: The HAPTO study will recruit adult patients with aSAH due to a burst aneurysm. These patients must be scheduled to have their aneurysm treated surgically to prevent further bleeds, and need an external ventricular drain for clinical reasons (to drain fluid and relieve pressure on the brain). At the end of their surgery for their aneurysm, a further drain will be left at the site of the surgery (which is in the basal cisterns) and they will additionally have a drain sited in their lumbar spine. Vancomycin will be given through these drains. Additionally, these drains will allow the fluid in the brain to be collected to measure how haemoglobin levels and vancomycin levels differ between compartments and change over time. Patients will participate in the study over a period from recruitment at three days after aSAH to a maximum of ten days after aSAH. The data will be analysed to determine the relationship in haemoglobin concentrations between different areas of the brain and spine after aSAH, and how vancomycin distribution is related to its route of administration. conditions: Subarachnoid Hemorrhage studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 14 type: ESTIMATED name: Insertion of drains name: Vancomycin measure: CSF-haemoglobin concentration sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06373627 id: 2024-A00534-43 briefTitle: Procedural Pain Management by Multimodal Sedation Analgesia Combining Hypnosis in Children With Congenital Heart Disease acronym: PEACE-HYPNO overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2025-05-02 date: 2025-05-03 date: 2024-04-18 date: 2024-04-18 name: Fondation Hôpital Saint-Joseph class: OTHER briefSummary: The aim of this prospective randomized controlled trial is to evaluate therapeutic hypnosis as a co-analgesia in thoracic drain removal in children with congenital heart disease. The hypothesis of this study is that therapeutic hypnosis combined with a minimal effective dose of medicated and inhaled sedation-analgesia is not inferior to higher doses of sedation-analgesia usually employed. This would make possible the reduction of cumulative dose of sedative medication and their side effects. conditions: Procedural Pain conditions: Congenital Heart Disease conditions: Heart Surgery conditions: Hypnosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 104 type: ESTIMATED name: Hypnosis name: Conventional medications used for sedation-analgesia name: Medications used in addition to hypnosis measure: Primary Outcome : Pain evaluation by VAS self-assessment measure: Hetero-assessment by FLACC scale of the pain during the intrathoracic drain removal measure: Maximum heart rate measure: Cumulative doses of intravenous analgesics measure: Respiratory depression measure: Parental satisfaction using Visual Analogic Scale (VAS) sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06373614 id: 2023/18 briefTitle: The Effect of Foot Massage and Bed Bath on Individuals With Cancer overallStatus: RECRUITING date: 2023-11-20 date: 2024-05-20 date: 2024-06-20 date: 2024-04-18 date: 2024-04-18 name: Saglik Bilimleri Universitesi class: OTHER briefSummary: Foot massage or bed bath will be applied to improve sleep quality and reduce fatigue levels of individuals with cancer. conditions: Patients studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: foot massage (intervention group) bed bath (intervention group) control (control group) primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 45 type: ESTIMATED name: foot massage name: bed bath measure: sleep quality measure: fatigue sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Health Sciences status: RECRUITING city: Istanbul state: Uskudar country: Turkey name: Ayşe Kabuk, Dr role: CONTACT phone: 05469596616 email: ayse.kabuk@beun.edu.tr name: Ayşe Kabuk, PhD role: CONTACT phone: +905469596616 email: ayseyalili@gmail.com name: Ayşe Kabuk, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06373601 id: SPAGO briefTitle: SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective acronym: SPAGO overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2027-02-01 date: 2027-02-01 date: 2024-04-18 date: 2024-04-18 name: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS class: OTHER briefSummary: The objective of the study is to compare angiographic outcomes of Selution sirolimus coated balloon (MedAlliance) versus SeQuent Please Neo paclitaxel coated balloon (Bbraun) for the treatment of de novo coronary artery lesions in medium size vessels (\>2.00 mm and ≤3.00 mm) with respect to Net Gain (mm) at 12 months follow-up. conditions: Coronary Artery Disease conditions: Stenosis Coronary conditions: Coronary Artery Lesion conditions: Percutaneous Coronary Intervention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A subject is randomized at a 1:1 ratio either to drug-coated balloon (DCB) angioplasty with a sirolimus-eluting Selution balloon (n=60 subjects) or DCB angioplasty with a paclitaxel-eluting Sequent Please Neo balloon (n=60 subjects). primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: sirolimus-eluting balloon (Selution) name: paclitaxel-eluting balloon (SeQuent Please Neo) measure: In-segment (balloon treated area) Net Gain (mm) at 12 months post-procedure measure: Device success (lesion based) measure: Procedure success measure: Angiographic outcomes 1 measure: Angiographic outcomes 2 measure: Angiographic outcomes 3 measure: Angiographic outcomes 4 measure: Device oriented Composite Endpoint (DoCE/ TLF) measure: Acute/subacute/early/late vessel thrombosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06373588 id: MP-37-2023-9418 briefTitle: Patient Navigator Intervention for Migrant Children With Special Healthcare Needs Experiencing Care Transitions overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-05 date: 2027-08 date: 2024-04-18 date: 2024-04-26 name: McGill University Health Centre/Research Institute of the McGill University Health Centre class: OTHER name: Canadian Institutes of Health Research (CIHR) name: Montreal Children's Hospital of the MUHC name: Unity Health Toronto name: The Hospital for Sick Children name: Women's College Hospital name: National Newcomer Navigation Network name: Centre for Refugee Children, Toronto briefSummary: The goal of this randomized controlled trial is to test if a patient navigator program improves healthcare experiences and outcomes for migrant families caring for a child or youth with special healthcare needs (i.e. chronic health condition).

The main questions are, for migrant families with a child or youth with special healthcare needs:

Does a patient navigator reduces barriers to care? Does a patient navigator improve care coordination, caregiver empowerment, caregiver stress and quality of life? What are the healthcare experiences for families with and without the patient navigator intervention?

Participants will:

* Receive the intervention, i.e., the patient navigator program, or continue with standard of care for 12 months
* Fill out questionnaires at 3 time points on barriers to care, caregiver stress, care coordination, and their child's health conditions: Patient Navigation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multi-centre, pragmatic, assessor-blinded, parallel randomized controlled trial with an embedded qualitative study. In the control arm, participants will receive a standard information package and care usually provided within their clinics. In the intervention arm, participants will receive support from a trained patient navigator. The patient navigator will contact participants: 1) Within 7 days of randomization; 2) At least once every 3 months up to 12 months; 3) As needed to follow-up on tasks identified in previous visits; and 4) As initiated by the participant. The navigator will tailor the topics addressed during these interactions according to the needs of the participant and compile a care plan with input from the patient, family, and clinicians. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 324 type: ESTIMATED name: Patient Navigator measure: Barriers to Care (BCQ) measure: Effective care coordination measure: Parental empowerment scale measure: Healthcare utilization measure: PROMIS - Pediatric Global Health 7 measure: Short-form survey 12 measure: Patient Health Questionnaire (PHQ-2) measure: Distress Thermometer measure: Perceived stress scale measure: Patient Satisfaction with Interpersonal Relationships with Navigators (PSN-I) sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Unity Health Toronto, Compass Clinic city: Toronto state: Ontario zip: M5B 1W8 country: Canada name: Ahrrabie Thirunavukkarasu role: CONTACT email: athirun@uwo.ca name: Shazeen Suleman, MD MPH FRCPC role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 facility: Women's College Hospital, Crossroads Clinic city: Toronto state: Ontario zip: M5S 1B2 country: Canada name: Xinyang Ye role: CONTACT email: xinyang.ye@unityhealth.to name: Meb Rashid role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 facility: CLSC de Parc-Extension city: Montréal state: Quebec zip: H3N 1Y9 country: Canada name: Patricia LI role: CONTACT email: patricia.li@mcgill.ca name: Patricia Li role: PRINCIPAL_INVESTIGATOR name: Juan Carlos Chirgwin role: SUB_INVESTIGATOR lat: 45.50884 lon: -73.58781 facility: Montreal Children's Hospital city: Montréal state: Quebec zip: H4A 3J1 country: Canada name: Melissa Tachdjian role: CONTACT phone: 514-233-1873 email: melissa.tachdjian@rimuhc.ca name: Patricia Li role: CONTACT phone: 438-402-0510 email: patricia.li@mcgill.ca name: Patricia Li role: PRINCIPAL_INVESTIGATOR lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06373575 id: 2023-SR-891 briefTitle: IVC and Lung Ultrasound B-lines Guided Decongestion in Critically Ill ESKD Patients With Heart Failure overallStatus: ENROLLING_BY_INVITATION date: 2024-05-01 date: 2025-04-30 date: 2025-06-30 date: 2024-04-18 date: 2024-04-18 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: The objectives of this trial are to determine whether, in critically ill ESKD patients randomization to fluid removal guided by lung and inferior vena cava ultrasound, compared to standard care, leads to Improved pulmonary congestion (primary outcome); and safety (secondary outcome) in the short-term. conditions: End-stage Renal Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Lung and inferior vena cava ultrasound guidance name: Conventional protocol guidance measure: Improvement in pulmonary congestion score measure: Improvement in heart failure symptoms score measure: Total ultrafiltration volume measure: Mean ultrafiltration rate during prolonged hemodialysis measure: Fluid balance (total outflow - total inflow) measure: Lung B-line reduction measure: The change of width of inferior vena cava measure: Incidence of hypotension during prolonged hemodialysis measure: Blood pressure variability during the prolonged hemodialysis measure: In-hospital mortality measure: Length of hospital stay sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jiangsu Province Hospital city: Nanjing state: Jiangsu zip: 210029 country: China lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06373562 id: Wrestlers briefTitle: Effect of Hypoxic Exposure on Blood Variables in Elite Wrestlers overallStatus: COMPLETED date: 2013-12-02 date: 2013-12-18 date: 2013-12-18 date: 2024-04-18 date: 2024-04-18 name: Poznan University of Physical Education class: OTHER briefSummary: Twelve male wrestlers of the National Polish Team were observed in the study during the camp. The hypoxia group (n=6) participated in sports training and hypoxic exposure, while the control group (n=6) included wrestlers participating only in sports training. The hypoxic group lived and slept in hypoxic rooms. During the camp, all wrestlers followed the same training schedule and diet. In the blood were determined levels of creatine kinase (CK), C-reactive protein (hsCRP) concentration, nitric oxide (NO), morphology, reticulocytes, lipid profile, and ferritin. Also vascular endothelial growth factor (VEGF, VEGFR2, and VEGFR3), erythropoietin (EPO), angiopoietin (Ang 1, Ang 2), endothelial cell adhesion factor-1 (VCAM-1), Erythropoietin (EPO) and hypoxia-inducible factor 1 (HIF-1). Body weight composition was determined. conditions: Hypoxia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Wrestlers in H group were living in hypoxic rooms for 8-14h/d and between that they were participating in sports training. C group was participating in the same training protocol. primaryPurpose: DIAGNOSTIC masking: NONE count: 12 type: ACTUAL name: hypoxia measure: CK measure: hsCRP measure: HIF-1 measure: EPO measure: VEGF, VEGF 2, VEGF 3. measure: Ang 1, Ang 2 measure: VCAM-1 measure: blood count measure: lipid profile measure: ferritin sex: MALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06373549 id: 2022/183-3896 briefTitle: Investigation of Myocardial Protection Efficacy of Cardioplegia Solutions Used in Open Heart Surgery overallStatus: COMPLETED date: 2022-12-08 date: 2023-07-24 date: 2023-07-24 date: 2024-04-18 date: 2024-04-18 name: Tamer cebe class: OTHER name: Istanbul University - Cerrahpasa (IUC) briefSummary: Cardioplegias are different pharmacokinetic solutions routinely used in cardiac surgery to protect the heart from ischemia and induce arrest. Various cardioplegia solutions (such as Bretschneider, del Nido, blood cardioplegia, crystalloid cardioplegia, St. Thomas) are used in clinical practice. There is no clear scientific data in the literature that demonstrates the superiority of one cardioplegia over the others. The choice of the appropriate cardioplegia depends on the surgeon's clinical experience and preference. In this study preferred the blood cardioplegia and del Nido cardioplegia, which are commonly used in clinic. Both cardioplegias have different advantages that contribute to their preference in clinical practice.

Blood cardioplegia is an autologous cardioplegia that includes physiological buffer systems, allowing for heart nourishment and containing native antioxidant systems. However, the need for repeated doses every 20 minutes after the initial application creates a disadvantage in terms of surgical comfort. On the other hand, del Nido cardioplegia is preferred by surgeons in complex cases due to its long application intervals. The adequacy of a single dose for up to 90 minutes after the initial application creates an advantage in terms of surgical comfort and surgical integrity. However, the content being predominantly electrolyte-based, containing 1:4 ratio of autologous blood, and the extended time of a single dose are disadvantages compared to blood cardioplegia in terms of heart nourishment and protection from ischemia. In addition to these different usage scenarios, the myocardial protective effects of cardioplegias on cellular redox homeostasis are also among the current research topics. Thesis project can contribute to the current literature and clinical practice on the cardioprotective advantages of cardioplegia solutions and the reasons for their preference in surgery. conditions: Cardiovascular Diseases conditions: Myocardial Reperfusion Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2 type: ACTUAL name: Patients with coronary artery bypass surgery routine procedural administration of cardioplegia solutions name: Patients who underwent heart valve surgery without coronary artery disease routine procedural administration of cardioplegia solutions measure: Evaluation of the myocardial protective effects of different cardioplegia solutions through oxidative stress and redox signaling molecules. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SBÜ. Dr. Siyami Ersek Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi Erişkin Kalp ve Damar Cerrahisi Kliniği city: Istanbul state: Kadıköy zip: 34668 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06373536 id: LMU-RAD-01167 briefTitle: Comparison of MRI-PDFF to TAEUS FLIP Device to Estimate Liver Fat Fraction in Adults overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-09-01 date: 2024-04-18 date: 2024-04-18 name: Endra Lifesciences class: INDUSTRY briefSummary: Primary nonalcoholic fatty Liver disease (NAFLD) is an excess of fat in the liver (steatosis) that is not a result of excessive alcohol consumption or other secondary causes11. NAFLD is defined by the presence of hepatic fat content (steatosis) in ≥ 5% of hepatocytes and is currently the most common liver disease worldwide14 . Non-Alcoholic Fatty Liver Disease (NAFLD) is the world\&#39;s most common liver disease and affects around 33% of the adult population.

Nonalcoholic steatohepatitis (NASH), a progressive form of nonalcoholic fatty liver disease (NAFLD), is a growing clinical concern associated with the increasing prevalence of obesity, type 2 diabetes, and metabolic syndrome. NASH is characterized by the presence of hepatic steatosis, inflammation, and hepatocellular injury and is predicted to be the leading indication for liver transplantation by 20201. Patients with NASH have an increased risk of developing cirrhosis and its complications, such as ascites, variceal hemorrhage, hepatic encephalopathy, hepatocellular carcinoma, and liver failure. The prevalence worldwide of NAFLD in the general population is estimated at 20-35%2 . Around 2-3% of the population have NASH.

In patients with type 2 diabetes, the prevalence is even over 50% (55.5% globally, 68% in Europe). In Germany, the NAFLD prevalence was 23% in 2016 and will be around 26% in 2030. The prevalence of non-alcoholic alcoholic steatohepatitis (NASH), i.e. the progressive form of NAFLD, is estimated at 4% of the adult population in Germany and will increase to 6% by 2030. This means that NAFLD is already the most common chronic liver disease worldwide and one of the leading causes of liver-related complications (cirrhosis, decompensation, hepatocellular carcinoma, liver transplantation) and deaths. NAFLD and NASH are largely underdiagnosed worldwide. conditions: Steatosis of Liver studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 80 type: ESTIMATED name: Thermoacoustic imaging, MRI and Ultrasound imaging measure: Thermoacoustic Fat Measurements measure: Estimate Accuracy of Thermoacoustic Fat Fraction measure: Usability Metric measure: Estimate Operator Variability sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Klinikum der Universität München Großhadern Klinik und Poliklink für Radiologie city: München zip: 81377 country: Germany name: Monika Dienst, M.Sc. role: CONTACT phone: +49 89 4400 76642 email: monika.dienst@med.uni-muenchen.de name: Dirk-Andre Clevert, Prof. Dr. med. role: PRINCIPAL_INVESTIGATOR lat: 48.13743 lon: 11.57549 hasResults: False

 nctId: NCT06373523 id: SHIELD briefTitle: MASLD in Primary Hypothyroidism and Efficacy of Dapaglifozin acronym: SHIELD overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-06-30 date: 2025-07-30 date: 2024-04-18 date: 2024-04-18 name: Post Graduate Institute of Medical Education and Research, Chandigarh class: OTHER briefSummary: Non-alcoholic fatty liver disease (NAFLD) is a global epidemic with a prevalence of 25-40%.Primary Hypothyroidism is one of Endocrinopathies who are at risk of developing NAFLD/NASH and estimated prevalence of Primary Hypothyroidism in NAFLD patients is 10-15 %.Though First line Management is Dietary changes and lifestyle modifications(LSM),unfortunately Adherence to Lifestyle has been poor,rise of Lean NAFLD is on rise, faster progression of NAFLD,evolving risk factors for NAFLD like endocrinopathies,these push need for Pharmacotherapy.Currently therapies for NAFLD patients without diabetes mellitus (DM) are limited, and are associated with various adverse side effects. Sodium-glucose cotransporter type-2 (SGLT2) inhibitors can reduce hepatic fat content in patients with DM which is independent of glycemic control. However, the role of SGLT2 inhibitors in NAFLD patients without DM has not been investigated.Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) is an emerging non-invasive imaging technique, and is more sensitive than liver biopsy/histology in quantifying liver fat change. Liver stiffness measurement (LSM) by Transient Elastography is a non-invasive method to diagnose fibrosis/cirrhosis with high accuracy.The novelty of utilizing the concept of "drug repositioning" by changing the role of SGLT2 inhibitors in treating DM to treating NAFLD in patients without DM deserves exploration.The investigators propose a double-blind, randomized, placebo-controlled trial to compare the effects of Dapagliflozin (a type of SLGT2 inhibitors) versus placebo (in a 1:1 ratio) in reducing hepatic fat content as measured by MRI-PDFF in NAFLD patients with Primary Hypothyroidism.The study results will determine whether SGLT2 inhibitors can reduce hepatic steatosis/hepatic fibrosis in NAFLD patients with Primary Hypothyroidism. conditions: Hepatic Steato-Fibrosis conditions: Non-Alcoholic Fatty Liver Disease studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Eligible subjects will be randomly allocated to either the Dapagliflozin group or placebo group (i.e. control group) primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The placebo pills will be manufactured in identical appearance to the study drug (Dapagliflozin) whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Dapagliflozin 10mg Tab name: Placebo name: Levothyroxine Replacement daily measure: Change in liver fat content measure: Proportion of participants achieving 1 Stage decrease in steatosis at 6 months asassessed by Transient Elastography measure: Changes in Improvement in hepatic fibrosis measured by non invasive parameters like Fib4 score at 3 and 6 months measure: Changes in Lipid Profile at 3 and 6 months sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PGIMER city: Chandigarh state: Punjab zip: 160012 country: India name: ASHU RASTOGI, MD,DM role: CONTACT phone: 9781001046 phoneExt: 91 email: rastogi.ashu@pgi.ac.in lat: 30.73629 lon: 76.7884 hasResults: False

 nctId: NCT06373510 id: ELCAV briefTitle: Longitudinal Evaluation of Antibody Kinetics of Vaccinated Patients With Non-mandatory Vaccine Following Administration of a Non-public Marketed Vaccine in the General Population, Real-life Study acronym: ELCAV overallStatus: NOT_YET_RECRUITING date: 2024-06-20 date: 2027-04-03 date: 2027-04-03 date: 2024-04-18 date: 2024-04-18 name: CerbaXpert class: OTHER briefSummary: The study would make it possible to document more explicitly the evolution of antibody titers at following a non-public vaccination over a large post-vaccination period in the French population .

Analysis of real-life data would enhance knowledge of vaccine response kinetics It would be useful to identify possible early declines requiring doses Similarly, by analyzing antibody kinetics by age, sex, and vaccination status, the would be possible to determine whether there are differences in the immune response between these different sub-groups. In addition, it would provide additional information to assess the real impact of these non-public vaccines in public health and guide vaccine policies. conditions: Vaccination Reaction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 10000 type: ESTIMATED name: Blood collection measure: Quantification of specific serum antibodies (IgM, IgG) at different times before and/or after vaccination by a reference technique such as ELISA. sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06373497 id: IIT2023-08-ATKINS-ATHERO-RT briefTitle: Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-04 date: 2026-04 date: 2024-04-18 date: 2024-04-18 name: Katelyn Atkins class: OTHER briefSummary: The prospective single-arm pilot study, ATHERO-RT: Real-Time Atherosclerosis Activity after Thoracic Radiotherapy using Sodium Fluoride Positron Emission Tomography, will aim to:

1. To deploy first-in-kind application of fluorine 18-sodium fluoride (18F-NaF) PET (Positron Emission Tomography) /MRI (Magnetic Resonance Imaging) imaging to detect real-time atherosclerosis activity at the time of cancer diagnosis and after cardiac radiation exposure
2. To detect longitudinal changes in clonal hematopoiesis (CH) genetic architecture following thoracic RT (Radiation Therapy) in patients at high risk of cardiac dysfunction, and
3. To measure perturbations in the immune-modulatory and metabolic states following thoracic RT (Radiation Therapy) exposure in patients at high risk of cardiac dysfunction.

Eligible patients will be adults (≥18 years old) with Stage II-III or oligo-metastatic stage IV malignancy (any histology) at high risk for RT-associated cardiac toxicity (defined as receiving ≥30 Gy (Gray) RT where the heart is in the treatment field54). The study will enroll a total of 10 subjects, recruited from Cedars-Sinai Medical Center. The primary endpoint will be successful completion of 18F-NaF PET imaging at the baseline and 6-month post-RT time points. Blood will be collected at baseline, end of RT, and 6-months post-RT. conditions: Oligometastatic Disease studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: 18-F-NaF Cardiac PET/MRI and name: CT Angiogram measure: Feasibility of using F-NaF PET/MRI imaging measure: To measure changes in standard uptake value (SUV) measure: To measure changes in coronary microcalcification activity (CMA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cedars Sinai Medical Center city: Los Angeles state: California zip: 90048 country: United States name: Clinical Trial Recruitment Navigator role: CONTACT phone: 310-423-2133 email: cancer.trial.info@cshs.org name: Katelyn Atkins, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Alan Kwan, MD, MS role: SUB_INVESTIGATOR name: Louise Thomson, MD role: SUB_INVESTIGATOR name: Andriana Nikolova, MD, PhD role: SUB_INVESTIGATOR name: Anja Karlstaedt, MD, Phd role: SUB_INVESTIGATOR name: Eric Vail, MD role: SUB_INVESTIGATOR name: Celeste Eno, PhD role: SUB_INVESTIGATOR name: Stephen Shiao, MD, PhD role: SUB_INVESTIGATOR name: Elizabeth McKenzie, PhD role: SUB_INVESTIGATOR lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06373484 id: 018-2022 briefTitle: Matching Assessment and Treatment for Children With Disruptive Behaviour and Their Parents acronym: MATCH-DB overallStatus: RECRUITING date: 2022-10-01 date: 2026-09 date: 2027-09 date: 2024-04-18 date: 2024-04-18 name: Centre for Addiction and Mental Health class: OTHER briefSummary: This study will develop and test whether personalized profiles of children with Disruptive Behaviour Disorder (DBD) and their parents based on important psychological, emotional, and neuropsychological indicators predict their response to child cognitive behavioral treatment and Behavioral Parent Training. conditions: Disruptive Behavior Disorder conditions: Emotional Disorder conditions: Behavioural Disorder conditions: Attention Deficit Hyperactivity Disorder conditions: Conduct Disorder conditions: Oppositional Defiant Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Behavioral Parent Training measure: Changes in parenting skills between baseline, post-treatment, and follow-up (6 months - 1 year) measure: Changes in parenting competencies between baseline, post-treatment, and follow-up (6 months - 1 year) measure: Changes in child emotional and behavioral problems between baseline, post-treatment, and follow-up (6 months - 1 year) sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Centre for Addiction and Mental Health status: RECRUITING city: Toronto state: Ontario zip: M6J 1H4 country: Canada name: Brendan F. Andrade, PhD role: CONTACT phone: 416-535-8501 phoneExt: 33642 email: brendan.andrade@camh.ca lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06373471 id: S-20230101 briefTitle: Improving Quality of Life in Older Patients With Frailty and Hematological Cancer Through Geriatric Assessment acronym: IMPROVE overallStatus: RECRUITING date: 2024-04-02 date: 2026-03-31 date: 2026-09-30 date: 2024-04-18 date: 2024-04-18 name: Odense University Hospital class: OTHER name: Velux Fonden name: Danish Cancer Research Foundation name: The Dagmar Marshall Foundation briefSummary: The Improve study is a randomized controlled trial investigating the efficacy of adding comprehensive geriatric assessment and treatment to standard of care compared with standard of care in older, frail patients with hematological cancer. The investigators aim to recruit 152 study participants who will be randomized 1:1 to intervention- or control group. Study participants in the intervention group will receive the intervention comprehensive geriatric assessment and treatment integrated in the cancer treatment. Study participants in the control group will receive cancer treatment and evaluation of comorbidity and frailty as is usual standard at Department of Hematology. Primary endpoint is elderly functional Index at 12 weeks. conditions: Hematologic Malignancy conditions: Treatment Adherence conditions: Treatment Complication conditions: Frailty conditions: Quality of Life studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 152 type: ESTIMATED name: Comprehensive geriatric assessment (CGA) and treatment measure: Elderly functional Index measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Elderly14 (EORTC QLQ-Eld14). measure: Handgrip strength measure: 30-second chair stand test measure: Treatment toxicity measure: Adherence to hematological cancer treatment measure: Polypharmacy yes/no measure: Unplanned hospital admissions measure: Overall and cancer specific survival sex: ALL minimumAge: 70 Years stdAges: OLDER_ADULT facility: Odense University Hospital status: RECRUITING city: Odense C zip: 5000 country: Denmark name: Nina Andersen, M.D. role: CONTACT phone: +4540437488 email: nina.andersen@rsyd.dk lat: 55.39594 lon: 10.38831 hasResults: False

 nctId: NCT06373458 id: STUDY-23-01508 briefTitle: Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy overallStatus: RECRUITING date: 2024-04-15 date: 2026-03 date: 2026-05 date: 2024-04-18 date: 2024-04-18 name: Icahn School of Medicine at Mount Sinai class: OTHER name: Pfizer briefSummary: Keloids are common, benign cutaneous overgrowths that manifest clinically as raised, hypertrophic, often hyperpigmented lesions which are formed in response to dermal injury or idiopathic stimuli. Although keloids are a common disease, it's exact incidence and prevalence is not known. Despite the debilitating nature of keloids, current treatment modalities are limited in efficacy; there is no universally effective therapy available to patients. The research team hypothesize that ritlecitinib as a JAK3/TEC inhibitor will be able to reverse both the systemic and local keloid disease process by re-establishing immune homeostasis. conditions: Keloid studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Ritlecitinib measure: Recurrence Rate measure: Change in Detroid Keloid Scale Score measure: Change in Peak keloid tension measure: Change in Detroid Keloid Scale Score (DKS) measure: Change in Pain Numerical Rating Scale (Pain-NRS) measure: Change in Itch-NRS measure: Change in PGIC (Patient Global Impression of Change) measure: Change in DLQI (Dermatology Life Quality Index) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT 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 email: giselle.singer@mssm.edu name: Sharlene Martin role: CONTACT phone: 212-241-3288 name: Emma Guttman role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06373445 id: 36264PR596 briefTitle: Interventional Neuromodulation in Fibromyalgia overallStatus: RECRUITING date: 2022-11-01 date: 2023-09-01 date: 2024-04-15 date: 2024-04-18 date: 2024-04-18 name: Tanta University class: OTHER briefSummary: This study was conducted on 40 eligible fibromyalgia patients with sleep disorders. They were randomized to have 20 sessions of active or sham rTMS (1 Hz, 120% of resting motor threshold with total 1200 pules /session) over the right dorsolateral prefrontal area (DLPFC) for 5 sessions/week for 4 weeks. All participants were subjected to baseline evaluation with Fibromyalgia Impact Questionnaire, polysomnography, sleep quality and sleep characteristics assessment using the Pittsburgh Sleep Quality Index and The Medical Outcomes Study Sleep Scale respectively.FM patients were reevaluated at 1, 3 months after the end of rTMS sessions. conditions: Neuromodulation and Sleep Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: participants randomly allocated to either no, one, some or all interventions simultaneously primaryPurpose: TREATMENT masking: SINGLE whoMasked: CARE_PROVIDER count: 60 type: ESTIMATED name: repetitive transcranial magnetic stimulation active stimulation name: repetitive transcranial magnetic stimulation sham stimulation measure: Pittsburgh Sleep Quality Index (PSQI) measure: The Medical Outcomes Study Sleep Scale (MOS ) measure: polysomnography measure: Pittsburgh Sleep Quality Index (PSQI) measure: The Medical Outcomes Study Sleep Scale (MOS) measure: polysomnography sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of medicine status: RECRUITING city: Tanta state: ElGharbia zip: 6620010 country: Egypt name: Marwa Y Badr role: CONTACT phone: 01003639125 phoneExt: Tanta email: drmoroneuro@yahoo.com lat: 30.78847 lon: 31.00192 hasResults: False

 nctId: NCT06373432 id: STUDY-22-01607 briefTitle: Frequency of Glucose Monitoring in Labor overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-11-26 date: 2024-11-26 date: 2024-04-18 date: 2024-04-18 name: Icahn School of Medicine at Mount Sinai class: OTHER briefSummary: The aim of this study is to assess rates of neonatal hypoglycemia with differing intrapartum glucose protocols. Currently at this time there is no guidance from professional medical organizations about when and how frequent to assess maternal glucose levels intrapartum. Several institutions have no protocols in place. The study will be a randomized controlled trial placing patients with Gestational Diabetes Mellitus (GDM) in "frequent" vs "infrequent" glucose monitoring intrapartum and assessing neonatal glucose levels at birth. conditions: Neonatal Hypoglycemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 160 type: ESTIMATED name: Fingerstick measure: Neonatal Hypoglycemia sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mount Sinai West Hospital city: New York state: New York zip: 10019 country: United States lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06373419 id: RP-1007 briefTitle: TFL vs MOSES Holmium Laser in the En-bloc Resection of Bladder Tumors overallStatus: RECRUITING date: 2023-10-16 date: 2025-10 date: 2026-10 date: 2024-04-18 date: 2024-04-18 name: Thunder Bay Regional Health Research Institute class: OTHER briefSummary: The goal of this randomized clinical trial is to determine if there is difference in pathological and clinical outcomes between MOSES and TFL in the transurethral laser enucleation of bladder tumors.

The main question it aims to answer is:

Is there a difference in pathological and clinical outcomes between MOSES Holmium and Thulium Fiber Laser (TFL) in the transurethral laser enucleation of bladder tumors?

Participants will randomized to either TFL of MOSES arm for their bladder resection procedure. conditions: Urolithiasis of Bladder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: TFL name: MOSES holmium laser measure: Presence of muscularis propria measure: Incidence of inconclusive pathology measure: Tumor-free rate (TFR) measure: Total operative time measure: Total procedural time measure: Number of recurrences measure: Total blood loss measure: Rate of complications measure: Number of inconclusive pathology measure: Lasing time measure: Total energy used measure: Frequency and severity of peri-operative complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Thunder Bay Regional Health Sciences Centre status: RECRUITING city: Thunder Bay state: Ontario zip: P7B 6V4 country: Canada name: Rabail Siddiqui role: CONTACT phone: (807) 684-6000 email: rabail.siddiqui@tbh.net name: Hazem Elmansy role: SUB_INVESTIGATOR lat: 48.38202 lon: -89.25018 hasResults: False

 nctId: NCT06373406 id: MHB036C-CP001CN briefTitle: A Study of MHB036C for Advanced Solid Tumor overallStatus: RECRUITING date: 2023-05-18 date: 2024-08 date: 2024-12 date: 2024-04-18 date: 2024-04-22 name: Minghui Pharmaceutical (Hangzhou) Ltd class: INDUSTRY briefSummary: Phase I/II, dose escalation and dose expansion study to evaluate the efficacy and safety of MHB036C in advanced malignant tumors. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: MHB036C measure: Incidence of participants with adverse events (AE) measure: Number of participants with dose-limiting toxicity (DLT) measure: Maximum Plasma Concentration (Cmax) measure: The area under the plasma concentration-time curve (AUC) 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 status: RECRUITING city: 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: NCT06373393 id: 1 briefTitle: SPIRIT: Study of the Patency of Spinal aRteries After the STABILISE Technique acronym: SPIRIT overallStatus: ENROLLING_BY_INVITATION date: 2024-04-16 date: 2024-07-31 date: 2024-12-31 date: 2024-04-18 date: 2024-04-22 name: Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA class: OTHER name: Cardiovascular Center of the University of Lisbon name: Unidade Local de Saúde Santa Maria briefSummary: The aim of the study is to evaluate the impact of the stent-assisted balloon-induced intimal disruption and relamination in aortic dissection repair (STABILISE) technique in the patency of intercostal and lumbar arteries detectable on computed tomography angiography (CTA) in patients with type B aortic dissection and its correlation with the occurrence of spinal cord ischaemia (SCI).

Primary end-point: patency of the intercostal and lumbar arteries on follow-up CTA.

Secondary end-point: spinal cord ischaemia conditions: Aortic Dissection conditions: Spinal Cord Ischemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 50 type: ESTIMATED name: STABILISE measure: number of patent intercostal and lumbar arteries measure: number of patients with spinal cord ischemia sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Unidade Local de Saúde Santa Maria city: Lisbon zip: 1500 country: Portugal lat: 38.71667 lon: -9.13333 hasResults: False

 nctId: NCT06373380 id: 23-293 briefTitle: A Study of HB-202/HB-201 in People With Human Papilloma Virus 16-Positive Head and Neck Squamous Cell Cancer (HPV 16+ HNSCC) overallStatus: RECRUITING date: 2024-04-15 date: 2027-04 date: 2027-04 date: 2024-04-18 date: 2024-04-18 name: Memorial Sloan Kettering Cancer Center class: OTHER name: Hookipa Biotech GmbH name: Naveris briefSummary: The researchers are doing this study to find out if HB-202/HB-201 is an effective treatment for people with HPV 16-positive head and neck squamous cell cancer (HPV 16+ HNSCC) who have received standard treatment for their disease but then tested positive for HPV 16-related tumor DNA in the blood through a test called NavDx. Participants will have no evidence of cancer on imaging scans (radiographically) or by medical examination (clinically). Past studies have shown that a positive NavDx test strongly suggests the possible presence of microscopic cancer, though we do not know if testing positive will definitely lead to the cancer coming back (recurrence). The NavDx blood test has not been approved by the FDA and is considered investigational. conditions: HPV16+ Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This will be a randomized multi-centered, double-blind, placebo-controlled trial primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The study will be conducted using a double-blind design. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 51 type: ESTIMATED name: HB-200 name: Placebo measure: Disease free survival (DFS) measure: Number of participants with adverse events (type, frequency, severity). sex: ALL 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: Winston Wong, MD role: CONTACT phone: 646-608-4245 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: Winston Wong, MD role: CONTACT phone: 646-608-4245 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: Winston Wong, MD role: CONTACT phone: 646-608-4245 lat: 41.04676 lon: -74.02292 facility: Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) status: RECRUITING city: Commack state: New York zip: 11725 country: United States name: Winston Wong, MD role: CONTACT phone: 646-608-4245 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: Winston Wong, MD role: CONTACT phone: 646-608-4245 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: Winston Wong, MD role: CONTACT phone: 646-608-4245 lat: 40.71427 lon: -74.00597 facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities) status: RECRUITING city: Uniondale state: New York zip: 11553 country: United States name: Winston Wong, MD role: CONTACT phone: 646-608-4245 lat: 40.70038 lon: -73.59291 hasResults: False

 nctId: NCT06373367 id: 461-24 briefTitle: Preeclampsia Educational Program Study (PrEPS) acronym: PrEPS overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-11-01 date: 2024-11-01 date: 2024-04-18 date: 2024-04-18 name: MemorialCare Health System class: OTHER briefSummary: Preeclampsia complicates approximately 8% of all pregnancies. A critical factor of outpatient monitoring is patient education; specifically, education regarding nature of the disease, ongoing short- and long-term risks, and warning signs and symptoms for worsening of disease. This study aims to compare patient knowledge using a novel illustration based app compared to standard discharge instructions. conditions: Preeclampsia conditions: Preeclampsia Severe conditions: Preeclampsia Mild conditions: Preeclampsia Postpartum studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 36 type: ESTIMATED name: Illustration based application name: Text based application measure: Preeclampsia knowledge score - short measure: Preeclampsia knowledge score - long measure: GAD-7 score measure: 72 hour BP check measure: Postpartum visit measure: Daily BP recordings measure: Accessed material measure: Unplanned readmission sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06373354 id: 2023-0924 id: NCI-2024-03341 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Comparison of Conspicuity of Masses and Architectural Distortions Between Wide- and Narrow-angle Digital Breast Tomosynthesis Systems overallStatus: NOT_YET_RECRUITING date: 2024-09-30 date: 2025-12-31 date: 2027-12-31 date: 2024-04-18 date: 2024-04-18 name: M.D. Anderson Cancer Center class: OTHER name: Siemens Medical Solutions briefSummary: To compare narrow-angle digital breast tomosynthesis (DBT) and wide-angle DBT. conditions: Architectural Distortions conditions: Breast Tomosynthesis studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Digital Breast Tomosynthesis (DBT) measure: Safety and adverse events (AEs) sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Tanya Moseley, MD role: CONTACT phone: 713-792-5755 email: tstephens@mdanderson.org name: Tanya Moseley, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06373341 id: NL85317.099.23 briefTitle: Hand and Arm Rehabilitation Using VR acronym: HANDQUEST overallStatus: RECRUITING date: 2024-01-15 date: 2026-01 date: 2027-01 date: 2024-04-18 date: 2024-04-18 name: Medical Centre Leeuwarden class: OTHER briefSummary: Patients admitted to the ICU due to critical illness often experience physical, mental, cognitive, or social issues. Research indicates that inadequate physical recovery is associated with lower handgrip strength, and hand function in ICU patients is lower compared to healthy individuals. To address this, a Virtual Reality (VR) exergame was developed to aid rehabilitation. This study aims to investigate the effect of a 4-week VR-exergame intervention on handgrip strength, hand and arm functionality, balance, mobility, and support needs in ICU patients staying for 48 hours or longer. It is a multicenter mixed-methods randomized controlled trial involving adult ICU patients. The intervention involves a 4-week VR-exergame program. Main study parameters include handgrip strength, hand and arm functionality, range of motion, balance, mobility, and support needs. The burden and risks associated with participation are minimal, as VR-based exercises are deemed safe and voluntary. Overall, the study aims to assess the effect of incorporating VR-based rehabilitation into standard care for ICU patients. conditions: Post-Intensive Care Syndrome conditions: ICU Acquired Weakness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 108 type: ESTIMATED name: VR training for arm and hand rehabilitation measure: Handgrip strength measure: Handgrip strength measure: Arm and hand functionality measure: Arm and hand functionality measure: Arm and hand range of motion measure: Balance and mobility measure: Support need and experience with VR training sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dept of intensive care, Medical Centre Leeuwarden status: RECRUITING city: Leeuwarden state: Friesland zip: 8901 BR country: Netherlands name: Lise Beumeler, PhD role: CONTACT phone: (058) 286 6738 email: lise.beumeler@mcl.nl name: Lise Beumeler, PhD role: PRINCIPAL_INVESTIGATOR name: Carina Bethlehem, MD role: PRINCIPAL_INVESTIGATOR lat: 53.20139 lon: 5.80859 hasResults: False

 nctId: NCT06373328 id: STUDY00006081 briefTitle: Post Pandemic Pneumococcal Carriage Among Children and Adults overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-09 date: 2026-03 date: 2024-04-18 date: 2024-04-18 name: University of Central Florida class: OTHER name: Merck Sharp & Dohme Corporation briefSummary: The PI propose to conduct a genomic epidemiology study of pneumococcal carriage among children and adults in a large metropolitan city. These data will allow PI to assess the post-pandemic population structure, investigate the phylogenetic relationship between isolates from children and adults, and compare pneumococcal populations across diverse geographic areas. conditions: Pneumococcal Carriage studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 900 type: ESTIMATED measure: Pneumococcal carriage prevalence and distribution of serotypes among children and adults calculated from the results of S. pneumoniae isolation using qPCR. measure: Phylogenetic relationship of pneumococcal isolates collected among child and adult populations using whole-genome sequencing libraries. measure: Putative transmission networks between children and adult populations from online questionnaires. sex: ALL minimumAge: 7 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06373315 id: 2023/11-18 briefTitle: The Effect of Smartphone and Hand Anthropometry on Pain and Upper Extremity Functions overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2024-06-30 date: 2025-05-02 date: 2024-04-18 date: 2024-04-18 name: Nigde Omer Halisdemir University class: OTHER briefSummary: Mobile phones have different uses in different disciplines, and this encourages long-term use. For optimum comfort use, it is important to ensure users' awareness when purchasing mobile phones that match their hand sizes. The number of studies in the literature on this subject is limited. In this context, the aim of our study is to investigate the relationship between smartphone and hand anthropometry measurements and upper extremity pain and functions. conditions: Upper Extremity Problem conditions: Smartphone Addiction studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 90 type: ESTIMATED measure: Hand anthropometric measurements: Hand length measure: Hand anthropometric measurements: Palm length measure: Hand anthropometric measurements: Width of the hand (Metacarpal) measure: Hand anthropometric measurements: Maximum hand spread measurement measure: Gross grip strength measurement measure: Pinch grip strength measure: Measurement of phone dimensions measure: Upper extremity functional status assessment measure: Pain assessment measure: Smartphone addiction sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nigde Omer Halisdemir University, Bor Faculty of Health Sciences city: Niğde state: Nigde zip: 51700 country: Turkey name: Feyza Altindal Karabulut, Assoc. Prof. role: CONTACT phone: +905056263833 email: fztfyz@gmail.com lat: 37.96583 lon: 34.67935 hasResults: False

 nctId: NCT06373302 id: IRAS 323948 briefTitle: Peripheral Arterial Disease Biomarkers acronym: PADBIRD overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2026-12-31 date: 2024-04-18 date: 2024-04-18 name: Norfolk and Norwich University Hospitals NHS Foundation Trust class: OTHER briefSummary: The study aims to determine how expression levels of biomarkers for peripheral arterial disease change over time in response to exercise therapy, surgical or endovascular intervention, and whether they can be used to predict disease progression. conditions: Peripheral Arterial Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 100 type: ESTIMATED measure: Correlation between PAD biomarker levels and walking distance. measure: Change in PAD biomarker levels following exercise therapy. measure: Change in PAD biomarker levels following endovascular intervention measure: To determine whether biomarker levels normalise with improved walking distance. measure: To determine whether biomarker levels can be used as a predictor of restenosis, occlusion or reintervention following endovascular intervention. measure: Levels of biomarkers and (Major Adverse Cardiovascular Events). sex: ALL minimumAge: 50 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06373289 id: 000539476 id: 1K23HD113837-01A1 type: OTHER domain: NICHD (pending) briefTitle: Target Oxygen Ranges in Infants With Pulmonary Hypertension acronym: TORPH overallStatus: NOT_YET_RECRUITING date: 2025-07-01 date: 2029-07-01 date: 2030-07-01 date: 2024-04-18 date: 2024-04-18 name: University of Alabama at Birmingham class: OTHER briefSummary: Around 50% of infants born extremely preterm develop a chronic lung disease known as bronchopulmonary dysplasia of which some infants will also develop pulmonary hypertension of which 50% of children will die before the age of 2. Physicians are currently limited in their ability to select the most appropriate oxygen targets that will improve outcomes in infants with this condition. This clinical trial will determine whether using different amounts of oxygen improve outcomes in infants with this disease. conditions: Bronchopulmonary Dysplasia conditions: Pulmonary Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Single center, randomized cross-over pilot study with a 1:1 parallel allocation of infants to SpO2 targets of 92-95% (control) and 95-98% (intervention) using a stratified permuted block design. Following 2 weeks of exposure A, infants will cross over to exposure B for 2 weeks with a 1-week washout period. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The PI will perform bedside echocardiography precluding masking to group allocation. All echocardiograms will be further reviewed by a cardiologist masked to group allocation with additional cardiologist review in instances of disagreement. Inter-rater reliability testing will also be performed. whoMasked: OUTCOMES_ASSESSOR count: 39 type: ESTIMATED name: higher oxygen saturation target using Nellcor pulse oximetry sensors name: lower oxygen saturation target using Nellcor pulse oximetry sensors measure: Intermittent hypoxemia event duration measure: Echocardiographic shunting measure: Echocardiographic interventricular septal flattening measure: Echocardiographic tricuspid regurgitation measure: Intermittent hypoxemia frequency measure: Cumulative hypoxemia measure: Brain natriuretic peptide sex: ALL minimumAge: 2 Months maximumAge: 5 Months stdAges: CHILD hasResults: False

 nctId: NCT06373276 id: 1511 briefTitle: The Effects of a Home-Based Fall Prevention Program on Community-Dwelling Elderly's Fall Risk Category overallStatus: RECRUITING date: 2024-01-15 date: 2024-04 date: 2024-05 date: 2024-04-18 date: 2024-04-18 name: Dilshaad Basrai Vad class: OTHER briefSummary: The primary goal of this dissertation study is to determine if a home-based multiplanar balance training program with electronic assistance, will be effective in reducing one's fall risk category.

Hypothesis: After 12 weeks, there will be a statistically significant decrease in the fall risk category for individuals in a home-based multiplanar balance training and educational program with electronic assistance as compared to no change in the fall risk category for individuals in an educational control group with electronic assistance Hypothesis: To determine if an individual's fear of falling is lower following a home-based multiplanar balance training and educational program, with electronic assistance as compared to no change in fear of falling following an educational control group with electronic assistance post-intervention.

Hypothesis: An individual's quality of life will improve following a home-based multiplanar balance training and educational program, with electronic assistance as compared to no change in the quality of life following an educational control group with electronic assistance post-intervention.

Hypothesis: Adherence and feasibility will be greater with a home-based multiplanar balance training program, with electronic assistance as compared to a control group with electronic assistance.

Hypothesis: There will be a statistically significant inverse relationship between an individual's fear of falling and their fall risk category. conditions: Fall Risk studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants in the multiplanar balance training home-based exercise and educational group (group A) will have a video, as well as written instructions, of the intervention and dosage, along with the five educational brochures loaded on their phone via the SAFE beta app. In the SAFE beta app, the participants will be prompted daily to click on the beta app to watch the demonstration of the interventional exercise. They are then prompted to begin their daily prescriptive intervention, which is a 7-day-a-week program for 12 weeks. Participants can view a video of the exercise intervention in real-time in order to "mirror" the exercises as they are completing the exercises. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The primary investigator, who delivers the treatment, is blinded to to the performance outcome measures. whoMasked: INVESTIGATOR count: 70 type: ESTIMATED name: multiplanar balance training exercise with education name: education only measure: Timed up and Go Test measured in Seconds measure: 3 stage balance test measured in seconds measure: 30-second chair stand measured in repeitions sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Metro PT status: RECRUITING city: New York state: New York zip: 10021 country: United States name: dilshaad vad, DPT role: CONTACT phone: 917-478-2444 email: dilshaad.vad@gmail.com name: Lior Cohen, DPT role: CONTACT phone: 9175549511 lat: 40.71427 lon: -74.00597 hasResults: False

 nctId: NCT06373263 id: 2024-4165 briefTitle: Evaluating Tools to Communicate Scleroderma Research Results to Patients acronym: SPIN-KT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-06 date: 2024-06 date: 2024-04-18 date: 2024-04-18 name: Lady Davis Institute class: OTHER briefSummary: Sharing research results with patients is required by ethical regulations. Yet, most researchers do not share results from their studies with patients. The investigators plan to conduct a series of randomized controlled trials among people with scleroderma, a rare autoimmune disease, in a large international cohort, to identify the most effective methods for communicating study results with patients.

The first trial in the series will compare a research dissemination tool (infographic) against a plain-language summary comparator. Participants will be randomly assigned to receive the dissemination tool or comparator. Study participants will rate communication tools for (1) information completeness; (2) understandability; and (3) ease of use of format. Our results can be used by researchers and patient organizations who disseminate research results so that they can tailor the way they disseminate results to patient needs. conditions: Scleroderma conditions: Systemic Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: OTHER masking: NONE count: 488 type: ESTIMATED name: Plain-language summary name: Dissemination Tool (Infographic) measure: Completeness measure: Understandability measure: Ease of use measure: Please to have received results measure: Intention to participate in future studies measure: Open-ended items sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06373250 id: sdilek7 briefTitle: Maternal Consequences of Membrane Stripping overallStatus: RECRUITING date: 2024-04-11 date: 2024-10-11 date: 2024-11-11 date: 2024-04-18 date: 2024-04-18 name: Kocaeli University class: OTHER briefSummary: This study aims to investigate the maternal effects of membrane stripping during vaginal birth. This study was designed as an experimental case-control study. The sample size in the study was determined by Njoku et al in 2023 to assess the effectiveness of membrane stripping applied to participants who had vaginal birth in reducing the incidence of prolonged pregnancy. Calculated based on the study conducted by. The sample size of the study was calculated using G\*Power 3.1.9.2, and the mean and standard deviation of the Bishop score in the relevant article were used to calculate the effect size. Using the mean and standard deviation of the relevant article, the blended effect size was calculated as 0.596. The minimum number of individuals that should be included in the sample of this research was calculated using G\*Power 3.1.9.2, effect size: 0.596, α= 0.05, power: 0.95 (stripping = 70, control = 70) and at least in each group in the sample size. The sample size was set at 70 participants. The research data will be collected by the researcher using the Informed Volunteer Consent Form, Participant Information Form, Bishop Scoring, Visual Analogue Scale, and Birth Satisfaction Scale Short Form, which were created by the researcher within the framework of the literature on the subject. conditions: Maternal Care for Other Abnormalities of Cervix studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 140 type: ESTIMATED name: Membrane stripping group name: Control group measure: Visual analogue scale evaluation of vaginal examination pain measure: Visual analogue scale evaluation of vaginal examination pain measure: Evaluation of the cervix with Bishop score measure: Evaluation of the amount of bleeding measure: Birth Satisfaction Scale Short Form sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Kocaeli University status: RECRUITING city: Kocaeli zip: 41380 country: Turkey name: Burcu Ozturk, M.Sc. role: CONTACT email: 1burcuozturk@gmail.com lat: 39.62497 lon: 27.51145 hasResults: False

 nctId: NCT06373237 id: INC-IG-2024-001 briefTitle: Outcome of Embryos Transferred After Initial Chaotic Results on PGT-A overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-26 date: 2024-05 date: 2026-05 date: 2024-04-18 date: 2024-04-18 name: Inception Fertility, LLC class: INDUSTRY name: Igenomix briefSummary: This is a retrospective review of treatment outcomes from fertility clinics in The Prelude Network who have used Igenomix for PGT-A and have transferred embryos with initial chaotic results, regardless if re-biopsy was performed. conditions: Infertility studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2000 type: ESTIMATED measure: Frequency of embryo re-biopsy measure: Re-biopsy results measure: Embryo disposition measure: Embryo transfer outcome measure: Pregnancy outcome sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Inception Fertility LLC city: Houston state: Texas zip: 77081 country: United States lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06373224 id: 23-037 briefTitle: Cold Saline Irrigation Before Endobronchial Biopsy overallStatus: RECRUITING date: 2023-12-01 date: 2024-12-02 date: 2025-02-02 date: 2024-04-18 date: 2024-04-22 name: TriHealth Inc. class: OTHER briefSummary: Patients undergoing an endobronchial ultrasound and biopsy can experience bleeding during the biopsy. These biopsies are read in real time by pathologists who travel to the endoscopy unit during the procedure. Often, when this happens, the blood contaminates the pathology slides making the slide unreadable. This then requires more biopsies to be performed, thus prolonging the procedure, and increasing anesthesia time. One innovative way to reduce bleeding may be to irrigate the bronchial wall with cold saline, where the biopsy is to be taken, immediately before biopsy, thus causing vasoconstriction and possibly resulting in less blood contamination on the biopsy slides. The current study will evaluate this prophylactic irrigation with saline to control bleeding, thus resulting in a quicker diagnostic result of the biopsies. conditions: Lung Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 120 type: ESTIMATED name: Flush measure: Incidence of unreadable biopsy slides sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bethesda North Hospital status: RECRUITING city: Cincinnati state: Ohio zip: 45242 country: United States name: Rachel Baker, PhD, RN role: CONTACT phone: 513-569-6191 email: Rachel_Baker2@trihealth.com lat: 39.12713 lon: -84.51435 hasResults: False

 nctId: NCT06373211 id: APHP230701 id: 2023-506942-22-01 type: OTHER domain: CTIS briefTitle: Early Immunotherapy With Intravenous Immunoglobulin, Cyclophosphamide and Methylprednisolone in Patients With Anti-Hu-associated Paraneoplastic Sensory Neuronopathy acronym: NESPA overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-06 date: 2027-06 date: 2024-04-18 date: 2024-04-18 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Paraneoplastic Neurological Syndromes are rare autoimmune complications linked to the presence of systemic cancer. Despite their autoimmune origin, they have historically shown little response to immunotherapy. The reason for this failure is probably related to too late administration of immunotherapy, at a stage where the inflammation has already disappeared and irreversible neuronal loss has occurred. The protocol focuses on patients with anti-Hu antibody sensory neuronopathy. This single arm trial consists of an early immunotherapy combining Intravenous Immunoglobulin (IVIG) for 3 months, cyclophosphamide and methylprednisolone for 6 months, at the rate of 1 cycle per month. The percentage of patients with clinical improvement will be evaluated (ONLS) at 3 months. The tolerance of the treatment will also be evaluated as well as other functional scales at 3 and 6 months. conditions: Paraneoplastic Sensory Neuronopathy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 21 type: ESTIMATED name: Immunoglobulins IV (CLAYRIG) name: Cyclophosphamide IV name: Methylprednisolone IV measure: Percentage of patients with clinical improvement on the ONLS (Overall Neuropathy Limitations Scale) at 3 months measure: Percentage of patients with clinical improvement on the ONLS (Overall Neuropathy Limitations Scale) at 3 and 6 months measure: Percentage of patients with improvement in the ataxic component on the Score of Ataxia scale at 3 and 6 months measure: Percentage of patients with improvement in neuropathic pain on the Numeric Rating Scale (NRS) at 3 and 6 months measure: Percentage of patients with functional improvement on the modified Rankin Score (mRS) at 3 and 6 months measure: Percentage of patients with functional improvement on the Barthel Index (BI) at 3 and 6 months measure: Percentage of patients alive and without tumor progression at 6 months measure: Tolerance to treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Pitié-Salpêtrière city: Paris zip: 75013 country: France name: Dimitri Psimaras, MD role: CONTACT email: dimitri.psimaras@aphp.fr name: Alice LEPRINCE-LAURENGE, MD role: CONTACT email: alice.laurenge@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06373198 id: 0040/2023-versión 1.0 briefTitle: Implementation of a Re-engagement Program for Hepatitis C Patients Lost to Follow-up in Argentina. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-01 date: 2025-01-15 date: 2024-04-18 date: 2024-04-18 name: Hospital El Cruce class: OTHER name: Gilead Sciences briefSummary: Hepatitis C virus (HCV) is a leading cause of morbidity and mortality worldwide. This infection continues to represent a major global public health concern. This is why the introduction of potent antivirals for the treatment of HCV has been one of the major breakthroughs of the current medical era.

From a public health perspective, HCV prevalence will be eliminated if the available treatment also targets those most likely to transmit the virus. Despite this scientific advance, a systematic review from the U.S. described that of the 43% of patients aware of their HCV diagnosis, only 16% started treatment. Clearly, the long-known barriers to accessing this treatment must be broken down in order to administer these effective antivirals. The World Health Organization (WHO) has set the ambitious goal of eliminating viral hepatitis as a public health threat by 2030. This goal is really difficult to achieve, especially in low and middle-income countries. Particularly in Argentina, there is a need to improve diagnosis, access to care, and treatment of viral hepatitis. The prospect of viral hepatitis elimination in our country is daunting due to the complexity of the health system and the cost of implementing different strategies. The most pragmatic approach would be to break down national elimination targets into smaller targets for individual populations, for which treatment and prevention interventions can be delivered more quickly and efficiently. This concept is known as micro-elimination. Focusing on micro-elimination of viral hepatitis means working to achieve the WHO target in specific subpopulations. Subpopulations known to have a higher prevalence of HCV infection include prisoners, people who inject drugs, and patients requiring hemodialysis, among others.

Currently, patient unawareness of HCV infection represents one of the major barriers to treatment. In many cases, the diagnosis of HCV was established many years ago and patients do not seek treatment probably because they do not recognize the urgency of treating this asymptomatic infection. It is our goal, then, to identify the group of individuals who have been diagnosed with HCV infection but are not currently undergoing regular visits with health care professionals. This strategy is now called re-linking to the medical care of patients with chronic HCV. conditions: Hepatitis C Chronic conditions: Hepatitis C studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 800 type: ESTIMATED name: standard of care measure: rate of relinked HCV patients measure: proportion of relinked patients who received antiviral treatment measure: Evaluation and characteristics of the treatment established sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06373185 id: 2023/21 briefTitle: Comparison of the Efficacy of Sacral Espb and Caudal Block for Pain Management After Urogenital Surgeries in Children acronym: SESPB overallStatus: RECRUITING date: 2024-04-22 date: 2024-05 date: 2024-06 date: 2024-04-18 date: 2024-04-23 name: Giresun University class: OTHER briefSummary: The aim of this study was to compare the efficacy of caudal block and sacral espb used as a postoperative analgesia method in urogenital pediatric surgery cases. conditions: Urogenital Diseases conditions: Nerve Block conditions: Pain, Postoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled double blind study primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Randomisation using a closed envelope method based on computer-generated random numbers was to assign patients to two equal groups. Group 1 received midline US-guided sacral erector spinae plane block and Group 2 received caudal block. The experienced anesthetist who opened the envelope performed the block according to the group code and patients were followed postoperatively by an anesthetist blinded to which block was performed. Patients were also blinded as to which block was performed. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Ultrasound-guided sacral erector spinae plane block name: Ultrasound-guided caudal block measure: Face, Leg, Activity, Cry, Consolability (FLACC) score measure: Analgesic requirement measure: Satisfaction of the patient's parents measure: Satisfaction of the surgeons sex: ALL minimumAge: 1 Year maximumAge: 7 Years stdAges: CHILD facility: Giresun Research and Training Hospital status: RECRUITING city: Gi̇resun state: Central zip: 28100 country: Turkey name: Bilge Olgun Keleş role: CONTACT phone: 05317338805 email: bilge.olgun@hotmail.com name: Dilek Yeniay role: CONTACT phone: 05375521553 email: dilekyeniay@hotmail.com lat: 40.91698 lon: 38.38741 hasResults: False

 nctId: NCT06373172 id: 202005-HR-003 briefTitle: Enhancing Clinical Reasoning Competency acronym: Reasoning overallStatus: COMPLETED date: 2020-05-01 date: 2020-06-01 date: 2023-03-01 date: 2024-04-18 date: 2024-04-18 name: Tongmyong University class: OTHER briefSummary: Enhancing Clinical Reasoning Competency for Undergraduate Nursing Students Using Virtual Simulation-based Education based on the Rasch model

Aims: Clinical reasoning is a core nursing competency that involves analyzing patient-related data and providing appropriate nursing practices. Simulation-based education is effective in improving the clinical reasoning competencies and communication skills of nursing students. This study aimed to verify the effectiveness of virtual simulation-based education. conditions: Clinical Reasoning conditions: Communication conditions: Development, Human studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This quasi-experimental study used a single-group pretest-posttest design to verify the effectiveness of virtual simulation-based education for undergraduate nursing students. primaryPurpose: OTHER masking: NONE count: 37 type: ACTUAL name: virtual simulation-based education program measure: Nurses Clinical Reasoning Scale measure: Communication Skills Scale sex: ALL minimumAge: 20 Years maximumAge: 28 Years stdAges: ADULT facility: Tongmyong Unoversity city: Busan zip: 48520 country: Korea, Republic of lat: 35.10278 lon: 129.04028 hasResults: False

 nctId: NCT06373159 id: 22643 briefTitle: An Observational Study to Learn About the Occurrence of Disseminated Intravascular Coagulation Among Adults With Sepsis in Japan overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-10 date: 2024-09-30 date: 2024-09-30 date: 2024-04-18 date: 2024-04-18 name: Bayer class: INDUSTRY briefSummary: This is an observational study in which data already collected from people with sepsis (blood poisoning) and/or disseminated intravascular coagulation (DIC) are studied.

In observational studies, only observations are made without participants receiving any advice or changes to their healthcare.

DIC is a serious blood disorder that can cause clots throughout the body, blocking blood vessels. People who have sepsis or cancer are at a higher risk of developing DIC.

To find a treatment that works well for people with DIC associated with sepsis, it is important to know about its occurrence, treatments people receive, and their outcomes. Japan is the only country that has officially approved medicines for DIC including a few newer medicines that prevent extensive blood clotting.

In this study, researchers will assess patient data from a hospital database in Japan.

The main purpose of this study is to learn more about how many adults develop DIC related to sepsis, thrombocytopenic sepsis (sudden decrease in the number of platelets in the blood), or septic shock (dangerously low blood pressure) in Japan every year.

To learn about this, researchers will collect the following information:

* The number of participants who developed DIC 14 days, 21 days and 28 days after their sepsis diagnosis
* The grading scores given to the participants which are used to assess the likelihood, cause, severity, treatment plan, and outcome of DIC (including scores called JAAM, ISTH, MHLW, and/or SOFA scores)
* The number of days between diagnosis of sepsis and the beginning of DIC

Researchers will study the data collected between June 2018 and June 2023. The data will come from TXP Medical, which collects data through the hospital health information system of 7 selected hospitals for this study across Japan.

In this study, only available data from routine care are collected. conditions: Sepsis conditions: Disseminated Intravascular Coagulation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 5740 type: ESTIMATED name: No study intervention measure: Incidence of DIC assessed at 14 days, 21 days and 28 days of the patient follow up measure: Distribution of JAAM DIC score measure: Distribution of ISTH DIC score measure: Distribution of MHLW DIC score measure: Distribution of SOFA score measure: Days from sepsis diagnosis to the onset of DIC measure: Number of participants per clinical characteristics measure: Number of participants per DIC treatment patterns in patients with sepsis-associated DIC following the onset of DIC measure: Incidence rates of clinical outcomes assessed in patients with sepsis-associated DIC measure: Cumulative incidences of clinical outcomes assessed in patients with sepsis-associated DIC measure: Number of participants per clinical characteristics in subgroup of patients who developed sepsis-associated DIC measure: Number of participants per treatment patterns in subgroup of patients who developed sepsis-associated DIC measure: Incidence rates of clinical outcomes in subgroup of patients who developed sepsis-associated DIC measure: Number of participants per clinical characteristics after the onset of DIC in patients with non-sepsis-associated DIC measure: Number of participants per treatment patterns after the onset of DIC in patients with non-sepsis-associated DIC measure: Incidence rates of clinical outcomes after the onset of DIC in patients with non-sepsis-associated DIC sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bayer city: Tokyo zip: 100-8265 country: Japan lat: 35.6895 lon: 139.69171 hasResults: False

 nctId: NCT06373146 id: 18750 id: I8F-MC-GPIV type: OTHER domain: Eli Lilly and Company briefTitle: A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2026-04 date: 2024-04-18 date: 2024-04-23 name: Eli Lilly and Company class: INDUSTRY name: Regeneron Pharmaceuticals briefSummary: The main purpose of this study is to determine if combining tirzepatide with the mibavademab will result in more weight loss in adult participants than tirzepatide alone. The study will last about 72 weeks and may include up to 19 visits. conditions: Obesity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 360 type: ESTIMATED name: Tirzepatide name: Mibavademab name: Tirzepatide-Placebo name: Mibavademab-Placebo measure: Mean Percent Change from Baseline in Body Weight measure: Mean Change from Baseline for Percent Change and Absolute Change in Body Weight (kg) measure: Mean Absolute Change from Baseline for Body Weight (kg) measure: Percentage of Participants Who Achieve ≥5% Body Weight Reduction measure: Percentage of Participants Who Achieve ≥10% Body Weight Reduction measure: Percentage of Participants Who Achieve ≥15% Body Weight Reduction measure: Percentage of Participants Who Achieve ≥20 Body Weight Reduction measure: Mean Percent Change from Randomization 2 for Body Weight measure: Mean Change from Randomization 2 for Body Weight (kg) measure: Mean Absolute Change from Randomization 2 for Body Weight (kg) measure: Change from Baseline to Week 24 in CoEQ Scores measure: Change from Baseline to Week 24 in CoEQ Scores measure: Change from Baseline in FCQ-T-r Scores measure: Change from Baseline in FCQ-T-r Scores sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Velocity Clinical Research, Gardena city: Gardena state: California zip: 90247 country: United States name: Mark T. Leibowitz role: PRINCIPAL_INVESTIGATOR lat: 33.88835 lon: -118.30896 facility: Irvine Clinical Research city: Irvine state: California zip: 92614 country: United States name: Elly R Lee role: PRINCIPAL_INVESTIGATOR lat: 33.66946 lon: -117.82311 facility: National Research Institute - Wilshire city: Los Angeles state: California zip: 90057 country: United States name: Juan Pablo Frias role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: Velocity Clinical Research, North Hollywood city: North Hollywood state: California zip: 91606 country: United States name: Samuel Penziner role: PRINCIPAL_INVESTIGATOR lat: 34.17223 lon: -118.37897 facility: Velocity Clinical Research, Panorama City city: Panorama City state: California zip: 91402 country: United States name: Maricor Grio role: PRINCIPAL_INVESTIGATOR lat: 34.22473 lon: -118.44981 facility: Velocity Clinical Research, Santa Ana city: Santa Ana state: California zip: 92704 country: United States name: Julie Vu role: PRINCIPAL_INVESTIGATOR lat: 33.74557 lon: -117.86783 facility: Diablo Clinical Research, Inc. city: Walnut Creek state: California zip: 94598 country: United States name: Bonnie S. Kimmel role: PRINCIPAL_INVESTIGATOR lat: 37.90631 lon: -122.06496 facility: Solaris Clinical Research city: Meridian state: Idaho zip: 83646 country: United States name: David J. Butuk role: PRINCIPAL_INVESTIGATOR lat: 43.61211 lon: -116.39151 facility: Tandem Clinical Research city: Marrero state: Louisiana zip: 70072 country: United States name: Adil Fatakia role: PRINCIPAL_INVESTIGATOR lat: 29.89937 lon: -90.10035 facility: Velocity Clinical Research, Metairie city: Metairie state: Louisiana zip: 70006 country: United States name: Scott P Striplin role: PRINCIPAL_INVESTIGATOR lat: 29.98409 lon: -90.15285 facility: Velocity Clinical Research, Norfolk city: Norfolk state: Nebraska zip: 68701 country: United States name: Charles Harold Harper role: PRINCIPAL_INVESTIGATOR lat: 42.02834 lon: -97.417 facility: Lillestol Research city: Fargo state: North Dakota zip: 58104 country: United States name: Michael J Lillestol role: PRINCIPAL_INVESTIGATOR lat: 46.87719 lon: -96.7898 facility: South Texas Clinical Research city: Corpus Christi state: Texas zip: 78404 country: United States name: Lloyd Stegemann role: PRINCIPAL_INVESTIGATOR lat: 27.80058 lon: -97.39638 facility: Dallas Diabetes Research Center city: Dallas state: Texas zip: 75230 country: United States name: Julio Rosenstock role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 facility: Northwest Clinical Research Center city: Bellevue state: Washington zip: 98007 country: United States name: Nazia Rahman role: PRINCIPAL_INVESTIGATOR lat: 47.61038 lon: -122.20068 facility: Centro de Investigacion en Artritis y Osteoporosis SC city: Mexicali state: Baja California zip: 21200 country: Mexico name: Francisco Fidencio Cons Molina role: PRINCIPAL_INVESTIGATOR lat: 32.62781 lon: -115.45446 facility: Clínicos Asociados BOCM city: Mexico City state: Distrito Federal zip: 03300 country: Mexico name: Israel Olvera-Alvarez role: PRINCIPAL_INVESTIGATOR lat: 19.42847 lon: -99.12766 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: Medical Care and Research SA de CV city: Merida state: Yucatán zip: 97070 country: Mexico name: Carlos Eduardo Medina role: PRINCIPAL_INVESTIGATOR lat: 20.97537 lon: -89.61696 facility: Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos city: Chihuahua zip: 31110 country: Mexico name: Luis Alejandro Nevarez role: PRINCIPAL_INVESTIGATOR lat: 28.63528 lon: -106.08889 hasResults: False

 nctId: NCT06373133 id: 2024 (82) briefTitle: SHR-8068 Combined With Adbelizumab and BP102 in the Treatment of Advanced Colorectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-11-01 date: 2026-11-01 date: 2024-04-18 date: 2024-04-18 name: West China Hospital class: OTHER briefSummary: To evaluate the efficacy and safety of SHR-8068 and Adebrelimab in Combination With Bevacizumabin in the treatment of microsatellite stable (MSS) advanced colorectal cancer. conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: SHR-8068 name: Adebrelimab name: BP102 measure: Dose-limiting toxicity measure: PFS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06373120 id: QX20231057-X-1 briefTitle: Interventional Ventricular Assist System for PCI in CHIP Patients acronym: REC-CHIPMCS overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-30 date: 2025-04-30 date: 2024-04-18 date: 2024-04-18 name: Xijing Hospital class: OTHER briefSummary: In patients with complex coronary artery disease (CAD), determining the optimal revascularization strategy (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) remains a challenge. These high-risk patients pose an extreme surgical risk. However, with the development of new interventional techniques and materials, PCI is a good alternative to CABG and is referred to as complex high-risk indicated PCI (CHIP).

During CHIP, hemodynamics can deteriorate because of temporary complete coronary occlusion or profound myocardial ischemia. This could result in loss of cardiac output and hemodynamics collapse. Mechanical support during CHIP facilitates native cardiac function by achieving a stable hemodynamic state to withstand repetitive derangements such as ischemia caused by prolonged and repeated balloon inflations, and resume original cardiac function immediately postprocedure or shortly thereafter.

There are several mechanical circulatory support (MCS) systems available, i.e., intra-aortic balloon counterpulsation (IABP), Impella, TandemHeart, and veno-arterial extracorporeal membrane oxygenation (VA-ECMO). These MCS have been widely studied in patients with acute myocardial infarction (MI) complicated by cardiogenic shock and showed conflicting results. However, studies regarding the use of MCS in the setting of CHIP are much less abundant and no randomized study has compared Impella with VA-ECMO in CHIP patients.

The aim of the study is to evaluate the effectiveness of interventional ventricular assist system (CorVad) compared to the venoarterial extracorporeal membrane oxygenation (VA-ECMO) system in providing circulatory support for complicated and high-risk patient with indications for PCI. conditions: High-Risk Percutaneous Coronary Intervention (High-risk PCI) conditions: Left Ventricular Assist Devices studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, 1:1 randomized, controlled, multicenter trial to assess effectiveness and safety of CorVad compared to VA-ECMO in complicated and high-risk patient with indications for PCI primaryPurpose: TREATMENT masking: SINGLE maskingDescription: A blinded and independent clinical event adjudication committee will adjudicate all primary and secondary outcomes whoMasked: OUTCOMES_ASSESSOR count: 262 type: ESTIMATED name: CorVad name: VA-ECMO measure: Major adverse event measure: All-cause death measure: Stroke measure: Myocardial infarction measure: Revascularization measure: Cardiovascular hospitalization measure: MCS-ARC defined type 3, 4, 5 bleeding measure: Acute kidney injury measure: Serious device-related adverse events measure: Cardiopulmonary resuscitation measure: Hospitalization time measure: Intensive care unit (ICU/CCU) stay time measure: ECMO/Corvad utilization time measure: Hemodynamic disorder measure: Transfusion rate measure: Units of transfusion measure: Device-related composite endpoint (DoCE) measure: Patient-related composite endpoint (PoCE) measure: Net adverse clinical events measure: Cardiac death measure: Ischemic stroke measure: Hemorrhagic stroke measure: Transient ischemic attack measure: Target vessel myocardial infarction measure: Target lesion revascularization measure: Target vessel revascularization measure: Clinically and physiologically driven target lesion revascularization (CPI-TLR) measure: Rehospitalization measure: MCS-ARC type 2 bleeding measure: Puncture complications measure: Aortic valve injury measure: Active Infection measure: ECMO/Corvad setup time measure: Complete revascularization rate measure: Change in left ventricular ejection fraction (LVEF) from baseline measure: Change in New York Heart Association (NYHA) classification from baseline measure: Change in Seattle Angina Questionnaire (SAQ) score from baseline measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline measure: Change in 5-level EQ-5D version (EQ-5D-5L) standardized health status scale score from baseline measure: Change in creatinine clearance rate from baseline measure: Stent thrombosis sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ling Tao status: RECRUITING city: Xi'an state: Shannxi zip: 710032 country: China name: Chao Gao, M.D., Ph.D. role: CONTACT phone: 86-18629551066 email: woshigaochao@gmail.com lat: 34.25833 lon: 108.92861 hasResults: False

 nctId: NCT06373107 id: 2117651-2 briefTitle: Investigating Effects of High-intensity Gait Training on Gait, Balance and Depression Post-stroke overallStatus: NOT_YET_RECRUITING date: 2024-04-11 date: 2025-10-30 date: 2026-01-31 date: 2024-04-18 date: 2024-04-18 name: Alvernia University class: OTHER name: Lehigh Valley Health Network briefSummary: The purpose of this research is to study the improvements from walking practice that is vigorous enough to keep participants' heart rate over a certain target level during their physical therapy sessions. The investigators want to know about improvements in participants' walking function and mental health after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect their attendance at physical therapy sessions. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: High intensity gait training measure: 3-meter backwards walk test measure: 6-minute walk test measure: 10-meter walk test measure: Surface electromyography (EMG) measure: Berg Balance Scale measure: Functional Gait Assessment measure: Borg Rating Scale of Perceived Exertion (RPE) measure: Patient Health Questionnaire (PHQ-9) measure: Rate of patient attendance (Compliance) to physical therapy measure: Newest Vital Sign measure: Multidimensional Scale of Perceived Social Support (MSPSS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lehigh Valley Health Network Outpatient Neurologic Rehab city: Allentown state: Pennsylvania zip: 18104-2310 country: United States name: Sandra M Tremblay, DPT role: CONTACT lat: 40.60843 lon: -75.49018 hasResults: False

 nctId: NCT06373094 id: DON102-CTP briefTitle: A Single Dose Escalation Study of HHT201 in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-03-31 date: 2025-03-31 date: 2024-04-18 date: 2024-04-18 name: Shanghai Synergy Pharmaceutical Sciences Co., Ltd. class: INDUSTRY briefSummary: The objective of this study is to evaluate the safety and pharmacokinetic profiles of HHT201 in healthy subjects. conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: Donepezil Dihydroxynaphthalate for Injection measure: Adverse events measure: Number of Participants With Abnormal Laboratory Values measure: Number of Participants With Abnormal ECG QT Interval measure: Number of Participants With Abnormal Vital signs measure: Number of Participants With Abnormal Physical examination measure: VAS measure: Cmax of Donepezil measure: Tmax of Donepezil measure: AUC0-t of Donepezil measure: AUC0-∞ of Donepezil measure: t1/2z of Donepezil measure: Vz/F measure: CLz/F sex: ALL minimumAge: 20 Years maximumAge: 59 Years stdAges: ADULT facility: Zhejiang Province Taizhou Hospital Luqiao Hospital (Enze Hospital) (Taizhou Hospital Phase I Center) city: Taizhou state: Zhe Jiang zip: 318000 country: China name: Donqing Lv role: CONTACT phone: 86-0576-85199816 email: lvdq@enzemed.com name: Zhanrong Ye role: CONTACT phone: 86-0576-85199816 email: Zoe.Ye@enzemed-crc.com lat: 32.49069 lon: 119.90812 hasResults: False

 nctId: NCT06373081 id: CD19-CD3E-CN-A1 briefTitle: Anti-CD19-CD3E-CAR-T Cells in Relapsed/Refractory Autoimmune Disease overallStatus: RECRUITING date: 2024-04-20 date: 2025-04-15 date: 2026-04-15 date: 2024-04-18 date: 2024-04-18 name: Shanghai Changzheng Hospital class: OTHER briefSummary: This is an investigator-initiated trial to evaluate the safety and efficacy of anti-CD19-CD3E-CAR-T cells in the relapse or refractory autoimmune diseases. conditions: Systemic Lupus Erythematosus (SLE) conditions: Sjogren's Syndrome conditions: Systemic Sclerosis conditions: Inflammatory Myopathy conditions: ANCA Associated Vasculitis conditions: Antiphospholipid Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: Anti-CD19-CD3E-CAR-T cells measure: The incidence of dose-limiting toxicities (DLTs) (Safety) measure: Proportion of patients for whom the desired dose of anti-CD19-CD3E-CAR-T cells can be successfully manufactured measure: Clinical response for relapsed/Refractory SLE measure: Clinical response for Sjögren's Syndrome measure: Clinical response for relapsed/refractory/progressive systemic sclerosis measure: Clinical response for relapsed/refractory/progressive inflammatory myopathy measure: Clinical response for relapsed/refractory anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis: measure: Clinical response for relapsed/refractory/Catastrophic Antiphospholipid Syndrome sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai ChangZheng hospital status: RECRUITING city: Shanghai zip: 200003 country: China name: Huji Xu role: CONTACT phone: 86021-81885514 email: xuhuji@smmu.edu.cn lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06373068 id: Resuscitation Orders ICU briefTitle: Association Between Resuscitation Orders and Mortality in ICU Patients overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2025-03 date: 2024-04-18 date: 2024-04-24 name: Karolinska Institutet class: OTHER briefSummary: The hypothesis of the study is that a resuscitation order other than full code is associated with increased mortality among critically ill patients. By incorporating conventional variables associated with death such as age, sex, and Simplified Acute Physiological Score, as well as including the new Clinical Frailty Scale in a statistical model, the aim is to investigate whether there is still an increased risk of death that remains unexplained. conditions: Critical Illness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1500 type: ESTIMATED name: Resuscitation orders measure: Mortality sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06373055 id: 4-2023-1232 briefTitle: Prediction of Therapeutic Response to Neoadjuvant Chemotherapy in Muscle Invasive Bladder Cancer Patients Using Spatial Transcriptomics overallStatus: RECRUITING date: 2024-05-01 date: 2033-11 date: 2033-11 date: 2024-04-18 date: 2024-04-18 name: Yonsei University class: OTHER briefSummary: Although neoadjuvant chemotherapy in muscle-invasive bladder cancer has significantly improved oncological outcomes, approximately 50% of patients do not respond to neoadjuvant chemotherapy, which has adverse effects on patients by causing treatment toxicity and surgical delays. Therefore, treatment tailored specifically to the individual patient based on the genetic and/or molecular profile of the patient is urgently needed. Among patients scheduled for neoadjuvant chemotherapy, the investigators should differentiate between patients who will be highly effective with neoadjuvant chemotherapy and those who will not, and preferentially select other treatments including radical cystectomy in the patients with high probability of failure to neoadjuvant chemotherapy. However, there is no standard which patients would benefit from neoadjuvant chemotherapy. This study plans to predict treatment response to neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer by analyzing genetic and molecular profiles of tumor tissues obtained through transurethral bladder tumor resection. conditions: Muscle-invasive Bladder Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: neoadjuvant chemotherapy followed by radical cystectomy measure: Identification of responder to neoadjuvant chemotherapy by genetic and molecular profiles measure: overall survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy measure: cancer-specific survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy measure: progression-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy measure: recurrence-free survival of bladder cancer patients who have undergone neoadjuvant chemotherapy and radical cystectomy sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Urology and Urological Science Institute, Yonsei University College of Medicine Seoul, Republic of Korea status: RECRUITING city: Seoul country: Korea, Republic of name: Won Sik Ham role: CONTACT phone: 02-2228-2310 email: uroham@yuhs.ac lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06373042 id: ADJUVANT-2 briefTitle: Tirofiban for Successful Endovascular Stroke Thrombectomy acronym: ADJUVANT-2 overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2026-07-31 date: 2026-10-31 date: 2024-04-18 date: 2024-04-18 name: Zhongming Qiu class: OTHER name: The Second Affiliated Hospital of Chongqing Medical University name: Mianyang Central Hospital name: The Second Hospital of Jiaozuo name: Chongzhou People's Hospital name: Xihua People's Hospital name: Xingguo People's Hospital briefSummary: Up to 50% of acute ischemic stroke patients with large vessel occlusion failed to achieve functional independence even after successful reperfusion therapy, a phenomenon that is referred to as "futile recanalization". The mechanism of futile recanalization is complex, and some studies have shown that it may be related to factors such as tissue no reflow, reocclusion, poor status of collateral circulation, hemorrhagic transformation, impaired cerebrovascular autonomic regulation, and low perfusion volume. Several studies suggested that maximizing the improvement of cerebral reperfusion is still the primary goal of acute large vessel occlusive stroke. Structural and functional alterations in the microvascular system may be a major obstacle to reperfusion. In animal models of cerebral ischemia, downstream microvascular thrombosis may occur in the early stage of cerebral ischemia and before vascular recanalization, which is the main factor leading to incomplete reperfusion and affecting the efficacy of endovascular thrombectomy.

Mechanical thrombectomy mainly addressed the occluded large arteries, and does not consider the distal arteries. However, the recanalization of occluded large arteries does not necessarily translate into successful reperfusion of the ischemic tissue supplied by the distal capillaries. Even with complete recanalization, impaired microcirculatory reperfusion may lead to poor clinical outcomes. Therefore, we speculate that at the end of endovascular thrombectomy, microthrombi remain present in the microcirculation of brain tissue in patients with complete or near-complete cerebral angiography, and that microthrombi is more likely to be dissolved than thrombus more proximal to the heart. Therefore, intra-arterial administration of pharmaceutical, such as tirofiban, may be the only possible option to ensure complete reperfusion of ischemic tissue. Tirofiban is a platelet glycoprotein IIb/IIIa receptor antagonist, which has been widely used in acute coronary syndrome, and its role in acute ischemic stroke has attracted more and more attention from stroke experts. Previous studies have suggested that tirofiban can further increase the incidence of successful recanalization, while reducing the reocclusion rate.

Whether early administration of intraarterial and intravenous tirofiban can further improve the clinical outcomes of patients with large vessel occlusive stroke after successful mechanical thrombectomy remains unclear. conditions: Stroke, Acute Ischemic 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: 712 type: ESTIMATED name: Intraarterial and intravenous tirofiban name: Intraarterial and intravenous placebo measure: Functional independence measure: Recanalization on follow-up CTA or MRA measure: Early neurologic improvement measure: Level of disability measure: Excellent outcome measure: Independent ambulation measure: Health-related quality of life measure: Long-term of disability level measure: Health-related quality of life (long-term) measure: Incidence of symptomatic intracranial hemorrhage (SICH) measure: Radiologic intracranial hemorrhage rate measure: Mortality measure: Incidence of non-hemorrhagic serious adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06373029 id: 2023PHB211-001(2) briefTitle: Deep-learning Enabled Ultrasound Diagnosis of Anterior Talofibular Ligament Injury overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-05-30 date: 2025-12-30 date: 2024-04-18 date: 2024-04-18 name: Peking University People's Hospital class: OTHER briefSummary: Ultrasound (US) is a more cost-effective, accessible, and available imaging technique to assess anterior talofibular ligament (ATFL) injuries compared with magnetic resonance imaging (MRI). However, challenges in using this technique and increasing demand on qualified musculoskeletal (MSK) radiologists delay the diagnosis. The investigators have already developed a deep convolutional network (DCNN) model that automates detailed classification of ATFL injuries. The investigators hope to use the DCNN in real-world clinical setting to test its diagnostic accuracy. conditions: Ultrasound conditions: Anterior Talofibular Ligament conditions: Deep Learning studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 400 type: ESTIMATED name: Ultrasound examination measure: classification of ATFL injury sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University People's Hospital city: Beijing state: Beijing zip: 100032 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06373016 id: 2015P000652 id: 2023005 type: OTHER_GRANT domain: Baszucki Foundation briefTitle: Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder overallStatus: RECRUITING date: 2024-01-26 date: 2027-02-01 date: 2027-02-01 date: 2024-04-18 date: 2024-04-18 name: Stony Brook University class: OTHER name: Massachusetts General Hospital name: Mclean Hospital briefSummary: The goal of this clinical trial is to test how specific components of diet affect brain function and behavior for individuals with bipolar. The main question it aims to answer is how glucose and ketones each affect the brain's response to risk and reward. Participants will be asked to provide blood (to assess baseline measures of how the body uses energy), and then to receive two MRI scan sessions, on separate days. During each MRI scan session, participants will play three games, from which they can win money, before and after drinking glucose (on one day) or ketones (on the other day). Investigators will compare individuals with and without bipolar to test whether the two groups differ in how their brains use energy, and to test how the brain's use of energy affects behavior. conditions: Bipolar Disorder conditions: Bipolar Disorder Type 1 studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 100 type: ESTIMATED name: Glucose name: Ketones measure: Stabilization of brain networks (general brain functioning) measure: Relative stabilization or destabilization of brain networks in response to metabolic bolus measure: Prefrontal-limbic circuit regulation measure: Cortico-striatal circuit regulation measure: Concentration of neurometabolites measured by Magnetic Resonance Spectroscopy (MRS) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: McLean Hospital status: RECRUITING city: Belmont state: Massachusetts zip: 02478 country: United States name: Dost Ongur, MD PhD role: CONTACT phone: 617-855-3922 email: dongur@mgb.org name: Virginie-Anne Chouinard, MD role: CONTACT phone: 617-855-3034 email: vchouinard@mgb.org name: Dost Ongur, MD PhD role: PRINCIPAL_INVESTIGATOR lat: 42.39593 lon: -71.17867 facility: Martinos Center for Biomedical Research, Building 149, 13th Street status: RECRUITING city: Charlestown state: Massachusetts zip: 02129 country: United States name: Lilianne Mujica-Parodi, PhD role: CONTACT phone: 631-428-8461 email: lstrey@mgh.harvard.edu name: Eva-Maria Ratai, PhD role: CONTACT phone: 781-521-4436 email: eratai@mgh.harvard.edu name: Eva-Maria Ratai, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.37787 lon: -71.062 facility: Laufer Center for Physical and Quantitative Biology , Stony Brook University status: ACTIVE_NOT_RECRUITING city: Stony Brook state: New York zip: 11794 country: United States lat: 40.92565 lon: -73.14094 hasResults: False

 nctId: NCT06373003 id: SNAPSITA briefTitle: Negative Antiphospholipid Syndrome: a Multicentric Study acronym: SNAPSITA overallStatus: RECRUITING date: 2024-03-31 date: 2026-03-31 date: 2026-03-31 date: 2024-04-18 date: 2024-04-18 name: Italian Society for Rheumatology class: OTHER briefSummary: Multicentre no-profit, national, (cross-sectional diagnostic) retrospective study, promoted by the Italian Society for Rheumatology.

The main objective of the study is to assess the diagnostic accuracy of non-criteria aPL (anti-vimentin/cardiolipin and anti-phosphatidylserine/prothrombin) in identifying APS in patients with thrombosis/recurrent adverse pregnancy outcomes.

The recruited patients have the following criteria:

(i)Patients fulfilling the classification criteria for antiphospholipid syndrome (seropositive APS, SP-APS) or patients with seronegative APS (SN-APS) or patients with clinical criteria (thrombotic or obstetric) for APS, negative for aPL, but without clinical features highly suggestive of APS; (ii) Age \<65 years; (iii) less than 5 years from the first event to the beginning of the study. conditions: Antiphospholipid Syndrome conditions: Seronegative Antiphospholipid Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 105 type: ESTIMATED name: Diagnostic accuracy measure: Primary endpoint measure: Secondary endpoint_1 measure: Secondary endpoint_2 measure: Secondary endpoint_3 measure: Exploratory Endpoint sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UOC di Reumatologia - AOU Policlinico Umberto I, "Sapienza" Università di Roma status: RECRUITING city: Roma state: Rome zip: 00185 country: Italy name: Simona Truglia, MD role: CONTACT phone: 06 49974631 email: simona.truglia@uniroma1.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06372990 id: 0015338 briefTitle: Rapid T-cell Analysis Test in Patients With Chronic HBV and HBV/HDV Disease acronym: BDTc overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-09-30 date: 2026-09-30 date: 2024-04-18 date: 2024-04-18 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER name: Duke-NUS Medical School (Singapore) briefSummary: Prospective, non-pharmacological, single-center, non-profit observational study.

The study design allows longitudinal evaluation of the immune response during the natural history of the infection and/or treatment, correlating the data with the outcome of the disease and antiviral therapies, which will be collected as study variables from the source documents.

The study population will be patients suffering from chronic HBV infection with or without HBV-HDV co-infection followed at the Division of Gastroenterology and Hepatology of Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico.

The present study is part of an international cooperation project between the Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (Milan, Italy) and the Duke-NUS Medical School, Singapore, financed by a grant (project MAECI-2023-23683653) and divided into two specific Work Packages:

* WP 1 Milan team (WP1.1 - Clinical and virological phenotyping of CHB and CHD patients; WP1.2 - Clinical evaluation of rapid HBV T cell test in CHB and CHD populations)
* WP 2 Singapore team (WP2.1 - Applicability of the rapid T cell assay approach; WP 2.2 - Optimization of the rapid T cell assay protocol)

The primary objective of the study is to define the prevalence of specific T cell responses in patients with chronic HBV and HBV-HDV infection, through the application of a specific rapid T cell assay. conditions: HBV conditions: HBV/HDV studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: Define the prevalence of specific T cell responses in patients with chronic HBV and HBV-HDV infection, through the application of a specific rapid T cell assay measure: Evaluate differences in terms of T cell response in patients with chronic HBV infection vs. HBV-HDV measure: Correlate the T cell response phenotype with the clinical profile (chronic infection vs. chronic hepatitis), disease severity (cirrhosis vs. non-cirrhosis) and response to specific HBV and HBV-HDV therapies measure: Improve the rapid T cell analysis protocol by simplifying the process, reducing analysis time and/or reducing the amount of material (blood) needed sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy. city: Milano state: MI zip: 20122 country: Italy name: Pietro Lampertico, MD role: CONTACT phone: 0255035432 email: pietro.lampertico@unimi.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06372977 id: kappa index in ms briefTitle: Kappa Index Versus Csf Oligoclonal Bands in Diagnosis of ms and Prediction of Disease Activity overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2026-05 date: 2024-04-18 date: 2024-04-18 name: Assiut University class: OTHER briefSummary: To:

1. Compare the diagnostic performance of cerebrospinal fluid kappa index to that of cerebrospinal fluid IgG oligoclonal bands in differentiating multiple sclerosis from other inflammatory and non-inflammatory neurological diseases .
2. Assess the role of kappa free light chain and oligoclonal bands in predicting disease activity (conversion from clinical isolated syndrome to multiple sclerosis) conditions: Multiple Sclerosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 140 type: ESTIMATED name: kappa index measure: Assess the diagnostic performance of CSF k index in differentiating MS from other inflammatory and non-inflammatory neurological diseases . measure: Assess the diagnostic performance of CSF IgG OCBs in differentiating MS from other inflammatory and non-inflammatory neurological diseases . measure: Assess the role of k FLC in predicting disease activity (conversion from CIS to MS) measure: Assess the role of OCBs in predicting disease activity (conversion from CIS to MS) sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06372964 id: ITI-007-421 briefTitle: Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients overallStatus: RECRUITING date: 2024-04 date: 2027-04 date: 2027-05 date: 2024-04-18 date: 2024-04-23 name: Intra-Cellular Therapies, Inc. class: INDUSTRY briefSummary: This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5). conditions: Bipolar Depression studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 384 type: ESTIMATED name: Lumateperone name: Placebo measure: Children's Depression Rating Scale-Revised (CDRS-R) measure: Clinical Global Impression Scale-Severity (CGI-S) sex: ALL minimumAge: 10 Years maximumAge: 17 Years stdAges: CHILD facility: Clinical Site status: NOT_YET_RECRUITING city: Anaheim state: California zip: 92805 country: United States lat: 33.83529 lon: -117.9145 facility: Clinical Site status: NOT_YET_RECRUITING city: Sacramento state: California zip: 95817 country: United States lat: 38.58157 lon: -121.4944 facility: Clinical Site status: NOT_YET_RECRUITING city: San Diego state: California zip: 92103 country: United States lat: 32.71533 lon: -117.15726 facility: Clinical Site status: NOT_YET_RECRUITING city: Colorado Springs state: Colorado zip: 80910 country: United States lat: 38.83388 lon: -104.82136 facility: Clinical Site status: NOT_YET_RECRUITING city: Gainesville state: Florida zip: 32607 country: United States lat: 29.65163 lon: -82.32483 facility: Clinical Site status: NOT_YET_RECRUITING city: Hialeah state: Florida zip: 33012 country: United States lat: 25.8576 lon: -80.27811 facility: Clinical Site status: NOT_YET_RECRUITING city: Miami Lakes state: Florida zip: 33014 country: United States lat: 25.90871 lon: -80.30866 facility: Clinical Site status: NOT_YET_RECRUITING city: Miami Lakes state: Florida zip: 33016 country: United States lat: 25.90871 lon: -80.30866 facility: Clinical Site status: RECRUITING city: Miami Springs state: Florida zip: 33166 country: United States lat: 25.82232 lon: -80.2895 facility: Clinical Site status: RECRUITING city: Orlando state: Florida zip: 32803 country: United States lat: 28.53834 lon: -81.37924 facility: Clinical Site status: NOT_YET_RECRUITING city: Atlanta state: Georgia zip: 30318 country: United States lat: 33.749 lon: -84.38798 facility: Clinical Site status: RECRUITING city: Decatur state: Georgia zip: 30030 country: United States lat: 33.77483 lon: -84.29631 facility: Clinical Site status: RECRUITING city: Lawrenceville state: Georgia zip: 30046 country: United States lat: 33.95621 lon: -83.98796 facility: Clinical Site status: NOT_YET_RECRUITING city: Savannah state: Georgia zip: 31405 country: United States lat: 32.08354 lon: -81.09983 facility: Clinical Site status: NOT_YET_RECRUITING city: Chicago state: Illinois zip: 60611 country: United States lat: 41.85003 lon: -87.65005 facility: Clinical Site status: NOT_YET_RECRUITING city: Indianapolis state: Indiana zip: 46202 country: United States lat: 39.76838 lon: -86.15804 facility: Clinical Site status: NOT_YET_RECRUITING city: Baltimore state: Maryland zip: 21229 country: United States lat: 39.29038 lon: -76.61219 facility: Clinical Site status: NOT_YET_RECRUITING city: Saint Charles state: Missouri zip: 63304 country: United States lat: 38.78394 lon: -90.48123 facility: Clinical Site status: NOT_YET_RECRUITING city: Lincoln state: Nebraska zip: 68526 country: United States lat: 40.8 lon: -96.66696 facility: Clinical Site status: NOT_YET_RECRUITING city: Kinston state: North Carolina zip: 28504 country: United States lat: 35.26266 lon: -77.58164 facility: Clinical Site status: NOT_YET_RECRUITING city: Avon Lake state: Ohio zip: 44012 country: United States lat: 41.50532 lon: -82.0282 facility: Clinical Site status: NOT_YET_RECRUITING city: Cincinnati state: Ohio zip: 45219 country: United States lat: 39.12713 lon: -84.51435 facility: Clinical Site status: NOT_YET_RECRUITING city: Garfield state: Ohio zip: 44125 country: United States facility: Clinical Site status: NOT_YET_RECRUITING city: Oklahoma City state: Oklahoma zip: 73112 country: United States lat: 35.46756 lon: -97.51643 facility: Clinical Site status: NOT_YET_RECRUITING city: Oklahoma City state: Oklahoma zip: 73116 country: United States lat: 35.46756 lon: -97.51643 facility: Clinical Site status: NOT_YET_RECRUITING city: Austin state: Texas zip: 78759 country: United States lat: 30.26715 lon: -97.74306 facility: Clinical Site status: NOT_YET_RECRUITING city: Frisco state: Texas zip: 75034 country: United States lat: 33.15067 lon: -96.82361 facility: Clinical Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77089 country: United States lat: 29.76328 lon: -95.36327 facility: Clinical Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77090 country: United States lat: 29.76328 lon: -95.36327 facility: Clinical Site status: NOT_YET_RECRUITING city: Bellevue state: Washington zip: 98007 country: United States lat: 47.61038 lon: -122.20068 hasResults: False

 nctId: NCT06372951 id: Lung ultrasound in neonate briefTitle: Lung Ultrasound in Neonatal Intensive Care Units overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-03 date: 2026-03 date: 2024-04-18 date: 2024-04-18 name: Assiut University class: OTHER briefSummary: Identification of lung diseases causing neonatal respiratory distress by lung ultrasound as a tool that can replace x-ray . conditions: Neonatal Respiratory Distress studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 132 type: ESTIMATED name: Ultrasound measure: Identifying causes of neonatal respiratory distress sex: ALL minimumAge: 1 Day maximumAge: 28 Days stdAges: CHILD hasResults: False

 nctId: NCT06372938 id: AEŞH-BADEK-2024-43 briefTitle: Role of Inflammatory Markers and Doppler Parameters in Late-Onset Fetal Growth Restriction: A Machine Learning Approach overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-31 date: 2024-04-30 date: 2024-04-30 date: 2024-04-18 date: 2024-04-18 name: Ankara Etlik City Hospital class: OTHER_GOV briefSummary: Fetal growth restriction (FGR) is a serious complication in pregnancy that can lead to various adverse outcomes. It's classified into early-onset (before 32 weeks) and late-onset (after 32 weeks), with late-onset associated with long-term risks like hypoxemia and developmental delays. The study focuses on the role of inflammation in FGR, introducing new blood markers for better understanding and diagnosis. It also addresses the challenges of using advanced diagnostic tools in low-resource settings and explores the use of machine learning to predict FGR based on inflammatory markers, highlighting the potential of artificial intelligence in overcoming these challenges. conditions: Fetal Growth Restriction conditions: Inflammatory Response studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 240 type: ACTUAL name: Ultrasound measurement name: Laboratory Tests and Inflammatory Markers measure: Evaluation of data measure: Machine learning modeling sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Etlik City Hospital city: Ankara state: Yenimahalle zip: 06170 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06372925 id: CKJX839A1CN04 id: CKJX839A1CN04 type: OTHER domain: Novartis briefTitle: Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction acronym: V-ACCELERATE overallStatus: NOT_YET_RECRUITING date: 2024-07-23 date: 2026-06-24 date: 2026-06-24 date: 2024-04-18 date: 2024-04-18 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: This study is to evaluate the effect of Inclisiran on coronary atherosclerosis using intravascular ultrasound (IVUS) and optical coherence tomography (OCT) in patients with acute myocardial infarction and elevated low-density lipoprotein cholesterol (LDL-C). conditions: Plaque, Atherosclerotic studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: IVUS/OCT will be conducted in local lab and blinded analyzed to Independent Review Committee(IRC). whoMasked: OUTCOMES_ASSESSOR count: 318 type: ESTIMATED name: atorvastatin name: IVUS/OCT name: inclisiran measure: Change in percent atheroma volume (PAV) measure: Change in minimum fibrous cap thickness (FCT) measure: Change in mean minimum FCT of all images measure: Change in normalized total atheroma volume (NTAV) measure: Proportion of participants with progression, regression, or no change in PAV measure: Change in LDL-C measure: Change in TC measure: Change in HDL-C measure: Change in non-HDL-C measure: Change in ApoB measure: Change in ApoA1 measure: Change in Lp(a) measure: Change in TG measure: Proportion of participants with LDL-C target attainment sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06372912 id: Complications-Bariatric-TJ briefTitle: Early Postoperative Complications in Patients Undergoing Bariatric Surgery overallStatus: RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-18 date: 2024-04-18 name: Instituto Mexicano del Seguro Social class: OTHER_GOV briefSummary: This study examined immediate postoperative complications in patients undergoing various bariatric surgeries, aiming to evaluate the safety and efficacy of these interventions. Conducted at specialized high-volume bariatric surgery centers in Tijuana, Mexico. Predominantly female patients with severe obesity underwent procedures like sleeve gastrectomy and Roux-en-Y gastric bypass. Immediate complications were rare, occurring in only 0.38% of patients, with bleeding being the most common issue. Surgical reintervention within 48 hours was required in 0.33% of cases. The study's low complication rate suggests that surgeon expertise is crucial in minimizing risks and improving postoperative outcomes in bariatric surgery. conditions: Bariatric Surgery Candidate conditions: Complication,Postoperative studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3000 type: ESTIMATED name: Sleeve gastrectomy, Roux-en-Y gastric bypass, mini-gastric bypass, SADIS, intragastric balloon insertion, and gastric band placement are bariatric surgeries. measure: Rate of Postoperative Complications measure: Long-term Weight Loss Efficacy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Elias Ortiz & Company Mexico Weight Loss Specialists. Ernesto Sarmiento 2308, Tijuana 22046, Baja California, Mexico. status: RECRUITING city: Tijuana state: Baja California zip: 22046 country: Mexico name: José a Guzmán Barba, MD, PhD role: CONTACT phone: 3471043237 email: • aldogbarba@hotmail.com lat: 32.5027 lon: -117.00371 hasResults: False

 nctId: NCT06372899 id: 855140 id: R01CA290541-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA290541-01A1 briefTitle: Alternative Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-11 date: 2028-03-31 date: 2024-04-18 date: 2024-04-19 name: University of Pennsylvania class: OTHER name: National Cancer Institute (NCI) briefSummary: This between-subjects study aims to evaluate whether e-cigarettes (ECIGS) versus oral nicotine pouches (ONPS) more readily substitute for combustible cigarettes among 200 cigarette smokers. After measuring baseline cigarette smoking rate, participants will be randomized to ECIGS or ONPS and be instructed to switch (versus smoking cigarettes) over a 6-week period. Relative reductions in biomarkers of exposure will be measured. ECIG- and ONP-associated subjective reward and the reinforcing value of ECIGS and ONPS relative to combustible cigarettes will be assessed as mechanisms. conditions: E-cigarette Use conditions: Cigarette Smoking conditions: Harm Reduction conditions: Tobacco Use studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 200 type: ESTIMATED name: E-cigarettes name: Oral nicotine pouches measure: Cigarette Consumption measure: Cigarette Smoking Across Follow-Up measure: Biomarkers of Exposure: Carbon Monoxide (CO) measure: Biomarkers of Exposure: Mean mid-expiratory forced expiratory flow (FEF25% - 75%) measure: Biomarkers of Exposure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) measure: Biomarkers of Exposure:1-hydroxypyrene (1-HOP) sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06372886 id: 2402-147-1516 briefTitle: Clinical Outcomes of Preservation Versus Resection of Portal/Superior Mesenteric Vein During Pancreaticoduodenectomy in Pancreatic Cancer Patients Who Respond to Neoadjuvant Treatment overallStatus: COMPLETED date: 2012-01-01 date: 2022-01-01 date: 2024-03-01 date: 2024-04-18 date: 2024-04-18 name: Seoul National University Hospital class: OTHER briefSummary: 1. There is a lack of evidence on the need to perform portal/superior mesenteric vein (PV/SMV) resection routinely in pancreatic ductal adenocarcinoma (PDAC) patients with venous involvement who responded to neoadjuvant treatment (NAT).
2. There is no significant differences in R0 rate, 5-year overall survival and recurrence-free survival between the PV/SMV preservation (PVP) group and PV/SMV resection (PVR) group.
3. PVP group showed significantly better 5-year PV/SMV stenosis free survival than the PVR group.
4. We propose that if dissection is possible and there is a high likelihood of achieving R0 resection after NAT, routine PVR may be unnecessary in PDAC patients with venous involvement. conditions: Pancreatic Head Cancer Patients Who Underwent Surgery After Neoadjuvant Treatment studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 264 type: ACTUAL name: portal/superior vein resection measure: 5-year overall survival measure: 5-year portal/superior mesenteric vein stenosis free survival sex: ALL maximumAge: 79 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06372873 id: 2023PHB211-001 briefTitle: Deep-learning For Ultrasound Classification of Anterior Talofibular Ligament Injury overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-01 date: 2024-04-30 date: 2025-05-30 date: 2024-04-18 date: 2024-04-23 name: Peking University People's Hospital class: OTHER briefSummary: Ultrasound (US) is a more cost-effective, accessible, and available imaging technique to assess anterior talofibular ligament (ATFL) injuries compared with magnetic resonance imaging (MRI). However, challenges in using this technique and increasing demand on qualified musculoskeletal (MSK) radiologists delay the diagnosis. Using datasets from multiple clinical centers, the investigators aimed to develop and validate a deep convolutional network (DCNN) model that automates classification of ATFL injuries using US images with the goal of providing interpretable assistance to radiologists and facilitating a more accurate diagnosis of ATFL injuries.

The investigators collected US images of ATFL injuries which had arthroscopic surgery results as reference standard form 13 hospitals across China;Then the investigators divided the images into training dataset, internal validation dataset, and external validation dataset in a ratio of 8:1:1; the investigators chose an optimal DCNN model to test its diagnostic performance of the model, including the diagnostic accuracy, sensitivity, specificity, F1 score. At last, the investigators compared the diagnostic performance of the model with 12 radiologists at different levels of expertise. conditions: Deep Learning conditions: Ultrasound conditions: Anterior Talofibular Ligament studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 3000 type: ESTIMATED name: re-evaluate by two senior radiologists in our medical center measure: To evaluate whether the US images are in consensus with the ATFL injury classification of the reference standard sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University People's Hospital city: Beijing state: Beijing zip: 100032 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06372860 id: RKS2018350 id: 3P20GM144269-02S2 type: NIH link: https://reporter.nih.gov/quickSearch/3P20GM144269-02S2 briefTitle: DPP Feasibility Study of Breastfeeding - eMOMS 2.0 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-02 date: 2024-04-18 date: 2024-04-18 name: University of Kansas Medical Center class: OTHER name: Ascension Health name: National Institute of General Medical Sciences (NIGMS) briefSummary: The purpose of this study is to investigate the impact of a comprehensive intervention that combines breastfeeding support with a diabetes prevention-based program (DPP) on postpartum weight retention and lactation duration among women with pre-pregnancy overweight or obesity. This intervention, named eMOMS, is delivered by a certified health coach via a mobile health (mHealth) application. conditions: Overweight or Obesity conditions: Pregnancy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Diabetes Prevention Program name: Breastfeeding name: Usual Care measure: Maternal weight measure: Maternal body mass index (BMI) measure: Initiation of Lactation measure: Duration of Lactation measure: Type of Infant Feeding measure: Recruitment Rate measure: Retention Rate measure: Research Engagement measure: Mobile Application Usage measure: Health Coach Interaction sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-02-07 uploadDate: 2024-04-09T16:15 filename: Prot_SAP_000.pdf size: 1164859 hasResults: False

 nctId: NCT06372847 id: Project ID 6214 briefTitle: DISE-HNS Effect Study acronym: DISE-HNS overallStatus: NOT_YET_RECRUITING date: 2024-04-23 date: 2028-03-31 date: 2028-03-31 date: 2024-04-18 date: 2024-04-18 name: University Hospital, Antwerp class: OTHER briefSummary: The purpose of this study is to assess the site, pattern and degree of upper airway collapse before and during hypoglossal nerve stimulation (HNS) treatment using clinical standard drug-induced sleep endoscopy (DISE) and using a novel, non-invasive method predicting site of collapse from raw polysomnography (PSG) data.

Furthermore, outcomes will be compared between responders and non-responders. conditions: Obstructive Sleep Apnea studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Before-and-after study primaryPurpose: BASIC_SCIENCE masking: NONE count: 58 type: ESTIMATED name: Hypoglossal nerve stimulation implant name: Polysomnography name: Drug-induced sleep endoscopy (DISE) measure: Δ%area-of-collapse at the level of the lateral walls measure: Δ%area-of-collapse at the level of the palate, tongue base and epiglottis measure: Δ%area-of-collapse at each possible site of upper airway collapse (palate, lateral walls, tongue base, epiglottis) in responders and non-responders measure: DISE-score during baseline DISE and during one-year follow-up DISE. measure: Non-invasive site and pattern of collapse sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-02-29 uploadDate: 2024-04-04T04:58 filename: Prot_SAP_000.pdf size: 425782 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-29 uploadDate: 2024-04-04T04:58 filename: ICF_001.pdf size: 336420 hasResults: False

 nctId: NCT06372834 id: B202205178 briefTitle: Adjuvant Accelerated piTBS for Reducing Suicidal Ideation in TRD Patients: A Randomized, Sham-controlled Trial overallStatus: RECRUITING date: 2022-11-07 date: 2024-12-31 date: 2024-12-31 date: 2024-04-18 date: 2024-04-18 name: Tri-Service General Hospital class: OTHER briefSummary: In this double-blind, randomized, sham-controlled trial, we aimed to examine the effect of accelerated piTBS on suicide risk in a group of treatment-resistant patients with MDD (i.e., TRD), using an extensive suicide assessment scale the primary outcome. We hypothesized that this intensified treatment protocol would be safe in TRD patients with suicide ideations and would result in significant decreases in suicide risk in the active treatment condition as compared to the sham condition. conditions: Major Depressive Disorder conditions: Treatment-Resistant Depression conditions: Suicide Ideations studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: piTBS being delivered using the Magstim Rapid2 stimulator measure: The change over time in the score of Beck Scale for Suicide Ideation (BSS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). measure: The change over time in the score of Snaith-Hamilton Pleasure Scale (SHAPS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). measure: The change over time in the score of Beck Hopelessness Scale (BHS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). measure: The change over time in the score of Montgomery-Å sberg Depression Rating Scale (MADRS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). measure: The change over time in the score of 17-item Hamilton Depression Rating Scale (HDRS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). measure: The change over time in the score of Hamilton Anxiety Rating Scale (HAM-A) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). measure: The change over time in the score of Young Mania Rating Scale (YMRS) (from baseline to the timepoints at 1 week after piTBS, at the end of piTBS, and at 1, 2, and 4 weeks after piTBS). measure: The changes over time in the results of Wisconsin Card Sorting Test (WCST) (from baseline to the timepoint at the end of piTBS). measure: The changes over time in the results of Color Trails Test (CTT) (from baseline to the timepoint at the end of piTBS). measure: The changes over time in the results of Stroop Color Word Test (SCWT) (from baseline to the timepoint at the end of piTBS). measure: The changes over time in the results of indices of heart rate variability (HRV) (from baseline to the timepoint at the end of piTBS) and the HRV indices during each piTBS session. measure: The changes over time in EEG absolute power and lag phase synchronization in the frontal electrodes in the delta, theta, alpha, beta and gamma range (from baseline to the end of piTBS). measure: The changes over time in high density near infrared spectroscopy (from baseline to the end of piTBS). measure: The changes over time in the results of Digit Symbol Substitution Test (DSST) (from baseline to the timepoint at the end of piTBS). sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tri-service general hospital status: RECRUITING city: Taipei zip: 114 country: Taiwan name: Hsin-An Chang, M.D. role: CONTACT phone: 011-886-2-8792-3311 phoneExt: 17389 email: chang.ha@mail.ndmctsgh.edu.tw name: Hsin-An Chang, M.D. role: PRINCIPAL_INVESTIGATOR lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06372821 id: 158160 briefTitle: A Trial Evaluating the Effect of NIO752 on Tau Synthesis Measured by a Process Known as SILK acronym: NIO-SILK overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-02 date: 2025-08 date: 2024-04-18 date: 2024-04-18 name: University College, London class: OTHER name: Washington University School of Medicine name: University of Washington name: Alzheimer's Association name: Sigrid Rausing Trust briefSummary: This study will assess if drug (NIO752) reduces production of a protein, tau, by the brain. Normally tau maintains the internal skeleton of nerve cells. In Alzheimer's disease (AD) it builds up in the brain, causing damage. Abnormal tau proteins cling to each other forming 'tangles' inside nerve cells, which interfere with how the nerve cells work, and eventually die. This is what causes the symptoms of dementia. It is thought that NIO752 reduces production of tau. conditions: Alzheimer Disease conditions: Autosomal Dominant Alzheimer Disease Due to Mutation of Presenilin 1 (Disorder) conditions: Autosomal Dominant Alzheimer Disease Due to Mutation of Presenilin 2 (Disorder) conditions: Autosomal Dominant Alzheimer Disease Due to Mutation of Amyloid Precursor Protein (Disorder) studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 10 type: ESTIMATED name: NIO752 name: Placebo measure: Tau synthesis rate inhibition in individuals with sporadic AD and ADAD measure: Compare efficacy of knockdown of tau production in sporadic AD and ADAD by measuring the synthesis rate of tau by determining the ratio of labelled to unlabeled tau (tracer to tracee ratio) in serial cerebrospinal fluid samples. measure: Number of participants with adverse events [safety and tolerability] measure: Comparison of number of Adverse Events reported between participants receiving one dose of NIO752 versus those receiving two doses of NIO752. measure: Compare rates of tau synthesis and clearance in sporadic AD and ADAD measure: Determine CSF tau concentration to tau production relationships in humans sex: ALL minimumAge: 21 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06372808 id: 2022/118 briefTitle: The Effect of Plyometric Training in Freestyle Adolescent Wrestlers overallStatus: RECRUITING date: 2023-10-01 date: 2024-06-18 date: 2024-09-15 date: 2024-04-18 date: 2024-04-19 name: Hasan Kalyoncu University class: OTHER briefSummary: This study aims to determine the effect of plyometric exercises on physical fitness parameters in freestyle adolescent wrestlers. conditions: Physical Fitness conditions: Power studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: The Plyometric Exercise name: The Regular Training measure: Change from Baseline in Strength at 8 weeks measure: Change from Baseline in Endurance at 8 weeks measure: Change from Baseline in Agility at 8 weeks measure: Change from Baseline in Wrestling Performance at 8 weeks sex: ALL minimumAge: 10 Years maximumAge: 15 Years stdAges: CHILD facility: Batipark Sports Hall status: RECRUITING city: Kahramanmaraş zip: 46050 country: Turkey name: Talha Gökçe, PT role: CONTACT phone: +905065624802 email: talhagokce89@gmail.com lat: 37.5847 lon: 36.92641 hasResults: False

 nctId: NCT06372795 id: KY2023635 briefTitle: Resistance Swallowing Training in Patients With Tracheotomy overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-12-31 date: 2024-04-18 date: 2024-04-18 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: The goal of this clinical trial is to learn investigate the effect of instrument-assisted early progressive resistance swallowing training on swallowing related muscle strength in critically ill patients. It will also learn about the safety of swallowing training. The main questions it aims to answer are:

* Does instrument-assisted early progressive resistance swallowing training increase the swallowing related muscle strength in critically ill patients?
* What medical problems do participants have when taking swallowing training?

Researchers will compare instrument-assisted early progressive resistance swallowing training to pure effortful swallowing to see if instrument-assisted early progressive resistance swallowing training works to increase muscle strength.

Participants will:

-Take instrument-assisted early progressive resistance swallowing training or pure effortful swallowing every day for 2 weeks and take muscle strength test every week. conditions: Swallowing Training on Muscle Strength studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 66 type: ESTIMATED name: pure effortful swallowing name: progressive resistance swallowing training measure: Forced swallowing tongue pressure sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06372782 id: 43CH2305 briefTitle: Comparing Pain, Safety and Effectiveness of Restylane Skinboosters Vital Lido and Vital Without Lido in Dorsal Hand overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-07 date: 2024-08 date: 2024-04-18 date: 2024-04-18 name: Galderma R&D class: INDUSTRY briefSummary: This is a randomized, multi-center, split-hand, subject-blinded study comparing pain, safety and effectiveness of Restylane Skinboosters Vital Lidocaine and Restylane Vital without lidocaine for improving appearance of the dorsal hands in Chinese subjects. conditions: Skin Aging of Dorsal Hands studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 90 type: ESTIMATED name: Restylane Skinboosters Vital Lidocaine name: Restylane Vital measure: The within-subject difference in VAS score (Restylane Skinboosters Vital Lidocaine- Restylane Vital) at end of injection (T0). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Galderma Research Site 01 city: Shanghai state: Shanghai country: China name: Principle Investigator role: CONTACT lat: 31.22222 lon: 121.45806 facility: Galderma Research Site 02 city: Hangzhou state: Zhejiang country: China name: Principle Investigator role: CONTACT lat: 30.29365 lon: 120.16142 facility: Galderma Research Site 03 city: Hangzhou state: Zhejiang country: China lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06372769 id: 20240304 briefTitle: Myoelectric Activity and Mandibular Movement for the Diagnosis of Temporomandibular Disorder overallStatus: COMPLETED date: 2022-02-01 date: 2022-07-15 date: 2023-02-10 date: 2024-04-18 date: 2024-04-18 name: Stomatological Hospital Affiliated with Fujian Medical University class: OTHER briefSummary: This study aimed to provide normal reference values of surface electromyography (sEMG) and mandibular kinematics in Chinese young adults, compare the sex differences and assess the diagnosis value of these indices. conditions: Temporomandibular Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 120 type: ACTUAL name: electromyograph and kinesiograph measure: Surface electromyography (μV) measure: Mandibular kinematics (mm, mm/s) sex: ALL minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: The Affiliated Stomatological Hospital of Fujian Medical University city: Fuzhou state: Fujian zip: 350002 country: China lat: 26.06139 lon: 119.30611 hasResults: False

 nctId: NCT06372756 id: 102122 briefTitle: Deep Learning Reconstruction Algorithms in Dual Low-dose CTA overallStatus: RECRUITING date: 2023-06-01 date: 2025-12 date: 2026-03 date: 2024-04-18 date: 2024-04-18 name: Hao Tang class: OTHER briefSummary: The goal of this observational study is to evaluate the impact of deep learning image reconstruction on the image quality and diagnostic performance of double low-dose CTA. The main question it aims to answer is to explore the feasibility of deep learning image reconstruction in double low-dose CTA. conditions: Deep Learning studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1200 type: ESTIMATED name: Deep learning image reconstruction measure: The specificity and sensitivity calculated through the optimal cutoff value of the receiver operating characteristic curve. measure: The signal-to-noise ratio calculated from image CT values and noise sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei zip: 430000 country: China name: Youfa M Tang role: CONTACT phone: +8613554101223 email: 1525573397@qq.com lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06372743 id: Alex Hospital briefTitle: Nurse-led Physician-supported Care for Patients With Chronic Kidney Disease and Multimorbidity acronym: INTEGREATCKD overallStatus: RECRUITING date: 2023-11-01 date: 2025-05-31 date: 2026-12-31 date: 2024-04-18 date: 2024-04-18 name: Alexandra Hospital class: OTHER name: National University Hospital, Singapore briefSummary: Chronic kidney disease (CKD) is a prevalent chronic disease and is often intertwined with the management of cardiovascular disease and the optimization of metabolic risk factors. In light of steeply rising rates of end-stage kidney disease (ESKD) and increased healthcare resource utilization by CKD patients, the investigators propose that the role of nurses could be expanded to support the care of CKD patients in the community.

A total of 220 patients will be randomized (1:1) to the intervention or control groups (usual care). The intervention entails enrolment into a nurse-led, physician-supported programme (INTEGREAT-CKD), comprising outpatient consultations and community-based ambulatory monitoring and counselling primarily driven by CKD-trained advanced practice nurses (APNs) and healthcare professionals conducted over 6 months. Patient-reported outcomes like health-related quality of life (HRQOL), as measured by EQ-5D and KDQOL, CKD self-management score and CKD health literacy will be assessed at baseline and after 6 months. The primary outcome is CKD self-management. Other secondary outcomes to be assessed and tracked including achievement of clinical targets relevant to slowing down CKD progression, attainment of CKD best practice guidelines as specified in the KDIGO CKD Evaluation and Management guidelines 2020. conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is a dual-centre two-arm, open-label randomized controlled trial (RCT). Patients are randomized with a one-to-one allocation into two parallel groups. primaryPurpose: TREATMENT masking: NONE count: 220 type: ESTIMATED name: INTEGREAT-CKD Intervention measure: Chronic Kidney Disease Self-Management (CKD-SM) Questionnaire measure: Secondary outcome sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wei Zhen Hong status: RECRUITING city: Singapore zip: 119228 country: Singapore name: Wei Zhen Hong role: CONTACT phone: 97330789 email: wei_zhen_hong@nuhs.edu.sg name: Priyanka Khatri, MBBS role: SUB_INVESTIGATOR lat: 1.28967 lon: 103.85007 hasResults: False

 nctId: NCT06372730 id: 29BRC23.0161 id: 2023-A01566-39 type: OTHER domain: IDRCB briefTitle: Residual Pulmonary Vascular Obstruction Index Computed With Ventilation/Perfusion SPECT/CT Imaging to Predict the Risk of Venous Thromboembolism Recurrence in Patients With Pulmonary Embolism (PRONOSPECT) acronym: PRONOSPECT overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-10 date: 2029-01 date: 2024-04-18 date: 2024-04-18 name: University Hospital, Brest class: OTHER briefSummary: Major risk after pulmonary embolism (PE) is recurrence, fatal in 10% of patients. Patients with PE can be stratified in 3 groups according to the risk of recurrence : very low risk, high risk or Intermediate risk. Little is known about this last group.

Anticoagulation is efficient to prevent recurrence but is currently not recommended for patient with an intermediate risk of recurrence.

Identifying risk factors of recurrent PE remains a major issue to identify sub-groups of patients who would require lifelong anticoagulation.

In 30-40% of cases, PE patients develop residual pulmonary vascular obstruction (RPVO), which has been found to be associated with an increased recurrence risk. This last observation was mostly reported in patients with unprovoked PE (patients with high risk of recurrence) and RPVO was measured using conventional planar lung scan.

In patients with an intermediate risk of recurrence, the impact of RPVO has been much less studied. In addition, the definition of RPVO was variable according to studies and correlation between RPVO burden and recurrence risk has not been clearly demonstrated. This might be explained by the inherent limitation of RPVO quantification using conventional planar imaging, which is only based on a visual estimation on 2-dimensional images.

Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT) is a new method of scintigraphic image acquisition that offers the advantage of 3-dimensional imaging, enabling more accurate and reproducible quantification of RPVO.

The main hypothesis of this study is that in patients with PE at intermediate risk of recurrence, RPVO computed with V/Q SPECT/CT imaging may be an important predictor of recurrence. conditions: Pulmonary Embolism conditions: Venous Thromboembolism studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Cohort study primaryPurpose: PREVENTION masking: NONE count: 665 type: ESTIMATED name: Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT) measure: Symptomatic recurrent venous thromboembolism (VTE), including objectively confirmed nonfatal symptomatic PE or proximal deep vein thrombosis or fatal PE during a 24-month follow-up after inclusion in the study measure: Adjudicated symptomatic objectively confirmed recurrent VTE during the follow-up period. measure: Percentage of patients with RPVO (as defined by a perfusion defect > 5%) on V/Q SPECT/CT imaging at inclusion in the study. measure: Different cut-offs of pulmonary vascular obstruction index will be evaluated to predict the risk of VTE recurrence at 2 years, by generating ROC curves measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: age measure: The following score will be computed : HERDOO2 (Hyperpigmentation, Edema, Redness, D-Dimer, Obesity, Old) measure: Potential predictors of RPVO including : demographics measure: Symptomatic recurrent VTE during a 3 Months follow-up period in patients with suspicion of PE recurrence who has been left untreated based on a negative V/Q SPECT/CT scan measure: Dyspnea index will be assessed using mMRC scale (Modified Medical Research Council) measure: Quality of life (QoL) will be assessed using PEmb-Qol (Pulmonary Embolism Quality of Life) measure: Number of Participants with chronic thromboembolic pulmonary hypertension (CTEPH). measure: Mortality of all causes. measure: Percentage of patients with RPVO (> 5%) on V/Q SPECT/CT imaging using Technegas and Krypton. measure: The following score will be computed : PADIS-PE score. measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: gender measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: obesity measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: D-Dimer measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: inherited or acquired thrombophilia measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: residual vein thrombosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Amiens city: Amiens zip: 80054 country: France name: Marie-Antoinette SEVESTRE, Pr role: CONTACT phone: +33322087306 email: sevestre.marie-antoinette@chu-amiens.fr lat: 49.9 lon: 2.3 facility: CHU Angers city: Angers zip: 49933 country: France name: Jeanne HERSANT, Pr role: CONTACT phone: +33661392285 email: Jeanne.hersant@chu-angers.fr lat: 47.46667 lon: -0.55 facility: CHU Brest city: Brest zip: 29609 country: France name: Pierre-Yves LE ROUX, Pr role: CONTACT phone: +33298223327 email: pierre-yves.leroux@chu-brest.fr name: Francis COUTURAUD, Pr role: PRINCIPAL_INVESTIGATOR lat: 48.3903 lon: -4.48628 facility: Hôpital Louis MourierAP-HP city: Colombes zip: 92700 country: France name: Isabelle MAHE, Pr role: CONTACT phone: +33147606490 email: isabelle.mahe@lmr.aphp.fr lat: 48.91882 lon: 2.25404 facility: CHD Vendée - La Roche sur Yon city: La Roche-sur-Yon zip: 85925 country: France name: Jean-Manuel KUBINA, Dr role: CONTACT phone: +33251446301 email: jean-manuel.kubina@ght85.fr lat: 46.66667 lon: -1.43333 facility: Kremlin-Bicêtre AP-HP city: Le Kremlin-Bicêtre zip: 94270 country: France name: David MONTANI, Pr role: CONTACT phone: +33145217976 email: david.montani@aphp.fr lat: 48.81471 lon: 2.36073 facility: CH Les Sables d'Olonne city: Les Sables-d'Olonne zip: 85340 country: France name: Nicolas BREBION role: CONTACT phone: +33251218824 email: nicolas.brebion@ght85.fr lat: 46.5 lon: -1.78333 facility: Hegp Ap-Hp city: Paris zip: 75015 country: France lat: 48.85341 lon: 2.3488 facility: CH Quimper city: Quimper zip: 29000 country: France name: Charles ORIONE, Dr role: CONTACT phone: +33298526096 email: charles.orione@ch-cornouaille.fr lat: 48.0 lon: -4.1 facility: CHU St-Etienne city: Saint-Étienne zip: 42055 country: France name: Laurent BERTOLETTI, Pr role: CONTACT phone: +33477127770 email: laurent.bertoletti@chu-st-etienne.fr lat: 45.43389 lon: 4.39 facility: CHIC Toulon city: Toulon zip: 83056 country: France name: Jean-Noël POGGI, Dr role: CONTACT phone: +33494145787 email: jean-noel.poggi@ch-toulon.fr lat: 43.12442 lon: 5.92836 facility: HIA Toulon city: Toulon zip: 83800 country: France name: Antoine-Raphaël BRONSTEIN, Dr role: CONTACT phone: +33483162553 email: antoine-raphael.bronstein@intradef.gouv.fr lat: 43.12442 lon: 5.92836 facility: CHU Toulouse city: Toulouse zip: 31059 country: France name: Alessandra BURA-RIVIERE, Pr role: CONTACT phone: +33561322438 email: bura-riviere.a@chu-toulouse.fr lat: 43.60426 lon: 1.44367 hasResults: False

 nctId: NCT06372717 id: AP30CP01 briefTitle: A Study to Investigate APL-4098 Alone and/or in Combination With Azacitidine in R/R AML and High-Risk MDS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-03-01 date: 2027-04-01 date: 2024-04-18 date: 2024-04-18 name: Apollo Therapeutics Ltd class: INDUSTRY briefSummary: This is an open-label, Phase 1/2 study to determine the safety, tolerability, and efficacy of APL-4098 alone and/or in combination with azacitidine for the treatment of relapsed or refractory (R/R) acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)/AML and MDS-excess blasts (EB). Participants with the MDS-EB subtype will be eligible for the Phase 1 part of the study only. conditions: Acute Myeloid Leukemia Refractory conditions: Myelodysplastic Syndrome Acute Myeloid Leukemia conditions: Myelodysplastic Syndrome With Excess Blasts conditions: Acute Myeloid Leukemia, in Relapse studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 112 type: ESTIMATED name: APL-4098 name: Azacitidine and APL-4098 measure: Incidence of Treatment Emergent Adverse Events [Safety] (Phase 1) measure: Incidence of Dose Limiting Toxicities [Tolerability] (Phase 1) measure: Estimate the Maximum Tolerated Dose (MTD) of APL-4098 alone and/or in combination with azacitidine (Phase 1) measure: Determine Recommended Phase 2 Dose (RP2D) levels of APL-4098 alone and/or in combination with azacitidine (Phase 1) measure: Assess the Pharmacokinetics of APL-4098 alone and/or in combination with azacitidine (Phase 1) measure: Assess the Pharmacokinetics of APL-4098 alone and/or in combination with azacitidine (Phase 1) measure: Assess the Pharmacokinetics of APL-4098 alone and/or in combination with azacitidine (Phase 1) measure: Assess efficacy of APL-4098 alone and/or in combination with azacitidine (Phase 2) measure: Assess response to disease with APL-4098 alone and/or in combination with azacitidine (Phase 1) measure: Duration of response with APL-4098 alone and/or in combination with azacitidine [Further efficacy] (Phase 2) measure: Time to response with APL-4098 alone and/or in combination with azacitidine [Further efficacy] (Phase 2) measure: Event Free Survival with APL-4098 alone and/or in combination with azacitidine [Further efficacy] (Phase 2) measure: Overall Survival with APL-4098 alone and/or in combination with azacitidine [Further efficacy] (Phase 2) measure: Incidence of Treatment Emergent Adverse Events [Further Safety] (Phase 2) measure: Incidence of Adverse Events leading to discontinuation of APL-4098 [Further Tolerability] (Phase 2) measure: Further assess the PK of APL-4098 alone and/or in combination with azacitidine (Phase 2) measure: Further assess the PK of APL-4098 alone and/or in combination with azacitidine (Phase 2) measure: Further assess the PK of APL-4098 alone and/or in combination with azacitidine (Phase 2) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06372704 id: 2024/72 briefTitle: Is the HIFEM Procedure an Effective Treatment for Men With Post-prostatectomy Incontinence? acronym: HIFEM for PPI overallStatus: COMPLETED date: 2024-02-01 date: 2024-04-01 date: 2024-04-05 date: 2024-04-18 date: 2024-04-24 name: Kirsehir Ahi Evran Universitesi class: OTHER briefSummary: Urinary incontinence after radical prostatectomy surgery is a common condition that negatively affects daily life. Patients often experience discomfort due to urine leakage and the resulting need to use pads daily. This study aimed to evaluate the efficacy and safety of high-intensity focused electromagnetic technology used therapeutically in patients with urinary incontinence after radical prostatectomy. conditions: Prostate Cancer conditions: Incontinence conditions: Pelvic Floor Muscle Weakness studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 27 type: ACTUAL name: HIFEM measure: This study demonstrated the safe and effective use of HIFEM technology to prevent PPI by strengthening the pelvic floor muscles in a variety of patients. sex: MALE minimumAge: 63 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: İbrahim Üntan city: Kirşehi̇r country: Turkey lat: 39.14583 lon: 34.16389 hasResults: False

 nctId: NCT06372691 id: PoplitealApproach SciaticBlock briefTitle: How Do We Ultrasound-Guided Popliteal Approach Sciatic Nerve Block? overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-01 date: 2024-09-01 date: 2024-04-18 date: 2024-04-18 name: Ankara City Hospital Bilkent class: OTHER briefSummary: The aim of this prospective, randomized, observer-blind study to compare subparaneural approach injection with interneural approach injection in popliteal sciatic nerve blocks. conditions: Adult conditions: Regional Anesthesia Morbidity conditions: Anesthesia Injection Site studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 809 type: ESTIMATED name: Subparaneural Injection (Grup S), Block name: Interneural Injection (Grup I), Block measure: Onset Time measure: Block Execution Times measure: Need for Multiple Injections Owing to Insufficient Anesthesia measure: Additional Rescue Analgesic measure: Adverse Effects to Anesthesia measure: Hemodynamic Effects Of The Block measure: Effects Of The Block On Heart Rate measure: Effects Of The Block On Peripheral Pulse Oximetry measure: Regression Time Of Sensory and Motor Block measure: Total Block Times sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06372678 id: CM326-102102 briefTitle: Study of CM326 in Participants With Chronic Rhinosinusitis With Nasal Polyposis overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2026-06-30 date: 2026-06-30 date: 2024-04-18 date: 2024-04-18 name: Keymed Biosciences Co.Ltd class: INDUSTRY briefSummary: This is a multi-center, randomized, double blind, placebo-controlled Phase II study to evaluate the efficacy and safety of CM326, and to observe the Pharmacokinetics, Pharmacodynamics and immumogenicity of CM326 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP). conditions: Chronic Rhinosinusitis With Nasal Polyps studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: CM326 name: Placebo measure: Changes from baseline of nasal polyp score (NPS) in eosinophilic chronic rhinosinusitis with nasal polyps (CRSwNP) at week 24. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tongren Hospital, CMU city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06372665 id: CDB-IV-JE-025202301 briefTitle: Safety Observation of the Japanese Encephalitis Vaccine Given With a Primary Immunization overallStatus: RECRUITING date: 2024-01-01 date: 2025-03-31 date: 2025-06-30 date: 2024-04-18 date: 2024-04-18 name: Liaoning Chengda Biotechnology CO., LTD class: INDUSTRY briefSummary: This is a single-arm, non-randomized, open-label post-marketing safety observation study. The purpose of this study is to investigate the safety of JEV-I given with primary immunization in a large amount of healthy children aged 8 months and older. conditions: Japanese Encephalitis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 28547 type: ESTIMATED measure: Number of Participants Reporting Solicited Local and Systemic Adverse Events, and Unsolicited Adverse Events sex: ALL minimumAge: 8 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Jiangsu Provincial Center for Disease Control and Prevention status: RECRUITING city: Nanjing state: Jiangsu zip: 210009 country: China name: Zhiguo Wang, Master role: CONTACT email: 120714991@QQ.com name: Zhiguo Wang, Master role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06372652 id: TE-8214-001 briefTitle: A Phase 1 Study of TE-8214 Solution in Healthy Volunteers overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2024-10-10 date: 2024-12-26 date: 2024-04-18 date: 2024-04-19 name: Immunwork, Inc. class: INDUSTRY briefSummary: This is a Phase 1, first-in-human, randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, and PK of TE-8214 in healthy volunteers. The study will assess single ascending doses (SAD) of TE-8214. conditions: Acromegaly studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 32 type: ESTIMATED name: TE-8214 - SAD name: Placebo measure: Safety and tolerability of TE-8214 by the incidence of treatment-emergent adverse events (TEAEs) measure: Safety and tolerability of TE-8214 by the incidence of treatment-related adverse events measure: Safety and tolerability of TE-8214 by the incidence of injection site reactions (ISRs) measure: Safety and tolerability of TE-8214 by the incidence of clinically significant laboratory findings measure: Safety and tolerability of TE-8214 by the changes in physical examination findings measure: Safety and tolerability of TE-8214 by the changes in ECG findings measure: PK Parameters: Maximum observed concentration (Cmax) measure: PK Parameters: Time to maximum observed concentration (Tmax) measure: PK Parameters: Area under the concentration-time curve (AUC) from time zero to the last measurable concentration (AUC 0-last) sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: CMAX Clinical Research city: Adelaide state: South Australia zip: 5000 country: Australia name: Jessica Gehlert, Dr role: CONTACT lat: -34.92866 lon: 138.59863 hasResults: False

 nctId: NCT06372639 id: TAU-PTSD-TMS briefTitle: Characterization and Modulation of Traumatic Memories in PTSD Patients Using TMS overallStatus: RECRUITING date: 2022-02-23 date: 2024-11-24 date: 2024-11-24 date: 2024-04-18 date: 2024-04-18 name: Tel Aviv University class: OTHER briefSummary: Characterization and modulation of traumatic memories in PTSD patients using TMS. conditions: Post Traumatic Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Trans-Cranial Magnetic Stimulation measure: CAPS-5 score measure: Neurological measures of functional connectivity measure: Intrusive memories sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tel Aviv University status: RECRUITING city: Tel Aviv zip: 69978 country: Israel name: Yair Bar-Haim, PhD role: PRINCIPAL_INVESTIGATOR lat: 32.08088 lon: 34.78057 hasResults: False

 nctId: NCT06372626 id: ZG005-004 briefTitle: Study of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma. overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2026-07 date: 2026-08 date: 2024-04-18 date: 2024-04-18 name: Suzhou Zelgen Biopharmaceuticals Co.,Ltd class: INDUSTRY briefSummary: The trial is divided into two parts. PART 1 is a dose escalation study of the ZG005 combined with Etoposide and Cisplatin, primarily assessing the tolerability and safety of this combined treatment. PART 2 is a dose expansion study, further evaluating the preliminary efficacy and safety of this combined treatment. conditions: Neuroendocrine Carcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 93 type: ESTIMATED name: ZG005 name: Etoposide name: Cisplatin name: Placebo measure: Dose Limiting Toxicity (DLT) measure: Objective Response Rate (ORR) measure: Adverse Event (AE) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chinese PLA General Hospital city: Beijing state: Beijing zip: 100853 country: China name: Jianming Xu role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06372613 id: LRG&UC briefTitle: Association Between LRG and Endoscopic Remission in Ulcerative Colitis overallStatus: RECRUITING date: 2024-02-25 date: 2024-12-31 date: 2024-12-31 date: 2024-04-18 date: 2024-04-18 name: Showa Inan General Hospital class: OTHER briefSummary: We attempt to clarify the serum leucine-rich α 2-glycoprotein (LRG) level which predicts endoscopic remission in ulcerative colitis patients in this study. Colonoscopy with histology is performed when endoscopic remission will be predicted based on serum LRG values, irrespective of symptoms. Serum LRG levels were analyzed by an enzyme-linked immunosorbent assay. conditions: Ulcerative Colitis in Remission studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Endoscopic remission of UC sex: ALL minimumAge: 20 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Showa Inan General Hospital status: RECRUITING city: Komagane country: Japan name: Akira Horiuchi role: CONTACT lat: 35.71657 lon: 137.93745 hasResults: False

 nctId: NCT06372600 id: 2023-181 briefTitle: Effect of Extracorporeal Shock Wave Combined With Autologous Platelet-rich Plasma Injection on Rotator Cuff Calcific Tendinitis overallStatus: NOT_YET_RECRUITING date: 2025-06-01 date: 2025-12-31 date: 2026-02-20 date: 2024-04-18 date: 2024-04-18 name: Xiali Xue class: OTHER briefSummary: The purpose of this study is to explore the effect of extracorporeal shock wave combined with autologous platelet-rich plasma injection on the rehabilitation of rotator cuff calcific tendinitis, to provide new treatment methods and evidence for the rehabilitation of rotator cuff calcific tendinitis, and to reduce patients; pain and return to normal life as soon as possible. conditions: Rotator Cuff Tendinitis conditions: Rotator Cuff Tendinosis 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: Extracorporeal shock wave therapy device name: Platelet-rich plasma measure: Visual Analogue Scale,VAS measure: American Shoulder and Elbow Surgeon's Form,ASES measure: the university of California at Los Angeles shoulder rating scale, UCLA measure: The location and size of the calcifications were examined by ultrasound sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06372587 id: 5502 briefTitle: Next-Generation alzheImer'S Therapeutics acronym: ENERGISE overallStatus: RECRUITING date: 2023-12-19 date: 2024-12-30 date: 2027-02-28 date: 2024-04-18 date: 2024-04-18 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Is this the right time to use next-generation approaches in Alzheimer's disease (AD)? In recent years, several large clinical trials testing treatments for AD have failed, putting the entire field on a reset. AD drug trials have almost exclusively sought to use antibodies targeted toward misfolded amyloid and tau proteins. Of note, although these approaches have failed, they were designed to cover both familial and sporadic forms of AD. On the other hand, the failure in developing new effective drugs is attributed to, but not limited to, the highly heterogeneous nature of AD with multiple underlying hypotheses and multifactorial pathology. The idea underlying this project is based on the assumption that learning and memory disorders can arise when the connections between neurons do not change appropriately in response to experience. Thus, by intervening on the core mechanisms of the cellular correlate of learning and memory, i.e., synaptic plasticity, the investigators expect to preserve some of the essential brain functions in AD. By overcoming the limits of traditional AD therapeutic approaches, the investigators will use genetically encoded engineered proteins (GEEPs), which the investigators developed and tested in vitro and in murine models, to control their activity in living human neurons boosting synaptic plasticity. Indeed, outstanding and relevant progress in understanding synaptic physiology empowers the possibility to prevent or limit brain disease like never before. The investigators designed GEEPs to address some of the leading causes of synaptic plasticity failures documented in AD. Thus, GEEPs will be tested in human induced pluripotent stem cells (hiPSCs)-derived living neurons obtained from reprogrammed peripheral tissues of participants with Alzheimer's diseases. hiPSCs will be obtained from fibroblast-derived from a skin biopsy of participants with AD and controls performed in local anesthesia using a 4 mm punch. The findings will provide the first preclinical study on the effect of genetically engineered proteins to control essential pathways implicated in synaptic plasticity on AD-related cognitive decline. conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 14 type: ESTIMATED name: genetically encoded engineered proteins measure: To use genetically encoded engineered proteins to obtain an inducible control of their activity in living human neurons preventing dendritic spines loss measure: To leverage genetically encoded engineered proteins to prevent alterations in the morphology of dendritic spines in living human neurons measure: To use genetically encoded engineered proteins to obtain an inducible control of their activity in living human neurons promoting functional synaptic plasticity measure: To use genetically encoded engineered proteins to obtain evaluate neuronal excitability in living human neurons sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario A. Gemelli IRCCS status: RECRUITING city: Roma zip: 00168 country: Italy name: CRISTIAN RIPOLI role: CONTACT phone: +390630154966 email: cristian.ripoli@policlinicogemelli.it name: CRISTIAN RIPOLI role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06372574 id: GO44669 briefTitle: A Study of RO7617991 in Patients With Locally Advanced or Metastatic MAGE-A4-Positive Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2028-02-01 date: 2028-02-01 date: 2024-04-18 date: 2024-04-18 name: Genentech, Inc. class: INDUSTRY briefSummary: This study will evaluate the safety, tolerability, and pharmacokinetics of RO7617991, and will make a preliminary assessment of the anti-tumor activity of RO7617991 in human leukocyte antigen (HLA)-A\*02 eligible patients with locally advanced or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive solid tumors. conditions: Refractory Cancer conditions: Recurrent Cancer conditions: Solid Tumor, Adult studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 210 type: ESTIMATED name: RO7617991 name: Tocilizumab measure: Incidence and Severity of Adverse Events measure: Number of Participants with Abnormal Values in Targeted Vital Signs measure: Number of Participants with Abnormal Values in Clinical Laboratory Test Parameters measure: Serum Concentration of RO7617991 at Specific Timepoints measure: Objective Response Rate (ORR), as Determined by the Investigator According to RECIST v1.1 measure: Duration of Response (DOR), as Determined by the Investigator According to RECIST v1.1 measure: Progression-Free Survival (PFS), as Determined by the Investigator According to RECIST v1.1 measure: Overall Survival (OS) measure: Prevalence of Anti-Drug Antibodies (ADAs) to RO7617991 at Baseline and Incidence of ADAs to RO7617991 During the Study sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06372561 id: Melatonin- vital pulp therapy briefTitle: Comparative Evaluation of Melatonin Versus MTA on Vital Pulp Therapy in Young Permanent First Molars: An in Vivo Study overallStatus: RECRUITING date: 2023-05-20 date: 2024-05-20 date: 2024-06-20 date: 2024-04-18 date: 2024-04-18 name: Suez Canal University class: OTHER briefSummary: The process of dental caries is dynamic and can be either reversible or irreversible depending on the balance between protective and pathologic factors in the oral cavity. Untreated dental caries causes pulpal injury, inflammation, and necrosis. Melatonin plays an essential role in the regulation of bone growth. The actions that melatonin exerts on odontoblasts may be similar to its action on osteoblasts. conditions: Dental Caries in Children conditions: Vital Pulp Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 45 type: ESTIMATED name: Mineral trioxide aggregate (dressing material) name: Melatonin (dressing material) measure: Clinically assessment (Modified visual analogue scale) measure: Clinically assessment (Millar's index) measure: Clinically assessment (presence or abscence) measure: Radiographic assessment (using Image J software program) measure: Radiographic assessment (using Image J software program) measure: Radiographic assessment (using Image J software program) measure: Radiographic assessment (using Image J software program) measure: Radiographic assessment (using Image J software program) sex: ALL minimumAge: 6 Years maximumAge: 8 Years stdAges: CHILD facility: Faculty of Medicine, Suez canal university status: RECRUITING city: Ismailia zip: 41522 country: Egypt name: Ismail Dahshan, PHD role: CONTACT phone: 01012715799 email: dahshan1633@gmail.com lat: 30.60427 lon: 32.27225 hasResults: False

 nctId: NCT06372548 id: NEADS0004 briefTitle: Rehabilitation Training Games for Children With Amblyopia overallStatus: RECRUITING date: 2023-03-01 date: 2024-06-01 date: 2024-08-01 date: 2024-04-18 date: 2024-04-18 name: Zhu Dian class: OTHER briefSummary: A gamification product was developed to guide children with amblyopia to develop rehabilitation training habits by combining cognitive evaluation theory and occlusion therapy. A randomized controlled trial was conducted to examine the ease of use, acceptability and treatment compliance of the game. conditions: Amblyopia conditions: Amblyopia Occlusion conditions: Child Behavior conditions: Adherence, Treatment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 34 type: ESTIMATED name: Find You! Cure My Animal Friends name: DuoBao Vision Training System measure: 8-Item Morisky Medication Adherence Scale (MMAS-8): measure: User Experience Questionnaire (UEQ) sex: ALL minimumAge: 7 Years maximumAge: 10 Years stdAges: CHILD facility: Shanghai Jiao Tong University status: RECRUITING city: Shanghai state: Shanghai zip: 200240 country: China name: Zhao Liu role: CONTACT phone: +8618901626266 email: hotlz@sjtu.edu.cn lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06372535 id: FujianUTCM-1 briefTitle: Effects of Tai Chi Chuan With Different Doses on Cognitive Function in Elderly Patients With Mild Cognitive Impairment overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-06-15 date: 2025-09-30 date: 2024-04-18 date: 2024-04-18 name: Lidian Chen class: OTHER name: Peking University Third Hospital briefSummary: To determine the impact of Tai Chi Chuan with different exercise volume on cognitive function in elderly patients with mild cognitive impairment. conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 540 type: ESTIMATED name: Tai Chi Chuan （dose 1） name: Tai Chi Chuan （dose 2） name: Tai Chi Chuan （dose 3） name: Tai Chi Chuan （dose 4） name: Tai Chi Chuan （dose 5） name: Tai Chi Chuan （dose 6） name: Tai Chi Chuan （dose 7） name: Tai Chi Chuan （dose 8） name: Tai Chi Chuan （dose 9） measure: Montreal Cognitive Assessment measure: Montreal Cognitive Assessment measure: Wechsler Memory Scale measure: Digital Symbol test measure: Trial Making Test part B measure: Stroop color word test measure: Boston naming test measure: Rey-Osterrieth complex graphics test measure: Rey Auditory Verbal Learning Test measure: Blood glucose metabolism index measure: Blood lipid metabolism index measure: Functional Magnetic Resonance Imaging measure: Electroencephalogram measure: Heart rate variability measure: Gut microflora measure: Sleep Quality measure: General health sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06372522 id: RMB-0517-23 briefTitle: Oxytocin in Multiparous Women overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2027-04 date: 2024-04-18 date: 2024-04-18 name: Rambam Health Care Campus class: OTHER briefSummary: This is a randomized controlled trial investigating whether continuous oxytocin infusion in multiparous women shortens time to delivery, without altering maternal or neonatal outcomes, in augmented deliveries, compared to intermittent infusion. conditions: Pregnancy Related studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 166 type: ESTIMATED name: Pitocin Injectable Product measure: The rate of women delivering within 24 hours. measure: Length of latent and active phases of labor. measure: The rate of instrumental and caesarean deliveries. measure: chorioamnionitis measure: obstetric anal sphincter injuries (OASIS) measure: hyponatremia measure: post-partum hemorrhage (PPH) measure: neonatal outcome - 1 and 5-minute Apgar score measure: umbilical artery pH measure: NICU admission measure: Women's satisfaction. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06372509 id: L2-070 briefTitle: A Proteomic Analysis for Understanding the Link Between Migraine and Cardiovascular Disease acronym: PMCD overallStatus: RECRUITING date: 2024-04-03 date: 2025-10-30 date: 2025-10-30 date: 2024-04-18 date: 2024-04-18 name: Centro Cardiologico Monzino class: OTHER name: IRCCS Policlinico S. Donato briefSummary: This is a multicenter, prospective observational study. Will be collecting data from 90 consecutive patients (aged 25- 60 years ) with and without migraine admitted at our Hospital. Primary aim of the study will be to assess the correlation between migraine and proteomic profiling of plasma and their possible correlation with known cardio and cerebrovascular disease and CV risk factors. conditions: Coronary Artery Disease conditions: Migraine conditions: Cardiovascular Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 90 type: ESTIMATED measure: Correlation between migraine and proteomic profiling of plasma sex: ALL minimumAge: 25 Years maximumAge: 60 Years stdAges: ADULT facility: Centro Cardiologico Monzino status: RECRUITING city: Milano state: Milan zip: 20131 country: Italy name: Daniela Trabattoni, MD role: CONTACT phone: 0258002780 email: daniela.trabattoni@cardiologicomonzino.it lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06372496 id: 219912 briefTitle: Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma overallStatus: NOT_YET_RECRUITING date: 2024-04-16 date: 2026-03-11 date: 2026-03-11 date: 2024-04-18 date: 2024-04-18 name: GlaxoSmithKline class: INDUSTRY briefSummary: The goal of this study is to assess and compare the effectiveness of fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI) with inhaled corticosteroids/long-acting beta-2 agonists (ICS/LABA) in adult participants with uncontrolled asthma conditions: Asthma studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1136 type: ESTIMATED name: Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate name: Inhaled corticosteroids/long-acting beta-2 agonists measure: Change from baseline in trough forced expiratory volume in 1 second (FEV1) measure: Number of participants achieving ≥0.5 point improvement from baseline for the Asthma Control Questionnaire-7 (ACQ-7) after 24 weeks of treatment measure: Number of participants achieving the composite endpoint at Week in participants after 52 weeks of treatment measure: Change from baseline in trough forced expiratory volume in 1 second (FEV1) after 52 weeks of treatment measure: Number of participants achieving ≥0.5 point improvement from baseline for the ACQ-7 after 52 weeks of treatment measure: Number of participants achieving ≥0.5 point improvement from baseline for the Asthma Control Questionnaire-6 (ACQ-6) after 24 and 52 weeks of treatment measure: Number of participants achieving ≥0.5 point improvement from baseline for the ACQ-5 after 24 and 52 weeks of treatment measure: Change from baseline in the ACQ-7 total score after 24 and 52 weeks of treatment measure: Change from baseline in the ACQ-5 total score after 24 and 52 weeks of treatment measure: Change from baseline in the ACQ-6 total score after 24 and 52 weeks of treatment measure: Change from baseline in the Asthma Control Test (ACT) score after 24 and 52 weeks of treatment measure: Number of participants achieving the composite endpoint among those on budesonide/formoterol prior to randomization measure: Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ-12) total scores after 24 and 52 weeks of treatment measure: Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ-12) domain scores after 24 and 52 weeks of treatment measure: Change from baseline in the four domains of the asthma-specific adaptation of the Work Productivity and Activity Impairment Questionnaire (WPAI:Asthma) after 24 and 52 weeks of treatment measure: Change from baseline in trough forced expiratory volume in 1 second (FEV1) among participants on budesonide/formoterol prior to randomization measure: Number of participants achieving ≥0.5 points improvement from baseline for ACQ-7 among participants on budesonide/formoterol prior to randomization measure: Change from baseline in the ACQ-7 total score among participants on budesonide/formoterol prior to randomization measure: Change from baseline in trough forced expiratory volume in 1 second (FEV1) for participants with no treatment prior to randomization. measure: Number of participants achieving ≥0.5 points improvement from baseline for ACQ-7 for participants with no treatment prior to randomization. measure: Change from baseline in the ACQ-7 total score for participants with no treatment prior to randomization. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GSK Investigational Site city: Little Rock state: Arkansas zip: 72205 country: United States 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: Karl V Sitz role: PRINCIPAL_INVESTIGATOR lat: 34.74648 lon: -92.28959 facility: GSK Investigational Site city: Newport Beach state: California zip: 92663 country: United States 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: Ryan Mitchell Klein role: PRINCIPAL_INVESTIGATOR lat: 33.61891 lon: -117.92895 facility: GSK Investigational Site city: Miami state: Florida zip: 33135 country: United States 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: Enrique Villa role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: GSK Investigational Site city: Miami state: Florida zip: 33173 country: United States 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: Ileana C. Rodicio role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: GSK Investigational Site city: Miami state: Florida zip: 33173 country: United States 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: Jaime Landman role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: GSK Investigational Site city: Orlando state: Florida zip: 32819 country: United States 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: Marvin Heuer role: PRINCIPAL_INVESTIGATOR lat: 28.53834 lon: -81.37924 facility: GSK Investigational Site city: Port Charlotte state: Florida zip: 33952 country: United States 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: Joseph Ravid role: PRINCIPAL_INVESTIGATOR lat: 26.97617 lon: -82.09064 facility: GSK Investigational Site city: Tallahassee state: Florida zip: 32308 country: United States 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: Ronald H. Saff role: PRINCIPAL_INVESTIGATOR lat: 30.43826 lon: -84.28073 facility: GSK Investigational Site city: Columbus state: Georgia zip: 31904 country: United States 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: Robert R Chrzanowski role: PRINCIPAL_INVESTIGATOR lat: 32.46098 lon: -84.98771 facility: GSK Investigational Site city: Normal state: Illinois zip: 61761 country: United States 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: Dareen Siri role: PRINCIPAL_INVESTIGATOR lat: 40.5142 lon: -88.99063 facility: GSK Investigational Site city: Bangor state: Maine zip: 04401 country: United States 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: Paul Alan Shapero role: PRINCIPAL_INVESTIGATOR lat: 44.80118 lon: -68.77781 facility: GSK Investigational Site city: Columbia state: Maryland zip: 21044 country: United States 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: David Nyanjom role: PRINCIPAL_INVESTIGATOR lat: 39.24038 lon: -76.83942 facility: GSK Investigational Site city: Brick state: New Jersey zip: 08724 country: United States 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: Bruce DeCotiis role: PRINCIPAL_INVESTIGATOR lat: 40.05928 lon: -74.13708 facility: GSK Investigational Site city: Linwood state: New Jersey zip: 08221 country: United States 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: Allen Silvey role: PRINCIPAL_INVESTIGATOR lat: 39.33984 lon: -74.57516 facility: GSK Investigational Site city: New Windsor state: New York zip: 12553 country: United States 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: Sashi Makam role: PRINCIPAL_INVESTIGATOR lat: 41.47676 lon: -74.02375 facility: GSK Investigational Site city: Asheville state: North Carolina zip: 28801 country: United States 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: David Cypcar role: PRINCIPAL_INVESTIGATOR lat: 35.60095 lon: -82.55402 facility: GSK Investigational Site city: Charlotte state: North Carolina zip: 28273 country: United States 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: Emeka M Eziri role: PRINCIPAL_INVESTIGATOR lat: 35.22709 lon: -80.84313 facility: GSK Investigational Site city: Greenville state: North Carolina zip: 27834 country: United States 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: Bryan Dunn role: PRINCIPAL_INVESTIGATOR lat: 35.61266 lon: -77.36635 facility: GSK Investigational Site city: Raleigh state: North Carolina zip: 27607 country: United States 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: Craig F LaForce role: PRINCIPAL_INVESTIGATOR lat: 35.7721 lon: -78.63861 facility: GSK Investigational Site city: Winston-Salem state: North Carolina zip: 27104 country: United States 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: Wendy C Moore role: PRINCIPAL_INVESTIGATOR lat: 36.09986 lon: -80.24422 facility: GSK Investigational Site city: Cincinnati state: Ohio zip: 45231 country: United States 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: David I Bernstein role: PRINCIPAL_INVESTIGATOR lat: 39.12713 lon: -84.51435 facility: GSK Investigational Site city: Philadelphia state: Pennsylvania zip: 19107 country: United States 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: Sadia Benzaquen role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 facility: GSK Investigational Site city: Philadelphia state: Pennsylvania zip: 19140 country: United States 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: Kartik Shenoy role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 facility: GSK Investigational Site city: Pittsburgh state: Pennsylvania zip: 15241 country: United States 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: Michael J. Palumbo role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 facility: GSK Investigational Site city: Rock Hill state: South Carolina zip: 29732 country: United States 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: Michael Denenberg role: PRINCIPAL_INVESTIGATOR lat: 34.92487 lon: -81.02508 facility: GSK Investigational Site city: Spartanburg state: South Carolina zip: 29303 country: United States 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: Farhan Siddiqui role: PRINCIPAL_INVESTIGATOR lat: 34.94957 lon: -81.93205 facility: GSK Investigational Site city: Dallas state: Texas zip: 75246 country: United States 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: Mark W Millard role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 facility: GSK Investigational Site city: Kerrville state: Texas zip: 78028 country: United States 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: Dale E Mohar role: PRINCIPAL_INVESTIGATOR lat: 30.04743 lon: -99.14032 facility: GSK Investigational Site city: Waco state: Texas zip: 76712 country: United States 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: Niran J. Amar role: PRINCIPAL_INVESTIGATOR lat: 31.54933 lon: -97.14667 facility: GSK Investigational Site city: Ciudad Autónoma de Buenos Aires state: Buenos Aires zip: C1192AAW country: Argentina 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: Ana Maria Stok role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: GSK Investigational Site city: Florencio Varela state: Buenos Aires zip: 1888 country: Argentina 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: Andrea Cintia Medina role: PRINCIPAL_INVESTIGATOR lat: -34.82722 lon: -58.39556 facility: GSK Investigational Site city: Mar del Plata state: Buenos Aires zip: 7600 country: Argentina 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: Luis Wehbe role: PRINCIPAL_INVESTIGATOR lat: -38.00228 lon: -57.55754 facility: GSK Investigational Site city: Cordoba state: Córdova zip: X5003DCE country: Argentina 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: Victor Hugo Cambursano role: PRINCIPAL_INVESTIGATOR lat: -31.4135 lon: -64.18105 facility: GSK Investigational Site city: Rosario state: Santa Fe zip: 2000 country: Argentina 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: Adriana M. Marcipar role: PRINCIPAL_INVESTIGATOR lat: -32.94682 lon: -60.63932 facility: GSK Investigational Site city: Rosario state: Santa Fe zip: S2000DBS country: Argentina 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: Ledit R F Ardusso role: PRINCIPAL_INVESTIGATOR lat: -32.94682 lon: -60.63932 facility: GSK Investigational Site city: Ciudad Autonoma de Buenos Aires zip: C1425BEN country: Argentina 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: Anahi Yanez role: PRINCIPAL_INVESTIGATOR lat: -34.61315 lon: -58.37723 facility: GSK Investigational Site city: Mendoza zip: 5500 country: Argentina 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: Pablo Saez Scherbovsky role: PRINCIPAL_INVESTIGATOR lat: -32.89084 lon: -68.82717 facility: GSK Investigational Site city: Rosario zip: 2000 country: Argentina 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: Gabriel Gattolin role: PRINCIPAL_INVESTIGATOR lat: -32.94682 lon: -60.63932 facility: GSK Investigational Site city: Bruce state: Australian Capital Territory zip: 2617 country: Australia 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: Amber Leah role: PRINCIPAL_INVESTIGATOR lat: -32.46667 lon: 138.2 facility: GSK Investigational Site city: Blacktown state: New South Wales zip: 2148 country: Australia 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: Rahul Mohan role: PRINCIPAL_INVESTIGATOR lat: -33.76667 lon: 150.91667 facility: GSK Investigational Site city: Campbelltown state: New South Wales zip: 2560 country: Australia 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: Belinda Cochrane role: PRINCIPAL_INVESTIGATOR lat: -34.06667 lon: 150.81667 facility: GSK Investigational Site city: Coffs Harbour state: New South Wales zip: 2450 country: Australia 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: Olga O Voloshyna role: PRINCIPAL_INVESTIGATOR lat: -30.29626 lon: 153.11351 facility: GSK Investigational Site city: Kanwal state: New South Wales zip: 2259 country: Australia 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: Dominic Douglas role: PRINCIPAL_INVESTIGATOR lat: -33.253 lon: 151.4911 facility: GSK Investigational Site city: Brisbane state: Queensland zip: 4006 country: Australia 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: Esmond Leong role: PRINCIPAL_INVESTIGATOR lat: -27.46794 lon: 153.02809 facility: GSK Investigational Site city: Spearwood state: Western Australia zip: 6163 country: Australia 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: Peter R Bremner role: PRINCIPAL_INVESTIGATOR lat: -32.10534 lon: 115.77797 facility: GSK Investigational Site city: Brampton state: Ontario zip: L6T 0G1 country: Canada 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: Naresh K. Aggarwal role: PRINCIPAL_INVESTIGATOR lat: 43.68341 lon: -79.76633 facility: GSK Investigational Site city: Windsor state: Ontario zip: N8X 1T3 country: Canada 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: Syed Anees role: PRINCIPAL_INVESTIGATOR lat: 42.30008 lon: -83.01654 facility: GSK Investigational Site city: Trois-Rivieres state: Quebec zip: G9A 4P3 country: Canada 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: Patrice Gauthier role: PRINCIPAL_INVESTIGATOR lat: 46.34515 lon: -72.5477 facility: GSK Investigational Site city: Saskatoon state: Saskatchewan zip: S7N OW8 country: Canada 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: Erika Dianne Penz role: PRINCIPAL_INVESTIGATOR lat: 52.13238 lon: -106.66892 facility: GSK Investigational Site city: Fukuoka zip: 802-0083 country: Japan 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: Shinichi Osaki role: PRINCIPAL_INVESTIGATOR lat: 33.6 lon: 130.41667 facility: GSK Investigational Site city: Fukuoka zip: 816-0813 country: Japan 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: Yuji Kawarada role: PRINCIPAL_INVESTIGATOR lat: 33.6 lon: 130.41667 facility: GSK Investigational Site city: Gifu zip: 509-6134 country: Japan 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: Hiroyuki Ohbayashi role: PRINCIPAL_INVESTIGATOR lat: 35.42291 lon: 136.76039 facility: GSK Investigational Site city: Hiroshima zip: 730-0853 country: Japan 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: Yoshinori Haruta role: PRINCIPAL_INVESTIGATOR lat: 34.4 lon: 132.45 facility: GSK Investigational Site city: Hyogo zip: 651-0053 country: Japan 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: Hiroki Kawabata role: PRINCIPAL_INVESTIGATOR facility: GSK Investigational Site city: Kagawa zip: 761-8073 country: Japan 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: Tadashi Kamei role: PRINCIPAL_INVESTIGATOR facility: GSK Investigational Site city: Miyazaki zip: 880-2112 country: Japan 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: Rei Fujiki role: PRINCIPAL_INVESTIGATOR lat: 31.91667 lon: 131.41667 facility: GSK Investigational Site city: Miyazaki zip: 889-4304 country: Japan 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: Kenjiro Nagai role: PRINCIPAL_INVESTIGATOR lat: 31.91667 lon: 131.41667 facility: GSK Investigational Site city: Niigata zip: 950-0088 country: Japan 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: Yuki Nishiyama role: PRINCIPAL_INVESTIGATOR lat: 37.88637 lon: 139.00589 facility: GSK Investigational Site city: Tokyo zip: 105-0001 country: Japan 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: Akira Mizoo role: PRINCIPAL_INVESTIGATOR lat: 35.6895 lon: 139.69171 facility: GSK Investigational Site city: Tokyo zip: 157-0066 country: Japan 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: Akiyoshi Sasamoto role: PRINCIPAL_INVESTIGATOR lat: 35.6895 lon: 139.69171 facility: GSK Investigational Site city: Tokyo zip: 160-0017 country: Japan 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: Takahiro Yokoyama role: PRINCIPAL_INVESTIGATOR lat: 35.6895 lon: 139.69171 facility: GSK Investigational Site city: Daegu zip: 41404 country: Korea, Republic of 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: Han-Ki Park role: PRINCIPAL_INVESTIGATOR lat: 35.87028 lon: 128.59111 facility: GSK Investigational Site city: Seoul zip: 02841 country: Korea, Republic of 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: Byung-Keun Kim role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: GSK Investigational Site city: Seoul zip: 03080 country: Korea, Republic of 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: Hye-Ryun Kang role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: GSK Investigational Site city: Seoul zip: 07061 country: Korea, Republic of 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: Min-Suk Yang role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: GSK Investigational Site city: Seoul zip: 133-792 country: Korea, Republic of 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: Sang-Heon Kim role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: GSK Investigational Site city: Kaohsiung zip: 807 country: Taiwan 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: Chau-Chyun Sheu role: PRINCIPAL_INVESTIGATOR lat: 22.61626 lon: 120.31333 facility: GSK Investigational Site city: Taichung zip: 40447 country: Taiwan 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: Chia-Hung Chen role: PRINCIPAL_INVESTIGATOR lat: 24.1469 lon: 120.6839 facility: GSK Investigational Site city: Taichung zip: 407219 country: Taiwan 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: Pin-Kuei Fu role: PRINCIPAL_INVESTIGATOR lat: 24.1469 lon: 120.6839 hasResults: False

 nctId: NCT06372483 id: VMX-C001-03 id: 2023-507059-32-00 type: CTIS briefTitle: Single Dose Trial of VMX-C001 in Healthy Subjects With and Without FXa Direct Oral Anticoagulant overallStatus: RECRUITING date: 2024-02-21 date: 2024-09 date: 2024-09 date: 2024-04-18 date: 2024-04-18 name: VarmX B.V. class: INDUSTRY briefSummary: A single centre, double-blind, randomized, placebo-controlled single dose study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of VMX-C001, conducted in two parts:

Part 1: Single dose of VMX-C001 or placebo in healthy volunteers.

Part 2: Single dose of VMX-C001 or placebo in combination with a selected factor 10a (FXa) direct oral anticoagulant (DOAC) in healthy older subjects. conditions: Coagulation Disorder studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Placebo controlled, single dose. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double-blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: VMX-C001 name: Placebo name: Rivaroxaban 20 mg Oral Tablet name: Apixaban 5 mg Oral Tablet name: Edoxaban 60 mg Oral Tablet measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part 1) measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Part 2) measure: PK of VMX-C001 in plasma - Cmax measure: PK of VMX-C001 in plasma - tmax measure: PK of VMX-C001 in plasma - t1/2 measure: PK of VMX-C001 in plasma - AUC0-last measure: PK of VMX-C001 in plasma - AUC0-inf measure: PK of VMX-C001 in plasma - Lambda z measure: PK of VMX-C001 in plasma - CL measure: PK of VMX-C001 in plasma - Vz measure: DOAC plasma concentrations (Part 2) measure: Change in Prothrombin time (PT) following dosing with VMX-C001 measure: Change in activated partial thromboplastin time (aPTT) following dosing with VMX-C001 measure: Change in D-dimer following dosing with VMX-C001 measure: Change in prothrombin fragments F1 and 2 following dosing with VMX-C001 measure: Change in thrombin generation, measured by lag time, following dosing with VMX-C001 measure: Change in thrombin generation, measured by endogenous thrombin potential, following dosing with VMX-C001 measure: Change in thrombin generation, measured by peak height, following dosing with VMX-C001 measure: Change in thrombin generation, measured by time to peak, following dosing with VMX-C001 measure: Change in thrombin generation, measured by velocity index, following dosing with VMX-C001 measure: Change in thrombin generation, measured by time to tail, following dosing with VMX-C001 measure: Change in diluted prothrombin time (dPT) following dosing with VMX-C001 measure: Change in diluted Russell Viper Venom time (dRVVT) following dosing with VMX-C001 measure: Change in real time activated clotting time (ACT) following dosing with VMX-C001 measure: Antibodies against VMX-C001 in plasma measure: Antibodies against human coagulation FX in plasma sex: ALL minimumAge: 18 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ICON status: RECRUITING city: Groningen zip: 9728 NZ country: Netherlands name: Salah Hadi, MD role: CONTACT phone: +31 50 8505 798 email: info@iconclinicaltrials.com lat: 53.21917 lon: 6.56667 hasResults: False

 nctId: NCT06372470 id: CLM-HTN-005 briefTitle: Personalised Dose Optimisation of Zestril Supported by the Digital Blood Pressure Diary in a Primary Care Environment in England: Pragmatic Observational Pilot Study for Remote Hypertension Treatment acronym: OptiZest overallStatus: RECRUITING date: 2024-04-15 date: 2024-08-31 date: 2024-08-31 date: 2024-04-18 date: 2024-04-23 name: Closed Loop Medicine class: INDUSTRY name: Pharmanovia briefSummary: A pragmatic observational proof-of-concept study which aims to determine the feasibility of a remote titration clinic, assisted by home blood pressure monitoring and digital solutions, and assess its impact on real-world outcomes. By incorporating home blood pressure monitoring, the study seeks to offer a promising solution for personalised drug titration and self-management, potentially enhancing patient outcomes while optimising Zestril utilisation conditions: Uncomplicated Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Zestril measure: Achieving target Home Blood Pressure measure: Reduction in systolic blood pressure (SBP) measure: Reduction in diastolic blood pressure (DBP) measure: The time to achieve BP Control (BPC) measure: Patient daily adherence to prescribed medication measure: Adherence to collecting data using the electronic BP diary measure: Patients' thoughts and feelings about BP/treatment measure: Discontinuation of Zestril due to unwanted side effects measure: Number and type of spontaneously reported unwanted side effects measure: User experience and feasibility of the blood pressure digital diary sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Norwich Health Centre status: RECRUITING city: Norwich country: United Kingdom name: Serge Engamba, MD role: CONTACT phone: 01603987074 email: serge.engamba@nhs.net name: Marc Buckingham role: CONTACT email: marc.buckingham@nhs.net lat: 52.62783 lon: 1.29834 hasResults: False

 nctId: NCT06372457 id: CV027-1107 briefTitle: COLLIGO-HCM: A Multinational Observational Study of the Real-World Effectiveness of Mavacamten Among Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) acronym: COLLIGO-HCM overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-01 date: 2025-03-01 date: 2025-06-15 date: 2024-04-18 date: 2024-04-18 name: Bristol-Myers Squibb class: INDUSTRY briefSummary: COLLIGO-HCM is a global observational study that will conduct observational research of hypertrophic cardiomyopathy (HCM) treatment in real-world clinical practice. conditions: Hypertrophic Cardiomyopathy (HCM) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 500 type: ESTIMATED name: Approved Hypertrophic Cardiomyopathy drug treatments name: Mavacamten measure: Participant age at Hypertrophic Cardiomyopathy (HCM) diagnosis measure: Participant age at mavacamten treatment initiation measure: Participant sex measure: Participant race/ethnicity measure: Participant insurance coverage measure: Participant employment status measure: Participant educational level measure: Date of Hypertrophic Cardiomyopathy (HCM) diagnosis measure: Participant body mass index (BMI) at Hypertrophic Cardiomyopathy (HCM) diagnosis measure: Hypertrophic Cardiomyopathy (HCM) subtype at diagnosis measure: Participant echocardiogram (ECHO) parameters at Hypertrophic Cardiomyopathy (HCM) diagnosis measure: Participant New York Heart Association (NYHA) class measure: Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis measure: Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis measure: Participant height measure: Participant weight measure: Participant blood pressure measure: Participant heart rate measure: Participant Hypertrophic Cardiomyopathy (HCM) symptoms measure: European participant CYP2C19 genotype measure: Participant family history of Hypertrophic Cardiomyopathy (HCM) measure: Participant family history of obstructive Hypertrophic Cardiomyopathy o(HCM) measure: Participant family history of sudden cardiac death (SCD) measure: Participant smoking status measure: Participant alcohol use measure: Participant recreational drug use measure: Participant involvement in a Hypertrophy Cardiomyopathy (HCM) randomized clinical trial (RCT) measure: Participant cardiovascular (CV) and CV-related comorbidities measure: Participant non-cardiovascular (CV)-related comorbidities measure: Participant electrocardiogram (ECG) rhythm results measure: Participant cardiac magnetic resonance imaging (MRI) results measure: Participant N-terminal pro-B-type natriuretic peptide (NT-proBNP) results measure: Participant cardiac troponin results measure: Participant cardiopulmonary exercise test (CPET) results measure: Participant cardiac monitoring results measure: Participant exercise test results measure: Participant blood creatine levels measure: Participant cardiovascular (CV) events measure: Type of procedures received by participants measure: Cardiovascular treatments prescribed to participants measure: Date of mavacamten prescription measure: Date of mavacamten treatment initiation measure: Date of mavacamten dosage change measure: Reason for mavacamten dosage change measure: Occurrence of mavacamten stable dose (a period of 6-months with the same dose) measure: Dates of follow-up after mavacamten treatment initiation measure: Date of mavacamten treatment interuption or discontinuation measure: Reason for mavacamten treatment interuption or discontinuation measure: Supportive care provided to participants measure: Heath care resource utilization (HCRU) measure: Hypertrophic Cardiomyopathy (HCM) symptom improvement post mavacamten treatment initiation measure: Participant obstructive Hypertrophic Cardiomyopathy (oHCM) symptoms measure: Participant family history of Hypertrophic Cardiomyopathy (HCM) or obstructive Hypertrophic Cardiomyopathy (oHCM) measure: Participant family history of sudden cardiac death (SCD) measure: Cardiovascular (CV) and CV-related comorbidities measure: Non-cardiovascular (non-CV) comorbidities measure: Participant electrocardiogram (ECG) rhythm results measure: Participant echocardiogram (ECHO) results measure: Participant cardiac MRI results measure: Participant NT-proBNP results measure: Participant cardiac tropin results measure: Participant cardiopulmonary exercise test (CPET) results measure: Participant cardiac monitoring results measure: Participant exercise test results measure: Hypertrophic Cardiomyopathy (HCM) subtype measure: Participant symptoms at Hypertrophic Cardiomyopathy (HCM) measure: Participant New York Heart Association (NYHA) class measure: Reason/trigger for initiating the path to Hypertrophic Cardiomyopathy (HCM) diagnosis measure: Date of reason/trigger that initiated the path to Hypertrophic Cardiomyopathy (HCM) diagnosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IQVIA city: Durham state: North Carolina zip: 27703 country: United States lat: 35.99403 lon: -78.89862 hasResults: False

 nctId: NCT06372444 id: 995725 briefTitle: Mechanisms of Acute Kidney Injury in Severe Infections acronym: PET-AKI overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-03 date: 2026-06-30 date: 2024-04-18 date: 2024-04-19 name: Uppsala University Hospital class: OTHER briefSummary: Renal perfusion and neutrophil-mediated inflammation will be assessed in the kidney in sepsis patients with acute kidney injury using positron emission tomography. For marked water will be used for renal perfusion and a newly developed PET tracer molecule (11C-GW457427) with specific binding to neutrophil elastase which provides a measure of the amount of infiltrating neutrophils in the renal parenchyma for inflammation. The study is performed in a PET-CT camera where anatomical imaging takes place at the same time as the PET examinations. conditions: Sepsis conditions: AKI - Acute Kidney Injury conditions: Positron Emission Tomography (PET) studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 15 type: ESTIMATED name: Positron emission tomography (PET) measure: Renal perfusion in patients with sepsis and acute kidney injury (AKI) measured by 15O-labeled water in dynamic positron emission tomography (PET) measure: Presence of neutrophil elastase in the kidneys in patients with sepsis and acute kidney injury (AKI) by 11C-GW457427 measured with dynamic positron emission tomography (PET) sex: ALL minimumAge: 30 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06372431 id: D1843R00360 briefTitle: PRospectIve ObseRvatIonal mulTicenter Study of Patients With Arterial hYpertension and CKD in the Population of Russia acronym: PRIORITY-CKD overallStatus: NOT_YET_RECRUITING date: 2024-04-24 date: 2025-10-31 date: 2025-10-31 date: 2024-04-18 date: 2024-04-18 name: AstraZeneca class: INDUSTRY briefSummary: This study is a multi-centre, non-interventional, observational, prospective study with retrospective analysis. The main purpose of the study is to describe the rate of CKD diagnosis in patients with AH and CKD markers. This study will include 10 000 adult outpatients with arterial hypertension, who have one or more Chronic Kidney Disease laboratory markers (without recorded CKD diagnosis prior to enrolment) and have no diabetes mellitus or chronic heart failure, who are monitored and treated by cardiologists or internal medicine specialists in approximately 50 outpatient sites in about 20 regions in Russia.

This observational study does not provide for any diagnostic and therapeutic procedures other than those used in routine practice. conditions: Arterial Hypertension, Chronic Kidney Disease studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 10000 type: ESTIMATED measure: To describe the rate of CKD diagnosis in patients with AH and CKD markers. measure: To describe demographic and clinical characteristics of patients with AH and CKD markers measure: To describe clinical characteristics of patients with AH and diagnosed CKD during this study (on Visit 1 or Visit 2) and profile of routine therapy before and after CKD diagnosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06372418 id: KEMRI/SERU/CGMR-C/238/4326 briefTitle: Providing Breastfeeding Support After Discharge From Hospital to Improve Growth and Development of Malnourished Infants acronym: IBAMI-2 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-02 date: 2027-02 date: 2024-04-18 date: 2024-04-18 name: University of Oxford class: OTHER briefSummary: The current guidelines used to manage malnutrition among infants aged below 6 months (u6m) recommend that infants admitted to hospital with malnutrition be supported to reestablish exclusive breastfeeding before discharge. Studies have shown that reestablishing exclusive breastfeeding among infants being treated for acute malnutrition is possible. However, follow-up of the infants after discharge has revealed poor growth raising questions about what happens to infant feeding practices after discharge and whether providing breastfeeding support to mothers after discharge would help improve the recovery and growth of their infants.

Providing a package of home-based care with breastfeeding support to mothers of infants u6m recovering from acute malnutrition has the potential to improve the retention of exclusive breastfeeding and lead to enhanced infant growth and survival. To date, no such post-discharge package of care is available in Kenya or other lower and meddle income countries (LMICs). The aim of this study is to apply participatory, qualitative and quantitative approaches to develop and evaluate the impact of a post-discharge package of care on the growth and development of acutely ill malnourished infants after discharge from hospital. conditions: Malnutrition, Infant conditions: Breastfeeding, Exclusive studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Control Trial:

Participants will be randomized to either receive Breastfeeding support intervention (BFSI) or standard of care. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Fieldworkers collecting endpoint data at 6 months of age will be blinded to group allocation to avoid any bias subject to knowledge of group allocation. whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: Breastfeeding peer support intervention name: Standard Care measure: Weight gain measure: Morbidity measure: Mortality sex: ALL minimumAge: 4 Weeks maximumAge: 12 Weeks stdAges: CHILD hasResults: False

 nctId: NCT06372405 id: PSP-501/D125/79/00000 briefTitle: Instructed Cognitive Reappraisal in Reducing Affective, Behavioral and Psychophysiological Symptoms of Misophonia overallStatus: RECRUITING date: 2024-03-18 date: 2024-12 date: 2025-09-30 date: 2024-04-18 date: 2024-04-18 name: University of Warsaw, Poland class: OTHER name: Duke University briefSummary: Misophonia is a disorder causing intense reactions to specific sounds, disrupting daily life. Current treatments lack evidence-based support. The goal of this study is to explore the effectiveness of cognitive reappraisal (CR) in reducing misophonic responses. The study involves 100 participants assigned to either a 4-week CR program or Autogenic Training. Emotional regulation, symptoms of anxiety and depression, quality of life, and more will be assessed using various questionnaire-based measures; perseverations with a task-based test (Wisconsin Card Sorting Test); the presence of psychiatric and personality disorders using face-to-face interviews (The Mini-International Neuropsychiatric Interview (M.I.N.I.) and "Structured Clinical Interview for DSM-5® Personality Disorders" (SCID-5-PD) conditions: Misophonia Treatment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 108 type: ESTIMATED name: Cognitive reappraisal name: Schultz Autogenic Training measure: Change in misophonia symptoms measured by S-Five - Externalizing subscale measure: Change in misophonia symptoms measured by S-Five - Internalizing subscale measure: Change in misophonia symptoms measured by S-Five - Threat subscale measure: Change in misophonia symptoms measured by S-Five - Impact subscale measure: CHange in misophonia symptoms measured by S-Five - Outburst subscale measure: Change of aversiveness rating (valence/pleasure) on the Manikin Scales. measure: Change of arousal rating on the Manikin Scales. measure: Change in Galvanic Skin Response measure: Change in average HR during the trigger presentation measure: Diagnosis of personality disorders as a predictor of worse treatment outcome. measure: Working Alliance Inventory will be related to better treatment outcomes. measure: Meeting criteria for psychiatric disorders - measure: Hearing test - standard and high frequency pure-tone audiometry sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Faculty of Psychology, University of Warsaw status: RECRUITING city: Warsaw state: Masovian Voivodeship zip: 00-183 country: Poland name: Marta Siepsiak, PhD role: CONTACT phone: 0048661152533 email: marta.siepsiak@psych.uw.edu.pl name: Marta Siepsiak, PhD role: PRINCIPAL_INVESTIGATOR lat: 52.22977 lon: 21.01178 hasResults: False

 nctId: NCT06372392 id: 1.0 briefTitle: Universal Fixed Meal Boluses Usage in Patients With Medtronic Minimed 780G Pumps overallStatus: RECRUITING date: 2023-10-10 date: 2024-06-10 date: 2024-12-01 date: 2024-04-18 date: 2024-04-18 name: Tartu University Hospital class: OTHER name: Estonia Research Council briefSummary: Cross-over study of 20 pediatric patients (age 7-19) randomized to the group receiving universal fixed meal boluses coefficients (300/TDD for breakfast and 400/TDD other meal) or to the group with individualized coefficients for the period of 14 days with consecutive analysis of the results from Carelink Raport. conditions: Type1diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: Universal meal coefficient utilization measure: Time in range (TIR) measure: TBR measure: TAR measure: auto-corrections % measure: coefficient of variability sex: ALL minimumAge: 7 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT facility: TartuUH status: RECRUITING city: Tartu state: Tartumaa zip: 50406 country: Estonia name: Aleksandr Peet role: CONTACT phone: 5532256 email: aleksandr.peet@kliinikum.ee lat: 58.38062 lon: 26.72509 hasResults: False

 nctId: NCT06372379 id: 8780_UC2 briefTitle: Development of a Multipurpose Dashboard to Monitor the Situation of Emergency Departments acronym: eCREAM-UC2 overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-01 date: 2027-09 date: 2024-04-18 date: 2024-04-18 name: Mario Negri Institute for Pharmacological Research class: OTHER name: Astir S.r.l. name: Orobix Life S.r.l. name: Fondazione Bruno Kessler briefSummary: An emergency department (ED) is a healthcare service that provides the first clinical assessment and treatment to patients with various acute conditions. These departments, however, are often overwhelmed by the large volume of patients. As a consequence, ED crowding has become a global concern and has been correlated to reduced timeliness and effectiveness of care and increased patient mortality. Concerning input, 20% to 30% of patients are brought to the ED by ambulance; the remaining are self-presenting for the vast majority. Notably, non-urgent conditions characterize a high proportion of all ED visits worldwide, and almost all of these visits involve self-presenting patients. Increasing the awareness of these patients about the mandate of EDs and the real-time situation of the neighboring emergency departments has the potential to reduce the self-presentation of patients with minor, non-urgent conditions. Such patient empowerment can be achieved through a dashboard. Concerning throughput, working in the ED requires emergency physicians and nurses to treat many patients at once while maintaining situational awareness of the surroundings. This is especially true for the head of the department, but it also holds for all physicians. It can be crucial, for example, for physicians to know if there is a bottleneck in the flow of the entire patient care process, such as a particularly high average waiting time for radiology reporting or cardiologic consultation. The availability of this information allows countermeasures to be put in place to regain efficiency. All this can be achieved through dedicated dashboards automatically fed from various information system. In addition, appropriate dashboards also enable health policymakers to monitor specific epidemiological phenomena, such as the emergence of certain infectious diseases, in a timely manner. conditions: Emergency Medicine studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 162000 type: ESTIMATED name: no intervention measure: Daschboards sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06372366 id: Dental caries and vit.difiency briefTitle: Relationship Between Vitamins Deficiency and Caries Experience Among a Group of Egyptian Children overallStatus: NOT_YET_RECRUITING date: 2024-07-15 date: 2024-10-15 date: 2025-12-15 date: 2024-04-18 date: 2024-04-19 name: Cairo University class: OTHER briefSummary: Dental caries is a worldwide condition characterized by localized destruction of dental hard tissue by acidic by-products from bacterial fermentation of dietary carbohydrates . Dental caries is considered to be the single most common chronic childhood disease, and its prevalence is thought to have increased recently. conditions: Dental Caries conditions: Vitamin Deficiency studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 2 type: ESTIMATED measure: Caries prevalence sex: ALL minimumAge: 3 Years maximumAge: 5 Years stdAges: CHILD hasResults: False

 nctId: NCT06372353 id: 777 briefTitle: The Effect Of Baduanjin Exercises In Patients With Idiopathic Pulmonary Fibrosis overallStatus: COMPLETED date: 2022-06-01 date: 2023-05-24 date: 2023-06-06 date: 2024-04-18 date: 2024-04-18 name: Marmara University class: OTHER briefSummary: Introduction and Objectives:IPF, characterized by shortness of breath and progressive deterioration in lung function.Baduanjin (BJ) is a mindbody health exercise that combines physical exercise with psychological properties to maximize both physical and mental health.The aim of the study is to investigate the effectiveness of these exercises in patients with IPF and to present an alternative in terms of the applicability of BJ exercises as a new treatment method

Methods: 28 volunteers were invited to the study.These patients were randomly divided into 2 groups.The subjects in the exercise group were given 24 sessions of supervised online BJ exercise training, 3 days a week, for 8 weeks. The patients included in the control group did not receive any training during the 8 week period conditions: Pulmonary Fibrosis, Idiopathic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 28 type: ACTUAL name: Baduanjin Exercise measure: Functional capacity measure: Pulmonary Function Tests measure: Pulmonary Function Tests measure: Pulmonary Function Tests measure: Pulmonary Function Tests measure: Respiratory muscle strength measure: Respiratory muscle strength measure: St. George's Respiratory Questionnaire sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: İstanbul University - Cerrahpaşa city: Istanbul state: Fatih country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06372340 id: 2023BJYYEC-217-01 briefTitle: Intelligent Diagnosis and Treatment System for Pelvic Floor Dysfunction in Elderly Women overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-08-31 date: 2025-12-31 date: 2024-04-18 date: 2024-04-18 name: Beijing Hospital class: OTHER_GOV briefSummary: The aim of this study is to propose an intelligent diagnosis and treatment system for for pelvic floor dysfunction in elderly women. The main question it aims to answer: 1) How can the investigators find out early if older women have different pelvic floor muscle functions? 2）How can the investigators give personalized treatment plans based on differences in pelvic floor function? Participants will be assigned different training programs by the system. The investigators will compare the treatment effects and costs of older women with pelvic floor dysfunction using and not using the system. All the participants will be offered examinations for pelvic floor function and different treatments. All examinations and treatments are non-invasive. conditions: Pelvic Organ Prolapse conditions: Urinary Incontinence conditions: Diagnosis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The participants will be allocated to experimental group(EG) or the control group(CG). Subjects in the experimental group (EG) will receive personalized pelvic floor muscle training guidance provided by the system, whereas subjects in the control group(CG) will exercise according to the handbook or oral guidance. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Assessments regarding pelvic floor muscle strength will be conducted by an assessor blind to treatment allocation. The assessor will go through a profound assessment training program. Due to the nature of the intervention neither participants nor care providers can be blinded to allocation, but are strongly inculcated not to disclose the allocation status of the participant at the follow up assessments. An employee outside the research team will feed data into the computer in separate datasets so that the researchers can analyse data without having access to information about the allocation. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Personalized pelvic floor rehabilitation program generated by the intelligent diagnosis and treatment system. name: Standard pelvic floor muscle training(PFMT) program measure: Modified Oxford Scale (MOS) measure: Surface Electromyography Data measure: The score of Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) measure: The score of the Pelvic Floor Distress Inventory (PFDI-20) measure: Subjective staging used Pelvic Organ Prolapse Quantification (POP-Q) System sex: FEMALE minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06372327 id: 73468 briefTitle: Move Often eVery Day 2.0 acronym: MOVD overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2026-07 date: 2024-04-18 date: 2024-04-19 name: Stanford University class: OTHER briefSummary: The purpose of this study is to assess a novel, widely-accessible intervention to both promote active breaks from work and improve cognitive and psychological performances at work in motivationally-accessible bouts. This will be done by interrupting prolonged sitting with 1-4 short (1-4 minutes), moderate-to-vigorous physical activity (MVPA) bouts with no equipment, and simple video-based instructions. The short bouts will be referred to as "exercise snacks." In this proposed exercise snacks intervention, investigators explicitly target a population with sedentary jobs due to the generalizability. conditions: Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: This will be a 2 (Exercise snack number) x 2 (Exercise snack length) factorial design. primaryPurpose: PREVENTION masking: NONE count: 40 type: ESTIMATED name: Daily Exercise Snacks measure: Number of self-reported exercise snack breaks at work at week 7 measure: Number of self-reported exercise snack breaks at work at week 18 measure: Number of self-reported exercise snack breaks at work at week 30 during follow-up measure: Liking of exercise snacks sex: FEMALE minimumAge: 30 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford University School of Medicine city: Stanford state: California zip: 94305-7240 country: United States lat: 37.42411 lon: -122.16608 hasResults: False

 nctId: NCT06372314 id: 1000081221 briefTitle: Isoleucine, Leucine, Valine and Tryptophan Requirements in TPN Fed Neonates overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2027-12 date: 2027-12 date: 2024-04-18 date: 2024-04-18 name: The Hospital for Sick Children class: OTHER briefSummary: This project will be conducted in 2 hospitals in Brazil to assess the requirements for four essential amino acids in TPN fed neonates. Using the Carbon Oxidation method (indicator amino oxidation and direct amino acid oxidation method), the investigators will determine the requirement of each of the 4 amino acids.

The investigators will determine the requirement for Isoleucine, Leucine, Valine and Tryptophan. The investigators will recruit 18- 20 babies per amino acid study. Breath and urine samples will be collected to determine the oxidation of the indicator amino acid. The response of the indicator amino acid to changes in intake of the test amino acid (isoleucine, leucine, valine and tryptophan) will be analyzed by bi-phase linear mixed effect model to determine the breakpoint or mean requirement for each amino acid. It is hypothesized that the requirement for isoleucine, leucine, valine and tryptophan will be at least 50% lower than what is currently available in commercial solutions used for TPN feeding of neonates. conditions: Stable Neonates Receiving Total Parenteral Nutrition (TPN) studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 80 type: ESTIMATED name: Total parenteral nutrition (TPN): this is total nutrition provided by central vein. measure: Amino acid oxidation using a labelled amino acid. sex: ALL minimumAge: 1 Day maximumAge: 28 Days stdAges: CHILD facility: Hospital de Caridade Dr. Astrogildo de Azevedo, and University Hospital of Santa Maria, Santa Maria, Brazil city: Santa Maria country: Brazil name: Ivo Dr Prola, MD, PhD role: CONTACT phone: 6477815786 email: iprolla@gmail.com name: Beatriz Dr Porto, MD role: CONTACT phone: 6475002171 email: bsilveiraporto@gmail.com lat: -29.68417 lon: -53.80694 hasResults: False

 nctId: NCT06372301 id: 1-10-72-179-23 briefTitle: Dobutamine Stress Echocardiography in LF/LG Aortic Stenosis and Wild-type Transthyretin Amyloid Cardiomyopathy acronym: DobAttrAS overallStatus: RECRUITING date: 2024-04-02 date: 2025-11-01 date: 2026-04-01 date: 2024-04-18 date: 2024-04-18 name: Steen Hvitfeldt Poulsen class: OTHER briefSummary: The goal of this prospective clinical study is improve the diagnosis of Low-flow low-gradient aortic stenosis (LF/LG AS), in patients with co-existing wild-type transthyretin cardiac amyloidosis (ATTRwt). The main question it aims to answer is whether the classic dobutamine-stress echocardiography can be used to determine AS severity in patients with ATTRwt and LF/LG AS This question will be tried to answer by comparing dobutamine stress echocardiography, with the invasively measured aortic valve area (which is considered as the gold standard).

In addition we aim to assess the degree of myocardial fibrosis and amyloid infiltration, assessed by light microscopy and cardiac magnetic resonance (CMRI) and evaluation of myocyte mitochondrial function by high resolution respirometry and their relation to AS severity and hemodynamic response to dobutamine. conditions: Transthyretin Amyloid Cardiomyopathy conditions: Aortic Stenosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 24 type: ESTIMATED name: Dobutamine stress echocardiography measure: The correlation between echocardiography derived projected aortic valve area (AVAproj) and invasively assessed AVAproj under dobutamine infusion. measure: Correlation between echocardiography derived AVA and invasively assessed AVA at rest and at different dobutamine infusion levels. measure: Increase of SVI, LV ejection fraction and LV-global longitudinal strain of 10 % during maximal dobutamine stimulation. measure: Correlation between echo- and invasive measured SVI. measure: Degree of myocardial fibrosis, amyloid infiltration and mitochondrial dysfunction and its relation to AS severity and hemodynamic response to dobutamine measure: Reduction of mean pulmonary artery wedge pressure and/or mean pulmonary artery pressure by 10 %. measure: Complication rate and symptomatic side effects during dobutamine challenge sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Department of Cardiology, Aarhus University Hospital status: RECRUITING city: Aarhus zip: 8200 country: Denmark name: Ali Hussein Jaber Mejren, MD role: CONTACT phone: 0045 91 65 18 48 email: alimej@clin.au.dk lat: 56.15674 lon: 10.21076 hasResults: False

 nctId: NCT06372288 id: 22-1754 briefTitle: Theta Burst TMS for Treatment of Methamphetamine Use Disorder overallStatus: RECRUITING date: 2023-12-20 date: 2024-12 date: 2025-12 date: 2024-04-18 date: 2024-04-26 name: Carilion Clinic class: OTHER name: Virginia Polytechnic Institute and State University briefSummary: This study is using Transcranial Magnetic Stimulation (TMS) to determine if interventional psychiatry treatment can help with the treatment of Methamphetamine Use Disorder. Individuals with Methamphetamine Use Disorder will receive 5 consecutive TMS treatment sessions based off of randomization. Participants will be randomized to one of two groups. TMS treatment arm or sham-TMS arm. conditions: Methamphetamine Abuse studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to either receive 5 transcranial magnetic stimulations or 5 sham transcranial magnetic stimulation (no therapeutic levels of stimulation) sessions. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: One study personnel not involved in participant interventions will be unblinded and will randomize participants and confirm the set up of the device for the session prior to the blinded study personnel interacting with the participant. Both the participant and the blinded study personnel will not know which group the participant will be part of throughout the study sessions. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Transcranial Magnetic Stimulation name: Sham Transcranial Magnetic Stimulation measure: Stimulant Craving Questionnaire (STCQ) measure: Urine Drug Screen (UDS) measure: Generalized Anxiety Disorder-7 (GAD-7) measure: Patient Health Questionnaire-9 (PHQ-9) measure: Quality - Life Enjoyment Scale - Questionnaire (Q-LES-Q) measure: Hamilton Anxiety Scale (HAM-A) measure: Montgomery Asberg Depression Rating Scale (MADRS) measure: Clinical Global Impression - Severity (CGI-S) measure: Clinical Global Impression - Improvement (CGI-I) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Carilion Clinic status: RECRUITING city: Roanoke state: Virginia zip: 24014 country: United States name: Sooraj John, M.D. role: CONTACT name: Maryann Hollen, B.S. role: CONTACT phone: 540-566-8081 lat: 37.27097 lon: -79.94143 hasResults: False

 nctId: NCT06372275 id: 0000 briefTitle: Investigating Two Prototype Mobile App Interventions to Increase Physical Activity overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-08-31 date: 2024-08-31 date: 2024-04-17 date: 2024-04-17 name: Mississippi State University class: OTHER name: Association for contextual behavioral science briefSummary: This randomized control trial aims to investigate whether writing about personal values helps enhance motivation to engage in physical activity, relative to general self-reflective writing. This study will help to (1) assess whether values clarification leads to increased motivation to engage in physical activity, greater stability in motivation, and improvements in engagement in physical activity and valued action, relative to engaging in self-reflection, (2) determine if the impact of values clarification on these outcomes vary depending on context (e.g., positive/negative affect, psychological inflexibility, stressful events), (3) explore whether values clarification procedures that employ distinct relational frames (hierarchical, conditional, distinction, and deictic) differentially impact motivation to engage in physical activity, and daily engagement in physical activity, and (4) explore whether the impact of values clarification vary depending on baseline self-compassion and/or intrinsic/extrinsic motivation. conditions: Health-Related Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: Values Clarification Mobile Application name: Self-Reflection Mobile Application measure: International Physical Activity Questionnaire (IPAQ) - Total physical activity measure: Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) - Total score measure: Amotivation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) measure: External Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) measure: Introjected Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) measure: Identified Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) measure: Integrated Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) measure: Intrinsic Regulation - Subscale of the Behavioral Regulation in Exercise Questionnaire, Version 3 (BREQ-3) measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Questionnaire v1.2 measure: Global Mental Health - Subscale of the PROMIS Global Health Questionnaire v1.2 (Patient-Reported Outcomes Measurement Information System) measure: Global Physical Health - Subscale of the PROMIS Global Health Questionnaire v1.2 (Patient-Reported Outcomes Measurement Information System) measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Satisfaction with Social Roles and Activities 8a measure: Multidimensional Psychological Flexibility Inventory - Short Form 24-item version (MPFI-24) measure: Contact With Values - Subscale of the Multidimensional Psychological Flexibility Inventory - Short Form 24-item version (MPFI-24) measure: Lack of Contact With Values - Subscale of the Multidimensional Psychological Flexibility Inventory - Short Form 24-item version (MPFI-24) measure: Values Clarity Questionnaire (VCQ) measure: Self-Compassion Scale Short Form (SCS-SF) measure: Random responding question measure: Credibility & Expectancy Questionnaire (CEQ) measure: System Usability Scale (SUS) measure: Treatment Evaluation Inventory-Short Form (TEI-SF) measure: Exercise ecological momentary assessment (EMA) questions measure: Multidimensional Psychological Flexibility Inventory - Short Form 24-item version adapted for ecological momentary assessment (MPFI-24 validated for EMA) measure: Momentary Contact With Values - Subscale of the Multidimensional Psychological Flexibility Inventory - Short Form 24-item version adapted for ecological momentary assessment (MPFI-24 validated for EMA) measure: Momentary Lack of Contact With Values - Subscale of the Multidimensional Psychological Flexibility Inventory - Short Form 24-item version adapted for ecological momentary assessment (MPFI-24 validated for EMA) measure: Emotion ratings measure: Current Motivation to Exercise measure: Previous Day Stress Level sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mindfulness and Acceptance Processes Lab city: Starkville state: Mississippi zip: 39759 country: United States lat: 33.45049 lon: -88.81961 hasResults: False

 nctId: NCT06372262 id: Rowers2022 briefTitle: Effect of 2000-meter Rowing Test on Parameters of Intestinal Integrity in Elite Rowers During Competitive Phase acronym: Rowers overallStatus: COMPLETED date: 2022-06-01 date: 2022-06-30 date: 2022-06-30 date: 2024-04-17 date: 2024-04-17 name: Poznan University of Physical Education class: OTHER briefSummary: The study aimed to check the 2000m ergometer test on markers of gut permeability in the competitive phase of rowers. 18 members of the Polish rowing team took part in the study. conditions: Endothelial Dysfunction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 18 type: ACTUAL name: ergometer test measure: I-FABP (intestinal fatty acid binding protein)to measure epithelial wall injury measure: zonulin to measure tight junction leakage measure: LBP (lipopolysaccharide binding protein) to measure endotoxin measure: LPS (lipopolysaccharide) to measure endotoxin measure: Lactic acid to measure fatigue after the race measure: energy measure: fiber intake measure: protein measure: carbohydrate measure: body mass measure: Body composition - water measure: Body composition - fat measure: Lean body mass sex: MALE minimumAge: 18 Years maximumAge: 23 Years stdAges: ADULT facility: Poznan University of Physical Education city: Poznań country: Poland lat: 52.40692 lon: 16.92993 hasResults: False

 nctId: NCT06372249 id: 22-249 id: 2U54MD012388-06 type: NIH link: https://reporter.nih.gov/quickSearch/2U54MD012388-06 briefTitle: A Clinical Trial of Soluble Fiber for Asthma overallStatus: RECRUITING date: 2024-04-02 date: 2027-04 date: 2027-04 date: 2024-04-17 date: 2024-04-17 name: Phoenix Children's Hospital class: OTHER name: Northern Arizona University name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: Randomized controlled trial of soluble fiber (NOVELOSETM 3490). Participants will complete an ASA 24 dietary recall questionnaire to access their fiber intake. If eligible for the study, participants will be supplemented to their target fiber dosage with either soluble fiber (NOVELOSETM 3490) or placebo. Collection of blood serum, fecal samples, and nasal wash will aid in analyzing the microbes present in one's gut and how fiber and diet may impact it. Thus, allowing researchers to better understand the pathways that may connect diet and asthma and if it is possible to improve asthma by altering one's diet. conditions: Asthma in Children studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 105 type: ESTIMATED name: NOVELOSETM 3490 measure: Alpha diversity. measure: Asthma control. measure: Gut microbiome composition. measure: Nasal inflammatory response. measure: Quantification of circulating short chain fatty acids. sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD facility: Phoenix Children's status: RECRUITING city: Phoenix state: Arizona zip: 85016 country: United States name: Destiny Ogbeama role: CONTACT lat: 33.44838 lon: -112.07404 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-01-17 uploadDate: 2024-04-02T16:19 filename: Prot_SAP_000.pdf size: 285020 hasResults: False

 nctId: NCT06372236 id: PG-001-025 briefTitle: UTAA06 Injection for Treatment of Advanced Malignant Solid Tumors overallStatus: RECRUITING date: 2023-12-01 date: 2024-12-01 date: 2026-12-01 date: 2024-04-17 date: 2024-04-17 name: Peking University class: OTHER briefSummary: This is a single-arm, open, early-stage clinical study. The main purpose of this study is to explore the maximum tolerated dose (MTD), the optimal phase II recommended dose, safety, initial anti-tumor activity, cytopharmacokinetics, immunogenicity, biomarkers and other characteristics of drug therapy in patients with advanced malignant solid tumors. Eligible subjects were transfused with UTAA06 injection after pretreatment, and their blood was collected before and after infusion for evaluation of cytopharmacokinetics, safety, immunogenicity and biomarkers. In this study, tumor evaluation was mainly performed using RECISTv1.1. In addition to the baseline period, the therapeutic efficacy was evaluated at the frequency of Q3m during 4w, 2m, 3m, and 6-24m after cell infusion. Tumor evaluation was performed until disease progression (PD), new anti-tumor therapy, death, intolerable toxicity, investigator's decision, or patient's voluntary withdrawal. Whichever comes first. conditions: Conditions or Focus of Study: B7-H3 Positive Relapsed/Advanced Malignant Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: UTAA06 injection primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: UTAA06 injection for treatment of advanced malignant solid tumors measure: MTD measure: To evaluate the preliminary antitumor activity of UTAA06 injection in patients with advanced malignant solid tumors measure: To evaluate the number of participants with treatment-related adverse events of UTAA06 injection in patients with advanced malignant solidtumors. measure: To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors. measure: To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors. measure: To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors. measure: To evaluate the efficacy, depth and persistence of UTAA06 injection in the treatment of patients with advanced malignant solid tumors. measure: To evaluate the pharmacokinetic (PK) characteristics of UTAA06 injection in patients with advanced malignant solid tumors. measure: To evaluate the pharmacokinetic (PK) characteristics of UTAA06 injection in patients with advanced malignant solid tumors. measure: To evaluate the immunogenicity of UTAA06 injection in patients with advanced malignant solid tumors. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PersonGen Anke Cellular Therapeutice Co.,Ltd status: RECRUITING city: Hefei state: Anhui zip: 230088 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: NCT06372223 id: SPH5030-102 briefTitle: A Food Effect Study of SPH5030 Tablets. overallStatus: COMPLETED date: 2024-03-04 date: 2024-03-25 date: 2024-03-25 date: 2024-04-17 date: 2024-04-17 name: Shanghai Pharmaceuticals Holding Co., Ltd class: INDUSTRY briefSummary: The purpose of this study is to evaluate the food effect of SPH5030 tablets in healthy Chinese adult subjects. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 16 type: ACTUAL name: SPH5030 name: SPH5030 measure: Peak Plasma Concentration (Cmax) measure: Peak time（Tmax） measure: Area under the plasma concentration versus time curve (AUC) measure: Incidence of Treatment-Emergent Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: West China Second Hospital ,Sichuan University city: Chengdu country: China lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06372210 id: 031-201-00521 briefTitle: A Trial to Assess a Wearable Patch's Functioning to Detect Medication Ingestion overallStatus: COMPLETED date: 2023-06-26 date: 2023-07-19 date: 2023-07-19 date: 2024-04-17 date: 2024-04-17 name: Otsuka Pharmaceutical Development & Commercialization, Inc. class: INDUSTRY briefSummary: The primary purpose of the study is to evaluate the positive detection accuracy (PDA) and detection latency measures of the D-Tect patch. conditions: Mental Disorder conditions: Schizophrenia conditions: Major Depressive Disorder conditions: Bipolar I Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 54 type: ACTUAL name: Placebo IEM tablet name: Abilify MyCite® name: D-Tect Patch measure: Cohort 1: Positive Detection Accuracy (PDA) of D-Tect Patch measure: Cohort 1 and 2: Patch Detection Latency Period measure: Cohort 1 and 2: Ingestion Data Transfer Latency Period measure: Cohort 1 and 2: Total Detection Latency Period measure: Number of Participants With Adverse Events (AEs) Graded By Severity, Device-related AEs, Serious AEs (SAEs), AEs Leading to Trial Discontinuation, and Unanticipated Adverse device Effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research site city: Garden Grove state: California zip: 92845 country: United States lat: 33.77391 lon: -117.94145 hasResults: False

 nctId: NCT06372197 id: LIGPATD briefTitle: Low-Income Group Psilocybin Assisted Therapy for Depression acronym: LIGPATD overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2024-08 date: 2024-10 date: 2024-04-17 date: 2024-04-17 name: Matthew Hicks class: OTHER briefSummary: Due to psilocybin-assisted therapy's success in previous research, growing cultural awareness and use of psilocybin and other psychedelics, the Oregon Psilocybin Services Act passed by ballot measure in 2020 and began offering services in 2023. While the program has had many successes, a significant problem it faces is affordability and no research to date has investigated the therapy in a low-income population.

Psychedelic research in recent decades has used the model of two therapists to one client to demonstrate an abundance of caution and safety to regulators, but no evidence has demonstrated this model to be safer or more effective than one with less practitioner oversight. This feasibility study would be the first investigation of Oregon Psilocybin Services as a model of care and among the first few to use a group therapy model. This study aims to test the feasibility of the model by assessing recruitment, retention, acceptability and safety of the treatment. In addition to an appropriate medical screening and intake the following questionnaire data will be collected: the Adverse Childhood Events (ACE) questionnaire, Credibility/Expectancy Questionnaire (CEQ), PROMIS-29, Altered States of Consciousness (11-ASC) rating scale, and a survey and structured interview.

Participants will consist of adults in Oregon with an income at or below 200% of the federal poverty level. Inclusion criteria will include DSM-5 diagnosis of major depression. Participants will be individually screened by a study investigator and placed into groups of five to six participants. Treatment will consist of two group preparation sessions, two psilocybin sessions, and two group integration sessions. An additional follow-up visit to collect further data will take place three months after conclusion of the treatment.

The proposed study will provide valuable information for designing future clinical trials investigating the efficacy, mechanisms, and cost-effectiveness of psilocybin-assisted group therapy for depression in low-income populations. conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Psilocybin measure: Recruitment Feasibility measure: Retention Feasibility measure: Acceptability measure: Preliminary Safety and Tolerability: incidence and severity of adverse events measure: Patient-Reported Outcomes Measurement Information System (PROMIS-29) measure: Altered State of Consciousness rating scale (11-ASC) sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06372184 id: WMT-AR-RCT briefTitle: Washed Microbiota Transplantation for Allergic Rhinitis overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2029-06-01 date: 2029-10-01 date: 2024-04-17 date: 2024-04-17 name: The Second Hospital of Nanjing Medical University class: OTHER briefSummary: Allergic rhinitis (AR) is characterized by sneezing, nasal congestion, nasal itching and nasal leakage and is caused by immunoglobulin E (IgE)-mediated reactions to inhaled allergens. Increasing evidence showed that gut microbiota could influence the development of AR, and we found that washed microbiota transplantation (WMT) could improve nasal symptoms in clinical practice. This clinical trial aims to evaluate the efficacy and safety of WMT for AR. conditions: Rhinitis, Allergic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 32 type: ESTIMATED name: Washed Microbiota Transplantation name: Placebo 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 measure: Changes in the Modified Lund-Kennedy endoscopic score measure: The changes in composition and metabolites of gut microbiota and nasal microbiota sex: ALL minimumAge: 18 Years maximumAge: 65 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 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: NCT06372171 id: NYCU112182AEF briefTitle: Effects of Liposomal Encapsulation on Vitamin C Absorption and Metabolism overallStatus: RECRUITING date: 2024-04 date: 2024-09 date: 2024-12 date: 2024-04-17 date: 2024-04-17 name: National Yang Ming University class: OTHER briefSummary: Vitamin C is an important antioxidant in the human body and plays many important roles. It is currently known that vitamin C has the functions of treating scurvy, assisting in collagen synthesis, whitening, and increasing immunity. Smokers, patients with cardiovascular disease, and patients with diabetes may have higher requirements for vitamins due to higher oxidative stress in the body. Liposome coating is a technology commonly used in food processing and medicine to protect active substances, increase absorption or slow release. Currently, vitamin C is commonly available on the market as an additive nutritional supplement in the form of powder packets, tablets, etc. The disadvantages are that vitamin C is relatively unstable, easily destroyed by gastric acid, and maintains blood concentration for a short time. Taking liposome microbial C has been Found to have the potential to increase bioavailability in the human body, it is expected that vitamin C coated with lecithin is relatively stable and can be stabilized in the small intestine without being damaged by gastric acid, while reducing the risk of gastrointestinal discomfort caused by the acidity of vitamin C. According to the revised seventh edition of the Reference Intake of Dietary Nutrients for Chinese People, the upper daily intake of vitamin C (tolerable upper intake levels, UL) for people aged 19 to 70 is 2,000 mg. According to literature, the absorption rate of vitamin C when consuming 30-180 mg per day is about 70-90%; when the daily intake exceeds 1000 mg, the absorption rate will drop to less than 50%. The dose of vitamin C used in this study is more than 1500 mg. The purpose is to explore whether the sustained-release characteristics of liposome coating technology can improve the absorption rate and achieve better bioavailability when consuming high-dose vitamin C powder. It is expected that through the egg The liposome vitamin C powder made of phospholipids increases its maintenance time in the blood, thereby increasing the supplementary effect of vitamin C powder and serving as another supplement option for vitamin C. conditions: Nutrition, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: Satge 1 name: Stage 2 measure: General examination measure: Hematology Test sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: National Yang Ming Chiao Tung University status: RECRUITING city: Taipei state: Beitou Dist. zip: 112 country: Taiwan name: Tze-Fang Wang, Ph.D. role: CONTACT phone: +886-2-28267907 email: tzefang@nycu.edu.tw lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06372158 id: NYCU112181AE briefTitle: Effects of Liposomal Encapsulation on Calcium Powder Absorption and Metabolism overallStatus: RECRUITING date: 2024-04-08 date: 2024-12 date: 2024-12 date: 2024-04-17 date: 2024-04-17 name: National Yang Ming University class: OTHER briefSummary: Compared with traditional calcium supplements, liposome calcium can increase the bioavailability of calcium and reduce the waste caused by gastric acid destruction of calcium. This allows calcium to be released slowly in the intestines, reducing the risk of indigestion or other side effects caused by excessive intake at one time. Liposomal calcium can be taken orally directly. It does not need to be dissolved in water before taking like other calcium supplements, making it more convenient to use. Based on the above advantages, liposomal calcium is a relatively safe and easy-to-absorb calcium supplement, suitable for long-term use, and can meet the body's demand for calcium. According to the recommendations of the World Health Organization, the daily calcium intake for adults should be 1000-1300 mg. In Taiwan, the seventh edition of the revised reference intake of dietary nutrients for Chinese people recommends that the daily intake for adults should be 1,000 mg. The calcium dose used in this study was 500 mg. The purpose was to explore whether the sustained-release characteristics of liposome coating technology can improve the absorption rate after consuming calcium powder and achieve better bioavailability. It is expected that microlipids made by lecithin can Lipid calcium powder increases its maintenance time in the blood, thereby increasing the supplementary effect of calcium, and is an alternative to calcium supplements. conditions: Osteoporosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: Stage 1 name: Stage 2 measure: General examination measure: Hematology Test sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: National Yang Ming Chiao Tung University status: RECRUITING city: Taipei state: Beitou Dist. zip: 112 country: Taiwan name: Tze-Fang Wang, Ph.D. role: CONTACT phone: +886-2-28267907 email: tzefang@nycu.edu.tw lat: 25.04776 lon: 121.53185 facility: National Yang Ming Chiao Tung University status: RECRUITING city: Taipei zip: 112 country: Taiwan name: ChienYu Huang, Bachelor role: CONTACT phone: +886-955-879163 email: chienyu.ns11@nycu.edu.tw lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06372145 id: LTS17043 id: 2023-503631-18 type: REGISTRY domain: CTIS id: U1111-1287-6797 type: REGISTRY domain: ICTRP briefTitle: A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis. overallStatus: RECRUITING date: 2024-04-25 date: 2029-04-30 date: 2029-04-30 date: 2024-04-17 date: 2024-04-17 name: Sanofi class: INDUSTRY briefSummary: This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 \[EFC16033\], GEMINI 2 \[EFC16034\], HERCULES \[EFC16645\], or PERSEUS \[EFC16035\]).

SUBSTUDY: ToleDYNAMIC substudy conditions: Relapsing Multiple Sclerosis conditions: Secondary Progressive Multiple Sclerosis conditions: Progressive Relapsing Multiple Sclerosis studyType: INTERVENTIONAL phases: PHASE3 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 2500 type: ESTIMATED name: Tolebrutinib name: Placebo name: Teriflunomide measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and AEs leading to permanent study intervention discontinuation measure: Number of Participants with Potentially clinically significant abnormalities (PCSAs) measure: Time to onset of 6-month confirmed disability worsening (CDW for RMS) or confirmed disability progression (CDP for PPMS and NRSPMS) for participants from pivotal studies measure: Annualized Relapse Rate (ARR) for RMS only measure: Number of new and/or enlarging T2-hyperintense lesions per year measure: Change from baseline in total volume of T2-hyperintense lesions measure: ToleDYNAMIC substudy Change from baseline in biomarkers sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Investigational Site Number : 0560005 status: RECRUITING city: Brugge zip: 8000 country: Belgium lat: 51.20892 lon: 3.22424 hasResults: False

 nctId: NCT06372132 id: NL85305.068.23 briefTitle: G-POEM vs PEG-J in Gastroparesis Patients overallStatus: RECRUITING date: 2024-03-14 date: 2027-01 date: 2028-01-01 date: 2024-04-17 date: 2024-04-17 name: Maastricht University Medical Center class: OTHER briefSummary: Study design: A randomized non-blinded controlled clinical trial with two study arms (G-POEM and PEG-J). Treatment success is measured using the GCSI at baseline before intervention and six months after intervention with a possible cross-over after six months of follow-up.

Study population: 50 patients with therapy refractory GP on dietary advices, prokinetics and possibly tube feeding (gastric rest) who have already been referred for additional treatment options in the form of PEG-J/ G-POEM.

Intervention: Group 1 will receive G-POEM treatment and group 2 will receive PEG-J treatment.

Main study parameters/endpoints: A clinically meaningful treatment success six months after G-POEM treatment, measured using the GCSI-score defined as a decrease of 1 or more point. conditions: Gastroparesis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: G-POEM measure: Number of patients with treatment success using the GCSI-score in patients with refractory GP undergoing G-POEM compared to patients receiving a PEG-J at t = 6 months. measure: Number of patients with treatment success using the GCSI-score in patients with refractory GP undergoing G-POEM compared to patients receiving a PEG-J at t = 12 months. measure: Degree of quality of life using the PAGI-QOL in the G-POEM group in comparison with the PEG-J intervention six months after intervention. measure: Number and severity of (s)AEs in the treatment groups. measure: Predictive value of the etiology of gastroparesis on treatment outcomes following G-POEM by measuring the rate of treatment success quantified by improvements in the GCSI-score. measure: Predictive value of the etiology of gastroparesis on treatment outcomes following PEG-J by measuring the rate of treatment success quantified by improvements in the GCSI-score. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maastricht University Medical Center status: RECRUITING city: Maastricht state: Zuid-Limburg zip: 6229 HX country: Netherlands name: Kim Sweerts, MD role: CONTACT phone: 0883887298 email: kim.sweerts@maastrichtuniversity.nl lat: 50.84833 lon: 5.68889 hasResults: False

 nctId: NCT06372119 id: 13/23/DD-BVMD briefTitle: Letrozole-stimulated Cycle Strategy Versus Artificial Cycle Strategy (LETSACT) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-17 date: 2024-04-17 name: Mỹ Đức Hospital class: OTHER briefSummary: The goal of this randomized clinical trial is to evaluate the effectiveness of the letrozole-stimulated cycle strategy versus the artificial cycle strategy for endometrial preparation in women with irregular menstrual cycles after one cycle of endometrial preparation. The primary question it aims to answer is:

• Does the letrozole-stimulated cycle strategy for endometrial preparation result in a higher live birth rate compared to the artificial cycle strategy in women with irregular menstrual cycles after one cycle of endometrial preparation?

Participants will undergo screening before endometrial preparation for frozen embryo transfer, following which they will be randomly assigned to one of two groups: LETS or AC. In the LETS group, investigators will prescribe Femara® 2.5 milligrams (Novartis, Switzerland) at a dose of 5 milligrams/day for 5 days to stimulate follicular development and Cyclogest® 400 milligrams (Actavis, UK) at a dose of 800 milligrams/day for luteal phase support. In contrast, the AC group will receive Valiera® 2 milligrams (Laboratories Recalcine, Chile) starting with a dose of 6 milligrams/day, up to a maximum dose of 12 milligrams/day) and Cyclogest® 400 milligrams (Actavis, UK) at a dose of 800 milligrams/day. Researchers will compare the LETS and AC groups to determine if there are differences in live birth rates. conditions: Embryo Transfer conditions: Irregular Menstruation conditions: Letrozole conditions: Hormone Replacement Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 480 type: ESTIMATED name: Letrozole-stimulated cycle strategy (LETS) name: Artificial cycle strategy (AC) measure: Live birth rate after one cycle of endometrial preparation measure: Positive pregnancy test after one cycle of endometrial preparation measure: Clinical pregnancy after one cycle of endometrial preparation measure: Ongoing pregnancy after one cycle of endometrial preparation measure: Multiple pregnancy after one cycle of endometrial preparation measure: Implantation rate after one cycle of endometrial preparation measure: Cycle cancellation rate measure: Ectopic pregnancy rate after one cycle of endometrial preparation measure: Threatened miscarriage rate before 12 weeks of gestation after one cycle of endometrial preparation measure: Early miscarriage rate after one cycle of endometrial preparation measure: Late miscarriage rate after one cycle of endometrial preparation measure: Gestational age at birth measure: Onset of labor measure: Mode of delivery measure: Very low birth weight measure: Low birth weight measure: High birth weight (macrosomia) measure: Very high birth weight (macrosomia) measure: Gestational diabetes (GDM) measure: Hypertensive disorders of pregnancy measure: Preterm birth measure: Stillbirth measure: Antepartum hemorrhage measure: Postpartum hemorrhage measure: Small for gestational age (singleton/twins) measure: Large for gestational age (singleton/twins) measure: Birth weight measure: Congenital anomalies measure: NICU admission measure: Reason for NICU admission measure: Neonatal mortality rate sex: FEMALE minimumAge: 18 Years maximumAge: 42 Years stdAges: ADULT hasResults: False

 nctId: NCT06372106 id: MA_PM_Mountain_2022_11496 briefTitle: Project Mountain - Comparing SpO2 and SaO2 for Accuracy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-17 date: 2024-04-17 name: Philips Clinical & Medical Affairs Global class: INDUSTRY briefSummary: The main goal of this study is to look at the performance of the neonatal, infant, and pediatric Philips SpO2 sensors with the Philips FAST Pulse Oximetry technology. Oxygen saturation measurements (SpO2) will be obtained via pulse oximetry and invasive arterial oxygen measurements (SaO2) will be obtained via arterial blood samples as part of your clinical care and assessed by co-oximetry. The study will aim to enroll a diverse population to help us understand the impact of skin pigmentation. conditions: SpO2 conditions: Nasal Alar Collapse, Bilateral conditions: Oxygen conditions: Measurement studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 560 type: ESTIMATED name: SaO2 Sampling measure: To observed accuracy expressed in ARMS of SpO2 measurements obtained from neonatal, infant, and pediatric sensors with the Philips FAST Pulse Oximetry technology within the range of 70-100% in comparison to the SaO2 as ground truth. measure: Secondary Endpoint -Non-disparate bias with consideration to skin pigmentation for each neonatal, infant, and pediatric SpO2 sensor under test with the Philips FAST Pulse Oximetry technology. measure: Secondary Endpoint- Proportion of paired SaO2 and SpO2 readings in which occult hypoxemia (i.e., SaO2 <88% with SpO2 ≥92%) is identified among patients within the broad categories of light, medium, and dark pigmentation. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06372093 id: PMH 2/11AII briefTitle: Evaluation of Bilirubin Measurements in Newborns From Smartphone Digital Images in a Population in Botswana overallStatus: COMPLETED date: 2023-03-16 date: 2024-02-26 date: 2024-02-26 date: 2024-04-17 date: 2024-04-17 name: Picterus AS class: INDUSTRY name: University of Copenhagen name: University of Botswana briefSummary: The general objective of this study is to evaluate the accuracy of a novel smartphone application for jaundice screening (Picterus Jaundice Pro) in a population with high melanin content in the skin.

The specific objectives for this study are:

i. To assess the correlation between bilirubin level measurements obtained by Picterus Jaundice Pro with Total Serum Bilirubin (TSB), and TcB, in newborns with high melanin content in the skin.

ii. To determine the accuracy of Picterus Jaundice Pro in newborns with high melanin content in the skin. conditions: Jaundice, Neonatal studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 172 type: ACTUAL name: Picterus Jaundice Pro measure: Enable high qualitative estimation of bilirubin levels in the blood of newborns in a population in Botswana using Picterus JP. measure: Correlation of bilirubin levels obtained by Picterus JP with Tsb and TcB measure: Sensitivity and specificity of Picterus JP to detect jaundice in newborns with high melanin content in the skin sex: ALL minimumAge: 1 Day maximumAge: 14 Days stdAges: CHILD facility: Princess Marina Hospital city: Gaborone country: Botswana lat: -24.65451 lon: 25.90859 hasResults: False

 nctId: NCT06372080 id: 19/SPS/054 briefTitle: Resistance Training and Hydrolyzed Collagen Supplementation in Healthy Young Adults overallStatus: COMPLETED date: 2020-01-06 date: 2021-09-29 date: 2023-03-31 date: 2024-04-17 date: 2024-04-17 name: Liverpool John Moores University class: OTHER briefSummary: The goal of this clinical trial is to investigate the effects of resistance training with hydrolyzed collagen ingestion on changes in muscle and tendon adaptation in healthy young men and women.

The main questions it aims to answer are:

* Does resistance training with hydrolyzed collagen ingestion lead to greater changes in tendon properties than resistance training alone?
* Does resistance training with hydrolyzed collagen ingestion lead to greater changes in muscle size than resistance training alone?

Participants will be randomly assigned to collagen or placebo groups. Participants will perform resistance training three times per week for 10 weeks and hydrolyzed collagen or maltodextrin will be given to collagen or placebo group respectively immediately before each resistance training session. Also, vitamin C will be given to both groups.

Researchers will compare collagen and placebo groups to see if hydrolyzed collagen ingestion with resistance exercise would have beneficial effects on changes in muscle and tendon more than resistance training alone. Therefore, using isokinetic dynamometer and ultrasonography, maximal leg strength, morphological, mechanical, and material properties of the patellar tendon and vastus lateralis muscle size and architecture will be assessed. conditions: Healthy Participants conditions: Nutrition conditions: Exercise Training studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study design is a single-blind (participants were unaware of their group allocation), randomized controlled trial. primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 23 type: ACTUAL name: Resistance training with hydrolyzed collagen ingestion in healthy young men name: Resistance training with hydrolyzed collagen ingestion in healthy young women measure: Maximal knee extensor (quadriceps) muscle strength measure: Maximal knee flexor (hamstring) muscle strength measure: Patellar tendon cross-sectional area measure: Patellar tendon stiffness measure: Vastus lateralis (VL) muscle size measure: Vastus lateralis (VL) muscle fascicle length measure: Vastus lateralis (VL) muscle fascicle pennation angle sex: ALL minimumAge: 18 Years maximumAge: 39 Years stdAges: ADULT facility: Research Institute for Sport and Exercise Sciences city: Liverpool state: Merseyside zip: L3 3AF country: United Kingdom lat: 53.41058 lon: -2.97794 hasResults: False

 nctId: NCT06372067 id: 17378 briefTitle: IM Screw vs. K-wire Fixation of Proximal/Middle Phalanx Fractures acronym: HANDFIX overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-12-31 date: 2026-03-01 date: 2024-04-17 date: 2024-04-17 name: McMaster University class: OTHER briefSummary: When people break their fingers, sometimes surgery is needed to align the bones to heal them properly. There are different ways to fix broken bones in hands, such as plates, pins, or screws. Each method has pros and cons; fixing a broken bone with plates is usually a larger surgery with more cutting but holds the bones very securely. Pins require little to no cutting but the patient needs to immobilize their hand for a few weeks afterwards. Screws are a newer method of fixing broken fingers that requires little cutting and also holds the bones securely. The goal of this study is to compare the effectiveness of using pins versus screws in surgery for broken fingers. The investigators are studying whether using screws leads to better hand function, patient satisfaction, and quicker return to work. conditions: Hand; Fracture, Phalanx studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, open-label, pilot randomized controlled trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: By nature of the interventions in this study, blinding will not be possible for the surgeon or the patient post-operatively. whoMasked: OUTCOMES_ASSESSOR count: 34 type: ESTIMATED name: Intramedullary screw name: Kirschner wire measure: Percentage of Patient Eligibility - Study Feasibility measure: Recruitment rate - Study Feasibility measure: Crossover rate - Study Feasibility measure: Compliance with intervention rate - Study Feasibility measure: Patient retention rate - Study Feasibility measure: Disability of the Arm, Shoulder, and Hand measure: Range of motion measure: Grip strength measure: Return to work measure: Complications/adverse events measure: Postoperative pain (visual analogue scale) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06372054 id: TORNADO briefTitle: TORNADO-Omics Techniques and Neural Networks for the Development of Predictive Risk Models overallStatus: RECRUITING date: 2024-02-05 date: 2025-02-05 date: 2027-02-05 date: 2024-04-17 date: 2024-04-17 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER name: University of Milan name: Italian Air Force name: A-Tono name: Ministry of Defense, Italy briefSummary: The goal of this observational study is to define a personalized risk model in the super healthy and homogeneous population of Italian Air Force high-performance pilots. This peculiar cohort conducts dynamic activities in an extreme environment, compared to a population of military people not involved in flight activity. The study integrates the analyses of biological samples (urine, blood, and saliva), clinical records, and occupational data collected at different time points and analyzed by omic-based approaches supported by Artificial Intelligence. Data resulting from the study will clarify many etiopathological mechanisms of diseases, allowing the creation of a model of analyses that can be extended to the civilian population and patient cohorts for the potentiation of precision and preventive medicine. conditions: Oxidative Injury conditions: Stress Physiological conditions: Discogenic Pain conditions: Cardiovascular Risk Factor conditions: Space Maintenance conditions: Epigenetic Changes conditions: LONGEVITY 1 conditions: Neuroplasticity conditions: NGS studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Biological sample collection measure: Assessment of flight-related exposure data and molecular modifications measure: Assessment of General Health measure: Assessment of Sleep Quality measure: Assessment of eating habits measure: Creation of reliable AI and disease-based models for personalized medicine sex: ALL minimumAge: 26 Years maximumAge: 38 Years stdAges: ADULT facility: CeMATA - Joint Center for Aerospace Medicine and Advanced Therapy status: RECRUITING city: Milan zip: 20139 country: Italy name: Stefania E Navone, PhD role: CONTACT phone: 0256660100 phoneExt: +39 email: stefania.navone@policlinico.mi.it name: Giovanni Marfia, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Laura Guarnaccia, PhD role: SUB_INVESTIGATOR name: Stefania E Navone, PhD role: SUB_INVESTIGATOR name: Monica R Miozzo, PhD role: SUB_INVESTIGATOR name: Orazio Granato, PhD role: SUB_INVESTIGATOR name: Silvana Pileggi, PhD role: SUB_INVESTIGATOR name: Luisella Vigna, MD, PhD role: SUB_INVESTIGATOR name: Matteo Bonzini, MD, PhD role: SUB_INVESTIGATOR name: Laura Fontana, PhD role: SUB_INVESTIGATOR name: Laura Begani, MSc role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06372041 id: 944/B briefTitle: Transcranial Alternating Current Stimulation in Cerebral Palsy (BOOSTTACS) acronym: BOOSTTACS overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-03-14 date: 2026-05-14 date: 2024-04-17 date: 2024-04-17 name: IRCCS Eugenio Medea class: OTHER name: IRCCS National Neurological Institute "C. Mondino" Foundation name: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia briefSummary: The present study aims to assess, through a randomized controlled trial (RCT), the efficacy of transcranial alternating current stimulation (tACS) in enhancing the functional changes due to an intensive motor training in children and adolescents with Cerebral Palsy (CP). Particularly, in two different groups active or sham tACS will be paired with the Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) and we will assess the effects on the upper limbs motor ability and daily functioning in 6 to 17 years old patients with CP having mild-to moderate upper limb deficits. The investigators hypothesized that, thanks to the intensive bimanual training, both the active and the sham group will improve in motor functioning. However, in light of findings showing that tACS effectively improves motor learning, the investigators hypothesized that active tACS might improve in a greater and more lasting extent than sham tACS the motor functioning. Moreover, as suggested by previous studies investigating the effect of non-invasive brain stimulation (NIBS) in pediatric population, the investigators expected that the treatment will be safe and well tolerated. Such a result would encourage the use of NIBS to boost the rehabilitative training of motor abilities in children and adolescents with CP. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: transcranial Alternating Current Stimulation measure: Assisting Hand Assessment (AHA) measure: Box and Block Test (BBT) measure: Visuomotor task measure: Canadian Occupational Performance Measure (COPM) measure: Children's Hand-Use Experience Questionnaire (CHEQ) measure: Melbourne Assessment 2 (MA2) measure: Gross Motor Function Measure (GMFM-66) measure: Vineland Adaptive Behavior Scale Version 2 (VABS II) measure: Pediatric quality of life inventory PedsQL(cerebral palsy module), (PEDS-QL) measure: Cortical rhythms at rest and during the Visuomotor task measure: Heart rate (HR) measure: Oxygen saturation (SPO2) measure: Tolerability of the stimulation measure: number of patients who accept to complete the 2-week training measure: number of sessions completed per patient measure: acceptability of the training sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD facility: Scientific Institute, IRCCS E. Medea city: Bosisio Parini state: Lecco zip: 23842 country: Italy name: Alessandra Finisguerra role: CONTACT phone: +39031877652 email: alessandra.finisguerra@lanostrafamiglia.it name: Cosimo Urgesi role: CONTACT phone: +39031877652 email: cosimo.urgesi@lanostrafamiglia.it name: Viola Oldrati role: SUB_INVESTIGATOR lat: 45.80075 lon: 9.29 hasResults: False

 nctId: NCT06372028 id: 944/A briefTitle: Non Invasive Vagus Nerve Stimulation in Cerebral Palsy (BOOSTTVNS) acronym: (BOOSTTVNS) overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-03-14 date: 2026-05-14 date: 2024-04-17 date: 2024-04-17 name: IRCCS Eugenio Medea class: OTHER name: IRCCS National Neurological Institute "C. Mondino" Foundation name: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia briefSummary: The present study aims to assess, through a randomized controlled trial (RCT), the efficacy of transcutaneous Vagus Nerve Stimulation (tVNS) in enhancing the functional changes due to an intensive motor training in children and adolescents with Cerebral Palsy (CP). Particularly, in two different groups active or sham tVNS will be paired with the Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) and we will assess the effects on the upper limbs motor ability and daily functioning in 6 to 17 years old patients with CP having mild-to moderate upper limb deficits. The investigators hypothesized that, thanks to the intensive bimanual training, both the active and the sham group will improve in motor functioning. However, taking into account that tVNS has the potential to facilitate in a bottom-up way neural plasticity, particularly in chronic disease conditions, the investigators hypothesized that active tVNS might improve in a greater and more lasting extent than sham tVNS the motor functioning. Moreover, as suggested by previous studies investigating the effect of non-invasive brain stimulation (NIBS) in paediatric population, the investigators expected that the treatment will be safe and well tolerated. Such a result would encourage the use of NIBS to boost the rehabilitative training of motor abilities in children and adolescents with CP. conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: transcutaneous vagus nerve stimulation (tVNS) measure: Assisting Hand Assessment (AHA) measure: Box and Block Test (BBT) measure: Visuomotor task measure: Canadian Occupational Performance Measure (COPM) measure: Children's Hand-UseExperienceQuestionnaire (CHEQ) measure: Melbourne Assessment 2 (MA2) measure: Gross Motor Function Measure (GMFM-66) measure: Vineland Adaptive Behavior Scale Version 2 (VABS II) measure: Pediatric quality of life inventory PedsQL(cerebral palsy module), (PEDS-QL) measure: Heart rate (HR). measure: Oxygen saturation (SPO2). measure: Tolerability of the stimulation measure: Number of patients who accept to complete the 2-week training measure: Number of sessions completed per patient measure: Acceptability of the training sex: ALL minimumAge: 6 Years maximumAge: 17 Years stdAges: CHILD facility: Scientific Institute, IRCCS E. Medea city: Bosisio Parini state: Lecco zip: 23842 country: Italy name: Alessandra Finisguerra role: CONTACT phone: +39031877652 email: alessandra.finisguerra@lanostrafamiglia.it name: Cosimo Urgesi role: CONTACT email: cosimo.urgesi@lanostrafamiglia.it name: Viola Oldrati role: SUB_INVESTIGATOR lat: 45.80075 lon: 9.29 hasResults: False

 nctId: NCT06372015 id: RC2023-24 briefTitle: Changes in the Lipidomic, Immunological and miRNA Profile in Patients Undergoing a Dietary Program or Bariatric Surgery overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2026-06-01 date: 2024-04-17 date: 2024-04-17 name: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis class: OTHER name: Notarnicola Maria name: Cozzolongo Raffaele name: Shahini Endrit name: De Pergola Giovanni name: Lippolis Giuseppe briefSummary: Obesity is a chronic disease characterized phenotypically by an increase in body weight (BMI\>30 kg/m2) and by a series of associated pathologies, such as hypertension, diabetes, hepatic steatosis.

The association of these pathologies compromises the patient's survival and quality of life. The multifactorial origin of obesity makes its etiopathology difficult to manage. It is often possible to follow only one therapeutic strategy, especially after the so-called standard treatments, such as dietary intervention and physical activity, have not brought benefit to the patient. In these cases, an appropriate treatment for the patient to enjoy significant weight loss is bariatric surgery.

Bariatric surgery refers to all those interventions aimed at reducing weight in those suffering from obesity, and treating the diseases associated with it.

Among the different types of bariatric surgery, the techniques most used in common clinical practice are intragastric balloons, gastric by pass (RYGB) and sleeve gastrectomy.

The choice of the surgeon, assisted by the multidisciplinary team, is binding in the choice of the type of operation to which the patient will be subjected. conditions: Obesity conditions: Liver Disease Parenchymal studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 60 type: ESTIMATED name: Nutritional Approach name: Surgery Approach measure: Variation of lipidomic parameters measure: The effect of intervention on routine blood chemistry parameters, relating to NAFLD and fibrosis measure: Variation in the microRNA profile sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS "Saverio de Bellis" city: Castellana Grotte state: Bari zip: 70013 country: Italy name: Rossella Donghia, Biologyst role: CONTACT phone: 0804994652 email: rossella.donghia@irccsdebellis.it lat: 40.88643 lon: 17.16549 hasResults: False

 nctId: NCT06372002 id: 05/23 briefTitle: Effectiveness and Cost-Effectiveness of Cognitive Stimulation Therapy - Spain (CST-ES) in People Living With Dementia overallStatus: ACTIVE_NOT_RECRUITING date: 2023-10-16 date: 2024-07-31 date: 2024-07-31 date: 2024-04-17 date: 2024-04-17 name: Instituto de Mayores y Servicios Sociales (IMSERSO) class: OTHER_GOV name: University of Castilla-La Mancha name: Confederación Española de Alzheimer (CEAFA) briefSummary: This study aims to evaluate the effectiveness and cost-effectiveness of CST-ES, the Spanish adaptation of Cognitive Stimulation Therapy (CST), to improve cognition and quality of life in people with mild to moderate dementia.

The evaluation will be conducted as a pragmatic multicenter randomized controlled clinical trial. Participants will be randomized to receive 7 weeks of CST-ES followed by 24 weeks of maintenance CST-ES (intervention group) or to continue their usual treatment (control group). conditions: Dementia conditions: Neurocognitive Disorders conditions: Mild Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A pragmatic, multicenter, randomized, controlled clinical trial is proposed to compare treatment with CST-ES followed by maintenance treatment with CST-ES with treatment as usual:

* First Phase: Participants who meet the inclusion criteria will be randomized to the CST-ES intervention group or a treatment-as-usual control group. Participants assigned to the intervention group will receive two sessions of CST-ES per week for 7 weeks, also they will continue their usual treatment. Participants in the control group will receive their usual treatment during the development of the study.
* Second Phase: After the first phase is completed, participants assigned to the intervention group will receive one session of maintenance CST-ES per week for 24 weeks besides continuing their usual treatment, whereas participants in the control group will continue their usual treatment during this second phase. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The technician in charge of the evaluation of those participating in the study must be blinded throughout the CST intervention, i.e., he/she will not know whether the users being evaluated belong to the intervention or the control group.

The CRE Alzheimer professional responsible for randomization and data analysis will also be blinded.

The participants and the technician performing the intervention cannot be blinded due to the nature of the intervention. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 683 type: ACTUAL name: Cognitive Stimulation Therapy (CST) measure: Cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG) measure: Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG) measure: Change in cognitive functioning assessed through Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-COG) measure: Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD) measure: Change in Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD) measure: Change in Quality of life evaluated through Quality of Life - Alzheimer's Disease (QoL-AD) measure: Cognitive functioning assessed through Mini-Mental State Examination (MMSE) measure: Change in Cognitive functioning assessed through Mini-Mental State Examination (MMSE) measure: Change in Cognitive functioning assessed through Mini-Mental State Examination (MMSE) measure: Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L) measure: Change in Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L) measure: Change in Quality of life evaluated through EuroQol-5D 5-level version (EQ-5D-5L) measure: Resource utilization evaluated through Resource Utilization in Dementia (RUD) measure: Change in resource utilization evaluated through Resource Utilization in Dementia (RUD) measure: Sociodemographic information gathered through the sociodemographic questionnaire measure: Adherence to the intervention and dropouts evaluated through a session form sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Centro de día de la Asociación de Familiares y Amigos de Enfermos de Alzheimer de Alcoy y Comarca city: Alcoy state: Alicante country: Spain lat: 38.70545 lon: -0.47432 facility: AFA Castalla y Onil city: Castalla state: Alicante country: Spain lat: 38.59694 lon: -0.67207 facility: AFA Elda, Petrer y Comarca del Medio Vinalopo city: Elda state: Alicante country: Spain lat: 38.47783 lon: -0.79157 facility: AFA Teulada - Moraira (Marina Alta) city: Teulada state: Alicante country: Spain lat: 38.7294 lon: 0.10383 facility: Asociación Familiares de Personas con Alzheimer de Villena y Comarca city: Villena state: Alicante country: Spain lat: 38.6373 lon: -0.86568 facility: Centro Terapéutico para Alzheimer y otras demencias "Antonia Blanco Sánchez" city: Mérida state: Badajoz country: Spain lat: 38.91611 lon: -6.34366 facility: Centro Alois II city: Cornellà De Llobregat state: Barcelona country: Spain lat: 41.35 lon: 2.08333 facility: Asociación de familiares de personas con Alzheimer y otras demencias del Maresme city: Mataró state: Barcelona country: Spain lat: 41.54211 lon: 2.4445 facility: Asociación de Familiares de Enfermos de Alzheimer de Iniesta (ADADI) city: Iniesta state: Cuenca country: Spain lat: 39.43333 lon: -1.75 facility: AFEAVA city: Hervás state: Cáceres country: Spain lat: 40.27081 lon: -5.86721 facility: AFA Faro de Chipiona city: Chipiona state: Cádiz country: Spain lat: 36.73663 lon: -6.43703 facility: Afa Puerto city: El Puerto De Santa María state: Cádiz country: Spain lat: 36.59389 lon: -6.23298 facility: Asoc familiares de enfermos de Alzheimer y otras demencias afines de Fernán Núñez city: Fernán Núñez state: Córdoba country: Spain lat: 37.67044 lon: -4.7264 facility: AFAMO city: Montilla state: Córdoba country: Spain lat: 37.58627 lon: -4.63805 facility: AFASUR Genil city: Puente Genil state: Córdoba country: Spain lat: 37.38943 lon: -4.76686 facility: Asociación de familiares de enfermos de Alzheimer de Motril - Contigo city: Motril state: Granada country: Spain lat: 36.75066 lon: -3.5179 facility: AFAMA Pollença city: Pollença state: Islas Baleares country: Spain lat: 39.87678 lon: 3.01626 facility: Asociación Alzheimer Bierzo city: Ponferrada state: León country: Spain lat: 42.54664 lon: -6.59619 facility: Afa Santa Marina Del Rey city: Santa Marina del Rey state: León country: Spain lat: 42.51334 lon: -5.86065 facility: Associació de Familiars i Malalts d'Alzheimer de Tàrrega i comarca city: Tàrrega state: Lleida country: Spain lat: 41.64704 lon: 1.13957 facility: AFA Pozuelo city: Pozuelo De Alarcón state: Madrid country: Spain lat: 40.43293 lon: -3.81338 facility: Asociación Alzheimer y otras Demencias Lorca city: Lorca state: Murcia country: Spain lat: 37.67119 lon: -1.7017 facility: Centro de día Alzheimer Estepona city: Estepona state: Málaga country: Spain lat: 36.42764 lon: -5.14589 facility: Centro de Día Nieves Barranco city: Marbella state: Málaga country: Spain lat: 36.51543 lon: -4.88583 facility: AFADAX city: Vélez-Málaga state: Málaga country: Spain lat: 36.78107 lon: -4.10266 facility: Asociación de Alzheimer "Virgen del Castillo" city: Lebrija state: Sevilla country: Spain lat: 36.92077 lon: -6.07529 facility: AFATA Asociación de familiares y amigos de personas con deterioro cognitivo, enfermedad de Alzheimer y otras demencias de Talavera de la Reina city: Talavera De La Reina state: Toledo country: Spain lat: 39.96348 lon: -4.83076 facility: ASFAL (Asociación de Familiares y Amigos de personas con Alzheimer de Algemesí) city: Algemesí state: Valencia country: Spain lat: 39.19042 lon: -0.43572 facility: AFA Alginet city: Alginet state: Valencia country: Spain lat: 39.26667 lon: -0.46667 facility: Centro de estimulación y Rehabilitación "La LLimera" de AFABALS city: Benifayó state: Valencia country: Spain lat: 39.28439 lon: -0.42598 facility: AFA Benavente y Comarca city: Benavente state: Zamora country: Spain lat: 42.00249 lon: -5.67826 facility: AFA Alicante city: Alicante country: Spain lat: 38.34517 lon: -0.48149 facility: Centre de Día AFA Barcelona city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 facility: Club de la memoria - Alzhei Cáceres city: Cáceres country: Spain lat: 39.47649 lon: -6.37224 facility: AFA Alzhe de Cadiz city: Cádiz country: Spain lat: 36.52672 lon: -6.2891 facility: Asociación San Rafael de Alzheimer y Otras Demencias city: Córdoba country: Spain lat: 37.89155 lon: -4.77275 facility: AFA Huelva city: Huelva country: Spain lat: 37.26638 lon: -6.94004 facility: Alzheimer León city: León country: Spain lat: 42.60003 lon: -5.57032 facility: Asociación de Familiares y Enfermos de Alzheimer y otras demencias de La Rioja (AFA Rioja) city: Logroño country: Spain lat: 42.46667 lon: -2.45 facility: AFALU city: Lugo country: Spain lat: 43.00992 lon: -7.55602 facility: AFA Málaga city: Málaga country: Spain lat: 36.72016 lon: -4.42034 facility: Centro de Referencia estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso city: Salamanca zip: 37008 country: Spain lat: 40.96882 lon: -5.66388 facility: AGADEA city: Santiago de Compostela country: Spain lat: 42.88052 lon: -8.54569 facility: AFAV (Asociación Familiares Enfermos de Alzheimer Valencia) city: Valencia country: Spain lat: 39.46975 lon: -0.37739 facility: Alzheimer Ávila city: Ávila country: Spain lat: 40.65724 lon: -4.69951 facility: AFARABA city: Gasteiz / Vitoria state: Álava country: Spain lat: 42.84998 lon: -2.67268 hasResults: False

 nctId: NCT06371989 id: 19/160 briefTitle: Vacuum Assisted Biopsy and Surgery Correlation in HER2 and TN Breast Cancer Subtypes MRI Responders After Neoadjuvant Therapy: BISUCO TRIAL acronym: BISUCO overallStatus: COMPLETED date: 2019-03-11 date: 2021-03-20 date: 2022-12-20 date: 2024-04-17 date: 2024-04-17 name: Hospital Universitario 12 de Octubre class: OTHER briefSummary: BACKGROUND AND CURRENT STATUS:

Advancements in neoadjuvant systemic treatments (NST) for HER2 positive and triple-negative (TN) breast cancer (BC) subtypes have led to high rates of pathologic complete response (pCR), raising questions about the necessity of subsequent surgery, especially for those undergoing adjuvant radiotherapy. While Magnetic Resonance Imaging (MRI) remains the most effective imaging technique for assessing neoadjuvant treatment response, surgery is still required to confirm pCR in cases of almost complete or complete MRI response (iCR). To safely avoid surgery in these BC "exceptional responders," a technique with high negative predictive value is imperative.

OBJECTIVE:

This study aims to establish the diagnostic efficacy of image-guided vacuum-assisted biopsy (VAB) in assessing pathological complete response (pCR) after NST in HER2 positive or TN breast cancer subtypes, particularly those showing post NST-MRI complete or almost complete response.

METHODS:

A prospective study was conducted at "Hospital Universitario 12 de Octubre de Madrid" from June 25, 2018, to October 25, 2029. Twenty-five patients with HER2-positive or TN operable invasive ductal carcinoma (IDC) BC subtype, at stages cT1-3/N0-2 undergoing primary NST and showing complete or almost complete response on post NST-MRI, were enrolled. Ultrasound or stereotactic-guided vacuum-assisted biopsy (VAB) of the previous clip and tumor bed area was performed before surgery. VAB pathological results were compared with surgical pathological results to evaluate the diagnostic efficacy of predicting pCR with VAB after NST. Pathological representativeness of the VAB sample was ensured. pCR was defined as the absence of invasive ductal carcinoma and in situ ductal carcinoma. conditions: Breast Cancer conditions: Breast Biopsy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single Group Assignment primaryPurpose: DIAGNOSTIC masking: NONE count: 25 type: ACTUAL name: Image guided vacuum assisted biopsy measure: The negative Predictive Value (NPV), Positive predictive value, specificity and sensibility of the VAB compared to Standard Surgery with Pathologic Evaluation sex: FEMALE minimumAge: 18 Years maximumAge: 95 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sara Jimenez Arranz city: Madrid zip: 28020 country: Spain lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06371976 id: APH240230 briefTitle: Evaluation of the HPA Axis in Patients With Vasoplegic Syndrome After Cardiac Surgery acronym: VASOCORT overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-04-01 date: 2025-04-01 date: 2024-04-17 date: 2024-04-17 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Vasoplegic syndrome after cardiac surgery is common and is associated with increased morbidity and mortality. It is characterized by early and prolonged arterial hypotension, with preserved cardiac output and low systemic vascular resistance. Vasoplegic syndrome therefore shares pathophysiological features with septic shock. There are no data in the literature on the function of the hypothalamic-pituitary-adrenal (HPA) axis during vasoplegic syndrome after cardiac surgery. In situations of acute stress and systemic inflammation, relative adrenal insufficiency has been reported in the most severe patients, particularly those in septic shock. The term ""CIRCI"" (Critical Illness-Related Corticosteroid Insufficiency) is currently defined as an increase in total plasma cortisol of less than 9 µg/dl after stimulation with 250 µg tetracosactide (synthetic ACTH), or a basal total plasma cortisol level of less than 10 µg/dl. However, recent studies have called into question the usefulness of the cosyntropin stimulation test for exploring the HPA axis in intensive care patients.

Tandem mass spectrometry (LC-MS/MS) assays can be used to measure steroid metabolites (steroidome), enabling more precise exploration of the corticotropic axis.

The aim of this study is to evaluate, on an exploratory basis, the impact of the presence of a post-cardiac surgery vasoplegic syndrome on adrenal function by steroidome mapping (LC-MS/MS). conditions: Vasoplegic Syndrome in Adult Cardiac Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Blood sampling name: Vital status measure: Impact of post-cardiac surgery vasoplegic syndrome on corticotropic function. measure: Evaluate corticotropic function by measuring steroid metabolites according to the presence or absence of ""CIRCI"" in patients with vasoplegic syndrome. measure: Evaluate the association between CIRCI and the severity of vasoplegic syndrome after cardiac surgery. measure: To assess the association between ""CIRCI"" and the duration of post-cardiac surgery vasoplegic syndrome. measure: To assess the association between ""CIRCI"" and length of stay in intensive care. measure: Evaluate the association between ""CIRCI"" and in-hospital mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pitié-Salpêtrière city: Paris state: Ile-de-France zip: 75013 country: France name: Adrien Bouglé, MD, PhD role: CONTACT phone: 00 33 42 16 29 91 email: adrien.bougle@aphp.fr name: Jérémie Guillemin, MD role: CONTACT phone: 00 33 84 82 82 58 email: jeremie.guillemin@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06371963 id: LinnaeusU REDs briefTitle: Relative Energy Deficiency in Sports (REDs) in Swedish Athletes acronym: REDs-Sweden overallStatus: RECRUITING date: 2022-05-10 date: 2024-05 date: 2026-12 date: 2024-04-17 date: 2024-04-18 name: Linnaeus University class: OTHER name: Swedish Olympic Committee name: Swedish Research Council for Sport Science name: World Anti-Doping Agency briefSummary: Background: Relative Energy Deficiency in Sport (REDs) describes impairment of health and performance due to problematic (long-term/severe) low energy availability (LEA), with or without eating disorders. LEA is frequently reported in sports with high training volumes, especially in leanness demanding sports, and 20% of female and 9% of male Norwegian national team athletes have been reported to have eating disorders. Potential trigger factors are e.g., dieting, injuries, coaching behavior, and subculture aspects e.g., focus on low body weight. The main questions that will be addressed are: 1. What is the prevalence of eating disorders and REDs among Swedish elite athletes and controls? 2. What is the impact of problematic LEA on health and performance aspects in both male and female athletes? Methods: National team athletes and gender and matched controls will be invited to an anonymous on-line survey. Elite athletes who agree to participate, will be invited to assessment of eating disorders, nutritional and physiological status (e.g., metabolic and endocrine markers, bone health, microbiota, dietary intake, energy availability, and performance). conditions: RED S conditions: Eating Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 500 type: ESTIMATED measure: Self-reported eating disorders measure: Eating disorders measure: Self-reported reproductive function in females not using hormonal contraceptives measure: Reproductive function in females not using hormonal contraceptives measure: Self-reported reproductive function in males measure: Reproductive function in males measure: Gastrointestinal function measure: Injury measure: Self- reported symptoms of depression measure: Compulsive exercise measure: The motivation for behavioral changes measure: Psychological flexibility measure: Changes in immune markers from pre to post exercise measure: Microbiota measure: Dietary intake measure: Maximal aerobic capacity measure: Explosive lower body power measure: Whole body strength measure: Muscular power measure: Resting Metabolic Rate measure: Body composition measure: Body weight measure: Body height measure: Glucose levels sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Linnaeus University status: RECRUITING city: Kalmar state: Småland country: Sweden name: Anna Melin, PhD role: CONTACT phone: 0732629714 email: anna.melin@lnu.se lat: 56.66157 lon: 16.36163 hasResults: False

 nctId: NCT06371950 id: 123608 briefTitle: Gut Microbiome in Orthopaedics acronym: GUMBO overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-01 date: 2027-01-01 date: 2024-04-17 date: 2024-04-17 name: Lawson Health Research Institute class: OTHER briefSummary: Patients having knee replacement surgery regularly experience joint pain and compromised bone quality leading to implant loosening and periprosthetic fractures. The role of the gut microbiome, which is the collection of bacteria and other microbes within the human gastrointestinal tract, is just beginning to be recognized, including its potential effects on pain, infection, and loosening after total joint replacement. Antibiotics are regularly used in orthopaedic surgery to reduce the risk of infection, but they also harm gut microbiota and reduce their potentially beneficial effects. Probiotics may have a role to play in enhancing bone quality and decreasing synovial inflammation after joint replacement surgery, and this study will explore the potential relationship of probiotic use with implant migration, bone density, and patient outcomes.

This study is a randomized, controlled, double-blinded trial comparing probiotic use with placebo in post-menopausal women undergoing primary total knee replacement. The main questions it aims to answer are:

* to compare implant migration between groups from baseline to six weeks post-surgery
* to compare bone density and joint inflammation between groups from baseline to six weeks post-surgery
* to compare gut microbiome composition and patient-reported outcome measures between groups from baseline to six weeks post-surgery conditions: Total Knee Arthroplasty conditions: Inflammation conditions: Gastrointestinal Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Probiotic Formula Bacillus subtilis name: Placebo measure: Implant Migration measure: Bone Density measure: Magnitude of 18-F-Fluoroethyl(2-(2-fluoroethoxy)phenyl)-proprionate ([¹⁸F]FEPPA) Tracer Uptake measure: Veterans Rand 12-Item Health Survey (VR-12) measure: EuroQol-5D (EQ-5D) measure: Western Ontario McMaster Osteoarthritis Index (WOMAC) measure: Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP) measure: Patient Global Assessment (PGA) measure: University of California, Los Angeles (UCLA) Activity Score measure: Oxford Knee Score - English for Canada measure: Knee Society Score (KSS) measure: Presence of MRSA measure: Microbial Diversity - Taxonomic Differences measure: Microbial Diversity - Taxonomic Correlation measure: Diet and Supplement Questionnaire measure: Histopathology measure: Immunohistochemistry measure: Inflammatory Blood Marker: C-Reactive Protein measure: Inflammatory Blood Marker: Interleukin-1B measure: Inflammatory Blood Marker: Interleukin-6 measure: Inflammatory Blood Marker: Interleukin-8 measure: Inflammatory Blood Marker: Tumor Necrosis Factor Alpha measure: Inflammatory Blood Marker: Erythrocyte Sedimentation Rate measure: Inflammatory Blood Marker: Alkaline Phosphatase measure: Inflammatory Blood Marker: Calcium measure: Inflammatory Blood Marker: Albumin measure: Inflammatory Blood Marker: Urate measure: Inflammatory Blood Marker: Total Protein measure: Inflammatory Blood Marker: Creatinine measure: Inflammatory Blood Marker: Vitamin D measure: Inflammatory Blood Marker: White Blood Cell Count measure: Inflammatory Blood Marker: Red Blood Cell Count measure: Inflammatory Blood Marker: Hemoglobin Concentration measure: Inflammatory Blood Marker: Hematocrit Percentage measure: Inflammatory Blood Marker: Platelet Count sex: FEMALE minimumAge: 55 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: London Health Sciences Centre city: London state: Ontario zip: N6A 5A5 country: Canada name: Rachel Vander Deen role: CONTACT phone: 519-685-8500 phoneExt: 34269 email: Rachel.VanderDeen@lhsc.on.ca name: Lyndsay Somerville, PhD role: CONTACT phone: 519-685-8500 phoneExt: 36645 email: Lyndsay.Somerville@lhsc.on.ca name: Brent Lanting, MD role: PRINCIPAL_INVESTIGATOR name: Jeremy Burton, PhD role: SUB_INVESTIGATOR name: Tom Appleton, PhD role: SUB_INVESTIGATOR name: Matthew Teeter, PhD role: SUB_INVESTIGATOR name: Jonath Thiessen, PhD role: SUB_INVESTIGATOR lat: 42.98339 lon: -81.23304 hasResults: False

 nctId: NCT06371937 id: 120687 briefTitle: iPSC Biobank of Biomarkers Diversity in Cardiovascular Disease acronym: INFERENCE overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2033-06-30 date: 2033-06-30 date: 2024-04-17 date: 2024-04-25 name: Lawson Health Research Institute class: OTHER name: Greenstone Biosciences, Inc. briefSummary: The Investigators will create a clinical database and a Biobank of stem cells derived from the blood of participants with cardiovascular disease. The Investigators will recruit participants from diverse racial and ethnic backgrounds with equal representation from both sexes. The Investigators expect to create stem cells and analyze the blood for protein biomarkers and genetic causes of cardiovascular disease. The stem cell biobank and clinical data will be a powerful tool for studying cardiovascular disease. conditions: Cardiovascular Diseases conditions: Arrythmia conditions: Cardiomyopathies conditions: Heart Failure conditions: Cerebrovascular Accident conditions: Congenital Heart Disease conditions: Cardiometabolic Syndrome studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: REDCap Database measure: Induced pluripotent stem cell (iPSC) Biobank measure: Differentiation into Cardiovascular lineages measure: Molecular profiling of participants measure: Bioinformatics analysis sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06371924 id: KCH23-156 briefTitle: Immunometabolism of Machine Perfusion Strategies acronym: iMaps overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-05-31 date: 2026-05-31 date: 2024-04-17 date: 2024-04-17 name: King's College Hospital NHS Trust class: OTHER name: King's College London briefSummary: There are not enough donated livers for everybody who needs one, and as a result, thousands of patients worldwide are waiting for liver transplants, with many dying while waiting for a life-saving organ. One reason for this shortage is that some usable livers from donors who are considered of high risk are being thrown away out of concern that they might not work well after transplantation due to a problem called ischaemia reperfusion injury (IRI).

The discarded organs are mostly those coming from donors who have died due to cardiac arrest (called 'donation after circulatory death' or DCD), with only 27% of them being used in the UK. The quality of these DCD organs could be improved by changing how they are preserved after being removed from the donor. The most commonly used strategy is still to remove the livers and put them in an icebox ('static cold storage' or SCS). The alternative approaches, which are more complex and expensive, but that can also improve the quality of the DCD livers, involve using machines to pump fluids through the livers ('machine perfusion' or MP).

There are three MP methods being used in patients: 1) normothermic regional perfusion (NRP), which involves pumping the donor's blood through the liver after the donor has died but the liver is still in the donor's body; 2) normothermic machine perfusion (NMP), in which the liver is pumped with blood outside of the donor's body; and 3) hypothermic machine perfusion (HOPE), which is also used outside of the donor's body by pumping cold fluid into the liver. HOPE and NRP have been shown to improve how well DCD livers function after transplantation. NMP can also improve the quality of the DCD livers, but its main advantage is that it allows confirming that the donated liver functions well before proceeding with the transplant. Until now, there has not been a proper comparison of these methods, and the doctors do not understand well the mechanisms through which MP improves the quality of the DCD livers.

The iInvestigators plan to conduct a study where 36 DCD human livers will be split into three groups: SCS, NRP, and HOPE. After that, they will be put in NMP to confirm that they are good enough to be transplanted and to study the mechanisms through which NRP, SCS and HOPE work. conditions: Liver Transplantation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The investigators propose to conduct a randomised clinical trial in which 36 DCD human livers will be allocated to 1 of 3 treatment arms:

i) SCS; ii)NRP; and iii) HOPE. This will be followed by a period of time in NMP in order to study the IRI response and determine if the quality of the livers is good enough to proceed to transplantation. This study will allow the doctors to decipher the mechanisms of liver IRI in humans in a much better way than what has been achieved to date. primaryPurpose: OTHER masking: NONE count: 36 type: ESTIMATED name: Machine Perfusion measure: To determine the effect of different preservation strategies on the development of mitochondrial damage following reperfusion during NMP. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06371911 id: 2023-A02762-43 briefTitle: Benefit of Adding Cureety TechCare Telemonitoring to Usual Care During Injectable Anticancer Treatment acronym: OPTIMACURE overallStatus: RECRUITING date: 2024-04-03 date: 2024-08-03 date: 2024-12-03 date: 2024-04-17 date: 2024-04-18 name: Centre Francois Baclesse class: OTHER name: Cureety briefSummary: Currently, during usual care, it is critical to assess whether a patient is apt to receive injectable anticancer treatment in the days prior to the administration. To assess this, blood tests are usually performed in the days leading up to the planned administration. A hospital staff member then telephones the patients and evaluates, using the tests results and other patient data (including the presence of adverse events (AEs) and Eastern Cooperative Oncology Group \[ECOG\] performance status), whether the patient is apt for treatment or whether the treatment needs to be deferred.

In France, the Centre François Baclesse in Caen (France) launched the OPTIMA program to optimize the prescription and preparation of chemotherapy in the ambulatory unit of the hospital.

A prospective study validating the OPTIMA program found that the prescription of chemotherapy was accurate with significantly reduced waiting times for patients between the planned appointment time and initiation of chemotherapyThe OPTIMA program is now part of usual care at the Centre François Baclesse.

Following the positive impact of both the OPTIMA and "Star" programs, several French healthcare centers have implemented similar programs. However, a large proportion of the data during the program are collected by telephone, particularly outgoing calls (from the hospital staff to patients). Thus, implementing these programs is expected to increase the number and/or duration of outgoing calls and consequently the workload of hospital staff.

Since the deployment of the OPTIMA program (between 2014 and 2016), and other equivalent programs, more and more patients have asked for the telephone calls to be replaced by a web-based application. Indeed, patients do not always respond to the telephone calls made by hospital staff, thus forcing staff to repeat calls several times. Also, some patients with language or hearing difficulties are unable to answer the questionnaires by telephone: a web-based alternative would be more appropriate for these patients.

Telemonitoring can collect blood test results and other patient data required to evaluate whether patients are apt for injectable cancer treatment. Telemonitoring can then identify the few patients that need to be contacted by hospital staff, thus reducing the number of outgoing telephone calls.

There is growing evidence of the benefits of adding telemonitoring to usual care for patients undergoing cancer treatment. The benefits include the early detection of AEs, improved quality of life (QoL), fewer admissions to emergency rooms or hospitalization, the longer remaining on chemotherapy for patients, and extended overall survival.

Cureety is a digital telemonitoring platform, specifically designed to monitor signs and symptoms of disease progression and AEs in cancer patients. The digital tool includes questionnaires for each class of medication to monitor patients' adverse events remotely. The data collected include blood results, treatment-related data (including delays, dose reductions), as well as QoL and safety data. In terms of safety, patients respond to an electronic patient-reported outcome (ePRO) questionnaire based on the NCI-CTCAE version (v)5.0. Depending on the responses, the Cureety TechCare algorithm classifies the patient state as "correct", "compromised", "to be monitored", or "critical". The patients are then notified of the actions to be taken according to their classification. In preparation for injectable cancer treatment, Cureety can collect the data necessary to evaluate whether patients are apt for treatment administration. The collection and evaluation of this data is expected to decrease outgoing calls by between 30% to 50%.

This study was designed to evaluate whether adding Cureety telemonitoring to usual care would reduce the number of outgoing calls for hospital staff during the management of patients undergoing injectable at one of the participating centers compared with the usual care including a program for anticipation of injectable treatment (OPTIMA program or equivalent). conditions: Adult Patients Initiating Injectable Anticancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 192 type: ESTIMATED name: Cureety telemonitoring name: OPTIMA or equivalent programs measure: Effectiveness of adding Cureety telemonitoring to usual care sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre hospitalier de Bligny status: NOT_YET_RECRUITING city: Bligny country: France name: Jean-Baptiste MERRIC, MD role: CONTACT email: jb.meric@chbligny.fr name: Jean-Baptiste MERRIC, MD role: PRINCIPAL_INVESTIGATOR facility: Centre François Baclesse status: RECRUITING city: Caen zip: 14000 country: France name: Audrey Faveyrial, MD role: CONTACT email: a.faveyrial@baclesse.unicancer.fr name: Jean-Michel Grellard role: CONTACT email: jm.grellard@baclesse.unicancer.fr name: Audrey Faveyrial, MD role: PRINCIPAL_INVESTIGATOR lat: 49.18585 lon: -0.35912 facility: Centre de Radiothérapie et Oncologie Médicale d'Osny status: NOT_YET_RECRUITING city: Osny country: France name: Abderrezak LADOUANI, MD role: CONTACT email: a.ladouani@crom95.com name: Abderrezak LADOUANI, MD role: PRINCIPAL_INVESTIGATOR lat: 49.0701 lon: 2.06277 hasResults: False

 nctId: NCT06371898 id: 29BRC24.0088 - MORDIGO briefTitle: Comparison of MORbidity of Submucosal DIssection Resection of Giant cOlon Lesions Versus Surgery: a National Multicenter Study (MORDIGO) acronym: MORDIGO overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-18 date: 2025-06-17 date: 2025-06-17 date: 2024-04-17 date: 2024-04-17 name: University Hospital, Brest class: OTHER briefSummary: Propose a one-piece endoscopic resection such as endoscopic submucosal dissection (ESD) rather than surgery for benign lesions and superficial T1 cancers colorectal cancers offers comparable efficacy with better tolerability. This approach is all the more in the rectum, even for giant lesions lesions (over 8cm), as rectal surgery is particularly morbid, with particularly morbid, with a functional impact that can impact, whereas rectal ESD is less prone to complications fewer complications than in the colon. Colonic ESD for giant lesions is a longer and more morbid more time-consuming and morbid than for smaller lesions, the question of colonic surgery in this indication. this indication. In order to compare the morbidity data of patients of giant lesions with those of colectomy, a control group colectomy, a surgical control group will be set up, including patients including patients having undergone surgery for in situ T1 or T2 in situ colon cancer. Surgical resections of resection of benign lesions is generally not indicated not indicated and would not provide the necessary necessary for a comparison. T3 and T4 lesions with their own their own morbidity will be excluded. conditions: Colonic Neoplasms studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 500 type: ESTIMATED measure: 30 days severe morbidity measure: morbidity of ESD group measure: comparison of morbidity in both groups measure: reintervention measure: stomia measure: length of hospital stay measure: readmission measure: mortality measure: risk factors for morbidity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Brest city: Brest zip: 29609 country: France lat: 48.3903 lon: -4.48628 hasResults: False

 nctId: NCT06371885 id: P.T.REC/012/004646 briefTitle: Shock Wave on Pillar Pain After Carpal Tunnel Release in Hand Burn overallStatus: ACTIVE_NOT_RECRUITING date: 2023-08-10 date: 2024-05-30 date: 2024-06-28 date: 2024-04-17 date: 2024-04-17 name: Cairo University class: OTHER briefSummary: "In burn cases, the reported causes of CTS are increased volume of carpal tunnel content due to edema and synovitis, wrist hyperextension, tight dressing, fibrosis, and direct burn to the nerve. There are two types of pain that occur in the palm of the hand after carpal tunnel surgery: incisional pain and pillar pain. The incision pain typically only lasts for a few days or weeks after surgery, while the pillar pain occurs on the sides of the incision in the thicker parts of the palm, called the thenar and hypothenar eminences. This is where the transverse ligament attaches to the carpal bones, forming the carpal tunnel.

So, in this study we will find out if shock wave therapy has therapeutic effect on pillar pain after carpal tunnel release in hand burn. conditions: Hand Burn conditions: Carpal Tunnel Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Interventional (clinical trial) primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Double mask for both groups (participant) whoMasked: PARTICIPANT count: 52 type: ACTUAL name: shock wave therapy name: traditional physical therapy measure: Visual Analog Scale measure: Hand held dynamometer measure: Michigan hand out Comes questionnaire sex: ALL minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: Shaimaa Mohamed Ahmed El Sayeh city: Cairo state: New Cairo zip: 02 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06371872 id: 2024-A00173-44 briefTitle: French Cohort of Patients With Rotator Cuff Lesions acronym: PRO-CUFF overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2035-12 date: 2035-12 date: 2024-04-17 date: 2024-04-17 name: GCS Ramsay Santé pour l'Enseignement et la Recherche class: OTHER briefSummary: The purpose of this study is to identify, at 5 years, the clinical and therapeutic factors associated with improvement in shoulder functionality and quality of life in patients with transfixing (total) rotator cuff injuries undergoing treatment. conditions: Rotator Cuff Injuries studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 519 type: ESTIMATED name: total transfixing injury to the rotator cuff measure: Shoulder Pain and Disability Index measure: European quality of life scale - EQ5D sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinique Maussins-Nollet city: Paris zip: 75019 country: France name: Geoffroy NOURISSAT, MD role: CONTACT email: gnourissat@wanadoo.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06371859 id: 3-3031-2915/1 briefTitle: Human-AI Collaborative Intelligence for Improving Fetal Flow Management overallStatus: RECRUITING date: 2024-04-15 date: 2024-12-01 date: 2025-12-01 date: 2024-04-17 date: 2024-04-23 name: Rigshospitalet, Denmark class: OTHER name: Slagelse Hospital name: Technical University of Denmark briefSummary: This randomized controlled study evaluates the effectiveness of explainable AI (XAI) in improving clinicians' interpretation of Doppler ultrasound images (UA and MCA) in obstetrics. It involves 92 clinicians, randomized into intervention and control groups. The intervention group receives XAI feedback, aiming to enhance accuracy in ultrasound interpretation and medical decision-making.

Objectives:

1. To develop an interpretable model for commonly used Doppler flows, specifically the Pulsatility Index (PI) of the umbilical artery (UA) and middle cerebral artery (MCA), with the aim to provide quality feedback on Doppler spectrum images and suggest potential gate placements.
2. To test the effects of providing Explainable AI (XAI)-feedback for clinicians compared with no feedback on their accuracy in ultrasound interpretation and management. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE maskingDescription: Sealed envelopes will be used and opened at the time of inclusion of each participant. Each participant will be randomized to either AI support or no support. The allocation of participants will be performed by (XYZ) who does not have access to the randomization order. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 92 type: ESTIMATED name: "XAI feedback on MCA/UA Doppler spectral curves and gate placement suggestions" measure: Responses will be reviewed independently by two fetal medicine sonographers, and in case of disagreement between the two experts, a consensus will be reached. measure: Accuracy of flow image management among competence groups sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Rigshospitalet status: RECRUITING city: Copenhagen state: Capital Region Of Denmark zip: 2100 country: Denmark name: Zahra Bashir, MD role: CONTACT name: Zahra Bashir, MD role: PRINCIPAL_INVESTIGATOR lat: 55.67594 lon: 12.56553 facility: Slagelse Hospital status: RECRUITING city: Slagelse state: Region Zealand zip: 4200 country: Denmark name: Zahra Bashir, MD role: CONTACT name: Zahra Bashir, MD role: PRINCIPAL_INVESTIGATOR lat: 55.40276 lon: 11.35459 hasResults: False

 nctId: NCT06371846 id: 2023 /10850/I briefTitle: Comparative Study of the Surface Electrocardiogram Signals During the Implantation of Conduction System Pacing Devices overallStatus: RECRUITING date: 2023-03-14 date: 2024-06-30 date: 2024-07-30 date: 2024-04-17 date: 2024-04-17 name: Parc de Salut Mar class: OTHER briefSummary: Introduction and objectives: Left bundle branch area pacing (LBBAP), is a novel modality of physiologic pacing that requires an adequate assessment of the endocardium as well as the body-surface electrocardiographic signals for a successful pacing-lead implantation. The objective of the study consist of assessing if LBBAP criteria, specifically septal and left bundle branch pacing (LBBP) criteria, can be satisfactory measured using the signals resulting from different cardiac pacing analyzers (PSAs) by comparing them to the 'conventional' signals obtained from multichannel polygraph systems (MPSs) during the implantation procedure.

Methods: Comparative observational, prospective, multicenter study between the signals obtained by PSA vs MPS of consecutive patients who underwent a LBBAP strategy as first intention. conditions: Conduction Disorder conditions: Pacemaker DDD studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 78 type: ESTIMATED name: Selected signals from Pacing System Analyzers measure: Similarity of signals between multichannel recording system and Pacing System Analyzers measure: Security sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jesus Jiménez López status: RECRUITING city: Barcelona state: Cataluña zip: 08005 country: Spain name: Jesus Jiménez López role: CONTACT phone: 680714927 email: jejilo78@gmail.com lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06371833 id: S-52 briefTitle: PRIMA EU Retrospective & Prospective overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-12 date: 2026-12 date: 2024-04-17 date: 2024-04-17 name: Limacorporate S.p.a class: INDUSTRY name: Iqvia Pty Ltd briefSummary: This clinical study aims at evaluating clinical, radiographic and patient-reported outcomes after total anatomic or reverse shoulder replacement using PRIMA humeral stem up to 24 months after surgery, in order to assess the short-term performance of the implant. Furthermore, the objective is also to collect short-term data on the survivorship of the implant and the incidence of complications. conditions: Arthroplasty conditions: Replacement conditions: Shoulder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 60 type: ESTIMATED name: Shoulder Arthroplasy with PRIMA humeral stem measure: Changes of Costant Murley Score (CS) measure: Changes in the American Shoudler and Elbow Surgeons (ASES) score measure: Changes in Range of Motion measures measure: Radiographic stability of the humeral component measure: Survival rate (Kaplan-Meier estimate) measure: Incidence, type and severity of Adverse Events and Adverse Device Effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06371820 id: 2014/1287-31/4 briefTitle: ESPRESSO (Epidemiology Strengthened by histoPathology Reports in Sweden) acronym: ESPRESSO overallStatus: ACTIVE_NOT_RECRUITING date: 1965-01-01 date: 2043-05-17 date: 2043-05-17 date: 2024-04-17 date: 2024-04-17 name: Karolinska Institutet class: OTHER briefSummary: The ESPRESSO study is a collection of data from all computerised gastrointestinal histopathology reports in Sweden. This allows us to study risk factors for gastrointestinal disease, as well as the prognosis of gastrointestinal disease.

A review of the study has been published here:

https://pubmed.ncbi.nlm.nih.gov/30679926/ conditions: Gastrointestinal Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 13000000 type: ACTUAL name: ESPRESSO [The study has no intervention] measure: Incident Mortality [especially rates] measure: Incident Cancer measure: Incident Cardiovascular disease measure: Incident Neurological disease measure: Incident Autoimmune diseases measure: Please note that the recorded outcomes above are examples. Other outcomes may also be studied. sex: ALL minimumAge: 0 Years maximumAge: 110 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06371807 id: EU CTR n.º 2023-507008-30-00 briefTitle: Trial for Treatment of High Risk BC With Two Sequences of Neoadjuvant Chemotherapy With Pembrolizumab acronym: KEYPARTNER overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-07 date: 2026-12 date: 2024-04-17 date: 2024-04-17 name: Fundacao Champalimaud class: OTHER briefSummary: Phase II, randomized, Active-controlled open label trial for treatment of high risk, HR-/HER2- (triple negative) breast cancer, with two sequences of neoadjuvant chemotherapy on a background of pembrolizumab conditions: Early Breast Cancer conditions: Triple Negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Pembrolizumab injection measure: Detect immunologic activation signal and the immunologically defined most suitable patient population for the synergistic interaction between pembrolizumab and chemotherapy backbone measure: Rate of pCR measure: Primary translational endpoint measure: Changes in the immunogenic phenotype measure: Incidence of treatment relatred Adverse events sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fundaçao Champalimaud, Avenida Brasilia, city: Lisbon zip: 1400-038 country: Portugal name: Ines Sousa, MSc role: CONTACT phone: +351 210480048 email: ines.sousa@fundacaochampalimaud.pt name: Fatima Cardoso, MD role: CONTACT phone: +351 210480048 email: fatimacardoso@fundacaochampalimaud.pt lat: 38.71667 lon: -9.13333 facility: Centro Hospitalar Universitário Lisboa Norte E.P.E city: Lisbon zip: 1649-028 country: Portugal lat: 38.71667 lon: -9.13333 facility: Instituto Português de Oncologia Francisco Gentil, E.P.E city: Oporto zip: 4200-072 country: Portugal name: Joana Maia role: CONTACT phone: 22 508 40 00 phoneExt: 2040 email: joana.h.maia@ipoporto.min-saude.pt name: Miguel Abreu, MD role: CONTACT phone: 22 508 40 00 phoneExt: 2040 email: antonio.m.abreu@ipoporto.min-saude.pt lat: 41.14961 lon: -8.61099 hasResults: False

 nctId: NCT06371794 id: ID 5460 briefTitle: EXploring novEl Molecular Determinants of DRAvet Syndrome Phenotype Heterogeneity acronym: EXEDRA overallStatus: ENROLLING_BY_INVITATION date: 2023-07-06 date: 2025-04-30 date: 2026-05-31 date: 2024-04-17 date: 2024-04-17 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER name: IRCCS San Raffaele briefSummary: Dravet syndrome is characterized as a developmental encephalopathy resulting from mutations of SCN1A, the gene encoding the alpha subunit of the voltage-gated sodium channel Nav1.1. The syndrome typically presents with drug-resistant epilepsy and varying degrees of cognitive disorders. Current treatment efficacy may be hindered by insufficient knowledge of undiscovered molecular determinants of the disease and its heterogeneous nature. Utilizing induced pluripotent stem cells (iPSCs) derived from skin biopsies, accessibility to patients' brain neurons has enabled successful modeling of various genetic neurological diseases. Neurons and brain organoids will be obtained from Dravet syndrome patients exhibiting diverse phenotypic severities, encompassing behavioral and developmental delays, to discern the molecular determinants of phenotypic diversity. Specifically, emphasis will be placed on investigating cellular and molecular mechanisms linking altered neuronal excitability with synaptic dysfunction.The study will focus on exploring the expression of newly identified modifiers potentially associated with neuronal excitability and synaptic function in iPSC-derived human neurons. This aims to establish correlations between the severity of epileptic and cognitive phenotypes and the altered expression of these proteins, whose functions are not fully understood.In the mid to long term, efforts will be directed towards overcoming the limitations of conventional therapeutic approaches for Dravet syndrome. This will involve attempting to reverse the observed morphological and functional alterations in Dravet syndrome neurons using viral vectors to promote overexpression/downregulation of identified modifiers correlated with disease severity. The anticipated outcomes of this project are expected to unveil novel molecular mechanisms underlying the pathophysiology of this severe neurogenetic disease, characterized by varying degrees of cognitive impairment. Moreover, these findings may pave the way for the discovery of innovative therapeutic strategies. conditions: Dravet Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The ethics committee of the foundation FPG considers the study interventional since patients will undergo skin biopsy procedures ( around 4 mm) primaryPurpose: BASIC_SCIENCE masking: NONE count: 16 type: ESTIMATED name: skin punch biopsy measure: TO CLASSIFY THE COGNITIVE/BEHAVIORAL PHENOTYPE SEVERITY OF DS PATIENTS measure: TO CLASSIFY THE COGNITIVE/BEHAVIORAL PHENOTYPE SEVERITY OF DS PATIENTS measure: TO CLASSIFY THE COGNITIVE/BEHAVIORAL PHENOTYPE SEVERITY OF DS measure: TO CLASSIFY THE BEHAVIORAL PHENOTYPE SEVERITY OF DS PATIENTS measure: TO CLASSIFY THE BEHAVIORAL PHENOTYPE SEVERITY OF DS PATIENTS measure: TO CLASSIFY THE EPILEPTIC PHENOTYPE SEVERITY OF DS PATIENTS sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Fondazione Policlinico Universitario A. Gemelli IRCCS city: Roma zip: 00168 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06371781 id: Cumhuriyetobgyn id: 1919B012108892 type: OTHER_GRANT domain: TUBITAK briefTitle: Examination of the Relationship Between Weight Gain During Pregnancy and Sfrp-5, Netrin-4 and Resistin Concentrations overallStatus: COMPLETED date: 2022-07-01 date: 2022-07-01 date: 2023-07-01 date: 2024-04-17 date: 2024-04-22 name: Cumhuriyet University class: OTHER name: Scientific and Technological Research Council of Turkey (TUBITAK) briefSummary: Researchers thought that the molecules Sfrp-5, Resistin and Netrin-4, which will be examine, they may have a significant effect on weight gain during pregnancy. Based on these foundations, researchers expect changes in the levels of these molecules in women who gain excessive weight during pregnancy. In this study, researchers aimed to examine the moderator relationship between the molecules will be examine and weight gain in women who gained weight above the normal limits determined during pregnancy. For this reason, 44 participant who gained excessive weight during pregnancy and 46 pregnant participant who gained normal weight were included in the study. The levels of Netrin-4, Sfrp-5 and Resistin molecules in the blood serum of the individuals in the study group were measured with a Commercial Elisa kit. conditions: Excessive Weight Gain During Pregnancy studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Pregnant women who were given birth at Cumhuriyet University Faculty of Medicine Hospital Gynecology and Obstetrics Clinic between July 1, 2021 and July 1, 2022 and whose pregnancy follow-ups were performed in our hospital will be included in our prospectively designed study. Researchers will divide the study into two main groups. The first group will consist of pregnant women with above-normal weight gain during pregnancy, and the other group will consist of pregnant women with normal weight gain during pregnancy. It is estimated that 46 control and 44 pregnant women with overweight will be reached during this period. In the study, first a form containing demographic data such as age, education, height and weight will be filled out. primaryPurpose: SCREENING masking: SINGLE whoMasked: PARTICIPANT count: 90 type: ACTUAL name: Serum Netrin-4, Resistin and Sfrp-5 level measurement measure: Obtaining blood serum for measurement of serum Sfrp-5, Netrin-4 and Resistin measure: Calculating BMI (kg/m^2) from height (m) and weight (kg) measurement values for diagnosis. sex: FEMALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Sivas Cumhuriyet University city: Sivas state: Centre zip: 58140 country: Turkey lat: 39.74833 lon: 37.01611 hasResults: False

 nctId: NCT06371768 id: Pro00115400 briefTitle: Symptom Management and Transitioning to Engagement With Post-treatment Care for Adolescent and Young Adult Cancer Survivors acronym: AYA STEPS overallStatus: NOT_YET_RECRUITING date: 2025-04-01 date: 2029-06-30 date: 2029-06-30 date: 2024-04-17 date: 2024-04-17 name: Duke University class: OTHER briefSummary: The purpose of this study is to determine the effectiveness of a digital health program called AYA STEPS, which is designed to help adolescent and young adult (AYA) cancer survivors manage symptoms and engage in recommended follow-up care. conditions: Cancer conditions: Breast Cancer conditions: Colorectal Cancer conditions: Sarcoma conditions: Lymphoma conditions: Testicular Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 260 type: ESTIMATED name: AYA Educational Information name: AYA STEPS measure: Pain severity and interference as measured by Brief Pain Inventory measure: Fatigue as measured by PROMIS Fatigue Scale measure: Emotional distress as measured by PROMIS Depression Short Form measure: Symptom interference as measured by MD Anderson Symptom Inventory (MDASI) Symptom Interference measure: Emotional distress as measured by PROMIS Anxiety Short Form measure: Health care engagement as measured by Patient Participation Questionnaire measure: Patient self-assessment of communication competency with health care providers as measured by Medical Communication Competence Scale (MCCS) patient subscale measure: Patient self-efficacy for chronic disease coping as measured by Self-Efficacy for Managing Chronic Illness Scale measure: Patient activation as measured by Patient Activation Measure (PAM) measure: Health care utilization: Chart Review measure: Area Deprivation Index (ADI) measure: Health-care utilization: Self-report measure: Health literacy as measured by Medical Term Recognition Test (METER) measure: Participant experiences of discrimination as measured by Everyday Discrimination Scale-Short Form measure: Participant evaluation of study mobile application as measured by User Version of the Mobile Application Rating Scale (uMARs) measure: Satisfaction with Treatment and Interventionist as measured by the Satisfaction with Therapy and Therapist Scale-Revised (STTS-R) measure: Web-based Portal Use as measured by total time using portal in minutes sex: ALL minimumAge: 18 Years maximumAge: 39 Years stdAges: ADULT hasResults: False

 nctId: NCT06371755 id: ULTRADXA briefTitle: Bone Evaluation by Ultrasound Radiofrequency Echographic Multi Spectrometry (REMS) vs Dual X-ray Absorptiometry (DXA) overallStatus: RECRUITING date: 2019-11-19 date: 2024-12-31 date: 2024-12-31 date: 2024-04-17 date: 2024-04-17 name: Paola Pisani class: INDUSTRY name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio briefSummary: Bone Density Evaluation by means of the Ultrasound Technology Named Radiofrequency Echographic Multi Spectrometry (REMS) in Comparison With DXA Technique.

Clinical Center involved in the study:IRCCS Orthopedic institute Galeazzi - Sant'Ambrogio The clinical study will evaluate the intra- and inter-operator repeatability of the REMS,(Radiofrequency Echographic Multi Spectrometry) ultrasound diagnostic technology implemented in the EchoStation device (Echolight Spa, Lecce) and the diagnostic accuracy in comparison with DXA (used as standard reference). conditions: Osteoporosis Diagnosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 296 type: ESTIMATED name: Ultrasound examination with REMS technology measure: 1. REMS Technology intra - and inter-operator repeatability Evaluation. measure: 1. Evaluation of the accuracy of the REMS Technology in comparison with the conventional DXA technique. sex: FEMALE minimumAge: 30 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio status: RECRUITING city: Milano state: MI zip: 20157 country: Italy name: Carmelo Messina, Professor role: CONTACT phone: 0039 02 8350 1406 email: carmelomessina.md@gmail.com lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06371742 id: 539HydrationNutr briefTitle: Study of the Fluid Intake Effect During Labour overallStatus: COMPLETED date: 2017-02-01 date: 2017-07-14 date: 2017-09-14 date: 2024-04-17 date: 2024-04-17 name: Egas Moniz - Cooperativa de Ensino Superior, CRL class: OTHER briefSummary: Ingestion during labor is an issue that has attracted the attention of the scientific community in recent decades, with different practices occurring in different countries. However, the scientific evidence of the risk / benefit of fluid intake in labor is still not fully understood. The aim of this study was to contribute with data that allow the evaluation of an eventual relationship between the amount of fluid ingested during labor and the type of delivery, the duration of labor, the occurrence of nausea and vomiting and the value of the Index of Apgar at the 1st and 5th minutes of the newborn's life. An observational study, with a convenience sample of 144 parturient from two hospitals of Portugal were employed. The analysis was based on recording the before mentioned variables and potentially confounding variables. In order to control for potential sources of bias in the study and to guarantee the homogeneity of the sample in the specific statistical treatment of each dependent variable, an observation grid was drawn up for all the participants in the study. Twenty eight of the parturient, the parturient's ambulation, labour analgesia, food intake during labour, the use of oxytocin during labour, the occurrence of postpartum complications, the birth weight of the newborn and the occurrence of birth complications. conditions: Labor Complication studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 144 type: ACTUAL name: Liquid ingestion during labour measure: Type of labour measure: Duration of labour measure: Occurrence of nausea and vomiting measure: Apgar index of the newborn (From 0 to 10) sex: FEMALE minimumAge: 18 Years maximumAge: 39 Years stdAges: ADULT facility: Egas Moniz School of Health and Science city: Almada state: Monte De Caparica zip: 2829-699 country: Portugal lat: 38.67902 lon: -9.1569 hasResults: False

 nctId: NCT06371729 id: DEEP-VT briefTitle: Substrate-based DEEP Mapping Versus Activation Mapping. A Prospective Randomized Multicenter Study. overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-07 date: 2027-07 date: 2024-04-17 date: 2024-04-18 name: IRCCS Ospedale San Raffaele class: OTHER briefSummary: Substrate-based DEEP mapping and activation mapping are the two main techniques used for ventricular tachycardia (VT) ablation. There is no sufficiently reliable data in the medical scientific literature comparing the extent of applicability, the results of the procedure strategy, and the long-term outcomes between the two mapping strategies. This randomized clinical trial aims to test whether activation mapping is superior to DEEP mapping to reduce ventricular tachycardia recurrence.

The primary outcome of the study is to compare the efficacy as a recurrence-free survival rate of ventricular tachycardia, at 6 and 12 months, of substrate-based DEEP mapping versus activation mapping in guiding catheter ablation to prevent VT recurrence. conditions: Ventricular Tachycardia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 222 type: ESTIMATED name: DEEP mapping name: Activation Mapping measure: Compare the efficacy of substrate-based DEEP mapping versus Activation mapping in guiding catheter ablation to prevent VT recurrences sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06371716 id: EUS-RFA ex-vivo 2016 briefTitle: Ex-vivo Ultrasound Guided Radiofrequency Ablation on Pancreatic Solid Lesions overallStatus: TERMINATED date: 2019-09-12 date: 2020-06-12 date: 2020-06-12 date: 2024-04-17 date: 2024-04-17 name: IRCCS San Raffaele class: OTHER briefSummary: The study investigates the feasibility and the efficacy to treat pancreatic solid lesions as pancreatic adenocarcinomas (PDAC) and neuroendocrine tumors (NET) with ex-vivo radiofrequency ablation (RFA) under ultrasound (US) control.

The study intent is to define the optimal radiofrequency ablation POWER of the system in terms of maximum sizes (diameters) of histological coagulative necrosis obtained at pathological samples. Results will be useful to define the optimal settings to ablate pancreatic solid lesions (PDAC and neuroendocrine tumours). conditions: Pancreatic Cancer conditions: Endoscopic Ultrasound conditions: Radiofrequency Ablation studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 15 resected PDAC without neoadjuvant treatment 15 resected PDAC with neoadjuvant treatment 15 resected neuroendocrine tumors

Each group (15 patients each) Subgroup A: 10 W (5 patients) Subgroup B: 30 W (5 patients) Subgroup C: 50 W (5 patients) primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: pathologists (two different pathologist blinded about the power of RFA applied and respect to the other pathologist) will evaluate the effect of ablation (coagulative necrosis at microscopic evaluation) whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 45 type: ACTUAL name: ex-vivo RFA under US control at 10 Watts (W) of power in 3 differents arms of lesions name: ex-vivo RFA under US control at 30 Watts (W) of power in 3 differents arms of lesions name: ex-vivo RFA under US control at 50 Watts (W) of power in 3 differents arms of lesions measure: diameter (millimeters) of coagulative necrosis obtained by RadioFrequency Ablation 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: NCT06371703 id: PETCT_INTEGO briefTitle: Enhancing Radiation Safety for Nuclear Medicine Radiographers: the Impact of Introducing the Automat-ed Radiopharmaceutical Preparation and Administration System overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2024-10 date: 2024-10 date: 2024-04-17 date: 2024-04-19 name: IRCCS San Raffaele class: OTHER briefSummary: This project aims to evaluate the impact of the introduction of an automated system for radiopharmaceutical preparation and administration on the radiation safety of the radiographers working in nuclear medicine. This study will help to fill the existing gap in the scientific literature and provide useful guidance for the selection of the safest and most effective automated infusion system. conditions: Radiation Exposure studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED name: automated system in reducing radiation exposure measure: Change in absorbed dose by radiographers during PET/CT procedures, measured in millisieverts (mSv). sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Irccs San Raffaele city: Milano country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06371690 id: 17-11/37 briefTitle: The Effects of Using the Web-Based Double Eye Control Program on Medication Error overallStatus: COMPLETED date: 2017-11-01 date: 2018-06-30 date: 2018-09-30 date: 2024-04-17 date: 2024-04-17 name: Izmir Katip Celebi University class: OTHER name: Ege University briefSummary: Methods: The study was carried out as a quasi-experimental study in the Pediatric Surgery Clinics of a university hospital using the "Pre-Test-Post-Test Model in a Single Group". The sample of the study consisted of all high-risk drugs administered by 24 nurses working in these clinics, taking part in medication and agreeing to take part in the study. Data were collected by the researcher using the Medication Observation Form. The Form was created based on the literature, and by making use of the "10 Correct Rules in Medication" and the Medication Skills Steps in the Double Eye Control Program. In the first step, medication error rates were determined through observation method. In the second step; the Web-Based Double-Eye Control Program, which is a standard drug dose calculation and medication program created by the researchers, was started to be implemented. Medication error rates were determined again through post-intervention observation method. Informed voluntary consent, ethics committee and hospital permissions were obtained for the implementation of the study. conditions: Main Heading (Descriptor) Terms studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 1070 type: ACTUAL name: Web-Based Double-Eye Control Program measure: Error rates sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Izmir Katip Celebi University city: İzmir state: Çi̇ğli̇ zip: 35620 country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False

 nctId: NCT06371677 id: KB/2024 briefTitle: Polish Nationwide Register of Hospitalized Patients in Cardiac Intensive Care Units acronym: POL-CICU overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2024-12-31 date: 2025-03-31 date: 2024-04-17 date: 2024-04-17 name: Medical University of Warsaw class: OTHER briefSummary: Cardiac Intensive Care Units (CICUs) provide care for a diverse patient population. Understanding the clinical characteristics, analysis of treatment modalities, and prognosis of patients hospitalized in the CICU are important to improve cardiovascular care. The purpose of this registry is to determine the demographics, clinical, treatment, and prognosis of patients hospitalized in the Polish CICUs. Data from this multicenter, prospective observational study will provide more robust data to facilitate quantitative characterization of cardiac care in contemporary Polish CICUs and enable the development of infrastructure for clinical trials in CICUs. conditions: Shock conditions: Death conditions: Cardiac Intensive Care Unit conditions: Treatment Complication conditions: Stroke conditions: Multiple Organ Failure conditions: Infections studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED measure: All-cause death measure: Shock (cardiogenic/hypovolemic/anaphylactic/septic/neurogenic/obstructive) measure: Treatment-related complications (tamponade, dissection, stroke, embolism, etc.) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06371664 id: 2023/02 briefTitle: Gingival Irritation Due to Bleaching Tray Design in an At-home Bleaching Treatment overallStatus: COMPLETED date: 2023-03-01 date: 2023-04-05 date: 2023-04-05 date: 2024-04-17 date: 2024-04-17 name: University of Santiago de Compostela class: OTHER briefSummary: The primary aim of this study is to assess whether the design of the bleaching tray used in at-home bleaching treatment is directly correlated with the risk of gingival irritation. Additionally, it aims to investigate whether the design influences the likelihood of dental sensitivity and its impact on the degree of tooth whitening. conditions: Gingival Inflammation studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, triple-blind clinical trial primaryPurpose: PREVENTION masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 72 type: ACTUAL name: Conventional Tray (1 mm) name: Extended Tray (3 mm) measure: Subjective questionnaire of gingival irritation measure: Objective clinical examination of gingival irritation measure: Questionnaire of dental sensitivity measure: Shade evaluation with a dental spectrophotometer sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: School of Medicine and Dentistry city: Santiago De Compostela state: A Coruña zip: 15705 country: Spain lat: 42.88052 lon: -8.54569 hasResults: False

 nctId: NCT06371651 id: 23-1462-3 briefTitle: Creatine and GAA for Brain Oxygenation acronym: CREGAA-OXY overallStatus: COMPLETED date: 2024-03-01 date: 2024-04-10 date: 2024-04-12 date: 2024-04-17 date: 2024-04-17 name: University of Novi Sad, Faculty of Sport and Physical Education class: OTHER briefSummary: The main aim of this randomized controlled trial is to evaluate cerebral blood oxygenation after 7-day administration of a creatine-guanidinoacetic acid (GAA) mixture in healthy adults before, during, and after a series of cognitive tests. conditions: Oxygen Deficiency studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 19 type: ACTUAL name: Supplement name: Placebo measure: Brain oxygen saturation measure: Hemoglobin index sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Applied Bioenergetics Lab at Faculty of Sport and PE city: Novi Sad state: Vojvodina zip: 21000 country: Serbia lat: 45.25167 lon: 19.83694 hasResults: False

 nctId: NCT06371638 id: 2024-01 briefTitle: Dexmedetomidine and Postoperative Cognitive Dysfunction (POCD) acronym: CODE-POCD overallStatus: COMPLETED date: 2024-01-07 date: 2024-03-01 date: 2024-03-07 date: 2024-04-17 date: 2024-04-19 name: Udayana University class: OTHER briefSummary: Postoperative cognitive dysfunction (POCD) affects all age groups and can lead to increased morbidity and more extended hospital stays. Dexmedetomidine reduces POCD by inhibiting the increase in proinflammatory cytokines IL-6 and TNF-α, and its anti-inflammatory activity contributes to its protective effect. Previous studies found that dexmedetomidine reduced POCD incidence in non-cardiac and cardiac surgery. Therefore, the goal of this study was to specifically investigate if using TCI dexmedetomidine to maintain anaesthesia in laparotomy surgeries reduces the incidence of POCD compared to inhalation anaesthesia by sevoflurane. conditions: Postoperative Cognitive Dysfunction conditions: Postoperative Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 112 type: ACTUAL name: Dexmedetomidine name: Sevoflurane measure: Postoperative cognitive dysfunction (POCD) measure: Postoperative cognitive dysfunction (POCD) measure: Intraoperative hemodynamics: mean arterial pressure (MAP) measure: Intraoperative hemodynamics: heart rate (HR) measure: Postoperative pain measure: Postoperative pain measure: Postoperative pain sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prof. Ngoerah General Hospital city: Denpasar state: Bali zip: 80114 country: Indonesia lat: -8.65 lon: 115.21667 hasResults: False

 nctId: NCT06371625 id: AP2202-30104 briefTitle: U/S Guided Transversus Thoracic and Pectoral Nerve Block Versus Pectoral Nerve Block in MRM overallStatus: COMPLETED date: 2022-07-02 date: 2023-08-01 date: 2023-10-01 date: 2024-04-17 date: 2024-04-22 name: Ahmed Mohamed Soliman class: OTHER briefSummary: Interfascial blocks score over regional anesthetic techniques such as Transversus Thoracic Plane Block and Pectoral Nerves (PECS) Block as they have no risk of sympathetic blockade, intrathecal or epidural spread, which may lead to hemodynamic instability and prolonged hospital stay. The transversus thoracic muscle plane block (TTP) block is a newly developed regional anesthesia technique which provides analgesia to the anterior chest wall. First described by Ueshima et al. in 2015, the TTP block is a single-shot nerve block that deposits local anesthetic in the transversus thoracic muscle plane between the internal intercostal and transversus thoracic muscles. TTP block targets the anterior branches of the intercostal nerves (T2-6).

Pectoral plane blocks are recently described . PECS block involves deposition of local anesthetic drug between muscle planes. PECS I block, between Pectoralis Major and Minor at third rib level, and PECS II block, the drug is deposited between Pectoralis minor and Serratus anterior muscle.

The pectoral nerves (PECS) block provides analgesia of the lateral mammary region, the intercostobrachial and lateral cutaneous branches of the intercostal nerves (T2-T6), the medial cutaneous nerve of the arm and forearm, and the long thoracic and thoracodorsal nerves. The modified PECS block produces excellent analgesia and can be used to provide balanced anesthesia. conditions: Breast Cancer conditions: Analgesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: to determine the analgesic effect of ultrasound guided Transversus Thoracic and Pectoral Nerve Block compared to ultrasound guided Pectoral Nerve Block in patients undergoing modified radical mastectomy regarding the following : 1-Post-operative opioid (morphine) consumption in the 1st 24 hours 2- Postoperative Numeric Pain Rating Scale. 3. Effect on hemodynamics: Mean arterial blood pressure and Heart rate. 4. Intraoperative fentanyl consumption. 5. Duration of analgesic effect primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: The patients will be randomly assigned into two equal comparable groups using computer- generated random numbers in opaque closed envelopes, each of which will include 11 per group. Randomization will be done by statistician and each group of the patient will revealed only when the included patient is transferred to preanesthetic room. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 22 type: ACTUAL name: Transeversus Thoracic Plane Block (TTPB) and Pectoral Nerves (PECS) Block name: Pectoral Nerves (PECS) Block measure: visual analogue scale "VAS score" measure: total morphine consumption measure: mean blood pressure measure: heart rate measure: first analgesic dose sex: FEMALE minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: National cancer Insititute Cairo university city: Cairo zip: 11796 country: Egypt lat: 30.06263 lon: 31.24967 facility: National cancer Insititute city: Cairo zip: 11796 country: Egypt lat: 30.06263 lon: 31.24967 facility: Ahmed Mohamed Soliman city: Giza country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06371612 id: MersinU*GUGUCU_004 briefTitle: Effect of Ball Squeezing and Adhesive Remover Use on Pain and Fear in Children Aged 6-9 Years During the Removal of Peripheral Intravenous Cannula overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-30 date: 2024-11-20 date: 2024-04-17 date: 2024-04-17 name: Mersin University class: OTHER briefSummary: Pediatric nurses have a key role in reducing pain related to interventions during the hospitalisation process. In this context, according to the type of invasive intervention, the nurse determines the appropriate non-pharmacological methods for the effective management of pain, taking into account the child's individuality, developmental stage and clinical presentation. For children during the hospitalisation process, the removal of a peripheral venous line is a painful and stressful experience, as is the insertion of a peripheral venous line. Children experience acute pain during the removal of hypoallergenic adhesives used for fixation of the peripheral venous line. The practice guideline recommends the use of alcohol-free silicone-based aerosol sprays for the removal of medical adhesive/ fixation materials (NICU Brain Sensitive Care Committee, 2015).

In this study, it was aimed to examine the effect of ball squeezing (active distraction) as a distraction method and the use of alcohol-free silicone-based aerosol adhesive remover spray on pain and fear in children aged 6-9 years during peripheral intravenous cannula removal. conditions: Procedural Pain conditions: Fear of Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: The children and their parents will be blinded to the groups. The principal researchers (R1, R2) will be blinded to the research hypotheses. The opaque envelopes are stored in a locked cabinet by the researcher who performed the randomization. Data entries will be performed using the codes A, B and C. Codes will be shared with the researchers after statistical analyses are conducted and the research report is written. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 96 type: ESTIMATED name: Standard Care name: Adhesive Remover Spray name: Ball Squeezing + Adhesive Remover Spray measure: Pain assesed by Wong-Baker FACES measure: Fear by Children's Fear Scale measure: Pain assesed by Wong-Baker FACES measure: Fear by Children's Fear Scale sex: ALL minimumAge: 6 Years maximumAge: 9 Years stdAges: CHILD facility: Mersin University city: Mersin state: Yenişehir zip: 33343 country: Turkey lat: 36.79526 lon: 34.61792 hasResults: False

 nctId: NCT06371599 id: MersinU*GUGUCU_003 briefTitle: The Effect of Watching Cartoons and Playing Games as Distraction Method During Peripheral Intravenous Cannula Placement on Pain and Fear in Children Aged 6-9 Years overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-06-30 date: 2024-11-20 date: 2024-04-17 date: 2024-04-17 name: Mersin University class: OTHER briefSummary: Active and passive distraction methods are frequently used in the nursing management of procedural pain in children. There are no studies comparing the effects of watching cartoon (passive) and playing game (active) as distraction methods on pain and fear associated with peripheral intravenous cannula placement in children aged 6-9 years.

This study aimed to compare the effects of playing game (active distraction) and watching cartoon (passive distraction) techniques on pain and fear during peripheral intravenous cannula placement in children aged 6-9 years. conditions: Procedural Pain conditions: Fear of Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: The children and their parents will be blinded to the groups. The principal researchers (R1, R2) will be blinded to the research hypotheses. The opaque envelopes are stored in a locked cabinet by the researcher who performed the randomization. Data entries will be performed using the codes A and B. Codes will be shared with the researchers after statistical analyses are conducted and the research report is written. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 64 type: ESTIMATED name: Playing game name: Watching cartoon measure: Pain assesed by Wong-Baker FACES measure: Fear by Children's Fear Scale measure: Pain assesed by Wong-Baker FACES measure: Fear by Children's Fear Scale sex: ALL minimumAge: 6 Years maximumAge: 9 Years stdAges: CHILD facility: Mersin University city: Mersin state: Yenişehir zip: 33343 country: Turkey lat: 36.79526 lon: 34.61792 hasResults: False

 nctId: NCT06371586 id: NCC4537 briefTitle: Neo-Sequence 2：NCT Plus Anti-angiogenesis Therapy and Immunotherapy for LADGC overallStatus: RECRUITING date: 2024-03-01 date: 2027-03-01 date: 2027-03-01 date: 2024-04-17 date: 2024-04-17 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER briefSummary: The regimen of Albumin paclitaxel+SOX+BEV neoadjuvant therapy lasted for 6 cycles, during which PD-1 monoclonal antibody therapy was interspersed for 4 cycles for locally advanced diffuse gastric cancer. conditions: Gastric Cancer conditions: Diffuse Type Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 67 type: ESTIMATED name: Albumin paclitaxel+SOX+BEV+ PD-1 monoclonal antibody therapy measure: Pathological response rate measure: EFS measure: OS measure: R0 measure: Safety (adverse events) and surgical complications sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer hospital，Chinese acadamy of medical sciences status: RECRUITING city: Beijing country: China name: Chunxia Du role: CONTACT phone: 87787121 email: retinadcx@vip.163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06371573 id: MPN-USspleen briefTitle: Ultrasound Examination for Spleen Volume Evaluation in Myeloproliferative Neoplasms overallStatus: COMPLETED date: 2017-04-20 date: 2024-01-20 date: 2024-03-20 date: 2024-04-17 date: 2024-04-17 name: Federico II University class: OTHER briefSummary: Adult patients (\>18 years) with newly diagnosis of Ph negative myeloproliferative neoplasms (MPNs) according to WHO 2016 criteria, will be recruited to this study.

This study is the result of the collaboration the Hematology Division of Federico II University Medical School of Naples (Italy), that performed the US investigation and the IRCCS SYNLAB SDN where the patients carried out MR. The study is conducted in accordance with the Declaration of Helsinki. All subjects gave informed consent to receive both US and MR scans of the spleen.

All spleen US scans were performed by the same operator (with\>10 years of experience in abdominal US), who used an EPIQ 5 Philips instrument with a 1-5 MHz broadband curvilinear probe. The spleen was scanned in patients who were fasting, in the longitudinal and transverse planes by using an intercostal approach, a subcostal approach, or both.

The patient was placed in a supine or right-sided position until complete organ visualization was achieved. Perimeter, longitudinal diameter (LD), and area, defined as the maximum measurements with splenic borders and angles clearly defined, were measured, and SV (in milliliters) was calculated automatically. For each subject, the mean value of 3 measurements repeated on the same imaging session was calculated and recorded for final analysis. Within two weeks from the US, each patient underwent an MRI of the upper abdomen to evaluate the splenic volume. MRI examinations were performed using a 3T Biograph mMR scanner (Siemens Healthcare, Erlangen, Germany) with 4-channel flex phased-array body coil. Routine clinical abdominal MRI acquisition includes coronal T2W Half-Fourier Acquisition Single-shot Turbo spin Echo imaging (HASTE), axial T1 Dual-echo FSE, axial T2 TSE Fat Sat, and an axial diffusion-weighted imaging (DWI). The DWI includes an apparent diffusion coefficient (ADC) map that was automatically generated at the time of acquisition. At last, an isotropic 2mm3 axial Volumetric Interpolated Breath-hold Examination (VIBE) sequence for SV evaluation was acquired. For the latter, attention was paid to optimize the field of view to the spleen, in order to reduce patient's apnea and possible respiratory artifacts. A radiologist with mote than 10 years of experience in abdominal MRI reporting performed measurement of the three orthogonal diameters of the spleen for each patient. Subsequently, SV was calculated using ITK-SNAP software and semi-automatic 3D segmentation approach, firstly based on a signal threshold. conditions: Myeloproliferative Neoplasm conditions: Polycythemia Vera conditions: Essential Thrombocythemia conditions: Primary Myelofibrosis conditions: Prefibrotic/Early Primary Myelofibrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 45 type: ACTUAL name: ULTRASOUND EXAM AND MRI SCAN measure: agreement between two different diagnostic methods sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Federico II University city: Naples zip: 80131 country: Italy lat: 40.85216 lon: 14.26811 hasResults: False

 nctId: NCT06371560 id: KAP-ABR-Perio briefTitle: Antibiotics, Antibiotic Resistance, and Prescribing Practices Among Periodontists: Cross Sectional KAP Study overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2024-09-30 date: 2024-10-30 date: 2024-04-17 date: 2024-04-23 name: Cairo University class: OTHER briefSummary: Antibiotic resistance is a global health threats that require attention from all healthcare providers. In Periodontology, antibiotic is prescribed in many clinical situations. The aim of this study is to assess the followings among Periodontists (1) The knowledge, attitude, and practices (KAP) towards antibiotics and antibiotic resistance; (2) The prescribing practices of antibiotics in periodontal therapy; (3) The correlation between personal perception of antibiotics uses and the professional prescription patterns; and (4) The differences in antibiotics prescription in relation to the years of experience and the academic background. conditions: Antibiotic Resistance conditions: Antibiotic Use conditions: Periodontitis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 400 type: ESTIMATED name: Questionnaire measure: KAP measure: The prescribing practices of antibiotics in periodontal therapy measure: The correlation between personal perception of antibiotics uses and the professional prescription patterns measure: The differences in antibiotics prescription in relation to the years of experience and the academic background. sex: ALL minimumAge: 25 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06371547 id: BEUFTR-3 briefTitle: Efficiency of Different Gastrocnemius Stretching Exercises overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-10-15 date: 2024-12-15 date: 2024-04-17 date: 2024-04-17 name: Bitlis Eren University class: OTHER briefSummary: The primary aim of this study is to investigate the effects of different types and durations of gastrocnemius stretching on the viscoelastic properties of the gastrocnemius muscle, Achilles tendon, and plantar fascia.In addition, pain threshold of the gastrocnemius muscle and plantar fascia, as well as on hamstring tightness will be measured. conditions: Muscle Tightness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Interventions and assessment will be performed by separate researchers. whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: Stretching Exercise measure: Measurement of the Viscoelastic Properties measure: Ankle-foot Dorsiflexion Index measure: Measurement of the Mechanosensitivity measure: Assessment of Hamstring Tightness measure: Dominant Leg Determination measure: Navicular Drop Test measure: Self-reported Effects of Stretching Exercises measure: The Satisfaction Level with the Stretching measure: Compliance with Stretching Exercise Program sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Bitlis Eren University city: Bitlis state: Merkez zip: 13000 country: Turkey lat: 38.40115 lon: 42.10784 hasResults: False

 nctId: NCT06371534 id: QL2109-101 briefTitle: A Study Comparing Pharmacokinetic and Safety of QL2109 and DARZALEX FASPRO® in Healthy Adults overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-17 date: 2024-04-17 name: Qilu Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: The goal of this clinical trial is to compare the pharmacokinetic and safety similarity of QL2109 with DARZALEX FASPRO® in healthy male volunteers.

Participants will receive a single injection of QL2109/ DARZALEX FASPRO® Researchers will compare pharmacokinetic, safety, and immunogenic similarities between the two groups. conditions: Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 228 type: ESTIMATED name: QL2109 name: DARZALEX FASPRO® measure: AUC0-∞ measure: Cmax sex: MALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: The First Affiliated Hospital of Zhejiang University School of Medicine city: Hangzhou state: Zhejiang zip: 310006 country: China name: qingwei zhao, Professor role: CONTACT email: qwzhao@zju.edu.cn name: qingwei zhao, Professor role: PRINCIPAL_INVESTIGATOR name: xingjiang hu, Professor role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 facility: The First Affiliated Hospital of Zhejiang University School of Medicine city: Hangzhou state: Zhejiang zip: 310006 country: China name: qingwei ZHAO, Professor role: CONTACT email: qwzhao@zju.edu.cn name: xingjiang HU, Professor role: CONTACT email: hxj319@163.com name: qingwei ZHAO, Professor role: PRINCIPAL_INVESTIGATOR name: xingjiang HU, Professor role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06371521 id: 4933 briefTitle: Ergogenic Effects of Sportlegs overallStatus: RECRUITING date: 2024-01-24 date: 2024-06-01 date: 2024-06-01 date: 2024-04-17 date: 2024-04-17 name: Christopher Bell class: OTHER briefSummary: Sportlegs is a commercially available dietary/sports supplement. It is manufactured by a local, Colorado-based company: Sport Specifics Inc. Although Sportlegs has been on the market for approximately 20-years, very little empirical research has been completed to determine if Sportlegs improves exercise performance. Sport Specifics Inc. has commissioned Colorado State University to investigate the ergogenic effects of Sportlegs. conditions: Performance Enhancing Product Use studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized, Placebo-Controlled, Double Blind Crossover Intervention primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: Investigators and Participants are both blinded to whether the participants will be consuming Sportlegs or Placebo during a given study visit. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 15 type: ESTIMATED name: Sportlegs name: Placebo measure: Maximal Oxygen Uptake measure: Lactate Threshold measure: Rating of Perceived Exertion (RPE) measure: Maximal sustained mean power sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Colorado State University status: RECRUITING city: Fort Collins state: Colorado zip: 80523 country: United States name: Christopher Bell, Ph.D. role: CONTACT phone: 970-491-7522 email: christopher.bell@colostate.edu name: Taylor R Ewell, MS role: CONTACT phone: 7197611417 email: taylor.ewell@colostate.edu lat: 40.58526 lon: -105.08442 hasResults: False

 nctId: NCT06371508 id: 14042024 briefTitle: Breast Cancer and Breast Self-examination Education overallStatus: RECRUITING date: 2024-02-01 date: 2024-05-15 date: 2024-06-15 date: 2024-04-17 date: 2024-04-17 name: Sakarya University class: OTHER briefSummary: According to a news published by the World Health Organization (WHO); More than 2.3 million cases of breast cancer occur each year, making it the most common cancer among adults. In 95% of all countries, breast cancer is the first or second cause of female cancer death. In 2020, 2.3 million women worldwide were diagnosed with breast cancer and 685,000 deaths occurred (WHO, 2023; https://www.who.int/news/item/03-02-2023-who-launches-new-roadmap- on-breast-cancer). In our country, breast cancer ranks first among the most common cancer types in women, and the number of breast cancer cases in women in 2020 was recorded as 74 638 (IARC, 2023). As a result of this situation, WHO (2023) published the Global Breast Cancer Initiative Framework to save 2.5 million lives from breast cancer by 2040. This published framework includes health promotion for early detection, timely diagnosis and comprehensive management of breast cancer.

One of the most effective ways to reduce breast cancer mortality and morbidity rate is early diagnosis. It is important to determine early diagnosis and signs and symptoms of cancer before they appear. Early diagnosis of breast cancer is possible with breast self-examination (BSE), clinical breast examination and mammography (Kayar, 2019). Breast self-examination is an important examination method in terms of detecting changes in breast tissue and preventing subsequent complications (Abo Al-Shiekh et al., 2021). It is also an easy-to-apply, cheap and non-invasive method. In our country, it is recommended that women regularly perform breast self-examination every month after the age of 20, women between the ages of 20 and 40 should have a clinical breast examination every two years, and women between the ages of 40 and 69 should have a clinical breast examination every year and have a mammogram every two years (Ministry of Health, 2019). .

There are studies showing that fear of breast cancer has a positive and negative impact on early diagnosis behaviors (Champion et al., 2004; Yavan et al., 2010). Champion et al. (2004) stated that women with moderate breast cancer fear had a high rate of early detection behavior, whereas low and high fear levels had a negative effect on behavior. In the study conducted by Yavan et al. (2010) on 188 women, 2% of the women. They found that 3 of them had regular BSE and 78.7% of them had never had a mammography. In addition, 85% of the women included in the study stated that they had a fear of breast cancer due to a family history of breast cancer, being diagnosed with breast cancer, and the presence of risk factors. Study results show that fear of breast cancer affects screening results. Therefore, our aim in the study is; To determine the effect of breast cancer and BSE training given to women on breast cancer fear and BSE skills. conditions: Breast Cancer conditions: Breast Self-Examination studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 96 type: ESTIMATED name: Education based on breast cancer and breast examination measure: Champion Breast Cancer Fear Scale Change measure: Breast Self Examination Checklist Success Score sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Kocadere Sağlık Evi status: RECRUITING city: Yalova country: Turkey name: Muge Saglık, Msc. role: CONTACT phone: +905343817563 email: mge.saglk@gmail.com lat: 40.65501 lon: 29.27693 hasResults: False

 nctId: NCT06371495 id: statins in ischemic stroke briefTitle: Statins Role in Acute Ischemic Stroke acronym: observation overallStatus: NOT_YET_RECRUITING date: 2024-08-13 date: 2025-02-28 date: 2025-08-30 date: 2024-04-17 date: 2024-04-17 name: Assiut University class: OTHER briefSummary: Strokes is amajor cause of death and disabilities in different countried conditions: Stroke, Acute studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 105 type: ESTIMATED name: rosuvastatin measure: Carotid duplex will be done at the onset and after 1 month and 3 months of the onset. sex: ALL minimumAge: 20 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06371482 id: Camel-01 briefTitle: Durvalumab Combined With Chemoradiotherapy for Limited Stage Small Cell Lung Cancer (Camel-01) overallStatus: RECRUITING date: 2023-06-01 date: 2024-12-31 date: 2027-12-31 date: 2024-04-17 date: 2024-04-17 name: Hebei Medical University Fourth Hospital class: OTHER briefSummary: This trial aims to assess efficacy and safety of durvalumab combined with chemoradiotherapy for limited stage small cell lung cancer. conditions: SCLC, Limited Stage studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 58 type: ESTIMATED name: Durvalumab name: Chemotherapy drug of EP regimen name: radiotherapy measure: Assessment of objective remission rate (ORR) in limited stage small cell lung cancer treated with durvalumab combined with chemoradiotherapy measure: Assessment of the incidence of treatment-related adverse events Incidence of Treatment-Emergent Adverse Events. measure: Assessment of overall survival (OS) in limited stage small cell lung cancer. measure: Assessment of progression-free survival (PFS) in limited stage small cell lung cancer. measure: Assessment of disease control rate (DCR) in limited stage small cell lung cancer. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fourth Hospital of Hebei Medical University status: RECRUITING city: Shijiazhuang state: Hebei zip: 050011 country: China name: Wenbin Shen, PhD role: CONTACT phone: +86 15831183879 email: wbshen1979@sina.com name: Hesong Wang, PhD role: CONTACT phone: +86 18810775196 email: wanghesongmz@163.com lat: 38.04139 lon: 114.47861 hasResults: False

 nctId: NCT06371469 id: KAEK-769 briefTitle: Program of Health Behaviour Against to Cancer (PHeBAC) acronym: PHeBAC overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-07-20 date: 2024-08-20 date: 2024-04-17 date: 2024-04-18 name: Akdeniz University class: OTHER briefSummary: The European Code Against Cancer contains 12 recommendations to reduce the risk of cancer. It is estimated that about half of all cancers could be prevented if all recommendations are followed.

The aim of this study was to evaluate the effectiveness of the Program of Health Behaviour Against Cancer (PHeBAC) applied to mothers of children with intellectual disabilities in increasing the participation of mothers and their children with intellectual disabilities in cancer screenings and their health behaviors against cancer. The goal is to improve the preventive health behaviors of children with intellectual disabilities and their mothers against cancer and to increase the rate of participation in cancer screenings. Specific targets are; not smoking and not being exposed to smoking, increasing physical activity, healthy nutrition, limiting alcohol consumption, protection from sunlight, HPV vaccination and increasing participation in breast, cervical and colorectal cancer screenings. conditions: Cancer Prevention conditions: Health Behavior conditions: Disability, Intellectual conditions: Parents conditions: Cancer Screening conditions: Experimental Study Designs conditions: Mothers conditions: Disabilities Mental studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Mothers participating in the research will not know that they are in the intervention or control group. The data of the research will be collected by an independent investigator. In addition telephone support during the research process will be provided by the independent investigator, too whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: PHeBAC name: Control Group measure: Health Behaviors and Participation in Cancer Screenings Data Collection Form measure: Healthy Life Style Behaviors Scale II (Physical Activity and Nutrition Sub-Factors) measure: Sun Protection Behavior Scale sex: FEMALE minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06371456 id: Ain Shams university 111 briefTitle: A Non Invasive Confirmatory Sign for Correct Epidural Catheter Placement During Normal Vaginal Delivery overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-08-01 date: 2024-04-17 date: 2024-04-17 name: Ain Shams University class: OTHER briefSummary: Epidural anesthesia for pain control during normal vaginal delivery is a blind maneuver and so we need a confirmatory sign for being in the correct epidural space.

Loss of resistance sign using air may guide us wrongly as it may occur if we entered into the paravertebral muscles or cavities in the interspinal ligaments.

So, additional confirmatory sign beside loss of resistance sign by air is strongly needed.

We noticed that after occurence of loss of resistance sign by air and insertion of the epidural catheter a dew was formed on the internal sides of the epidural catheter after aspiration to be sure that there are no blood or cerebrospinal fluid in the catheter.

This dew formation (Ramy sign) is characteristic for air in the epidural space when transferred from the warm epidural space (temperature about 38-39 celsius degree) to the colder aspect of the catheter outside the patient which nearly has the same operating room temperature (22 celsius degree).

This sign may be associated with correct placement and good function of the epidural catheter. conditions: Normal Delivery Pain studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: epidural catheter placement measure: appearance of the dew sign measure: epidurogram measure: visual analogue score measure: mean blood pressure measure: mean blood pressure measure: heart rate measure: heart rate sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06371443 id: ayselkokcudogan briefTitle: Suction and Swalloing Exercises for Premature Babies overallStatus: COMPLETED date: 2021-12-03 date: 2022-06-01 date: 2022-08-01 date: 2024-04-17 date: 2024-04-17 name: Istanbul Medipol University Hospital class: OTHER briefSummary: Underdeveloped oral structures of preterm infants cause feeding problems. Therefore, the development of sucking reflexes of premature babies should be supported.

This study aimed to investigate the effect of suck-swallow training on the transition to oral feeding in premature infants.

The study was conducted as a randomized controlled experimental trial in the NICU of a public hospital in Istanbul. The study sample consisted of 82 premature infants. Of these infants, 41 were assigned to the experimental group and 41 to the control group. Study data were collected using the investigator-developed Premature Infant Data Collection Form and Early Feeding Skills Assessment Tool. Throughout the study, preterm infants in the experimental group (n=41) were given suck-swallow exercises for 12 minutes once a day before feeding for 14 days. SPSS21 was used to analyze the data. conditions: Premature Infant studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 41 type: ACTUAL name: Sucking and swallowing exercises measure: The early feeding skills assessment tool (EFS) sex: ALL minimumAge: 34 Weeks maximumAge: 37 Weeks stdAges: CHILD facility: Medipol University city: Istanbul state: Beykoz zip: 34810 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06371430 id: Biointelligent Technology Syst briefTitle: Bone Bioactive Liquid Efficiency in Improving Dental Implant Osteointegration Oral Soft Tissue Hellingand Oral Surgery acronym: BBLIS overallStatus: RECRUITING date: 2021-04-14 date: 2024-02-14 date: 2024-06-14 date: 2024-04-17 date: 2024-04-17 name: Biointelligent Technology Systems SL class: INDUSTRY name: Universidad Pública de Navarra name: Dasman Diabetes Institute briefSummary: The investigators implanted 264 Galaxy TS implants (with or without BBL) in 33 patients across both jaws. Implant stability and osseointegration were assessed using Initial Stability Quotient (ISQ) measurements, computed tomography (CBCT) scans and pain evaluations at various intervals post-surgery. Further, implant surfaces were examined using scanning electron microscopy (SEM) and atomic force microscopy (AFM). In vitro studies evaluated the efficacy of BBL on dental pulp pluripotent stem cells (DPPSCs) osteogenesis, and inflammatory factor modulation in human macrophages. conditions: Wound Healing Disorder conditions: Wounds and Injuries conditions: Wound Surgical studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 33 type: ESTIMATED name: Dental Implant insertion and tooth extraction measure: ISQ measurements measure: Pain measure: CBCTs analysis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Biointelligent Technology Syst status: RECRUITING city: Barcelona zip: 08009 country: Spain name: Maher Atari, PhD role: CONTACT email: matari@biointelligentsl.com lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06371417 id: RAY902CT briefTitle: Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial) overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2026-06-30 date: 2026-06-30 date: 2024-04-17 date: 2024-04-17 name: Chugai Pharmaceutical class: INDUSTRY briefSummary: This Phase 1b basket trial will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RAY121, a inhibitor of classical complement pathway, after multiple dose administration in patients with immunological diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), Behçet's Syndrome (BS), dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM) and immune thrombocytopenia (ITP). conditions: Antiphospholipid Syndrome (APS) conditions: Bullous Pemphigoid (BP) conditions: Behçet's Syndrome (BS) conditions: Dermatomyositis (DM) conditions: Immune-mediated Necrotizing Myopathy (IMNM) conditions: Immune Thrombocytopenia (ITP) studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 144 type: ESTIMATED name: RAY121 measure: Adverse events (AEs) measure: RAY121 concentration measure: AUCτ measure: Cmax measure: Cmin measure: Active C1s measure: Total C1s measure: Complement activity (classical pathway) measure: Anti-RAY121 antibodies sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Oregon Health & Science University city: Portland state: Oregon zip: 97239 country: United States lat: 45.52345 lon: -122.67621 facility: Hokkaido University Hospital city: Sapporo state: Hokkaido zip: 060-0808 country: Japan lat: 43.06667 lon: 141.35 facility: Tohoku University Hospital city: Sendai state: Miyagi zip: 980-8574 country: Japan lat: 38.26667 lon: 140.86667 facility: Osaka University Hospital city: Suita state: Osaka zip: 565-0871 country: Japan lat: 34.76143 lon: 135.51567 facility: Hamamatsu University Hospital city: Hamamatsu state: Shizuoka zip: 431-3192 country: Japan lat: 34.7 lon: 137.73333 facility: Toho University Omori Medical Center city: Ota-ku state: Tokyo zip: 143-8540 country: Japan lat: 36.3 lon: 139.36667 hasResults: False

 nctId: NCT06371404 id: 2000037129 briefTitle: Imaging Traumatic Stress and Alcohol Use Disorder With [18F]Bavarostat overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2030-06-01 date: 2031-06-01 date: 2024-04-17 date: 2024-04-17 name: Yale University class: OTHER briefSummary: The overall objective of this study it to use Positron Emission Tomography (PET) brain imaging and a radiotracer that measures the epigenetic marker Histone Deacetylase 6 (HDAC6) to examine HDAC6 expression in people with Post-Traumatic Stress Disorder (PTSD), Alcohol Use Disorder (AUD), or concurrent PTSD and AUD with control groups. While there are a large number of studies conducted in preclinical stress and addiction models, these findings have not been translated to people living with these disorders. We will examine relationships between HDAC6 and clinical variables of interest. Findings could direct treatment development. conditions: Alcohol Use Disorder conditions: Post Traumatic Stress Disorder studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: RETROSPECTIVE count: 150 type: ESTIMATED name: Bavarostat measure: HDAC6 expression in people with Post-Traumatic Stress Disorder measure: HDAC6 expression in people with Alcohol use Disorder sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yale University city: New Haven state: Connecticut zip: 06518 country: United States name: Kelly Cosgrove, PhD role: CONTACT phone: 203-737-6969 email: kelly.cosgrove@yale.edu name: Marc Grasso, Ba role: CONTACT phone: 2037377074 email: marc.grasso@yale.edu name: Kelly Cosgrove, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.30815 lon: -72.92816 hasResults: False

 nctId: NCT06371391 id: 2023-02077 briefTitle: Environmental and Occupational Noise Exposure in Relation to Incidence of Type 2 Diabetes overallStatus: ACTIVE_NOT_RECRUITING date: 1992-01-01 date: 2013-12-31 date: 2026-12-31 date: 2024-04-17 date: 2024-04-19 name: Karolinska Institutet class: OTHER name: The Swedish Research Council briefSummary: Large parts of the population are exposed to traffic noise, particularly in urban areas, and high noise levels occur in many workplaces. The aims of this project are to estimate exposure-response relationships for incidence of type 2 diabetes (T2D) related to long-term exposure to road traffic, railway and aircraft noise, as well as occupational noise. Furthermore, mediation by sleep disturbances and overweight/obesity is investigated, as well as interactions with air pollution and clinical biomarkers, to elucidate important etiological pathways. The project is based on pooled analyses of nine Scandinavian cohorts, totally including more than 300 000 individuals. Detailed longitudinal exposure to traffic noise from different sources, air pollutants and greenness, as well as occupational exposures, are estimated with state-of-the-art methods and supplemented with questionnaire and registry data on risk factors as well as clinical measurements. Incidence of T2D is assessed by combining information from medical examinations, high quality registers, questionnaires and biomarker measurements. Population attributable risks are estimated by combining population data on exposure with information on exposure-response relationships. In several aspects the project is unique and addresses questions which have never been studied before. Our results will provide important guidance for prioritization of preventive measures to promote health sustainable urban development and safe workplaces. conditions: Environment Related Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 300000 type: ESTIMATED name: No intervention measure: Type 2 diabetes (T2D) sex: ALL minimumAge: 16 Years maximumAge: 98 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06371378 id: gastric residual volume briefTitle: Effect of Different Peep Values on Gastric Residual Volume overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-05 date: 2024-06-01 date: 2024-09-01 date: 2024-04-17 date: 2024-04-19 name: Ankara City Hospital Bilkent class: OTHER briefSummary: The aim of this study was to predict the effect of gastric antrum diameter before extubation on intra-abdominal pressure changes and consequently on the risk of pulmonary aspiration in patients undergoing elective spinal surgery under general anaesthesia in the prone position in the Neurosurgery Operating Theatre of the Ministry of Health Ankara City Hospital and to take precautions accordingly. Gastric antrum diameter and intraabdominal pressure measurements may contribute to the improvement of anaesthetic practice by reducing the risk of pulmonary aspiration and additional complications. conditions: Respiratory Aspiration of Gastric Content studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 90 type: ESTIMATED name: PEEP 0 name: PEEP 4 name: PEEP 8 measure: Gastric antrum diameter measure: Intraabdominal pressure (IAP) measurement measure: gastric volume measurement measure: Vital parameters Pulse oximetry (%) measure: Vital parameters systolic and diastolic blood pressure (mmHg) measure: Vital parameters heart rate (beats/minute) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara City Hospital city: Ankara state: Çankaya country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06371365 id: KMUHIRB-E(II)-20220204 briefTitle: Adverse Events for Free Flap Surgery in Head and Neck Cancer overallStatus: COMPLETED date: 2022-10-19 date: 2023-09-24 date: 2023-09-24 date: 2024-04-17 date: 2024-04-18 name: Kaohsiung Medical University class: OTHER name: Kaohsiung Medical University Chung-Ho Memorial Hospital briefSummary: This is a cohort study collecting patients with head and neck cancer who underwent free flap surgery at a single medical center between January 2019 and January 2022. conditions: Surgical Flaps conditions: Flap Failure Risk Factors conditions: Hematoma Risk Factors conditions: Thrombosis Risk Factors studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 540 type: ACTUAL name: Free Flap surgery measure: Number of participants with flap failure measure: Number of participants with hematoma measure: Number of participants with thrombosis sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kaohsiung Medical University Chung-Ho Memorial Hospital city: Kaohsiung country: Taiwan lat: 22.61626 lon: 120.31333 hasResults: False

 nctId: NCT06371352 id: JagiellonianU73 briefTitle: Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep, Daytime Sleepiness, and Fatigue in Depression overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-12 date: 2027-05 date: 2024-04-17 date: 2024-04-17 name: Jakub Antczak class: OTHER name: Institute of Psychiatry and Neurology, Warsaw briefSummary: Intermittent and continuous theta-burst stimulation (iTBS and cTBS respectively) are the newer modalities of transcranial magnetic stimulation with documented efficacy in treatment of depressed mood but with conflicting results regarding their efficacy in treatment of other symptoms of depression such as insomnia, daytime sleepiness and fatigue. This study will investigate the efficacy of iTBS over the left dorsolateral prefrontal cortex (DLPFC) and cTBS over the right DLPFC, compared to sham stimulation, in treatment of insomnia, daytime sleepiness and fatigue in depression. conditions: Unipolar Depression conditions: Bipolar Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, randomized, sham-controlled clinical trial in parallel design primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Placebo intervention will be delivered with a sham-coil for magnetic stimulation, which looks identical and elicits similar sounds as the coil used for active stimulation, but induces only negligible magnetic field. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: iTBS name: cTBS name: Sham measure: Beck Depression Inventory 2 measure: Pittsburgh Sleep Quality Index measure: Brief Psychiatric Rating Scale measure: Epworth Sleepiness Scale measure: Fatigue Assessment Scale measure: Quality of Life in Depression Scale measure: Sleep propensity non-rapid eye movement 1 sleep stage measure: Sleep propensity non-rapid eye movement 2 sleep stage sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute of Psychiatry and Neurology city: Warsaw zip: 02957 country: Poland name: Bogdan Stefanowski role: CONTACT phone: +48 22 45 82 532 email: bstefanowski@ipin.edu.pl name: Jakub Antczak, MD role: CONTACT phone: +48 12 400 25 50 email: jakub.antczak@uj.edu.pl lat: 52.22977 lon: 21.01178 hasResults: False

 nctId: NCT06371339 id: 23 VADS 03 briefTitle: Optimization With a Gamma Camera of the Individualized Patient Dosimetry in Radioiodine Therapy of Thyroid Diseases acronym: THIDOS overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-06 date: 2024-04-17 date: 2024-04-17 name: Institut Claudius Regaud class: OTHER name: Laboratoire IJCLab briefSummary: This is a pilot, single-center, prospective, open-label clinical investigation of a medical device (ambulatory gamma camera " MoTI " (Mobile Therapy Imager)) for patients with hyperthyroidism (Graves' disease, toxic nodule and toxic multiheteronodular goiter) for whom 131I treatment is indicated.

Its aim is to assess the feasibility of using this ambulatory gamma camera (MoTI) in the clinic in this patient population. The camera will be used to measure the 131I uptake/fixation rates during the thyroid scintigraphy.

20 patients will be included in the study. conditions: Hyperthyroidism studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 20 type: ESTIMATED name: Additional acquisitions with the investigational gamma-camera " MoTI ". measure: The clinical feasibility of using an ambulatory gamma camera. measure: The level of acceptance of the gamma camera by operators for carrying out examinations measure: The quality of the images for the expected clinical use measure: The ability of the gamma camera to generate images compatible with the Picture Archiving and Communication System (PACS) measure: The quality of the images obtained with the ambulatory gamma camera compared with those obtained during the standard examination (i.e. gamma camera used in the department, Syngula) measure: The 131I fixation rates will be measured in percent at different times. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IUCT-O city: Toulouse country: France name: Slimane ZERDOUD role: CONTACT phone: 05 31 15 56 28 email: zerdoud.slimane@iuct-oncopole.fr lat: 43.60426 lon: 1.44367 hasResults: False

 nctId: NCT06371326 id: BJQLZT002004 briefTitle: A Study of ZT002 Injection in Participants With Overweight or Obesity overallStatus: ENROLLING_BY_INVITATION date: 2023-11-21 date: 2024-08-30 date: 2024-09-30 date: 2024-04-17 date: 2024-04-17 name: Beijing QL Biopharmaceutical Co.,Ltd class: INDUSTRY briefSummary: This study will comprise a randomized, double-blind, placebo-controlled, multiple-ascending-dose, safety, tolerability, and pharmacokinetics study of ZT002 in participants with Overweight or Obesity. conditions: Overweight or Obesity studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 28 type: ESTIMATED name: ZT002 Injection name: Placebo measure: Safety and tolerability of a multiple escalation dose of ZT002 through the incidence and severity of treatment emergent adverse events in MAD Cohorts. Number of participants with treatment-emergent adverse events. measure: Safety and tolerability of a multiple escalation dose of ZT002 through the incidence severity of serious adverse events in MAD Cohorts. Number of participants with serious adverse events. measure: The Pharmacokinetics (PK) profile of a multiple escalation dose of ZT002 in participants with overweight or obesity. measure: The Pharmacokinetics (PK) profile of a single escalation dose of ZT002 in participants with overweight or obesity. measure: The anti-drug antibody (ADA) response through testing serum or plasma of the participants post-dosing. sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: First Affiliated Hospital of Bengbu Medical College city: Bengbu country: China lat: 32.94083 lon: 117.36083 hasResults: False

 nctId: NCT06371313 id: GuangdongWCH-LiLi03 briefTitle: Endocrine, Metabolic and Inflammatory Characteristics of Offspring of Mothers With PCOS Hyperandrogenism overallStatus: COMPLETED date: 2023-05-01 date: 2024-03-05 date: 2024-03-05 date: 2024-04-17 date: 2024-04-17 name: Guangdong Women and Children Hospital class: OTHER briefSummary: This study is a cross-sectional study to explore the endocrine metabolism and inflammatory characteristics of the offspring of mothers with PCOS hyperandrogenism, in order to provide a theoretical basis for finding the cause of PCOS. conditions: PCOS studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 42 type: ACTUAL measure: Testosterone measure: Androstenedione measure: Dehydroepiandrosterone Sulfate measure: Sex Hormone Hinding Globulin measure: Free Androgen Index measure: Fasting Insulin measure: White Blood Cell Count measure: Neutrophil Count measure: High-sensitivity C-reactive Protein measure: Interleukin-6 sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Guangdong Women and Children Hosptial city: Guanzhou state: Guangdong zip: 511400 country: China hasResults: False

 nctId: NCT06371300 id: HLS21156 briefTitle: Photobiomodulation With REd vs BluE Light (REBEL) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-08 date: 2025-12 date: 2024-04-17 date: 2024-04-23 name: Aston University class: OTHER briefSummary: The use of photobiomodulation or low-level light therapy (LLLT) in the ophthalmic field stemmed from dermatology which has shown impact on skin blood flow and regeneration. There has been a rise in clinical interest with emerging evidence in the benefits of photobiomodulation in managing chronic inflammatory conditions such as dry eye disease including improvements in ocular discomfort symptoms, tear film stability and tear volume. Despite the observed clinical benefits, limited research has been done to compare photobiomodulation utilising different wavelengths, as most research on dry eye disease has focused on red wavelengths. It has been purported that blue wavelengths may disrupt microbial growth while red wavelengths stimulate energy production and hence increase heat in the affected tissues, although research into these differential impacts at the ocular surface and external eye has been limited. Hence, the aim of this exploratory clinical trial is to compare the impact of using LLLT incorporating red versus blue wavelengths on eyelid haemodynamics and microbiome, as well as conventional ocular surface measures of patients with dry eye disease and blepharitis (inflammation of the eyelids).

Participants with dry eye disease, oil gland disruption and blepharitis will receive 3 treatments with these LLLT, each separted by 1 week apart, and followed up to 1 month after the final treatment session. Participants will be randomised to either of 3 groups: Red light only group, Red + Blue light group, or a sham treatment group. conditions: Dry Eye Syndromes conditions: Meibomian Gland Dysfunction conditions: Blepharitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Each participant is randomised to either of 3 groups: Red light only group, red plus blue light group, or sham treatment group. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: Red LLLT name: Blue LLLT name: Sham Red LLLT name: Sham Blue LLLT measure: Change from Baseline in Non-invasive Tear Break Up Time to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Visual Acuity to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Blink Rate to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Tear Meniscus Height to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Lipid Layer Pattern Grading to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Bulbar Conjunctival Hyperaemia to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Limbal Conjunctival Hyperaemia to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Bacterial Colony to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Blood Flow to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Saponification Grading to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Demodex Presence to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Number of Blocked or Capped Meibomian Glands to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Lid Margin Telangiectasia Grading to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Meibum Expressibility to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Meibum Quality to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Fluorescein Corneal Staining to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Bulbar Conjunctival Staining to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Lissamine Green Lid Wiper Epitheliopathy to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Meibography Meiboscore to the Final Follow-up 1 Month After Final Treatment Session measure: Change from Baseline in Total Corneal Nerve Length to the Final Follow-up 1 Month After Final Treatment Session sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aston Dry Eye Clinic city: Birmingham state: West Midlands zip: B4 7ET country: United Kingdom name: Jeremy Chung Bo Chiang, PhD role: CONTACT phone: +441212043934 phoneExt: 3934 email: j.chiang@aston.ac.uk lat: 52.48142 lon: -1.89983 hasResults: False

 nctId: NCT06371287 id: 64696022.1.0000.5346 briefTitle: Effect of Musical Auditory Training on Subjects With Tinnitus Disorder overallStatus: RECRUITING date: 2023-02-20 date: 2024-08-10 date: 2025-02-10 date: 2024-04-17 date: 2024-04-24 name: Universidade Federal de Santa Maria class: OTHER briefSummary: Among the theories of tinnitus generation, there is that of central neuroplastic changes, which reports the association between changes and reorganization that occur in central auditory pathways and impacts on associated areas due to the altered neural signal. Auditory training modifies these altered pathways through auditory exercises, which provoke positive neuroplasticity. Musical auditory training is a proposal to stimulate auditory, cognitive and metalinguistic skills with activities focused on musicality. Therefore, the objective of this study is to verify the effect of musical auditory training (MAT) on the neuroplasticity of the auditory system and the perception of tinnitus disorder in young adults. conditions: Tinnitus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Treinamento Auditivo Musical name: Placebo measure: Changes in latency of the long latency auditory evoked potential (LLAEP) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Universidade Federal de Santa Maria status: RECRUITING city: Santa Maria state: RS zip: 97.105-970 country: Brazil name: Dayane Domeneghini Didoné role: CONTACT phone: 553220-9362 email: dayane.didone@ufsm.br name: Dayane Domeneghini Didoné D Dayane Domeneghini Didoné role: PRINCIPAL_INVESTIGATOR lat: -29.68417 lon: -53.80694 facility: Universidade Federal de Santa Maria status: RECRUITING city: Santa Maria state: RS zip: 97.105-970 country: Brazil name: Dayane D Didoné, Professora role: CONTACT phone: 553220-9362 email: dayane.didone@ufsm.br name: Christine G Schumacher, Mestranda role: PRINCIPAL_INVESTIGATOR lat: -29.68417 lon: -53.80694 hasResults: False

 nctId: NCT06371274 id: ZYYY-IIT-TNBC-001 briefTitle: A Study on the Efficacy and Safety of Oral All-trans Retinoic Acid Combined With Toripalimab in TNBC. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-04-30 date: 2024-04-17 date: 2024-04-17 name: First Affiliated Hospital of Zhejiang University class: OTHER name: Shanghai Longfine Biotechnology Co., Ltd. name: TopAlliance briefSummary: To evaluate the clinical efficacy and safety of oral all-trans retinoic acid in combination with toripalimab in patients with locally advanced, recurrent, or metastatic triple-negative breast cancer who had failed second-line and subsequent therapy. conditions: Triple-negative Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: ATRA name: Toripalimab measure: Objective Response Rate (ORR) measure: Progression-Free Survival (PFS) measure: Duration of Response (DOR) measure: Overall Survival (OS) measure: Incidence of Treatment-Emergent Adverse events as assessed by NCI-CTCAE 5.0 measure: Exploratory biomarkers-peripheral blood lymphocyte analysis measure: Exploratory biomarkers-Serum Metabolomics Analysis measure: Exploratory biomarkers-Fecal Microbiota Analysis sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The first affiliated hospital, Zhejiang University School of Medicine city: Hangzhou state: Zhejiang Province, P.R. China zip: 310003 country: China name: Meihua Lin, MS role: CONTACT name: Jian Liu, MS role: PRINCIPAL_INVESTIGATOR name: Xiaochen Zhang, MD role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06371261 id: 2023/CHU/07 briefTitle: Pathogenicity of Species of the Achromobacter Genus in Patients From Reunion Island With Cystic Fibrosis acronym: ACHROMO-MUCO overallStatus: RECRUITING date: 2024-02-29 date: 2027-03 date: 2027-03 date: 2024-04-17 date: 2024-04-26 name: Centre Hospitalier Universitaire de la Réunion class: OTHER briefSummary: The pathogenicity of Achromobacter bacteria is not yet well established, but studies show a decline in respiratory function and an increase in mortality associated with chronic colonisation, making it possible to classify the Achromobacter genus as an emerging pathogen in cystic fibrosis. It is possible that certain species or clones are more virulent or resistant, requiring the adaptation of measures to prevent cross-transmission in the centres concerned.

However, until now, the identification of Achromobacter species has involved the use of molecular biology techniques that are not routinely applicable in diagnostic laboratories, limiting studies and the collection of epidemiological data. Recently, a database using MALDI-TOF mass spectrometry has been built for rapid and accurate species identification.

In view of the local epidemiology and the current lack of data, it would be necessary and interesting to use this tool to study a cohort of cystic fibrosis patients in Réunion island (North and South sites) to see whether one species has a greater clinical impact than another (pathogenicity), and/or is more responsible for chronic colonisation. conditions: Cystic Fibrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 35 type: ESTIMATED name: Biological analyses measure: Frequency of pulmonary exacerbations according to the species of the Achromobacter genus colonising/infecting cystic fibrosis patients. measure: Frequency of pulmonary exacerbations as a function of Achromobacter spp. colonisation status. measure: Emergence or existing presence of clones within the species of the genus Achromobacter circulating among cystic fibrosis patients in Réunion, using genomic analyses. measure: Presence of virulence factors in these strains using genomic analyses measure: Search for genes responsible for antibiotic resistance by genomic analysis of these strains measure: To describe the epidemiology of Achromobacter spp. in cystic fibrosis patients in Réunion sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: CHU la Réunion North status: RECRUITING city: Saint-Denis country: Réunion name: VERHILLE Juliette, MD role: CONTACT email: Juliette.verhille@chu-reunion.fr name: Juliette VERHILLE, MD role: PRINCIPAL_INVESTIGATOR lat: -20.88231 lon: 55.4504 facility: CHU la Réunion South status: RECRUITING city: Saint-Pierre country: Réunion name: PERISSON Caroline, MD role: CONTACT email: Caroline.perisson@chu-reunion.fr name: Caroline PERISSON, MD role: PRINCIPAL_INVESTIGATOR lat: -21.3393 lon: 55.47811 hasResults: False

 nctId: NCT06371248 id: 2850 briefTitle: Steady Feet: Preventing Falls in the Community overallStatus: COMPLETED date: 2018-11-19 date: 2019-12-20 date: 2019-12-20 date: 2024-04-17 date: 2024-04-17 name: Changi General Hospital class: OTHER briefSummary: The purpose of this study is to examine the feasibility of Steady Feet, a three-month community-based falls prevention exercise program. conditions: Fall conditions: Feasibility conditions: Older Adults conditions: Exercise studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 65 type: ACTUAL name: Steady Feet name: Usual care for fall prevention measure: Short Physical Performance Battery (SPPB) measure: CONFbal measure: Six-minute walk test (6MWT) measure: Timed up and go (TUG) measure: Four square step test (FSST) measure: Feedback and satisfaction survey measure: Attendance and completion rates measure: Safety of Steady Feet sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Changi General Hospital city: Singapore zip: 529889 country: Singapore lat: 1.28967 lon: 103.85007 hasResults: False

 nctId: NCT06371235 id: 2024-A00739-38 briefTitle: Study of the Transmission of Anti-interferon Type 1 Alpha Autoantibodies From Mother to Child Via the Placental Barrier acronym: Pregiferon overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2024-09 date: 2027-03 date: 2024-04-17 date: 2024-04-17 name: CerbaXpert class: OTHER briefSummary: The main objective of the study is to evaluate the frequency of placental transfer of self-Ab directed against the mother's IFN alpha in the newborn, in all women suffering from a pathology frequently associated with the presence of these autoantibodies and in those seropositive during the pregnancy. conditions: Woman Suffering From a Pathology Frequently Associated With the Presence of These Anti-autoantibodies Type-I Interferons studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 250 type: ESTIMATED name: Pregiferon measure: Frequency of placental transfer of self-Ab directed against IFN alpha from mother to newborn. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06371222 id: BSMMU/2023/6502 briefTitle: Role of Ivabradine on Heart Rate and Quality of Life in Patients With Mitral Stenosis in Sinus Rhythm overallStatus: COMPLETED date: 2023-02-01 date: 2024-01-31 date: 2024-02-01 date: 2024-04-17 date: 2024-04-17 name: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh class: OTHER briefSummary: Mitral stenosis, a condition characterized by narrowing of the mitral valve orifice, remains a significant cause of morbidity and mortality worldwide, particularly in regions where rheumatic fever is endemic. Despite advancements in medical and surgical management, patients with mitral stenosis often suffer from symptoms such as dyspnea, fatigue, and reduced exercise tolerance, significantly impacting their quality of life (QoL) \[1\].

One of the hallmark features of mitral stenosis is the development of sinus rhythm, which can be associated with elevated heart rates due to decreased diastolic filling time and compensatory mechanisms to maintain cardiac output. Persistent tachycardia in patients with mitral stenosis contributes to increased myocardial oxygen demand, exacerbating symptoms and potentially leading to adverse outcomes \[2\].

In recent years, ivabradine, a selective inhibitor of the If current in the sinoatrial node, has emerged as a promising therapeutic option for controlling heart rate in various cardiovascular conditions, including chronic heart failure and ischemic heart disease \[3\]. By specifically targeting the cardiac pacemaker cells, ivabradine reduces heart rate without affecting myocardial contractility or conduction, offering a unique mechanism of heart rate control compared to traditional beta-blockers or calcium channel blockers \[4\].

However, the role of ivabradine in patients with mitral stenosis in sinus rhythm remains uncertain, and there is limited evidence regarding its efficacy and impact on QoL in this specific patient population. Therefore, the aim of this randomized controlled trial (RCT) is to investigate the effects of ivabradine on heart rate control and QoL in patients with mitral stenosis in sinus rhythm. conditions: Mitral Stenosis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: RCT primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 42 type: ACTUAL name: Ivabradine name: Beta blocker measure: effect of ivabradine in MS patients measure: quality of life of MS patients sex: ALL minimumAge: 17 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: BSMMU city: Dhaka zip: 1200 country: Bangladesh lat: 23.7104 lon: 90.40744 hasResults: False

 nctId: NCT06371209 id: 2022P000619 briefTitle: Kinematics of Ewing Amputees overallStatus: ENROLLING_BY_INVITATION date: 2022-05-17 date: 2024-06-29 date: 2024-07-01 date: 2024-04-17 date: 2024-04-17 name: Brigham and Women's Hospital class: OTHER briefSummary: The agonist-antagonist myoneural interface (AMI) construct, known as the Ewing amputation at the trans-tibial level, has been shown to create a bi-directional neural communication platform as a means of controlling and interpreting proprioceptive feedback from a prosthetic joint. In AMI constructs, agonist-antagonist muscles are mechanically coupled within the residual limb, and volitional contraction of an agonist passively stretches that muscle's antagonist. The natural neural responses from muscle spindles within both muscles are then interpreted by the central nervous system as sensations of joint position and speed, associated with movement of the prosthesis.

The aim of this research protocol is to evaluate the electromyographic and kinematic patterns of participants who have undergone unilateral lower extremity Ewing Amputation in order to determine how similar their residual limb data is when compared to their intact limb data. A secondary aim of this research may include comparison of the Ewing participant cohort's biomechanical patterns to a similar cohort of participants who have undergone standard amputation.

The investigators hypothesize that the affected limb of patients with the Ewing procedure will demonstrate a pattern of electromyographic activation of their AMI constructs and kinematic data that recapitulates the pattern seen in their intact limb. The investigators secondarily hypothesize that the kinematic assessment of Ewing Amputation patients will demonstrate patterns that are significantly more physiologic than those witnessed in similar assessments of standard amputees. conditions: Lower Extremity Amputation conditions: Trans-Tibial Amputation conditions: Traumatic Lower Extremity Amputation conditions: Agonist-Antagonist Myoneural Interface studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 32 type: ESTIMATED name: Modified Amputation name: Standard Amputation measure: Duration of co-contraction of the ankle dorsi/plantar-flexor muscles during gait measure: Symmetry of duration of co-contraction of the ankle dorsi/plantar-flexor muscles during gait measure: Symmetry of ankle power generation measure: Symmetry of peak knee flexion during stance measure: Symmetry of step length sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mass General Brigham city: Boston state: Massachusetts zip: 02129 country: United States lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06371196 id: BBD-PBC 2024-03 briefTitle: Clinical Study on the Treatment of Elevated Total Bilirubin in Primary Biliary Cholangitis With Baobao Dan Capsule overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2025-07-25 date: 2025-12-31 date: 2024-04-17 date: 2024-04-17 name: Mei Han class: OTHER briefSummary: 1. Explore the effect of Babaodan Capsule on the serum total bilirubin level of primary biliary cholangitis patients with elevated total serum bilirubin;
2. To observe the positive intervention effect of Babaodan Capsule on the clinical symptoms of primary biliary cholangitis patients with elevated total bilirubin. conditions: Primary Biliary Cholangitis studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Babaodan Capsule measure: Total bilirubin (TBil) reversion rate measure: Total bilirubin (TBil) efficacy rate measure: biological response rate measure: ALT measure: AST measure: ALP measure: TBA measure: DBil measure: IBil measure: 5-D Pruritus Scale Score measure: Fatigue section of the PBC-40 questionnaire measure: Immunological indicators - serum IgM measure: Immunological indicators - serum IgG measure: Immunological indicators - serum IgA measure: Immunological indicators - anti-gp210 antibody measure: Immunological indicators - anti-sp100 antibody measure: Immunological indicators - autoantibodies AMA/AMA-M2 measure: Histopathology of the liver - grading of inflammatory activity measure: Histopathology of the liver - staging of the degree of fibrosis measure: 12-lead electrocardiogram measure: Physical examination measure: Routine blood test measure: Renal Function Tests-BUN measure: Renal Function Tests-UA measure: Renal Function Tests-Scr measure: Urinalysis measure: Coagulation tests-PT measure: Coagulation tests-APTT measure: Coagulation tests-TT measure: Coagulation tests-FIB measure: Urine beta-hCG pregnancy test measure: adverse event measure: Body temperature measure: Heart rate measure: Number of breaths in 1 min measure: Blood pressure-Diastolic blood pressure(mmHg) measure: Blood pressure-Systolic blood pressure(mmHg) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06371183 id: AOMSaidB briefTitle: A Comparative Study of Clinical, Endoscopic and Histopathological Features of Colitis in Children on June 2024 overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-05-30 date: 2027-05-30 date: 2024-04-17 date: 2024-04-17 name: Assiut University class: OTHER briefSummary: A Comparative study of clinical, endoscopic and histopathological features of colitis in children conditions: Role of Ileoscopy in Diagnosis of Colitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients who complaining of lower GI manifestations primaryPurpose: DIAGNOSTIC masking: NONE count: 196 type: ESTIMATED name: Colonoscope measure: Role of ileoscopy in diagnosis of colitis measure: To correlate clinical manifestations by colonoscopic picture sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06371170 id: CCPC- 001/22 briefTitle: Rivaroxaban for Intracardiac Thrombosis in the Pediatric Population overallStatus: RECRUITING date: 2023-01-01 date: 2025-01-01 date: 2027-01-01 date: 2024-04-17 date: 2024-04-19 name: Azienda Ospedaliero, Universitaria Ospedali Riuniti class: OTHER briefSummary: The goal of this observational study is to determine the efficacy of rivaroxaban treatment for intracardiac thrombi resolution in pediatric patients (\< 16 years old) diagnosed with intracardiac thrombosis. The main question it aims to answer is: Does rivaroxaban treatment resolve the thrombosis during a 3-month treatment?

Participants already taking rivaroxaban as part of their regular medical care for thrombosis resolution. They will undergo monthly visits to check that the treatment is progressing correctly and that no major bleeding has occurred. After 3 months of treatment, they will repeat the radiological imaging investigation to verify the actual resolution of the thrombosis. conditions: Intracardiac Thrombus studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Rivaroxaban measure: Thrombus resolution measure: Bleeding sex: ALL minimumAge: 1 Month maximumAge: 16 Years stdAges: CHILD facility: CCPC status: RECRUITING city: Ancona state: Marche zip: 60123 country: Italy name: Francesco Bianco, M.D. role: CONTACT phone: +39 071 596 5316 email: francesco.bianco@ospedaliriuniti.marche.it lat: 43.5942 lon: 13.50337 hasResults: False

 nctId: NCT06371157 id: AK104-308 briefTitle: A Study of AK104+Lenvatinib in Combination With Transarterial Chemoembolization (TACE) Versus TACE in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-07-02 date: 2025-10-25 date: 2026-05-23 date: 2024-04-17 date: 2024-04-17 name: Akeso class: INDUSTRY briefSummary: A study to evaluate cadonilimab (AK104) + lenvatinib in combination with transarterial chemoembolization (TACE) versus TACE in participants with incurable/non-metastatic hepatocellular carcinoma conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 469 type: ESTIMATED name: AK104 name: Lenvatinib name: TACE name: Placebo for AK104 name: Placebo for Lenvatinib measure: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) measure: Overall Survival (OS) measure: PFS per RECIST 1.1 measure: Objective Response Rate (ORR) per RECIST 1.1 and Modified Response Evaluation Criteria in Solid Tumors (mRECIST) measure: Duration of Response (DOR) per RECIST 1.1 and mRECIST measure: Disease Control Rate (DCR) per RECIST 1.1 and mRECIST measure: Time to Response (TTR) per RECIST 1.1 and mRECIST sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Henan Cancer Hospital city: Zhengzhou state: Henan zip: 450004 country: China name: Hailiang Li role: CONTACT lat: 34.75778 lon: 113.64861 facility: Hunan Cancer Hospital city: Changsha state: Hunan zip: 410006 country: China name: Shanzhi Gu role: CONTACT lat: 28.19874 lon: 112.97087 facility: Zhongda Hospital Southeast University city: Nanjing state: Jiangsu zip: 210009 country: China name: Gaojun Teng role: CONTACT lat: 32.06167 lon: 118.77778 facility: Shanxi Cancer Hospital city: Taiyuan state: Shanxi zip: 030009 country: China lat: 37.86944 lon: 112.56028 facility: Sichuan Cancer Hospital city: Chengdu state: Sichuan zip: 610041 country: China lat: 30.66667 lon: 104.06667 facility: Yunnan Cancer Hospital city: Kunming state: Yunnan zip: 650100 country: China lat: 25.03889 lon: 102.71833 facility: Zhejiang Cancer Hospital city: Hangzhou state: Zhejiang zip: 310005 country: China name: Guoliang Shao role: CONTACT lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06371144 id: NHREC/16/05/22/130 briefTitle: A Randomized Control Trial on Intravenous Paracetamol Versus Intramuscular Tramadol as Intra Partum Labor Analgesia overallStatus: COMPLETED date: 2022-06-03 date: 2022-09-10 date: 2022-09-10 date: 2024-04-17 date: 2024-04-17 name: Darlington-Peter Chibuzor Ugoji class: OTHER briefSummary: ABSTRACT BACKGROUND: Labor pain is one of the most excruciating pain experienced by women. It affects maternal psychology and the course of labor causing apprehension, anxiety, and stress. Therefore there is a need for a safe and effective analgesic with minimal maternal and fetal side effects like intravenous paracetamol which has been shown to have great analgesic effect in labour with minimal maternal and neonatal side effects.

OBJECTIVE: To compare intravenous paracetamol versus intramuscular tramadol as labour analgesia and to evaluate the incidence of side effects on mother and baby of both drugs.

METHOD: This would be a hospital based randomized controlled trial comparing intravenous paracetamol to intramuscular tramadol as labour analgesia in pregnant women in active phase of labour in the department of obstetrics and gynecology at Alex-Ekwueme Federal University Teaching Hospital and St. Patrick Mile 4 hospital, Abakaliki. A total of 194 pregnant women in active phase of labour will be included in study after fulfilling the inclusion criteria. These women will be divided into 2 groups of 97 each. Group A will receive a 100ml intravenous infusion containing 1000mg of paracetamol single dose over 15min. Group B: will receive intramuscular tramadol hydrochloride 100mg single dose. Pain intensity of women with both drugs will be noted before administration of drug, one hour, two hours and three hours after administration of drug using the visual analog scale. Perinatal outcome will also be recorded.

10 ANALYSIS AND RESULTS: Data will be collated, tabulated and then statistically analyzed using Statistical Package for Social Science (IBM SPSS) software (version 24, Chicago II, USA). Continuous variables will be presented as mean and standard deviation (Mean ± 2SD) or median and range as appropriate, while categorical variables will be presented as frequencies and percentages. Chi-square test( or Fisher's exact test where applicable) will be used for comparison between groups for categorical variables while student t test or Mann-Whitney U test will be used for comparison between groups for continuous variables KEYWORDS Labour analgesia, intravenous paracetamol, intramuscular tramadol, visual analog scale, neonate, side effects. conditions: Pain studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: To compare intravenous paracetamol versus intramuscular tramadol as labour analgesia and to evaluate the incidence of side effects on mother and baby of both drugs primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Double blinded whoMasked: PARTICIPANT count: 194 type: ACTUAL name: Paracetamol measure: Mean pain score sex: FEMALE minimumAge: 15 Years maximumAge: 45 Years stdAges: CHILD stdAges: ADULT facility: AEFUTHA city: Abakaliki state: Ebonyi zip: 234 country: Nigeria lat: 6.32485 lon: 8.11368 hasResults: False

 nctId: NCT06371131 id: PONV of Thyroid Surgery briefTitle: Effect of Stellate Ganglion Block on Postoperative Nausea and Vomiting overallStatus: RECRUITING date: 2023-04-17 date: 2024-05-30 date: 2024-08-30 date: 2024-04-17 date: 2024-04-26 name: The Second Affiliated Hospital of Chongqing Medical University class: OTHER briefSummary: Postoperative nausea and vomiting is one of the most common postoperative complications second only to postoperative pain. Studies have reported that without any antiemetic prevention treatment, the overall incidence of PONV in surgical operations is up to 20-30%, and the incidence of PONV in high-risk patients such as thyroid surgery is even up to 70-80%. PONV not only increased discomfort and prolonged hospital stay; Severe cases can lead to wound dehysis, acid-base imbalance, water and electrolyte metabolism disorders, seriously affect the prognosis of patients. Although various prevention and treatment measures have been adopted in clinical practice, it still cannot be completely eliminated. Therefore, postoperative nausea and vomiting of thyroid is still a concern in clinical anesthesia work, so it is urgent to explore more simple and effective measures to prevent thyroid PONV. SGB is the injection of local anesthetics into loose connective tissue containing stellate ganglion. It has a clear effect on postoperative analgesia of thyroid surgery, and can play a certain role in preventing thyroid PONV by reducing the application of perioperative opioids. Few studies have reported that the incidence of PONV can be significantly reduced after the application of SGB in patients with thyroid surgery, which provides a certain basis for the prevention of thyroid PONV. Therefore, this study aims to explore the effect of right stellate ganglion block on preventing postoperative nausea and vomiting of thyroid, and to explore the possible mechanism of action. conditions: Stellate Ganglion Block conditions: Thyroid Surgery conditions: Postoperative Nausea and Vomiting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Experimental group: right stellate ganglion block 30 minutes before anesthesia induction.Control group: No treatment was given 30minutes before anesthesia induction.Data was recorded at the corresponding time points. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Right -stellate ganglion block measure: Incidence of Postoperative nausea and vomiting measure: Incidence of Postoperative nausea and vomiting during preemptive analgesia measure: Intensity of nausea and vomiting during preemptive analgesia measure: Intensity of nausea and vomiting during hospitalization measure: Hemodynamic parameters after preemptive analgesia measure: Postoperative pain intensity measure: Recovery of gastrointestinal function measure: Sleep quality measure: Satisfaction score and postoperative analgesia satisfaction score sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Chongqing Medical University status: RECRUITING city: Chongqing state: Chongqing zip: 400000 country: China name: ling Dan, BD role: CONTACT phone: 86 13983072922 email: 302069@hospital.cqmu.edu.cn lat: 29.56278 lon: 106.55278 hasResults: False

 nctId: NCT06371118 id: PI 20210032 briefTitle: HPV Self-sampling for Women Who do Not Attend Cervical Cancer Screening Programme acronym: HERSELF overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2024-11 date: 2024-04-17 date: 2024-04-17 name: Universidade do Porto class: OTHER name: Unidade de Saúde Familiar de Garcia de Orta, Porto name: Unidade de Saúde Familiar da Prelada, Porto name: Unidade de Saúde Familiar de Cedofeita, Porto name: Instituto Portugues de Oncologia, Francisco Gentil, Porto briefSummary: This study aims to test the effectiveness and cost-effectiveness of two different strategies of home-delivered HPV self-sampling, in comparison to the standard of care strategy, to increase adherence to cervical cancer screening.

An experimental and population-based study will be implemented at three primary healthcare centers located in the Western Porto region: Cedofeita, Garcia de Orta, and Prelada. Eligible women will be randomized into a control group or an intervention group. The control group will correspond to the standard of care (invitation to screening in a clinical setting). The intervention group will be randomized into two subgroups: 1) a "directly mailed" group that will receive a self-sampling kit at their home addresses by post; 2) an "opt-in" group that will receive an invitation at home asking if they want to receive a self-sampling kit, with a pre-paid envelope to return the answer to this question. Women who answer "yes" will receive the self-sampling kit at their home addresses by post.

Self-sampling samples will be subjected to HPV genotyping. In parallel, high-risk HPV positive women will be called in by their family doctors to undergo screening in a clinical setting so that they can continue their clinical follow-up in the conventional pathway. conditions: Papillomavirus Infections conditions: Early Detection of Cancer conditions: Cervix Cancer conditions: Self-Examination studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 1000 type: ESTIMATED name: Directly mailed self-sampling kit to collect a vaginal sample name: Mailed self-sampling kit to collect a vaginal sample after opt-in prodecure name: Standard of care - screening in a clinical setting measure: Adherence to conventional screening in control group measure: Adherence to HPV self-sampling in intervention 1 (directly mailed) group measure: Adherence to HPV self-sampling in intervention 2 (opt-in) group measure: Adherence proportion to HPV self-sampling in intervention 1 (directly mailed) group VS Adherence proportion to conventional screening in control group measure: Adherence proportion to HPV self-sampling in intervention 2 (opt-in) group VS Adherence proportion to conventional screening in control group measure: Adherence to first follow-up step in control group measure: Adherence to first follow-up step in intervention 1 (directly mailed) group measure: Adherence to first follow-up step in intervention 2 (opt-in) group measure: Adherence to first follow-up step in control group among women referred for follow-up measure: Adherence to first follow-up step in intervention 1 (directly mailed) group among women referred for folow-up measure: Adherence to first follow-up step in intervention 2 (opt-in) group among women referred for folow-up measure: Adherence to colposcopy in control group measure: Adherence to colposcopy in intervention 1 (directly mailed) group measure: Adherence to colposcopy in intervention 2 (opt-in) group measure: Adherence to colposcopy in control group among women referred for colposcopy measure: Adherence to colposcopy in intervention 1 (directly mailed) group among women referred for colposcopy measure: Adherence to colposcopy in intervention 2 (opn-in) group among women referred for colposcopy measure: Timelapse (in days) between the shipment of self-sampling kit and the return of the sample, in intervention 1 (directly mailed) group measure: Timelapse (in days) between the invitation to receive a self-sampling kit and the return of the opt-in answer, in intervention 2 (opt-in) group measure: Timelapse (in days) between the shipment of self-sampling kit and the return of the sample, in intervention 2 (opt-in) group measure: Adherence proportion to first follow-up step in intervention 1 (directly mailed) group VS Adherence proportion to first follow-up step in control group measure: Adherence proportion to first follow-up step in intervention 2 (opt-in) group VS Adherence proportion to first follow-up step in control group measure: Adherence proportion to first follow-up step in intervention 1 (directly mailed) group among women referred for follow-up VS Adherence proportion to first follow-up step in control group among women referred for follow-up measure: Adherence proportion to first follow-up step in intervention 2 (opt-in) group among women referred for follow-up VS Adherence proportion to first follow-up step in control group among women referred for follow-up measure: Adherence proportion to colposcopy in intervention 1 (directly mailed) group VS Adherence proportion to colposcopy in control group measure: Adherence proportion to colposcopy in intervention 2 (opt-in) group VS Adherence proportion to colposcopy in control group measure: Adherence proportion to colposcopy in intervention 1 (directly mailed) group among women referred for colposcopy VS Adherence proportion to colposcopy in control group among women referred for colposcopy measure: Adherence proportion to colposcopy in intervention 2 (opt-in) group among women referred for colposcopy VS Adherence proportion to colposcopy in control group among women referred for colposcopy measure: Proportion of HR-HPV positivity in control group measure: Proportion of HR-HPV positivity in intervention 1 (directly mailed) group measure: Proportion of HR-HPV positivity in intervention 2 (opt-in) group measure: Proportion of HR-HPV positivity in control group among women who adhered to conventional screening measure: Proportion of HR-HPV positivity in intervention 1 (directly mailed) group among women who returned the self-sample measure: Proportion of HR-HPV positivity in intervention 2 (opt-in) group among women who returned the self-sample measure: Proportion of HR-HPV 16/18 positivity in control group measure: Proportion of HR-HPV 16/18 positivity in intervention 1 (directly mailed) group measure: Proportion of HR-HPV 16/18 positivity in intervention 2 (opt-in) group measure: Proportion of HR-HPV 16/18 positivity in control group among women who adhered to conventional screening measure: Proportion of HR-HPV 16/18 positivity in intervention 1 (directly mailed) group among women who returned the self-sample measure: Proportion of HR-HPV 16/18 positivity in intervention 2 (opt-in) group among women who returned the self-sample measure: Positive predictive value of self-sampling for the detection of HR-HPV, using clinician-sampling results as gold standard measure: Sensitivity of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Specificity of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Positive likelihood ratio of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Negative likelihood ratio of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Accuracy of HR-HPV testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Sensitivity of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Specificity of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Positive likelihood ratio of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Negative likelihood ratio of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Accuracy of HR-HPV non 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Sensitivity of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Specificity of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Positive likelihood ratio of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Negative likelihood ratio of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard measure: Accuracy of HR-HPV 16/18 testing and methylation analysis in self-samples, using biopsy results as gold standard sex: FEMALE minimumAge: 26 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06371105 id: 014_2018 briefTitle: Aquatic_Training in Obese Women overallStatus: COMPLETED date: 2019-01-02 date: 2019-03-30 date: 2019-03-30 date: 2024-04-17 date: 2024-04-17 name: University of Taipei class: OTHER briefSummary: This study aims to assess the effects of 10-week water-based aerobic training (thrice a week) on anthropometrics, biochemicals, cardiovascular parameters, and explosive strength in young overweight and obese women. The findings indicate that water-based aerobic training could be a useful program to enhance body composition, biochemical, cardiovascular, and explosive strength parameters in young overweight and obese women compared to inactive persons conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 31 type: ACTUAL name: 10-week water-based aerobic training measure: fasting glycemia in millimoles per liter measure: total cholesterol in millimoles per liter measure: high-density lipoprotein cholesterol in millimoles per liter measure: low-density lipoprotein cholesterol in millimoles per liter measure: triglyceride concentrations in millimoles per liter measure: systolic blood pressure in millimeters of mercury measure: diastolic blood pressure in millimeters of mercury measure: heart rate in beat per minute measure: fasting glycemia in millimoles per liter measure: total cholesterol in millimoles per liter measure: high-density lipoprotein cholesterol in millimoles per liter measure: low-density lipoprotein cholesterol in millimoles per liter measure: triglyceride concentrations in millimoles per liter measure: systolic blood pressure in millimeters of mercury measure: diastolic blood pressure in millimeters of mercury measure: heart rate in beat per minute measure: countermovement jump in centimetres measure: squat jump in centimeters measure: chest 3-kg medicine ball throw in meters measure: countermovement jump in centimetres measure: squat jump in centimeters measure: chest 3-kg medicine ball throw in meters sex: FEMALE minimumAge: 29 Years maximumAge: 35 Years stdAges: ADULT facility: Department of Exercise and Health Sciences, University of Taipei city: Taipei zip: 11153 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06371092 id: 2023/01 briefTitle: Efficacy of a Desensitizing Agent During At-home Bleaching overallStatus: COMPLETED date: 2023-01-31 date: 2023-02-22 date: 2023-03-01 date: 2024-04-17 date: 2024-04-17 name: University of Santiago de Compostela class: OTHER briefSummary: The main objective of this study is to evaluate if the use of UltraEZ during at-home bleaching treatment is effective in reducing tooth sensitivity, as well as doesn't affect the degree of tooth bleaching. conditions: Sensitivity, Tooth studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, triple-blind clinical trial primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 32 type: ACTUAL name: UltraEZ name: Placebo measure: Questionnaire of dental sensitivity measure: Shade evaluation with a dental spectrophotometer sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: School of Medicine and Dentistry city: Santiago De Compostela state: A Coruña zip: 15705 country: Spain lat: 42.88052 lon: -8.54569 hasResults: False

 nctId: NCT06371079 id: NO-OVD-ICL briefTitle: Safety and Suitability of ICL for Correction of Refractive Errors Without the Use of Dispersive OVDs overallStatus: RECRUITING date: 2024-03-01 date: 2024-05-30 date: 2024-06 date: 2024-04-17 date: 2024-04-17 name: Loay Abdulmutalib Almusawi class: OTHER briefSummary: The goal of this observational study is to test whether surgeries for lenses designed to be implanted in the eye to correct refractive error can be done without the need for using viscoelastic substances that are used routinely nowadays to make it easier to introduce them inside the human eye and protect the inside of the eye during the operation.

The main question it aims to answer is that is it safe to do the surgery without using them? to answer this question researchers will access recorded data of patients that underwent refractive surgeries in a private clinic since 2017 and compare them as two groups: those who underwent the traditional procedures and those who had it without the use of dispersive viscoelastics in regard to their vision before and after surgery, their ocular pressure and biomicroscopic analysis of the inside of their corneas before and after surgery. conditions: Refractive Errors conditions: Myopia conditions: Myopic Astigmatism conditions: Hypermetropia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 400 type: ESTIMATED name: phakic intraocular lens implantation traditional name: phakic intraocular lens implantation reduced OVD measure: unaided visual acuity after the procedure measure: best corrected visual acuity after the procedure measure: Intraocular pressure postoperatively measure: Specular microscopy parameter: endothelial cell density measure: Specular microscopy parameter: endothelial cells hexagonality measure: Specular microscopy parameter: coefficient of variation of corneal endothelial cells measure: postoperative complications sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Al-Ferdows private eye hospital status: RECRUITING city: Baghdad country: Iraq name: Sohaib A Mahmood, CABMS role: CONTACT phone: 00971585358111 email: sohaib.mahmood@meciq.edu.iq name: Sami A Hasoon role: CONTACT phone: +9647901867279 email: Ferdouseyeshospital@yahoo.com name: Sohaib A Mahmood, CABMS role: PRINCIPAL_INVESTIGATOR name: Loay A Almusawi, FIBMS role: SUB_INVESTIGATOR name: Hamid M Altaha, CABMS role: SUB_INVESTIGATOR name: Bashar Alwash, CABMS role: SUB_INVESTIGATOR lat: 33.34058 lon: 44.40088 hasResults: False

 nctId: NCT06371066 id: EAkyuz-2 briefTitle: The Effect of Video-based Training on the Knowledge Levels of Nursing Students overallStatus: COMPLETED date: 2021-02-01 date: 2021-04-01 date: 2021-06-10 date: 2024-04-17 date: 2024-04-17 name: Kırıkkale University class: OTHER briefSummary: Although face-to-face education is widely used as a traditional method, emerging computer technology has allowed new training approaches such as video-based training (VBT) platforms to flourish, especially in the last four decades. Educators adopted VBT as a cost-effective and accessible medium to address some of their training needs. It contains purposely designed visual cues and draws learners' attention during the learning process, and the dynamic details enable learners to better understand the learning contents. The use of new technologies such as e-learning, computer-assisted learning, VBT, and web-based applications for clinical skill education has increased learner satisfaction compared with conventional education methods. Preoperative patient preparation is a crucial element of preoperative nursing care. A surgical nurse is a specialized coordinator of patient care, and the main purposes of this role are to meet the patient's and the family's needs individually and to prepare them for the scheduled procedure and postoperative recovery. Preoperative patient preparation contains multiple components and steps such as preoperative education, including physical, social, psychological, and legal preparation, and preparation for the night and day of surgery. the nature of the process has many components and steps, it is not easy for students to learn this subject, and nursing educators were able to experience this in a clinical practice environment. And the educators started to search for new teaching techniques to teach this subject like the other colleagues. the investigator's aim in this project is to determine the effect of VBT on the knowledge levels of nursing students on preoperative patient preparation when compared to traditional training methods. conditions: Student Nursing conditions: Medical-surgical Nursing conditions: Nursing Care conditions: Education studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: intervention, control primaryPurpose: OTHER masking: SINGLE maskingDescription: it was an educational intervention. All participants were in the same class so we blinded only statisticians. whoMasked: OUTCOMES_ASSESSOR count: 97 type: ACTUAL name: experimental group name: Control group measure: The Student Information Form measure: The Knowledge Form for Preoperative Patient Preparation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kirikkale University city: Kirikkale country: Turkey lat: 39.84528 lon: 33.50639 hasResults: False

 nctId: NCT06371053 id: community - dementia briefTitle: The Effect of Community Intervention on Different Degrees of Dementia overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-05 date: 2024-05 date: 2024-04-17 date: 2024-04-17 name: Babujinaya Cela class: OTHER_GOV briefSummary: The goal of this clinical trial is to explore the impact of Community Intervention on Dementia and Activities of Daily Living in community-dwelling elderly individuals (≥60 year old) with Alzheimer's disease. It primarily aims to address: the effects of Community Intervention on Dementia and Activities of Daily Living in community-dwelling elderly individuals with Alzheimer's disease in different degrees. All participants are required to undergo a continuous 2-week (14 days) Community Intervention, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each. conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Community Intervention measure: Mini-Mental State Examination measure: Barthel Index measure: Functional near-infrared spectroscopy sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06371040 id: V1.0, CART-20230619 briefTitle: Safety and Efficacy of CD19-BCMA Targeted CAR-T Therapy for Refractory Generalized Myasthenia Gravis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-03-01 date: 2026-12-01 date: 2024-04-17 date: 2024-04-17 name: Ting Chang, MD class: OTHER briefSummary: This study is a single-center, open-label, single-arm, dose-exploration study to evaluate the safety and preliminary effectiveness of CD19-BCMA CAR-T in the treatment of refractory, generalized myasthenia gravis. The study is a dose escalation trial in adult, refractory, systemic MG patients. The Keyboard method will be used to perform dose escalation to explore the maximum tolerated dose (MTD). A total of 12 MG patients who meet the inclusion criteria are expected to be recruited. conditions: Myasthenia Gravis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: CD19-BCMA Targeted CAR-T Dose 1 5.0 e5/ kg CD19-BCMA CAR-T positive T cells

CD19-BCMA Targeted CAR-T Dose 2 1.5 e6/ kg CD19-BCMA CAR-T positive T cells

CD19-BCMA Targeted CAR-T Dose 2 5 e6/ kg CD19-BCMA CAR-T positive T cells primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: CD19-BCMA Targeted CAR-T Dose 1 name: CD19-BCMA Targeted CAR-T Dose 2 name: CD19-BCMA Targeted CAR-T Dose 2 measure: Frequency, type, and severity of adverse events measure: Frequency, type, and severity of abnormal laboratory indicators related to treatment measure: Changes of blood pressure measure: Changes of pulse rate measure: Changes of weight measure: Changes of Myasthenia Gravis Activities of Daily Living (MG-ADL) scores measure: Changes of Quantitative Myasthenia Gravis (QMG) scores measure: Changes of Myasthenia Gravis Composite (MGC) scores measure: Proportion of subjects who achieved improvement measure: Time to achieve clinical improvement measure: Changes of myasthenia gravis-specific autoantibody titers measure: Changes of immunoglobulins measure: Changes in proportion of peripheral blood immune cell measure: serum inflammatory markers levels sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tangdu Hospital, The Fourth Military Medical University city: Xi'an state: Shaanxi zip: 710038 country: China lat: 34.25833 lon: 108.92861 hasResults: False

 nctId: NCT06371027 id: RECO6U/22-2022 briefTitle: Novel Silk Fibroin Nanofiber Membrane Using Minimally Invasive Surgery in Treatment of Periodontal Intrabony Defects: A Randomized Clinical Trial overallStatus: COMPLETED date: 2022-11-01 date: 2024-02-15 date: 2024-04-01 date: 2024-04-17 date: 2024-04-17 name: October 6 University class: OTHER briefSummary: Clinically and radiographically by cone beam CT evaluate the regenerative potentials of silk fibroin (SF) nanofiber membrane, using minimally invasive surgery, for the regenerative treatment of intrabony periodontal defects. conditions: Intrabony Periodontal Defect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ACTUAL name: Minimally Invasive Surgery Technique (MIST) + Novel Silk Fibroin (SF) nanofiber membrane name: Minimally Invasive Surgery Technique (MIST) + collagen membrane name: Minimally Invasive Surgery Technique (MIST) measure: Novel Silk Fibroin Nanofiber Membrane using minimally invasive surgery in Treatment of Periodontal Intrabony Defects sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: faculty of dentistry O6U city: Giza country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06371014 id: Ondansetron mouth soluble film briefTitle: Comparative Study on the Efficacy and Safety of Ondansetron Oral Membrane for the Prevention of Vomiting During Moderate Hypoemetic Chemotherapy acronym: Ondansetron overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-30 date: 2024-12-31 date: 2024-04-17 date: 2024-04-17 name: Shanghai Children's Medical Center class: OTHER briefSummary: Children aged 4-15 years scheduled to receive Moderate or low emetic chemotherapy were randomly assigned to arm-A (Ondansetron mouth soluble film) or arm-B (Ondansetron tablet). Children recruited to arm-A received ondansetron mouth soluble film plus dexamethasone. Children recruited to arm-B received Ondansetron tablet plus dexamethasone. Ondansetron and dexamethasone were given continuously until 48hours after completion of chemotherapy. The primary end point of the study was to determine the proportion of patients who achieved a CR, defined as no vomiting, no retching, and no use of rescue medication, the proportion of patients who achieved a CR during the acute phase (0-24 hours) after administration of the last dose of chemotherapy. Secondary end points were the proportion of patients who achieved a CR during the 24-120 hours (delayed phase) and overall after administration of the last dose of chemotherapy conditions: To Analyze and Compare the Efficacy and Safety of Ondansetron and Tablet for the Prevention of Moderate and Hypoemetic Chemotherapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Ondansetron oral membrane measure: Complete Remission Rates in the Acute Phases measure: Complete Remission Rates in the Delayed Phases sex: ALL minimumAge: 4 Years maximumAge: 15 Years stdAges: CHILD hasResults: False

 nctId: NCT06371001 id: Helicobacter Pyloi and CKD briefTitle: Prevalance Of Helicobacter Pylori Infection In Chonic Kidney Diseased Patient Admitted To Luxor Medical Complex overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-07-01 date: 2024-04-17 date: 2024-04-17 name: Assiut University class: OTHER briefSummary: Detect prevalence of Helicobacter pylori infection in chronic kidney diseased patient admitted to Luxor medical complex and possible role of Helicobacter pylori in pathogenesis of chronic kidney diseased patient of unknown etiology conditions: Chronic Kidney Diseases studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 122 type: ESTIMATED name: disease measure: Helicobacter pylori infection and Chronic kidney diseased patient measure: possible role of H pylori in pathogenesis of chronic kidney diseased patient of unkown etiology sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06370988 id: 4343 briefTitle: Theta-Burst Stimulation for Bipolar Depression acronym: TRIBE overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2029-05 date: 2029-05 date: 2024-04-17 date: 2024-04-22 name: Centre for Addiction and Mental Health class: OTHER name: University Health Network, Toronto briefSummary: The purpose of this trial is to determine if intermittent theta-burst stimulation (iTBS) can reduce the symptoms of depression in treatment-resistant bipolar disorder. To do this, some of the participants in this study will receive treatment with active iTBS stimulation, while others will receive sham iTBS stimulation. Participants will come for 30 days of either active iTBS or sham iTBS, with a 6-week follow-up period. Symptoms of depression (for determining treatment efficacy) and mania (for determining treatment safety) will be assessed using the 17-item Hamilton Rating Scale for Depression (HRSD-17) and the Young Mania Rating Scale (YMRS) every five treatments during the treatment course, and at 1 week and 6 week after treatment completion. conditions: Bipolar Depression conditions: Bipolar Disorder conditions: Treatment- Resistant Bipolar Disorder conditions: Type 2 Bipolar Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This trial will use a multi-centre randomized controlled trial for individuals with treatment-resistant Bipolar Depression comparing iTBS applied to the left DLPFC with sham treatment and examining differences in efficacy and safety outcomes between groups over 6 weeks of treatment. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: rTMS treatment will be delivered using the MagPro X100/R30 stimulator and use the Cool-B70 A/P coil (MagVenture, Farum, Denmark), a figure 8 coil with active cooling, in which both the sham and active coils are contained internally. Its symmetric design ensures there is no indication of which side is active or sham with only the side of the coil delivering the treatment differing. The sham coil has been designed in such a way that it produces a similar auditory experience as the active coil. To account for the tactile sensation of active stimulation, both treatment allocations will have scalp electrodes placed that deliver a weak electrical stimulation to mask this tactile sensation. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 124 type: ESTIMATED name: iTBS Stimulation name: Sham iTBS Stimulation measure: Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17) measure: Symptoms of Mania sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Health Network city: Toronto state: Ontario zip: M5T 2S8 country: Canada name: Eileen Lam role: CONTACT phone: 437-553-0367 email: Eileen.lam@uhn.ca name: Daphne Voineskos, M.D., Ph.D role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 facility: Centre for Addiction and Mental Health city: Toronto state: Ontario zip: M6J 1H4 country: Canada name: Elizabeth Clancy role: CONTACT phone: 416-535-8501 phoneExt: 36434 email: Elizabeth.Clancy@camh.ca name: Tyler Kaster, M.D., Ph.D role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06370975 id: Fluid resuscitation in trauma briefTitle: Effect of Fluid Resuscitation on Lactate in Traumatic Injury Patients overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2025-08 date: 2025-09 date: 2024-04-17 date: 2024-04-17 name: Assiut University class: OTHER briefSummary: The study aims to investigate the effect of 3% hypertonic saline resuscitation on lactate clearance in comparison to ringer's lactated solution and 0.9% normal saline in traumatic injury patients.

Also to provide insights into the optimal fluid resuscitation strategy for traumatic injury patients conditions: Fluid Resuscitation studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: 3% hypertonic Saline name: Ringer's lactated solution name: 0.9% Normal saline measure: Rate of lactate clearance following resuscitation with different solutions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06370962 id: 69HCL24_0076 id: 2024-A00343-44 type: OTHER domain: ID-RCB briefTitle: Circadian Rhythm Disorders in Children With Cystic Fibrosis Under CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) Modulators acronym: CHRONO-MUCO overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-11 date: 2026-01 date: 2024-04-17 date: 2024-04-17 name: Hospices Civils de Lyon class: OTHER briefSummary: Cystic fibrosis (CF) is a rare disease affecting one out of 4,500 newborns in France (INSERM 2021). Despite major advances in patient care over the past two decades, with significant improvements in life expectancy, cystic fibrosis remains a pathology that considerably impairs quality of life.

Several studies have reported the possibility of respiratory and non-respiratory sleep disorders (SD) in patients with CF. Respiratory disorders are reported to affect 30% of children with CF (Barbosa 2020). Among non-respiratory SD, sleep onset and maintenance insomnia are well known in these patients, while chronotype abnormalities (circadian rhythm disorders) are understudied. Chronotype refers to a person's tendency to be more efficient in the morning or evening.

The existence of chronotype abnormalities has been suggested in CF patients, but no precise data are available (Louis 2022). The involvement of CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) protein dysfunction in the central nervous system (CNS) has been hypothesized as a contributory factor. In vivo, in a mouse model of CF, dysregulation of clock genes such as Clock, Cry2 and Per2 was found in the CNS (Barbato 2019). Among them, certain genes such as Rev-erbα could regulate endobronchial inflammation and contribute to the severity of respiratory pathology. All in all, chronotype abnormalities could be at the origin of sleep debt, impaired cognitive functions or metabolic disturbances.

In the era of highly effective modulator therapy (HEMT) for the treatment of CF, the impact of these new therapies on chronotype has been understudied. Assuming that chronotype abnormalities are a direct consequence of CFTR protein dysfunction in the retina and anterior hypothalamus, HEMT should improve sleep quality. However, between 20% and 30% of adult and pediatric patients express an increase in chronotype abnormalities following initiation of treatment.

Paradoxically, the perceived gain in respiratory quality of life is counterbalanced by the occurrence of these disorders. Some patients would effectively reverse their treatment in order to limit the phenomenon. A single polysomnographic study evaluated the effect of HEMT Kaftrio-Kalydeco on sleep in adults with CF (Welsner 2022). After 3 months of treatment, patients had a significant reduction in respiratory events, with no change in total sleep time, sleep efficiency or sleep architecture. Chronotype was not mentioned. Currently, no studies on chronotype in children or adults with CF have been carried out. Our hypothesis is that CF patients treated with HEMT would develop an abnormal chronotype of late sleep onset.

The aim of this study is to evaluate the chronotype of children with CF treated with HEMT. Chronotype abnormalities could have major consequences for quality of life, the immune system, cognitive functions and metabolism. Systematic detection of these disorders via anamnesis, followed by diagnosis by questionnaire, actimetrics and/or urinary melatonin dosage, would enable their early management, starting with the reversal of Kaftrio-Kalydeco intake between morning and evening. conditions: Cystic Fibrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 180 type: ESTIMATED measure: Result of the Horne and Ostberg questionnaire. sex: ALL minimumAge: 2 Years maximumAge: 17 Years stdAges: CHILD facility: Service de pédiatrie, CHRU de Nancy - Hôpitaux de Brabois city: Nancy zip: 54500 country: France name: Iulia IOAN, MD role: CONTACT phone: 03.83.15.47.94 phoneExt: +33 email: ic.ioan@chru-nancy.fr name: Iulia IOAN, MD role: PRINCIPAL_INVESTIGATOR lat: 48.68439 lon: 6.18496 facility: Service de pneumologie pédiatrique, Hôpital Armand Trousseau city: Paris zip: 75012 country: France name: Jessica TAYTARD, MD role: CONTACT phone: 01 44 73 63 46 phoneExt: +33 email: jessica.taytard@aphp.fr name: Jessica TAYTARD, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06370949 id: 2024-01/17 briefTitle: The Effectiveness of Bupivacaine and Bupivacaine+Dexmedetomidine Combination in Transversus Abdominis Plane* Block acronym: TAP overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-09-30 date: 2024-11-30 date: 2024-04-17 date: 2024-04-17 name: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital class: OTHER briefSummary: Transversus abdominis plane (TAP) block is an anesthesia method that provides somatic analgesia to the anterior and lateral abdominal walls. Thus, TAP block is widely implemented in perioperative management of colorectal cancer patients.

Researchers aimed to evaluate the analgesic effectiveness and duration of effect of dexmedetomidine added to bupivacaine in the TAP block applied in colorectal cancer surgeries. conditions: Colorectal Cancer conditions: Colorectal Neoplasms studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 84 type: ESTIMATED name: Bupivacain name: bupivacain+dexmedetomidine measure: Analgesic effectiveness of bupivacain and bupivacain+dexmedetomidine combination in colorectal cancer surgery sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Turkey Dr.Abdurrahman Yurtaslan Ankara Oncology Train and Research Hospital city: Ankara state: Cankaya zip: 06110 country: Turkey name: Hazal E Guran Aytug, MD role: CONTACT phone: 05078448449 email: drekinguran@gmail.com lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06370936 id: NL84824.091.23 id: NL84824.091.23 type: OTHER domain: CCMO / Toetsingonline briefTitle: The EXPLAIN Study: Exploring Plant-Based Meat Analogues for Their Impact on Health acronym: EXPLAIN overallStatus: RECRUITING date: 2024-04 date: 2025-03 date: 2025-03 date: 2024-04-17 date: 2024-04-17 name: Wageningen University class: OTHER briefSummary: Plant-based diets with little to no meat are considered healthy and sustainable by the general public. The increasingly popular plant-based meat analogues (PBMAs) allow consumers to easily decrease meat intake while maintaining their dietary patterns. However, scientific knowledge on the health impact of PBMAs on humans is currently very limited.

The primary objective of this clinical trial is to evaluate if and to what extent replacing all meat products in an average Dutch diet with currently commercially available PBMAs affects the systolic blood pressure of middle-aged men and women in a 2x8 week fully dietary controlled crossover intervention study. The secondary objectives are to assess the effect of this replacement of meat products with PBMAs on cardiometabolic health, gut microbiome, intestinal health, well-being, and underlying biological mechanisms.

114 men and women with a BMI of 23-40 kg/m2, aged 45-75 years will be included in the study. Participants will follow both an 8-week completely controlled diet in which all meats are of plant-based origin (PBMAs) and an 8-week diet in which all meats are of animal origin in randomized order with a 10-week wash-out period. Before the intervention starts, the participants will be characterized to describe them on anthropometrics, glucose tolerance and insulin sensitivity, genetics, sleep patterns, and stress levels. Before the start and at the end of each 8-week dietary intervention period, several measurements, including systolic blood pressure monitoring and secondary outcome measures will be done. Additionally, systolic and diastolic blood pressure will be monitored throughout the dietary interventions and a small quantity of parameters related to the secondary objectives will be measured. conditions: Blood Pressure conditions: Cardiometabolic Health studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants will follow both an 8-week completely controlled dietary intervention followed by a 10-week washout period followed by another 8-week completely controlled dietary intervention. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Treatment order (PBMA intervention - Meat intervention versus Meat intervention - PBMA intervention) is masked for the researchers. The order is not masked for participants. whoMasked: INVESTIGATOR count: 114 type: ESTIMATED name: Standardized diet with commercially available animal meats (comparator products) name: Standardized diet with commercially available PBMAs (intervention products) measure: Systolic blood pressure measure: Diastolic blood pressure measure: Home systolic blood pressure measure: Home diastolic blood pressure measure: Home heart rate measure: Fasting blood HbA1c levels measure: Fasting blood glucose levels measure: Fasting blood insulin levels measure: Fasting blood lipid spectrum measure: Fasting blood metabolite profile measure: Fasting blood proteomic profile measure: Fasting blood cell transcriptomic profile measure: Fasting blood nutritional status measure: Blood immune markers measure: Blood immune cell populations measure: Metabolites in 24-hour urine measure: Interstitial glucose profile measure: Physical activity measure: Fecal microbiome composition measure: Fasting and postprandial circulating metabolites with a high fat mixed meal (HFMM) challenge measure: Oral microbiome composition measure: Microbiome metabolites measure: Microbiome functionality measure: Self-reported gastro-intestinal symptoms measure: Self-reported constipation measure: Self-reported stool consistency and frequency measure: Gastro-intestinal transit time measure: Self reported product-specific attitude towards meat and PBMAs measure: Self reported meal-specific satiety with meat and PBMAs measure: Self-reported general attitude toward meat and PBMAs measure: Body composition measure: Genetic variation measure: Oral glucose tolerance test (OGTT) measure: Habitual dietary intake measure: Perceived stress measure: Chronotype assessment measure: Sleeping habits measure: Self reported habitual meat and PBMA consumption measure: 24-hour dietary recall measure: Home environment microbiome composition sex: ALL minimumAge: 45 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wageningen University, Division of Human Nutrition status: RECRUITING city: Wageningen state: Gelderland zip: 6708 WE country: Netherlands lat: 51.97 lon: 5.66667 hasResults: False

 nctId: NCT06370923 id: 1R01MH133488-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01MH133488-01 briefTitle: Harnessing Male Peer Networks to Enhance Engagement With HIV Prevention acronym: IMPERATIVE overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-07 date: 2028-12 date: 2024-04-17 date: 2024-04-17 name: University of Stellenbosch class: OTHER name: Biomedical Research and Training Institute, Zimbabwe name: Imperial College London name: University of Lincoln name: University College London Hospitals name: University of Copenhagen name: University of Washington name: Heidelberg University briefSummary: Novel strategies are needed to engage men in Sub Saharan Africa (SSA) with HIV testing, treatment and prevention services to drive the epidemic towards elimination. Suboptimal engagement with HIV prevention by men increases their risk of HIV acquisition, and is an important driver of new HIV infections in women. HIV self-testing (HIVST) addresses several key facility-based access barriers and HIVST distribution through leveraging male peer networks for HIV prevention is feasible, acceptable and effective in SSA.

The objective of this project is to use an implementation science approach to establish the impact of HIVST distribution through male social networks, with phone-based support and improved risk perception, on PrEP (Pre-Exposure Prophylaxis) uptake among men in Eastern Zimbabwe. The project will leverage infrastructure and data associated with 20-year programme of HIV surveillance and behavioural research in a well-characterized population cohort hosted by the Manicaland Centre for Public Health Research, Zimbabwe.

The study will utilise a cluster randomised design of 44 clusters (22 Intervention:22 control) comprising on average 81 men in each cluster (total N = 3591) followed for 6 months (giving \>80% power to detect a difference in PrEP initiation among men of 2% versus 8.5%). In intervention clusters the investigators will identify initial distributors who will receive an HIVST kit for personal use and HIVST kits to distribute to local peers. These peers can subsequently become distributors, allowing the intervention to propagate through peer networks. A toll-free helpline will provide pre- and post-test support and an SMS (Short Message Service) -based risk assessment will expedite PrEP initiation at the clinic. The study team will conduct a performance (process) evaluation of the intervention. to assess implementation fidelity, causal mechanisms underlying trial effectiveness including how characteristics of peer networks affect outcomes. Results of the study will be used to quantify the population level impacts and cost-effectiveness of male peer to peer HIVST distribution strategies on the uptake of PrEP in HIV hyper-endemic settings using a fully calibrated individual-based mathematical model. The envisaged long-term impact of this research is the development of a generalizable, multicomponent male peer-based HIVST and PrEP uptake model for settings where HIV incidence is high. conditions: HIV Infections studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Cluster randomised trial primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Analysts blinded to allocation whoMasked: OUTCOMES_ASSESSOR count: 3591 type: ESTIMATED name: Peer Distribution name: Community Health Worker Distribution measure: PrEP initiation measure: PrEP adherence measure: ART adherence measure: Confirmatory tests sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-11-07 uploadDate: 2024-04-11T04:41 filename: Prot_000.pdf size: 766804 hasResults: False

 nctId: NCT06370910 id: CAAE 58569421.5.0000.5327 briefTitle: Comparison Low-Level Laser Therapy With Cryotherapy in Parturients With Laceration and/or Episiotomy on Pain Reduction acronym: CL overallStatus: COMPLETED date: 2023-08-01 date: 2024-01-05 date: 2024-01-10 date: 2024-04-17 date: 2024-04-17 name: Federal University of Rio Grande do Sul class: OTHER briefSummary: The changes that occur during pregnancy can lead to symptoms and complaints for women. Vaginal delivery has several benefits for both the mother and baby; however, during labor, some injuries may occur, such as lacerations and episiotomies. It is known that the postpartum period is when the body is involuting to its pre-pregnancy state. The perineal pain caused by these injuries during childbirth is a determining factor for recovery, and it may affect not only the physical but also the psychological well-being of women. Therefore, it is necessary to employ techniques that can alleviate pain and edema in the immediate postpartum period, directly influencing recovery.

Objective: To compare the use of photobiomodulation with cryotherapy in the immediate postpartum period of 2 hours in parturients who suffered 1st and 2nd-degree lacerations and/or episiotomies.

Methods: A randomized clinical trial will be conducted to compare two interventions. Data collection will be through a questionnaire and scales for the evaluation of pain and edema, with women who experienced vaginal delivery and those who suffered 1st and 2nd-degree lacerations or episiotomies.

Expected results: Reduction of pain, edema, and inflammatory processes with non-pharmacological techniques, leading to greater comfort and better postpartum recovery. conditions: Episiotomy; Complications conditions: Laceration studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: randomized clinical trial primaryPurpose: TREATMENT masking: NONE count: 56 type: ACTUAL name: Low-Level Laser Therapy measure: To compare two techniques: Low-level laser and cryotherapy measure: Pain reduction assessed by the Visual Analog Scale (VAS). measure: Pain reduction assessed by McGill Pain Scale measure: Evaluate reduction of swelling using the REEDA scale. sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Hospital de Clínicas de Porto Alegre city: Porto Alegre zip: RS country: Brazil lat: -30.03306 lon: -51.23 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-04-04 uploadDate: 2024-04-12T18:23 filename: Prot_SAP_000.pdf size: 47665 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-04-04 uploadDate: 2024-04-12T18:21 filename: ICF_001.pdf size: 66023 hasResults: False

 nctId: NCT06370897 id: 337421 briefTitle: Prediction & Mechanisms of Recovery Following IEDS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-04 date: 2028-09 date: 2024-04-17 date: 2024-04-17 name: University of Plymouth class: OTHER briefSummary: Inner Ear Decompression sickness (IEDS) accounts for 20% of all types of decompression sickness (the bends) in divers. The condition commonly affects the peripheral vestibular system (inner ear). IEDS results in acute symptoms of dizzyness (vertigo) and imbalance. Even with the recommended treatment of hyperbaric oxygen therapy some people do not recovery fully. However, even in the presence of a permanent vestibular deficit many people can show a behavioural recovery where symptoms improve over time. Recovery can be aided by vestibular rehabilitation (VR) which is now routine for acute IEDS but was not provided before 2021, and is not widespread across the UK (United Kingdom) or world, meaning people may have a suboptimal recovery.

This project will investigate if and how people recover after an acute episode of IEDS and whether people who had IEDS in the past show changes in the central (brain) processing of vestibular function and in symptoms of dizziness, balance and posture.

This project has two main parts. Part one is a prospective observational study where people with an acute onset of IEDS are serially monitored while they are receiving hyperbaric treatment and VR over 10-14 days. Part two is a retrospective observational study where who have had IEDS in the past 15 years are re-assessed in a one-off session. The tests in both parts involve clinical tests and specialist eye movement recordings that assess vestibular function. We will also determine the site of any vestibular pathology by using selective stimulation of the vestibular end organ or nerve and assess whether there are any changes in how the structure and function of central vestibular pathways in the brain. In people with chronic IEDS with vestibular symptoms we will offer participants a course of VR over 12 weeks and assess whether this is associated with any improvement in symptoms. conditions: Decompression Sickness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 41 type: ESTIMATED measure: Side of peripheral vestibular damage: Prospective cohort measure: Site of peripheral vestibular damage: Prospective cohort measure: Extent of peripheral vestibular damage: Prospective cohort measure: Side of peripheral vestibular damage: Retrospective cohort measure: Site of peripheral vestibular damage:Retrospective cohort measure: Extent of peripheral vestibular damage:Retrospective cohort measure: VOR gain v HIT: Prospective Study measure: VOR gain: Prospective Study measure: VOR Time constant:Prospective Study measure: Patient reported outcome measure: Prospective Study measure: Clinical measure of walking: Prospective Study measure: Clinical measure of balance: Prospective Study measure: Posturography: Prospective Study measure: Perception of verticality: Prospective Study measure: Functional MRI response to an optokinetic stimulus: Prospective Study measure: Vestibular Evoked myogenic Potentials latency: Prospective Study measure: Vestibular Evoked myogenic Potentials amplitude: Prospective Study measure: VOR gain: Retrospective Study measure: VOR Time constant: Retrospective Study measure: Patient reported outcome measure: Retrospective Study measure: Clinical measure of walking: Retrospective Study measure: Clinical measure of balance: Retrospective Study measure: Posturography: Retrospective Study measure: Perception of verticality: Retrospective Study measure: Functional MRI response to an optokinetic stimulus: Retrospective Study measure: Vestibular Evoked myogenic Potentials latency: Retrospective Study measure: Vestibular Evoked myogenic Potentials amplitude: Retrorospective Study sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06370884 id: SURG-2023-29833 briefTitle: Intestinal Microbiota Transplantation in Patients Undergoing Colon Resection overallStatus: RECRUITING date: 2024-02-01 date: 2025-10-01 date: 2026-02-01 date: 2024-04-17 date: 2024-04-17 name: University of Minnesota class: OTHER briefSummary: This is a single-center, open-label study for safety and feasibility of IMT in patients undergoing colonic surgery. After consent, individuals of the ages of 18-75 with a history of diverticulitis will be enrolled to have a feeding tube placed at the time of surgery and receive either IMT or a saline solution on postoperative day 2-3 (at least 48 hours following IV antibiotics) with the subsequent removal of the feeding tube. Prior to administration of IMT or saline, recipients will be screened for inclusion/exclusion criteria, interviewed for medical history and medications, and consented. Additionally, prior to undergoing IMT/saline, baseline blood and fecal samples will be collected. The use of a nasogastric feeding tube has specifically been chosen over colonoscopic introduction of the IMT. This is because colonoscopy introduces increased intraluminal carbon dioxide and pressure as well as mechanical stress on the colon in the setting of a newly created bowel anastomosis, which may contribute to the potential risk of anastomotic disruption. The nasogastric feeding tube will be placed while the patient is under anesthesia under direct visualization to minimize any risk of bowel perforation, albeit very low. The study will specifically utilize a 10F 43" Corpak feeding tube (Halyard Health, Alpharetta, GA). Patients will be monitored while in-patient in person. Following discharge, they will undergo follow-up either by phone, video or in-person visit, or via online survey of symptoms and chronic medical conditions potentially related to IMT, beginning on the day following discharge through post-operative day 14, and then monthly up to 6 months post- IMT to screen for SAEs and AEs. Screening for SAEs and AEs will be done using a symptom questionnaire as well as by asking patients during our interview. Fecal samples will be collected from participants on months one, three and six post-IMT to assess for changes in recipient microbiome (engraftment kinetics). conditions: Recurrent Clostridioides Difficile Infection conditions: Colonic Surgery studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a phase 1 pilot clinical trial that will evaluate the initial safety and feasibility of intestinal microbiota transplantation (IMT) in patients undergoing colon resection. primaryPurpose: OTHER masking: DOUBLE maskingDescription: The study will be double-blinded; assignments of study staff to either the blinded or unblinded team will be made in advance of enrollment of the first study participant and will be recorded as such on regulatory documents (e.g., blinded/unblinded DOA). whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 20 type: ESTIMATED name: IMT name: Saline solution measure: Evaluate safety of IMT in patients undergoing colon surgery measure: compare fecal microbiota prior to and after IMT measure: Evaluate engraftment of donor microbiota measure: Evaluate changes in circulating markers of inflammation: WBC measure: Evaluate changes in circulating markers of inflammation: Hemoglobin measure: Evaluate changes in circulating markers of inflammation: Platelets measure: Evaluate changes in circulating markers of inflammation: Electrolytes measure: Evaluate changes in circulating markers of inflammation measure: Evaluate changes in circulating markers of inflammation: alkaline phosphatase measure: Evaluate changes in circulating markers: Albumin measure: Evaluate changes in microbial metabolites: Fecal short-chain fatty-acids measure: Evaluate changes in microbial metabolites: Fecal IgA measure: Compare baseline microbiome characteristics with changes over time after IMT sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Minnesota status: RECRUITING city: Minneapolis state: Minnesota zip: 55414 country: United States name: Kathryn Vera, PhD role: CONTACT phone: 612-625-5018 email: giero002@umn.edu lat: 44.97997 lon: -93.26384 hasResults: False

 nctId: NCT06370871 id: 1403-0006 id: 2022-502985-26-00 type: REGISTRY domain: CTIS (EU) id: U1111-1292-9594 type: REGISTRY domain: WHO Registry briefTitle: Brightline-3: A Study to Find Out Whether Brigimadlin in Combination With Ezabenlimab Helps People With Advanced Soft Tissue Sarcoma overallStatus: NOT_YET_RECRUITING date: 2024-06-04 date: 2026-07-03 date: 2028-10-13 date: 2024-04-17 date: 2024-04-24 name: Boehringer Ingelheim class: INDUSTRY briefSummary: This study is open to adults with specific types of advanced soft tissue sarcoma. People with undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) can join the study if they have a normal version of the TP53 gene. This is a study for people whose earlier treatment isn't working anymore, and their doctors suggest a new treatment to stop the sarcoma from getting worse.

The purpose of this study is to compare a medicine called brigimadlin in combination with another medicine called ezabenlimab with chemotherapy. Brigimadlin is a so-called MDM2-p53 antagonist that is being developed to treat cancer. Ezabenlimab is an antibody that may help the immune system fight cancer.

Participants are put into 3 groups by chance:

* Ezabenlimab group: Participants receive ezabenlimab as an infusion into a vein every 3 weeks
* Brigimadlin + ezabenlimab group: Participants take brigimadlin as tablets and receive ezabenlimab as an infusion into a vein every 3 weeks
* Chemotherapy group: Participants get chemotherapy as an infusion into a vein on 2 days every 3 weeks. Chemotherapy is a combination of gemcitabine and docetaxel which is often used in the treatment of sarcoma.

There are twice as many participants in the brigimadlin + ezabenlimab group and in the chemotherapy group, compared to those in the ezabenlimab group.

Participants can continue treatment in the study as long as they benefit from it and can tolerate it.

Doctors regularly check the size of the tumor and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects. Participants in this study use an app on a mobile phone to regularly answer questions about their health and well-being. This is to find out if their quality of life is changing. conditions: Advanced Soft Tissue Sarcoma conditions: Undifferentiated Pleomorphic Sarcoma (UPS) conditions: Myxofibrosarcoma (MFS) studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 263 type: ESTIMATED name: Brigimadlin name: Ezabenlimab name: Gemcitabine name: Docetaxel measure: Progression-free survival measure: Overall survival measure: Objective response measure: Duration of objective response measure: Disease control measure: Duration of disease control measure: Occurrence of treatment-emergent adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5 measure: Occurrence of treatment-emergent AEs leading to study drug discontinuation measure: Mean change from baseline to Week 12 in the domain fatigue (based on items from the European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) and the EORTC item library) measure: Mean change from baseline to Week 12 in the domain fatigability (based on items from the EORTC QLQ-C30 and the EORTC item library) measure: Mean change from baseline to week 12 in the domain physical functioning (based on items from the EORTC QLQ-C30) measure: Mean change from baseline to week 12 in the domain pain (based on items from the EORTC QLQ-C30) measure: Mean change from baseline to week 12 in the domain dyspnea (based on items from the EORTC QLQ-C30) measure: Mean change from baseline to week 12 in the domain global health status / quality of life (based on items from the EORTC QLQ-C30) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06370845 id: 0000-00000; kt24timper briefTitle: Abundance of a Natural Odour in Human Cerebrospinal Fluid After Olfactory Exposure acronym: OLFO-Brain overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-31 date: 2024-10-30 date: 2024-04-17 date: 2024-04-17 name: University Hospital, Basel, Switzerland class: OTHER briefSummary: The goal of this clinical trial is to investigate the abundance of a natural odour in human cerebrospinal fluid in obese and lean participants after inhalation thereof. Participants will undergo blood sample collection and inhalation of either a natural odour or placebo through an inhaler in addition to a liquor puncture prescribed in standard of care context. conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 32 type: ESTIMATED name: Inhalation - Natural Odour name: Inhalation - Placebo measure: Detection of a natural odour in human CSF measure: Abundance of a natural odour in human CSF of obese versus lean participants measure: Change in abundance of a natural odour in blood before and after olfactory stimulation in relation to abundance in human CSF. measure: Change in abundance of a natural odour in blood before and after olfactory stimulation in obese as compared to lean participants. sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: University Hospital Basel city: Basel zip: 4031 country: Switzerland name: Katharina Timper, Prof. Dr. med. role: CONTACT phone: 0041 61 328 57 42 email: katharina.timper@usb.ch name: Isabel M Hofer role: CONTACT phone: 0041 61 328 68 14 email: isabelmarie.hofer@usb.ch lat: 47.55839 lon: 7.57327 hasResults: False

 nctId: NCT06370832 id: 22-5171 briefTitle: Inspiratory Muscle Training in Lung Transplant Candidates overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-09-30 date: 2027-09-30 date: 2024-04-17 date: 2024-04-17 name: University Health Network, Toronto class: OTHER name: Canadian National Transplant Research Program name: Canadian Institutes of Health Research (CIHR) name: Ozmosis Research Inc. briefSummary: Recovery after lung transplantation (LTx) may be complicated by prolonged mechanical ventilation (MV) and protracted intensive care unit (ICU) stay leading to immobilization and impaired health-related quality of life (HRQoL). In the critical care setting, diaphragm atrophy and weakness have been associated with difficulty weaning from MV, increased risk for readmission to hospital or ICU, and increased mortality. Increasing respiratory muscle strength by inspiratory muscle training (IMT) as part of pre-rehabilitation mitigates respiratory muscle dysfunction peri-operatively and may reduce the risk of post-operative complications. However, IMT is not widely used prior to LTx and the benefits of pre-operative IMT on post-transplant outcomes in LTx candidates have not been studied. Objectives: 1) To evaluate the feasibility of a randomized clinical trial of IMT in LTx candidates in terms of recruitment rate, retention, program adherence, safety and outcome ascertainment. 2)To establish whether IMT improves pre-transplant dyspnea perception, diaphragm structure and function, HRQoL and post-transplant ICU, hospital and 3-month outcomes. 3)To characterize the effect of pre-transplant IMT on peri-transplant diaphragm myofibrillar cross-sectional area, oxidative capacity, inflammatory markers and diaphragm muscle thickness and function. Methods: Prospective study of 50 LTx candidates recruited from the pulmonary rehabilitation program at University Health Network (UHN). Participants will have baseline evaluations of maximal inspiratory pressure (MIP), dyspnea, respiratory muscle endurance, diaphragm thickness and thickening fractions, as well as health-related quality of life questionnaires. After baseline assessments, participants will be randomized to the two study groups: IMT or usual care. IMT will be progressed weekly (max of 70% total MIP) until transplant. Participants will have repeat assessments (from baseline) at 4,8 and 12 weeks and then every 3 months until transplant (final assessment 3 months post-LTx). conditions: Inspiratory Muscle Training studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Pre-lung transplant candidates will be randomized to one of two groups: (1) IMT + exercise training; or (2) exercise training alone. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Ascertainment of post-transplant clinical outcomes (including histopathology assessments) will be blinded by assessors to study group up to 3 months post-transplant. whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: IMT and exercise training group measure: Study Recruitment According to Research Team Records measure: Participant Retention in the Study According to Research Team Records measure: Self-Reported Adherence to Inspiratory Muscle Training According to Participant IMT Diary measure: Adverse Events and IMT Training Side Effects Reported by Participants measure: Inspiratory Muscle Training Satisfaction Questionnaire (IMT Group Only) measure: Respiratory Muscle Endurance Test measure: Dyspnea Severity Assessed by Medical Research Council Dyspnea Scale measure: Qualitative Measures of Dyspnea Assessed by Qualitative Dyspnea Scale measure: Mood Assessed by Depression, Anxiety, and Stress Scale measure: Health-Related Quality of Life Assessed by St. George's Respiratory Questionnaire measure: Respiratory Muscle Strength Assessed by Maximal Inspiratory Pressure measure: Physical Activity and Exercise Behaviors Assessed by International Physical Activity Questionnaire measure: Pulmonary Function Testing (Spirometry) measure: Aerobic Endurance Assessed by the Six-Minute Walk Test measure: Physical Function Assessed by the Short Physical Performance Battery measure: Pre-Transplant Hospitalizations measure: Peri-Transplant Mechanical Ventilation Bridging measure: Post-Transplant Duration of Mechanical Ventilation (Days) measure: WIND Weaning Classification measure: Post-Transplant Hospital Length of Stay (Days) measure: Post-Transplant Discharge Disposition measure: Primary Graft Dysfunction measure: Post-Transplant Mortality measure: Days Alive and at Home at 90 Days (DAAH90) measure: Diaphragm Thickness and Thickening Fraction Assessed by Ultrasound measure: Histopathology Analyses of Diaphragm Biopsies (Optional) measure: Biochemical Analyses of Diaphragm Biopsies (Optional) measure: Mitochondrial Respirometry Analyses of Diaphragm Biopsies (Optional) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Health Network city: Toronto state: Ontario zip: M5G 2C4 country: Canada name: Dmitry Rozenberg, MD, PhD role: CONTACT phone: 416-340-4800 phoneExt: 7358 email: dmitry.rozenberg@uhn.ca lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06370819 id: NN9541-4923 id: U1111-1292-3441 type: OTHER domain: Universal Trial Number id: 2023-506381-32 type: OTHER domain: EU CT Number briefTitle: A Research Study Looking Into Blood Levels of the Medicine NNC0519-0130 in the Body in Participants With Normal or Reduced Kidney Function overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-19 date: 2025-04-19 date: 2024-04-17 date: 2024-04-17 name: Novo Nordisk A/S class: INDUSTRY briefSummary: NNC0519-0130 is a new medicine to improve the treatment options for people living with type 2 diabetes and people with overweight. In this study one dose of NNC0519-0130 will be given and blood levels of NNC0519-0130 will be compared between people with reduced kidney function and people with normal kidney function. The study will last up to 52 days including a screening phase of up to 28 days prior to dosing. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: NNC0519-0130 measure: Area under the curve (AUC)0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with normal function, and mild, moderate and severe impairment measure: Maximum concentration (Cmax),NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with normal function, and mild, moderate and severe impairment measure: AUC0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve after a single dose in participants with kidney failure measure: Cmax,NNC0519-0130,SD: Maximum observed NNC0519-0130 plasma concentration after a single dose in participants with kidney failure measure: Number of adverse events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Charité Research Organisation GmbH city: Berlin zip: 10117 country: Germany lat: 52.52437 lon: 13.41053 hasResults: False

 nctId: NCT06370806 id: INTERAPNEA-Women briefTitle: Lifestyle Intervention for Obstructive Sleep Apnea in Women acronym: INTERAPNEA-W overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-01 date: 2025-12-01 date: 2024-04-17 date: 2024-04-17 name: Universidad de Granada class: OTHER name: Fundación BBVA name: Universidad Loyola Andalucia briefSummary: Obesity is a major risk factor for obstructive sleep apnoea (OSA), the most common sleep-disordered breathing related to neurocognitive and metabolic syndromes, type II diabetes, and cardiovascular diseases. Although strongly recommended for this condition, there are no studies on the effectiveness of an interdisciplinary weight loss and lifestyle intervention including nutrition, exercise, sleep hygiene, and smoking and alcohol cessation in women. INTERAPNEA-Women is a randomized controlled trial with a two-arm parallel design aimed at determining the effects of an interdisciplinary tailored weight loss and lifestyle intervention on OSA outcomes. The study will include 180 females aged 18-65 with a body mass index of ≥25 kg/m2 and severe to moderate OSA randomly assigned to usual care (i.e., continuous positive airway pressure), or interdisciplinary weight loss and lifestyle intervention combined with usual care. Outcomes will be measured at baseline, intervention end-point, and six-month post-intervention, including apnoea-hypopnoea index (primary outcome), other neurophysical and cardiorespiratory polysomnographic outcomes, sleep quality, daily functioning and mood, body weight and composition, physical fitness, blood biomarkers, and health-related quality of life. INTERAPNEA may serve to establish a cost-effective treatment not only for the improvement of OSA and its vast and severe comorbidities, but also for a potential remission of this condition. conditions: Obstructive Sleep Apnea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: Weight loss and lifestyle intervention measure: Apnoea-hypopnoea index (AHI) measure: Oxygen desaturation index (ODI) measure: Oxygen saturation (SaO2) mean measure: Oxygen saturation (SaO2) nadir measure: Sleep efficiency measure: Light sleep (N1 and N2 stages) measure: Deep sleep (N3 stage) measure: Rapid eye movement (REM) sleep measure: Excessive daytime sleepiness (EDS) measure: Sleep Quality measure: Wake After Sleep Onset (WASO) measure: Fat mass (kg) measure: Visceral adipose tisue (g) measure: Body weight (kg) measure: Neck circumference (cm) measure: Chest circumference (cm) measure: Waist circumference (cm) measure: Mean blood pressure (mm HG) measure: Plasma glucose (mg/dL) measure: Change in total cholesterol (mg/dL) from baseline to post-intervention measure: Change in total triglycerides (mg/dL) from baseline to post-intervention sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06370793 id: NBU-2024-011 briefTitle: Ningbo Severe Mental Disorders Cohort acronym: NEED overallStatus: ACTIVE_NOT_RECRUITING date: 2018-07-01 date: 2023-12-31 date: 2026-12-31 date: 2024-04-17 date: 2024-04-18 name: Ningbo University class: OTHER name: The Affiliated Kangning Hospital of Ningbo University briefSummary: In recent years, the prevalence of severe mental disorders in China has continued to grow, and the burden of disease in society has continued to rise. In order to improve the prognosis of patients with severe mental disorders and reduce the risk of disease relapse or readmission, researchers established a cohort based on the Ningbo Mental Health Information System in Ningbo, a sub-provincial city in the southern wing of the Yangtze River Delta of China, with a resident population of more than 9 million, and linked it to the residents' health records, and through the data linkage obtained data on patients in the full cycle of pre-diagnosis, diagnosis, follow-up, disease changes and death, realising full-cycle management of patients with severe mental disorders.

Currently, NEED has accumulated data on more than 50,000 patients with severe mental disorders and obtained multi-dimensional longitudinal information through long-term follow-up and data linkage. All diseases follow the World Health Organization International Classification of Diseases 10th Edition (ICD-10) for clinical coding, and available data include baseline demographics, past history, family history, social functioning deficit screening scale scores, risk assessment, and so on and longitudinal health information from electronic health records (EHR), providing a solid data base for future real-world studies. conditions: Severe Mental Disorder conditions: Schizophrenia conditions: Bipolar Disorder conditions: Schizo-Affective Psychosis conditions: Paranoid Psychoses conditions: Mental Retardation conditions: Epileptic Psychosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 57212 type: ACTUAL name: Patient with severe mental disorder without intervention measure: Risk of circulatory system diseases measure: Risk of endocrine system diseases measure: Risk of pulmonary system and allergy diseases measure: Risk of gastrointestinal system diseases measure: Risk of musculoskeletal system diseases measure: Risk of urogenital system diseases measure: Risk of hematological system diseases measure: Risk of cancers measure: Risk of neurological system diseases measure: Risk of suicide measure: Risk of violence sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ningbo Mental Health Information System city: Ningbo state: Zhejiang zip: 315000 country: China lat: 29.87819 lon: 121.54945 hasResults: False

 nctId: NCT06370780 id: 5UG3AI176592-02 type: NIH link: https://reporter.nih.gov/quickSearch/5UG3AI176592-02 briefTitle: Exploring, Predicting, and Intervening on Long-term Viral Suppression Electronically acronym: EPI-LoVE overallStatus: RECRUITING date: 2024-02-09 date: 2025-04-30 date: 2025-04-30 date: 2024-04-17 date: 2024-04-26 name: University of California, Los Angeles class: OTHER name: Florida State University name: University of California, Irvine name: University of North Carolina, Chapel Hill name: AIDS Healthcare Foundation briefSummary: Despite the widespread availability of effective antiretroviral therapy (ART) in the United States, there remains significant numbers of people living with HIV (PLWH) who fail to achieve and or maintain viral suppression (VS). Disparities persist with the lowest levels of VS among Black individuals, people who use drugs, youth ages 18-24 and people residing in rural areas. Investigators will examine the syndemics underlying these outcomes including substance use, mental health, and barriers to HIV care including racial discrimination, stigma and rural isolation. conditions: HIV Infections studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE maskingDescription: N/A - all participants get the app count: 1000 type: ESTIMATED name: EPI LOVE measure: Incidence of HIV Viral Suppression measure: Level of Adherence to HIV medication measure: Level of Adherence based on HIV appointments sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, Los Angeles status: RECRUITING city: Los Angeles state: California zip: 90095 country: United States name: Pamina Gorbach, DrPh, MHS role: CONTACT phone: 310-794-2555 email: pgorbach@ucla.edu name: Valerie El-Alfi, MA role: CONTACT email: velalfi@mednet.ucla.edu lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06370767 id: 25634 briefTitle: Peer Facilitated Waitlist Controlled Transportation Study overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-17 date: 2024-04-17 name: Temple University class: OTHER briefSummary: The goal of this clinical trial is to test the effectiveness of a peer-facilitated travel intervention in adults with serious mental illnesses. This project aims to address the following hypotheses:

1. Individuals with SMI receiving either of the two peer-mediated travel training transportation interventions will experience an increase in transportation self-efficacy and transportation skills.
2. Participants in the intervention arms will increase their transport utilization, participate in significantly more activities in the community, and make significantly more trips in the community.
3. Individuals with SMI receiving peer-mediated travel training interventions will retain post-test levels of community participation and self-efficacy 2 months after intervention.

Participants will be assigned to an 8-week travel-training intervention either using a bike-share program or public transportation. All participants will complete three data-collection research interviews. conditions: Serious Mental Illness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomly assigned to either start the intervention program immediately, or be placed on an 8-week waitlist. Once randomized, the participant will again be randomized into a treatment condition: 1) peer-mediated bikeshare training intervention; or 2) peer-mediated public travel training intervention. 20 participants from each condition who have not opted out of being in the GPS subsample will be randomly assigned to be invited to a GPS subgroup. primaryPurpose: OTHER masking: NONE count: 180 type: ESTIMATED name: Bike-Share Travel Training name: Public Transportation Travel Training measure: Temple University Community Participation Measure measure: LASA Sedentary Behaviors Questionnaire measure: Transportation Appraisal Scale measure: Indego Skills Survey measure: SEPTA Skills Survey measure: University of California, San Diego Performance-Based Skills Assessment (UPSA- Modified) measure: National Household Travel Survey measure: GPS measure: Internalized Stigma of Mental Illness Inventory (ISMI) (Brief Version) measure: University of California, Los Angeles, Loneliness Scale measure: Pearlin Mastery Scale (Coping) measure: SF- 36 v2 measure: The PERMA - Profiler Measure measure: Recovery Assessment Scale (RAS) measure: Group Identification Scale (GIS) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-07 uploadDate: 2024-04-10T09:43 filename: Prot_SAP_000.pdf size: 450285 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-12-07 uploadDate: 2024-04-10T09:43 filename: ICF_001.pdf size: 235105 hasResults: False

 nctId: NCT06370754 id: 2401289-19-2403 briefTitle: Newly Emerging Immunotherapy for Pancreatic Cancer Treatment acronym: FD-IMPACT overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2026-04-30 date: 2027-04-30 date: 2024-04-17 date: 2024-04-17 name: Fudan University class: OTHER briefSummary: This is a Phase Ib/II platform clinical study to evaluate the initial efficacy and safety of different novel immunotherapies in patients with advanced pancreatic cancer. conditions: Pancreatic Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 117 type: ESTIMATED name: JS001 name: JS004 name: JS007 name: JS015 name: Irinotecan Liposome Injection name: 5-Fluorouracil (5-FU) name: Leucovorin (LV) name: Nab paclitaxel name: Gemcitabine measure: Incidence of dose-limiting toxicity (DLT) (phase IB) measure: Objective Response Rate (ORR) (phase II) measure: Objective Response Rate (ORR) (phase IB) measure: Disease control rate (DCR) measure: Duration of Response (DOR) measure: Progression free survival (PFS) measure: Overall Survival (OS) measure: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University city: Shanghai state: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06370741 id: OkanUni. briefTitle: Effect of Stretching Exercises on Plantar Fascia overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-05 date: 2024-06 date: 2024-04-17 date: 2024-04-17 name: Okan University class: OTHER briefSummary: The plantar fascia (PF) extends over the calcaneal bone with a thin band corresponding to the calcaneal periosteum, continuing as the paratenon of the Achilles tendon.The triceps surae complex, serving as the main extensor and propulsion system of the foot, involves the Achilles tendon, posterior part of the calcaneus, and Plantar Aponeurosis, all integrated with the fibrous skeleton of the triceps surae. Plantar fasciitis, a prevalent musculoskeletal condition affecting individuals of various ages and activity levels (Hye Chang Rhim), is a primary cause of heel pain in adults. Studies have identified the superior efficacy of stretching protocols targeting the Achilles tendon and/or plantar fascia compared to alternative treatments. However, the limitations of traditional approaches become apparent when considering the intricate biomechanics of the foot and ankle. Conventional calf stretches often prove inadequate for addressing its specific lengthening requirements. While contemporary methods like PF-Specific Stretching integrate plantar fascia and calf stretches, their reliance on individual upper extremity strength introduces potential limitations.

Therefore, although the exact effect of stretching on the biomechanical properties of the plantar fascia is not known, it will be aimed to determine whether an instrument aid to be designed will have an effect and which method is more effective. In this way, it is planned to guide clinicians in the rehabilitation of possible pathologies specific to the plantar fascia in clinical practice.

Myotonometry is a convenient method to assess the stiffness of the plantar fascia because it is cheap, simple and fast. Previous studies have shown that MyotonPRO can reliably assess the stiffness of the plantar fascia. Although the exact effect of stretching on the biomechanical properties of the plantar fascia is not known, it will be determined whether stretching with an instrument to be designed will have an effect and which method is more effective with or without an instrument. conditions: Stretch conditions: Plantar Fascia; Contracture conditions: Fasciitis, Plantar studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Pilot study primaryPurpose: DEVICE_FEASIBILITY masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 10 type: ESTIMATED name: Stretching with/without device measure: Plantar Fascia Mechanical Properties sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06370728 id: 18621 id: J2A-MC-GZPJ type: OTHER domain: Eli Lilly and Company briefTitle: A Drug-Drug Interaction (DDI) Study of Orforglipron With Carbamazepine in Healthy Participants overallStatus: NOT_YET_RECRUITING date: 2024-05-03 date: 2024-07-15 date: 2024-07-15 date: 2024-04-17 date: 2024-04-29 name: Eli Lilly and Company class: INDUSTRY briefSummary: The main purpose of this study is to assess the effect of carbamazepine on the amount of orforglipron in the bloodstream and how long it takes the body to get rid of orforglipron when given orally in healthy study participants. The safety and tolerability of orforglipron and carbamazepine when given separately or together will also be evaluated. The study may last up to approximately 77 days for each participant. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 30 type: ESTIMATED name: Orforglipron name: Carbamazepine measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-∞]) of Orforglipron measure: PK: Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Orforglipron measure: PK: Maximum Observed Concentration (Cmax) of Orforglipron sex: ALL minimumAge: 21 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ICON Early Phase Services city: San Antonio state: Texas zip: 78209 country: United States role: CONTACT phone: 210-255-5437 name: Robert Bass role: PRINCIPAL_INVESTIGATOR lat: 29.42412 lon: -98.49363 hasResults: False

 nctId: NCT06370715 id: 18269 id: I8B-MC-ITTA type: OTHER domain: Eli Lilly and Company briefTitle: A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-07 date: 2025-07 date: 2024-04-17 date: 2024-04-17 name: Eli Lilly and Company class: INDUSTRY name: Cipla Ltd. briefSummary: The purpose of this study is to assess the safety of insulin lispro-aabc in adult participants with Type 2 diabetes mellitus in India.

The study will last about 33 weeks for each participant, including screening (1 week), Lead-in period (4 weeks), treatment period (26 weeks) and follow up period (2 weeks). conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 112 type: ESTIMATED name: Insulin Lispro-aabc name: Insulin Glargine measure: Percentage of Participants with at least 1 Episode of Hypoglycemia measure: Percentage of Participants with Severe Hypoglycemic Events measure: Percentage of Participants with Nocturnal Hypoglycemia Events measure: Percentage of Participants with Nocturnal and All Documented Hypoglycemic Events measure: Change from Baseline to Week 26 in Body Weight measure: Change from Baseline to Week 26 in Insulin Treatment Satisfaction Questionnaire (ITSQ) Score measure: Change from Baseline to Week 26 in Hemoglobin A1c (HbA1c) measure: Percentage of Participants Achieving HbA1c Less Than (<) 7% measure: Change from Baseline to Week 26 in 1- and 2-hour Postprandial Glucose (PPG) Values measure: Change from Baseline to Week 26 in Bolus Insulin Dose, Basal Insulin Dose, and Basal: Bolus Ratio measure: Change from Baseline to Week 26 in 9-Point Self-Monitored Blood Glucose (SMBG) Values sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: King George Hospital, Visakhapatnam city: Vizag state: Andhra Pradesh zip: 530002 country: India name: Bongi Vivekanand role: PRINCIPAL_INVESTIGATOR lat: 17.68009 lon: 83.20161 facility: Diabetes Research Centre city: Royapuram state: Chennai zip: 600013 country: India name: VIJAY VISHWANATHAN role: PRINCIPAL_INVESTIGATOR lat: 13.11405 lon: 80.29474 facility: Vijyaratna Dibetes Diagnosis Treatment Centre city: Ahmedabad state: Gujarat zip: 380007 country: India name: Sanjeev Phatak role: PRINCIPAL_INVESTIGATOR lat: 23.02579 lon: 72.58727 facility: Center for Diabetes and Endocrine Care city: Bengaluru state: Karnataka zip: 560043 country: India name: K M Prasanna Kumar role: PRINCIPAL_INVESTIGATOR lat: 12.97194 lon: 77.59369 facility: Chellaram Diabetes Institute city: Pune state: Maharashtra zip: 411021 country: India name: Unnikrishnan Gopalkrishnan role: PRINCIPAL_INVESTIGATOR lat: 18.51957 lon: 73.85535 facility: Sahyadri Super Speciality Hospital city: Pune state: Maharashtra country: India name: Uday Phadke role: PRINCIPAL_INVESTIGATOR lat: 18.51957 lon: 73.85535 facility: S. P. Medical College & A G Hospital city: Bikaner state: Rajasthan zip: 334003 country: India name: Bal Kishan Gupta role: PRINCIPAL_INVESTIGATOR lat: 28.01762 lon: 73.31495 facility: Rajasthan University of Health Sciences city: Jaipur state: Rajasthan zip: 302033 country: India name: Sudhir Bhandari role: PRINCIPAL_INVESTIGATOR lat: 26.91962 lon: 75.78781 facility: Kovai Diabetes Speciality Center and Hospital city: Coimbatore state: Tamil Nadu zip: 641009 country: India name: Ramanathan Balamurugan role: PRINCIPAL_INVESTIGATOR lat: 11.00555 lon: 76.96612 facility: Osmania Medical College & Hospital city: Hyderabad state: Telangana zip: 500012 country: India name: Rakesh Sahay role: PRINCIPAL_INVESTIGATOR lat: 17.38405 lon: 78.45636 facility: Brij Medical Center Pvt. Ltd. city: Kanpur state: Uttar Pradesh zip: 208020 country: India name: brij mohan role: PRINCIPAL_INVESTIGATOR lat: 26.46523 lon: 80.34975 facility: Medical College & Hospital, Kolkata city: Kolkata state: West Bengal zip: 700073 country: India name: Animesh Maiti role: PRINCIPAL_INVESTIGATOR lat: 22.56263 lon: 88.36304 hasResults: False

 nctId: NCT06370702 id: 23-054 briefTitle: Evaluating the Use of Grip Exercises to Decrease Deep Vein Thrombosis in Adult Patients With PICC Lines overallStatus: RECRUITING date: 2023-10-06 date: 2026-12-31 date: 2027-06-30 date: 2024-04-17 date: 2024-04-17 name: TriHealth Inc. class: OTHER briefSummary: Patients who have a peripherally-inserted central catheter (PICC) placed are at a risk of developing a deep vein thrombosis (DVT). At TriHealth, approximately 2-4 patients per month who have a PICC placed experience a subsequent DVT. One innovative way to possibly mitigate the risk of DVTs is hand grip exercises. The current study will be the first study to evaluate hand grip exercises for the prevention of DVTs in adult patients hospitalized in the United States. conditions: Deep Vein Thrombosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 2500 type: ESTIMATED name: Handgrip Exercises measure: Deep vein thrombosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Good Samaritan Hospital status: RECRUITING city: Cincinnati state: Ohio zip: 45220 country: United States name: Rachel Baker, PhD, RN role: CONTACT phone: 513-569-6191 email: Rachel_Baker2@trihealth.com lat: 39.12713 lon: -84.51435 facility: Bethesda North Hospital status: RECRUITING city: Cincinnati state: Ohio zip: 45242 country: United States name: Rachel Baker, PhD, RN role: CONTACT phone: 513-569-6191 email: Rachel_Baker2@trihealth.com lat: 39.12713 lon: -84.51435 hasResults: False

 nctId: NCT06370689 id: PRE-OX briefTitle: Comparison of Three Pre-oxygenation Strategies overallStatus: NOT_YET_RECRUITING date: 2024-05-23 date: 2024-12-31 date: 2025-07-30 date: 2024-04-17 date: 2024-04-17 name: Institute of Mountain Emergency Medicine class: OTHER briefSummary: Study objective: Comparing the efficacy of three different preoxygenation strategies, i.e. non-rebreather face mask (NRM), bag-valve-mask (BVM) with and BVM without additional positive end-expiratory pressure (PEEP) in three subgroups of spontaneously breathing volunteers.

Study endpoints

Primary Endpoint:

The time taken from the start of preoxygenation until reaching an expiratory oxygen concentration (FeO2) of ≥ 90% or a maximum preoxygenation time of 3 min.

Secondary endpoints:

* Changes in regional ventilation within the posterior lung regions from baseline to the time when FeO2≥ 90% is achieved, assessed using electrical impedance tomography (EIT)
* Difference in Oxygen Reserve Index (ORi) when FeO2≥ 90% is achieved

Number of participants 15 participants per subgroup, i.e. 45 participants in total.

Inclusion criteria

* Normal-weight adults (body mass index, BMI 18.5-24.9 kg/m2) with an "American Society of Anesthesiologists Physical Status Classification System (ASA) " score of I or II
* Adults with a BMI 25-39.9 kg/m2 with and ASA score \<3
* Healthy (ASA I) children aged 6-12 years Exclusion criteria ASA 3, Age \< 6 and age 12-18, pregnant women, missing informed consent, signs and symptoms of an acute respiratory illness on the study day.

After informed consent and a medical check-up, baseline measurements will be done for 10 minutes (peripheral oxygen saturation SpO2, ORI, regional ventilation). Then the participants will undergo 3 different preoxygenation sessions with the 3 interfaces (i.e. non-rebreather facemask with reservoir and a bag-valve-mask with and without PEEP) in a randomized order and a 20 min washout between the sessions. Each preoxygenation session is conducted in a supine position and will be proceeded until the measured FeO2 (end expiratory O2 fraction) reaches 90% or up to a maximum time of 3 min. Afterwards 10 min of SpO2, ORI and regional ventilation measurements will follow. conditions: Emergencies conditions: Anesthesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 45 type: ESTIMATED name: Preoxygenation measure: Difference in Oxygen Reserve index (ORi) after 3 minutes of preoxygenation measure: Difference in expiratory oxygen concentration (FeO2) after 3 minutes of preoxygenation measure: Time to Oxygen Reserve index (ORi) = 1.0 sex: ALL minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06370676 id: ESO-TIP briefTitle: Accuracy of Core Body Temperature Measurement Depending on Oesophageal Probe Tip Location acronym: ESO-TIP overallStatus: NOT_YET_RECRUITING date: 2024-05-23 date: 2024-12-31 date: 2025-07-30 date: 2024-04-17 date: 2024-04-17 name: Institute of Mountain Emergency Medicine class: OTHER briefSummary: Background An accurate measurement of the core body temperature (CBT) is of pivotal importance in the management of severely hypothermic patients. For instance, triage decisions for or against extracorporeal rewarming of hypothermic patients in cardiac arrest strongly depend on CBT. CBT measurement with an oesophageal probe is currently considered the gold standard in hypothermic patients with a secured airway in the prehospital setting, with the tip of the probe placed into the distal third of the oesophagus (i.e., posteriorly to the heart and distal to the tracheal bifurcation). However, the correct placement of the probe tip cannot be verified in the prehospital setting, and it is unknown how incorrect placement affects temperature readings.

Hypothesis and aim The investigators hypothesise that an incorrect placement of the oesophageal temperature probe tip could lead to inaccurate measurements (i.e., temperature readings not reflecting the real CBT). Particularly, a tip location too high in the oesophagus in close proximity to the trachea could lead to falsely low temperature readings, especially when the patient is ventilated with cold air. The aim of the proposed study is to investigate the influence of oesophageal temperature probe tip location on CBT measurement.

Methods Experimental, interventional study on 16 healthy volunteers. During the test oesophageal temperature is measured while participants are breathing ambient air first at 20°C (baseline) followed by cold (-20°C) ambient air in supine position for 20 minutes each test in an environmental simulator (terraXcube). Each participant repeats the 20-min test two times with the oesophageal temperature probe tip placed either in the lower third of the oesophagus (i.e., correct position) or too high in the oesophagus, i.e. behind the trachea. conditions: Emergencies conditions: Hypothermia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: DIAGNOSTIC masking: SINGLE maskingDescription: The participant is blinded for the location of the oesophageal temperature probe tip. whoMasked: PARTICIPANT count: 16 type: ESTIMATED name: Oesophageal temperature measurement measure: Difference in core body temperature between the two tip positions sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06370663 id: SDZLEC2023-109-01 briefTitle: First-line Treatment for Unresectable Locally Advanced Distal Cholangiocarcinoma Combining Radiotherapy and HAIC overallStatus: RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-04-01 date: 2024-04-17 date: 2024-04-17 name: Shandong Cancer Hospital and Institute class: OTHER briefSummary: The median survival of intrahepatic cholangiocarcinoma remains less than one year, highlighting the need for new treatments. Hepatic arterial infusion chemotherapy (HAIC), especially with fluoropyrimidine-based regimens, has shown promise in ICC treatment due to increased local drug concentration and reduced systemic toxicity. A combined approach of radiotherapy and HAIC with gemcitabine infusion may offer a hopeful strategy for locally advanced cholangiocarcinoma. However, clinical research on this combination is lacking as first-line therapy for unresectable ICC. Therefore, a single-center, single-arm study aims to assess this treatment approach's safety, efficacy, and molecular predictors. Improved HAIC delivery through modified percutaneous implantation provides a reliable pathway for effective treatment. In conclusion, exploring the synergistic effects of radiotherapy and HAIC in ICC could pave the way for more effective and personalized treatment strategies for this challenging cancer type. conditions: Intrahepatic Cholangiocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Combining radiotherapy with Hepatic Arterial Infusion Chemotherapy primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: Radiotherapy name: HAIC (GEMOX) name: Chemotherapy measure: Adverse Events measure: Progression-Free Survival (PFS) 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, Doctor role: CONTACT phone: 0531-67626929 email: Len.Xu@hotmail.com lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06370650 id: soh-med-24-1-9 briefTitle: Effect of Platelet Rich Plasma on Outcome of Narrow Band UVB in Treatment of Vitiligo; Clinical and Histopathological Study overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-08 date: 2024-01-25 date: 2024-06-30 date: 2024-04-17 date: 2024-04-17 name: Sohag University class: OTHER briefSummary: For each patient, one side of body will be treated with NB-UVB alone while the other side will be treated with NB-UVB therapy in addition to intradermal injection of PRP every 2 weeks. Patients will be photographed at the first visit, in the middle and at the end of therapy. Each patient will sign a written consent form to be included in the study and to be photographed. conditions: Management of Stable Vitiligo studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ACTUAL name: platelet rich plasma, narrow band UVB measure: Improvement of vitiligo sex: ALL minimumAge: 15 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT facility: Faculty of Medicine, Sohag University city: Sohag zip: 82515 country: Egypt lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06370637 id: Survey Protocol briefTitle: Efficacy of Cream for Moisture Associated Skin Damage From Fecal Incontinence and/or Diarrhea acronym: Survey overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2026-05 date: 2024-04-17 date: 2024-04-17 name: Scotiaderm class: OTHER briefSummary: Scotiaderm Inc. has developed a cream formulation to be used in the treatment of MASD caused diarrhea or fecal incontinence. This study aims to evaluate the efficacy and safety of a plant extract incorporated into a standard barrier in the treatment of MASD from diarrhea and/or fecal incontinence. The goal of this research is to conduct an open-label outpatient study of this novel cream in a population with MASD secondary to diarrhea and/or fecal incontinence. conditions: Incontinence-associated Dermatitis conditions: Moisture Associated Skin Damage (MASD) (E.G., Incontinence-Associated Dermatitis [IAD], Perspiration, Drainage) conditions: Fecal Incontinence Incontinence-associated Dermatitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: The aim of this study is to evaluate the efficacy and safety of a plant extract incorporated into a standard barrier in the treatment of MASD from diarrhea and/or fecal incontinence. The goal of this research is to conduct an open-label outpatient study of this novel cream in a population with MASD secondary to diarrhea and/or fecal incontinence. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: A total of 40 patients will be enrolled in the study. If the patient agrees to participate and written consent is given to participate, the research coordinator will assess the eligibility criteria of the patient based on the inclusion and exclusion criteria. Participants will be provided 2x2cm patch test on the forearm to test for contact dermatitis to the cream D after obtaining consent. Participants do not react to the Cream D will be randomized. Participants who react will be excluded from the study. The research coordinator will have a list for arm 1 and arm 2 where the code for the participant enrolled will be entered daily. The first participants to be enrolled on any given day will be assigned to arm 1, and the second patient to arm 2. The research coordinator will have 40 envelopes with the protocols coded with arm 1 or arm 2, and cream containers also coded with arm 1 and arm 2. whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: MASD Control Arm measure: Analysis of Efficacy and Safety for Cream D Primary Outcome measure: Analysis of Efficacy and Safety for Cream D Secondary Outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06370624 id: 2022/03OCT/360 briefTitle: PEDI-REAVASC Resonance Imaging of Infants With Hypoxic Ischemic Encephalopathy After Hypothermia Treatment. acronym: PEDI-REAVASC overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-17 date: 2025-09-15 date: 2025-10-01 date: 2024-04-17 date: 2024-04-17 name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain class: OTHER briefSummary: This study is a prospective, observational, single-center study to assess the correlation between rs-fMRI measures and clinical measures of standard MRI, NIRS, EEG and clinical scores.

The target population was neonates with HIE referred to MRI after hypothermia treatment, which was initiated within 6 hours of birth, continued for 72 hours and followed by a slow rewarming period of 6-12 hours.

A one-year clinical and imaging follow-up is planned. As the aim of the present study is to assess the predictiveness of the outcome one year after the HIE event, no follow-up is planned. conditions: Encephalopathy, Hypoxic-Ischemic studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: One group will be followed - with both the standard of care continuous EEG monitoring and near infrared spectroscopy (NIRS) \& the MRI-scan performed at the same time. primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ESTIMATED name: MRI-scan measure: quantifying cerebrovascular reactivity (CVR) by resting-state functional MRI (r-fMRI) in infants with moderate to severe hypoxic-ischaemic encephalopathy (HIE) sex: ALL minimumAge: 1 Hour maximumAge: 14 Months stdAges: CHILD facility: Cliniques Universitaires Saint Luc city: Brussels zip: 1200 country: Belgium lat: 50.85045 lon: 4.34878 hasResults: False

 nctId: NCT06370611 id: 2314027 briefTitle: Early Remote Rehabilitation to Improve Health of the Elderly After Cardiac Surgery. (RECARD Trial) acronym: RECARD overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-09-30 date: 2026-09-30 date: 2024-04-17 date: 2024-04-17 name: Ivy susanne Modrau, MD class: OTHER name: Aalborg University Hospital briefSummary: An increasing number of older patients undergo heart surgery. Despite seemingly successful outcomes, these vulnerable patients may face prolonged decreased functional capacity, reduced self-efficacy, and impaired quality of life after discharge. Early engagement in physical activity and education plays a key role in health and well-being after heart surgery The goal of this clinical trial is to evaluate the effectiveness of an app-based exercise program and weekly calls from a physiotherapist in the early stages after open heart surgery.

Eligible patients will be randomly assigned to either a control group receiving standard care or an intervention group, which will be introduced to an individually tailored exercise program as an addition to standard care.

Follow-up is planned with an out-patient visit six weeks after discharge and a telephone interview six months post-surgery.

All participants will undergo assessments at enrollment and during follow-up. Physical performance will be evaluated through physical tests. General well-being, quality of life, self-reported physical activity, and cost-effectiveness of the intervention will be assessed through questionnaires. Muscle health will be examined through blood sampling, CT scans, and muscle biopsies.

The primary endpoint is the 30-second Chair Stand Test serving as a measurement of physical function. conditions: Cardiac Rehabilitation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Bi-center, prospective, randomized, controlled, parallel (1:1), two-arm, open-label, blinded evaluation (PROBE) trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Allocation cannot be concealed from the participants, care providers or investigator. Outcome assessors will be blinded regarding allocation. whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Early mobile health intervention supplemented by weekly calls from a physiotherapist measure: Change (Δ) 30-second chair stand test (30CST) baseline vs. 6-week FU measure: Change (Δ) in 10-meter Walk Test (10MWT) baseline vs. 6-week FU measure: Difference in 6-minute Walk Test (6MWT) between groups at 6-week FU measure: Change (Δ) in WHO-5-score baseline vs. 6-week FU measure: Change (Δ) in ASS-2-score baseline vs. 6-week FU measure: Change (Δ) in MDI-2-score baseline vs. 6-week FU measure: Change (Δ) in Self-reported Physical Activity baseline vs. 6-week FU measure: Change (Δ) in EuroQol-score baseline vs. 6-week FU measure: Change in skeletal muscle mass maximum 3 months prior to surgery vs. 6-week FU measure: Cost-effectiveness analysis measure: Changes in markers of musculoskeletal health through blood samples baseline vs. 6-week FU measure: Changes in markers of inflammation through blood samples baseline vs. 6-week FU measure: Changes in markers of nutrition through blood samples baseline vs. 6-week FU measure: Changes in markers of liver function through blood samples baseline vs. 6-week FU measure: Changes in markers of kidney function through blood samples baseline vs. 6-week FU measure: Changes in markers of hormone levels through blood samples baseline vs. 6-week FU sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Aarlborg University Hospital city: Aalborg zip: 9000 country: Denmark name: Stian Ingemann-Molden, PT, MHSc role: CONTACT phone: +45 97664210 email: s.ingemannmolden@rn.dk lat: 57.048 lon: 9.9187 facility: Aarhus University Hospital city: Aarhus zip: 8200 country: Denmark name: Rikke Daugaard, PT, MHSc role: CONTACT phone: +45 41282266 email: daugaard@clin.au.dk lat: 56.15674 lon: 10.21076 hasResults: False

 nctId: NCT06370598 id: TP-122 briefTitle: Phase 1/2a to Assess the Safety and Tolerability of TP-122A for the Treatment of Ventilator-Associated Pneumonia acronym: RECOVER overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-05 date: 2025-06 date: 2024-04-17 date: 2024-04-17 name: Technophage, SA class: INDUSTRY name: VectorB2B briefSummary: Given the challenges of treating complex cases of VAP caused by P. aeruginosa and K. pneumoniae, TechnoPhage developed a bacteriophage cocktail (TP-122) against those pathogens, aiming to provide a hospital-based add-on therapy to the SoC including antibiotic therapy, administered by nebulization. TP-122 is a bacteriophage cocktail divided in two different components: TP-122A is comprised of three bacteriophages against infections caused by Pseudomonas aeruginosa and TP-122B includes three bacteriophages against K. pneumoniae . For this study, an effective sample of 15 subjects will be randomly allocated into two arms, in a 3:2 ratio, with 9 subjects receiving TP-122A, in addition to SoC, and 6 subjects receiving the SoC alone. conditions: Pneumonia, Ventilator-Associated studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: TP-122A measure: Evaluate safety and tolerability following nebulization of multiple doses of TP-122A measure: Proportion of subjects achieving "Clinical Cure" CR measure: Time to achieve "Clinical Cure" CR measure: Proportion of subjects achieving "Eradication" or "Presumed Eradication" MR of TP-122A target bacteria measure: Time to achieve "Eradication" or "Presumed Eradication" MR sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CH Nantes city: Nantes country: France name: Antoine Roquilly, MD role: CONTACT name: Antoine Roquilly, MD role: PRINCIPAL_INVESTIGATOR lat: 47.21725 lon: -1.55336 hasResults: False

 nctId: NCT06370585 id: SOPH229-0823/I briefTitle: Clinical Study to Evaluate the Safety and Tolerability of PRO-229 Ophthalmic Solution Compared to Lagricel® Ofteno PF overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2024-09-30 date: 2024-09-30 date: 2024-04-17 date: 2024-04-17 name: Laboratorios Sophia S.A de C.V. class: INDUSTRY briefSummary: This is a phase I study evaluating safety and tolerability of PRO-229 ophthalmic solution through he incidence of unexpected adverse events, changes in Best Corrected Visual Acuity (BCVA), incidence of chemosis, and changes in ocular surface staining using the Sjögren's International Collaborative Clinical Alliance (SICCA) Ocular Staining Score (OSS) scale compared to Lagricel® Ofteno PF in clinically healthy subjects. conditions: Dry Eye Disease conditions: Ocular Surface Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase I, controlled, comparative, double-masked, single-center, randomized, controlled clinical trial. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: PRO-229 name: Lagricel® Ofteno PF measure: Incidence Unexpected Related Adverse Reactions measure: Changes in Best Corrected Visual Acuity (BCVA) measure: Changes in ocular surface staining using SICCA ocular staining score scale measure: Incidence of chemosis measure: Incidence of grade 3 or 4 conjunctival hyperemia. measure: Adherence to treatment (adherence) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06370572 id: CIRB23-1162 id: U54AG063546 type: NIH link: https://reporter.nih.gov/quickSearch/U54AG063546 briefTitle: Pragmatic Use of PAIN-Advanced Dementia Scale in Emergency Departments overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-05 date: 2025-05 date: 2024-04-17 date: 2024-04-19 name: University of Chicago class: OTHER name: National Institute on Aging (NIA) name: University of North Carolina, Chapel Hill briefSummary: The purpose of this study is to learn if the Pain in Advanced Dementia (PAINAD) scale can improve emergency pain care in persons living with dementia (PLWD). It is hypothesized that a PAINAD electronic health record (EHR) prompt that appears to emergency department (ED) staff will enable them to accurately assess pain levels and lead to better pain treatment for PLWD. conditions: Dementia conditions: Hip Pain conditions: Emergency Department Patient conditions: Pain in Advanced Dementia Scale studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: This is a interrupted time series intervention, which allows a pre- and post-intervention assessment of the effect of PAINAD scale. primaryPurpose: TREATMENT masking: NONE count: 1899 type: ESTIMATED name: PAINAD EHR Prompt measure: Percentage of eligible patients receiving a PAINAD assessment upon ED arrival measure: Change in time to administration of first analgesic medication measure: Change in pain score for patients receiving a repeat PAINAD assessment sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: University of Chicago city: Chicago state: Illinois zip: 60637 country: United States name: Teresita M Hogan, MD role: CONTACT phone: 773-702-9500 name: Teresita M Hogan, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: University of North Carolina at Chapel Hill city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Michelle Meyer, PhD, MPH, CPH role: CONTACT phone: (919) 966-6442 name: Michelle Meyer, PhD, MPH, CPH role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False

 nctId: NCT06370559 id: 339042 briefTitle: Relationship Between Repetitive Negative Thinking and CBT Outcomes overallStatus: COMPLETED date: 2022-01-01 date: 2024-02-01 date: 2024-02-01 date: 2024-04-17 date: 2024-04-17 name: South London and Maudsley NHS Foundation Trust class: OTHER briefSummary: The goal of this observational study is to learn about the role of repetitive negative thinking (measured by the RTQ) in adult populations from an anxiety disorders and trauma clinic.

The main questions it aims to answer are:

* Whether the repetitive negative thinking can be used to predict i. initial symptom severity, and ii. therapy outcome (measured by change in scores on disorder specific measures).
* Whether change in RTQ mediates change in outcome Participants are sent weekly questionnaires that measure their progress. Within these questionnaires are the RTQ and other disorder-specific measures that we will be analysing.

Researchers may also compare clients with different disorders to see the accuracy the RTQ can predict treatment outcomes for each disorder. conditions: Anxiety Disorders conditions: Obsessive-Compulsive Disorder conditions: Post-traumatic Stress Disorder conditions: Social Anxiety Disorder conditions: Specific Phobia conditions: Panic Disorder conditions: Body Dysmorphic Disorders studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 320 type: ACTUAL measure: Change in Repetitive Ruminative Thinking Questionnaire score measure: Change in disorder-specific measure score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre for Anxiety Disorders and Trauma city: London zip: SE5 8AZ country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False

 nctId: NCT06370546 id: 229/2022 briefTitle: Cardiac Response to Strength Training in Hypertensive Individuals overallStatus: RECRUITING date: 2023-03-20 date: 2024-07-20 date: 2024-07-20 date: 2024-04-17 date: 2024-04-25 name: Universidad Católica del Maule class: OTHER briefSummary: This study aims to determine the acute and chronic effects of high and low-intensity strength training on cardiac autonomic control in hypertensive subjects conditions: Physical Exercise conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized clinical trial, single blinded. primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: Low intensity name: high intensity measure: Heart rate variability measure: Blood pressure systolic measure: Blood pressure diastolic measure: Blood pressure mean measure: Heart Rate sex: ALL minimumAge: 30 Years maximumAge: 60 Years stdAges: ADULT facility: Universidad Católica del Maule status: RECRUITING city: Talca state: Maule zip: 3469001 country: Chile name: Luis Benavides Roca, PhD(c) role: CONTACT phone: +5699926 8137 email: benavides.roca@gmail.com name: Luis Benavides Roca, PhD(c) role: PRINCIPAL_INVESTIGATOR lat: -35.4264 lon: -71.65542 hasResults: False

 nctId: NCT06370533 id: HGWG-pro briefTitle: Healthy Gestational Weight Gain Programme overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-01-31 date: 2026-01-31 date: 2024-04-17 date: 2024-04-19 name: Peking University class: OTHER name: W.F. Maternal and Child Health Hospital briefSummary: This study aims to evaluate the efficacy of a multi-component lifestyle interventions during pregnancy on promoting appropriate gestational weight gain, preventing GDM, and improving pregnancy, delivery, and neonatal outcomes among overweight or obese pregnant women. The intervention strategies are developed based on the transtheoretical model and mobile health (via WeChat Public Account in smartphone), and will be conducted online and offline. This study will recruit and follow-up 200 overweight or obese singleton pregnant women (pre-pregnancy BMI≥24 kg/m2) during the first trimester of pregnancy from Weifang maternal and Child Health Center, Shandong Province, China. The 200 overweight or obese pregnant women will be randomly allocated at a 1:1 ratio to either the intervention or control group, stratified by the categorical variables of age, BMI and parity. Participants in the control group will be provided usual prenatal care. The lifestyle intervention will last for approximately 6 months (from 10-14 weeks to 32-36 weeks of gestation). Follow-up timepoints included 10-14 weeks of gestation,24-28 weeks of gestation,32-36 weeks of gestation. The interventions are composed of health education related to gestational weight gain and healthy lifestyles, diet modification, active physical activity, regular individual in-person and telephone sessions, diet behavior monitoring, physical activity monitoring, and weight monitoring with Huawei smart watch. The hypothesis is that lifestyle interventions based on the transtheoretical model and mobile health will result in more appropriate gestational weight gain and lower risk of adverse pregnancy outcomes compared with usual care. conditions: Gestational Weight Gain conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: behavioral interventions measure: Total gestational weight gain measure: Gestational weight gain before OGTT screening measure: Weekly rate of gestational weight gain between study clinical assessments measure: Proportion of women who exceed the Chinese reference/2009 IOM guidelines for total gestational weight gain measure: Proportion of women who exceed the Chinese reference/2009 IOM guidelines for appropriate weekly rate of GWG in second and third trimester measure: Proportion of women who exceed the Chinese reference/2009 IOM guidelines for appropriate weekly rate of GWG before OGTT screening measure: Rate of Gestational Diabetes Mellitus diagnosed according to International Association of Diabetes and Pregnancy Study Group (IADPSG) criteria measure: Rate of Preeclampsia/Gestational hypertension measure: Rate of Cesarean Section measure: Absolute/Mean Infant birth weight measure: Rate of Macrosomia measure: Absolute/Mean Apgar scores at 1 min or 5 min measure: Change of Blood pressure measure: Change of body fat percentage (%) measure: Change of fat free mass (kg) measure: Change of muscle mass (kg) measure: Change of handgrip strength (kg) measure: Change of Attitude and knowledge measure: Change of dietary intake measure: Change of physical activity measure: Change of sleep quality measure: Change of Quality of life (12-Item Short Form Survey, SF-12) measure: Incidence of depression measure: Incidence of anxiety measure: The Change of Self-efficacy score (General Self-Efficacy Scale, GSES) measure: The stage of change related to gestational weight control behavior measure: Rate of Postpartum weight retention measure: Absolute/mean offspring weight in kilograms measure: Absolute/mean offspring height in centimetres measure: Absolute/mean offspring head circumference sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06370520 id: 123 briefTitle: Screening Emotions in Adolescents at the Hospital for mTBI acronym: SEARCH-mTBI overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-09 date: 2028-12 date: 2024-04-17 date: 2024-04-23 name: University of California, Davis class: OTHER name: Pediatric Emergency Care Applied Research Network briefSummary: The goal of this observational study is to develop and validate a clinical tool to predict which adolescents aged 11 to less than 18 years of age with mild traumatic brain injury (mTBI) are at an increased risk for developing significant new or worsening mental health conditions.

The main aims the study wish to answer are:

* Does the adolescent have new or worsening depression or anxiety defined as a change from their previous medical history using self-reported questionnaires at either one or three months post-injury?
* Does the adolescent have unmet mental health care needs, defined as not receiving any mental or behavior health care in patients with new or worsening anxiety or depression as defined by the self reported questionnaires?

Participants will be enrolled after being diagnosed in the emergency department (ED) with an mTBI. During the ED visit, the child's parent/caregiver and the adolescent will complete several questionnaires related to mental health which include tools to measure anxiety and depression. Participants will be asked to complete these questionnaires again at 1 month and 3 months post enrollment. conditions: Brain Injury Traumatic Mild conditions: Brain Injuries conditions: Brain Injuries, Acute conditions: Head Injury With Intracranial Hemorrhage conditions: Head Injury Trauma conditions: Brain Injury Traumatic Focal With Loss of Consciousness conditions: Skull Fractures conditions: Diffuse Axonal Injury conditions: Intracranial Hemorrhages conditions: Head Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2592 type: ESTIMATED name: Validated Questionnaires name: Questionnaires name: Clinician / Medical Record Variables measure: New or worsening depression or anxiety measure: Unmet mental health care needs in patients with new or worsening depression or anxiety measure: Decline in quality of life measure: Persistent mTBI symptoms measure: New deficits in emotional/behavioral functioning or hyperactivity/inattention measure: Parent Perception of Unmet Mental Health Needs sex: ALL minimumAge: 11 Years maximumAge: 17 Years stdAges: CHILD facility: University of California, Davis Medical Center city: Sacramento state: California zip: 95817 country: United States name: Maria Marois, PhD, MPH role: CONTACT phone: 916-734-0373 email: mtmarois@ucdavis.edu name: Kyle Pimenta, BAS role: CONTACT phone: 916-734-8847 email: kpimenta@ucdavis.edu name: Daniel K Nishijima, MD, MAS role: PRINCIPAL_INVESTIGATOR lat: 38.58157 lon: -121.4944 facility: Children's Hospital of Philadelphia city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Daniel Corwin, MD role: CONTACT phone: 215-327-2306 email: corwind@chop.edu name: Melissa Godfrey, MPH role: CONTACT phone: 302-598-2134 email: godfreym2@chop.edu name: Kristy Arbogast, PhD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 facility: Hasbro Children's Hospital and Brown University city: Providence state: Rhode Island zip: 02903 country: United States name: Mark Zonfrillo, MD role: CONTACT phone: 401-606-3532 email: mark_zonfrillo@brown.edu name: Mhina Johnbaptiste, MPH role: CONTACT phone: 954-591-1222 email: mjohnbaptiste@lifespan.org name: Mark Zonfrillo, MD, MSCE role: PRINCIPAL_INVESTIGATOR lat: 41.82399 lon: -71.41283 facility: University of Texas Southwestern Medical Center city: Dallas state: Texas zip: 75390 country: United States name: Mohamed Badawy, MD role: CONTACT phone: 214-456-7106 email: Mohamed.Badawy@UTSouthwestern.edu name: Aja Bayo, MSc role: CONTACT phone: 214-457-1793 email: aja.bayo@utsouthwestern.edu name: Mohamad Badawy, MD role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 facility: Baylor College of Medicine, Texas Children's Hospital city: Houston state: Texas zip: 77030 country: United States name: Andrea Cruz, MD, MPH role: CONTACT phone: 832-824-5582 email: acruz@bcm.edu name: Victor Gonzalez, MD role: CONTACT phone: 832-824-5977 email: vmgonzal@bcm.edu name: Andrea Cruz, MD, MPH role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 facility: The Medical College of Wisconsin, Inc. city: Milwaukee state: Wisconsin zip: 53226 country: United States name: Danny G Thomas, MD, MPH role: CONTACT phone: 414-266-2625 email: dthomas@mcw.edu name: Najia Ali role: CONTACT phone: 414-266-2767 email: naali@mcw.edu name: Danny G Thomas, MD, MPH role: PRINCIPAL_INVESTIGATOR lat: 43.0389 lon: -87.90647 hasResults: False

 nctId: NCT06370507 id: UPO2# briefTitle: Monitoring of Lung Ventilation Through Electrical Impedance Tomography During Pediatric Surgery acronym: VentiPed overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-31 date: 2025-07-31 date: 2024-04-17 date: 2024-04-17 name: Azienda Ospedaliero Universitaria Maggiore della Carita class: OTHER briefSummary: Given the scarcity of studies aimed at assessing the effect of anesthesia and m ventilation on the distribution of lung ventilation in pediatric patients undergoing surgery, with the exclusion of thoracic surgery, the present prospective observational study would shed the light on ventilation practice in pediatric anesthesia for surgery. This study wold fill the actual gap allowing the evaluation, through electrical impedance tomography (EIT) of the distribution of lung ventilation across the different phases of anesthesia for pediatric surgery. These insights could contribute to improve clinical practice and research in the management of ventilation in pediatric patients undergoing anesthesia for surgery. conditions: Ventilator Lung conditions: Surgery conditions: Pediatric studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 800 type: ESTIMATED name: Electrical impedance tomography assessment of ventilation distribution in course of sedation/general anesthesia for pediatric surgery measure: Ventilation distribution measure: Intraoperative ventilatory respiratory mechanics measure: Postoperative pulmonary complications measure: Intraoperative oxygenation measure: Intraoperative hemodynamics sex: ALL minimumAge: 0 Days maximumAge: 14 Years stdAges: CHILD hasResults: False

 nctId: NCT06370494 id: IRB2020-0956D briefTitle: Testing New Models of Diabetes Self-Management to Improve Population Health overallStatus: COMPLETED date: 2019-02-01 date: 2022-03-31 date: 2022-03-31 date: 2024-04-17 date: 2024-04-17 name: Texas A&M University class: OTHER name: Blue Cross Blue Shield briefSummary: Aim 1.1 To understand if diabetes self-management education and support (DSMES) improves diabetes-related outcomes among those with Type 2 diabetes living in Texas.

Aim 1.2 To examine how rurality affects study participation, engagement in, and effectiveness of different education interventions.

These aims are based on a randomized controlled trial of different evidence-based diabetes self-management interventions. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: A randomized controlled trial (RCT) was conducted to assess the outcomes associated with different technological intervention approaches. This 3-arm RCT assessed independent and combined interventions: primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 191 type: ACTUAL name: Living Healthier with Diabetes measure: A1C -Change in HbA1c between baseline, 3 months, and 6 months is the primary outcome. measure: Diabetes Knowledge: Knowledge of diabetes will be measured by the simplified version of the Revised Diabetes Knowledge Scale (True/False version). measure: Diabetes Self Care measure: Diabetes Care Confidence measure: Diabetes care distress measure: A1C sex: ALL minimumAge: 25 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Texas A&M Health city: College Station state: Texas zip: 77843-1266 country: United States lat: 30.62798 lon: -96.33441 hasResults: False

 nctId: NCT06370481 id: IRB-300012349 briefTitle: HIV, Equity, and Addiction Training (HEAT) Program acronym: HEAT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2029-06 date: 2029-12 date: 2024-04-17 date: 2024-04-26 name: University of Alabama at Birmingham class: OTHER briefSummary: This project is a pilot study to determine the feasibility and acceptability of a telemedicine intervention for substance use disorder service delivery in diverse people living with HIV in Alabama. conditions: Substance Use Disorders conditions: Hiv conditions: Opioid Use Disorder conditions: Stimulant Use (Diagnosis) studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Telemedicine name: Standard of care measure: Percent of participants who have a follow-up healthcare visit sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama at Birmingham city: Birmingham state: Alabama zip: 35294 country: United States name: Tyler O'Rear role: CONTACT phone: 205-721-5735 email: storear@uabmc.edu name: Ellen F Eaton, MD, MSPH role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 hasResults: False

 nctId: NCT06370468 id: 2024-CR-China briefTitle: The Epidemiological and Intrinsic Characteristics of Chronic Rhinitis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2027-08-01 date: 2024-04-17 date: 2024-04-22 name: Zheng Liu ENT class: OTHER name: Peking Union Medical College name: Hainan People's Hospital name: Shandong Second Provincial General Hospital name: First Affiliated Hospital of Chongqing Medical University name: First Affiliated Hospital of Xinjiang Medical University briefSummary: Chronic rhinitis affects 10-40% of China's population, or over 300 million people, and can lead to respiratory and psychological issues. Despite treatment progress, 30% of patients have poor outcomes, likely due to the disease's complexity and a lack of new treatment targets. The incidence is rising, but there's a lack of nationwide studies on its variations. This study addresses this through a multicentric survey to create a national database on chronic rhinitis, including epidemiological, clinical, and biological data. The goal is to understand chronic rhinitis's causes and risks, improve treatments, and develop preventive strategies. The study will survey 30,000 patients across China, using questionnaires and nasal exams, and preserve biological samples in a biobank for detailed analysis. This will lay the groundwork for understanding the disease's mechanisms, developing new diagnostics, and tailoring prevention and treatment approaches for different forms of chronic rhinitis. conditions: Chronic Rhinitis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 150000 type: ESTIMATED name: Epidemiological investigation measure: The prevalence and distribution patterns of chronic rhinitis within the Chinese population measure: The clinical features and endotype of chronic rhinitis sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hosptial affiliated to Tongji Medical college of Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430030 country: China lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06370455 id: 36264MS429/11/23 briefTitle: Comparison of Septal Advancement Flap and Columellar Strut Effect on Nasal Tip overallStatus: RECRUITING date: 2024-01-23 date: 2025-02-23 date: 2025-04-20 date: 2024-04-17 date: 2024-04-22 name: Tanta University class: OTHER briefSummary: The aim of the study to compare and evaluate the effect of septal advancement flap in preserving and reshaping the nasal tip with columellar strut graft conditions: Rhinoplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: comparison of septal advancement flap effect on nasal tip in primary rhinoplasty to columellar strut technique measure: subjective assessment using Rhinoplasty Outcome Evaluation Questionnaire measure: measuring the degree of tip projection and rotation preoperative and postoperative sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Otorhinolaryngology department -Tanta University Hospitals status: RECRUITING city: Tanta country: Egypt name: Mohamed Elsayed Elkady, MD role: CONTACT phone: 01004582738 phoneExt: +2 lat: 30.78847 lon: 31.00192 hasResults: False

 nctId: NCT06370442 id: 2137695 briefTitle: Intranasal Dexmedetomidine vs. Standard of Care for Emergency Department (ED) Procedural Sedation in the Older Adult overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-05-31 date: 2025-09-01 date: 2024-04-17 date: 2024-04-22 name: State University of New York - Upstate Medical University class: OTHER briefSummary: The purpose of the study is to determine if intranasal dexmedetomidine could be an alternative to the current standard of care (injectable benzodiazepines or antipsychotics) for sedation prior to computerized tomography (CT) or magnetic resonance imaging (MRI) in those greater than or equal to 65 years of age (older adults) that are seen in the Emergency Department (ED). conditions: Altered Mental Status studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 60 type: ESTIMATED name: Dexmedetomidine name: Lorazepam name: Haloperidol measure: Sedation sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06370429 id: 8743432956-050.99-621064 briefTitle: Effect of Online Exercises for Premenstrual Syndrome on Couple's Stress and Family Function overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-08-30 date: 2024-12-30 date: 2024-04-17 date: 2024-04-17 name: Suleyman Demirel University class: OTHER briefSummary: Universe of Research The universe of the research; It will consist of women and their spouses with premenstrual syndrome complaints who use social media.

3.6. Sample of the Research The number of samples of the study was composed of a total of 60 (Intervention = 30, Control = 30) participants.

Criteria for inclusion in the study:

* Being married and living with his wife
* Being between the ages of 18-45,
* The woman's ability to use a mobile phone and/or computer to receive online
* The woman and her husband must be literate
* The woman does not have a hearing problem that would prevent her from understanding the voice recording, 9. Scoring 110 or above on the Premenstrual Syndrome Scale 10. Having regular menstrual cycles for the last six months, 13. Having no other medical disease in the last six months, 14. Participant who does not use oral contraceptives, 16. Not pregnant or breastfeeding, 17. No history of cancer. 18. Those who do not use medical drugs to reduce premenstrual syndrome 19. Those who do not use herbal medicine to reduce premenstrual syndrome 20. Do not practice exercise, yoga, etc. to reduce premenstrual syndrome.

Exclusion criteria from the study:

1. He or his spouse fills out the research survey forms incompletely,
2. Pregnancy occurs,
3. Receiving breathing exercise consultancy from another consultant during the study period

Data Collection Method and Duration Descriptive Characteristics Data Form, Perceived Stress Scale (PSS) and Family Assessment Scale will be applied to the sampled women and their spouses. Data collection will continue until the calculated sample number is reached. conditions: Premenstrual Syndrome conditions: Exercises conditions: Stress Level conditions: Family Characteristics studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The sample was divided into intervention and control groups primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ESTIMATED name: Progressive Relaxation Exercises, randomized pretest-posttest measure: Premenstrual Syndrome Scale measure: Family Assessment Scale measure: Perceived Stress Scale sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Suleyman Demirel University city: Isparta zip: 32500 country: Turkey lat: 37.76444 lon: 30.55222 hasResults: False

 nctId: NCT06370416 id: HSKY002 briefTitle: the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With Trilaciclib overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-04-30 date: 2025-12-31 date: 2024-04-17 date: 2024-04-17 name: Henan Cancer Hospital class: OTHER_GOV name: Jiangsu Simcere Pharmaceutical Co., Ltd. briefSummary: This study is a single arm, exploratory clinical study aimed at evaluating the efficacy and safety of tralazili before chemotherapy in patients with NSCLC.After pathological diagnosis of non-small cell lung cancer(NSCLC), 40 eligible subjects who met the inclusion criteria were screened and given a treatment regimen of trilaciclib before chemotherapy, after signing informed consent. conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 40 type: ESTIMATED name: Trilaciclib measure: The incidence of grade ≥ 3 neutropenia during chemotherapy treatment measure: The incidence of grade 4 neutropenia during chemotherapy treatment measure: The incidence of grade 3 or grade 4 thrombocytopenia measure: The incidence of grade 3 or 4 anemia during chemotherapy treatment measure: Objective relief rate measure: Disease control rate measure: Progression free survival measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Henan Tumor Hospital city: Zhengzhou state: Henan zip: 450000 country: China lat: 34.75778 lon: 113.64861 hasResults: False

 nctId: NCT06370403 id: LithuanianSportsU-21 briefTitle: Effects of Head and Neck Cooling and Heating on Fatigue in Multiple Sclerosis and Healthy Men overallStatus: COMPLETED date: 2014-02-04 date: 2016-03-01 date: 2017-01-08 date: 2024-04-17 date: 2024-04-19 name: Lithuanian Sports University class: OTHER briefSummary: Local head and neck cooling strategies can help reduce multiple sclerosis-related fatigue, while heating can exacerbate heat-related fatigue. However, no study has detailed the peripheral and central responses to head and neck cooling (at 18°C) and heating (at 43 ± 1°C next to the scalp and neck skin) during fatiguing isometric exercise in non-challenging ambient temperature in multiple sclerosis and healthy male subjects. In addition, there is a lack of data describing the effects of head and neck cooling/heating and strenuous exercise on blood markers, muscle temperature, motor accuracy, and rate of perceived exertion. The investigators hypothesized that: (i) men with multiple sclerosis would be more affected by central and peripheral fatigue compared to healthy subjects; (ii) local cooling will result in greater central fatigue but will be associated with greater peripheral fatigue, whereas heating will result in greater central and peripheral fatigue in multiple sclerosis men; (iv) local cooling and heating will have a greater effect on the release of stress hormones, rate of perceived exertion and motor accuracy compared to the control condition in both multiple sclerosis and healthy groups. conditions: Multiple Sclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: NONE maskingDescription: The researchers who analyzed the venous blood samples were blinded. count: 40 type: ACTUAL name: Cooling of the head and neck name: Heating of the head and neck measure: Body weight (kg) measure: Body fat (%) measure: Body free fat mass (kg) measure: Body mass index (kg/m2) measure: Change in muscle temperature (°C) measure: Change in plasma cortisol (nmol/L) concentrations measure: Change in plasma dopamine (nmol/L) concentrations measure: Change in plasma prolactin (ng/mL) concentrations measure: Change in subjective rating of perceived exertion measure: Change in muscle activity (mV) measure: Change in muscle activity (Hz) measure: Change in voluntary torque (Nm) measure: Change in involuntary torque (Nm) measure: Change in muscle contraction and relaxation (ms) measure: Change in central activation ratio (percent) measure: Change in constant error measure: Change in absolute error measure: Height (m) sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Lithuanian Sports University city: Kaunas zip: LT 44221 country: Lithuania lat: 54.90272 lon: 23.90961 hasResults: False

 nctId: NCT06370390 id: community - stroke dysphagia briefTitle: Community-based Group Rehabilitation Program for Stroke Patients With Dysphagia overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-06 date: 2024-04-17 date: 2024-04-17 name: Copka Sonpashan class: OTHER_GOV briefSummary: Community-based exercise programs have demonstrated potential for implementation in older adults; however, it remains imperative to ascertain whether this strategy will yield comparable benefit in stroke patients with dysphagia.Participants were randomly assigned to either the intervention group or the control group. Patients in the intervention group received swallowing function training in community public spaces for 5 days every week for four-week period (60 minutes per day). Patients in the control group received no intervention. Penetration-Aspiration Scale and Standardized Swallowing Assessment (SSA), depressive symptoms (Geriatric Depression Scale-15), and meal duration were assessed before and after all the treatment. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: swallowing function training measure: Standardized Swallowing Assessment Scale measure: Time consumed in eating measure: Penetration-Aspiration Scale measure: 15-item Geriatric Depression Scale sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06370377 id: 0305899 briefTitle: Nurses' Adherence to Professional Nursing Code of Ethics and Quality of Nursing Care Satisfaction overallStatus: COMPLETED date: 2022-12-01 date: 2023-02-28 date: 2023-02-28 date: 2024-04-17 date: 2024-04-17 name: Matrouh University class: OTHER briefSummary: Nursing code of ethics is an essential part of nursing professional practice. Nurses' adherence to a code of ethics is an important pillar of improving their performance, providing good nursing care and achieving patient satisfaction. conditions: Professional Role conditions: Nurse's Role conditions: Ethics, Narrative conditions: Satisfaction, Patient studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 400 type: ACTUAL name: the Egyptian code of ethical practice measure: Questionnaire to measure source of nurses' knowledge about Egyptian code of ethics measure: Observational checklist to measure measure: Questionnaire to measure patient satisfaction with the quality of nursing care 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: NCT06370364 id: 25 briefTitle: Nurses' Practice of Safe Blood Transfusion in Surgical and Critical Care Units overallStatus: COMPLETED date: 2020-12-01 date: 2021-04-30 date: 2021-04-30 date: 2024-04-17 date: 2024-04-17 name: Matrouh University class: OTHER briefSummary: Blood transfusions are an important part of nursing procedure. Nurses play a key role in safely administering blood products to patients in surgical and critical care unit conditions: Practice Nurse's Scope conditions: Blood Transfusion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 350 type: ACTUAL name: Nurses' Practice of Safe Blood Transfusion measure: Questionnaire to measure factors affecting safe blood transfusion measure: observational checklist to measure nurses' practice of safe blood transfusion 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: NCT06370351 id: SENS-501-101 id: 2023-504466-28-00 type: CTIS briefTitle: A Phase I/II Clinical Trial With SENS-501 in Children Suffering From Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations acronym: AUDIOGENE overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2027-04 date: 2031-04 date: 2024-04-17 date: 2024-04-17 name: Sensorion class: INDUSTRY briefSummary: This study intends to assess safety, tolerability, and efficacy of SENS-501 in children between the ages of 6-31 months with pre-lingual hearing loss due to a mutation in the Otoferlin gene. conditions: OTOF Gene Mutation conditions: DFNB9 conditions: Congenital Deafness conditions: Hearing Disorders conditions: Ear Diseases conditions: Otorhinolaryngologic Diseases conditions: Deafness conditions: Hearing Loss, Sensorineural studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: SENS-501 administration measure: Safety and tolerability of SENS-501 measure: Efficacy of SENS-501 assessed by ABR measure: Safety and tolerability of SENS-501 measure: Efficacy of SENS-501 assessed by ABR measure: Efficacy of SENS-501 assessed by PTA measure: Clinical performance of the administration system measure: Safety of the administration system measure: Usability of the administration system sex: ALL minimumAge: 6 Months maximumAge: 31 Months stdAges: CHILD facility: Hopital Necker Enfants Malades city: Paris zip: 75015 country: France name: Natalie LOUNDON, Pr role: CONTACT phone: +33(0)171396782 email: natalie.loundon@aphp.fr name: Natalie LOUNDON, Pr role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06370338 id: 2024B0101 briefTitle: Cardiothoracic Critical Care as Subspecialty and Its Core Competencies overallStatus: RECRUITING date: 2024-04-11 date: 2025-04-30 date: 2025-04-30 date: 2024-04-17 date: 2024-04-18 name: Ohio State University class: OTHER briefSummary: The aim of this study is to develop a consensus on the curriculum for training cardiothoracic critical care by first evaluating the need for the field, based on a Delphi consensus among a panel of experts in this field. conditions: Consensus Development studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 68 type: ESTIMATED name: Delphi Questionnaire measure: Degree of consensus on the curriculum for training cardiothoracic critical care by first evaluating the need for the field measure: Degree of consensus on defining training core competencies, goals, and milestones. measure: Degree of consensus on the definitions of "Scholarship", "Patient", "Safety", "Quality" sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The Ohio State University Wexner Medical Center status: RECRUITING city: Columbus state: Ohio zip: 43210 country: United States name: Alberto Uribe, MD role: CONTACT phone: 614-293-3559 email: alberto.uribe@osumc.edu name: Jeremy Reeves, BA role: CONTACT phone: 6148067569 email: jeremy.reeves@osumc.edu lat: 39.96118 lon: -82.99879 hasResults: False

 nctId: NCT06370325 id: 23-00987 briefTitle: Neuromuscular Electrical Stimulation in Foot and Ankle Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-08 date: 2024-08 date: 2024-04-17 date: 2024-04-17 name: NYU Langone Health class: OTHER briefSummary: This is a pilot randomized controlled trial, wherein the intervention group will undergo NMES five days a week beginning three weeks postoperative and lasting for ten weeks. Both the control and intervention groups will start standard physical therapy six weeks postoperative. Primary outcome measure will be the isometric strength of the gastrocnemius muscle. The secondary outcomes will comprise subjective clinical evaluations (using the Lower Extremity Functional Scale \[LEFS\]), functional assessments such as the sit-to-stand test, 2-minute walk test, stair climb test and objective clinical evaluation using contralateral comparison of calf circumference. conditions: Ankle Fractures studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: VPOD Wireless Tens Unit name: Physical Therapy name: Biodex measure: Isometric Strength of Gastrocnemius Muscle measure: Isometric Strength of Gastrocnemius Muscle measure: Isometric Strength of Gastrocnemius Muscle measure: Bilateral Calf Circumference measure: Bilateral Calf Circumference measure: Bilateral Calf Circumference measure: Lower Extremity Functional Scale (LEFS) Questionnaire Score measure: Lower Extremity Functional Scale (LEFS) Questionnaire Score measure: Lower Extremity Functional Scale (LEFS) Questionnaire Score measure: Sit-to-Stand Test measure: Sit-to-Stand Test measure: Sit-to-Stand Test measure: 2 Minute Walk Test measure: 2 Minute Walk Test measure: 2 Minute Walk Test measure: Stair Climb Test measure: Stair Climb Test measure: Stair Climb Test sex: ALL minimumAge: 18 Years maximumAge: 70 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: NCT06370312 id: 2023-07921-01 briefTitle: Analysis of Articular Biomarkers From Osteoarthritic Thumb Basal Joints overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2027-04-30 date: 2024-04-17 date: 2024-04-17 name: Region Skane class: OTHER briefSummary: The study project aims at examining molecular markers in synovial fluid, bone and articular cartilage from osteoarthritic thumb basal joints. The degradation of extracellular matrix (ECM) proteins in thumb basal joints will be evaluated in association to the metabolic profile of the patient, but we also aim to compare the ECM degradation and inflammatory profiles with articular cartilage degradation ECM profile from knee joints with osteoarthritis. A third aim is to evaluate associations between patient-reported hand function, pain, strength and range of thumb motion to analyses of synovial fluid. conditions: Osteoarthritis Thumb conditions: Osteoarthritis, Knee conditions: Metabolic Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Trapeziectomy measure: Serum cholesterol levels sex: ALL minimumAge: 25 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06370299 id: 2023-06402-01 briefTitle: Screening of Multidrug Resistant Bacteria, and the Clinical Implication for the Patient overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12 date: 2025-06 date: 2024-04-17 date: 2024-04-17 name: Region Skane class: OTHER name: Lund University briefSummary: The goal of this observational study is to evaluate the screening for multidrug resistant bacteria in patients admitted to hospitals in Scania. The main questions it aims to answer are:

* admission rates after screening
* 30-day and one-year mortality after screening Participants will be evaluated for positive screening results with following multidrug resistant gram negative bacilli: ESBL producing Enterobacterales, Carbapenemase producing Enterobacterales, Carbapenem resistant P.aeruginosa and carbapenem resistant Acinetobacter baumannii. Researchers will compare patients with positive and negative screening results to see, if the relative risks in the two groups differ in admission rates and mortality. conditions: Multi-antibiotic Resistance studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 10000 type: ESTIMATED name: (exposure of) MDR carriage measure: The ratio of the probability of all-cause admission in patients who are screening positive to the probability of all-cause admission in patients who are screening negative. measure: The ratio of the probability of death in patients who are screening positive to the probability of death in patients who are screening negative. measure: The ratio of the probability of antibiotic use in patients who are screening positive to the probability of antibiotic use in patients who are screening negative. measure: prevalence of positive screening results measure: prevalence of MDR in clinical samples measure: time to first occurrence of phenotypically same MDR as in screening measure: prevalence of MDR in clinical samples in patients with negative screening results sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06370286 id: PACNL_rueihongli_CE_IC briefTitle: The Effect of Acute Concurrent Exercise on Inhibitory Control: An Event-related Potential Study overallStatus: COMPLETED date: 2021-02-15 date: 2021-08-15 date: 2022-02-15 date: 2024-04-17 date: 2024-04-18 name: National Taiwan Normal University class: OTHER briefSummary: The present study aimed to determine the effects of acute concurrent exercise on inhibitory control via behavioral and event-related potential approaches and to examine its potential mediational role on lactate among younger adults. The main questions it aims to answer are: (1) Does acute concurrent exercise improve inhibitory control via behavioral and event-related potential approaches? (2) Does lactate play a potential mediational role in the effect of acute concurrent exercise on inhibitory control? conditions: Exercise conditions: Cognition studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants were randomly assigned to either a concurrent exercise (CE), aerobic exercise (AE), or control (CON) group. Participants in the CE group engaged in 12-minutes of AE (40%-59% of heart rate reserve \[HRR\]) coupled with 13-minutes of resistance exercise (1 set, with 75% of 10-repetition maximum, and 12 repetitions of 8 movements). The AE group participated in 25 minutes of AE (40%-59% HRR). Prior to and following exercise onset, participants in both the CE and AE groups completed a 5-minute warm-up and cool-down. Participants in the CON group read books for 35 minutes. Lactate concentrations were measured at timepoint of 0-, 17-, and 30-minutes relative to the treatment onset. Response time (RT) and accuracy in the Stroop test, as well as P3 amplitudes, were assessed before and after the treatment. primaryPurpose: TREATMENT masking: NONE count: 78 type: ACTUAL name: concurrent exercise (CE) name: aerobic exercise (AE) measure: Inhibitory control measure: Blood lactate sex: ALL minimumAge: 20 Years maximumAge: 30 Years stdAges: ADULT facility: Department of Physical Education and Sport Sciences, National Taiwan Normal University city: Taipei zip: 106 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06370273 id: 1009305 briefTitle: Thromboprophylaxis in Lower Limb Immobilisation acronym: TiLLI overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-02 date: 2028-02 date: 2024-04-17 date: 2024-04-17 name: Queen Mary University of London class: OTHER briefSummary: The goal of this clinical trial is to find out the clinical and cost effectiveness of Thromboprophylaxis in participants who have been placed in a plaster cast or splint after injury.

The main questions it aims to answer are:

* whether giving tablets to people at high risks of clots after a leg injury is as good as injections (standard care)
* whether giving any medication after a leg injury is better than standard care (advice only) for people at low risk of clots.

Participants will be assessed to be high risk (TiLLI High) or low risk (TiLLI Low). People who are at high risk of clots will have either tablets or injections to reduce their risk. People at low risk will receive tablets, injections or no medication.

Drug treatments will be provided for the duration of immobilisation or up to 42 days (whichever is earlier), in accordance with current NICE guidelines. The participants will be followed up for 90 days following randomisation. conditions: Thrombosis conditions: Injury Leg studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A pragmatic, open-label, linked pair of randomised controlled trials with common outcomes and parallel economic analysis each with internal pilot phases, conducted across 30 NHS sites primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Open-label study. Trial Statistician and Health Economist to be blinded for analysis whoMasked: OUTCOMES_ASSESSOR count: 10044 type: ESTIMATED name: Rivaroxaban name: Apixaban name: Enoxaparin Injectable Solution name: Tinzaparin Injectable Solution name: Dalteparin Injectable Solution name: Fondaparinux Injectable Product measure: Composite of net clinical benefit comprising clinical VTE event, major bleeding, and cause-specific mortality measure: Symptomatic VTE event occurrence measure: Major bleeding occurrence measure: Cause-specific mortality occurrence measure: Adverse and Serious adverse events measure: Medication adherence measure: Health utility (EQ-5D-5L) measure: Patient satisfaction regarding the burdens and benefits of anticoagulation measure: Hospital readmission/reattendance measure: Health and social care resource use measure: Patient longer term outcome VTE and bleeding data sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06370260 id: INTM-PMCF-UNIGEL id: 571/13.02.2023 type: OTHER domain: INTERMED S.A briefTitle: Assessing the Efficacy of a Hydrogen Peroxide Gel for Oral Wound Healing and Oral Hygiene overallStatus: COMPLETED date: 2023-05-02 date: 2023-12-27 date: 2023-12-27 date: 2024-04-17 date: 2024-04-17 name: National and Kapodistrian University of Athens class: OTHER name: Ioulia And Irene Tseti Pharmaceutical Laboratories S.A. briefSummary: This study aims to assess the effectiveness and safety of a hydrogen carbamide/peroxide gel, called UNISEPT® ORAL GEL, in promoting oral wound healing, alleviating postoperative symptoms, and enhancing oral hygiene.

Study participants will include individuals with any suspicious lesion in their gums or the roof of their mouth. They will undergo a procedure to remove a small piece of tissue for testing (biopsy) in order to confirm the diagnosis.This is a standardized diagnostic procedure that involves the use of a punch, which is a plastic handpiece with a cylindrical cutting blade. Subsequently, the wound heals naturally without the need for sutures.

Researchers are comparing this gel with a placebo (a look-and-taste-alike substance that contains no active ingredients) to see if it is helpful with healing of wounds in the mouth and associated symptoms, improving oral hygiene. Participants randomly get the hydrogen carbamide/peroxide gel or the placebo one to use for 14 days after the biopsy. The researchers will not know which one they are providing as the gel tubes will be identical.

Oral wound healing, postoperative symptoms (such as pain, eating and speech difficulties), oral hygiene (dental plaque and gingival inflammation) and quality of life are assessed during a 14-day period after the biopsy. Participants are required to visit the clinic three times, one for the initial biopsy, one at 7 days and one at 14 days after the biopsy. They are asked to fill in some questionnaires, while certain procedures (taking a photo the site of the biopsy) and assessments (like evaluating the dental plaque and gingival inflammation) take place. During the first week they, also, keep a diary of their symptoms, as instructed. conditions: Wound Heal conditions: Postoperative Pain conditions: Biopsy Wound conditions: Wound; Mouth conditions: Quality of Life conditions: Dental Plaque conditions: Gingival Inflammation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This trial is designed as a prospective, randomized, placebo-controlled, triple blinded, with two parallel groups and an equal allocation ratio in all groups. In this study, the intervention consists of delivery of a hydrogen carbamide/peroxide gel or placebo gel, made by the same manufacturer. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 54 type: ACTUAL name: Hydrogen Carbamide/Peroxide Gel name: Placebo Gel measure: Assessment of wound healing based on Percentage Healing Index on day 14 measure: Assessment of wound healing based on Percentage Healing Index on day 7 measure: Postoperative symptoms (pain, eating and speech difficulty) during the first week (at home) measure: Postoperative symptoms (pain, eating and speech difficulty) on day 7 measure: Postoperative symptoms (pain, eating and speech difficulty) on day 14 measure: Wound healing based on clinical signs measure: Oral Hygiene - Dental Plaque: Sextant Plaque Index measure: Oral Hygiene - Gingival Inflammation: Sextant Gingival Index measure: Oral Health Related Quality of Life measure: Adverse Events measure: Participant's comments and satisfaction regarding the provided treatment/use of the products measure: Compliance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Oral Medicine & Pathology and Hospital Dentistry, School of Dentistry city: Athens state: Attiki zip: 11527 country: Greece lat: 37.97945 lon: 23.71622 hasResults: False

 nctId: NCT06370247 id: Soh-Med-23-04-07PD. briefTitle: First-time Usage of SGLT2 Inhibitors in Type 2 Diabetic Patients Who Are Fasting During Ramadan: Safety and Efficacy overallStatus: COMPLETED date: 2023-04-25 date: 2023-06-25 date: 2023-09-25 date: 2024-04-17 date: 2024-04-17 name: Sohag University class: OTHER briefSummary: All healthy Muslim adults are required to observe the Ramadan fast, which is one of Islam's five pillars. People with Type 2 Diabetes Mellitus frequently fast throughout Ramadan (T2DM).

Although fasting during Ramadan is said to have positive effects on diabetes patients, such as a reduction in excess body weight and an improvement in lipid profile it can be linked to a slight increased risk for metabolic complications that need immediate attention, such as hypoglycemia and hyperglycemia, dehydration, and diabetic ketoacidosis (DKA The number of diabetics worldwide was projected to reach 537 million in 2021. Studies have shown that there are a rising number of people in this category, and by 2045, there will be 738 million people worldwide who have diabetes. Almost 150 million Muslims worldwide have diabetes, and this number is progressively rising. Research estimates that 118 million of these Muslims who have diabetes fast throughout Ramadan, underscoring the need of choosing the best treatment strategy at this time. Almost two-thirds of all Muslims with T2DMfast throughout the month of Ramadan, according to studies from CREED, Epidemiology of Diabetes, and Ramadan.According to this, the most recent study showed that 86% of patients with T2DMreported a fast for at least 2 weeks.

Patient education, which should cover information on risks, lifestyle modifications, glucose monitoring, diet, exercise, and medication, is a crucial component of managing diabetes during Ramadan.Several studies have demonstrated the effectiveness and safety of sodium glucose cotransporter 2 inhibitors (SGLT2 I) in T2DM patients who are fasting throughout Ramadan. In individuals with T2DM, SGLT2 inhibitors have shown to reduce cardiovascular events and slow the course of renal disease.

In the literature published so far, SGLT2i has shown lower rates of hypoglycemia and hypovolemia during fasting as compared to sulphonylureas (SU). conditions: SGLT2 Inhibitors, First Time Use conditions: Type2 Diabetes conditions: Fasting in Ramadan studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ACTUAL name: HbA1c, serum creatinine, eGFR urine analysis and serum electrolyte Na and K measure: blood glucose level monitoring measure: safety of SGLT2 inhibitors usage during ramadan sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Sohag Faculty of Medicine city: Sohag country: Egypt lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06370234 id: 201412166MINA briefTitle: The Prediction Model of NAC Response for Breast Cancer Based on The Parametric Dynamics Features. overallStatus: COMPLETED date: 2015-04-21 date: 2019-06-30 date: 2020-03-03 date: 2024-04-17 date: 2024-04-17 name: National Taiwan University Hospital class: OTHER name: Ministry of Science and Technology, Taiwan briefSummary: The main purpose of this study is to develop a computer-aided prediction model for NAC treatment response. Based on the heterogeneity of internal parametric tumor composition commonly observed, this study will utilize the histologic characteristics and treatment response to investigate the image features as input data for predicting treatment response using Deep Learning technology. Using this technique, preoperative treatment evaluation may be facilitated by tumor heterogeneity analysis from developed dynamic radiomics, and the possibility of personal medicine can be realized not far ahead. In the first two years of this study using images from DCE-MRI, PET/CT and QDS-IR, we plan to develop the image processing algorithms, including segmenting breast and tumor region, extracting image feature which reflects angiogenic properties and permeability of tumor, which are highly correlated with NAC treatment response. During the third year of the project, the morphology and texture features from first two years can be combined for PET/MRI and prediction model can be achieved in accordance with the features extracted from dynamic features extraction using longitudinal images of PET/MRI. conditions: Breast Cancer conditions: Chemotherapy Effect conditions: Diffusion Weighted MRI conditions: PET Imaging conditions: Multiparametric Magnetic Resonance Imaging studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 60 type: ACTUAL name: Whole body 18F-FDG Positron Emission Tomography measure: Model Prediction power of pathological complete response(pCR) measure: Comparison of models in prediction of pathological complete response(pCR) sex: FEMALE minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06370221 id: psoriatic Arthritis briefTitle: The Effect of Psoriatic Arthritis on Female Sexual Dysfunction overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-20 date: 2024-12-30 date: 2024-04-17 date: 2024-04-17 name: Egymedicalpedia class: INDUSTRY briefSummary: Psoriasis is one of the most common immunemediated chronic inflammatory skin disorders. conditions: Psoriatic Arthritis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 180 type: ESTIMATED name: The effect of psoriatic Arthritis measure: Evaluation of female sexual function sex: FEMALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Qena Hospital city: Qinā country: Egypt name: Eisa Hegazy, Assist.Prof role: CONTACT phone: 01094337795 email: eisa_mohamed4152@med.svu.edu.eg lat: 26.16418 lon: 32.72671 hasResults: False

 nctId: NCT06370208 id: LUMHS/B12/Temp/13.04.2024 briefTitle: Prophylactic Effect of Probiotic Streptococcus Salivarius K12 Against Recurrent Streptococcus Pyogenes Pharyngotonsillitis Infection in Pediatrics overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-11-30 date: 2024-12-31 date: 2024-04-17 date: 2024-04-17 name: Liaquat University of Medical & Health Sciences class: OTHER briefSummary: Recurrent Streptococcus pyogenes pharyngotonsillitis infection in children presents a significant health concern, characterized by frequent episodes of sore throat, fever, and swollen tonsils. These recurrent infections can lead to missed school days, discomfort, and potential complications if left untreated. Current treatment typically involves antibiotics to eradicate the bacterial infection. However, drawbacks exist with this approach, including the risk of antibiotic resistance, disruption of the gut microbiota, and potential adverse effects such as gastrointestinal upset or allergic reactions. Moreover, antibiotics do not prevent future episodes and may contribute to recurrent infections by disrupting the balance of the throat microbiome. Therefore, there is a growing interest in alternative approaches such as probiotics, which aim to support the body's natural defenses and restore microbial balance in the throat and oral cavity. conditions: Streptococcus Pyogenes Pharyngotonsillitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Probiotic Bactoblis® (Streptococcus salivarius K12) measure: Recurrence of Streptococcus pyogenes pharyngotonsillitis infection measure: Probiotic safety and tolerability measure: Protection against viral infection measure: Protection against Acute Otitis Media infection measure: Protection against respiratory infection measure: Protection against Rhinitis measure: Protection against flu measure: Protection against Enteritis measure: Protection against Stomatitis sex: ALL minimumAge: 3 Years maximumAge: 10 Years stdAges: CHILD facility: Liaquat University of Medical and Health Sciences city: Jamshoro zip: 76090 country: Pakistan name: Dr. Ikram Ujjan, MBBS, PhD role: CONTACT phone: 03000506955 email: amjadkhan@lumhs.edu.pk lat: 25.43773 lon: 68.28522 hasResults: False

 nctId: NCT06370195 id: SGB-Liuxian briefTitle: Effect of Stellate Ganglion Block on Drooling in Parkinson's Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-17 date: 2024-04-17 name: Babujinaya Cela class: OTHER_GOV briefSummary: This is a randomized controlled study, including dysphagic patients with Parkinson's syndrome who were received in the department of rehabilitation medicine. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, Functional Oral Intake Scale, Drooling amount, depression are assessed. conditions: Parkinson's Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Comprehensive rehabilitation name: Stellate ganglion block name: Lidocaine hydrochloride name: Placebo injection measure: Drooling amount measure: Modified Barthel Index measure: Patient Health Questionnaire-9 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06370182 id: ANA2401 briefTitle: Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA5 Device acronym: ATHENA overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-12 date: 2026-03 date: 2024-04-17 date: 2024-04-17 name: Anaconda Biomed S.L. class: INDUSTRY briefSummary: The objective of this study is to assess the safety and effectiveness of mechanical thrombectomy using the ANA funnel catheter to treat people with acute ischemic stroke within 24 hours of symptom onset. The device facilitates the placement of other devices such as stent retrievers and intravascular catheters during the procedure. conditions: Acute Ischemic Stroke From Large Vessel Occlusion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: ANA Funnel Catheter name: Control measure: Proportion of subjects with "near-complete" reperfusion after one thrombectomy pass (FPE, eTICI 2c-3, extended Thrombolysis in Cerebral Infarction scale) in the target vessel after one reperfusion attempt. measure: Rate of symptomatic intracranial hemorrhage (sICH), attributable to the device or procedure. sex: ALL minimumAge: 22 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06370169 id: ROSC 1 briefTitle: EUS Guided Coil Embolization for Primary Prophylaxis of Gastric Varices acronym: EUS overallStatus: RECRUITING date: 2022-08-01 date: 2024-03-30 date: 2024-08-10 date: 2024-04-17 date: 2024-04-17 name: Asian Institute of Gastroenterology, India class: OTHER briefSummary: The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue. Our study will evaluate the efficacy of EUS guided coil as primary prophylaxis for high-risk gastric varices. All procedures will be performed with patient under deep sedation or general anaesthesia under the supervision of an anaesthesiologist. conditions: Gastric Varices Bleeding studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 50 type: ESTIMATED name: Endoscopic ultrasound placement of Coil and glue measure: The outcome will measure number of patient had achieved complete obliteration of varices measure: Number of patient needed re intervention measure: Number of patient needed had bleeding following intervention like immediate (with in 5 days) or later (5-90 days) sex: ALL minimumAge: 18 Months maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Asian institute of Gastroenterology status: RECRUITING city: Hyderabad state: Telangana zip: 500082 country: India name: Jahangeer Dr Basha, MD DM role: CONTACT phone: 04023378888 email: drjahangeer09@gmail.com name: Sandeep Dr Nath, MD role: CONTACT phone: 04023378888 email: sandip.nath@ymail.com lat: 17.38405 lon: 78.45636 hasResults: False

 nctId: NCT06370156 id: TWEAK in plaque psoriasis briefTitle: Evaluation of TWEAK in Plaque Psoriasis and Psoriatic Arthritis Patients overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2025-06-10 date: 2024-04-17 date: 2024-04-17 name: Egymedicalpedia class: INDUSTRY briefSummary: Psoriasis vulgaris is associated with significant comorbidity including depression, increased risk of cardiovascular events, diminished quality of life, as well as overall increased mortality.

Moreover, concomitant psoriatic arthritis is present in up to 40% of psoriasis patients or will develop in the future.

To enhance quality of life and potentially lower the risk of concomitant disease in psoriasis patients, effective treatment of this immune-mediated systemic inflammatory disease is required conditions: Plaque Psoriasis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Adalimumab measure: Treatment of psoriasis vulgaris and psoriatic arthritis measure: Evaluation of serum TWEAK sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: South Valley Hospitals city: Qinā country: Egypt name: Eisa Mohamed Hegazy, Professor role: CONTACT phone: +201094337795 email: eisa_mohamed4152@med.svu.edu.eg lat: 26.16418 lon: 32.72671 hasResults: False

 nctId: NCT06370143 id: 24-083 briefTitle: A Study Collecting Health Information to Understand and Prevent Gastric Cancer overallStatus: RECRUITING date: 2024-04-11 date: 2036-04-11 date: 2036-04-11 date: 2024-04-17 date: 2024-04-17 name: Memorial Sloan Kettering Cancer Center class: OTHER briefSummary: The purpose of this study is to create a registry of participants with precursor lesions for gastric cancer, including gastric atrophy, intestinal metaplasia, and dysplasia. Normal controls and individuals with gastric cancer for comparison of baseline characteristics will also be enrolled. conditions: Gastric Atrophy conditions: Gastric Intestinal Metaplasia conditions: Dysplasia conditions: Gastric Adenocarcinoma conditions: Gastric Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3200 type: ESTIMATED name: Questionnaire measure: Creation of participant registry sex: ALL 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: Monika Laszkowska, MD role: CONTACT phone: 212-639-6857 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: Monika Laszkowska, MD role: CONTACT phone: 212-639-6857 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: Monika Laszkowska, MD role: CONTACT phone: 212-639-6857 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: Monika Laszkowska, PhD role: CONTACT phone: 212-639-6857 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: Monika Laszkowska, MD role: CONTACT phone: 212-639-6857 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: Monika Laszkowska, MD role: CONTACT phone: 212-639-6857 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: Monika Laszkowska, MD role: CONTACT phone: 212-639-6857 lat: 40.65871 lon: -73.64124 hasResults: False

 nctId: NCT06370130 id: AerospaceCH briefTitle: Different Dose of Esketamine Inhibiting Response to Laryngeal Mask Airway Insertion overallStatus: COMPLETED date: 2022-05-01 date: 2022-12-20 date: 2023-03-10 date: 2024-04-17 date: 2024-04-17 name: Aerospace Center Hospital class: OTHER briefSummary: Objective To prospectively determine the median effective dose (ED50) of propofol for inhibiting a response to laryngeal mask airway (LMA) insertion when combined with different doses of esketamine in female patients.

Methods Fifty-eight female patients (aged 20-60, ASAⅠ-Ⅱ) scheduled for elective hysteroscopy were enrolled and randomly divided into two groups, one administered 0.2 mg/kg of esketamine (K1 group, n = 28) and the other 0.3 mg/kg of esketamine (K2 group, n = 30). The two groups received the corresponding doses of esketamine intravenously, followed by an intravenous injection of propofol (injection time was 30 s). The initial dose of propofol was 2 mg/kg, and the dose ratio of propofol in the adjacent patients was 0.9. If there was a positive reaction to LMA insertion, the dose ratio in the next patient was increased by one gradient, and if not, the dose ratio was decreased by one gradient. The median effective dose (ED50), 95% effective dose (ED95) and 95% confidence interval (95%CI) of propofol for inhibiting a response to LMA insertion in the two esketamine groups were calculated using a probit analysis. conditions: Anesthesia studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 58 type: ACTUAL name: Esketamine 0.2mg/kg name: Esketamine 0.3mg/kg measure: Record of the patient response during LMA placement measure: Overall condition of LMA placement measure: Record related indicators measure: Record related indicators measure: Record related indicators measure: Record related indicators measure: Record of additional doses of propofol and the adverse reactions of positive patients during the induction process (hypotension, bradycardia and apnoea, etc.) sex: FEMALE minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Liang-Yuan Lu city: Beijing state: Beijing zip: 100049 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06370117 id: Aydın Adnan Menderes briefTitle: The Effects of Three Different Nonpharmacological Methods Used During Vascular Access in Children on Pain and Anxiety overallStatus: COMPLETED date: 2023-02-01 date: 2023-10-30 date: 2023-12-30 date: 2024-04-17 date: 2024-04-17 name: Aydin Adnan Menderes University class: OTHER briefSummary: The research was conducted to evaluate the effects of three different non-pharmacological methods (playing a music video, buzzy application, listening to a music video + buzzy application) on the pain and anxiety levels of children in the 4-12 age group during vascular access.

H0.1. Playing music (music video) during the vascular access procedure has no effect on children's pain and anxiety levels.

H0.2. Applying buzzy during the vascular access procedure has no effect on children's pain and anxiety levels.

H0.3. Listening to a music video + applying buzzy during the vascular access procedure has no effect on children's pain and anxiety levels. conditions: Pain conditions: Anxiety conditions: Nurse's Role studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: It is a randomized controlled experimental study. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 126 type: ACTUAL name: Buzzy name: Music video listening name: Buzzy+ Music video listening measure: Wong-Baker Facial Expression Rating Scale measure: Children's Fear and Anxiety Scale sex: ALL minimumAge: 4 Years maximumAge: 12 Years stdAges: CHILD facility: Bircan Kahraman Berberoğlu city: Aydın state: AYDIN-efeler zip: 0900 country: Turkey lat: 37.84501 lon: 27.83963 hasResults: False

 nctId: NCT06370104 id: NL85041.018.23 briefTitle: Treating Suicidality Remotely acronym: TREASURE overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2028-04-25 date: 2028-04-25 date: 2024-04-17 date: 2024-04-17 name: 113 Suicide Prevention class: OTHER name: Amsterdam UMC briefSummary: Background: Practical and psychological barriers make it difficult for people with Suicidal Thoughts and Behaviors (STBs) to get professional help. Online interventions have the potential to overcome many of these barriers, but the online interventions to date have produced small or short-lived effects and have only been found to reduce suicidal thoughts, not behaviors. This is a crucial limitation, since previous studies have shown that interventions that reduce suicidal thoughts often do not prevent suicide attempts, and vice versa.

Methods: A fully remote randomized controlled trial will be conducted in which 364 participants of 16 years and older will be recruited through the website of a suicide prevention helpline in the Netherlands and randomized with an allocation ratio of 1:1 to either Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT-SP) or a semi-guided online self-help course that has previously been found superior to waitlist in reducing suicidal thoughts. The primary outcome of the study is the number of suicide attempts, measured with the Columbia Suicide Severity Rating Scale. Secondary outcomes are self-reported suicidal ideation, healthcare utilization, treatment satisfaction, adverse effects, and quality of life. All outcomes will be assessed at baseline, immediately after the treatment and at 18 months follow-up.

Discussion: If remote BCBT-SP proves effective, the findings of this study will add to the evidence base of BCBT-SP as one of very few psychological interventions with replicated effectiveness in preventing suicide attempts and provide the first evidence to date that remote interventions cannot only reduce suicidal thoughts, but also prevent suicidal behavior. conditions: Suicide Attempt studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel randomized controlled trial with a 1:1 allocation ratio. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Participants are not blind to the treatment condition, but are unaware which is the experimental condition and which the control condition. whoMasked: OUTCOMES_ASSESSOR count: 364 type: ESTIMATED name: Brief Cognitive Behavioral Therapy for Suicide Prevention name: Living under control measure: Number of suicide attempts measure: Severity of suicidal ideation measure: Severity of suicidal Thoughts and Behaviors Composite measure: Treatment satisfaction measure: Adverse effects measure: Co-occuring mental health issues measure: Quality of life sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: 113 Suicide Prevention city: Amsterdam state: Zuid-Holland zip: 1105BP country: Netherlands name: Wilco Janssen, MSc role: CONTACT phone: 020 3 113 883 email: w.janssen@113.nl name: Saskia Mérelle, PhD role: CONTACT phone: 020 3 113 883 email: s.merelle@113.nl lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06370091 id: PICVII19-41 briefTitle: Effect of Xylitol-based Chewing Gums, Sugar-free and Sugared, on Salivary Flow and pH in Young Adults overallStatus: RECRUITING date: 2023-12-12 date: 2024-05-31 date: 2024-07-31 date: 2024-04-17 date: 2024-04-24 name: Universidad Católica de Cuenca class: OTHER briefSummary: This study was planned to evaluate the effects of xylitol-based chewing gums, sugar-free and sugared, on salivary flow and pH in young adults. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: It will be an experimental study through a double-blind parallel randomized controlled trial.

All saliva samples will be collected using the spitting method. Each participant will provide a basal saliva sample for 5 minutes. Participants must meet the following inclusion criteria: having at least 20 teeth, providing written informed consent, and being willing to comply with the study procedures. The exclusion criteria will include individuals with systemic, infectious, or inflammatory diseases or those taking medications, antibiotics, or fluoride in the last month; regular consumers of products and mouthwashes containing xylitol or sorbitol, with abnormal salivary flow (\<1 ml/min), pregnant women or those on contraceptive pill treatment, or with abnormal dietary habits; subjects with periodontal disease or presence of dental caries primaryPurpose: OTHER masking: DOUBLE maskingDescription: Participants who meet the selection criteria will be probabilistically assigned using simple random sampling through a lottery system. An urn will be used to draw colors corresponding to a type of chewing gum whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: Gum of Xylitol name: Gum of sugar free name: Gum of sugar name: Paraffin wax measure: G1: Gum of xilytol measure: G2: Gum of sugar free measure: G3: Gum of sugar measure: G4: Parafinn wax sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Miriam Lima status: RECRUITING city: Cuenca state: Azuay zip: 010101 country: Ecuador name: Miriam Lima, Ph D role: CONTACT phone: 0999975073 email: mlimai@ucacue.edu.ec lat: -2.90055 lon: -79.00453 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-12-12 uploadDate: 2024-04-13T10:26 filename: Prot_000.pdf size: 1132158 hasResults: False

 nctId: NCT06370078 id: Ahmed Helal briefTitle: Effect of Early Administration of Albumin 20% Versus Crystalloid overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-11-01 date: 2025-11-15 date: 2024-04-17 date: 2024-04-17 name: Egymedicalpedia class: INDUSTRY briefSummary: Sepsis and septic shock are global health problems, leading to a high mortality rate. They are often associated with extremely low blood pressure and multiple organ dysfunctions, which are the main causes of death in critically ill patients. Fluid resuscitation is one of the most critical treatments for patients with sepsis and septic shock.

An early administration of an appropriate fluid to patients is considered the most effective way to increase blood pressure, improve tissue perfusion, and save their lives. Crystalloid fluids are a subset of intravenous solutions composed of mineral salts and other small, water-soluble molecules, including normal, isotonic or hypertonic saline, and various buffered solutions. conditions: Septic Shock studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 46 type: ESTIMATED name: Albumin Human measure: Recovery from shock sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Assuit University hospitals city: Assiut country: Egypt name: Ahmed Abdelhamed Helal Mohamed, MSc role: CONTACT phone: +201140415513 email: Ahmedel3oksh@gmail.com name: Amany Hassan Abdelwahab, Assist.Prof. role: CONTACT phone: +201004610623 email: Amanihassan1976@yahoo.com name: Noha Yahia Mohamed, Lecturer role: PRINCIPAL_INVESTIGATOR lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06370065 id: HLX10IIT70-TJ briefTitle: Serplulimab Combined With Bevacizumab Biosimilar and HAIC in Advanced Hepatocellular Carcinoma (HCC) Patients overallStatus: RECRUITING date: 2023-04-27 date: 2024-06-30 date: 2024-12-31 date: 2024-04-17 date: 2024-04-17 name: Tianjin Medical University Cancer Institute and Hospital class: OTHER briefSummary: Evaluation of the efficacy and safety of Serplulimab combined with bevacizumab biosimilar and HAIC in Advanced Hepatocellular Carcinoma (HCC) patients conditions: Advanced Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: HAIC+Serplulimab（HLX10）+ Bevacizumab Biosimilar（HLX04） measure: ORR measure: PFS measure: OS sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tianjin Cancer Hospital Airport Hospital status: RECRUITING city: Tianjin state: Tianjin country: China name: Huikai Li, MD role: CONTACT lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06370052 id: CHCRI-DJ-HS briefTitle: Pathophysiological Basis of Hidradenitis Suppurativa overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2026-12-31 date: 2024-04-17 date: 2024-04-17 name: Clinical Hospital Center Rijeka class: OTHER briefSummary: HS is a chronic inflammatory disease manifested by recurrent inflammatory nodules, abscesses and tunnels under the skin. This disease is characterized by an inflammatory process that takes place in hair follicles, sebaceous glands and surrounding tissue. Because of its frequent recurrence and chronicity, it represents a major public health problem and there is a need for better diagnosis and new and more effective drugs. This research can be a part of realizing the stated needs. conditions: Hidradenitis Suppurativa studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: excision measure: The pathohistological changes measure: The expression of cytokines measure: The correlation of the clinical Hurley classification and pathohistological changes sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06370039 id: INV-102-CS-003 briefTitle: Study of INV-102 Ophthalmic Solution in Adults With Moderate to Severe Dry Eye Disease overallStatus: RECRUITING date: 2024-03-27 date: 2024-08 date: 2024-08 date: 2024-04-17 date: 2024-04-24 name: Invirsa, Inc. class: INDUSTRY briefSummary: Phase 2 study to assess the efficacy of topically administered eyedrops of INV-102 during 4-week repeat dosing in subjects with moderate to severe dry eye disease. conditions: Dry Eye Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 110 type: ESTIMATED name: INV-102 name: Vehicle measure: Change from Baseline in corneal fluorescein staining total score on the National Eye Institute (NEI)/Industry scale measure: Percentage of eyes with complete clearing of central corneal fluorescein staining sex: ALL minimumAge: 18 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT facility: iuvo BioScience status: RECRUITING city: Rush state: New York zip: 14543 country: United States lat: 42.9959 lon: -77.64556 hasResults: False

 nctId: NCT06370026 id: KSD-101-CR004 briefTitle: KSD-101 Therapy for Standard Treatment Failed EBV-associated Nasopharyngeal Carcinoma: an Exploratory Clinical Trial overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2026-12-31 date: 2024-04-17 date: 2024-04-17 name: Sun Yat-sen University class: OTHER name: Kousai Bio Co., Ltd. briefSummary: The main purpse of this study is to evaluate the safety of KSD-101 in patients with EBV-associated Nasopharyngeal Carcinoma,to evaluate the initial clinical outcomes and evaluate the immune response to KSD-101 for the treatment in Patients with EBV-associated Nasopharyngeal Carcinoma. conditions: Nasopharyngeal Carcinoma studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: KSD-101 measure: The incidence Adverse events (Safety endpoint) measure: EBV-DNA load 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: Levels of EBV-specific CD8+ T cells measure: Levels of B cells measure: Levels of NK cells measure: According to EORTC QLQ-C30 measure: According to EQ-5D-5L measure: According to EORTC QLQ-H&N35 measure: According to ECOG fitness status sex: ALL minimumAge: 18 Years maximumAge: 70 Years 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: NCT06370013 id: TT00420US14 briefTitle: Rollover Study to Provide Continued Access to TT-00420 (Tinengotinib) for Subjects With Advanced Solid Tumors overallStatus: AVAILABLE date: 2024-04-17 date: 2024-04-17 name: TransThera Sciences (Nanjing), Inc. class: INDUSTRY briefSummary: This study is an open-label, multicenter study for Continued Characterization of Safety and Tolerability of TT-00420 (tinengotinib) Tablet Monotherapy in Adult Patients with Advanced Solid Tumors conditions: Advanced Solid Tumors conditions: Cholangiocarcinoma studyType: EXPANDED_ACCESS name: Tinengotinib sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Chicago Medical Center status: AVAILABLE city: Chicago state: Illinois zip: 60637 country: United States lat: 41.85003 lon: -87.65005 facility: Roswell Park Comprehensive Cancer Center status: AVAILABLE city: Buffalo state: New York zip: 14203 country: United States lat: 42.88645 lon: -78.87837 facility: Sarah Cannon Research Institute status: AVAILABLE city: Nashville state: Tennessee zip: 37203 country: United States lat: 36.16589 lon: -86.78444 facility: MD Anderson Cancer Center status: AVAILABLE city: Houston state: Texas zip: 77030 country: United States lat: 29.76328 lon: -95.36327 facility: UW Carbone Cancer Center status: AVAILABLE city: Madison state: Wisconsin zip: 53705 country: United States lat: 43.07305 lon: -89.40123 hasResults: False

 nctId: NCT06370000 id: MCC-23-20817 id: HM20029540 type: OTHER domain: Virginia Commonwealth University briefTitle: Oral Azacitidine in Transplant-Eligible Patients With Acute Myeloid Leukemia (AML) Suffering From Health-Inequality acronym: REMAIN1 overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-10-31 date: 2028-10-31 date: 2024-04-17 date: 2024-04-17 name: Virginia Commonwealth University class: OTHER briefSummary: Test feasibility of an oral maintenance strategy for transplant eligible AML patients in first CR who are medically underserved or have a disadvantage in the CDC SDOH domains conditions: Acute Myeloid Leukemia studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Oral Azacitidine measure: Rate of completion of at least 4 cycles an oral maintenance strategy for transplant eligible AML patients in CR who are medically underserved or have a disadvantage in the CDC SDOH domains measure: Overall survival (OS) measure: Leukemia Free Survival (LFS) 3 months after beginning of treatment and at relapse, completion of treatment or removal from study measure: Measure rates of measurable residual disease (MRD) negativity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Virginia Commonwealth University city: Richmond state: Virginia zip: 23298 country: United States name: Kristin Lantis, MSN, RN role: CONTACT phone: 804-828-2177 email: kllantis@vcu.edu name: Massey Heme Malig Team role: CONTACT email: MasseyHemMlg@vcu.edu name: Keri Maher, DO role: PRINCIPAL_INVESTIGATOR lat: 37.55376 lon: -77.46026 hasResults: False

 nctId: NCT06369987 id: 46238 briefTitle: Visual Performance of Dailies Total1 Multifocal and Acuvue Oasys Max 1-Day Multifocal in Presbyopic Lens Wearers acronym: GIRAFFE overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-10 date: 2024-10 date: 2024-04-17 date: 2024-04-17 name: University of Waterloo class: OTHER name: Alcon Research briefSummary: The purpose of this study is to measure the logMAR visual acuity when presbyopic soft lens wearers are fit with Dailies Total1 Multifocal and ACUVUE OASYS MAX 1-DAY Multifocal. conditions: Presbyopia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Deleficon A (multifocal) name: Senofilcon A (multifocal) measure: High contrast visual acuity (logMAR) at 6m measure: High contrast visual acuity (logMAR) at 40cm sex: ALL minimumAge: 42 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre for Ocular Research & Education (CORE) city: Waterloo state: Ontario zip: N2L 3G1 country: Canada name: Jill Woods, MSc, MCOptom role: CONTACT phone: 519-888-4567 phoneExt: 36746 email: jwoods@uwaterloo.ca name: Lyndon Jones, PhD, FCOptom role: PRINCIPAL_INVESTIGATOR lat: 43.4668 lon: -80.51639 hasResults: False

 nctId: NCT06369974 id: 2024P000386 briefTitle: Single Participant Study of an Experimental ASO Treatment for TUBB4A-related Leukodystrophy overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-06 date: 2024-04-17 date: 2024-04-18 name: Massachusetts General Hospital class: OTHER name: n-Lorem Foundation briefSummary: This research project entails delivery of a personalized antisense oligonucleotide (ASO) drug designed for a single pediatric participant with TUBB4A associated leukodystrophy. conditions: Genetic Disease studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single participant interventional study primaryPurpose: TREATMENT masking: NONE maskingDescription: Open label study count: 1 type: ESTIMATED name: Antisense oligonucleotide treatment (ASO) measure: Neurological assessments measure: Feeding and swallow evaluation measure: Safety and tolerability sex: ALL minimumAge: 4 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06369961 id: TDFCANCERPAIN20230101 briefTitle: Correlation Between the Analgesic Effect of Fentanyl Transdermal Patches and Nutritional Status in Cancer Pain Patients overallStatus: COMPLETED date: 2023-03-01 date: 2023-07-31 date: 2023-12-31 date: 2024-04-17 date: 2024-04-17 name: Chongqing University Cancer Hospital class: OTHER briefSummary: The goal of this observational study is to investigate the correlation and quantitative relationship between the analgesic effect of fentanyl transdermal patches in cancer pain patients and their nutritional status. conditions: Cancer Pain conditions: Nutrition Disorders studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 151 type: ACTUAL name: transdermal fentanyl measure: 11-point numeric rating scale (NRS) after TDF treatment measure: the occasions that breakthrough pain attacks per day after TDF treatment measure: The dose adjustment of TDF measure: The kinds of other analgesics combined with TDF measure: Adverse effects sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chao Li city: Chongqing zip: 400030 country: China lat: 29.56278 lon: 106.55278 hasResults: False

 nctId: NCT06369948 id: M703 briefTitle: Quality Of Recovery After Pericapsular Nerve Group (PENG) Block For Hip Hemiarthroplasty Under Spinal Anesthesia overallStatus: RECRUITING date: 2024-03-01 date: 2024-09-01 date: 2024-09-01 date: 2024-04-17 date: 2024-04-17 name: Fayoum University Hospital class: OTHER briefSummary: Patients undergoing hip hemiarthroplasty can benefit significantly from regional anesthesia in terms of pain management and recovery . There is a wide range of regional anesthetic techniques. The most common in this anatomical region and those with the greatest published research are fascia iliac block, lumbar plexus block, and femoral nerve block . Alternative methods include lateral femoral cutaneous nerve and selective obturator nerve infiltration blocks. Novel techniques, including local infiltration analgesia and quadratus lumborum block, have been reported.

While femoral nerve and lumbar plexus blocks are two common opioid-sparing regional anesthetic procedures that are successful, they come with a risk of undesired lower limb muscle weakness . On the other hand, the fascia iliac block does not always offer sufficient pain relief following hip surgery. The important landmarks targeted on the hip joint branches from the femoral nerve and the auxiliary obturator nerve may now be identified thanks to a recent anatomical study on hip innervation .

This led to the discovery of a novel localized anesthetic treatment termed pericapsular nerve group block (PENG), which blocks these nerves to target the hip's anterior capsule. The PENG block has been suggested as a successful motor-sparing block for hip hemiarthroplasty . The objective of the current study is to evaluate the efficacy of the pericapsular nerve group block (PENG) for the reduction of opioid consumption and management of postoperative pain after hip hemiarthroplasty. conditions: Hip Hemiarthroplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: We will include 60 patients who will undergoe elective hip hemiarthroplasty. Patients will be divided into two groups randomized by computer generated random numbers that will be placed in separate opaque envelopes that will be opened by study investigators just before the block.

Pericapsular Nerve Group (PENG) Block (P group) includes 30 patients who will receive a PENG block.

Control group (C group) includes 30 patients who will not receive a PENG block. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Patients will be divided into two groups randomized by computer generated random numbers that will be placed in separate opaque envelopes that will be opened by study investigators just before the block. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Pericapsular Nerve Group (PENG) Block name: elective hip hemiarthroplasty without receiving a PENG block. name: bupivacaine 0.5% injection measure: Total opioid consumption post operative measure: 2) a Visual Analogue Scale (VAS) ranging from zero (no pain) to 10 (severe pain) for dynamic and static pain measure: 3) Time to first opioid use measure: 4) Ability to perform physiotherapy measure: 5) Opioid-related side effects. measure: 6) Total length stay of hospital measure: 7) Complications of local anesthetic toxicity sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fayoum University Hospital status: RECRUITING city: Madīnat Al Fayyūm state: Fayoum Governorate zip: 63514 country: Egypt name: Atef Mohamed Sayed, MS.C role: CONTACT phone: 01003973883 email: amk04@fayoum.edu.eg lat: 29.31667 lon: 30.83333 hasResults: False

 nctId: NCT06369935 id: 20240407 briefTitle: A Real World Study of Equecabtagene Autoleucel in Subjects With Relapsed and Refractory Multiple Myeloma. overallStatus: NOT_YET_RECRUITING date: 2024-06-20 date: 2026-08-20 date: 2027-08-20 date: 2024-04-17 date: 2024-04-17 name: Peking University People's Hospital class: OTHER briefSummary: This study is a multicenter, observational, single-arm real world study. The purpose of this study is to describe demographic and disease characteristics, treatment patterns, and clinical outcomes in the real-world setting among participants in China with relapsed/refractory multiple myeloma (RRMM) who have been treated with Equecabtagene Autoleucel. This study will use both prospective and retrospective data conditions: Relapsed/Refractory Multiple Myeloma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 260 type: ESTIMATED name: Equecabtagene Autoleucel measure: Best Overall Response Rate， BOR measure: PFS rate of 6 month measure: OS rate of 6 month measure: Time to Response， TTR measure: Time to Complete Response， TTCR measure: Adverse Event， AE sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University People's Hospital city: Beijing country: China name: Yang Liu role: CONTACT phone: +8613716926210 email: pkuphliuyang@bjmu.edu.cn lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06369922 id: STUDY00009315 briefTitle: TENS Analgesia During Outpatient Urethral Bulking for Stress Urinary Incontinence. acronym: TENSUB overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-03-31 date: 2026-06-01 date: 2024-04-17 date: 2024-04-19 name: University of Rochester class: OTHER briefSummary: This will be a double-blind randomized control trial in women with stress urinary incontinence who are undergoing an outpatient transurethral bulking procedure for stress urinary incontinence. Subjects will be identified by the University of Rochester urologists and urogynecologists participating in the study who currently oversee stress incontinence care. Subjects will be randomized into two groups. One group will be undergoing the cystoscopy with transcutaneous electrical nerve stimulation (TENS) for analgesia, and the second group will have the cystoscopy with placebo TENS. conditions: Stress Incontinence Female conditions: Urinary Incontinence conditions: Urinary Incontinence,Stress conditions: Pain conditions: Pain Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: TENS name: Control TENS measure: Mean pain measured by Visual Analog Scale (VAS) measure: Mean pain measured by Visual Analog Scale (VAS) measure: Mean pain measured by Visual Analog Scale (VAS) measure: Mean pain measured by Likert scale measure: Mean pain measured by Likert scale measure: Mean pain measured by Likert scale measure: Number of participants with side effects measure: Mean satisfaction with the procedure measure: TENS or NO TENS sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pelvic Health and Continence Specialties city: Rochester state: New York zip: 14623 country: United States name: Jared M Floch, DO, MS role: CONTACT phone: 585-895-9301 email: jared_floch@urmc.rochester.edu name: Diego Hernandez-Aranda, MD role: CONTACT phone: (585) 487-3400 email: diego_hernandezaranda@urmc.rochester.edu name: Jared M Floch, DO, MS role: PRINCIPAL_INVESTIGATOR lat: 43.15478 lon: -77.61556 hasResults: False

 nctId: NCT06369909 id: K5507 briefTitle: Study on AI-assisted Multimodal Diagnosis System of Autoimmune Pancreatitis overallStatus: RECRUITING date: 2024-01-31 date: 2025-01-31 date: 2026-01-31 date: 2024-04-17 date: 2024-04-17 name: Peking Union Medical College Hospital class: OTHER name: Tianjin Medical University General Hospital name: The Second Hospital of Hebei Medical University briefSummary: The existing comprehensive diagnostic system for autoimmune pancreatitis (AIP) is complex, with multidimensional clinical information including morphological changes and a lack of specific biomarkers. Endoscopic ultrasound (EUS) can provide all the elements for morphological diagnosis of AIP, but the long learning curve and large observer differences make it difficult to popularize and promote. The cooperation units of the three regions in this project have found in the early stage that Klebsiella pneumoniae (KP) induced follicular helper T cells (Tfh) activation is an important mechanism of AIP, but the identification of pathogenic components of the strain and clinical validation need to be explored. We have established a national multicenter AIP queue in the early stage and extracted EUS audio-visual features to establish a scoring model, but intelligent assistance is still needed to improve efficiency. Therefore, we plan to integrate gut microbiota, Tfh activation markers, and EUS imaging features to establish an AI assisted multimodal diagnostic system for AIP. This study will collaborate across multiple centers to identify and validate the components that induce Tfh activation in KP bacterial cells, to extract EUS pancreatic ultrasound features and optimize artificial intelligence assisted diagnostic algorithms, and to establish and validate an artificial intelligence assisted multimodal diagnostic system based on clinical information, biomarkers, and EUS. The aim of this study is to provide new diagnosis and treatment evaluation methods for AIP with high accuracy, convenience, and easy promotion for clinical practice. conditions: Autoimmune Pancreatitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 180 type: ESTIMATED name: EUS-FNA measure: Tfh level in blood measure: Microbiota composition measured by 16S rRNA sequencing measure: AI-EUS differentiation measure: Cytokine level in blood sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: Mai Li role: CONTACT phone: 13683296860 email: pumchkyc@126.com name: Xi Wu role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06369896 id: SpyIDUSForNonictericStricture briefTitle: Digital Single-operator Cholangioscopy and Intraductal Ultrasound for Nonicteric Biliary Strictures acronym: Spy+IDUS overallStatus: NOT_YET_RECRUITING date: 2024-05-05 date: 2025-12-25 date: 2026-12-25 date: 2024-04-17 date: 2024-04-17 name: Soonchunhyang University Hospital class: OTHER briefSummary: This study aims to evaluate the usefulness of disposable digital single-operator cholangioscopy (SOC) and intraductal ultrasound (IDUS) for the accurate diagnosis of indeterminate biliary stricture. conditions: Cholangiocarcinoma conditions: Biliary Stricture studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 36 type: ESTIMATED measure: diagnostic accuracy of SOC measure: Diagnostic accuracy of IDUS measure: Technical success of SOC measure: Technical success of IDUS measure: Adverse event sex: ALL minimumAge: 19 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06369883 id: 2022/41 briefTitle: How Often and What Type of Deformity is Detected in All Spine Radiographs? overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-06-30 date: 2024-08-30 date: 2024-04-17 date: 2024-04-17 name: Bakirkoy Dr. Sadi Konuk Research and Training Hospital class: OTHER_GOV briefSummary: The study will be done retrospectively.The aim of this study is to retrospectively examine the spinal pathologies of patients with a prediagnosis of spinal deformity and for whom spinal radiography is requested and to evaluate the clinical features of these patients. conditions: Scoliosis conditions: Kyphosis conditions: Radiography studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: RETROSPECTIVE count: 632 type: ESTIMATED name: Spine radiography measure: Who should have full spine radiographs? measure: We aimed to determine the frequency of kyphosis, types and percentages of scoliosis detected on the radiographs. sex: ALL minimumAge: 1 Year maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06369870 id: PAINCARE briefTitle: Interpectoral-pectoserratus Plane Block for Minimally Invasive Aortic Valve Replacement Via Right Anterior Minithoracotomy acronym: PAINCARE overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-11 date: 2027-12 date: 2024-04-17 date: 2024-04-17 name: Algemeen Ziekenhuis Maria Middelares class: OTHER briefSummary: The goal of this clinical trial is to evaluate the analgesic effect of locoregional anaesthesia, specifically the interpectoral pectoserratus plane (IPP-PSP) block, in comparison to a placebo (sham block) after Aortic Valve Replacement via Right Anterior Minithoracotomy (AVR-RAT). The main question the trial aims to answer is: Can the IPP-PSP block effectively reduce opioid consumption within the first 48 hours after AVR-RAT surgery? The purpose is to understand the impact of the IPP-PSP block on postoperative pain. Therefore, the aim is to investigate the influence of the IPP-PSP block on the amount of pain medication administered during the patients' first 48 hours after surgery.

Participants, who are scheduled for AVR-RAT surgery, will be randomly assigned to receive either the IPP-PSP block or the sham block. Researchers will compare opioid consumption among other outcomes, including differences in pain scores, incidence of nausea and vomiting, quality of recovery, quality of life, and the length of hospital stay between the two groups.

Patients will be monitored during their hospitalization, and a follow-up phone call will be conducted 30 days after surgery. conditions: Analgesic Effect studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The trial is designed as a single-center, prospective, double-blind, randomized controlled superiority trial. Patients will be randomly assigned to either the IPP-PSP block group or the sham block group (placebo). primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Neither the participant, anesthesiologist, study nurse, surgeon, nor the doctors and nurses in the Intensive Care Unit will know the participant's group assignment. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 144 type: ESTIMATED name: Levobupivacaine Hydrochloride 0.25 % Injectable Solution name: Sodium chloride 0.9% measure: Cumulative opioid consumption measure: Number of episodes of postoperative pain measure: Time to need for rescue medication measure: Number of patients with respiratory complications measure: PaCO2 levels measure: Postsurgical Quality of Recovery measured by the Quality of Recovery questionnaire measure: Number of episodes of postoperative nausea and vomiting measure: Time to extubation measure: Number of hours spent in the Intensive Care Unit measure: Hospitalization duration measure: Quality of life measured by the 5 level version of the EuroQoL-5 Dimension questionnaire measure: Days alive and at home measure: Vital status (whether the patient is alive or dead) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bart Vaes city: Gent state: Oost-Vlaanderen zip: 9000 country: Belgium name: Bart Vaes, MD role: CONTACT phone: +3292461700 email: bart.vaes@mijnziekenhuis.be name: Steffi Ryckaert, MSc role: CONTACT phone: +3292461910 email: steffi.ryckaert@mijnziekenhuis.be lat: 51.05 lon: 3.71667 hasResults: False

 nctId: NCT06369857 id: PPY briefTitle: Pectopexy for Apical Prolapse Management overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-02 date: 2025-08 date: 2024-04-17 date: 2024-04-17 name: Assiut University class: OTHER briefSummary: This study was designed to evaluate the efficacy of pectopexy for treatment of apical pelvic organ prolapse at follow up at 12 months. Investigator also evaluates complications, improvement of symptoms, quality-of-life outcomes and patient satisfaction with surgery.

Assessment of restoration of normal pelvic anatomy and lower urinary tract symptoms using transperineal ultrasound conditions: Pelvic Organ Prolapse studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Case series study primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Pectopexy measure: Pelvic Organ Prolapse Quantification stage measure: Urinary Symptoms questionnaire measure: Bladder neck measurements using Transperineal US sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06369844 id: 1.2023-440 briefTitle: Pressure Injury Education Intervention for Pediatric Intensive Care Nurses: A Randomized Controlled Trial overallStatus: ENROLLING_BY_INVITATION date: 2024-04-01 date: 2024-04-03 date: 2024-04-30 date: 2024-04-17 date: 2024-04-17 name: Ankara Yildirim Beyazıt University class: OTHER name: Ankara City Hospital Bilkent briefSummary: The purpose of this observational study is to find out the impact of pressure injury education on the knowledge level of pediatric intensive care nurses and the likelihood of pediatric pressure injury occurrence. The main questions it aims to answer are:

* Does pressure injury education increase nurses knowledge level on pediatric pressure injuries?
* Does the rate of pediatric pressure injuries decrease after the education?

The researcher will compare nurses working in two separate pediatric intensive care units where similar patients are treated to see if planned education on pressure injuries affects nurses knowledge level and the rate of pediatric pressure injuries.

* Volunteer nurses participating in the study will answer pressure injury survey questions prepared by the researcher.
* Nurses in the intervention group will attend planned education sessions provided by the researcher.
* Two weeks after the completion of the education sessions, all nurses in the intervention and control groups who wish to continue participating in the study will answer the pressure injury survey questions prepared by the researcher again. conditions: Pressure Injury Prevention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study design will be two-group and pretest-posttest design. primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 50 type: ESTIMATED name: Pressure injury education measure: Stop Pressure Injuries" Education Evaluation Survey sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara yıldırım Beyazıt Üniversitesi city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06369831 id: ABS011-1 id: 2024-511419-22-00 type: CTIS briefTitle: HER2 Targeted Molecular Imaging in mBC Using 68Ga-ABS011 acronym: HERMIA overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-01 date: 2025-06 date: 2024-04-17 date: 2024-04-17 name: ABSCINT NV/SA class: INDUSTRY briefSummary: This phase II study aims to confirm the diagnostic performance and accuracy of 68Ga-ABS011 PET/CT in determining the HER2 expression status, and to evaluate 68Ga-ABS011's ability to drive changes in therapeutic treatment. 68Ga-ABS011 will be compared to the current standard of care (SOCa) diagnostic methods including immunohistochemistry (IHC), in situ hybridization (ISH) and imaging tools used for treatment response follow-up including Fluorodeoxyglucose F-18 (18F-FDG) positron emitted tomography (PET) and contrast enhanced computed tomography (ceCT). conditions: Metastatic Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Interventional, prospective, single arm radio-diagnostic study. Driven by number of biopsied lesions (and not by number of patients) primaryPurpose: DIAGNOSTIC masking: NONE count: 60 type: ESTIMATED name: 68Ga-NOTA-ABSCINT-HER2 PET/CT measure: positive, negative, and overall diagnostic agreement between 68Ga-ABS011 PET/CT and the standard of care IHC (and ISH) HER2 status test. measure: Safety of 68Ga-ABS011. measure: Change in treatment management measure: reliability of whole body 68Ga-ABS011 PET/CT compared to HER2-targeted treatment response (Early tumor shrinkage) measure: reliability of whole body 68Ga-ABS011 PET/CT compared to HER2-targeted treatment response (metabolic response) measure: Tumor heterogeneity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: OLV Aalst city: Aalst state: East-Flanders zip: 9300 country: Belgium name: G. Huygh, Dr. role: CONTACT lat: 50.93604 lon: 4.0355 facility: AZ Delta city: Brussels zip: 1070 country: Belgium name: C. Closset, Dr. role: CONTACT lat: 50.85045 lon: 4.34878 facility: Cliniques Universitaires Saint-Luc city: Brussels zip: 1070 country: Belgium name: F. Duhoux, Prof. role: CONTACT lat: 50.85045 lon: 4.34878 facility: Free University Brussels (VUB) city: Brussels zip: 1070 country: Belgium name: C. Fontaine, Dr. role: CONTACT lat: 50.85045 lon: 4.34878 facility: Institut Jules Bordet city: Brussels zip: 1070 country: Belgium name: E. De Azambuja, Prof. role: CONTACT lat: 50.85045 lon: 4.34878 hasResults: False

 nctId: NCT06369818 id: AnIt23-02 briefTitle: Correlation of Cardiac Output Determined by Echocardiography and Indirect Calorimetry in Critically Ill Patients in Cardiogenic Shock on Extracorporeal Circulatory Life Support overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-09 date: 2027-02 date: 2024-04-17 date: 2024-04-17 name: Universität Münster class: OTHER briefSummary: This observational study investigates whether the daily measured trend of cardiac output as evaluated by indirect calorimetry correlates with the same evaluated by transthoracic echocardiography. conditions: Cardiogenic Shock studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Correlation of t two methods of determining cardiac output (determined by transthoracic echocardiography and determined by indirect calorimetry sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Münster city: Münster zip: 48149 country: Germany name: Thilo von Groote, MD role: CONTACT phone: +49-251-47255 lat: 51.96236 lon: 7.62571 hasResults: False

 nctId: NCT06369805 id: 2021-00731 briefTitle: EVALUATION OF BLOOD BIOMARKER-BASED DIAGNOSTIC AID IN OUTPATIENTS SUFFERING FROM DEPRESSION overallStatus: COMPLETED date: 2021-06-02 date: 2022-11-17 date: 2022-11-17 date: 2024-04-17 date: 2024-04-17 name: Les Toises - Psychiatry and Psychotherapy Center class: OTHER briefSummary: This is an observational (non-interventional) study, carried out in an outpatient setting, which involves a blood sampling. The primary objective of this study is to confirm the association between the EDIT-B® editing signature and early unipolar or bipolar differentiation. Results of this research may provide an aid to early diagnosis and guide clinical practice towards individualized treatment. conditions: Depressive Disorder conditions: Bipolar Disorder conditions: Bipolar Depression studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 307 type: ACTUAL name: there is no intervention measure: Psychiatric symptomatology sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Les Toises - Psychiatry and Psychotherapy Center city: Lausanne zip: 1005 country: Switzerland lat: 46.516 lon: 6.63282 hasResults: False

 nctId: NCT06369792 id: 2020-00266 briefTitle: PROSPECTIVE EVALUATION OF BLOOD BIOMARKERS AS AN AID TO DIAGNOSTIC AND TREATMENT IN DRUG-NAIVE PATIENTS WITH DEPRESSION overallStatus: RECRUITING date: 2020-10-20 date: 2024-12-31 date: 2024-12-31 date: 2024-04-17 date: 2024-04-17 name: Les Toises - Psychiatry and Psychotherapy Center class: OTHER briefSummary: This is an observational (non-interventional) prospective study, carried out in drug-naïve outpatients who start a treatment with escitalopram, fluoxetine, sertraline or quetiapine. Five blood samples are collected (i.e. before initiating the drug, and then after 1, 2, 4 and 8 weeks of treatment). It does not affect the choice or the treatment dose. The primary objective of this study is to measure the association between the EDIT-B® editing signature and response to pharmacological treatment in drug-naïve patients. Results of this research could provide an aid to early diagnosis, optimize pharmacological treatment and guide clinical practice towards individualized treatment. conditions: Depressive Disorder conditions: Bipolar Disorder conditions: Bipolar Depression studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: psychiatric symptomatology measure: EDIT-B profiling sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Les Toises - Psychiatry and Psychotherapy Center status: RECRUITING city: Lausanne zip: 1005 country: Switzerland name: Aurélie Reymond-Delacrétaz, PhD role: CONTACT phone: +41584580580 email: aurelie.delacretaz@lestoises.ch lat: 46.516 lon: 6.63282 hasResults: False

 nctId: NCT06369779 id: OTCS 36406866 briefTitle: Clinical Evaluation of a New Flowable and a New Sculptable Universal Bulk-fill Composite for Direct Restorative Treatment overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-12 date: 2030-12 date: 2024-04-17 date: 2024-04-17 name: Ivoclar Vivadent AG class: INDUSTRY briefSummary: The overall objective of this clinical investigation is to evaluate the clinical safety and performance of the new flowable composite TM Flow and the new sculptable composite TM Fill for restoration of class I and class II cavities. The fillings are assessed according to selected FDI criteria at baseline (7-10 days after placement of filling) and after 1, 6, 12, 24, 36 and 60 months. conditions: Class I or II Cavities in Premolars or Molars studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 65 type: ESTIMATED name: TM Fill and TM Flow measure: Postoperative hypersensitivity measure: evaluation of functional (e.g. fracture of the material and retention), biological (e.g. caries at restoration margins) and aesthetic (e.g. color match) properties of the restorations sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06369766 id: 2023-02144; ko23Papadopoulou4 briefTitle: REtinal Markers In Neuroinflammatory Diseases ("REMIND") overallStatus: RECRUITING date: 2024-01-31 date: 2028-12 date: 2029-02 date: 2024-04-17 date: 2024-04-17 name: University Hospital, Basel, Switzerland class: OTHER name: University of Basel briefSummary: The goal of this observational study, including patients with Multiple Sclerosis, patients with other neuroinflammatory diseases and healthy controls, is to determine the predictive value of retinal markers in predicting disease progression. Participants complete a questionnaire and undergo various non-invasive retinal routine clinical examinations. conditions: Multiple Sclerosis conditions: Neuroinflammatory Diseases studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Optical coherence tomography (OCT) name: Static retinal vessel analyzer name: Dynamic retinal vessel analyzer name: Laser speckle flowgraphy system name: Questionnaire measure: Occurence of Progression Independent of Relapse Activity (PIRA) measure: Neuroaxonal loss in the retina (as marker of neurodegeneration in the CNS) measure: Neuroinflammation in the retina measure: Fixation instability (as marker of global neuronal dysfunction in the CNS) measure: Structural changes of the retinal vessels (as marker of systemic microvascular health) measure: (For a subgroup of participants) Functional/perfusional changes of the retinal vessels measure: Relative value of retinal markers for the prediction of PIRA compared to or combined with other biomarkers of neuroaxonal damage measure: Comparison of the examined retinal markers of Multiple Sclerosis patients with Healthy Controls and with patients with other neuroinflammatory diseases of the CNS measure: The relationship between neuroaxonal loss, functional deficits and vascular changes in Multiple Sclerosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Basel, Department of Neurology status: RECRUITING city: Basel zip: 4031 country: Switzerland name: Athina Papadopoulou, PD Dr. med. role: CONTACT phone: +41 61 32 85704 email: Athina.Papadopoulou@usb.ch name: Athina Papadopoulou, PD Dr. med. role: PRINCIPAL_INVESTIGATOR lat: 47.55839 lon: 7.57327 hasResults: False

 nctId: NCT06369753 id: PR(AG)459/2023B briefTitle: Visible Abdominal Distension overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-05 date: 2025-07 date: 2024-04-17 date: 2024-04-17 name: Hospital Universitari Vall d'Hebron Research Institute class: OTHER briefSummary: Background. Abdominal distention is produced by an abnormal somatic postural tone. The authors developed an original biofeedback technique. In a randomized, placebo-controlled trial the authors demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention. However, the technique is technically complex and unpractical.

Aim. To prove the efficacy of a noninstrumental biofeedback technique, transmitted by a standard training program, for the treatment of abdominal distension in different centers.

Selection criteria. Episodes of visible abdominal distension. Intervention. Patients will be randomized into biofeedback and placebo groups. Three sessions of either biofeedback or placebo intervention will be performed during the first 3 weeks of the intervention period.

Biofeedback: Patients will be taught to control abdominal and thoracic muscular activity by providing instructions using an original video support. In each center one operator will receive a standard training on how to deliver the noninstrumental biofeedback treatment. Patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period.

Placebo: Sham measurements of abdominal and thoracic motion will be performed, and a pill of placebo containing 0.21 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period. conditions: Irritable Bowel Syndrome conditions: Dyspepsia conditions: Functional Bloating studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Biofeedback name: Placebo measure: Visible abdominal distension measure: Sensation of abdominal pressure/fullness measure: Sensation of abdominal discomfort/pain measure: Follow-up after biofeedback sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitari Vall d'Hebron city: Barcelona zip: 08035 country: Spain lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06369740 id: ENZ20-2024-INDIANAPOLIS briefTitle: Case and Use Scenario Study to Gain Knowledge on the User Needs for a Medical Device for Hemophilia A Monitoring overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-06-04 date: 2024-06-04 date: 2024-04-17 date: 2024-04-17 name: Enzyre B.V. class: INDUSTRY name: Indiana Hemophilia & Thrombosis Center briefSummary: This observational study consists of two parts.

In part one, case scenario focus groups with hemophilia A patients and healthcare providers (HCPs) will be held. This parts aims to identify potential use scenarios of a point of care (POC) in vitro medical for patients with hemophilia A. The main questions it aims to answer are:

* How is coagulation lab testing for patients with hemophilia A currently organized?
* What is the interest and what are desired alternatives of a POC in-vitro diagnostic medical device for patients with hemophilia A?

Part two of the study consists of a use scenario study in which patients with hemophilia A and HCPs will evaluate two types of non-functional mock-ups of a POC in vitro medical device. The main goal of this part is to evaluate the usability of the current prototypes of the POC device. conditions: Hemophilia A studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 102 type: ESTIMATED name: Case scenarios - questionnaire name: Case scenarios - Focus groups name: Use scenarios - Usability test name: Use scenarios - interview measure: Current management of Hemophilia A coagulation lab testing measure: Potential case scenarios for a point of care in-vitro diagnostic device for hemophilia A measure: Usability issues of the current POC in-vitro diagnostic device prototypes measure: User preferences for the point of care in-vitro diagnostic device measure: Problems with current Hemophilia A coagulation monitoring measure: Potential benefits of a POC device for home use, near-patient use or in clinic use sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Indiana Hemophilia & Thrombosis Center city: Indianapolis state: Indiana zip: 46260 country: United States lat: 39.76838 lon: -86.15804 hasResults: False

 nctId: NCT06369727 id: MOB015B-VI briefTitle: Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult Patch Test Design acronym: RIPT overallStatus: COMPLETED date: 2017-10-15 date: 2018-02-15 date: 2018-02-15 date: 2024-04-17 date: 2024-04-17 name: Moberg Pharma AB class: INDUSTRY briefSummary: A Randomized, Controlled Study to Evaluate the Sensitizing Potential of MOB015B in Healthy Subjects Using a Repeat Insult Patch Test Design To evaluate the sensitization potential conditions: Erythema studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE maskingDescription: NA- Safety study count: 250 type: ACTUAL name: MOB015B name: MOB015B vehicle name: Negative irritant solution of 0.9% saline measure: To determine the potential of MOB015B to induce sensitization by repeated topical application to the healthy skin of humans under controlled conditions. measure: To assess safety sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: TKL Research, Inc city: Fair Lawn state: New Jersey zip: 07410 country: United States lat: 40.94038 lon: -74.13181 hasResults: False

 nctId: NCT06369714 id: CHEC2023-296 briefTitle: Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of ADHD in Children. acronym: ADHD overallStatus: RECRUITING date: 2023-02-24 date: 2025-02-24 date: 2025-02-24 date: 2024-04-17 date: 2024-04-17 name: Lei Lei, MD class: OTHER briefSummary: A multi-center, randomized controlled trial is being conducted to investigate the efficacy of a novel digital therapeutics (DTx) program that utilizes a cross-training approach between neurofeedback training and executive function training for pediatric patients (aged 6-12) diagnosed with ADHD. This gamified interactive program is designed to improve attention deficits and executive function impairments in pediatric patients with ADHD. It is delivered through an engaging iPad game in a home-based treatment format. Patients will be randomly assigned to one of three groups: medication alone, digital therapeutics alone, or a combination of both interventions. Subjects will undergo 30 treatment sessions over the 8-week period, with each session lasting 30 minutes. Investigators will reassess symptoms of ADHD, executive functions, and objective measures of attention at the end of the treatment. Additionally, questionnaires will be distributed to parents to gather their insights and feedback on the treatment approach. This innovative digital therapeutics approach is expected to improve ADHD symptoms individually and enhance therapeutic outcomes when used alongside conventional drug treatment regimens. conditions: Attention Deficit Disorder With Hyperactivity conditions: Executive Function Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Concerta name: Digital therapeutics measure: Swanson, Nolan, and Pelham IV Rating Scale measure: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for ADHD measure: Questionnaire-Children with Difficulties measure: Behavior Rating Inventory of Executive Function measure: Continuous Performance Test measure: Digital Cancellation Test sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Changzheng Hospital, Naval Medical University status: RECRUITING city: Shanghai state: Shanghai zip: 200003 country: China name: Yujiao Wang, MBBS role: CONTACT phone: 15021500051 email: 2191916146@qq.com lat: 31.22222 lon: 121.45806 facility: Changhai Hospital, Naval Medical University status: RECRUITING city: Shanghai state: Shanghai zip: 200433 country: China name: Yuanhao Cai, MBBS role: CONTACT phone: 15001969690 email: 15552283399@163.com name: Yuanhao Cai, MBBS role: SUB_INVESTIGATOR name: Lei Lei, MD role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06369701 id: C.2024.019 briefTitle: Effects Compressive Tissue Flossing on Lateral Elbow Tendinopathy in US Service Members overallStatus: RECRUITING date: 2024-02-13 date: 2024-05 date: 2024-06 date: 2024-04-17 date: 2024-04-17 name: Brooke Army Medical Center class: FED briefSummary: The purpose of this research study will be to assess the effects of a compressive tissue flossing (CTF) program on the symptoms of lateral elbow tendinopathy in United States service members. Dependent variables will be the Defense and Veteran's Pain Rating Scale (DVPRS), decrease their Patient-Rated Tennis Elbow Evaluation (PRTEE) score, increase their maximal grip strength in the affected upper extremity (UE). Measurements will be taken at baseline, immediately after the first CTF intervention, and at the 1-week follow-up, for a total of 3 measurements. conditions: Lateral Elbow Tendinopathy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Within-subjects repeated measures design primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Compressive tissue floss band measure: Patient's report of pain on the Defense and Veteran's Pain Rating Scale measure: Patient-Rated Tennis Elbow Evaluation measure: Maximal grip strength in the affected upper extremity sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brooke Army Medical Center status: RECRUITING city: Fort Sam Houston state: Texas zip: 78234 country: United States name: Carly R Cooper, PhD role: CONTACT phone: 210-808-2240 email: carly.r.cooper2.mil@health.mil name: Brian T Gregg, PhD role: CONTACT phone: (210) 808-2269 email: brian.t.gregg.mil@health.mil name: John E Elam, DSc Fellow role: PRINCIPAL_INVESTIGATOR name: Carly R Cooper, PhD role: SUB_INVESTIGATOR name: Katelyn A Culley, DSc Fellow role: SUB_INVESTIGATOR name: Tara A Haugen, DSc Fellow role: SUB_INVESTIGATOR lat: 29.45746 lon: -98.4472 hasResults: False

 nctId: NCT06369688 id: Baqiyatallah University briefTitle: IDEAL SKIIN CARES Bundle to Prevent Pressure Injury acronym: IdealSkinCares overallStatus: NOT_YET_RECRUITING date: 2025-10-01 date: 2026-10-01 date: 2027-10-01 date: 2024-04-17 date: 2024-04-17 name: Baqiyatallah Medical Sciences University class: OTHER name: Tehran University of Medical Sciences name: Hamadan University of Medical Science name: Tabriz University of Medical Sciences briefSummary: The study will be a multi-center, triple-blinded, cluster randomized controlled trial (c-RCT) conducted with a three-arm parallel design and a 1:1:1 allocation ratio. The experimental groups will consist of two arms: the intervention group, where patients will receive training in relevant pressure injury care bundles, and the placebo group, where patients will receive training in an irrelevant topic like respiratory care. Both intervention and placebo groups will receive specialized pressure injury prevention (PIP) care bundle from trained wound specialist nurses (WSNs). The third arm will be the control group comprising patients who do not undergo any training course and will receive only routine standard care for PIP care bundle. The aim of c-RCT will be to compare the incidence of hospital-acquired pressure injury (HAPI) in the three study groups and to provide detailed evidence on the effect of the developed pressure injury care bundle, administered by WSNs on the development of HAPI in trained hospitalized patients, as opposed to those receiving routine standard care for PIP care bundle without training. conditions: Pressure Ulcer conditions: Pressure Injury conditions: Bed Sore conditions: Pressure Sore conditions: Decubitus Sore conditions: Decubitus Ulcer conditions: Skin Ulcer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: C-RCT will be conducted with a three-arm parallel design and a 1:1:1 allocation ratio. The experimental groups will consist of two arms: the intervention group and the placebo group. The third arm will be the control group. primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: In this placebo-controlled trial, patients will be blinded to their group allocations. Additionally, WSNs, who are trained for delivering special PIP care bundles, as well as nursing staff who are responsible for measuring wounds and collecting data, and data analyst, will also be blinded. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1620 type: ESTIMATED name: IDEAL SKIIN CARES bundles name: IDEAL SKIIN CARES bundles workshop name: Respiratory care workshop measure: Incidence of hospital-acquired pressure injury (HAPI) measure: Pressure Injury Stage measure: Patient participation in care measure: Healthcare costs measure: Self-report Patient participation in care sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06369675 id: MOB015B-V briefTitle: Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design acronym: CIPT overallStatus: COMPLETED date: 2017-10-19 date: 2017-11-14 date: 2017-11-14 date: 2024-04-17 date: 2024-04-17 name: Moberg Pharma AB class: INDUSTRY briefSummary: A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of MOB015B in Healthy Subjects Using a Cumulative Irritant Patch Test Design To evaluate the irritation potential of MOB015B on normal skin. Single center, randomized, controlled, evaluator blinded, within-subject comparison study conditions: Erythema studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 45 type: ACTUAL name: MOB015B name: 0.2% SLS name: 0.9% Saline name: MOB015B vehicle measure: To determine the potential of MOB015B to cause skin irritation after repeated topical application to the healthy skin of humans under controlled conditions. measure: To assess safety sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: TKL Research, Inc city: Fair Lawn state: New Jersey zip: 07410 country: United States lat: 40.94038 lon: -74.13181 hasResults: False

 nctId: NCT06369662 id: SECI-CD155 id: SECI-IRB-IORG0006563-545 type: OTHER domain: Scientific Research Unit briefTitle: CD155 Expression in Acute Myeloid Leukemia overallStatus: ACTIVE_NOT_RECRUITING date: 2022-07-01 date: 2023-12-31 date: 2024-08-30 date: 2024-04-17 date: 2024-04-17 name: Assiut University class: OTHER briefSummary: Acute myeloid leukemia (AML) is a heterogeneous hematologic malignancy. It is the most common form of acute leukemia among adults. In the United States, an estimated 19,940 people will be diagnosed with AML in 2020.

CD155 expression was associated with an unfavorable prognosis in solid tumors such as colon cancer, breast cancer, lung adenocarcinoma, pancreatic cancer, melanoma, and glioblastoma, as it correlated with tumor migration, development of metastases, tissue and lymph node invasion, relapse, and poorer survival. conditions: Acute Myeloid Leukemia studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 93 type: ACTUAL name: Flow cytometric immunophenotyping name: Complete blood count name: Bone marrow aspiration name: Cytogenetic testing name: FLT3-ITD using High resolution melting curve (HRM) analysis measure: CD155 expression level in AML patients sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: South Egypt Cancer Institute, Assiut University city: Assiut zip: 71111 country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06369649 id: COOLSENSE-1 briefTitle: Coolsense and Buzzy Use on Pain Score and Anxiety Level During Insulin Injection Application overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-08-31 date: 2025-12-31 date: 2024-04-17 date: 2024-04-17 name: Ankara Yildirim Beyazıt University class: OTHER briefSummary: This study aims to determine the effect of using Coolsense, which is created using the proven effect of cold application during insulin injection, and Buzzy, which is a combination of vibration and cold application, in reducing pain and anxiety in children diagnosed with Type 1 diabetes mellitus.This randomized controlled clinical study is planned to be conducted between 05.2024-12.2025 with 147 participants between the ages of 6-12. Participants will be divided into three groups according to the randomization method: buzzy group (n = 49), coolsense group (n = 49) and control group (n = 49). Participants in the Coolsense group will receive a cold application using the coolsense device for 5 seconds before the injection. Participants in the Buzzy group will be subjected to vibration and cold application 30-60 seconds before the procedure. Participants in the control group will continue the clinic's standard procedure. Changes in participants' pain score and fear level, heart rate, blood pressure, respiratory rate and oxygen saturation will be measured at three time points: immediately before and after the procedure. Data descriptive information form, application registration form, Facial Expressions Pain Scale (FPS-R) and Child Fear Scale (CFS) will be used. The collected data will be analyzed using SPSS 15 software. The main questions it aims to answer:

* Does buzzy and coolsense application have an effect the pain score of children during the insülin injection?
* Does buzzy and coolsense application have an effect the fear score of children during the insülin injection?
* Does buzzy and coolsense application have an effect the heart rate of children during the insülin injection?
* Does buzzy and coolsense application have an effect the oxygen saturation of children during the insülin injection?
* Does buzzy and coolsense application have an effect the blood pressure of children during the insülin injection?
* Does buzzy and coolsense application have an effect the respiratory rate of children during the insülin injection? conditions: Injection Fear conditions: Injection Site Coldness conditions: Pain conditions: Type 1 Diabetes Mellitus conditions: Pediatric Disease conditions: Nurse's Role studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Single blinding (participants) will be used in the research and the researchers will not have information about the other group.

While applying both scales, care will be taken to ensure that children, parents and observers do not see each other's evaluations and are not influenced by each other. In this way, the child, parent and independent observer will score blindly before and after the procedure. whoMasked: PARTICIPANT count: 147 type: ESTIMATED name: Coolsense and Buzzy measure: Faces Pain Scale- Revised (FPS-R) measure: Children's Fear Scale (CFS) measure: Heart rate measure: Oxygen saturation measure: Respiratory rate measure: Blood pressure sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD hasResults: False

 nctId: NCT06369636 id: myucesu briefTitle: Comparison of El-Ganzouri Risk Index and Airway Ultrasonographic Evaluation in Thyroid Surgery overallStatus: COMPLETED date: 2023-06-01 date: 2023-10-31 date: 2024-01-28 date: 2024-04-17 date: 2024-04-17 name: Ankara City Hospital Bilkent class: OTHER briefSummary: The primary purpose of this prospective observational study was to compare these tests used to predict difficult intubation in patients undergoing thyroid surgery. Secondarily; By comparing these tests, we aim to find the test that best predicts difficult intubation and to determine the incidence of difficult intubation in patients who will undergo thyroid surgery. conditions: Thyroid Surgery conditions: Difficult Intubation studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 120 type: ACTUAL name: Thyroid Surgery measure: Compare EGRI and airway ultrasonographic parameters measure: Find which is the best test predicts difficult intubation measure: Finding the incidence of difficult intubation in thyroid surgery sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Bilkent City Hospital city: Ankara state: Çankaya zip: 06800 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06369623 id: IRB2023-00466 briefTitle: Monetary Incentive Delay Task for Probing Reward-related Neural Processes acronym: MID overallStatus: RECRUITING date: 2024-04-06 date: 2028-11-30 date: 2028-11-30 date: 2024-04-17 date: 2024-04-17 name: Stony Brook University class: OTHER briefSummary: 150 males and 150 females ages 14-17 years-old will be enrolled in an observational, longitudinal study. There are three planned in-person visits: a baseline assessment, an 18-month follow-up, and a 36-month follow-up. The in-person visits will include assessment of substance use and other individual differences (e.g., reward function, psychiatric history), neuromelanin-sensitive MRI, as well as functional brain activation collected while the participant is at rest (resting-state fMRI) and while the participant completes a Monetary Incentive Delay task. Subjects will also be asked to complete past 90-day substance use assessments remotely every 90 days for 36 months. conditions: Adolescent Development studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 300 type: ESTIMATED name: Monetary Incentive Delay Task measure: Functional Brain Activation from Monetary Incentive Delay Task sex: ALL minimumAge: 14 Years maximumAge: 17 Years stdAges: CHILD facility: Stony Brook Medicine status: RECRUITING city: Stony Brook state: New York zip: 11794 country: United States name: Greg Perlman, PhD role: CONTACT phone: 631-638-1922 email: greg.perlman@stonybrookmedicine.edu name: Roman Kotov, PhD role: CONTACT name: Greg Perlman, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.92565 lon: -73.14094 hasResults: False

 nctId: NCT06369610 id: GMROA2256 id: NCI-2024-03020 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 22-012591 type: OTHER domain: Mayo Clinic Institutional Review Board id: GMROA2256 type: OTHER domain: Mayo Clinic in Arizona briefTitle: Risk Stratified De-escalated Hormone Therapy With Radiation Therapy for the Treatment Prostate Cancer overallStatus: RECRUITING date: 2024-04-22 date: 2027-04-22 date: 2027-04-22 date: 2024-04-17 date: 2024-04-24 name: Mayo Clinic class: OTHER briefSummary: This phase II trial tests how well risk based de-escalated hormone therapy (i.e., fewer treatments) with radiation works in treating patients with prostate cancer. Androgen deprivation therapy (ADT), such as gonadotropin-releasing hormone analogs (LHRH) and abiraterone acetate (Zytiga), lower the amount of the male hormone, testosterone, made by the body. This may help kill or stop the growth of tumor cells that need testosterone to grow. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Research has shown that long-term ADT is beneficial for patients with high-risk prostate cancer. However, there are few studies that determine ADT treatment based on risk factors. Giving risk based de-escalated ADT with radiation therapy may be as effective as giving more ADT in treating high-risk prostate cancer. conditions: Oligometastatic Prostate Carcinoma conditions: Prostate Adenocarcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: Abiraterone Acetate name: Biospecimen Collection name: Computed Tomography name: Gonadotropin-releasing Hormone Analog name: Magnetic Resonance Imaging name: Positron Emission Tomography name: Questionnaire Administration name: Radiation Therapy measure: Hormonal domain scores 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: Carlos E. Vargas, M.D. role: PRINCIPAL_INVESTIGATOR lat: 33.50921 lon: -111.89903 hasResults: False

 nctId: NCT06369597 id: Robot2024 briefTitle: A Randomized Controlled Trial of the Safety and Efficacy of Robotic Telesurgery Versus Laparoscopic Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-31 date: 2025-03-31 date: 2024-04-17 date: 2024-04-17 name: Sun Yat-sen University class: OTHER briefSummary: This is a randomized controlled trial that will be preceded by a safety trial focusing on the safety and efficacy of robotic telesurgery. The hypothesis is that robotic telesurgery has a non-inferior primary endpoint event rate to local laparoscopic surgery. conditions: Liver Cancer conditions: Renal Cancer conditions: Rectal Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 177 type: ESTIMATED name: Robotic telesurgery name: Laparoscopic surgery measure: Surgical complication measure: Surgical time (min) measure: Intraoperative blood loss (mL) measure: Postoperative hospitalization days measure: Physician satisfaction measure: Remote metrics sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital, Sun Yat-Sen University city: Guangzhou state: Guangdong zip: 510080 country: China name: Kuang Ming, PhD role: CONTACT phone: 008687755766 phoneExt: 8576 email: kuangm@mail.sysu.edu.cn lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06369584 id: PEPAD briefTitle: Prone Position During ECMO in Pediatric Patients With Severe ARDS acronym: PEPAD overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-07-01 date: 2024-04-17 date: 2024-04-17 name: Seventh Medical Center of PLA General Hospital class: OTHER name: Gansu Provincial Maternal and Child Health Care Hospital name: Xian Children's Hospital name: Henan Provincial People's Hospital name: People's Hospital of Guangxi name: Guangdong Provincial People's Hospital briefSummary: In 2023, the second Pediatric Acute Lung Injury Consensus Conference (PALICC-2) updated the diagnostic and management guidelines for Pediatric Acute Respiratory Distress Syndrome (PARDS). The guidelines do not provide sufficient evidence-based recommendations on whether prone positioning ventilation is necessary for severe PARDS patients. However, the effectiveness of Extracorporeal Membrane Oxygenation (ECMO) in treating severe PARDS has been fluctuating around 70% according to recent data from Extracorporeal Life Support Organization (ELSO).

In 2018, the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) study group conducted a retrospective analysis and concluded that ECMO does not significantly improve survival rates for severe PARDS. However, this retrospective study mainly focused on data from North America, with significant variations in annual ECMO support cases among different centers, which may introduce bias. With advancements in ECMO technology and materials, ECMO has become safer and easier to operate. In recent years, pediatric ECMO support technology has rapidly grown in mainland China and is increasingly being widely used domestically to rescue more children promptly.

ECMO can also serve as a salvage measure for severely ARDS children who have failed conventional mechanical ventilation treatment. When optimizing ventilator parameters (titrating positive end expiratory pressure (PEEP) levels, neuromuscular blockers, prone positioning), strict fluid management alone cannot maintain satisfactory oxygenation (P/F\<80mmHg or Oxygen Index (OI) \>40 for over 4 hours or OI \>20 for over 24 hours), initiating ECMO can achieve lung-protective ventilation strategies with ultra-low tidal volumes to minimize ventilator-associated lung injury. conditions: Pediatric Acute Respiratory Distress Syndrome conditions: Extracorporeal Membrane Oxygenation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 7 type: ESTIMATED name: prone position measure: Mortality measure: Failure of supine position measure: ECMO successful weaning rate measure: Total duration of ECMO Support measure: Number of ECMO-free days measure: Duration of mechanical ventilation days after ECMO successful weaning. measure: Duration of Pediatric Intensive Care Unit (PICU) stay. measure: Duration of hospitalization measure: Incidence of brain injury before discharge measure: Number of days with organ failure measure: Number of days alive without organ failure measure: Number of ventilator assist pneumonia, bacteriemia, and cannula infection episodes measure: Number of days with hemodynamic support with catecholamines measure: Number of days without hemodynamic support with catecholamines sex: ALL minimumAge: 1 Month maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: seventh medical center of Chinese PLA General Hospital city: Beijing state: Beijing zip: 100700 country: China name: Xiaoyang Hong, M.D. role: CONTACT phone: 13311057633 email: jyhongxy@163.com name: Zhe Zhao role: CONTACT phone: 18500179885 email: derekpicu@outlook.com lat: 39.9075 lon: 116.39723 facility: Gansu Provincial Maternal and Child Health Care Hospital city: Lanzhou state: Gansu zip: 730050 country: China name: Weikai Wang, M.D. role: CONTACT phone: 0931-5188650 email: 35487284@qq.com lat: 36.05701 lon: 103.83987 facility: The Second School of Clinical Medicine, Southern Medical University city: Guangzhou state: Guangdong country: China name: Yuxiong Guo, M.D. role: CONTACT phone: 13423661583 email: 2003kellylaw@163.com lat: 23.11667 lon: 113.25 facility: The People's Hospital of Guangxi Zhuang Autonomous Region city: Nanning state: Guangxi country: China name: Hanwu Huang, M.D. role: CONTACT phone: 15107710327 email: 2503133021@qq.com lat: 22.81667 lon: 108.31667 facility: Henan Children's Hospital city: Zhengzhou state: Henan zip: 450014 country: China name: Feng Wang, M.D. role: CONTACT phone: 0371-85515892 email: wang.f365@163.com lat: 34.75778 lon: 113.64861 facility: Henan Provincial People's Hospital city: Zhengzhou state: Henan zip: 463599 country: China lat: 34.75778 lon: 113.64861 facility: Xi'an Children's Hospital city: Xi'an state: Shaanxi zip: 710002 country: China name: Yi Wang, M.D. role: CONTACT phone: 18591953652 email: wangyichengxian@163.com lat: 34.25833 lon: 108.92861 hasResults: False

 nctId: NCT06369571 id: IRB00439268 briefTitle: Improving Cardiovascular Health Risks in Adults With Epilepsy on a Modified Atkins Diet overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2027-01 date: 2027-12 date: 2024-04-17 date: 2024-04-17 name: Johns Hopkins University class: OTHER name: American Heart Association briefSummary: Ketogenic diet therapies (KDTs) emphasize high fat and very low carbohydrate intake and help to control seizures in adults who fail to respond to medications. However, KDT use can lead to increased cholesterol levels in some adults with epilepsy (AWE). Treatments that can reverse elevations in cholesterol observed with long-term KDT use without compromising diet adherence and seizure control are needed. The proposed study will explore the feasibility and safety of diet modification and statin use to lower cholesterol in this population. Study findings will help guide doctors utilizing KDTs in adults with epilepsy on how to approach managing elevations in cholesterol. conditions: Epilepsy conditions: Dyslipidemia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 22 type: ESTIMATED name: Atorvastatin 10mg name: Modification of dietary fat composition measure: Diet adherence as assessed by 3 day food records measure: Statin Adherence measure: LDL Change measure: Change in weekly seizure frequency measure: Seizure severity questionnaire score measure: Frequency of adverse events measure: Blood ketone change sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06369558 id: BiruniUniversi briefTitle: Plyometric Exercise Training in Athletes With Chronic Low Back Pain overallStatus: COMPLETED date: 2024-01-01 date: 2024-04-04 date: 2024-04-04 date: 2024-04-17 date: 2024-04-17 name: Ugur Cavlak class: OTHER name: Biruni University briefSummary: The aim of this study is to examine the effectiveness of plyometric exercise training in the athletes with chronic low back pain. 32 professional volunteer athletes participated in the study. conditions: Low Back Pain, Mechanical studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial primaryPurpose: TREATMENT masking: NONE count: 32 type: ACTUAL name: PLYOMETRIC TRAINING name: CLASSIC PHYSIOTHERAPY PROGRAM measure: VISUAL ANALOG SCALE measure: OSWESTRY DISABILITY INDEX measure: SIT AND REACH TEST measure: VERTICAL JUMP TEST measure: FLAMINGO BALANCE TEST measure: SHUTTLE RUNNİNG (20 MİN.) measure: MANUAL MUSCLE STRENGTH TEST sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Faculty of Health Sciences in Biruni University city: İ̇stanbul state: Zeytinburnu zip: 34010 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06369545 id: BiruniUniver briefTitle: Chronic Pelvic Pain Syndrome in Males overallStatus: RECRUITING date: 2024-01-01 date: 2024-04-04 date: 2024-08-15 date: 2024-04-17 date: 2024-04-17 name: Biruni University class: OTHER briefSummary: The aim of this study is to evaluate the effectiveness of ESWT (Extracorporeal Shock Wave Therapy) and TENS (Transcutaneous Electrical Nerve Stimulation) in individuals diagnosed with chronic pelvic pain syndrome and treated with medication. The study was organized as a randomized controlled trial. The sample size is 30 patients suffering from chronic pelvic pain syndrome. conditions: Pelvic Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controled Trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 38 type: ESTIMATED name: EXERCISE name: TENS name: ESWT measure: VISUAL ANALOUGE SCALE measure: National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) measure: ALGOMETER measure: Hospital Anxiety and Depression Scale- HAD measure: Nottingham Health Profile-NHP measure: Digital Muscle Testing measure: Flexibility Measurements measure: ROM Assessments measure: Lasegue Test sex: MALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Faculty of Health Sciences in Biruni University status: RECRUITING city: İ̇stanbul state: Zeytinburnu zip: 34010 country: Turkey name: UGUR CAVLAK, Prof., PhD. role: CONTACT phone: 00905324519644 email: ucavlak@biruni.edu.tr lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06369532 id: ONZ-2023-0460 briefTitle: Combination of Neurostimulation and Psychotherapy to Stop Worrying overallStatus: RECRUITING date: 2024-03-06 date: 2026-02-20 date: 2027-02-20 date: 2024-04-17 date: 2024-04-17 name: University Hospital, Ghent class: OTHER briefSummary: This study aims to investigate whether the combination of transcranial Direct Current Stimulation (tDCS) and cognitive-behavioral therapy (CBT) is more effective for treating repetitive negative thinking (RNT) in patients with the symptom of high rumination. High ruminators will be included (Group1, active tDCS-CBT group; Group2, sham tDCS-CBT group). All patients will receive active or sham tDCS. conditions: Active tDCS conditions: Sham tDCS studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Participants will be allocated into two groups randomly (using a code). The psychotherapist, the study managers and the patients will not be aware of treatment allocation. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 85 type: ESTIMATED name: Active tDCS name: Sham tDCS measure: the therapeutic effect of the combination therapy for repetitive negative thinking measure: the consolidation effect of tDCS on CBT measure: Change of neuroimaging data sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Ghent status: RECRUITING city: Ghent state: East-Flanders zip: 9000 country: Belgium name: Chris Baeken, Prof. role: CONTACT name: Josefien Dedoncker, M.Sc. role: CONTACT lat: 51.05 lon: 3.71667 hasResults: False

 nctId: NCT06369519 id: 2023#17-23 briefTitle: Optimization of Management for Sporadic Bilateral Renal Cell Carcinoma overallStatus: COMPLETED date: 2000-01-01 date: 2020-12-31 date: 2020-12-31 date: 2024-04-17 date: 2024-04-17 name: Peking University First Hospital class: OTHER briefSummary: Sporadic bilateral renal cell carcinoma (BRCC) is a rare situation of RCC. The treatment for BRCC is controversial and there is a lack of authoritative guidelines about the management of BRCC. The goal of this cohort study is to identify prognostic factors, construct predictive nomograms, and optimize management for sporadic BRCC patients. The main questions it aims to answer are:

What are the factors influencing the prognosis of BRCC patients? What's the appropriate treatment for BRCC patients?

Researchers will analysis the prognostic factors and compare the prognosis of BRCC patients receiving different treatments. conditions: Kidney Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3677 type: ACTUAL name: Surgery treatment or local tumor destruction. measure: Overall survival (OS) measure: Cancer-specific survival (CSS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University First Hospital city: Beijing state: Beijing zip: 100034 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06369506 id: PYO.DIS.1904 Protocol ID:4467 briefTitle: Evaluation of Gingival Thickness Measurement at Different Anatomical Landmarks overallStatus: COMPLETED date: 2022-09-10 date: 2023-08-05 date: 2023-12-17 date: 2024-04-17 date: 2024-04-17 name: Ondokuz Mayıs University class: OTHER briefSummary: In this study, the point at which gingival thickness (GT) should be measured was investigated. Measurements were made from three different points. It was classified as thin and thick in two ways, according to the average of these three different points and the point corresponding to the base of the gingival groove, which is frequently used in the literature. And these two classifications were compared. conditions: Gingival Thickness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants were divided into two different classifications: "thin" and "thick". The first classification was made by measuring the GT of the point corresponding to the base of the gingival sulcus. GT was defined as thin if ≤1 mm, and thick if \>1 mm. In the second classification, GT was measured from three different points. And according to the average GT of three points, they were equally classified as "thin" and "thick". primaryPurpose: SCREENING masking: NONE count: 50 type: ACTUAL name: GTmeasurement measure: Examining the sensitivities and sensitivities of two different gingival phenotype classifications based on three-point average GT measurement and single-point measurement using Receiver Operating Characteristic Analysis (ROC). measure: Examining the agreement of GT measurements at three different points in 50 patients, 1195 teeth, using Kappa analysis. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ondokuz Mayis University Faculty of Dentistry Department of Periodontology city: Samsun zip: 55000 country: Turkey lat: 41.27976 lon: 36.3361 hasResults: False

 nctId: NCT06369493 id: OMUKAEK: 2022/210 briefTitle: Examining The Relationship Between Gingival Thickness and Tooth and Gingival Parameters overallStatus: COMPLETED date: 2022-09-01 date: 2023-12-01 date: 2023-12-18 date: 2024-04-17 date: 2024-04-17 name: Ondokuz Mayıs University class: OTHER briefSummary: This study aims to assess whether there is a valid correlation between the identified multiple clinical and morphometric parameters and the gingival thickness. conditions: Gingival Thickness studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 50 type: ACTUAL measure: Evaluation of the correlation between KGW, CW, CL PH parameters of GT measured in "mm" with a digital caliper with 0.001 mm precision in 1200 teeth in 50 participants using Spearman correlation analysis. measure: Evaluation of the effect of GT on keratinized gingival width, measured in "mm" by digital caliper with a precision of 0.001 mm, both by binary logistic regression analysis of 50 participants. measure: Examining the effect of age and gender of 50 participants on the gingival thickness measured in mm using binary logistic regression analysis. measure: Evaluation of researcher reliability by ICC (Intra-Class Correlation Coefficient) in 10 participants in 2 weeks sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ondokuz Mayis University Faculty of Dentistry Department of Periodonthology city: Samsun zip: 55200 country: Turkey lat: 41.27976 lon: 36.3361 hasResults: False

 nctId: NCT06369480 id: Journal-nr.: R-23057752 briefTitle: Prognostic Factors for Survival in Patients With Cholangiocarcinoma overallStatus: RECRUITING date: 2024-02-01 date: 2024-08-31 date: 2024-08-31 date: 2024-04-17 date: 2024-04-17 name: Rigshospitalet, Denmark class: OTHER briefSummary: The objective of this retrospective study is to determine the survival rates of CCA patients based on different therapeutic approaches. Additionally, we aim to investigate the risk factors associated with poor survival within a cohort of patients treated over a seven-year period across four Danish hospitals. We anticipate that our findings could provide additional evidence for clinical decision-making, improve patient outcomes, and contribute to the knowledge in the field. conditions: Cholangiocarcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2000 type: ESTIMATED name: Resection/Ablation of tumor name: Palliative chemotherapy name: Neoadjuvant chemotherapy name: Stereotatic radiotherapy name: Best supportive care measure: Aim I measure: Aim II sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Rigshospitalet status: RECRUITING city: Copenhagen zip: 2100 country: Denmark name: Hans-Christian Pommergaard, MD DMSc PhD role: CONTACT email: hans-christian.pommergaard@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06369467 id: R5458-668-ALG-2219 id: 2024-511032-27-00 type: REGISTRY domain: EU CT Number briefTitle: Short-Term Linvoseltamab Treatment, on Top of Chronic Dupilumab Treatment, for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy overallStatus: NOT_YET_RECRUITING date: 2024-04-12 date: 2026-04-24 date: 2026-04-24 date: 2024-04-17 date: 2024-04-17 name: Regeneron Pharmaceuticals class: INDUSTRY briefSummary: This study is researching an experimental drug called linvoseltamab when combined with another drug called dupilumab. The study is focused on patients who have IgE-mediated food allergy. If the patient has an allergy, the immune system overreacts to an allergen (eg, certain foods such as peanuts, milk, shellfish) by producing antibodies called IgE. IgE antibodies are released by cells such as plasma cells. These antibodies and allergen bind to other cells that release chemicals, causing an allergic reaction. The aim of the study is to see how safe and tolerable linvoseltamab is when combined with dupilumab.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drugs
* Whether linvoseltamab when combined with dupilumab has an effect on other types of antibodies in the blood at different times
* How much study drug(s) is in the blood at different times conditions: Food Allergy studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 6 type: ESTIMATED name: linvoseltamab name: dupilumab measure: Incidence of treatment-emergent adverse events (TEAEs) measure: Severity of TEAEs measure: Incidence of adverse event of special interest (AESIs) measure: Severity of AESIs measure: Incidence of serious adverse events (SAEs) measure: Severity of SAEs measure: Absolute change in the serum concentration of total IgE over time measure: Percent change in the serum concentration of total IgE over time measure: Time to reach unquantifiable total serum IgE concentration measure: Time to reach baseline level and/or the lower limit of the normal ranges of serum IgG measure: Time to reach baseline level and/or the lower limit of the normal ranges of serum immunoglobulin M (IgM) measure: Time to reach baseline level and/or the lower limit of the normal ranges of serum immunoglobulin A (IgA) measure: Incidence of participants with unquantifiable concentrations of serum total IgE measure: Absolute change in the serum concentration of food allergen-specific IgE measure: Percent change in the serum concentration of food allergen-specific IgE measure: Time to reach unquantifiable food allergen-specific serum IgE levels sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06369454 id: B7981090 briefTitle: A Study to Learn About How Different Forms of the Study Medicine Called Ritlecitinib Pass the Intestines of Healthy Male Adults When Taken With or Without Food overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-03 date: 2024-08-03 date: 2024-04-17 date: 2024-04-17 name: Pfizer class: INDUSTRY briefSummary: The purpose of this study is to learn about how different forms of the study medicine called ritlecitinib pass the intestines of healthy male adults when taken with or without food.

This study is seeking healthy participants who have:

* Aged 18 years or older;
* male who are healthy as determined by medical assessment;
* BMI of 16-32 kg/m2, and a total body weight \>45 kg (99 lb).

All participants in this study will receive a ritlecitinib oral dose in two different forms (solution without food, capsule with or without food).

The study will take up to 3 months, including the screening period and follow-up phone call. Participants will have to stay at the study clinic for at least 11 days. There will be 3 periods in total, and a washout period of at least 3 days between dosings in Period 1 and Period 2, and at least 7 days between dosings in Period 2 and Period 3 for this study. On day 1 of each period, participants will take one form of Riltecitinib without food for the first two periods and with food for the last period. Participants will have blood samples taken both before and after taking ritlecitinib. A follow-up phone call will be made at 28 to 35 days after the last study period. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 12 type: ESTIMATED name: Ritlecitinib measure: Site of capsule disintegration and MR microsphere dispersion measure: Gastric emptying time measure: Small intestine residence/transit time measure: Colon arrival time measure: Colon (ascending, transverse, descending) residence/transit time measure: Total transit time measure: Maximum plasma concentration (Cmax) measure: Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf) measure: Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) measure: Time for Cmax (Tmax) measure: Terminal half-life (t1/2) measure: Frequency of adverse events measure: Frequency of abnormal clinical laboratory tests measure: Frequency of abnormal vital signs measure: Frequency of abnormal 12-lead ECG sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06369441 id: Ovation-23-001 briefTitle: Collection of Biological Specimens and Associated Health Information overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2034-04 date: 2024-04-17 date: 2024-04-17 name: Ovation.io, Inc. class: INDUSTRY briefSummary: The purpose of this study is to collect blood samples from a large number of individuals with cancer to create a database for researchers to use in future studies. Researchers may use this database to discover new ways to detect and treat cancer and other diseases. Future studies may use stored blood samples to discover how genes affect health and disease. conditions: Cancer conditions: Other Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 10000 type: ESTIMATED measure: Biorepository sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ovation.io city: Portland state: Maine zip: 04101 country: United States name: Stephanie Balcaitis role: CONTACT phone: 617-795-4947 phoneExt: 2 email: ClinicalAffairs@ovation.io name: Ed Stepanski, PhD role: CONTACT email: ClinicalAffairs@ovation.io name: Pauline Gee, PhD role: PRINCIPAL_INVESTIGATOR lat: 43.66147 lon: -70.25533 hasResults: False

 nctId: NCT06369428 id: CDRB436BFI02 briefTitle: Patient Characteristics, Treatment Patterns, and Healthcare Resource Utilization of Metastatic Melanoma Patients overallStatus: COMPLETED date: 2021-06-23 date: 2023-04-13 date: 2023-04-13 date: 2024-04-17 date: 2024-04-17 name: Novartis class: INDUSTRY briefSummary: This was a retrospective, non-interventional, registry study based on secondary electronic medical record (EMR) data collected in Helsinki and Uusimaa hospital district (HUS data lake), hospital district of Southwest Finland (VSSHP data lake) and Pirkanmaa hospital district (PSHP data lake) as a part of their routine clinical practice. Social Insurance Institution of Finland (SII; reimbursed drug purchases) was utilized in this study to complement the medication data. The metastatic melanoma patients were stratified by first-line treatment and by hospital district. conditions: Metastatic Melanoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1795 type: ACTUAL measure: Mean Age-standardized Annual Incidence of Metastatic Melanoma in 2014-2021 measure: Point Prevalence per 100,000 Population measure: Mean Age of Patients at Index Date per Hospital District measure: Mean Length of Follow-up at Index Date per Hospital District measure: Gender at Index Date per Hospital District measure: Number of Patients with Lactate Dehydrogenase (LDH) Levels Less than the Upper Limit of Normal (ULN) at Index Date per Hospital District measure: Number of Patients with LDH Levels Between the ULN and 1.5 Times ULN at Index Date per Hospital District measure: Number of Patients with LDH Levels Greater than 1.5 Times ULN at Index Date per Hospital District measure: Number of Patients with Positive Proto-oncogene B-Raf (BRAF) Status at Index Date per Hospital District measure: Number of Patients with Negative BRAF Status at Index Date per Hospital District measure: Number of Patients by Charlson Comorbidity Index (CCI) Score Category at Index Date per Hospital District measure: Number of Patients by Number of Metastatic Organs at Index Date per Hospital District measure: Number of Patients by Location of Metastases at Index Date per Hospital District measure: Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per Hospital District measure: Number of Patients by Most Prevalent (greater than 5%) Baseline Comorbidities per First-line Medication measure: Overall Survival (OS) measure: Time to Next Treatment (TTNT) of the First-line (1L) by Type of Treatment measure: Duration of Treatment (DoT) measure: Mean Age at Index Date per First-line (1L) Medication measure: Length of Follow-up at Index Date per 1L Medication measure: Time to Treatment at Index Date per 1L Medication measure: Gender at Index Date per 1L Medication measure: Number of Patients with Lactate Dehydrogenase (LDH) Levels Less than the Upper Limit of Normal (ULN) at Index Date per 1L Medication measure: Number of Patients with LDH Levels Between the ULN and 1.5 Times ULN at Index Date per 1L Medication measure: Number of Patients with LDH Levels Greater than 1.5 Times ULN at Index Date per 1L Medication measure: Number of Patients with Positive Proto-oncogene B-Raf (BRAF) Status at Index Date per 1L Medication measure: Number of Patients with Negative BRAF Status at Index Date per 1L Medication measure: Number of Patients by Charlson Comorbidity Index (CCI) Score Category at Index Date per 1L Medication measure: Number of Patients by Number of Metastatic Organs at Index Date per 1L Medication measure: Number of Patients by Location of Metastases at Index Date per 1L Medication measure: Number of Patients by Tumor, Nodes, and Metastasis (TNM) Stage per 1L Medication measure: Number of Patients that Received Radiotherapy During 1L Treatment measure: Number of Patients Switched from Immuno-oncology (IO) 1L Treatment to Targeted Therapy (TT) Second-line (2L) Treatment measure: Number of Patients Switched from IO 1L Treatment to Chemotherapy (Chemo) 2L Treatment measure: Number of Patients Switched from TT 1L Treatment to IO 2L Treatment measure: Number of Patients Switched from TT 1L Treatment to Chemo 2L Treatment measure: Number of Patients Switched from Chemo 1L Treatment to IO 2L Treatment measure: Number of Patients Switched from Chemo 1L Treatment to TT 2L Treatment measure: Number of Patients Switched from IO 2L Treatment to TT Third-line (3L) Treatment measure: Number of Patients Switched from IO 2L Treatment to Chemo 3L Treatment measure: Number of Patients Switched from TT 2L Treatment to IO 3L Treatment measure: Number of Patients Switched from TT 2L Treatment to Chemo 3L Treatment measure: Number of Patients Switched from Chemo 2L Treatment to IO 3L Treatment measure: Number of Patients Switched from Chemo 2L Treatment to TT 3L Treatment measure: Number of Healthcare Contacts and Associated Costs per Patient Year measure: Number of Healthcare Contacts and Associated Costs per Patient measure: Number of Healthcare Contacts and Associated Total Costs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Novartis city: Basel zip: 4056 country: Switzerland lat: 47.55839 lon: 7.57327 hasResults: False

 nctId: NCT06369415 id: 04/24/DD-BVMD briefTitle: Health of Babies Born From IVF Versus IVM at 5 Years Old acronym: FM-BABIES-5Y overallStatus: RECRUITING date: 2024-04-16 date: 2025-12-30 date: 2026-03-30 date: 2024-04-17 date: 2024-04-17 name: Mỹ Đức Hospital class: OTHER briefSummary: The investigators conduct a long-term follow-up at five years on offspring born from our randomized controlled trial (RCT) to investigate whether or not there is any difference in developmental outcomes in children born after capacitation IVM (CAPA IVM) compared with conventional IVF in order to give strong evidence about the safety of IVM in women with high antral follicle count. conditions: Infertility conditions: IVF conditions: IVM conditions: Development, Child studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 231 type: ESTIMATED name: Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3 and behavioural screening according to Strength and Difficulties Questionnaires (SDQ's) measure: Normal ASQ-3 score rate. measure: Normal SDQ score rate. measure: Normal weight rate measure: Thinness rate measure: Overweight rate measure: Obesity rate measure: Score of Communication (ASQ-3 questionnaire) measure: Score of Gross motor (ASQ-3 questionnaire) measure: Score of Fine motor (ASQ-3 questionnaire) measure: Score of Problem solving (ASQ-3 questionnaire) measure: Score of Personal-Social (ASQ-3 questionnaire) measure: Score of Emotional symptoms (SDQ questionnaire) measure: Score of Conduct problems (SDQ questionnaire) measure: Score of hyperactivity/inattention (SDQ questionnaire) measure: Score of peer relationship problems (SDQ questionnaire) measure: Score of prosocial behavior (SDQ questionnaire) measure: The total difficulties score. sex: ALL minimumAge: 5 Years maximumAge: 5 Years stdAges: CHILD facility: Mỹ Đức Hospital status: RECRUITING city: Ho Chi Minh City state: Tan Binh country: Vietnam name: Tuong M Ho, MD, MCE role: CONTACT phone: +84903633377 email: tuongho.ivfmd@gmail.com lat: 10.82302 lon: 106.62965 hasResults: False

 nctId: NCT06369402 id: 0963 briefTitle: Cognitive Impairment and Cerebral Haemodynamics in Individuals With Symptomatic Peripheral Arterial Disease acronym: CInCH PAD overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-02 date: 2025-02 date: 2024-04-17 date: 2024-04-25 name: University of Leicester class: OTHER name: University Hospitals, Leicester briefSummary: Background:

Arterial disease of the legs causes symptoms such as pain when walking and may ultimately lead to a leg amputation. Many older people with arterial disease of the legs also have problems with their thinking and memory. Blood flow in the brain may be altered in these people and may be a cause for memory and thinking problems.

Aim:

The aim of this project is to investigate whether people with arterial disease of the legs have altered blood flow in the brain causing problems with memory and thinking.

Research plan:

Twenty people with arterial disease of the legs causing pain while walking and twenty healthy people will have a series of non-invasive assessments. Arterial disease in the legs will be measured using ankle blood pressures before and after walking. Blood flow in the brain will be measured using ultrasound whilst performing memory and thinking tests. Results will be compared between the people with arterial disease in the legs and the healthy people to see if there are any differences in blood flow to the brain and memory and thinking.

Benefits to society:

This project will help determine if there is a link between arterial disease of the legs and memory and thinking problems caused by altered blood flow in the brain. It will enable future research in people with cognitive impairment caused by altered blood supply to the brain and to prevent confusion and further memory and thinking problems in people undergoing surgery for arterial disease of the legs. conditions: Peripheral Arterial Disease conditions: Cognitive Impairment studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED name: Cerebral haemodynamic testing using transcranial Doppler name: Ankle-brachial pressure index name: Six-minute walk test measure: Peak % change of CBv from baseline measure: Autoregulation index (Tieck's model) measure: Absolute score achieved on the Addenboook's cognitive examination (III) measure: Digit span forward and backward scores measure: Claudication distance measure: Maximal walking distance measure: Ankle-brachial pressure index sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Glenfield Hospital Leicester city: Leicester state: Leicestershire zip: LE3 9QP country: United Kingdom lat: 52.6386 lon: -1.13169 hasResults: False

 nctId: NCT06369389 id: RC31/23-0417 briefTitle: Real-life Management of Patients Eligible for CAR-T Cell Therapy acronym: CARAVAGE overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2033-12-31 date: 2034-12-31 date: 2024-04-17 date: 2024-04-17 name: University Hospital, Toulouse class: OTHER name: Ligue contre le cancer, France name: Janssen, LP briefSummary: Adoptive immunotherapy using CAR-T cells is now one of the Advanced Therapy Medicines routinely used for relapsed or refractory lymphoid hemopathies. In 2023, in France, 5 types of CAR-T cells have marketing authorization for 6 different indications. However, these marketing authorizations are based on clinical trials involving a limited number of selected patients. Real-life data are essential for assessing the post-authorization use of these innovative treatments. The French national DESCAR-T registry, promoted by LYSARC and in which Toulouse University Hospital plays an active role, is an international reference for this real-life evaluation. It does not, however, allow precise evaluation of patient-centered indicators and care pathways.

With the increasing number of indications and candidate patients, Toulouse University Hospital, the only healthcare facility authorized in the Western Occitanie region to administer CAR-T cells, is faced with growing hospital needs and longer treatment times. In 2023, this has necessitated the implementation of new ambulatory and inter-facility care pathways in collaboration with the referral centers of the Onco-Occitanie Ouest regional cancer network. The selection of patients for CAR-T cell treatment is based on objective clinical criteria linked to the pathology (histology, morphological localization, size and kinetics of the tumor mass) and the patient (physiological age, performance index, comorbidities, patient choice). Because of their innovative nature, in a difficult psychological and physical context for the patient (refractory disease), CAR-T cell care pathways also need to be evaluated in terms of their "quality of life" dimension. The impact of non-biological determinants (also described as social and territorial inequalities in health) such as place of residence and distance from healthcare provision, marital, economic and social status, has never been explored on the accessibility and progress of the CAR-T cell treatment pathway.

The creation of a registry of patients eligible for CAR-T cells at Toulouse University Hospital will enable these lines of research to be explored on the scale of a region with a population of 3 million. conditions: Hemopathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 550 type: ESTIMATED name: Patients eligible for CAR-T treatment measure: Overall survival of patients with hemopathy eligible for CAR-T cell therapy measure: Compare progression-free survival and overall survival of patients according to care pathway and type of hemopathy, and investigate clinical and socioeconomic factors associated with better survival measure: Evaluate the time taken to treat patients with CAR-T cells sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Toulouse city: Toulouse state: CHU De Toulouse zip: 31059 country: France name: Pierre BORIES, MD role: CONTACT phone: 0531156415 phoneExt: 33 email: bories.pierre@iuct-oncopole.fr name: Sandra DE BARROS role: CONTACT phone: 0561145982 email: debarros.s@chu-toulouse.fr lat: 43.60426 lon: 1.44367 hasResults: False

 nctId: NCT06369376 id: ONZ-2022-0072 briefTitle: Electrodiagnostic Approach for Pectoral Nerve Conduction Studies overallStatus: COMPLETED date: 2023-06-30 date: 2023-11-29 date: 2024-04-12 date: 2024-04-17 date: 2024-04-17 name: University Hospital, Ghent class: OTHER briefSummary: Anatomical studies have challenged traditional perceptions of the pectoral nerve structure, revealing a network of three branches rather than the previously accepted medial and lateral branches. This study aims to explore the implications of this updated anatomy on nerve conduction studies of the pectoral nerve and proposes a modified nerve conduction study protocol to enhance diagnostic accuracy.

A study on 25 volunteers was conducted, examining the three parts of the pectoral nerve. Electrode placement followed a detailed methodology ensuring precise data collection. The nerve conduction study was performed bilaterally, exploring latency and amplitude while addressing inter-observer variability and demographic influences. conditions: New Nerve Conduction Protocol for Pectoral Nerve studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 25 type: ACTUAL name: New nerve conduction protocol measure: Latency measure: Amplitude sex: ALL minimumAge: 22 Years maximumAge: 68 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZ Gent city: Gent state: Oost-Vlaanderen zip: 9000 country: Belgium lat: 51.05 lon: 3.71667 hasResults: False

 nctId: NCT06369363 id: STUDY000024245 briefTitle: Estrogen Deficiency on Cardiovascular Risk overallStatus: NOT_YET_RECRUITING date: 2025-09 date: 2027-09 date: 2027-11 date: 2024-04-17 date: 2024-04-17 name: Milton S. Hershey Medical Center class: OTHER briefSummary: To explore how estrogen deficiency impacts the blood pressure (BP) and sympathetic nerve activity (SNA), and how it impacts the production of the key pro-inflammatory mediators such as Tumor necrosis factor α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6). It is hypothesized that estrogen deficiency increases BP, SNA and the pathway activities of the key pro-inflammatory mediators. Those effects are impacted through the downregulation of the estrogen receptor. conditions: Postmenopausal Symptoms conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Placebo name: Estradiol measure: Red blood cell flux measure: Mean arterial pressure (mmHg) measure: baseline plasma TNF-α concentration (pg/ml) measure: One week post-intervention plasma TNF-α concentration (pg/ml) measure: baseline plasma IL-1β concentration (pg/ml) measure: One week post-intervention plasma IL-1β concentration (pg/ml) measure: baseline plasma IL-6 concentration (pg/ml) measure: One week post-intervention plasma IL-6 concentration (pg/ml) measure: baseline plasma estrogen (pg/ml) measure: One week post-intervention plasma estrogen (pg/ml) sex: FEMALE minimumAge: 54 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06369350 id: STUDY000020217 id: 940567 type: OTHER_GRANT domain: American Heart Association briefTitle: Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-09 date: 2025-09 date: 2024-04-17 date: 2024-04-17 name: Milton S. Hershey Medical Center class: OTHER name: American Heart Association briefSummary: In this study, we are trying to see if vitamin B6 can minimize the amplified blood pressure response to exercise following ischemia-reperfusion injury. We are interested in a protein called P2X3, of which function can be blocked by vitamin B6, in the neurons of our nervous system. It is very important for blood pressure regulation. We would like to see if the P2X3 plays a role in patients' rising blood pressure during exercise. The results of the proposed studies will provide a base for those two potential economic and non-invasive inventions to improve the overall health and well-being of PAD patients. conditions: Ischemia Reperfusion Injury conditions: Peripheral Artery Disease studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Vitamin B6 25 MG name: Vitamin B6 50 MG name: Vitamin B6 100 MG name: Placebo measure: baseline blood pressure in mmHg measure: Second visit blood pressure in mmHg measure: baseline heart Rate in beats per minute measure: Second visit heart Rate in beats per minute measure: baseline muscle sympathetic nerve activity in burst/min measure: Second visit muscle sympathetic nerve activity in burst/min measure: baseline walking time in minutes measure: Second visit walking time in minutes sex: ALL minimumAge: 21 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06369337 id: 014-24 briefTitle: Ultrasound Study of the Submentonian Musculature and Its Relationship in Dysphagia overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-06 date: 2024-04-17 date: 2024-04-22 name: Universidad Europea de Madrid class: OTHER name: Hospital Universitario Ramon y Cajal briefSummary: Acquired dysphagia is one of the most frequent complications suffered by patients in intensive care units (ICU) after orotracheal extubation. Ultrasound has proven to be a useful method in the morphological and kinematic exploration of the main swallowing structures. AIM: to evaluate, through ultrasound procedures, the evolution of the morphology of the tongue and muscles of the floor of the mouth and the hyolaryngeal kinematics in patients intubated \>48h and to correlate these measurements with the possible development of acquired dysphagia. The incidence of dysphagia and ICU acquired weakness (ICUAW) in subjects with \>48h of intubation and the relative risk factors associated with baseline characteristics and clinical variables will be described. METHODOLOGY: Design: Single-center cohort study (Ramón y Cajal University Hospital). Participants: subjects \>18 years old, admitted to an intensive care unit (ICU), with \>48 hours of orotracheal intubation who meet eligibility criteria. Outcomes: the study of socio-demographic and clinical variables related to ICU admission will be included. The physical function variables will be analyzed through the Medical Research Council (MRC) and Functional Status Score (FSS), as well as swallowing function variables through the Volume-Viscosity Swallow (VVS-T) and Functional Oral Intake Scale scales. (FOIS) and Gugging Swallowing Screen (GUSS). Measurements will be made of the thickness and echogenicity of the submental and tongue muscles, as well as hyolaryngeal kinematics conditions: Dysphagia, Oropharyngeal conditions: Deglutition Disorders conditions: Mechanical Ventilation Complication studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED name: Ultrasound measure: Thickness of the submental muscles measure: Hyolaryngeal displacement measure: Muscle strength measure: Functional Status measure: Swallowing function measure: Swallowing function measure: Swallowing function sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06369324 id: 05 briefTitle: Efficacy of Pain Neuroscience Education and Physiotherapy in Patients Diagnosed With Spondyloarthritis overallStatus: RECRUITING date: 2024-02-15 date: 2024-04-11 date: 2024-04-11 date: 2024-04-17 date: 2024-04-18 name: Universidad de Extremadura class: OTHER briefSummary: Spondyloarthritis, notably ankylosing spondylitis (AS), represents a chronic rheumatic condition typified by persistent back pain and stiffness. It constitutes a substantial portion of diagnoses within rheumatology units and exhibits a higher prevalence among males. Diagnosis relies upon comprehensive clinical evaluation, including patient history, physical examination, and adjunctive radiological assessments, with genetic predisposition, particularly the presence of the HLA-B27 antigen, playing a significant role.

Management strategies encompass a multidisciplinary approach, with physiotherapy emerging as a cornerstone therapeutic modality. Various exercise interventions, particularly those supervised by trained professionals, demonstrate efficacy in improving pain, stiffness, and overall functional capacity. Furthermore, patient education plays a pivotal role in enhancing treatment adherence and optimizing outcomes by aligning patient expectations with therapeutic goals.

The evolving landscape of spondyloarthritis management underscores the necessity of further research into multimodal treatment approaches, particularly in integrating novel interventions such as electrophysical agents. By elucidating the mechanisms of action and exploring their synergistic effects, clinicians can refine treatment protocols and ultimately enhance the quality of care provided to individuals living with spondyloarthritis. conditions: Spondyloarthropathies conditions: Ankylosing Spondylitis conditions: Exercise Therapy conditions: Physical Therapy Modalities conditions: Pain Management studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Pain education name: Exercise supervised by external focus name: Therapy by means of electrical stimulation (electro-massage) measure: Numeric Pain Rating Scale (NPRS) measure: Cervical and Lumbar Joint Position Sense Error measure: Cervical Range of Motion (CRoM) measure: Pressure Pain Threshold (PPT) measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) measure: Bath Ankylosing Spondylitis Motility Index (BASMI) measure: Bath Ankylosing Spondylitis Functional Index (BASFI). measure: Kinesophobia measure: Catastrophizing Pain measure: Fear-Avoidance Beliefs Questionnaire (FABQ) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine and Health Sciences status: RECRUITING city: Badajoz zip: 06006 country: Spain name: Carlos Fernández-Morales, MSc role: CONTACT lat: 38.87789 lon: -6.97061 hasResults: False

 nctId: NCT06369311 id: 2000037345 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-17 date: 2024-04-17 name: [Redacted] hasResults: False

 nctId: NCT06369298 id: JK07.2.01 briefTitle: Study of JK07 in Patients With Chronic Heart Failure acronym: RENEU-HF overallStatus: RECRUITING date: 2024-03-28 date: 2025-12-31 date: 2026-06-30 date: 2024-04-16 date: 2024-04-18 name: Salubris Biotherapeutics Inc class: INDUSTRY briefSummary: This is a Phase 2, randomized, double-blind, placebo-controlled, multiple dose study to assess the safety, tolerability, and efficacy of JK07 in participants aged 18-85 with heart failure.

There will be 2 cohorts in this study:

Cohort 1: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) of ≤ 40%.

Cohort 2: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) \> 40% and ≤ 65%.

Participants in both cohorts will be randomized into either low dose JK07, high dose JK07 or placebo. Participants will have a 2:1 chance of receiving JK07 versus placebo. conditions: Heart Failure With Reduced Ejection Fraction conditions: Heart Failure With Preserved Ejection Fraction studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 282 type: ESTIMATED name: JK07 name: Placebo measure: Safety - Cohort 1 measure: Efficacy - Cohort 1 measure: Safety - Cohort 2 sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Southern California Heart Specialists status: RECRUITING city: Pasadena state: California zip: 91105 country: United States name: Gregory Giesler role: CONTACT lat: 34.14778 lon: -118.14452 facility: New Generation of Medical Research status: RECRUITING city: Hialeah state: Florida zip: 33016 country: United States name: Karelia Ruiz role: CONTACT lat: 25.8576 lon: -80.27811 facility: Louisiana Heart Center status: RECRUITING city: Covington state: Louisiana zip: 70433 country: United States name: Bruce Iteld, MD role: CONTACT lat: 30.47549 lon: -90.10042 facility: Cardiology and Vascular Associates status: RECRUITING city: Bloomfield Hills state: Michigan zip: 48304 country: United States name: Kirit Patel role: CONTACT lat: 42.58364 lon: -83.24549 facility: St. Louis Heart and Vascular Cardiology status: RECRUITING city: Saint Louis state: Missouri zip: 63136 country: United States name: Harvey Serota role: CONTACT lat: 38.62727 lon: -90.19789 facility: Southwest Family Medicine status: RECRUITING city: Dallas state: Texas zip: 75235 country: United States name: Chriistte Dharma role: CONTACT lat: 32.78306 lon: -96.80667 hasResults: False

 nctId: NCT06369285 id: PUMA-ALI-1201 id: 2024-511497-79-00 type: CTIS briefTitle: A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer acronym: ALISCA-Breast1 overallStatus: NOT_YET_RECRUITING date: 2024-12-31 date: 2027-06-30 date: 2028-12-31 date: 2024-04-16 date: 2024-04-16 name: Puma Biotechnology, Inc. class: INDUSTRY briefSummary: PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy. conditions: Hormone Receptor Positive HER-2 Negative Breast Cancer conditions: Metastatic Breast Cancer conditions: Recurrent Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Alisertib name: Endocrine therapy measure: Objective Response Rate (ORR) Within Dose Subgroup measure: Duration of Response (DOR) Within Dose Subgroup measure: Disease Control Rate (DCR) Within Dose Subgroup measure: Progression Free Survival (PFS) Within Dose Subgroup measure: Overall Survival (OS) Within Dose Subgroup measure: Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the Enrolled Population measure: Objective Response Rate (ORR) Within Biomarker-Defined Subgroup measure: Duration of Response (DOR) Within Biomarker-Defined Subgroup measure: Disease Control Rate (DCR) Within Biomarker-Defined Subgroup measure: Progression Free Survival (PFS) Within Biomarker-Defined Subgroup measure: Overall Survival (OS) Within Biomarker-Defined Subgroup sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06369272 id: mRNA-1273-P919 briefTitle: Study to Assess Maternal and Infant Outcomes Following Exposure to SPIKEVAX During Pregnancy overallStatus: COMPLETED date: 2023-03-01 date: 2023-10-20 date: 2023-10-20 date: 2024-04-16 date: 2024-04-16 name: ModernaTX, Inc. class: INDUSTRY briefSummary: The primary objectives of this study are:

In infants of women exposed to SPIKEVAX during pregnancy, to assess:

* If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of major congenital malformations (MCMs).
* If exposure to SPIKEVAX during pregnancy is associated with an increased birth prevalence of adverse neonatal and infant outcomes, specifically neonatal encephalopathy, small for gestational age, respiratory distress in the newborn, and incidence of hospitalization due to infections including coronavirus disease 2019 (COVID-19).
* In women exposed to SPIKEVAX during pregnancy, to assess whether exposure to SPIKEVAX is associated with an increased prevalence of hypertensive disorders \[e.g., pre-eclampsia, eclampsia, and gestational hypertension\] gestational diabetes, and post-partum hemorrhage; and
* To assess whether exposure to SPIKEVAX during pregnancy is associated with an increased incidence of stillbirth, preterm birth, and medically attended spontaneous abortion. conditions: Maternal Outcomes conditions: Infant Outcomes conditions: Pregnancy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1192 type: ACTUAL measure: Number of MCMs measure: Number of Adverse Neonatal and Infant Outcomes measure: Number of Participants with Hypertensive Disorders measure: Number of Stillbirths, Preterm Births, and Medically Attended Spontaneous Abortions measure: Demographics: Participant Region of Residence measure: Demographics: Age at LMP measure: Demographics: Number of Overweight or Obese Participants measure: Demographics: Duration of Health Plan Enrolment Prior to Pregnancy measure: Demographics: Calendar Date of the Pregnancy Outcome measure: Demographics: Participant Race and Ethnicity measure: Demographics: Participant Socio-economic Status measure: Healthcare Utilization: Number of Office Visits, Emergency Department Visits, and Hospitalizations measure: Healthcare Utilization: Number of Distinct Medications Used sex: FEMALE minimumAge: 13 Years maximumAge: 49 Years stdAges: CHILD stdAges: ADULT facility: Carelon Research city: Newton state: Massachusetts zip: 02458 country: United States lat: 42.33704 lon: -71.20922 hasResults: False

 nctId: NCT06369259 id: 2023-0997 id: NCI-2024-03302 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Open-label Phase 2 Study of Avutometinib (RAF/MEK Clamp) in Combination With Defactinib (FAK Inhibitor) and Cetuximab in Patients With Unresectable, Anti-EGFR-Refractory Advanced Colorectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-10-31 date: 2026-02-01 date: 2028-02-01 date: 2024-04-16 date: 2024-04-16 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To learn if avutometinib in combination with defactinib and cetuximab can help to control unresectable, anti-EGFR-refractory, advanced colorectal cancer. conditions: Advanced Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 33 type: ESTIMATED name: Defactinib name: Cetuximab name: Avutometinib 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: 77807 country: United States name: Christine Parseghian, MD role: CONTACT name: Christine Parseghian, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06369246 id: 2023-0893 id: NCI-2024-03308 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: PRORAD-5 PROstate RADiation in 5 Fractions: Phase Ib Five Fraction Radiotherapy for Patients With Advanced Prostate Cancer overallStatus: NOT_YET_RECRUITING date: 2024-10-31 date: 2025-09-01 date: 2027-09-01 date: 2024-04-16 date: 2024-04-16 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To look at the safety and effectiveness of stereotactic body radiation therapy (SBRT) in treating advanced or high-risk prostate cancer. conditions: Advanced Prostate Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 70 type: ESTIMATED name: Stereotactic Body Radiation Therapy 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: Comron Hassanzadeh, MD role: CONTACT phone: 713-657-9802 email: cjhassanzadeh@mdanderson.org name: Comron Hassanzadeh, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06369233 id: LNC-MS-002 briefTitle: Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield®-SP in Comparison With Guardix-SP Plus After Spine Surgery overallStatus: RECRUITING date: 2024-04-01 date: 2025-02-28 date: 2025-02-28 date: 2024-04-16 date: 2024-04-25 name: L&C Bio class: INDUSTRY name: PROMeDis briefSummary: This study is Interventional, Parallel, Double-blinded, Randomized study. Subjects aged 20 to 70 years who had a Lumbar discectomy or laminectomy, MegaShield-SP® and Guardix-SP Plus will be applied. conditions: Herniation, Disc studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: MegaShield®-SP name: Guardix-SP Plus measure: MRI scar score measure: Oswestry Disability Index(ODI) score measure: Visual Analog Scale(VAS) Back & Leg Pain Score sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eunpyeong ST. Mary's Hospital status: RECRUITING city: Seoul zip: 03312 country: Korea, Republic of name: HyungYul Park role: CONTACT phone: 02-2030-4536 email: matrixbest@naver.com name: HyungYul Kim, Professor role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: Severance Hospital status: RECRUITING city: Seoul zip: 03722 country: Korea, Republic of name: Siyoung Park role: CONTACT phone: 2228-2194 email: drspine90@yuhs.ac name: Siyoung Park, Professor role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: Gangnam Severance Hospital status: RECRUITING city: Seoul zip: 06273 country: Korea, Republic of name: Jiwon Kwon role: CONTACT phone: 2019-3411 email: KWONJJANNG@yuhs.ac name: Jiwon Kwon, Professor role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: Bundang Seoul National University Hospital status: RECRUITING city: Seoul zip: 13620 country: Korea, Republic of name: Hojung Kim role: CONTACT phone: 031-787-7202 email: oshjkim@gmail.com name: Hojung Kim, Professor role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06369220 id: LIA-STI-542 briefTitle: A Study of the Cobas® Liat CT/NG/MG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2024-10-31 date: 2024-10-31 date: 2024-04-16 date: 2024-04-16 name: Hoffmann-La Roche class: INDUSTRY name: Roche Molecular Systems, Inc briefSummary: This study is designed to assess the comparative clinical utility of the point of care cobas® liat CT/NG/MG to current standard practices in the diagnosis and treatment of urogenital infections with Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG). conditions: Chlamydia Trachomatis Infection conditions: Neisseria Gonorrhoeae Infection conditions: Mycoplasma Genitalium Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 348 type: ESTIMATED name: cobas® liat CT/NG/MG nucleic acid test name: Standard of Care (SOC): Clinician's Standard Practice measure: Percentage of Participants Given Inappropriate Treatments for All Pathogens Combined (CT, NG, and MG) measure: Percentage of Participants Given Inappropriate Treatment for CT Infection measure: Percentage of Participants Given Inappropriate Treatment for NG Infection measure: Percentage of Participants Given Inappropriate Treatment for MG Infection measure: Mean Satisfaction and Confidence Rating Scores of SOC and POC, According to Healthcare Professionals' Responses to the CSDT Questionnaire measure: Mean Satisfaction Rating Scores of SOC and POC, According to Participants' Responses to the PSDT Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06369207 id: 113454 briefTitle: Investigation of the Transmission Pathways of Reflux in Patients With Chronic Venous Evaluation of Reflux Transmission Pathways in Chronic Venous Insufficiency Patients Secondary to Saphenofemoral Reflux overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-12 date: 2024-02-15 date: 2024-09 date: 2024-04-16 date: 2024-04-22 name: Golestan University of Medical sciences class: OTHER briefSummary: Chronic venous insufficiency (CVI) is one of the most common medical problems in adults that occurs secondary to the reflux of blood through incompetent valves of lower extremity veins. The most common involved valve is the valve located at the saphenofemoral junction. Although the pathway of reflux transmission is not the same in all patients, the removal or ablation of the greater saphenous vein (GSV) is considered a standard treatment in these patients. However, in patients whose reflux is transmitted to branches other than GSV, this treatment leads to the unnecessary destruction of a competent segment of GSV in addition to remaining at least some segments of incompetent veins. So, in this study, the investigators intend to investigate the different pathways of reflux transmission in chronic venous insufficiency patients who are candidates for GSV ablation/stripping because of saphenofemoral junction insufficiency. This cross-sectional study will be conducted with a descriptive-analytical approach. . conditions: Venous Insufficiency studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ACTUAL measure: Determination of reflux transmission pathways in CVI patients with SFJ incompetency measure: Anatomic variations of GSV in CVI patients with SFJ incompetency measure: Prevalence of reflux along GSV main trunk in CVI patients with SFJ incompetency measure: Prevalence of reflux along accessory saphenous veins in CVI patients with SFJ incompetency sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pezhman Kharazm, MD city: Gorgan state: Golestan zip: 4917956808 country: Iran, Islamic Republic of lat: 36.8427 lon: 54.44391 hasResults: False

 nctId: NCT06369194 id: POWER5 briefTitle: POWER AUDIT, Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-14 date: 2024-04-15 date: 2024-04-15 date: 2024-04-16 date: 2024-04-19 name: Grupo Español de Rehabilitación Multimodal class: OTHER briefSummary: The main objective of this study is to analyze the impact on five years survival of an enhanced recovery program (PRI) after radical surgery for colorectal cancer. As secondaries objectives, we propose to analyze comparing survival distributions between patient groups (ERAS/no ERAS) and the relationship between the ERAS program and early incorporation into oncology therapies (RIOT).

It is proposed to review the medical records of oncology patients included in POWER 1 (as already foreseen in that study), with the aim of performing a 5-year follow-up.

To create comparable treatment and control groups, the Propensity Index method will be used. To study each variable, multivariate regression will be used. Kaplan-Meier will be used for survival and the log-rank test for comparisons. Significance will be considered if p \<0.05 (two tails). conditions: Colorectal Surgery conditions: Critical Pathways conditions: Enhanced Recovery After Surgery conditions: Retrospective Studies conditions: Chemotherapy, Adjuvant studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 847 type: ACTUAL name: Colorectal Surgery measure: Overall Survival measure: Disease-free survival measure: Time to disease recurrence measure: Time to return to intended oncologic treatment (RIOT) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Virgen de los Lirios de Alcoy city: Alcoy state: Alicante country: Spain lat: 38.70545 lon: -0.47432 facility: Hospital General Universitario de Elche city: Elche state: Alicante country: Spain lat: 38.26218 lon: -0.70107 facility: Hospital Universitario Central de Asturias city: Oviedo state: Asturias country: Spain lat: 43.36029 lon: -5.84476 facility: Hospital de Igualada city: Igualada state: Barcelona country: Spain lat: 41.58098 lon: 1.6172 facility: Hospital de Sant Joan Despí Moisès Broggi city: Sant Joan d'Espi state: Barcelona country: Spain lat: 41.36718 lon: 2.0574 facility: Fundación Hospital del Espíritu Santo city: Santa Coloma De Gramenet state: Barcelona country: Spain lat: 41.45152 lon: 2.2081 facility: Hospital Universitari Mútua Terrassa city: Terrassa state: Barcelona country: Spain lat: 41.56667 lon: 2.01667 facility: Hospital Universitario de Vic city: Vic state: Barcelona country: Spain lat: 41.93012 lon: 2.25486 facility: Hospital General Universitario de Castellón city: Castellon de la Plana state: Castellón country: Spain lat: 39.98567 lon: -0.04935 facility: Hospital Universitario Puerta de Hierro city: Majadahonda state: Madrid country: Spain lat: 40.47353 lon: -3.87182 facility: Hospital Universitario de Móstoles city: Mostoles state: Madrid country: Spain lat: 40.32234 lon: -3.86496 facility: Hospital Universitario Rafael Méndez city: Lorca state: Murcia country: Spain lat: 37.67119 lon: -1.7017 facility: Hospital Costa del Sol city: Marbella state: Málaga country: Spain lat: 36.51543 lon: -4.88583 facility: Hospital Nuestra Señora del Prado city: Talavera de la Reina state: Toledo country: Spain lat: 39.96348 lon: -4.83076 facility: Hospital Universitario Araba city: Alava country: Spain lat: 43.36057 lon: -6.19946 facility: Hospital General Universitario de Alicante city: Alicante country: Spain lat: 38.34517 lon: -0.48149 facility: Hospital Clínic Universitat de Barcelona city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 facility: Hospital del Mar city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 facility: Hospital Universitario Santa Creu i Sant Pau city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 facility: Hospital Universitario Vall d´Hebrón city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 facility: Hospital General Universitario de Ciudad Real city: Ciudad Real country: Spain lat: 38.98626 lon: -3.92907 facility: Hospital de Galdakao-Usansolo city: Galdakao country: Spain lat: 43.23333 lon: -2.83333 facility: Hospital Universitario Insular de Gran Canaria city: Las Palmas de Gran Canaria country: Spain lat: 28.09973 lon: -15.41343 facility: Hospital Universitario de Gran Canaria Doctor Negrín city: Las Palmas country: Spain lat: 28.58232 lon: -16.16555 facility: Hospital de La Princesa city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: Hospital Universitario 12 de Octubre city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Infanta Leonor city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: Hospital Universitario Ramón y Cajal city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: Hospital Universitario San Carlos city: Madrid country: Spain lat: 40.4165 lon: -3.70256 facility: Complejo Hospitalario de Salamanca city: Salamanca country: Spain lat: 40.96882 lon: -5.66388 facility: Hospital Universitario Donostia city: San Sebastián country: Spain lat: 43.31283 lon: -1.97499 facility: Hospital Universitario Virgen Macarena city: Sevilla country: Spain lat: 37.38283 lon: -5.97317 facility: Consorcio Hospital General Unidersitario de Valencia city: Valencia country: Spain lat: 39.46975 lon: -0.37739 facility: Hospital Clínico Universitario de Valencia city: Valencia country: Spain lat: 39.46975 lon: -0.37739 facility: Hospital Clínico de Valladolid city: Valladolid country: Spain lat: 41.65518 lon: -4.72372 facility: Hospital Universitario Miguel Server city: Zaragoza country: Spain lat: 41.65606 lon: -0.87734 hasResults: False

 nctId: NCT06369181 id: NET 2020 briefTitle: Neuroendocrine Transformation in RB1/TP53 Inactivated NSCLC overallStatus: RECRUITING date: 2021-01-01 date: 2027-12-31 date: 2028-12-31 date: 2024-04-16 date: 2024-04-23 name: Fudan University class: OTHER briefSummary: Histology transformation from non-small cell lung cancer (NSCLC) to neuroendocrine carcinomas (NEC), especially from epidermal growth factor receptor (EGFR) mutant lung adenocarcinoma (LADC) to small cell lung cancer (SCLC), is widely recognized as a rare mechanism for NSCLC to confer tyrosine kinase inhibitors (TKIs) resistance. The probability of its occurrence is about 3-14% in NSCLC patients who are resistant to TKI treatment. In addition to EGFR mutations, NSCLC patients carrying ALK/ROS1 mutations and receiving corresponding TKI treatment may also experience NEC transformation(NET).

In a previous study \[Pubmed ID: 35609408\], the investigators demonstrated that NET also develops in NSCLCs without TKI targets or treatments. This phenomenon could be under-recognized, because re-biopsy was less frequently performed in these patients. The investigators had also shown that p53/Rb inactivation might correlated with NET and should be considered for NET risk prediction. In another retrospective studies, it was found that NSCLC patients with RB1/TP53 dual inactivation mutations had a significantly higher probability of NEC pathological transformation than those without RB1/TP53 inactivation mutations (43 times higher than those without mutations). Therefore, the subgroup of NSCLC patients with tumor suppressor gene RB1/TP53 dual inactivation might have elevated risk for NET.

In this study, the investigators proposed to prospectively follow up NSCLC patients with dual RB1/TP53 inactivation (approximately 5% of the total NSCLC). Through prospective and systematic collection of baseline pathological information, clinical treatment process, and imaging data, and as much as possible, repeat pathological biopsies will be performed during disease progression. conditions: Neuroendocrine Carcinoma conditions: Non-small Cell Lung Cancer conditions: Histology Transformation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: neuroendocrine transformation rate 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: Zhengfei Zhu, MD role: CONTACT phone: +86 18017312901 email: fuscczzf@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06369168 id: Kliniken Essen-Mitte briefTitle: Auricular Acupuncture and Hot Flashes During Adjuvant Endocrine Therapy acronym: OhrHit overallStatus: NOT_YET_RECRUITING date: 2024-05-20 date: 2024-11-20 date: 2025-11-20 date: 2024-04-16 date: 2024-04-23 name: Kliniken Essen-Mitte class: OTHER name: Karl and Veronica Carstens Foundation briefSummary: With this clinical trial we investigate whether auricular acupuncture during adjuvant endocrine therapy has an improving effect on hot flashes, which are often perceived as psychologically and physically stressful in self-assessment of women with breast cancer.

Empirical studies indicate that body acupuncture has positive effects on hot flashes. As auricular acupuncture offers a number of advantages over body acupuncture, a three-armed randomised controlled research design is being used to investigate whether hot flashes caused by endocrine therapy are also reduced by ear acupuncture. Balanced ear acupuncture will be compared with NADA ear acupuncture in terms of efficacy and effectiveness. In addition, the effects of the two forms of therapy on the patients' individual quality of life, fatigue, stress perception and sleep quality will be analysed. conditions: Hot Flashes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 99 type: ESTIMATED name: auricular acupuncture measure: subscale somato-vegetative symptoms of the Menopause Rating Scale (MRS) measure: Menopause Rating Scale (MRS) total score measure: Psychological symptoms and urogenital symptoms subscales of the MRS measure: functional assessment of cancer therapy - breast (FACT-B) measure: perceived stress questionnaire (PSQ) measure: insomnia severity index (ISI) measure: big five inventory (BFI) measure: Expected effect of the respective intervention on a 100mm visual analogue scale measure: intensity and degree of impairment due to hot flashes on a 100mm visual analogue scale measure: adverse events (AEs) sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06369155 id: 24-061 briefTitle: Azenosertib in Uterine Serous Carcinoma: Biomarker Study overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-01-31 date: 2027-01-31 date: 2024-04-16 date: 2024-04-16 name: Joyce Liu, MD class: OTHER name: National Cancer Institute (NCI) name: Zentalis briefSummary: This research study is being done to investigate how Azenosertib affects tumor cells of persistent or recurrent uterine serous carcinoma.

The name of the study drug involved in this study is:

-Azenosertib (a type of Wee1 inhibitor) conditions: Uterine Serous Carcinoma conditions: Uterine Carcinoma conditions: Uterine Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Azenosertib measure: Percentage Change in Replication Fork Speed in Overall Response measure: Percentage Change in Replication Fork Speed in 6 Month Progression Free Survival (PFS6) measure: Overall Response Rate (ORR) measure: 6-month Progression-Free Survival (PFS6) measure: Clinical Benefit Rate (CBR) measure: Median Duration of Overall Response (DOR) measure: Median Progression-Free Survival (PFS) measure: Grade 3-5 Treatment-related Toxicity Rate sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02215 country: United States name: Joyce Liu, MD, MPH role: CONTACT phone: 617-632-5269 email: joyce_liu@dfci.harvard.edu name: Joyce Liu, MD, MPH role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Dana-Farber Cancer Institute city: Boston state: Massachusetts zip: 02215 country: United States name: Joyce Liu, MD, MPH role: CONTACT phone: 617-632-5269 email: joyce_liu@dfci.harvard.edu name: Joyce Liu, MD, MPH role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06369142 id: GE IDE No. L00123 briefTitle: Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy acronym: ISAR-WAVE overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2027-04-30 date: 2027-07-31 date: 2024-04-16 date: 2024-04-16 name: Deutsches Herzzentrum Muenchen class: OTHER name: Gemeinsamer Bundesaussschuss name: EvidentIQ Germany GmbH name: Monitoring Services GmbH name: Institute of AI and Informatics in Medicine Technical University of Munich briefSummary: The clinical trial is intended to evaluate the efficacy, safety and economic benefit of coronary lithotripsy compared to other additional procedures (cutting or super high pressure balloon angioplasty, ablative procedures) in lesion preparation and interventional treatment of severely calcified coronary stenoses. conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The study participant as well as the follow-up physicians and site personal are blinded. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 666 type: ESTIMATED name: Intravascular lithotripsy (IVL) name: Standard non-IVL methods measure: Combined endpoint of major cardiac and cerebrovascular events measure: Mortality measure: Cardiac mortality measure: Non-fatal myocardial infarction measure: Non-fatal stroke measure: Clinically indicated target vessel revascularization measure: Definite stent thrombosis measure: Clinically indicated non-target vessel revascularization measure: Hospitalization due to acute coronary syndrome measure: Symptoms of coronary heart disease (CHD): physical health status measure: Symptoms of CHD: mental health status measure: Bleeding during index hospitalization or ≤30 days (BARC 3-5) measure: Procedural failure (failed application of study-related additional procedure, final TIMI flow <3, >30% residual stenosis, vessel perforation, stent loss, stent delivery failure) measure: Medical costs (index hospitalization and costs for re-hospitalization due to acute coronary syndrome) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Deutsches Herzzentrum München city: Munich state: Bavaria zip: 80636 country: Germany name: Salvatore Cassese, MD, PHD role: CONTACT phone: 0049891218 phoneExt: 2764 email: cassese@dhm.mhn.de name: Salvatore Cassese, MD, PDH role: PRINCIPAL_INVESTIGATOR lat: 48.13743 lon: 11.57549 hasResults: False

 nctId: NCT06369129 id: CEBD-CU-2024-06-16 briefTitle: Accuracy& Orbital Volume Using Patient Specific Titanium Implant Vs Zirconia for Orbital Floor Reconstruction overallStatus: RECRUITING date: 2024-04-06 date: 2025-08 date: 2025-08 date: 2024-04-16 date: 2024-04-17 name: Cairo University class: OTHER briefSummary: Comparative study used to assess if the patient specific zirconia implant will provide better accuracy, intraoperative adaptability, precise orbital volume and soft tissue reaction with more cost effectiveness than the patient specific titanium implants in orbital floor reconstruction after blow out fractures . conditions: Blow-Out Fractures conditions: Orbital Fractures conditions: Orbital Floor Fracture conditions: Orbital Trauma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized clinical trial.

* Parallel group study.
* A trial will be carried out in hospital of Oral and Maxillofacial surgery department - Faculty of Oral and Dental Medicine - Cairo University .
* Equal randomization : participants with equal probabilities for intervention.
* Positive controlled : Both groups receiving treatment. primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Orbital floor reconstruction with Patient Specific Zirconia Implant name: Orbital floor reconstruction with Patient Specific Titanium Implant measure: Orbital Volume measure: Accuracy of the patient specific implant in the orbital floor reconstruction measure: Cost effectiveness measure: Patient satisfaction sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Cairo University status: RECRUITING city: Cairo zip: 11511 country: Egypt name: OLA A. ELMORSY, PHD role: CONTACT phone: 00201141234877 email: dr.ola.elmorsy@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06369116 id: CLS-017B id: HSTAR012 type: OTHER domain: HSTAR Programme id: WRHI071 type: OTHER domain: Ezintsha briefTitle: Trial of Hepatitis C Self-Testing in the Hands of Untrained Lay Users overallStatus: RECRUITING date: 2023-10-12 date: 2023-11-17 date: 2024-04-22 date: 2024-04-16 date: 2024-04-16 name: bioLytical Laboratories class: INDUSTRY briefSummary: This is a controlled study intended to evaluate the usability, label comprehension and performance of the INSTI® HCV Self Test in the hands of untrained lay users using fingerstick blood, with instructions for use specifically designed for a lay person who has not used any hepatitis C rapid self test prior to the study and to assess "lay" users ability to comprehend key concepts and information provided on the outside of the pouch and in the accompanying Instructions for Use. Comprehension will be assessed without product familiarization (demonstration/training) by a healthcare professional. conditions: Hepatitis C studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Participants are recruited and enrolled to conduct INSTI HCV Self Test and then participate in the usability portion of the study. primaryPurpose: SCREENING masking: SINGLE whoMasked: CARE_PROVIDER count: 1400 type: ESTIMATED name: INSTI HCV Self Test measure: Clinical sensitivity and specificity of INSTI HCV Self Test measure: To assess the usability and label comprehension of the INSTI HCV Self Test sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ezintsha, a division of Wits Health Consortium (Pty) Ltd status: RECRUITING city: Parktown zip: 2193 country: South Africa name: Vanessa Tiyamike Msolomba role: CONTACT phone: +27 74 830 9063 email: vmsolomba@ezintsha.org lat: -26.18205 lon: 28.02671 hasResults: False

 nctId: NCT06369103 id: FMBSUREC/03032024/Fakhry briefTitle: The Sedative Effects of Dexmedetomidine VS Propofol During Peribulbar Anesthesia in Patients Undergoing Vitrectomy Surgery overallStatus: RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-05-01 date: 2024-04-16 date: 2024-04-16 name: Beni-Suef University class: OTHER briefSummary: The aim of the work to compare the Sedative Effects of Dexmedetomidine and Propofol during peribulbar anesthesia in patients undergoing vitrectomy surgery on hemodynamic, respiratory parameters, recovery profile, analgesic effects, post-operative cognitive function, patients satisfaction and adverse events. conditions: Patient conditions: Satisfaction studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 420 type: ESTIMATED name: Dexmedetomidine name: Propofol measure: Patient satisfaction measure: Visual analogue scale sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beni Suef University Hospital status: RECRUITING city: Banī Suwayf state: Beni Suef zip: 62814 country: Egypt name: Dina M Fakhry, MD role: CONTACT phone: 0201289998680 email: dina_fakhry_91@yahoo.com name: Dina M Fakhry, MD role: CONTACT phone: +201289998680 email: dina_fakhry_91@yahoo.com lat: 29.07441 lon: 31.09785 hasResults: False

 nctId: NCT06369090 id: JP/1/2013 briefTitle: Effect of Breast Size on the Electrical Impedance Tomography Measurement overallStatus: COMPLETED date: 2013-11-01 date: 2014-05-31 date: 2014-05-31 date: 2024-04-16 date: 2024-04-16 name: Czech Technical University in Prague class: OTHER briefSummary: Twenty-two healthy female volunteers were monitored using electrical impedance tomogprahy (EIT) in two different situations. First, with electrode belt placed over the breast tissue and second, with the electrode belt under the breast tissue. The EIT measurement was performed with adjunct spirometric measurement. The changes of regional ventilation related to the breast tissue and the size of breast tissue were evaluated. conditions: Effect of Breast Tissue on EIT Lung Monitoring studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Monitoring of 22 subjects, each subject was measured twice with electrode belt in two different positions. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 22 type: ACTUAL name: Electrical impedance tomography (EIT) measure: Regional ventilation changes possibly caused by the breast tissue measure: Female subjects enrollment in EIT studies and clinical applications sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Faculty of Biomedical Engineering, Czech Technical University in Prague city: Kladno zip: 27201 country: Czechia lat: 50.14734 lon: 14.10285 hasResults: False

 nctId: NCT06369077 id: CTGlaucoma1 briefTitle: How Much Does Reduced Dosing of Latanoprost and Dorzolamide-timolol Affect Pressure? overallStatus: RECRUITING date: 2024-04 date: 2024-07 date: 2024-07 date: 2024-04-16 date: 2024-04-17 name: CT Glaucoma Associates class: OTHER briefSummary: IOP effect of half-dose latanoprost dorzolamide-timolol will be compared to full dose. Further comparison will be made timolol-brimonidine-dorzolamide-bimatoprost. Dry eye effects of the different treatments will be assessed. conditions: Glaucoma, Open-Angle conditions: Glaucoma; Drugs studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Subjects will have baseline IOP measurements (7-9 am and 3-5 pm) after using using latanoprost every other day and dorzolamide-timolol every morning. They will then randomly be assigned in phase 2 to either: double the frequency to latanoprost daily and dorzolamide-timolol twice daily; or use every morning compounded timolol-brimonidine-dorzolamide-bimatoprost. IOP measurements will be repeated 3 weeks after using the phase 2 medications. For phase 3, subjects will use the treatment to which they were not assigned in phase 2, and IOP measurements will again be repeated 3 weeks later.

At each study visit, dry eye signs will be assessed and brief dry eye survey will be administered. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Technician measuring IOP and assessing dry eye is masked regarding phase 2 and phase 3 crossover assignment order. whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: dorzolamide/timolol measure: intraocular pressure measure: dry eye sex: ALL minimumAge: 25 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CT Glaucoma Associates status: RECRUITING city: Norwalk state: Connecticut zip: 06851 country: United States name: Peter E Libre, MD role: CONTACT phone: 203-853-2020 email: pel3@cumc.columbia.edu name: Faria Mahjabin, BA role: CONTACT email: faria.mahjabin@quinnipiac.edu lat: 41.1176 lon: -73.4079 hasResults: False

 nctId: NCT06369064 id: 2023A02707-38 briefTitle: Continuous Veno-venous Hemodialysis and Continuous Veno-venous Hemodiafiltration on Urea Reduction Rate in Intensive Care Patient acronym: CompEER overallStatus: NOT_YET_RECRUITING date: 2024-06-15 date: 2026-08-15 date: 2026-08-15 date: 2024-04-16 date: 2024-04-16 name: Centre Hospitalier Universitaire de Nīmes class: OTHER briefSummary: In patients requiring renal replacement therapy (RRT) in the intensive care unit (ICU), continuous techniques are predominantly using due to better hemodynamic tolerance. The most employed techniques in ICU are continuous venovenous hemodiafiltration (CVVHDF) and continuous venovenous hemodialysis (CVVHD).

To our knowledge, there are no prospective studies comparing the efficiency of these two techniques with the same dose of dialysis (and the same filter).

In the CompEER study, we aim to compare the efficiency of CVVHD and CVVHDF on urea reduction rate in intensive care patients with acute kidney injury.

The research hypothesis is that CVVHD citrate technique is as effective as CVVHDF heparin technique for urea reduction and provides prolonged and stable clearance, facilitating antibiotic management during RRT. conditions: Acute Kidney Injury conditions: Continuous Renal Replacement Therapy conditions: Intensive Care Unit studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: CVVHD Dialysis parameters name: CVVHDF Dialysis parameters measure: urea reduction rate (URR) measure: Creatinine clearance at H24 measure: Urea clearance at H24 measure: Urea clearance at H48 measure: ICU Mortality measure: Mortality at Day 28 measure: Organ failure-free days at Day 28 measure: Hypokalemia at Day 28 measure: Hypophosphatemia at Day 28 measure: Hypomagnesemia at Day 28 measure: Hyperkalemia at Day 28 measure: Medical Cost sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Nimes city: Nîmes zip: 30029 country: France name: Claire Roger, MD, PhD role: CONTACT email: claire.roger@chu-nimes.fr name: Claire Roger, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Aurèle Buzancais, MD role: SUB_INVESTIGATOR name: Sylvain Garnier, MD role: SUB_INVESTIGATOR lat: 43.83333 lon: 4.35 hasResults: False

 nctId: NCT06369051 id: YSEmploy briefTitle: Supporting Self-employment in Young Adults With Stroke overallStatus: RECRUITING date: 2023-01-01 date: 2025-12-31 date: 2026-12-31 date: 2024-04-16 date: 2024-04-16 name: Chinese University of Hong Kong class: OTHER briefSummary: This project will investigate the effects of an 8-week theory-driven online/hybrid Self-employment Skill Building Intervention on the rate of self-employment, self-efficacy, life satisfaction, and psychosocial outcomes among working-age stroke survivors. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 156 type: ESTIMATED name: Self-employment support intervention measure: Self-employment rate measure: Self-efficacy measure: Life satisfaction measure: Emotional well-being measure: Community reintegration sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: Non-government organisations status: RECRUITING city: Hong Kong country: Hong Kong name: Suzanne Lo role: CONTACT phone: 85239434485 email: suzannelo@cuhk.edu.hk lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06369038 id: CUP3222024 briefTitle: Children's Drawing as a Projective Tool to Assess Dental Anxiety overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-12-30 date: 2025-12-30 date: 2024-04-16 date: 2024-04-16 name: Cairo University class: OTHER briefSummary: The aim in this study is to compare the results of anxiety measurement of the child using the CD:H scale with the long-used Face,Legs,Activity,Cry and Consolability scale (FLACC scale) and pulse oximeter reading, to see if the drawing alone can be a reliable tool to predict the child's behaviour before the dental procedure. conditions: Dental Anxiety studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 138 type: ESTIMATED name: observation of level of dental anxiety in children measure: FLAAC behavioral scale sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD hasResults: False

 nctId: NCT06369025 id: PreVio briefTitle: Preventing Physical and Emotional Violence by Parents and Teachers in Public Schools in Tanzania (ICC-T/ICC-P_Tanz) acronym: PreVio overallStatus: RECRUITING date: 2024-04-15 date: 2025-02-28 date: 2025-07-30 date: 2024-04-16 date: 2024-04-17 name: Bielefeld University class: OTHER name: Technical University of Munich name: Dar es Salaam University College of Edcuation name: Muhimbili University of Health and Allied Sciences briefSummary: More than 1.7 billion children worldwide experience violence in their upbringing. Prevalence rates are particularly high in Africa. Toxic stress associated with violence impacts the developing brain. This affects behavioral, social, and emotional functioning of children. The present project will test an intervention that simultaneously aims at reducing violence against children at home and at school. Within the project, (1) the feasibility, acceptability, and cost-effectiveness of the Intervention and (2) the initial effectiveness of reducing parental and teacher violence will be tested. To this end, a mixed-methods two-arm school-based pilot cluster-randomized controlled trial (CRCT) in Tanzania will be conducted.

One unique and novel aspect of this project is to test a school-based intervention approach that targets both teachers and parents. A school-based approach including both teachers and parents has the following key advantages: (1) parents of different social, economic, and educational backgrounds can be motivated to participate and (2) using the existing infrastructure of schools reduces costs and will later improve the scalability of the program. The project is bringing together the global health, development economy, and psychological perspectives to promote our collaboration within the German global health community and with research and policy partners in Tanzania. conditions: Violence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 1840 type: ESTIMATED name: Interaction Competencies with Children measure: Reduction of children's exposure to emotional and physical violence by parents and teachers measure: Reduction of parents' or teachers' use of emotional and physical violence measure: Change of parents' and teachers' attitudes towards emotional and physical violence measure: Improvement of children's mental health measure: Increase of children's quality of life measure: Improvement of school climate measure: Reduction of children's perceived stress measure: Reduction of parents' and teachers' perceived stress measure: Improvement of teachers' decision making measure: Improvement of teachers' self-efficacy sex: ALL minimumAge: 9 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Daressalaam University College of Education status: RECRUITING city: Daressalam country: Tanzania name: Mabula Nkuba, Dr. role: CONTACT name: Eliud Kabelege role: CONTACT lat: -6.82349 lon: 39.26951 hasResults: False

 nctId: NCT06369012 id: Rania Gamal briefTitle: Management of Abnormal Uterine Bleeding overallStatus: RECRUITING date: 2024-03-01 date: 2024-09-01 date: 2024-09-30 date: 2024-04-16 date: 2024-04-16 name: Egymedicalpedia class: INDUSTRY briefSummary: Abnormal uterine bleeding "AUB" describes all abnormal forms of menstrual bleeding which may result from several causes including anovulation, problems related to pregnancy, infections, vaginal and cervical abnormalities, uterine pathologies including benign and malignant tumors, coagulopathies, endocrine disorders, trauma, foreign bodies, systemic diseases and iatrogenic causes. AUB may be clinically presented by menorrhagia, metrorrhagia or menometrorrhagia. It's the most common complaint for the reproductive age females and accounts for 33% of female patients referred to gynecologists conditions: Abnormal Uterine Bleeding studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 130 type: ESTIMATED name: Mefenamic acid 500 mg measure: Bleeding Control sex: FEMALE minimumAge: 15 Years maximumAge: 45 Years stdAges: CHILD stdAges: ADULT facility: Ain Shams University Hospitals status: RECRUITING city: Cairo country: Egypt name: Rania Gamal Anwar, M.D role: CONTACT phone: +201283262383 email: dr.raniagamal2015@yahoo.com lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06368999 id: EEGCOV briefTitle: Neurophysiological and Neuropsychological Evalution in Healthcare Workers acronym: EEGCOV overallStatus: COMPLETED date: 2020-05-27 date: 2020-12-21 date: 2021-01-09 date: 2024-04-16 date: 2024-04-16 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: The goal of this observational study is to compare in participant population the effect of stress condition on cerebral EEG activity Participants will do an 8 minutes EEG registration. Researchers will compare EEG activity of heathcare workers. conditions: Stress Disorders, Post-Traumatic studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: study of brain EEG activity primaryPurpose: SCREENING masking: NONE count: 40 type: ACTUAL name: EEG measure: EEG activity sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico city: Milan zip: 20122 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06368986 id: 222420 briefTitle: A Study to Investigate the Effect of Food on the Bioavailability of a Capsid Inhibitor (CAI) in Male and Female Healthy Participants overallStatus: NOT_YET_RECRUITING date: 2024-04-16 date: 2024-06-12 date: 2024-06-12 date: 2024-04-16 date: 2024-04-16 name: ViiV Healthcare class: INDUSTRY briefSummary: The purpose of this study is to evaluate effect of food (in fasted and fed conditions) on the bioavailability of CAI VH4011499. conditions: HIV Infections studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: VH4011499 measure: Area under the plasma concentration - time curve from time zero (pre-dose) to infinity time (AUC[0-inf]) of VH4011499 measure: Area under the plasma drug concentration - time curve from zero (pre-dose) to the end of the dosing interval at steady state (AUC[0-tlast) of VH4011499 measure: Maximum observed plasma drug concentration (Cmax) of VH4011499 measure: Time to maximum observed plasma concentration (Tmax) of VH4011499 measure: Number of participants with AEs (Adverse Events), by severity measure: Number of participants with maximum toxicity grade increase from baseline for liver laboratory parameters measure: Change from baseline in liver panel parameters: total bilirubin and direct bilirubin (micromoles per liter) measure: Change from baseline in liver panel parameters: ALT, ALP and AST (International units per liter) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06368973 id: RC16-4-2023 briefTitle: Mechanical Ventilation-Associated Complications and Co-Morbidities in Children Admitted in Pediatric Intensive Care Unit overallStatus: COMPLETED date: 2021-01-01 date: 2023-12-01 date: 2023-12-31 date: 2024-04-16 date: 2024-04-16 name: Benha University class: OTHER briefSummary: The goal of this study was to identify the prevalence of mechanical ventilation-associated complications and co-morbidities in pediatric patients admitted to the PICU of Benha University Hospital, uncover how often these problems occur, their types, factors linked to them and to compare the epidemiology of MV-associated complications. conditions: Mechanical Ventilation Complication studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 315 type: ACTUAL measure: Adverse events associated with mechanical ventilation sex: ALL minimumAge: 1 Month maximumAge: 16 Years stdAges: CHILD facility: Benha University Hospital city: Cairo zip: 13511 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06368960 id: BM201-1001 id: CTR20223162 type: REGISTRY domain: National Medical Products Administration briefTitle: BM201 in Combination With Radiotherapy in Patients With Advanced Solid Tumors acronym: BM201-1001 overallStatus: RECRUITING date: 2022-11-07 date: 2024-12-31 date: 2024-12-31 date: 2024-04-16 date: 2024-04-16 name: InnoBM Pharmaceuticals Co., Ltd. class: INDUSTRY briefSummary: This is a non-randomized，open-label，controlled multi-center Phase Ⅰ study to evaluate tolerability, pharmacokinetics, and preliminary efficacy of BM201 injection in combination with radiotherapy in patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors who have failed standard therapy or are unable to receive standard treatment. conditions: Advanced Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Radiotherapy name: BM201 injection measure: DLT and MTD measure: Pharmacokinetic (PK) parameters measure: Number of patients with adverse events (AEs) measure: ORR measure: Peripheral blood cytokine profiling in study participants. measure: The variation in peripheral blood tumor biomarker concentrations. measure: Other exploring outcomes sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanjing Drum Towel Hospital /The Affiliated Hospital of Nanjing University Medical School status: RECRUITING city: Nanjing state: Jiangsu zip: 210008 country: China name: Juan L GCP Director role: CONTACT phone: 800-555-5555 email: njglyygcp@163.com name: Baorui L Chief Physician role: PRINCIPAL_INVESTIGATOR lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06368947 id: B.30.2.ATA.0.01.00/172 briefTitle: Therapeutic Play on Pain Tolerance and Emotion Regulation in Children overallStatus: RECRUITING date: 2024-03-29 date: 2024-12-29 date: 2026-12-29 date: 2024-04-16 date: 2024-04-17 name: Ataturk University class: OTHER briefSummary: The research is a randomized controlled experimental study. The population of the research will consist of 10-18 year old children who were diagnosed with acute lymphoblastic leukemia and received chemotherapy, who were admitted to the Children's Hematology Clinic of Adana City Training and Research Hospital between 19.05.2024 and 19.05.2025. Therapeutic play sessions will occur over a 4-week period during chemotherapy treatment. conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 66 type: ESTIMATED name: Therapeutic Play measure: Pain Tolerance Scale for Children with Cancer measure: Emotion Regulation Scale for Children and Adolescents sex: ALL minimumAge: 10 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Ataturk University Nursing of Faculty status: RECRUITING city: Erzurum zip: 25240 country: Turkey name: ARZU SARIALİOĞLU, PHD role: CONTACT phone: 04422315795 email: arzu.celebi@atauni.edu.tr lat: 39.90861 lon: 41.27694 hasResults: False

 nctId: NCT06368934 id: KY2024-011 briefTitle: Sub-lobectomy for IDH Wild-type and TERT Promoter Mutant Glioblastoma overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2026-12 date: 2027-06 date: 2024-04-16 date: 2024-04-16 name: Huashan Hospital class: OTHER briefSummary: Glioblastoma is recognized as the most common and aggressive form of primary malignant brain tumor, with treatment options that are limited and prognosis that is extremely poor, showing median progression-free survival of 12 months and median overall survival of less than 18 months. Surgical resection plays a critical role in the treatment, with the extent of resection significantly impacting patient outcomes. Historical approaches to surgical resection have evolved, moving from radical strategies to more conservative ones that aim to preserve normal brain function while removing the tumor as completely as possible. Recent studies have suggested that increasing the extent of surgical resection, particularly along the T2 FLAIR border rather than the traditional T1-enhanced border, can significantly improve patient prognosis. There is, however, a lack of consensus on the optimal surgical approach, and the heterogeneity of tumors presents challenges in standardizing surgical strategies. Extended resection has been shown to prolong survival, and novel intraoperative molecular diagnostics have emerged to improve accuracy in tumor classification and prognosis. Building on these advancements, a multicenter, prospective, randomized controlled trial is proposed to evaluate the efficacy of sub-lobectomy in treating IDH wild-type/TERTp-mutant glioblastoma, aiming to improve evidence levels and establish standardized surgical practices for this devastating disease. conditions: Glioma conditions: Glioblastoma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Type of study: randomized parallel controlled, open-label, multicenter clinical trial.

Interventions: the intervention group was to receive frontal, temporal, parietal, and occipital sub-lobotomies that met anatomical criteria, and the control group was to receive imaging total resection (T1-enhanced borders) that met the Response Assessment in Neuro-Oncology (RANO) criteria.

Randomization The control group and intervention group were equal in size. Following intraoperative pathological diagnosis, participants were randomly assigned using a centralized randomization system known as the Interactive Web Response System (IWRS). Stratification factors included preoperative age brackets of \[18-65\] and (65-80), gender (male or female), and tumor site in the frontal, temporal, parietal, and occipital lobes. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: This study employed a single-blind approach whereby the participants were unaware of the kind of surgical resection they were receiving. whoMasked: PARTICIPANT count: 326 type: ESTIMATED name: sub-lobectomy name: imaging total resection measure: Progression-free Survival measure: Overall Survival measure: Postoperative quality of life measure: Adverse effects measure: Cognitive function measure: Language function measure: Limb muscle strength sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hushan Hospital, Fudan University city: Shanghai state: Shanghai zip: 200040 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06368921 id: VRT106-C01 briefTitle: A Study of Recombinant Oncolytic Virus M1(VRT106) in Patients With Solid Tumors overallStatus: RECRUITING date: 2024-04 date: 2025-09 date: 2025-12 date: 2024-04-16 date: 2024-04-16 name: Guangzhou Virotech Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: To Evaluate the safety and tolerability of single and multiple intratumoral injections of recombinant oncolytic virus M1 (VRT106) in patients with locally advanced/metastatic solid tumors. conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: VRT106 measure: Evaluate the safety and tolerability of escalating doses of intratumoral injection of VRT106. measure: Characterize the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) levels. measure: Examine the biological distribution characteristics and shedding patterns of intratumoral injection of VRT106. measure: Assess the immunogenicity of intratumoral injection of VRT106. measure: Assess the anti-tumor effect of VRT106, including objective response rate (ORR) as efficacy indicators. measure: Assess the anti-tumor effect of VRT106, including disease control rate (DCR) as efficacy indicators. 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 country: China name: Hongyun Zhao role: CONTACT email: zhaohy@syscc.org.cn lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06368908 id: 6I/2023/3 briefTitle: Transcutaneous Functional Magnetic Muscle Stimulation in Critically Ill acronym: FMS_ICU overallStatus: RECRUITING date: 2023-12-08 date: 2024-10-30 date: 2024-12-30 date: 2024-04-16 date: 2024-04-16 name: General and Teaching Hospital Celje class: OTHER briefSummary: ICU-Acquired weakness (ICU-AW) is a significant complication of critical illness. ICU-AW is common in patients with sepsis, systemic inflammatory response, and mechanically ventilated. It is estimated that around 50% of patients recovering from the primary illness remain in intensive care with characteristic muscle weakness. This leads to dependence on mechanical ventilation, prolonging costly intensive care hospitalization. The myopathy causes persistent functional impairment, endangering patients long after hospital discharge.

Magnetic stimulation prevents inactivation atrophy of skeletal muscles, as demonstrated in the mobilized limb of rats. Transcutaneous magnetic stimulation of the quadriceps via the femoral nerve is a safe and painless method even when applied to humans.

In patients with chronic obstructive pulmonary disease (COPD), quadriceps magnetic stimulation increased spontaneous contraction force compared to the control group and improved quality of life. Patients with COPD tolerate quadriceps magnetic stimulation well, as it does not affect oxidative stress in muscles but does increase the size of slow-twitch muscle fibers.

In intensive care medicine, magnetic stimulation has been primarily used for diagnostic purposes in assessing diaphragm function, peripheral muscle strength assessment, and transcranial electrical stimulation as a diagnostic tool and therapeutic stimulation of brain cells. With the development of modern transcutaneous magnetic stimulators, the possibility arises for their use in intensive care medicine for therapeutic purposes such as preventing critical illness myopathy.

To date, no research has been conducted on the use and effectiveness of magnetic stimulation of peripheral muscles in critically ill individuals.

The aim of the study is to investigate the effect of Functional Muscle Magnetic Stimulation (FMS) on the development of ICU-AW. conditions: Critical Illness Myopathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: One of legs is randomised to be stimulated by trans-cutaneous functional magnetic stimulation (Arm 1), the other leg is control (Arm 2) primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Transcutaneous Functional Magnetic Muscle Stimulation measure: Measurement of Thickness of Thigh Muscles measure: Measurement of Thigh Circumference measure: Assessment of Muscle Strength and Communication Ability measure: Body composition measurement by bioimpedance- Extracellular water measure: Body composition measurement by bioimpedance- Intracellular water measure: Body composition measurement by bioimpedance- skeletal muscle mass sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: General Hospital Celje status: RECRUITING city: Celje zip: 300 country: Slovenia lat: 46.23092 lon: 15.26044 hasResults: False

 nctId: NCT06368895 id: 2188 briefTitle: Fecal Microbiota Transplantation by Oral Capsules for Hepatic Encephalopathy Treatment overallStatus: RECRUITING date: 2021-04-07 date: 2025-06 date: 2025-06 date: 2024-04-16 date: 2024-04-16 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: This interventional study aims to evaluate the safety and efficacy of oral capsule fecal microbiota transplantation (FMT) for treating hepatic encephalopathy refractory to conventional rifaximin and lactulose therapy in patients with liver cirrhosis. Patients diagnosed with hepatic encephalopathy refractory to rifaximin and lactulose therapy will be randomized into three groups. While continuing conventional therapy, the first group receives FMT via colonoscopy and oral capsule administration, the second group receives only oral capsule administration, and the third group serves as a control, receiving only conventional therapy.

The aims of the study are:

To evaluate the efficacy and safety of FMT by oral capsules in cirrhotic patients with hepatic encephalopathy refractory to standard therapy.

To evaluate changes in the gut microbiota composition and in the intestinal and systemic inflammatory condition occurring after FMT and if they can be associated with clinical improvement.

To evaluate metabolic modifications occurring after FMT and if they can be associated with clinical improvement. conditions: Hepatic Encephalopathy conditions: Dysbiosis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Fecal microbiota transplantation delivery through colonoscopy name: Fecal microbiota transplantation delivery through oral capsules measure: Evaluation of safety of fecal microbiota transplantation by oral capsules in the treatment of cirrhotic patients with hepatic encephalopathy refractory to conventional therapy measure: Evaluation of efficacy of fecal microbiota transplantation by oral capsules in the treatment of cirrhotic patients with hepatic encephalopathy refractory to conventional therapy measure: Evaluation of changes in the gut microbiota composition following the fecal microbiota transplantation measure: Evaluation of changes in the systemic inflammatory following the fecal microbiota transplantation measure: Evaluation of changes in the intestinal inflammatory following the fecal microbiota transplantation measure: Comparison between protein metabolites concentration (ppm) in serum, urine and feces before and after microbiota transplantation measure: Comparison between lipid metabolites concentration (ppm) in serum, urine and feces before and after microbiota transplantation measure: Comparison between carbohydrates metabolites concentration (ppm) in serum, urine and feces before and after microbiota transplantation sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Agostino Gemelli IRCCS status: RECRUITING city: Rome 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: NCT06368882 id: Yongping _Chen briefTitle: Efficacy and Safety of Antiviral Therapy With Peg-interferon for Chronic Hepatitis B Complicated With Nonalcoholic Fatty Liver Disease（OCEAN PROJECT） overallStatus: RECRUITING date: 2024-01-01 date: 2028-12-31 date: 2028-12-31 date: 2024-04-16 date: 2024-04-16 name: First Affiliated Hospital of Wenzhou Medical University class: OTHER briefSummary: This is a prospective, multicenter, open-label, non-randomized controlled real-world study to explore the efficacy and safety and to accumulate more evidence-based medical data of an antiviral treatment programme for chronic viral hepatitis B with nonalcoholic fatty liver disease.

A total of 1500 patients with chronic hepatitis B complicated with nonalcoholic fatty liver disease are divided into test group (1000 patients receiving PEG-IFNα-based antiviral therapy (combined NAs or Peg-IFNα monotherapy) and control group（500 patients receiving NAs monotherapy） according to their treatment intention. Laboratory and medical data from specified follow-up points are collected, and adverse events and drug combinations are recorded detailly.

The primary efficacy indicator is HBsAg clearance at 48 weeks of treatment, and the secondary indicators included: (1) HBsAg clearance at 96 weeks of treatment, (2) Cumulative HBsAg clearance at week 24、120、144、168、192、216 and 240; (3) The improvement of liver function level(ALT, AST, TBIL, etc.), blood lipid (TC, TG, LDL-C, HDL-C, etc.), fasting blood glucose, insulin resistance index (HOMA-IR), controlled attenuation parameter, body mass index , liver stiffness measurement, liver histological fibrosis, FIB-4 index from baseline; (4)Incidence of liver cirrhosis and hepatocellular carcinoma during follow-up.

The security assessment includes adverse events, vital signs, and imaging. conditions: Nonalcoholic Fatty Liver Disease conditions: Chronic Hepatitis b studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1500 type: ESTIMATED name: Peg-Interferon α measure: HBsAg clearance measure: HBsAg clearance at 96 weeks measure: Cumulative HBsAg clearance rate measure: Liver Function Tests measure: The incidence of liver cirrhosis and liver cancer sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Ningbo No.2 Hospital status: RECRUITING city: Ningbo country: China name: Hongshan Li role: CONTACT phone: 13738865021 lat: 29.87819 lon: 121.54945 facility: Ruian People's Hospital status: RECRUITING city: Rui'an country: China name: Liang Hong role: CONTACT phone: 13958805550 facility: The Second Affiliated Hospital of Wenzhou Medical University status: RECRUITING city: Wenzhou country: China name: Chenwei Pan role: CONTACT phone: 13587655994 lat: 27.99942 lon: 120.66682 facility: Wenzhou People's Hospital status: RECRUITING city: Wenzhou country: China name: Ran Ding role: CONTACT phone: 18057788513 lat: 27.99942 lon: 120.66682 facility: Yueqing People's Hospital status: RECRUITING city: Yueqing country: China name: Hui Zhao role: CONTACT phone: 13968713322 hasResults: False

 nctId: NCT06368869 id: #1/2022 briefTitle: The Effect of Different Types of Resin Cements on the Color Stability of Two Different Types of Ceramic Veneers overallStatus: COMPLETED date: 2023-01-10 date: 2024-01-20 date: 2024-01-20 date: 2024-04-16 date: 2024-04-16 name: amr elshimy class: OTHER briefSummary: Aim of the study was to evaluate the color stability of lithium disilicate ceramic veneers and zirconia reinforced lithium silicate ceramic veneers by using two different types of resin cements including light cured and dual cured cements. conditions: Color; Change Teeth, Posteruptive studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 44 type: ACTUAL name: Livento press veneers luted with dual cured resin cement name: Livento press veneers luted with light cured resin cement name: Celtra duo veneers luted with dual cured resin cement name: Celtra duo veneers luted with light cured resin cement measure: Color stability assessment sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Faculty of Dentistry, Alexandria University city: Alexandria country: Egypt lat: 31.21564 lon: 29.95527 hasResults: False

 nctId: NCT06368856 id: 20CH024 id: 2020-006105-30 type: EUDRACT_NUMBER briefTitle: Pharmacology of Mupirocin in Nasal Application in Healthy Volunteers: Monocentric Study acronym: MUPIPHARM overallStatus: RECRUITING date: 2024-02-29 date: 2024-11 date: 2025-03 date: 2024-04-16 date: 2024-04-16 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER briefSummary: Mupirocin is an old antibiotic used topically since the 1970s. Initially used in the treatment of skin infections for its antistaphylococcal action, it is now part of the decolonization strategy for Staphylococcus aureus (SA) carriage, in association with chlorhexidine. This decolonization strategy has been recommended in France for preoperative cardiac surgery in nasal SA carriers since 2013 by the French Hospital Hygiene Society, and recommended for cardiac and orthopedic surgery in SA carriers by the World Health Organization (WHO) since 2016. This strategy includes nasal decolonization using mupirocin ointment nasally (2 to 3 applications/day), a daily shower with chlorhexidine soap and + /- mouthwashes all over 5 days, often pre-operatively.

As a result, mupirocin is now widely used throughout the world, all the more so as, for reasons of ease of organization, many centers use this decolonization procedure universally (i.e. without prior screening for Staphylococcus aureus carriage), thus further increasing the use of this molecule.

Mupirocin administration methods are very vague, ranging from 2 to 3 applications per day and the application of "a match head", i.e. 50 mg, to 500 mg per nostril.

Mupirocin is bacteriostatic at low doses, becoming bactericidal at higher concentrations; low concentrations could favor the selection of resistance, so using the most effective dosage seems essential. This lack of precision in administration is linked to an almost complete ignorance of the pharmacokinetics of mupirocin and its metabolite (monic acid) after nasal application.

It therefore seems essential to conduct a pharmacokinetic study of this molecule, in order to eventually offer patients the regimen with the administration methods offering the best characteristics in terms of dosage and efficacy. conditions: Healthy conditions: Staphylococcus Aureus Infection studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Single-center, randomized, open-label pharmacokinetic study of mupirocin in 40 healthy subjects with 2 randomization :

* first randomization - single dose part : 50mg or 500mg of mupirocin
* wash-out: one month
* second randomization - repeated doses part: 50mg mupirocin twice a day or 50 mg 3 times a day 500mg mupirocin twice a day or 500mg mupirocin 3 times a day primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: Mupirocin (50 mg) name: Mupirocin (500 mg) name: blood samples after Single dose part name: nasal swab after Single dose part name: Collection of urine after Single dose part name: nasal swab during Repeated dose part name: Collection of urine during Repeated dose part name: nasal swab after Repeated dose part measure: plasma concentrations of mupirocin measure: plasma concentrations of mupirocin measure: plasma concentrations of mupirocin measure: intranasal concentrations of mupirocin measure: intranasal concentrations of mupirocin measure: intranasal concentrations of mupirocin measure: intranasal concentrations of mupirocin measure: intranasal concentrations of mupirocin measure: intranasal concentrations of mupirocin measure: presence of Staphylococcus aureus measure: presence of Staphylococcus aureus measure: presence of Staphylococcus aureus measure: presence of Staphylococcus aureus measure: urinary concentrations of monic acid measure: urinary concentrations of monic acid measure: urinary concentrations of monic acid measure: urinary concentrations of monic acid sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de SAINT-ETIENNE status: RECRUITING city: Saint-Étienne country: France name: Kasra AZARNOUSH, MD PhD role: PRINCIPAL_INVESTIGATOR name: Elisabeth BOTELHO-NEVERS, MD PhD role: SUB_INVESTIGATOR name: Anne CARRICAJO, MD role: SUB_INVESTIGATOR name: Philippe BERTHELOT, MD PhD role: SUB_INVESTIGATOR lat: 45.43389 lon: 4.39 hasResults: False

 nctId: NCT06368843 id: Ketamine for POST briefTitle: the Impact of Ketamine Gargling on the Incidence of Post Intubation Sore Throat overallStatus: NOT_YET_RECRUITING date: 2024-04-25 date: 2024-08-15 date: 2024-09-20 date: 2024-04-16 date: 2024-04-16 name: Al-Azhar University class: OTHER briefSummary: Tracheal intubation often causes trauma to the airway mucosa, leading to postoperative sore throat (POST), which has been reported to occur in 21-65% of cases. While considered a minor complication, POST can contribute to postoperative discomfort and patient dissatisfaction. conditions: Postoperative Sore Throat studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Gargle with ketamine measure: Sore throat measure: Cough measure: Hoarseness of voice sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Ministry of Health city: Baghdad state: Thi-Qar zip: 00964 country: Iraq lat: 33.34058 lon: 44.40088 hasResults: False

 nctId: NCT06368830 id: 2024-0337 id: A534100 type: OTHER domain: UW Madison id: Protocol Version 3/4/24 type: OTHER domain: UW Madison briefTitle: Oral and Swallowing Function in Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2026-05 date: 2024-04-16 date: 2024-04-16 name: University of Wisconsin, Madison class: OTHER briefSummary: The purpose of this study is to learn about oral and swallowing function in older adults presenting to the emergency department. The hypothesis is that older adults often have problems with oral and swallowing function and these problems relate to other conditions. Study activities are done during the emergency department visit and include providing saliva samples, completing a bedside water swallow test, completing oral function assessments, completing respiratory function tests, and answering survey questions. conditions: Oropharyngeal Dysphagia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: 3-ounce water swallow test name: Kayser-Jones Brief Oral Health Status Examination (BOHSE) name: Tongue pressure name: Test of Masticating and Swallowing Solids (TOMASS) name: Respiratory function tests measure: Positive oropharyngeal dysphagia screen prevalence measure: Mean brief oral health status examination (BOHSE) score measure: Oral dryness prevalence measure: Decreased tongue pressure prevalence measure: Decreased masticatory function prevalence measure: pH of saliva sample measure: Extensional viscosity of saliva sample measure: Salivary Substance P Concentration measure: Oral microbiome measure: Cell barrier function measure: Protein composition measure: Gene expression measure: Immunofluorescent staining measure: Immune cell trafficking sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06368817 id: ACNS2321 briefTitle: Chemotherapy Followed by Response-Based Reduced Radiation Therapy for Patients With Central Nervous System Germinomas overallStatus: NOT_YET_RECRUITING date: 2024-05-04 date: 2033-11-04 date: 2033-11-04 date: 2024-04-16 date: 2024-04-16 name: Children's Oncology Group class: NETWORK briefSummary: A phase II trial that is attempting to build upon the excellent results of ACNS1123 stratum 2 by reducing the Radiotherapy (RT) dose for patients in a Complete Response (CR) after chemotherapy. The trial will be testing a further reduction in the whole ventricular irradiation (WVI) dose. Additionally, patients with metastatic disease and basal ganglia and thalamic germinoma will be included, and they will be treated with craniospinal irradiation (CSI) or whole brain irradiation (WBI) respectively. conditions: Intracranial Germ Cell Tumor conditions: Childhood Central Nervous System Germinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 240 type: ESTIMATED name: 3-Dimensional Conformal Radiation Therapy name: Carboplatin name: Etoposide name: Intensity-Modulated Radiation Therapy measure: Event-free survival (EFS) measure: Estimate the EFS distribution for eligible and evaluable patients in Stratum 2 measure: To estimate the EFS distribution for eligible and evaluable patients in Stratum 3 measure: Overall Survival (OS) measure: Determine the impact of tumor location, treatment regimen and treatment modalities on the long-term neuroendocrine function for patients with CNS germinomas. measure: Prospectively evaluate processing speed of children and young adults with CNS germinoma through the Children's Oncology Group (COG) Standardized assessment battery. measure: EFS distribution for eligible and evaluable patients in Stratum 4 and Stratum 5. measure: EFS distribution for eligible and evaluable patients in Stratum 6 and Stratum 7. measure: prospectively collect blood, cerebrospinal fluid, and tumor tissue at diagnosis and second-look surgery (if feasible) for future biology studies. measure: Incidence of cerebral vascular events (stroke or transient ischemic attacks) of children and young adults with CNS germinoma through the COG Standardized assessment battery: Patient-reported outcome measures measure: Incidence of cerebral vascular events (stroke or transient ischemic attacks) of children and young adults with CNS germinoma through the COG Standardized assessment battery: Health-reported quality of life sex: ALL minimumAge: 3 Years maximumAge: 30 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06368804 id: ANTEIPA id: 2022-A01575-38 type: OTHER domain: ID-RCB briefTitle: Comparison of Two Antibiotic Regimens for the Treatment of Early Airways Infection With PA in Adults With Bronchiectasis acronym: ANTEIPA overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-11-01 date: 2028-06-01 date: 2024-04-16 date: 2024-04-18 name: Centre Hospitalier Intercommunal Creteil class: OTHER name: Assistance Publique - Hôpitaux de Paris briefSummary: Chronic airways infection with Pseudomonas aeruginosa (PA) is associated with increased frequency of exacerbations, deterioration in quality of life and increased mortality in adult patients with bronchiectasis. Current guidelines suggest the prescription of an eradication antibiotic treatment for a first episode of PA infection (early PA infection). Several antibiotic regimens may be proposed, ranging from a monotherapy with oral fluoroquinolone (FQ) to an intravenous cotherapy with the addition of inhaled antibiotics that seems to improve the rate of PA eradication. As no study strictly favoured one regimen, current practices are heterogeneous and could certainly benefit from stronger evidence, with both medical and economic impact. conditions: Bronchiectasis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 196 type: ESTIMATED name: Antibiotic monotherapy treatment and follow-up name: Antibiotic bitherapy treatment and follow-up measure: PA-eradication rate measure: Time to first exacerbation measure: 1 year-exacerbation rate measure: Quality-of-life using questionnaires measure: Quality-of-life using questionnaires measure: Treatment burden assessment using questionnaires measure: Quality-of-life using questionnaires measure: Detection of PA at 3-month and 1 year measure: Time to first PA-recurrence measure: Emergence of FQ-resistant strains of (PA or other bacteria) measure: Adverse event (AE) and serious AE at 12 months follow-up measure: Number of premature ending of one of the treatment in study due to any AE measure: Number of premature ending of one of the treatment in study measure: Proportion of non-administered doses of nebulized colistin measure: Cost and incremental cost effectiveness ratio at 1 year measure: Cost and incremental cost effectiveness ratio at 1 year measure: Cost and incremental cost effectiveness ratio at 1 year sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Amiens-Picardie city: Amiens country: France name: Damien BASILLE role: CONTACT lat: 49.9 lon: 2.3 facility: CHU Haut Leveque, Bordeaux city: Bordeaux country: France name: Julie MACEY role: CONTACT lat: 44.84044 lon: -0.5805 facility: CHRU Brest city: Brest country: France name: Francis COUTURAUD role: CONTACT lat: 48.3903 lon: -4.48628 facility: CH Pontoise city: Cergy-Pontoise country: France name: Bruno PHILIPPE role: CONTACT lat: 49.03894 lon: 2.07805 facility: Centre hospitalier intercommunal de Créteil city: Créteil zip: 94010 country: France name: Bernard MAITRE role: CONTACT lat: 48.78333 lon: 2.46667 facility: APHP, Henri Mondor city: Créteil country: France name: Fréderic SCHLEMMER role: CONTACT lat: 48.78333 lon: 2.46667 facility: Hôpital de la Croix Rousse, HCL, Lyon city: Lyon country: France name: Gilles DEVOUASSOUX role: CONTACT lat: 45.74848 lon: 4.84669 facility: CHU Nantes city: Nantes country: France name: François-Xavier BLANC role: CONTACT lat: 47.21725 lon: -1.55336 facility: CHU H. Pasteur, Nice city: Nice country: France name: Sylvie LEROY role: CONTACT lat: 43.70313 lon: 7.26608 facility: APHP, Cochin city: Paris country: France name: Clémence MARTIN role: CONTACT lat: 48.85341 lon: 2.3488 facility: APHP, Saint Louis city: Paris country: France name: Abdellatif TAZI role: CONTACT lat: 48.85341 lon: 2.3488 facility: APHP, Tenon city: Paris country: France name: Nathalie ROZENSTAJ role: CONTACT lat: 48.85341 lon: 2.3488 facility: Hôpital Foch, Suresnes city: Suresnes country: France name: Emilie CATHERINOT role: CONTACT lat: 48.87143 lon: 2.22929 facility: CHU H. Larrey, Toulouse city: Toulouse country: France name: Marlene MURIS-ESPIN role: CONTACT lat: 43.60426 lon: 1.44367 facility: CH Versailles city: Versailles country: France name: Charlotte COLIN role: CONTACT lat: 48.8 lon: 2.13333 facility: CH Villefranche s/Saône city: Villefranche-sur-Saône country: France name: Sonia BLANDIN role: CONTACT lat: 45.98333 lon: 4.71667 hasResults: False

 nctId: NCT06368791 id: 30001479 briefTitle: Anti-Stress Intervention Among Physicians Study acronym: ASIP overallStatus: RECRUITING date: 2024-04-15 date: 2024-06-30 date: 2024-10-30 date: 2024-04-16 date: 2024-04-26 name: Charite University, Berlin, Germany class: OTHER briefSummary: Medical practice often comes with high stress. Stress negatively affects our health and well-being and is linked to doctors making mistakes, some of which can be deadly.

In this study, the effect of two quick stress-relief methods on daily stress levels is estimated. The two anti-stress exercises are designed to easily fit into daily routines:

1. Box breathing (6 minutes) is known to reduce stress and lower the heart rate. It is used by the military and law enforcement, among others, to manage stress.
2. Breathing and mindfulness exercise (10 minutes): This guided breathing and mindfulness intervention combines mindful breathing with simple body movements, developed to reduce the perceived level of stress.

The effectiveness of these interventions is being examined in a series of N-of-1 trials. Each participant can choose between the interventions. After being randomly allocated to an individual sequence of one-week intervention and control phases, the study begins. Participants record their stress levels daily over the four-week study period. The intervention is only performed in the intervention phases. Upon completing the study, the stress levels during the intervention phases are compared to those in the control phases. Each participant will receive an individual analysis based on the collected data. In addition, the investigators will estimate the effects at the population level.

Three months after the study, a survey will be sent to the participants to check if the benefits have persisted. conditions: Stress, Psychological conditions: Burnout, Psychological conditions: Subjective Stress conditions: Occupational Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 34 type: ESTIMATED name: Box Breathing name: Breathing and Mindfulness Exercise name: Everyday life control measure: Daily perceived stress measure: Daily expectation of perceived stress level on the following day measure: Level of agreement between expected and actually perceived level of stress measure: Compliance with the study protocol: number of participant reported outcomes measure: Compliance with the study protocol: number of performed anti-stress interventions measure: Successful study completion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Charité - Universitätsmedizin Berlin status: RECRUITING city: Berlin zip: 10117 country: Germany name: Valentin M Vetter, MD role: CONTACT phone: 0049 30 450 566 298 email: valentin.vetter@charite.de lat: 52.52437 lon: 13.41053 hasResults: False

 nctId: NCT06368778 id: 166591 briefTitle: Real-Time Biofeedback on Partial Weightbearing Training overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-13 date: 2025-04 date: 2025-04 date: 2024-04-16 date: 2024-04-26 name: University of Utah class: OTHER briefSummary: The purpose of this study is to investigate the effectiveness of a biofeedback device (Loadsol) in training healthy subjects to comply with partial weightbearing, and to compare its outcomes with the standard of care training. Partial weightbearing is an essential component of rehabilitation and recovery for many orthopedic patients, yet it remains challenging for individuals to accurately gauge their weightbearing restrictions without proper guidance and feedback.

The primary objective of the study is to determine whether the use of the biofeedback device (Loadsol) can reduce the time it takes for healthy subjects to learn and comply with partial weightbearing, compared to traditional training methods. The Loadsol device provides real-time auditory feedback on the individual's weightbearing status, potentially enhancing the learning process and adherence to weightbearing restrictions.

Secondary objectives of the study include:

Assessing the compliance of subjects with weightbearing restrictions in both the biofeedback and standard of care training groups, and comparing the results to identify any significant differences in adherence to the prescribed weightbearing limitations.

Evaluating subject satisfaction with the training methods, as measured through questionnaires and the use of Patient-Reported Outcomes Measurement Information System (PROMIS) tools. This evaluation will help determine if the biofeedback device (Loadsol) leads to higher levels of satisfaction among subjects compared to the standard of care training.

By examining these objectives, this study aims to provide valuable insights into the potential benefits of using a biofeedback device in partial weightbearing training, and to establish whether its implementation can lead to improved outcomes in learning, compliance, and overall patient satisfaction. conditions: Physical Therapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 105 type: ESTIMATED name: Verbal Advice name: Bathroom Scale name: Loadsol Biofeedback measure: Average peak force (Newtons, (N)) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: University of Utah Orthopaedic Center city: Salt Lake City state: Utah zip: 84108 country: United States lat: 40.76078 lon: -111.89105 hasResults: False

 nctId: NCT06368765 id: BL72 briefTitle: Oral Rehydration Solution and Dehydration Recovery overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-11 date: 2024-11 date: 2024-04-16 date: 2024-04-16 name: Abbott Nutrition class: INDUSTRY briefSummary: This is a prospective, randomized, controlled, blinded, crossover, study to evaluate the effects of an oral hydration solution. conditions: Dehydration studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Oral Rehydration Solution (ORS) name: Water measure: Plasma Volume measure: Body Mass measure: Hydration Status Urine measure: Blood Biomarker - Plasma Osmolality measure: Blood Biomarker - Plasma Electrolyte Concentration measure: Blood Biomarker - Plasma Glucose Concentration measure: Body Temperature measure: Body Composition measure: Reaction Time measure: Handgrip Strength measure: Urine Volume measure: Hydration Status Saliva measure: Heart Rate measure: Blood Pressure measure: Thirst Sensation Scale measure: Gagge Thermal Scale measure: Urine Color measure: Palatability measure: Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06368752 id: H-22063621 briefTitle: The Role of Endogenous GIP in Glycosis Metabolism During Fasting overallStatus: ENROLLING_BY_INVITATION date: 2023-05-04 date: 2023-12-12 date: 2025-12-31 date: 2024-04-16 date: 2024-04-16 name: Frederikke Koefoed-Hansen class: OTHER briefSummary: This research project aims to investigate the role of endogenous GIP during fasting. With the infusion of a GIP receptor antagonist (GIP\[3-30\]NH2), is it possible to selectively remove the effect of endogenous GIP, and thus describe its effects by comparing it with what happens during a saline infusion. conditions: Obesity studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The trial is a randomized, double-blind, crossover study. We give intravenous infusion of GIP\[3-30\]NH2, and thus describe the effects of GIP by comparing with what happens during a saline infusion (placebo). primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: The infusion is mixed by an external coordinator. Neither the investigator or the participants knows whether is the GIP\[3-30\]NH2 infusion or saline infusion that is being given. Which infusion that is given on each trial day is randomized for each participant. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 12 type: ESTIMATED name: GIP[3-30]NH2 name: Saline measure: Plasma glucagon concentrations measure: Plasma levels of C-peptide measure: Plasma levels of insulin measure: Resting metabolic rate measure: Activity in brown adipose tissue measure: Appetite measure: Blood pressure measure: Puls sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gentofte Hospital city: Hellerup zip: 2900 country: Denmark lat: 55.73204 lon: 12.57093 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-04-10 uploadDate: 2024-04-11T04:12 filename: Prot_SAP_000.pdf size: 120286 hasResults: False

 nctId: NCT06368739 id: STUDY00005622 briefTitle: Evaluation of Medicaid Food & Nutrition Support Program for Pregnant Women overallStatus: ACTIVE_NOT_RECRUITING date: 2022-10-17 date: 2024-05-01 date: 2024-08-01 date: 2024-04-16 date: 2024-04-16 name: University of Texas at Austin class: OTHER name: Driscoll Health Plan briefSummary: With funding from the Episcopal Health Foundation, the researchers will conduct a secondary data analysis to evaluate the impact of Driscoll Health Plan's Nurture program for pregnant members using claims data. conditions: Pregnancy Related conditions: Financial Gift conditions: Nutrition, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: From the eligible population, DHP randomly selected a subset of approximately 500 women during the pilot period, from which approximately 200 were in the program, the "exposed group." The women who were covered during the same period but were not selected were not exposed to the program and will compose the "comparison group." primaryPurpose: PREVENTION masking: NONE count: 224 type: ACTUAL name: Nurture program name: Regular benefits measure: Composite outcome 1: Adverse health events during pregnancy measure: Composite outcome 2: Adverse health events at birth and newborn-related measure: Emergency Department visits measure: Cost (outpatient) measure: Cost (inpatient) measure: Cost (pharmacy/medication) measure: Cost (total) measure: Delivery mode (vaginal, C-section) measure: Birthweight sex: FEMALE minimumAge: 30 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Driscoll Health Plan city: Corpus Christi state: Texas zip: 78415 country: United States lat: 27.80058 lon: -97.39638 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-01-24 uploadDate: 2024-02-12T16:26 filename: Prot_SAP_000.pdf size: 630078 hasResults: False

 nctId: NCT06368726 id: SFND04042024 briefTitle: Result of tDCS in ASD Children With Comorbidities Like PANDAS, Rare Genetic Diseases or Autoimmune Disorders acronym: tDCS&ASD overallStatus: ENROLLING_BY_INVITATION date: 2024-04-01 date: 2025-05-01 date: 2025-07-01 date: 2024-04-16 date: 2024-04-16 name: Spanish Foundation for Neurometrics Development class: OTHER name: Fundacion para la Salud Materno Infantil briefSummary: Results of the application of 100 sessions of tDCS for 12 months in children between 6 and 11 years old with autism spectrum disorder with rare diseases, genetic problems or PANDAS conditions: Attention conditions: Visual Perceptual Weakness conditions: Social Behavior conditions: Fluency Disorder conditions: EEG With Periodic Abnormalities studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups of childs: 90 childs receive tDCS treatment and 90 traditional treatments with Risperidone educational training, speech therapy and visual training. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Assessments regarding clinical recovery will be conducted by an assessor blind to treatment allocation. whoMasked: INVESTIGATOR count: 180 type: ESTIMATED name: tDCS or Transcranial Direct Current Stimulation name: Risperidone measure: FFT measure: Power Density Spectrum Changes or PSD measure: ERP MMN changes measure: ERP MMN Changes measure: Attention measure: Social Skills measure: Language measure: Visual Contact sex: ALL minimumAge: 6 Years maximumAge: 11 Years stdAges: CHILD facility: New Remedies Ltd city: Liverpool state: Merseyside zip: L1 0AH country: United Kingdom lat: 53.41058 lon: -2.97794 hasResults: False

 nctId: NCT06368713 id: PD-GIEX briefTitle: Exercise Improves Gastrointestinal Function in Peritoneal Dialysis Patients overallStatus: RECRUITING date: 2024-03-01 date: 2025-06-30 date: 2025-12-31 date: 2024-04-16 date: 2024-04-16 name: Sichuan Academy of Medical Sciences class: OTHER briefSummary: This study will investigate the impact of exercise on gastrointestinal function in peritoneal dialysis patients. conditions: Peritoneal Dialysis conditions: Exercise conditions: Gastrointestinal Function conditions: Quality of Life conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 132 type: ESTIMATED name: Exercise measure: Change in GIQLI measure: Change in GSRS measure: Change in PAC-SYM measure: Change in 6-MWT measure: Change in SGA measure: Change in measured Gastrointestinal Hormones sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital,School of Medicine, University of Electronic Science and Technology of China status: RECRUITING city: Chengdu state: Sichuan zip: 610000 country: China name: Jin Chen, Doctor role: CONTACT lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06368700 id: CL-00001 briefTitle: The Hyalex Early Feasibility Study (EFS) overallStatus: RECRUITING date: 2024-04-04 date: 2025-10 date: 2026-10 date: 2024-04-16 date: 2024-04-16 name: Hyalex Orthopaedics, Inc. class: INDUSTRY briefSummary: The Hyalex Early Feasibility Study is a prospective, multicenter, open-label, single-arm, 2-phase early feasibility 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, will be enrolled in the study and undergo implantation of the HYALEX Knee Implant. conditions: Cartilage Injury conditions: Cartilage Damage studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 20 type: ESTIMATED name: Hyalex Knee Cartilage System measure: Freedom from implant rejection and infection. measure: Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) at 12 months. sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital for Special Surgery status: RECRUITING city: New York state: New York zip: 10021 country: United States name: Ava Neijna role: CONTACT phone: 917-260-3677 email: SGResearch@hss.edu name: Morgan Rizy role: CONTACT name: Sabrina Strickland, M.D. role: PRINCIPAL_INVESTIGATOR name: Andreas Gomoll, M.D. role: SUB_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Oregon Health & Science University status: RECRUITING city: Portland state: Oregon zip: 97239 country: United States name: Jessica Ballin role: CONTACT phone: 503-418-9580 email: ballin@ohsu.edu name: Dennis Crawford, M.D. role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 hasResults: False

 nctId: NCT06368687 id: 2023-06112-01 briefTitle: TRANPAS - TReating Anorexia Nervosa Plus Autism Spectrum acronym: TRANPAS overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-12-31 date: 2026-12-31 date: 2024-04-16 date: 2024-04-16 name: Göteborg University class: OTHER briefSummary: In a pilot study, we will validate a so-called autism care location in an inpatient ward. The care location will be adapted for patients with anorexia nervosa (AN) and concurrent autism (AN+autism). In order to investigate the effect of a tailored care location for patients with AN + autism, the evaluation will include weight development and changes in nutritional intake, eating disorder and anxiety symptoms. The overall aim is to improve treatment for this specific AN subgroup, that otherwise has a worse prognosis regarding AN recovery. conditions: Anorexia Nervosa conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pilot study. Ten consecutive patients with anorexia nervosa (AN) plus autism will be admitted to the autism care location at an inpatient ward for eating disorders. The planned period of care for each patient is 12 weeks. The patient will be assessed (including weight, height, self-report questionnaires and interviews) before admission, at discharge and 6 months later. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Anorexia nervosa plus autism measure: BMI change between baseline and discharge 12 weeks later measure: Change of level of anxiety between baseline and discharge 12 weeks later measure: Change of Quality of life between baseline and discharge 12 weeks later sex: ALL minimumAge: 25 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06368674 id: 2023-00363 briefTitle: Bridging the Gap: Creating a Continuum of Care overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2026-12-31 date: 2027-02-01 date: 2024-04-16 date: 2024-04-22 name: Göteborg University class: OTHER name: Vastra Gotaland Region name: Narhalsan Reasearch and Development primary care Region Vastra Gotaland name: Sahlgrenska University Hospital, Sweden name: Forte briefSummary: Coordination and integration between care settings is essential for the quality of care of frail older patients. An active follow-up by a case manager (CM) after discharge form an acute geriatric hospital ward has the potential to bridge the gap between hospital, primary and municipality care for frail older people. This study evaluates the effects of an active follow-up by a CM in primary care after discharge from a geriatric ward, with the following research questions: Can an active follow-up by CM for frail older people discharged from an acute geriatric ward, compared to those not receiving active follow up, Maintain/increase independence in activities of daily living, self-rated health and life satisfaction? Increase satisfaction with health care? Reduce health care consumption/be cost-effective? How feasible is the intervention and the study design from the perspective of the caregivers and the older person? This is a clinical controlled study with a process evaluation. Inclusion criteria are 75 years or older, frail and admitted to a geriatric ward.

This study is relevant since today's highly specialized acute care is poorly adapted to the comprehensive needs of frail older people, and exposes them to avoidable risks such as loss of functional capacities causing unnecessary care needs and decreased wellbeing. Active follow-up by a CM after discharge may be an important way to integrate the care for frail older people, after receiving in-hospital geriatric care. This can improve the quality of care for this vulnerable group, and direct the right health care actions towards those in most need.

The intervention is a active follow-up after discharge by a CM (nurse) in primary care. CM will secure that discharge and care plans are executed and to address new needs. If there are unmet needs, the CM will ensure that adequate actions are performed to meet the needs. The intervention group consists of participants discharged to a primary health care centre with a CM, who actively follows-up after discharge. The control group consists of participants discharged to a primary health care centre without CM, and thereby no active follow-up after discharge. All participants will be followed-up by the research team during one year, concerning dependence in activities of daily living, self-rated health, health care consumption and satisfaction with care. conditions: Frailty conditions: Dependence conditions: Integrated Care studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Clinical control study primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Intervention group Case Manager (CM) name: Control Group measure: Dependency in Activities of Daily Living (ADL) measure: Self-rated health measure: Life satisfaction measure: Satisfaction with quality of care measure: Health economics sex: ALL minimumAge: 75 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06368661 id: 23.79 Colo-MAR 1 briefTitle: Dietary Factors Associated to Colorectal Premalignant Lesions (COLOMAR-1) overallStatus: RECRUITING date: 2023-09-01 date: 2024-10-01 date: 2024-12-31 date: 2024-04-16 date: 2024-04-16 name: Fundación Vithas class: OTHER name: CEU San Pablo University briefSummary: This study aims to find a correlation between fish protein intake and other dietary habits and colorectal premalignant lesions in healthy volunteers. It also aims to describe gut microbial profiles for each dietary pattern, in order to elucidate the role of fish intake in cancer prevention. conditions: Nutrition Related Neoplasm/Cancer studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 30 type: ESTIMATED measure: Dietary habits registry from participants: the dietary intake measure: Biomarkers in colon mucosa, precancerous lesions and colorectal cancer measure: Gut microbiota profile sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ciro Cabezas Checchi status: RECRUITING city: Vigo state: Pontevedra zip: 36206 country: Spain name: Ciro Cabezas Checchi, MD role: CONTACT phone: +34 986 82 11 00 email: CabezasCC@vithas.es lat: 42.23282 lon: -8.72264 hasResults: False

 nctId: NCT06368648 id: CP-1 briefTitle: CoMind Early Feasibility Study acronym: CoMind EFS overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-03 date: 2025-04 date: 2024-04-16 date: 2024-04-16 name: CoMind Technologies Limited class: INDUSTRY name: Lindus Health briefSummary: The purpose of this research, which has been determined as non-significant risk by the central IRB overseeing the study, is to obtain information to help further develop a machine (a medical device) to measure the pressure around the brain from the outside (this pressure is called intracranial pressure or ICP). Monitoring and managing ICP is an important part of care for patients with conditions such as Traumatic Brain Injury (TBI). However, the current way of measuring ICP requires surgery to drill a hole into the skull, and therefore can introduce additional risks such as infections and pain.

Recent research has shown it may be possible to measure ICP without needing surgery. This technology is in development, but large amounts of data is required to build these new devices.

Through collecting a large database of information from patients who have both the routine surgical device and the research device applied to their head, the research team will work to develop and test an effective and potentially safer way of monitoring patient ICP. conditions: Intracranial Pressure conditions: Intracranial Pressure Changes conditions: Traumatic Brain Injury conditions: Intracerebral Hemorrhage conditions: Encephalitis conditions: Encephalopathy conditions: Hydrocephalus conditions: Stroke conditions: Autoregulation studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 581 type: ESTIMATED measure: A test of the difference in estimation errors between two non-invasive ICP estimation models: one trained with ABP and CoMind One EFS CBFi, and one trained only using ABP measure: Models trained using CoMind CBFi and ABP will be evaluated based on their limits of agreement (LOA) with invasive ICP. measure: Demonstration that non-invasive ICP estimation using the CoMind One EFS device is insensitive to differences in skin tone across the population. measure: Demonstration of a non-invasive ICP model that can classify the transition between ICP 'states', i.e. transitions between low ICP (less than 20 mmHg), and high ICP (greater than 20 mmHg). measure: Demonstration of a non-invasive ICP waveform prediction model and assessment of its accuracy against the invasively-measured ICP waveform. measure: Demonstration of an non-invasive ICP model that can predict trends in ICP measure: A comparison of metrics of CAR derived from CoMind One EFS CBFi, CoMind One EFS device estimates of ICP, and ABP. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06368635 id: 2022-GSP-QN-8 briefTitle: The Cerebral Microcirculation Diseases and Coronary Microcirculation Disease Study acronym: CCMD overallStatus: RECRUITING date: 2024-01-01 date: 2024-12-31 date: 2025-03-31 date: 2024-04-16 date: 2024-04-18 name: Weijing Wang class: OTHER_GOV name: Chinese Academy of Medical Sciences, Fuwai Hospital briefSummary: Ischaemic heart disease (IHD) and degenerative brain disease are two major sources of death and disability affecting all countries. While the consequences of obstructive disease in major vessels supplying blood to both organs have been widely documented, less attention has been paid to disease processes affecting the microcirculation that may affect cardiac and cerebral function. Yet, over the last decade significant progress has been made in understanding the substrate of microvascular disease in both organs. In the heart, arteriolar thickening and capillary rarefaction that reduce the conductance of the microvasculature and its ability to vasodilate in response to increased myocardial oxygen demands constitute the leading cause of coronary microvascular dysfunction (CMD). In the brain, concentric hyaline thickening of deep penetrating small arteries (arteriolosclerosis) with associated fibrosis of the vessel wall constitutes the most frequent substrate for cerebral small vessel disease (CSVD). Of note, both CMD and CSVD share common risk factors, such as age, hypertension, and diabetes.3 These factors might have a common effect on the microvascular domain of cardiac and cerebral vascular beds.

Although a potential link between both conditions has been hypothesized based on the similarities between pathological changes and risk factors, advance in knowledge exploring this has been hampered by lacking objective evidence of CMD and pathological brain changes indicative of CSVD in prior research studies. Thus, the relationship between CMD and CSVD is unknown.

The main objective of this study was to analyse the relationship between cerebrovascular disease and CMD in patients with atherosclerotic coronary artery disease (CAD). conditions: Microcirculation conditions: Coronary Artery Disease conditions: Cerebrovascular Circulation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Coronary angiography measure: MACE measure: MACE measure: Cerebral microcirculation measure: Cerebral microcirculation sex: ALL minimumAge: 45 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College status: RECRUITING city: Beijing state: Beijing zip: 100000 country: China name: Weijing Wang, PhD role: CONTACT phone: +8601088326200 email: wangweijing99@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06368622 id: CDM10001814 briefTitle: Evolve China PMCF Study overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-11 date: 2031-08 date: 2024-04-16 date: 2024-04-16 name: Stryker Neurovascular class: INDUSTRY name: Stryker (Beijing) Healthcare Products Co., Ltd briefSummary: A prospective, multi-center, single-arm, open-label, observational post-market real-world registry. The expected duration of the study is 8 years (including up to 5-years' follow-up).

Each subject will be followed in accordance with the standard of care (SOC) at each participating hospital. conditions: Intracranial Aneurysm studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Surpass Evolve Flow Diverter System measure: Neurological death or disabling stroke measure: 100% occlusion without significant parent artery stenosis measure: Procedure- and device-related serious adverse events measure: Key neurological events measure: Procedural success measure: Device success measure: Re-sheathing success sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xuanwu Hospital Capital Medical University city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06368609 id: 2024-09 briefTitle: Preliminary Evaluation of Two Rapid Diagnostic Test Prototypes for Strongyloides Stercoralis Infection acronym: PROTOSS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-05 date: 2024-05 date: 2024-04-16 date: 2024-04-18 name: IRCCS Sacro Cuore Don Calabria di Negrar class: OTHER briefSummary: Single center, no profit experimental study on sera available in the Tropica Biobank. conditions: Strongyloides Stercoralis Infection studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: IgG RDT name: IgG4 RDT measure: RDTs IgG results: positive or negative measure: RDTs IgG4 results: positive or negative measure: Agreement between readers sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Sacro Cuore Don Calabria hospital city: Negrar state: Verona zip: 37024 country: Italy name: Dora Buonfrate role: CONTACT email: dora.buonfrate@sacrocuore.it name: Dora Buonfrate role: PRINCIPAL_INVESTIGATOR lat: 45.52918 lon: 10.93899 hasResults: False

 nctId: NCT06368596 id: 2024-04 briefTitle: ENDS (ENDometriosis & FuSobacterium) Unveiling the Contribution of Fusobacterium Infection to the Development of Endometriosis acronym: ENDS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-10 date: 2025-10 date: 2024-04-16 date: 2024-04-16 name: IRCCS Sacro Cuore Don Calabria di Negrar class: OTHER briefSummary: This will be a clinical interventional longitudinal study, without pharmacological intervention/device evaluation.

A control group would however be recruited for secondary objective 1 and 2.

The study is classified as interventional, as Fusobacterium detection is not part of the routine management of these patients; from the patients' point of view, participation in the study will involve the execution of additional vaginal and cervical swabs as additional procedure, while the endometrial biopsy will not represent an additional examination, as the study will include only patients for whom this examination is expected as per normal clinical practice. conditions: Endometriosis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 845 type: ESTIMATED name: Fusobacterium detection measure: Fusobacterium sp presence (Y/N) in endometrial biopsy in women with endometriosis measure: Fusobacterium presence (Y/N) in endometrial biopsy in women without endometriosis measure: Fusobacterium presence (Y/N) in vaginal and cervical swab in all women enrolled measure: Fusobacterium presence (Y/N) in endometrial biopsy in women with and without PID complicating endometriosis . measure: Fusobacterium presence (Y/N) in biopsies of endometrial tissue involving different sites (superficial lesions, deep endometriosis, ovarian endometrioma), if present measure: Fusobacterium presence (Y/N) in endometrial biopsy in women with and without infertility associated to endometriosis measure: Fusobacterium presence (Y/N) in endometrial biopsy in women with and without hysteroscopic signs of chronic endometritis in patients with and without endometriosis sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Sacro Cuore Don Calabria di Negrar city: Negrar state: Verona country: Italy name: Marcello Ceccaroni, Doctor role: CONTACT email: marcello.ceccaroni@sacrocuore.it role: CONTACT phone: 0456013111 name: Marcello Ceccaroni role: PRINCIPAL_INVESTIGATOR name: Dora Buonfrate role: SUB_INVESTIGATOR lat: 45.52918 lon: 10.93899 hasResults: False

 nctId: NCT06368583 id: 24-05 briefTitle: The Patient AS EDUcator in Anesthesia: Exploring the Patients' and Providers' Experience During Neuraxial Labour Analgesia acronym: PAS-EDU-NLA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-16 date: 2024-04-23 name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital class: OTHER briefSummary: During the process of labour and delivery, patients may experience a wide range of events in a short time frame. This study focuses on exploring these experiences and aims to incorporate the improvements from these experiences so that in future, the expectations of patients delivering can be met as much as possible. Since every patient and encounter is unique, they might have a variety of experiences, be it during the labour epidural placement or during the delivery of the baby. Our study aims to explore the patients' perspective and learn about their preferences, concerns and suggestions regarding their experience and to then use this information to enhance the quality of future anesthesia care during labour and delivery.

Patients who underwent labour and delivery and received labour epidural for pain management will be approached the day following the delivery, while their recollection of their experience is still fresh, and given the opportunity to participate in the study which will involve the completion of a questionnaire as well as an interview lasting approximately 20-25 minutes. In addition to interviewing the patients, the study will also involve several interviews of the obstetricians, anesthesiologists, and nurses with the goals of seeing how the patients' experiences compare to the providers' perspective of the care they are delivering. Following the gathering of this information and identification of potential improvements in current practice, a follow up study will be performed aiming to implement changes and improve the quality of anesthesia care during labour and delivery. conditions: Well-Being, Psychological studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Interview measure: Patient questionnaire measure: Patient interview sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Mount Sinai Hospital city: Toronto state: Ontario zip: M5G1X5 country: Canada name: Sabine Nabecker, MD role: CONTACT phone: 416-586-4800 phoneExt: 5270 email: sabine.nabecker@sinaihealth.ca name: Ron George, MD role: SUB_INVESTIGATOR name: Kristi Downey, MSc role: SUB_INVESTIGATOR name: Sunti Barahi, MD role: SUB_INVESTIGATOR name: Ratesh Bassi, MD role: SUB_INVESTIGATOR name: Afsheen Nasir, MD role: SUB_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06368570 id: 24-04 briefTitle: The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During Routine Cesarean Delivery acronym: PAS-EDU-RCD overallStatus: RECRUITING date: 2024-04-25 date: 2024-12 date: 2024-12 date: 2024-04-16 date: 2024-04-26 name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital class: OTHER briefSummary: This study aims to explore the experience that the patient has as they undergo a routine Cesarean Delivery (CD). The indication for undergoing a routine CD varies amongst patients, but usually there is either an obstetric or medical reason for requiring a planned delivery of an infant via CD. Similarly, the experience of the CD varies significantly between patients as there are many patient, surgical and anesthetic factors that interact to create the unique experience each patient has. This study aims to explore the patients' perspective and learn about their preferences, concerns and suggestions regarding their experience of CD and to then use this information to enhance the quality of future anesthesia care for elective CD.

Patients who have undergone a routine CD will be approached the day following their delivery, while their recollection of their experience is still fresh, and given the opportunity to participate in the study, which will involve the completion of a questionnaire as well as an interview lasting approximately 20-25 minutes. In addition to interviewing the patients, the study will also involve several interviews of obstetricians, anesthesiologists and nurses with the goal of seeing how the patients' experiences compare to the providers' perspective of the care they are delivering. Following the gathering of this information and identification of potential improvements in current practice a follow up study will be performed aiming to implement changes and improve the quality of anesthesia care during elective CD. conditions: Well-Being, Psychological studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Interview measure: Patient questionnaire measure: Patient interview sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Mount Sinai Hospital status: RECRUITING city: Toronto state: Ontario zip: M5G1X5 country: Canada name: Sabine Nabecker, MD role: CONTACT phone: 416-586-4800 phoneExt: 5270 email: sabine.nabecker@sinaihealth.ca name: Ron George, MD role: SUB_INVESTIGATOR name: Kristi Downey, MSc role: SUB_INVESTIGATOR name: Fernanda Septimio Lanza Oliveira, MD role: SUB_INVESTIGATOR name: Lada Kordich, MD role: SUB_INVESTIGATOR name: Afsheen Nasir, MD role: SUB_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False

 nctId: NCT06368557 id: 22/59602 briefTitle: Internet-based Cognitive Behavioral Intervention for Adolescents With Anxiety Disorders overallStatus: RECRUITING date: 2023-10-10 date: 2025-03 date: 2025-06 date: 2024-04-16 date: 2024-04-16 name: Region of Southern Denmark class: OTHER name: University of Aarhus briefSummary: The goal of the randomized controlled trial is to find out if the internet-based therapy (iCBT) intervention CoolMinds, is effective in helping adolescents with anxiety. The adolescents in the study are aged between 12 and 17 years of age, who live in the region of Southern Denmark. They must have an anxiety diagnosis according to the

Diagnostic and Statistical Manual-5 (DSM-5) criteria. The main questions it aims to answer are:

1. If getting anxiety treatment with CoolMinds will lead to a greater reduction in anxiety symptoms, compared to a waitlist.
2. What effect different degrees of therapist support have on the treatment.

Participants will be getting 14 weeks of the iCBT intervention CoolMinds, and they will be asked to answer questionnaires about their mental health before and after the treatment.

Researchers will compare three different groups, with 56 adolescents in each group. The first group will receive iCBT with weekly scheduled feedback. The second group will get iCBT with feedback whenever the adolescents ask for it. The last group will be on a waiting list for 14 weeks, before receiving treatment. conditions: Anxiety Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: The RCT is designed as a superiority RCT with the three conditions 1) iCBT with planned feedback 2) iCBT with on-demand feedback and 3) waitlist control. The allocation ratio is 1:1:1 for each condition. The participants will be stratified by aged into the age groups 12-14 years and 15-17 years respectively to secure an even age distribution across conditions. Additionally upon completing session 8 in the program, participants will be randomized to receive or not receive a booster session 12 weeks after finishing the intervention with an allocation ratio of 1:1. The design of the randomized trial is thus factorial including two factors: type of therapist feedback (factor 1) and booster or no booster (factor 2). Data will be collected with parent and adolescent questionnaires at five time points: pre-treatment, post-treatment and at follow-ups after 3, 6 and 12 months. primaryPurpose: TREATMENT masking: NONE maskingDescription: As the study concerns itself with psychotherapy and examines the difference in therapist support, it is practically impossible to blind participants and clinicians, and thus they are not blinded. The research team is involved in the day-to-day operation of the project, including the screening for suicidality, why blinding of the research team is also practically impossible with the current setup. However the analyzes of the trial results will be pseudo-anonymized, so that only the ID number appears on the data sheet in order to get as close to blinding as possible in relation to the research design. count: 168 type: ESTIMATED name: CoolMinds: Internet-based cognitive behavioral therapy (iCBT) measure: The Youth Online Diagnostic Assessment - Child and Parent Versions measure: Spence Children's Anxiety Scale- Child and Parent Versions measure: Child Anxiety Life Interference Scale- Child and Parent Version measure: The Mood and Feelings Questionnaire- Child and Parent Version measure: Working Alliance Inventory - Short Form measure: Working Alliance Inventory for Online Interventions measure: Children´s Anxiety Scale measure: The Short Mood and Feelings questionnaire measure: EuroQol-5 Dimension Youth measure: Client Satisfaction Questionnaire-8 measure: Systems Usability Scale measure: Negative Effects Questionnaire measure: Sociodemographic measures measure: Engagement measure: Cost-effectiveness measure: Cost-effectiveness measure: The Anxiety Disorders Interview Schedule for Children sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD facility: Centre for Digital Psychiatry status: RECRUITING city: Odense state: Region Of Southern Denmark zip: 5000 country: Denmark name: Helene Skaarnes, MSc (psych)) role: CONTACT phone: +4529649702 email: helene.skaarnes@rsyd.dk name: Kim Mathiasen, Ph.d. role: CONTACT phone: +4561677747 email: kmathiasen@health.sdu.dk lat: 55.39594 lon: 10.38831 hasResults: False

 nctId: NCT06368544 id: M2023816 briefTitle: Effect of Early Gait Training on Knee Cartilage Degeneration After Anterior Cruciate Ligament Reconstruction overallStatus: RECRUITING date: 2024-01-07 date: 2030-02-07 date: 2030-02-07 date: 2024-04-16 date: 2024-04-16 name: Peking University Third Hospital class: OTHER briefSummary: A randomized controlled clinical study was conducted to elucidate the relationship between the lower extremity biomechanics of patients undergoing early gait training after ACLR surgery.The relationship between the biochemical characteristics of cartilage and the biomechanical risk index were proposed to providing exercise guidance and training for middle-aged people and it is suggested that it can prevent and reduce the risk of cartilage degeneration early after operation. conditions: Anterior Cruciate Ligament Injuries conditions: Cartilage Degeneration studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 30 type: ESTIMATED name: lower-body positive-pressure measure: Gait biomechanical data measure: Gait biomechanical data measure: Gait biomechanical data measure: Gait biomechanical data measure: Gait biomechanical data measure: Biochemical characteristics of knee cartilage measure: Biochemical characteristics of knee cartilage sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Peking University Third Hospital status: RECRUITING city: Beijing country: China name: ren shuang role: CONTACT phone: xixishuang123@126.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06368531 id: 2314270 briefTitle: Long-term Monitoring of Sleep With Ear-EEG in Patients With Chronic Pain overallStatus: RECRUITING date: 2024-04-04 date: 2025-02-15 date: 2025-08-15 date: 2024-04-16 date: 2024-04-16 name: Odense University Hospital class: OTHER name: University of Aarhus name: T&W Engineering A/S briefSummary: Insomnia is reported by more than 50% of patients with chronic pain. In this study, the investigators aim to advance the understanding of physiological sleep in individuals with chronic pain. To do this the investigators will monitor at-home sleep with an ear-EEG over 20 nights in patients with chronic pain and collect self-reported measures of sleep and pain. The collected data will be used to explore and characterize intra-individual variations in sleep metrics (e.g. total sleep time, time in each sleep stage (N1, N2, N3, REM), sleep latency, REM stage latency, wake after sleep onset, sleep efficiency, number of arousals and arousal index) over 20 nights. conditions: Chronic Pain conditions: Insomnia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 25 type: ESTIMATED measure: sleep period time (SPT) from Ear EEG measure: Qualitative sleep parameters obtained from sleep diary. measure: Pain intensity rating measure: Time from sleep onset until final awakening (TST) from Ear EEG measure: Sleep efficiency (SE) from Ear EEG measure: Sleep onset latency (SOL) from Ear EEG measure: Wake after sleep onset (WASO) from Ear EEG measure: REM sleep latency from Ear EEG 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: Adverse device effects measure: Polysomnography measure: Sleep quality measure: Insomnia measure: The Graded Chronic Pain Scale Revised measure: Age measure: Sex measure: Ethnicity measure: Height measure: Weight measure: Level of education measure: Obstructive sleep apnea sex: ALL minimumAge: 18 Years maximumAge: 65 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 lat: 55.39594 lon: 10.38831 hasResults: False

 nctId: NCT06368518 id: ID01/2024/MZHCM-Reg/NV briefTitle: Austrian HCM Registry overallStatus: RECRUITING date: 2024-03-08 date: 2034-03 date: 2034-03 date: 2024-04-16 date: 2024-04-16 name: Medical University of Graz class: OTHER briefSummary: The Austrian Hypertrophic Cardiomyopathy (HCM) Registry is a prospective, multicenter registry enrolling patients at multiple outpatient clinics across Austria including academic and non-academic centers. Patients will undergo a structured examination process including assessment for symptoms of HCM, past medical history, concomitant medication, family history and the presence of HCM-specific red flags. Furthermore, clinical data derived from electrocardiogram, echocardiography, laboratory analysis, and genetic testing will be collected focusing on a lean variable dictionary and, in addition, specific hypothesis-driven research parameters. All data are entered into an electronic case report form (eCRF) (Phoenix Clinical Trial Management System). In order to perform multicenter analyses, data can be extracted from the eCRF after approval by the steering committee. conditions: Hypertrophic Cardiomyopathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: All cause mortality measure: Cardiovascular events sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Graz status: RECRUITING city: Graz state: Styria zip: 8036 country: Austria name: Nicolas Verheyen, MD, PHD role: CONTACT phone: 004331638530173 email: nicolas.verheyen@medunigraz.at name: Viktoria Santner, MD role: CONTACT email: viktoria.santner@medunigraz.at name: Nicolas Verheyen, MD, PHD role: PRINCIPAL_INVESTIGATOR lat: 47.06667 lon: 15.45 hasResults: False

 nctId: NCT06368505 id: R.24.02.2506.R1 briefTitle: Platelet-Rich Plasma Injection Versus Hydrodissection in the Treatment of Carpal Tunnel Syndrome overallStatus: RECRUITING date: 2024-01-16 date: 2024-06-16 date: 2024-07-16 date: 2024-04-16 date: 2024-04-16 name: Osama Ahmed Elshafei class: OTHER briefSummary: The goal of this clinical trial is to compare the efficacy of Ultrasound-Guided Platelet-Rich Plasma Injection versus Hydrodissection (using 2ml saline, 2ml dexamethasone and 1ml lidocaine) in the Treatment of Carpal Tunnel Syndrome. The main questions it aims to answer are:

* Which modality is more effective in reducing symptoms and improving function in patients with Carpal tunnel syndrome
* Asses safety profile of both methods

Participants will:

* Randomized to one of the two arms
* Visit the clinic 1 and 3 months after intervention
* Assessed for efficacy and safety of the intervention conditions: Carpal Tunnel Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 64 type: ESTIMATED name: ultrasound guided PRP injection name: ultrasound guided hydrodissection measure: Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) measure: The visual analog scale (VAS) measure: The cross-sectional area (CSA) of the Median nerve sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mansoura University status: RECRUITING city: Mansoura zip: 35511 country: Egypt name: osama elshafei, MD PHD role: CONTACT email: osama_elshafei@mans.edu.eg name: Dena El-Ghzzawy role: CONTACT email: Profdr_os@yahoo.com name: Dena El-Ghzzawy, MD role: SUB_INVESTIGATOR name: OSAMA ELSHAFEI, MD PHD role: PRINCIPAL_INVESTIGATOR lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06368492 id: P137 id: 2021-002909-10 type: EUDRACT_NUMBER id: NL78008.068.21 type: OTHER domain: METC azM/Maastricht University briefTitle: The Impact of Psilocybin on Pain in Fibromyalgia Patients acronym: PsiloFM overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2025-12 date: 2024-04-16 date: 2024-04-16 name: Maastricht University class: OTHER name: Leiden University Medical Center briefSummary: Rationale: Recent evidence shows that Lysergic Acid Diethylamide (LSD), even when administered in low, non-hallucinogenic doses, can produce analgesic effects and improve pain tolerance in a sample of healthy volunteers. Such results complement what was already observed with other serotonergic psychedelics such as psilocybin: survey studies and case series indicate that its use may lead to improvements in chronic pain conditions such as migraines, cluster headaches and phantom limb pain even at low, non-psychedelic doses. These effects have however not yet been investigated and confirmed in clinical populations under controlled experimental conditions.

Fibromyalgia (FM) is a chronic condition characterised by widespread pain, hyperalgesia, anxiety, disturbed sleep patterns, impaired cognitive functioning and comorbid mood disorders. Most suggested therapies are only associated with small improvements in pain ratings and quality of life. Currently, there is no data concerning the effectiveness of serotonergic psychedelics in improving pain ratings in fibromyalgia patients.

Objective: The present study will explore the effects that the administration of a placebo and 2 low psilocybin doses (5 mg or 10 mg) will have on pain perception in a group of fibromyalgia patients.

Study design: The present study uses a double-blind, randomized, placebo-controlled design. All participants will receive a placebo and 2 doses of psilocybin (5 mg or 10 mg) and will undergo the Cold Pressor Test (CPT) and the Pain Pressure Threshold Task (PPT) o test its analgesic effects. conditions: Fibromyalgia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: double-blind, randomized, within-subjects, placebo-controlled design. primaryPurpose: TREATMENT masking: NONE maskingDescription: Blinding will be handled by one of the study pharmacies and order and allocation of the treatment to each participant will be completely randomized. This setup ensures that neither the participant nor the experimenter running the test day will be aware of the contents of the capsule. count: 35 type: ESTIMATED name: Psilocybin name: Hypnosis script measure: Ischemic Pain perception measure: Pressure-evoked Pain perception measure: Self-reported pain measure: Subjective effects: psychedelic phenomenology measure: Subjective effects: mood measure: Subjective effects: intensity of effects measure: Subjective effects: Ego dissolution measure: Subjective effects: Dissociation measure: Psychiatric symptoms measure: Cognitive performance measure: Vigilance measure: Empathy measure: Creativity measure: Creativity measure: Autobiographical memory measure: Autobiographical memory measure: Treatment expectancy measure: Treatment expectancy measure: Fibromyalgia-related pain measure: Personality measure: Absorption measure: Interpersonal Reactivity measure: Depression sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maastricht University city: Maastricht state: Limburg zip: 6226AK country: Netherlands name: Mauro Cavarra, MSc role: CONTACT phone: +313494438261 email: m.cavarra@maastrichtuniversity.nl lat: 50.84833 lon: 5.68889 facility: Leiden University Medical Center city: Leiden state: South Holland zip: 2333 country: Netherlands name: Monique van Velzen, PhD role: CONTACT email: M.van_Velzen@lumc.nl lat: 52.15833 lon: 4.49306 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-09-08 uploadDate: 2023-10-30T07:36 filename: Prot_SAP_000.pdf size: 673739 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-10-10 uploadDate: 2023-10-30T07:38 filename: ICF_001.pdf size: 451492 hasResults: False

 nctId: NCT06368479 id: CLS-016B briefTitle: A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Site Settings overallStatus: RECRUITING date: 2024-03-20 date: 2024-07-01 date: 2024-07-01 date: 2024-04-16 date: 2024-04-16 name: bioLytical Laboratories class: INDUSTRY briefSummary: A prospective cross-sectional study in which surgically non-invasive sample-taking is done only for the purpose of testing the samples on iStatis HBsAg Test at the point of care. conditions: Hepatitis B conditions: Hepatitis B Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 4400 type: ESTIMATED name: iStatis HBsAg Test measure: iStatis Performance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Epicentre Health Research status: RECRUITING city: Hillcrest state: Kwazulu Natal zip: 3650 country: South Africa name: Cherie Cawood role: CONTACT phone: +27828202955 email: cheriec@epicentre.org.za hasResults: False

 nctId: NCT06368466 id: CLS-016A briefTitle: A Prospective Cross-Sectional Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Sites overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-08-30 date: 2024-09-01 date: 2024-04-16 date: 2024-04-16 name: bioLytical Laboratories class: INDUSTRY name: St Vincent's Hospital Melbourne briefSummary: A prospective cross-sectional study in which surgically non-invasive sample-taking is done only for the purpose of the study. Capillary (fingerstick) whole blood and EDTA venipuncture whole blood are collected by a healthcare professional. The collected samples of capillary and EDTA whole blood are tested on iStatis and EDTA whole blood sample will be processed to obtain serum and plasma samples to be tested on the iStatis. An aliquot of the collected serum sample will be shipped to the central laboratory for confirmatory testing. The results from iStatis HBsAg Test results will not be used for patient management decisions. conditions: Hepatitis B conditions: Hepatitis B Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 350 type: ESTIMATED name: iStatis HBsAg Test measure: Performance measure: Sensitivity and Specificity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St. Vincent's Hospital, Melbourne city: Melbourne state: Fitzroy Victoria zip: 3065 country: Australia name: Alex Thompson role: CONTACT lat: -37.814 lon: 144.96332 hasResults: False

 nctId: NCT06368453 id: CLS-003 briefTitle: A Study to Evaluate the Performance, Usability, and Result Interpretation of INSTI® HIV Self-Test overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-05-01 date: 2024-04-16 date: 2024-04-16 name: bioLytical Laboratories class: INDUSTRY briefSummary: The objective of this study is to evaluate the performance, usability, and result interpretation of the INSTI® HIV Self-Test (referred to INSTI® HIV ST) in the intended use population across the United States (US). The INSTI® HIV Self-Test is a single use in vitro test that is used as a self-test for the detection of antibodies to HIV-1 and HIV-2 in human fingerstick blood. This study is designed to evaluate INSTI® HIV ST performance in the hands of non-professionals and untrained lay users who are inexperienced in HIV blood-based self-testing.

The study aims to:

To evaluate the clinical performance (i.e., diagnostic sensitivity and specificity) of the INSTI® HIV Self-Test in a lay user population.

To assess the user's comprehension of the INSTI® HIV ST results (e.g., interpreting positive, negative, and invalid results).

To evaluate the usability of the INSTI® HIV ST and understand users' experience in performing the test. conditions: Human Immunodeficiency Virus I Infection conditions: Human Immunodeficiency Virus II Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: SINGLE whoMasked: CARE_PROVIDER count: 1700 type: ESTIMATED name: INSTI® HIV Self-Test measure: Clinical sensitivity and specificity of the INSTI® HIV Self-Test measure: The INSTI® HIV Self-Test usability and result interpretation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06368440 id: D7860C00003 briefTitle: A Study to Investigate the Safety and Pharmacokinetics of AZD6793 in Healthy Japanese and Chinese Participants overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-10-04 date: 2024-10-04 date: 2024-04-16 date: 2024-04-16 name: AstraZeneca class: INDUSTRY briefSummary: The main purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of oral AZD6793 in healthy Japanese and Chinese participants. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: AZD6793 name: AZD6793 name: Placebo measure: Part 1 (SAD): Number of Participants with Adverse Events measure: Part 2 (MAD): Number of Participants with Adverse Events measure: Part 1 (SAD) : Maximum Observed Plasma Drug Concentration measure: Part 1 (SAD): Time to Reach Peak Concentration (tmax) measure: Part 1 (SAD): Terminal Rate Constant, Estimated by Log-Linear Least Squares Regression of the Terminal Part of The Concentration-Time Curve (λz) measure: Part 1 (SAD): Half-life Associated with Terminal Slope of a Semi-Logarithmic Concentration-Time Curve (t1/2λz) measure: Part 1 (SAD): Partial Area Under the Plasma Concentration Time Curve from Time Zero to Time 12 (AUC[0-12]) measure: Part 1 (SAD): Partial Area Under the Plasma Concentration Time Curve from Time Zero to Time 24 (AUC[0-24]) measure: Part 1 (SAD): Area Under the Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast) measure: Part 1 (SAD): Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf) measure: Part 1 (SAD): Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F) measure: Part 1 (SAD): Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Vz/F) measure: Part 1 (SAD): Dose Normalized AUClast measure: Part 1 (SAD): Dose Normalized AUCinf measure: Part 1 (SAD): Dose Normalized Cmax measure: Part 2 (MAD): Maximum Observed Plasma Drug Concentration (Cmax) measure: Part 2 (MAD) : Concentration at the End of The Dosing Interval (Ctrough) measure: Part 2 (MAD): Temporal Change Parameter (TCP) measure: Part 2 (MAD): Time to Reach Peak Concentration (tmax) measure: Part 2 (MAD): Terminal Rate Constant, Estimated by Log-Linear Least Squares Regression of the Terminal Part of The Concentration-Time Curve (λz) measure: Part 2 (MAD): Half-life Associated with Terminal Slope of a Semi-Logarithmic Concentration-Time Curve (t1/2λz) measure: Part 2 (MAD): Partial Area Under the Plasma Concentration Time Curve from Time Zero to Time 24 (AUC[0-24]) measure: Part 2 (MAD): Area Under the Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast) measure: Part 2 (MAD): Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf) measure: Part 2 (MAD): Area Under Plasma Concentration-Time Curve in The Dosing Interval Tau (AUCtau) measure: Part 2 (MAD): Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F) measure: Part 2 (MAD): Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Vz/F) measure: Part 2 (MAD): Dose Normalized AUClast measure: Part 2 (MAD): Dose Normalized AUCtau measure: Part 2 (MAD): Dose Normalized Cmax measure: Part 2 (MAD): Ratio of the Area Under the Curve (Rac AUC) measure: Part 2 (MAD): Accumulation Ratio Based on Cmax (Rac Cmax) measure: Part 2 (MAD): Amount of Unchanged Drug Excreted into Urine from Time t1 to Time t2 (Ae[t1-t2]) measure: Part 2 (MAD): Cumulative Amount of Unchanged Drug Excreted into Urine (Aeinf) measure: Part 2 (MAD): Renal Clearance (CLR) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Research Site city: Glendale state: California zip: 91206 country: United States lat: 34.14251 lon: -118.25508 hasResults: False

 nctId: NCT06368427 id: D5980R00100 briefTitle: Change in Patient-repOrted Outcomes in COPD Patients Newly Initiated on TRIXEO AEROSPHERE in Real worlD acronym: COnCORD overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-09-30 date: 2025-09-30 date: 2024-04-16 date: 2024-04-16 name: AstraZeneca class: INDUSTRY briefSummary: The purpose of this study is to describe patients' clinical and self-reported outcomes of treatment with budesonide / glycopyrronium / formoterol Metered dose inhaler (BGF MDI) in Romania in real-life setting, up to 6 month of observation period. The study will focus primarily on the change in self-perceived health status in the first 12 weeks (3 months) of treatment with no pre-defined hypothesis. conditions: Chronic Obstructive Pulmonary Disease (COPD) studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 250 type: ESTIMATED name: budesonide / glycopyrronium / formoterol measure: Change from baseline to 12 weeks (3 months) in the COPD Assessment Test (CAT) score measure: Change from baseline to 6 months in the CAT score measure: Treatment Satisfaction Questionnaire for Medication (TSQM) scores after 12 weeks and 6 months of treatment measure: Percent responders of the CAT [MID=2] after 12 weeks of treatment measure: Proportion of days covered (PDC) Time to discontinuation Reasons for treatment discontinuation measure: Drivers for initiation or switch to BGF MDI via physician questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06368414 id: KCMLWP-2021-04 briefTitle: A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia acronym: AsterA overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2028-08-31 date: 2028-08-31 date: 2024-04-16 date: 2024-04-16 name: Korean Society of Hematology class: NETWORK briefSummary: To evaluate the efficacy of asciminib adding on tyrosine-kinase inhibitors (TKI) to achieve treatment-free remission (TFR) in chronic myeloid leukemia (CML) patients in chronic phase who failed prior cessation study of TKI conditions: Chronic Myeloid Leukemia, Chronic Phase studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 69 type: ESTIMATED name: Asciminib measure: MR3.0 or less by 1 year sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-03-21 uploadDate: 2024-04-11T22:40 filename: Prot_000.pdf size: 903002 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-03-21 uploadDate: 2024-04-11T22:40 filename: Prot_001.pdf size: 903226 hasResults: False

 nctId: NCT06368401 id: TP_01428 briefTitle: A First in Human Study for the Versa Device for Tricuspid Regurgitation overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-31 date: 2025-12-31 date: 2024-04-16 date: 2024-04-16 name: Versa Vascular, Inc class: INDUSTRY briefSummary: This study is prospective, non-randomized, single-arm,first in human study to evaluate the safety and feasibility of the Versa Vascular System for intervention in adults with severe tricuspid regurgitation who are not surgical candidates. conditions: Tricuspid Regurgitation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 10 type: ESTIMATED name: Versa Implant measure: Acute Procedural Success measure: Incidence of major adverse events (MAE) measure: Tricuspid Regurgitation Severity Change sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Auckland City Hospital city: Auckland country: New Zealand name: Mark Webster, MD role: CONTACT lat: -36.84853 lon: 174.76349 hasResults: False

 nctId: NCT06368388 id: S64854 briefTitle: Bacteriophage Therapy for Difficult-to-treat Infections: the Implementation of a Multidisciplinary Phage Task Force acronym: PHAGEFORCE overallStatus: RECRUITING date: 2021-06-01 date: 2024-12-01 date: 2025-06-01 date: 2024-04-16 date: 2024-04-16 name: Universitaire Ziekenhuizen KU Leuven class: OTHER name: KU Leuven briefSummary: PHAGEFORCE is a prospective, observational registry study. The University Hospitals Leuven has approved the application of phage therapy as standard-of-care only in patients for whom no curative treatment alternatives (antibiotic and/or surgical) are available ('last-resort cases'). A multidisciplinary phage task force, referred to as the Coordination group for Bacteriophage therapy Leuven (CBL) was set up. The CBL screens patients with difficult-to-treat infections, evaluates who could benefit from phage therapy and sets up the treatment protocol. With this study, the CBL aims to gain insight in the safety and efficacy of phage therapy by integrating and optimizing phage therapy in five distinct medical disciplines (with distinct routes of administration), facilitating long-term follow-up of patients. Furthermore, this study will gain insight in the biodistribution and exact mechanisms of action of phage therapy and thus be able to provide standardized guidelines for each patient population and route of administration. conditions: Musculoskeletal Infection conditions: Chronic Rhinosinusitis (Diagnosis) conditions: Sepsis conditions: Pulmonary Infection conditions: Hidradenitis Suppurativa studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Prospective data collection name: Prospective data collection measure: Disease free period measure: Bacterial eradication measure: PROMIS global health (patient-reported outcome measurement information system) measure: PROMIS (patient-reported outcome measurement information system) physical function measure: PROMIS (patient-reported outcome measurement information system) pain interference measure: Sino-nasal outcome test (SNOT)-22 measure: Visual Analogue Scale (VAS) score measure: Cystic fibrosis questionnaire (CF-Q-R) measure: Dermatology Life Quality Index (DLQI) measure: Hidradenitis Suppurativa Quality of Life (HiSQoL) measure: Rate of exacerbations measure: Abscess and inflammatory nodule (AN) count with Hidradenitis suppurativa Clinical Response (HiSCR) measure: Lund-Mackay CT score measure: Lund Kennedy endoscopy score measure: Modified Davos score sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospitals Leuven status: RECRUITING city: Leuven zip: 3000 country: Belgium name: Jolien Onsea, PhD role: CONTACT phone: 003216342041 email: jolien.onsea@uzleuven.be name: Willem-Jan Metsemakers, MD, PhD role: CONTACT phone: 003216344277 email: willem-jan.metsemakers@uzleuven.be name: Willem-Jan Metsemakers, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 50.87959 lon: 4.70093 hasResults: False

 nctId: NCT06368375 id: PRPF31-3102022BO2 briefTitle: Clinical and Genetic Findings in Patients With PRPF31-associated Retinitis Pigmentosa overallStatus: COMPLETED date: 2023-01-01 date: 2023-06-30 date: 2023-06-30 date: 2024-04-16 date: 2024-04-16 name: University Hospital Tuebingen class: OTHER briefSummary: Retrospective chart review study to elucidate the genotype and phenotype of patients with PRPF31-associated retinitis pigmentosa and asymptomatic carriers of the respective variant(s) conditions: Retinitis Pigmentosa studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 87 type: ACTUAL measure: Best Corrected Visual Acuity (BCVA) measure: Visual Field (VF) measure: Fundus Photography (FP) measure: Optos measure: Autofluorescence (AF) measure: Optical Coherence Tomography (OCT) measure: Full-Field Electroretinogram (ff-ERG) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Tuebingen city: Tuebingen state: Baden-Wuerttemberg zip: 72076 country: Germany lat: 48.52266 lon: 9.05222 hasResults: False

 nctId: NCT06368362 id: CBM-I001 briefTitle: Cognitive Bias Modification for Interpretation Individuals With Chronic Musculoskeletal Pain overallStatus: COMPLETED date: 2020-11-17 date: 2021-05-01 date: 2021-05-01 date: 2024-04-16 date: 2024-04-16 name: University of Southampton class: OTHER name: Economic and Social Research Council, United Kingdom briefSummary: Cognitive Bias Modification for Interpretation (CBM-I) trains participants to interpret ambiguous information as neutral or benign, rather than interpret it as being related to pain. The goal of this randomised controlled trial was to explore the feasibility and potential clinical benefits of CBM-I in people with chronic pain and also healthy, pain-free individuals. conditions: Chronic Pain conditions: Musculoskeletal Pain Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups of participants (chronic musculoskeletal pain, healthy) were recruited, and within each group participants were randomised to one of two experimental conditions with a 1:1 allocation ratio with a parallel design. Participants with chronic musculoskeletal pain were randomised to benign CBM-I or no CBM-I, and healthy participants were randomised to benign CBM-I or pain-related CBM-I. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants are not informed of the conditioned they are randomised to in this psychological intervention. whoMasked: PARTICIPANT count: 84 type: ACTUAL name: Benign cognitive bias modification for interpretation name: Pain-related cognitive bias modification for interpretation measure: Emotional response to exercise induced pain measure: Emotional response to pain-related images measure: Fear of Pain measure: Anxiety measure: Depression measure: Emotional response to average clinical pain measure: Pain severity measure: Pain interference measure: Pain-related interpretation bias index sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Southampton city: Southampton state: Hampshire zip: SO17 1BJ country: United Kingdom lat: 50.90395 lon: -1.40428 hasResults: False

 nctId: NCT06368349 id: 202101771B0 briefTitle: Persistent Lymphopenia in Liver Transplantation and Its Molecular Insights for Hepatocellular Carcinoma overallStatus: COMPLETED date: 2022-03-01 date: 2023-06-21 date: 2023-06-30 date: 2024-04-16 date: 2024-04-18 name: Chang Gung Memorial Hospital class: OTHER briefSummary: A total of 145 Liver transplantation (LT) recipients with hepatocellular carcinoma (HCC) were retrospectively enrolled at Kaohsiung Chang Gung Memorial Hospital between 2006 and 2019. Clinical records from 7 days before LT (pre-LT) to 1 year after LT (post-LT) were analysed. In a prospective study from March 2022 to June 2023, 20 lymphopenia and 25 non-lymphopenia HCC recipients were enrolled, and a phenotypic analysis of peripheral blood lymphocytes was performed using multiparameter flow cytometry. conditions: Lymphopenia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 190 type: ACTUAL measure: Persistent lymphopenia predict poor overall survival measure: T cell and its subtype were mainly decrease in pre-LT lymphopenia population of HCC patient measure: Long-term peri-LT lymphopenia HCC recipients is associated with increased sirolimus use and decreased tacrolimus use sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Surgery city: Kaohsiung zip: 833 country: Taiwan lat: 22.61626 lon: 120.31333 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2021-10-20 uploadDate: 2024-04-11T03:02 filename: Prot_SAP_000.pdf size: 422513 hasResults: False

 nctId: NCT06368336 id: 994894 briefTitle: Health Related Quality of Life After Intensive Care for Sepsis, a National Cohort Study. overallStatus: COMPLETED date: 2008-01-01 date: 2022-04-01 date: 2022-12-31 date: 2024-04-16 date: 2024-04-17 name: Uppsala University Hospital class: OTHER name: Sepsisfonden briefSummary: The study aims to map the health-related quality of life (HRQoL) after intensive care for Sepsis with the hypothesis that it will be lower than that in the general population. The investigators also want to identify factors that are associated with low HRQoL, to see if those are available for interventions from the health care system and society to improve quality of life after treatment for sepsis in the intensive care unit (ICU). conditions: Sepsis conditions: Septic Shock conditions: Sepsis, Severe studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 210484 type: ACTUAL measure: Health-related Quality of Life after ICU (intensive care unit) treatment with/for sepsis measure: Ability to work before and after ICU (intensive care unit) treatment for Sepsis measure: The burden of disease at ICU (intensive care unit) admittance and after ICU treatment for Sepsis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06368323 id: H-01-24-9931 briefTitle: Effect of Community Choir Singing in People With Chronic Post-stroke Aphasia overallStatus: RECRUITING date: 2024-04-22 date: 2025-12-31 date: 2025-12-31 date: 2024-04-16 date: 2024-04-22 name: University of Ottawa class: OTHER name: Toronto Metropolitan University name: Université de Montréal name: Université du Québec à Trois-Rivières name: University of South Florida briefSummary: The goal of this randomized controled trial is to test the effects of assigning people with chronic post-stroke aphasia to 12 weekly choir sessions, compared to usual care.

The main question it aims to answer is:

Does the assignment to a choir singing program causes a beneficial effect on functional communication and language recovery as well as psychosocial outcomes compared to usual care in the rehabilitation of people with chronic post-stroke aphasia?

Participants will have:

12 in-person choir-singing sessions (1 session/week, 1,5 h/session, total 18h) conducted by a choir master, and home singing training (3 x 30-minutes-sessions/week, total 18h) conditions: Aphasia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A parallel group randomized trial design with a secondary crossover extension primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcomes will be measured by blinded assessors where possible, using blinded video or audio recordings. whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Choir singing name: Usual care measure: Communication Index measure: Level of confidence in communication measure: Aphasia severity index measure: Speech and language in functional communication measure: Apraxia of speech severity measure: Health related quality of life assessed by the the Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) measure: Emotional wellbeing measure: Social participation measure: Generic measure of health measure: Appetence to music measure: Singing voice abilities measure: Voice - Pitch measure: Voice - Maximum Phonation Time measure: Voice - Dynamic range measure: Mood measure: Biosocial indexes measure: Expectations on a 100-scale measure: Satisfaction on a 100-scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of South Florida status: NOT_YET_RECRUITING city: Tampa state: Florida zip: 33620 country: United States name: Jennifer Bugos, Ph.D. role: CONTACT email: bugosj@usf.edu lat: 27.94752 lon: -82.45843 facility: University of Ottawa status: RECRUITING city: Ottawa state: Ontario zip: K1N 6N5 country: Canada name: Anna Zumbansen, PhD role: CONTACT phone: 613-562-5800 phoneExt: 8393 email: azumbans@uottawa.ca name: Narges Bayat, Master role: CONTACT phone: 613-562-5800 phoneExt: 8393 email: nbaya063@uottawa.ca lat: 45.41117 lon: -75.69812 facility: Toronto Metropolitan University status: NOT_YET_RECRUITING city: Toronto state: Ontario zip: M5B 0C3 country: Canada name: Arla Good, Ph.D. role: CONTACT email: arla.good@torontomu.ca lat: 43.70011 lon: -79.4163 facility: Université de Montréal status: NOT_YET_RECRUITING city: Montréal state: Quebec zip: H3C 3J7 country: Canada name: Carole Anglade, Ph.D. role: CONTACT email: carole.anglade@umontreal.ca lat: 45.50884 lon: -73.58781 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-04-16 uploadDate: 2024-04-10T11:45 filename: ICF_000.pdf size: 129388 hasResults: False

 nctId: NCT06368310 id: R124807 id: 23/WM/0166 type: OTHER domain: NHS Research Ethics Committee Reference briefTitle: FIH Clinical Investigation of Graphene Electrodes for Brain Mapping overallStatus: NOT_YET_RECRUITING date: 2024-05-28 date: 2025-01-31 date: 2025-01-31 date: 2024-04-16 date: 2024-04-16 name: University of Manchester class: OTHER name: Northern Care Alliance NHS Foundation Trust name: European Commission name: Inbrain Neuroelectronics briefSummary: The goal of this clinical investigation of a medical device is to test the safety of graphene based electrodes when used during surgery for resection of brain tumors. The main questions that it aims to answer are:

* To understand the safety of these new electrodes when used during brain tumor surgery (primary objective);
* To assess the quality of the brain signals recorded with the new electrodes, their ability to stimulate the brain, how stable their function is over the duration of an operation, and their suitability for use in the operating theatre (secondary objectives).

Participants will undergo tumor surgery as usual with the study electrodes being tested alongside a standard monitoring system. If they are awake for part of their surgery they may be asked to complete specific tasks such as naming objects from a list modified for the study. They will be monitored subsequently for any complications including undergoing an additional MRI scan 6 weeks after their surgery. conditions: Brain Tumor conditions: Glioma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 8 type: ESTIMATED name: INBRAIN Graphene Cortical Interface measure: To evaluate the preliminary safety of the investigational device for its intended use measure: Assess the ability of the device to record signals from the brain measure: Evaluate the ability of the device to provide functional stimulation of the brain measure: Assess stability of sensing and stimulating electrodes measure: Evaluate device usability - an assessment by questionnaire of the operating surgeon's impression of the suitability of the device for sensing and stimulation during brain tumor surgery measure: Assess the quality of the recorded somatosensory evoked potentials (SEPs) - sensing part A (exploratory) measure: Assess the quality of the recorded baseline brain activity - sensing part B (exploratory) measure: Assess the ability of detecting brain evoked responses during stimulation of the brain (exploratory) measure: Evaluate decoding capability from data recorded during language task (exploratory) measure: Evaluate signal characteristics of tumour infiltrated brain regions (exploratory) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust city: Salford state: Greater Manchester zip: M6 8HD country: United Kingdom name: Hannah Howlett role: CONTACT email: RDResearch@nca.nhs.uk name: David J Coope, PhD FRCS role: PRINCIPAL_INVESTIGATOR lat: 53.48771 lon: -2.29042 hasResults: False

 nctId: NCT06368297 id: BSERE22-APP007-FED briefTitle: The Effect of Ketone Ester Supplementation and Ketogenic Diet on Brain Plasticity in Overweight/Obese Adults overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-08 date: 2024-08 date: 2024-04-16 date: 2024-04-16 name: University of Macau class: OTHER briefSummary: This project comprises an initial crossover placebo-controlled neurophysiological study to ascertain the effect of acute ketone ester ingestion on motor cortex plasticity, followed by a second 2-week intervention study aimed to compare the effect of a ketogenic diet versus ketone ester supplementation on motor cortex plasticity, resting brain function and structure, and metabolic and neuroendocrine responses. conditions: Overweight and Obesity conditions: Cognitive Change conditions: Psychophysiologic Reaction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Ketone Monoester Supplementation name: Ketogenic diet measure: Brain Plasticity measure: Grey Matter Volume measure: Cortical Thickness measure: Blood-Oxygen-Level-Dependent (BOLD) Signal Changes measure: Blood Glucose measure: Blood Beta-Hydroxybutyrate measure: Blood Insulin measure: Leptin measure: Ghrelin measure: Brain-Derived Neurotrophic Factor measure: Reaction Time of Attention Network Test measure: Accuracy of Attention Network Test measure: Reaction Time of Stroop Task measure: Accuracy of Stroop Task measure: Reaction Time of N-back Task measure: Accuracy of N-back Task measure: Cerebral Hemoglobin Concentration measure: Height in Kilograms measure: Weight in Meters measure: Body Fat Percentage measure: Fat Mass measure: Muscle Mass measure: Body Water measure: Body Mass Index measure: Skinfold Thickness measure: Maximal Oxygen Uptake sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT hasResults: False

 nctId: NCT06368284 id: IRB-MTP_2022_09_202201170 briefTitle: Perineal Trauma After Jet Ski Accidents and Long-term Functional Outcomes Results acronym: TP-JET overallStatus: RECRUITING date: 2023-01-01 date: 2024-04-01 date: 2024-12-31 date: 2024-04-16 date: 2024-04-16 name: University Hospital, Montpellier class: OTHER briefSummary: French multicentric retrospective cohort study including patients who underwent an ano-perineal trauma following a personal watercraft/jet-ski accident and that were treated in France from January 2017 to December 2023.

Aims of the study were to describe the initial management of the patients and to evaluate the digestive, urological and sexual functional outcomes as well as the quality of life, using validated questionnaires commonly employed in clinical practice. conditions: Perineum; Tear, Traumatic conditions: Anal Tear conditions: Anal Incontinence studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 20 type: ESTIMATED name: Patients who experienced an ano-perineal trauma following a PWC/Jet-Ski accident measure: Rate of fecal incontinence measure: Rate of permanent stoma measure: Rate of acontractile bladder measure: Rate of sexual dysfunction measure: Rate of impact on quality of life sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chu Montpellier status: RECRUITING city: Montpellier zip: 34295 country: France name: Thomas BARDOL, MD role: CONTACT phone: 04 67 33 90 69 email: t-bardol@chu-montpellier.fr lat: 43.61092 lon: 3.87723 hasResults: False

 nctId: NCT06368271 id: Lipidomix briefTitle: Acute Effects of Dietary Medium-chain Fatty Acids on Lipid Profile acronym: Lipidomix overallStatus: COMPLETED date: 2021-10-01 date: 2024-02-28 date: 2024-02-28 date: 2024-04-16 date: 2024-04-16 name: University of Copenhagen class: OTHER briefSummary: In the present study the plasma lipid profile was elucidated in healthy, lean males by the use of lipidomic analysis in the hours after an acute intake of medium-chain fatty acids (MCT) and long chain fatty acids (LCT),, respectively. In addition oxygen uptake was measured to study energy turnover. conditions: Healthy Nutrition conditions: Diet, Healthy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study is a randomized, double-blinded crossover design. Participants ingest Medium-chain-fatty acids (MCT) or Long-chain fatty acids (LCT) oil on two test days with one-week period between the experimental days. The day prior to the experimental days, the participants consume a eucaloric control diet, and abstain from alcohol and vigorous physical activity to ensure similar conditions on experimental days. primaryPurpose: BASIC_SCIENCE masking: NONE count: 4 type: ACTUAL name: Lipidomics measure: Meal test including medium-chain fatty acids measure: Resting metabolic rate sex: MALE minimumAge: 20 Years maximumAge: 30 Years stdAges: ADULT facility: University of Copenhagen city: Copenhagen zip: 2100 country: Denmark lat: 55.67594 lon: 12.56553 facility: Department of Nutrition, Exercise and Sports city: Copenhagen country: Denmark lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06368258 id: Curr-RYR2023 briefTitle: Middle Term Effect of Red Yeast Rice on Plasma Lipids and Proteoma in Individuals With Suboptimal Cholesterolemia overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2024-12-01 date: 2025-05-02 date: 2024-04-16 date: 2024-04-16 name: University of Bologna class: OTHER briefSummary: The primary purpose of our research will be to evaluate if, in healthy subjects with a low- moderate cardiovascular risk (CV risk\>1% but \< 5%) evidenced by sub-optimal cholesterol levels as per ESC/EAS guidelines (LDL cholesterol \>115 mg/dL, \< 190 mg/dL) supplementation with a red yeast rice food supplement containing less than 3 mg total monacolins per daily dose is able to significantly influence plasma lipid levels. Furthermore, liver and muscle proteomic pattern and vascular response to dietary supplementation will be investigated. conditions: Hypercholesterolemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Red yeast rice name: Placebo measure: Treatment-dependent change in LDL-C measure: Treatment-dependent change in Total Cholesterol measure: Treatment-dependent change in Non-HDL-C measure: Treatment-dependent change in liver parameters measure: Treatment-dependent change in CPK plasma levels measure: Treatment-dependent change in plasma proteomic pattern sex: ALL minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AOU Policlinico S.Orsola-Malpighi city: Bologna country: Italy lat: 44.49381 lon: 11.33875 hasResults: False

 nctId: NCT06368245 id: SMART briefTitle: Durability of Suppl. Rod Constructs-SuppleMentAry Rod Technique for Long-segment Posterior Instrumented Spinal Fusions overallStatus: NOT_YET_RECRUITING date: 2024-10-15 date: 2027-12-15 date: 2029-07-31 date: 2024-04-16 date: 2024-04-16 name: AO Foundation, AO Spine class: OTHER briefSummary: This is a multicenter retrospective comparative cohort study. The index surgery for this study is primary or revision long-segment posterior thoracolumbar (TL) instrumented fusion using either a supplementary rod construct or a dual-rod construct. Eligible patients who already had index surgery, will be identified for enrollment through a review of medical records of the participating surgeons at the study sites. conditions: Spinal Fusion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1244 type: ESTIMATED name: long-segment posterior TL instrumented fusion measure: Rod fracture (RF) measure: Time to rod fracture measure: Time to rod fracture measure: Configurations of supplementary rod constructs measure: Treatment for rod fracture measure: Recurrent RFs measure: Other mechanical failures measure: Surgical complications sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Minnesota Medical Center city: Minneapolis state: Minnesota zip: 55454 country: United States name: David Polly, MD role: CONTACT email: pollydw@umn.edu lat: 44.97997 lon: -93.26384 facility: University of Virginia city: Charlottesville state: Virginia zip: 22908 country: United States name: Justin S Smith, MD, PhD role: CONTACT phone: 434-243-6339 email: jss7f@virginia.edu name: Judith G Beenhakker role: CONTACT email: JGB3P@uvahealth.org lat: 38.02931 lon: -78.47668 hasResults: False

 nctId: NCT06368232 id: 19.036.123.125 briefTitle: Nutritional Status After Sleeve Gastrectomy in Morbid Obesity: 6-Month Study overallStatus: COMPLETED date: 2022-02-15 date: 2023-04-15 date: 2023-04-15 date: 2024-04-16 date: 2024-04-16 name: Ankara Yildirim Beyazıt University class: OTHER briefSummary: This study aims to evaluate the nutritional status of morbidly obese patients following gastric bypass surgery. Data from 76 patients aged 19-64, who will be monitored by a dietitian for at least six months, will be analyzed. Preoperative and postoperative biochemical parameters along with anthropometric measurements will assess. conditions: Bariatric Surgery Candidate conditions: Gastrostomy conditions: Obesity studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 76 type: ACTUAL name: püPatients undergoing bariatric surgery measure: Body Weight measure: BMI (Body Mass Index) measure: Lean Mass measure: Fat Mass measure: Fasting Blood Glucose measure: HbA1c measure: Iron levels measure: Vitamin D level measure: Lipid Profile (Triglycerides, LDL, HDL) sex: ALL minimumAge: 19 Years maximumAge: 64 Years stdAges: ADULT facility: Ankara Yıldırım Beyazıt University city: Ankara zip: 06760 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06368219 id: 0108161 briefTitle: Propofol or Benzodiazepine Combined With Ketamine for Procedural Sedation in Emergency Setting overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2024-10 date: 2024-04-16 date: 2024-04-16 name: Alexandria University class: OTHER briefSummary: This single blinded parallel randomized clinical trial will be conducted on 50 patients presented to Emergency Department of Alexandria Main University Hospital who are indicated for procedural sedation. All patients included in the study will be allocated randomly using computer software with concealment of randomization in to two groups:

* Group A: 25 patients will receive ketamine (0.5 mg/kg) plus midazolam (0.05 mg/kg)
* Group B: 25 patients will receive ketamine (0.5 mg/kg) plus propofol (0.5 mg/kg) Additional ketamine (0.25 mg/kg) will be administered in case of inadequate sedation in both groups.

the two groups will be compared as regard incidence of complications World Society of Intravenous Anesthesia (SIVA) international sedation task force to standardize reporting adverse events conditions: Procedural Sedation studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: ketamine- midazolam versus ketamine- propofol measure: Induction and recovery time for both combinations measure: incidence and severity of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06368206 id: OBPM_Calfree2024 briefTitle: Evaluation of the Performance and Safety of the Aktiia Spot-check Optical Blood Pressure Monitoring (OBPM) Device at Fingertip (Aktiia G2C) Against Double Auscultation, and Comparison With Oscillometry and Aktiia Bracelet G2 overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-12-31 date: 2024-12-31 date: 2024-04-16 date: 2024-04-23 name: Aktiia SA class: INDUSTRY briefSummary: The present study, OBPM_Calfree2024, with N = 85 participants minimum over 1 visit (lasting around 1h), has been designed to evaluate the performances and safety of the Aktiia.product-G2C that doesn't require any calibrations, as compared against double auscultation for BP reference measurements, and finger pulse oximeter for pulse rate reference measurements, for a cohort of subjects characterized by a wide variety of phenotypes. conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 1 study cohort that will test investigational device (Aktiia G2C) and Blood Pressure and Pulse Rate references. primaryPurpose: OTHER masking: NONE count: 85 type: ESTIMATED name: Investigational device Aktiia G2C name: Marketed device used as reference for blood pressure monitoring: double auscultation cuff name: Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2 name: Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff name: Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuff name: Marketed device used as reference for pulse rate monitoring: pulse finger oximeter measure: Blood pressure mean value of differences measure: Blood pressure standard deviation of differences measure: Pulse rate root-mean-square error sex: ALL minimumAge: 21 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHUV city: Lausanne zip: 1011 country: Switzerland lat: 46.516 lon: 6.63282 hasResults: False

 nctId: NCT06368193 id: Neuralert 001 briefTitle: The Neuralert Stroke Monitor Pilot Trial overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2027-05-01 date: 2024-04-16 date: 2024-04-16 name: Neuralert Technologies LLC class: INDUSTRY briefSummary: This trial aims to demonstrate that the Neuralert Monitoring System will detect strokes before they would be identified by current standard of care. Each patient will be monitored for up to five days, depending on device connectivity or battery duration. Each monitoring session will consist of wearing a Neuralert device on each arm. For this pilot trial, we are interested in learning about Wi-Fi connectivity, successful data transmission, clinical usability, and tolerability. conditions: Stroke conditions: Surgery studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: Neuralert Monitor measure: Data Aggregation measure: Time to alarm reception measure: Time to alarm reponse measure: Stroke detection sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital of the University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Stephanie Cummings role: CONTACT phone: 215-662-3363 email: stephanie.cummings@pennmedicine.upenn.edu name: Scott Kasner, MD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06368180 id: 439106274 briefTitle: The Efficacy of a RAGT & BWSTT on Children With CP overallStatus: COMPLETED date: 2020-08-30 date: 2021-02-21 date: 2021-03-08 date: 2024-04-16 date: 2024-04-16 name: King Saud University class: OTHER briefSummary: This study compared the effects of RAGT and body weight support treadmill training (BWSTT) on spatio-temporal gait parameters and walking capacity among ambulatory children with bilateral CP conditions: Cerebral Palsy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Robotic-assisted gait training Body weight-supported treadmill training primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Robotic assisted gait training measure: Gait spatio-temporal parameters measure: Six-minute walk test (6MWT) sex: ALL minimumAge: 5 Years maximumAge: 14 Years stdAges: CHILD facility: King Abdu Aziz Medical City city: Riyadh country: Saudi Arabia lat: 24.68773 lon: 46.72185 hasResults: False

 nctId: NCT06368167 id: SHR2554-202 briefTitle: A Phase II Study of SHR2554 in Patients With Relapsed or Refractory Follicular Lymphoma overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-04 date: 2024-04-16 date: 2024-04-16 name: Jiangsu HengRui Medicine Co., Ltd. class: INDUSTRY briefSummary: The study is being conducted to evaluate the efficacy and safety of SHR2554 in Patients with Relapsed or Refractory Follicular Lymphoma conditions: Follicular Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 105 type: ESTIMATED name: SHR2554 measure: Objective response rate (ORR) assessed by independent review committee (IRC) measure: ORR assessed by investigator measure: Progression free survival measure: Time to Response measure: Duration of response measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Cancer Hospital city: Beijing state: Beijing zip: 100142 country: China name: Yuqin Song role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06368154 id: HCHLL-2019-08 briefTitle: Exosome microRNAs as Potential Biomarkers of Metabolic Bone Disease of Prematurity overallStatus: RECRUITING date: 2024-01-01 date: 2026-12-31 date: 2026-12-31 date: 2024-04-16 date: 2024-04-16 name: Hunan Children's Hospital class: OTHER_GOV briefSummary: Metabolic bone disease of prematurity (MBDP) is caused by insufficient content of calcium, phosphorus, and organic protein matrix in preterm infants or bone metabolism disorder, which is one of the complications affecting the quality of life of preterm infants. The early symptoms of MBDP are insidious, and there is no unified and clear diagnostic method. The diagnosis is mostly based on typical clinical manifestations and X-ray findings, but at this time, bone mineral density has decreased significantly, so early detection and diagnosis are difficult. Studies have shown that exosomal micrornas have biological characteristics and targeting specificity, and can be used as new molecular diagnostic markers for diseases. Several studies have reported the use of plasma or serum microRNAs as molecular markers for early prediction of bone diseases. In our previous study, we extracted plasma exosomes from preterm infants for high-throughput sequencing of microRNAs, and identified differentially expressed micrornas related to bone metabolism. In this study, exosomes were used as carriers, and digital PCR was used to verify the specificity and sensitivity of plasma exosomal microRNA as biomarkers of MBDP in a large sample size. The above biomarkers were compared and verified before and after treatment in children with MBDP. Further revealing plasma exosomal microRNA as a biological indicator for evaluating the efficacy of MBDP may improve the diagnostic level of MBDP, improve the outcome and prognosis of very low birth weight preterm infants, thereby improving global health and reducing socioeconomic costs. conditions: Exosomes conditions: Newborn conditions: Bone Diseases, Metabolic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: exosomes sex: ALL minimumAge: 0 Hours maximumAge: 72 Hours stdAges: CHILD facility: Hunan Children's Hospital status: RECRUITING city: Changsha state: Hunan zip: 410007 country: China name: yinzhi y liu, master role: CONTACT phone: 13467532228 email: liuyinzhi0837@163.com lat: 28.19874 lon: 112.97087 hasResults: False

 nctId: NCT06368141 id: 2023294 briefTitle: Neoadjuvant Chemotherapy Plus Sequential Immune Checkpoint Inhibitor (ICI) Therapy in Locally Advanced Colon Cancer acronym: NeoCHIC overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-02-28 date: 2026-04-30 date: 2024-04-16 date: 2024-04-16 name: Ruijin Hospital class: OTHER briefSummary: The goal of this clinical trial is to learn the effect of neoadjuvant chemotherapy plus sequential immune checkpoint inhibitor (ICI) therapy in locally advanced colon cancer. The main questions it aims to answer are:

* Does this neoadjuvant chemotherapy increase the pathologic complete response (pCR) of locally advanced colon cancer?
* Does this neoadjuvant chemotherapy improve the long-term survival of locally advanced colon cancer?

Participants will receive:

* a pre-operative CAPEOX (capecitabine oral + oxaliplatin i.v.)regimen.
* a sequential CAPEOX plus Serplulimab regimen.
* a standard complete mesocolic excision (CME) operation. conditions: Colon Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: Serplulimab name: Capecitabine name: Oxaliplatin measure: pathologic complete response sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ruijin Hospital city: Shanghai state: Shanghai zip: 200025 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06368128 id: HS-24_51 briefTitle: Climbing Lifestyle Intervention for Modifying Physical Activity Behaviors: Pilot Study acronym: CLIMB overallStatus: RECRUITING date: 2024-04-10 date: 2024-12-31 date: 2024-12-31 date: 2024-04-16 date: 2024-04-16 name: Northern Michigan University class: OTHER briefSummary: The aim of this pilot study is to determine the effects of a 12-week indoor rock climbing training program on heart health, mental health, and behavioral health in generally healthy adults aged 18-35 years old who do not exercise. Participants will learn to rock climb using ropes on an indoor rock climbing wall and participate in the training program 2-3 days per week for 60 minutes each session over 12 weeks. Health outcomes will be measured at 4 time points over the course of the study (pre-intervention, 6-weeks/mid-intervention, 12-weeks/post-intervention, and 24-weeks post-intervention). conditions: Lifestyle Factors conditions: Physical Inactivity conditions: Quality of Life studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial with participants allocated to either a control or intervention group; comparison between groups and within groups primaryPurpose: PREVENTION masking: NONE count: 12 type: ESTIMATED name: Indoor Rock Climbing Exercise Training Program measure: Fasting lipids measure: Fasting glucose measure: Hemoglobin a1c measure: Physical activity and sedentary behavior measure: Sedentary behavior bouts (30 min, 60 min, >60 min) measure: Cardiorespiratory fitness measure: Muscular fitness measure: Handgrip strength asymmetry measure: Lower-body dynamic balance measure: Health-related quality of life using CDC Health-Related Quality of Life Scale measure: Exercise self-efficacy measured via Self-efficacy for exercise scale measure: Perceptions of exercise measured via Views and Attitudes Toward Exercise Scale measure: Perceived stress measure: Blood pressure measure: Body composition measure: Bone density sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Northern Michigan University status: RECRUITING city: Marquette state: Michigan zip: 49855 country: United States name: Lisa Eckert, PhD role: CONTACT phone: 906-227-1291 email: leckert@nmu.edu name: Megan C Nelson, PhD role: PRINCIPAL_INVESTIGATOR lat: 46.54354 lon: -87.39542 hasResults: False

 nctId: NCT06368115 id: 00023453 id: 4R33AG069794 type: NIH link: https://reporter.nih.gov/quickSearch/4R33AG069794 briefTitle: A Program to Reduce Inappropriate Medications Among Older Adults With Alzheimer's Disease: Implementation Phase 2 acronym: DPRESCRIBE-AD2 overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2025-06 date: 2024-04-16 date: 2024-04-16 name: University of Massachusetts, Worcester class: OTHER name: National Institute on Aging (NIA) name: Harvard Pilgrim Health Care name: Humana Healthcare Research, Inc. name: Carelon Research briefSummary: Potentially inappropriate prescribing includes the use of medications that may no longer be necessary or that may increase the risk of harm. Inappropriate prescribing can increase the overall symptom burden, and negatively affect health-related quality of life and function. The inappropriate prescription of certain drug categories such as sedative/hypnotics, antipsychotics, and strong anticholinergic agents poses particular risks for older adults, and may be more common among those with Alzheimer's disease and Alzheimer's disease- related dementias (AD/ADRD) due to a higher prevalence of multimorbidity and more frequent prescription of five or more medications. The D-PRESCRIBE-AD (Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly with Alzheimer's Disease) study will test a health plan-based intervention using the NIH Collaboratory's Distributed Research Network, which employs the Food and Drug Administration (FDA) Sentinel System infrastructure. The overarching goal of this randomized controlled trial is to assess the effect of a patient/caregiver- centered, multifaceted educational intervention on potentially inappropriate prescribing in patients with AD/ADRD. The research hypothesis is that education on inappropriate prescribing among patients/caregivers and their providers can reduce medication-related morbidity in patients with AD/ADRD and improve medication safety for this vulnerable population. The study population will include community-dwelling patients with AD/ADRD, identified based on diagnoses codes of AD/ADRD or use of a medication for Alzheimer's Disease, who have evidence of potentially inappropriate prescribing the three drug classes above. The trial will evaluate the effect of mailed educational interventions, including the effect of a second reminder mailing, designed to spur patient/caregiver-provider communication about medication safety (versus usual care) on the proportion of patients with inappropriate prescribing, the primary outcome of this study. The trial will be conducted in two large, national health plans. conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study design will be a prospective, randomized, "open-label" educational intervention trial with three arms: (1) a combined patient/caregiver and provider educational intervention mailed one time; (2) a combined patient/caregiver and provider educational intervention mailed two times; and (3) usual care. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 10000 type: ESTIMATED name: Educational Materials measure: Absence of Inappropriate Medication Prescription Dispensing measure: Dose Change measure: Polypharmacy measure: Rates of Health Care and Emergency Care Utilization measure: Mortality measure: Switching within Classes sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UMass Chan Medical School city: Worcester state: Massachusetts zip: 01605 country: United States name: Cassie L Saphirak role: CONTACT phone: 508-856-3493 email: cassandra.saphirak@umassmed.edu lat: 42.26259 lon: -71.80229 hasResults: False

 nctId: NCT06368102 id: R6-03 briefTitle: Prophylactic Effects for Preventing Surgical Site Infection in Third Molar Surgery overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04 date: 2025-08 date: 2024-04-16 date: 2024-04-16 name: Uji Takeda Hospital class: OTHER briefSummary: The purpose of this study is to determine the incidence of surgical site infection (SSIs) after third molar surgery for different duration of intravenous ampicillin administration. conditions: Surgical Site Infection studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 70 type: ESTIMATED name: Ampicillin measure: Occurrence of surgical site infection measure: Occurrence of alveolar osteitis sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06368089 id: REC.66-474-30-2 id: MR-PSU:66-30-21-406 type: OTHER_GRANT domain: Faculty of Medicine, Prince of Songkla University briefTitle: Short Effects of SIMT and EM in Prolonged Mechanically Ventilated Patients overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-02 date: 2026-03 date: 2024-04-16 date: 2024-04-16 name: Prince of Songkla University class: OTHER briefSummary: Using mechanical ventilation for more than 18 hours can affect respiratory muscle and postural muscle control, making it difficult to wean off the ventilator and reducing mobility. The aim of this study is to:

1. Compare the effects of respiratory muscle strength training and early mobilization on dynamic lung compliance and maximum inspiratory pressure before and after a 7-day training period.
2. Compare the success rate of weaning and the duration of weaning between the respiratory muscle strength training and the early mobilization program. conditions: Ventilator Dependent studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomization primaryPurpose: TREATMENT masking: NONE count: 46 type: ESTIMATED name: Inspiratory muscle training (IMT) group name: Early mobilization (EM) group measure: Maximum inspiratory pressure (MIP) measure: Dynamic lung compliance (Cdyn) measure: Weaning time measure: Weaning outcome measure: Grip strength measure: chest wall expansion sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical Respiratory Care Unit (MRCU), Prince of Songklanakarind Hospital city: Songkhla zip: 90110 country: Thailand lat: 7.19882 lon: 100.5951 hasResults: False

 nctId: NCT06368076 id: H-23065096 briefTitle: High-intensity Interval Training in Patients With Spinal Muscular Atrophy overallStatus: RECRUITING date: 2024-01-09 date: 2024-08 date: 2025-01 date: 2024-04-16 date: 2024-04-16 name: Rigshospitalet, Denmark class: OTHER briefSummary: Patients with spinal muscular atrophy who are wheelchair users often experience lower back - and gluteal pain, reduced sleep quality, constipation and reduced quality of life - symptoms that regular exercise could potentially alleviate. However, only very little research has been done on exercise for patients who are wheelchair users. The aim of this study is to explore the impact of cycle exercise on patients with spinal muscular atrophy. conditions: Spinal Muscular Atrophy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Exercise measure: Questionnaire on fatigue measure: Questionnaire on pain. measure: Questionnaire on constipation measure: Questionnaire on quality of life measure: Questionnaire on sleep quality measure: Blood sample measure: Blood sample measure: Blood sample measure: Blood sample measure: Blood sample measure: Blood sample measure: Blood sample measure: Blood sample measure: Blood sample measure: Blood sample measure: MRI scan liver size measure: MR-elastography measure: MRI scan liver steatosis measure: Ultrasound scan measure: MRI scan measure: MRI scan measure: Exercise test measure: Motorscore sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Rigshospitalet status: RECRUITING city: Copenhagen zip: 2100 country: Denmark name: Sophia Frølich, stud.med role: CONTACT phone: + 45 3545 3561 email: sophia.vera.froelich.01@regionh.dk name: Noémie Receveur, stud.med role: CONTACT phone: +4535453561 email: noemie.anne-marie.receveur.03@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06368063 id: HE-202301 briefTitle: The Study of Huaier Granule in Postoperative Adjuvant Therapy of Resectable Pancreatic Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-03 date: 2028-03 date: 2024-04-16 date: 2024-04-25 name: Health Science Center of Xi'an Jiaotong University class: OTHER name: LinkDoc Technology (Beijing) Co. Ltd. name: Huazhong University of Science and Technology briefSummary: The study is a multicenter, prospective clinical study aimed at evaluating the efficacy and safety of Huaier Granule in postoperative adjuvant treatment of resectable pancreatic cancer conditions: Pancreatic Cancer Resectable studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 642 type: ESTIMATED name: Huaier granule name: chemotherapy drugs measure: Disease-free survival measure: Overall survival measure: Progression-free survival measure: The incidence and severity of adverse events (AE) and severe adverse events (SAE) measure: The incidence and severity of ADR, severe adverse reactions (SADR), suspicious and unexpected severe adverse reactions (SUSAR) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06368050 id: IRB00067187.2 briefTitle: Implementation of an Evidence-Based Intervention to Improve Head Impact Safety in Youth Football overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2024-11 date: 2024-11 date: 2024-04-16 date: 2024-04-16 name: Wake Forest University Health Sciences class: OTHER name: Childress Institute briefSummary: The objective of this study is to evaluate the feasibility of implementing an evidence-based intervention program, COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) on a larger scale. Coaches of 12U (12 years old and under), and 13U (13 years old and under) teams within six youth football organizations will pilot test the intervention. Aim 1 will conduct focus groups with coaches, parents, and organizational leaders to assess organizational needs, capacity, and readiness to adopt the intervention program. Aim 2 will evaluate the effectiveness of the intervention program at reducing HIE and injuries and evaluate implementation success. Aim 2 results (intervention outcomes) are reported herein. conditions: Head Injury conditions: Sport Injury studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ESTIMATED name: practice structure intervention measure: Number of practice head impacts measure: Number of practice head acceleration events measure: Practice head impact rate measure: Practice head acceleration even rate measure: Median linear acceleration measure: Median rotational acceleration measure: Median rotational velocity measure: 95th percentile linear acceleration measure: 95th percentile rotational acceleration measure: 95th percentile rotational velocity measure: Feasibility of Intervention Measure (FIM) Values measure: Acceptability of Intervention Measure (AIM) Values measure: Number of practices the intervention was implemented as prescribed measure: Average minutes per practice of live time sex: ALL minimumAge: 11 Years maximumAge: 14 Years stdAges: CHILD facility: Wake Forest University Health Sciences city: Winston-Salem state: North Carolina zip: 27157 country: United States name: Jill Urban, PhD, MPH role: CONTACT phone: 336-716-0947 email: jurban@wakehealth.edu name: Konstantia Strates role: CONTACT phone: 336-713-1263 email: kcstrate@wakehealth.edu name: Jill Urban, PhD, MPH role: PRINCIPAL_INVESTIGATOR lat: 36.09986 lon: -80.24422 hasResults: False

 nctId: NCT06368037 id: DragonFire-02 briefTitle: Feasibility Study of the DragonFire for Hypertrophic Obstructive Cardiomyopathy overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-06 date: 2026-06 date: 2024-04-16 date: 2024-04-16 name: Hangzhou Valgen Medtech Co., Ltd class: INDUSTRY briefSummary: This study is a prospective, single-center, single-group design exploratory clinical research. No control group is set, and only subjects meeting the indications of the study device are treated. After patients sign informed consent, they are screened, and those meeting the inclusion criteria are enrolled. The treatment involves using myocardial radiofrequency ablation system and catheter-based myocardial radiofrequency ablation needle and its guidance system for treating obstructive hypertrophic cardiomyopathy. All subjects are followed up before discharge, and at 30 days, 3 months, 6 months, and 12 months postoperatively. conditions: Obstructive Hypertrophic Cardiomyopathy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: DragonFire Transcatheter Myocardial Radiofrequency Ablation System measure: The rate of freedom from major adverse events at 30 days postoperatively measure: The success rate of treatment at 6 months postoperatively sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northern Theater Command General Hospital of the Chinese People's Liberation Army city: Shenyang country: China lat: 41.79222 lon: 123.43278 hasResults: False

 nctId: NCT06368024 id: CL-12-600 briefTitle: Establishment of Delphi-MD Safety Performance and Reliability overallStatus: COMPLETED date: 2023-11-28 date: 2023-11-28 date: 2023-11-28 date: 2024-04-16 date: 2024-04-26 name: QuantalX Neuroscience class: INDUSTRY briefSummary: A retrospective analysis of collected datasets. In this study we aim to establish Delphi-MD's safety and performance reliability for assessment and monitoring of Transcranial Magnetic Stimulation (TMS) Evoked Potentials (TEPs) as neurophysiological measurements. conditions: Neurologic Disorder conditions: Healthy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 263 type: ACTUAL name: This is a retrospective analysis study of data collected with a diagnostic medical device measure: Cortical Excitability measure: Specific Peak Amplitudes measure: GMFP sex: ALL minimumAge: 50 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: QuantalX Neuroscience Ltd. city: Kfar Saba state: Center zip: 4453001 country: Israel lat: 32.175 lon: 34.90694 hasResults: False

 nctId: NCT06368011 id: MustafaKU-CINCINOGLU-001 briefTitle: The Impact of Acceptance and Commitment Therapy on Stigmatization overallStatus: ENROLLING_BY_INVITATION date: 2023-04-15 date: 2023-07-31 date: 2024-06-30 date: 2024-04-16 date: 2024-04-16 name: Mustafa Kemal University class: OTHER briefSummary: The goal of study is to determine the effect of acceptance and commitment therapy-based psychoeducation on the level of stigmatization applied to relatives of schizophrenia patients.

Type of study: This study was planned as a pretest-posttest quasi-experimental design with an observation and control group.

Participants: The population of the study consisted of the relatives of schizophrenia patients who were registered and actively attending the Community Mental Health Center in a state hospital in Ankara.

Intervention: Before the psychoeducation process started, personal information form and scales were applied to the relatives of the patients in the experimental and control groups. An ACT-based psychoeducation program consisting of 8 sessions was applied to the experimental group. each session lasted approximately 90 minutes. The control group did not receive any intervention. After the psychoeducation, the scales were reapplied to the experimental and control groups. In addition, the experimental group was asked to fill out the psychoeducation evaluation form. The scales were reapplied to the experimental group after the 1-month follow-up study and evaluated. conditions: Stigmatization studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: acceptance and commitment therapy measure: Stigma Scale for Relatives of Patients with Schizophrenia measure: Stigma Scale for Relatives of Patients with Schizophrenia measure: Stigma Scale for Relatives of Patients with Schizophrenia measure: Stigmatization Scale measure: Stigmatization Scale measure: Stigmatization Scale sex: ALL minimumAge: 18 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Hatay Mustafa Kemal Üniversitesi city: Hatay country: Turkey lat: 38.40227 lon: 27.10486 hasResults: False

 nctId: NCT06367998 id: PC24MISV0017 briefTitle: The Effect of Pregabalin on Shoulder Pain of Patients With Central Sensitization Who Undergo Arthroscopic Rotator Cuff Repair overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2026-05-01 date: 2024-04-16 date: 2024-04-16 name: The Catholic University of Korea class: OTHER name: Viatris Korea briefSummary: This study aims to investigate the effects of Pregabalin intake on shoulder pain management in patients with central sensitization undergoing arthroscopic rotator cuff repair. Although Pregabalin is known to be effective in controlling pain after shoulder arthroscopy, research on its efficacy in pain management for patients with central sensitization is scarce. Utilizing a list that identifies central sensitization, this study will explore whether Pregabalin can reduce postoperative pain in these patients and potentially improve joint mobility, emotional, and physical functioning. A prospective randomized study is planned, with inclusion criteria set for patients aged between 19 and 70 who have undergone arthroscopic rotator cuff repair.

The study will compare clinical outcomes up to one year postoperatively between two groups of 38 patients each. The case group will receive standard postoperative medications (NSAIDs) plus Pregabalin oral intake from the day before surgery to six weeks postoperatively, while the control group will receive only the standard postoperative medications without Pregabalin. conditions: Rotator Cuff Tears conditions: Central Sensitisation conditions: Neuropathic Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 76 type: ESTIMATED name: Pregabalin measure: VAS pain score measure: Constant shoulder score measure: American shouler and elbow surgeons (ASES) score sex: ALL minimumAge: 20 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06367985 id: 03/24/DD-BVMD briefTitle: CAPA-IVM Culture With Low Oxygen Tension overallStatus: NOT_YET_RECRUITING date: 2024-05-03 date: 2024-06-01 date: 2025-06-01 date: 2024-04-16 date: 2024-04-29 name: Mỹ Đức Hospital class: OTHER name: Vrije Universiteit Brussel briefSummary: Capacitation in-vitro maturation (CAPA-IVM) has recently been advanced in culturing oocytes from the germinal vesicle (GV) stage following mild or no controlled ovarian stimulation. Recent research suggested that O2 concentration may significantly regulate oocyte maturation and early embryo development through hypoxia-inducible factor (HIF). Nonetheless, it has been challenging to create the environmental culture conditions for addressing the optimal number of oocytes and the highest possibility of embryo development since consensus on the oxygen (O2) concentration index in the IVM culture environment has not been reached. Based on the outcomes of atmospheric O2 concentration (20%) and low O2 concentration (5%) during CAPA-IVM culture in mice, it has been hypothesized that a 5% O2 was the optimal culture condition for the pre-IVM step. A 20% O2 was more suitable for the IVM culture step. Therefore, this study is designed to enhance the CAPA-IVM culture system, improving treatment efficiency and providing various benefits for patients undergoing assisted reproductive technology. conditions: In Vitro Fertilization studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Sibling oocytes primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Air Oxygen Concentration CAPA-IVM culture name: Low Oxygen Concentration CAPA-IVM culture measure: Maturation rate measure: Total number of oocytes retrieval measure: Number of patients with no oocyte retrieved measure: Number of MII oocytes measure: Number of GV oocytes measure: Number of patients with no matured oocyte measure: Number of 2PN oocytes measure: Fertilization rate measure: Abnormal fertilization rate measure: Number of patients with no day-3 embryo measure: Number of day-3 embryos measure: Number of good quality Day-3 embryos measure: Number of frozen day-3 embryos measure: Number of blastocyst (day 5 or day 6 embryo) measure: Number of patients with no blastocyst measure: Number of good quality blastocysts measure: Number of frozen blastocysts measure: Number of embryos transferred measure: Quality of embryos transferred (Grade 1, Grade 2, Grade 3) measure: Positive pregnancy test rate measure: Implantation rate measure: Clinical pregnancy rate measure: Ectopic pregnancy rate measure: Ongoing pregnancy rate measure: Miscarriage <12 weeks rate (Early miscarriage) measure: Miscarriage <22 weeks rate (late miscarriage) measure: Live birth rate measure: Multiple pregnancy rate measure: Multiple delivery rate measure: Mode of delivery measure: Gestational age at birth measure: Birth weight measure: Very low birth weight rate measure: Low birth weight rate measure: High birth weight rate measure: Very high birth weight rate measure: Small for gestational age rate measure: Large for gestational age rate measure: Hypertension in pregnancy rate measure: Gestational diabetes mellitus rate measure: Still birth rate measure: Premature birth rate measure: Antepartum haemorrhage rate measure: Major congenital abnormalities rate measure: Neonatal mortality rate measure: NICU admission rate measure: Reason for NICU admission sex: FEMALE minimumAge: 18 Years maximumAge: 42 Years stdAges: ADULT facility: My Duc Hospital city: Ho Chi Minh City country: Vietnam name: Tuong M Ho, MSc, MD role: CONTACT phone: +84 90 3633377 email: tuongho.ivfmd@gmail.com lat: 10.82302 lon: 106.62965 hasResults: False

 nctId: NCT06367972 id: 2024-0070 id: NCI-2024-03278 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: A Randomized Phase II Basket Trial EXTENDing Efficacy of Systemic Therapy With Local Consolidative Therapy for OligoProgressive Metastatic Disease (EXTEND-OP) overallStatus: NOT_YET_RECRUITING date: 2024-10-31 date: 2028-10-10 date: 2030-10-10 date: 2024-04-16 date: 2024-04-16 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To find out if local consolidation therapy (such as radiation therapy with or without other local therapies such as surgery, ablation \[the removal or destruction of a body part or tissue or its function\], or embolization \[a procedure that uses particles, such as tiny gelatin sponges or beads, to block a blood vessel\]) to all progressive sites of disease can help to control the disease compared with next-line systemic therapy. conditions: OligoProgressive Metastatic Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Local Consolidation Therapy name: Next-line Systemic Therapy 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: Ethan Ludmir, MD role: CONTACT phone: 832-729-0998 email: ebludmir@mdanderson.org name: Ethan Ludmir, MD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06367959 id: 2021-0324 id: NCI-2024-02939 type: OTHER domain: NCI-CTRP Clinical Trials Registry briefTitle: Health Benefits of Writing Therapy Among Asian American Cancer Survivors overallStatus: RECRUITING date: 2023-07-27 date: 2026-08-31 date: 2026-08-31 date: 2024-04-16 date: 2024-04-17 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To learn more about participant experience as a Asian American immigrant breast cancer survivor and how writing about participant experiences may affect participant's health. conditions: Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 192 type: ESTIMATED name: Esays name: Questionnaires measure: Primary Outcome Measure: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 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: Qian Lu, MD, PHD role: CONTACT phone: 713-745-8324 email: qlu@mdanderson.org name: Qian Lu, MD, PHD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06367946 id: XH-24-0093 briefTitle: Mechanism Study of Ventilator-Induced Lung Injury in Elderly People. overallStatus: RECRUITING date: 2023-06-01 date: 2024-07-01 date: 2027-06-30 date: 2024-04-16 date: 2024-04-16 name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine class: OTHER briefSummary: 1. We collect lung tissues from patients with different ages and confirm that KLK8 expression is positively correlated with age.
2. We collect peripheral blood from patients with different ages and duration of mechanical ventilation to explore the correlation between the degree of endothelial/epithelial damage, age and duration of mechanical ventilation. conditions: Ventilator-Induced Lung Injury studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: mechanical ventilation measure: KLK8 concentration of lung tissue measure: Endothelial/epithelial damage index concentration in peripheral blood sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Xinhua hospital status: RECRUITING city: Shanghai zip: 200000 country: China name: Lai Jiang, PhD role: CONTACT phone: 13817719616__ email: jianglaimz@sina.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06367933 id: MISNM briefTitle: Mini-invasive Spine Surgery for Neuromuscolar Scoliosis acronym: MISNM overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2026-05 date: 2024-04-16 date: 2024-04-25 name: Istituto Ortopedico Rizzoli class: OTHER briefSummary: Neuromuscular scoliosis (SNM) are deformities related to the impairment of normal function of the central nervous system (CNS) and/or peripheral nervous system (PNS) resulting in alterations to the of the functional unit represented by the integrated motor sequence (SIM). At the level of the spine, dysfunction of the SIM results in altered dynamic support of the spine. This results in a control of the trunk that is not harmonious due to the lack of effective mechanisms of muscle compensation. In particular, a greater degree of pelvic tilt with respect to the ground plane, with an increase in the degree of the so-called pelvic obliquity (OP), a fundamental parameter in walking and maintaining the seated posture. Spinal deformity causes severe alterations of the rib cage resulting in respiratory failure that often requires ventilatory supports and is associated with frequent airway infections, including pneumonias, often fatal. SNMs also express other comorbidities: cardiac (heart failure), neurological (epilepsy), nutritional that necessitate careful management multidisciplinary and especially anesthesiological evaluation for the peri-operative management. The surgical treatment of SNM constitutes a topic that is still debated due to both the bio-mechanical peculiarities of SNM and the clinical features, particularly comorbidities, that characterize this patient population. Compared with idiopathic scoliosis surgery, in SNM there is a higher rate of complications. To date, most of the complications are respiratory in nature (23%), followed by complications mechanical of the implanted surgical instrumentation (13%), and surgical site infections (11%). Furthermore, there is evidence that SNM surgery correlates with increased blood loss intraoperative. To date, it is recognized in the literature that the safest and most effective surgical treatment for SNMs is arthrodesis posterior instrumented with pedicle screws extended to the pelvis. In the years, mini-invasive surgical techniques have become increasingly prominent. invasive with the goal of reducing operative time, blood loss and complications themselves. conditions: Neuromuscular Scoliosis conditions: Spine Deformity conditions: Surgery conditions: Vertebral Fusion studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: mini-invasive spine surgery measure: Visual Analogue Scale measure: Visual Analogue Scale measure: Spine Correction measure: Spine Correction sex: ALL minimumAge: 9 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Istituto Ortopedico Rizzoli city: Bologna zip: 40136 country: Italy lat: 44.49381 lon: 11.33875 hasResults: False

 nctId: NCT06367920 id: 2022-02-005 briefTitle: Multicenter Study on Rehabilitation Medical Data for Pediatric Big Brain Development overallStatus: RECRUITING date: 2023-03-23 date: 2024-12-31 date: 2024-12-31 date: 2024-04-16 date: 2024-04-16 name: Bundang CHA Hospital class: OTHER briefSummary: Retrospective study for development of imaging-genetics (brain imaging/genome big data) models and algorithms that are clinically explainable and have high predictive performance in brain research on pediatric developmental disorders conditions: Pediatric ALL conditions: Healthy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2000 type: ESTIMATED name: Magnetic Resonance Imaging, Behavioral assessments measure: Brain magnetic resonance imaging measure: Medical records sex: ALL maximumAge: 20 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: NCT06367907 id: SM 68/6-1 briefTitle: Biological Effects of Schema Therapy acronym: BE-ST overallStatus: RECRUITING date: 2021-09-09 date: 2024-12 date: 2025-06 date: 2024-04-16 date: 2024-04-16 name: Jena University Hospital class: OTHER briefSummary: Background: The major aim of this study is to compare the effects of emotion focused (experiential) and cognitive interventions of schema therapy (ST) on emotion regulation deficits in patients with borderline personality disorder (BPD) according to DSM-V (alternative model) criteria. In a randomized, single-blinded parallel-group design clinical effects as well as effects on neurotransmitter metabolism and connectivity will be compared.

Method: While the 9-weeks treatment protocol of particular interest includes emotion focused interventions (ST-EF, n=60) such as chair dialogs, imagery rescripting or role play, the active control condition (ST-AC, n=60) is restricted to cognitive interventions, e.g. psychoeducation or pro/contra discussions. MEGA-PRESS 1H-MR spectroscopy and resting-state functional MR imaging (rs-fMRI) will be used before/after treatment protocols (T0-T1) and 6 months after the end of therapy (T2) to assess the effects on glutamate (Glx) and GABA metabolism in key regions of the target networks (executive control network, ECN: dorsolateral prefrontal cortex, DLPFC; salience network, SN: anteromedial cingulate cortex, aMCC; default mode network, DMN: pregenual cingulate cortex, pgACC) and to investigate the corresponding altered connectivity in these networks. The biological aberrations at T0 as compared to healthy controls (n=60) and treatment effects (at T1 and T2, n≥40 in each condition) on these aberrations will be linked to clinical effects measured by an extensive test battery with particular interest on emotion regulation, and specified by the Reliable Change Index (RCI). For longitudinal data mixed model analysis will be performed.

The main questions are (1) whether the emotion regulation deficit and the pattern of BPD-specific symptomatology are associated with a specific pattern of Glx and GABA concentrations in the DLPFC, aMCC and pgACC and corresponding deviations of functional connectivity within the ECN, SN and DMN. Hypothesis: Depending on primary and secondary outcome measures at T0, altered RSFC in the DMN, SN and ECN and corresponding altered Glx or GABA concentrations are assumed. (2) whether both treatment conditions have different clinical effects on the ability to regulate emotions and whether the respective clinical effects are associated with the changes in neurobiological aberrations. Hypothesis: It is hypothesized that the ST-EF condition will improve emotion regulation skills more effectively than the control condition. Only in the ST-EF condition are higher response and remission rates expected in the primary and secondary outcome measures, as well as effects on the ECN, SN and DMN with corresponding changes in RSFC and Glx or GABA concentrations. conditions: Personality Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized, parallel-group, single-blinded primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Parallel-group: Both conditions (emotion focussed, ST-EF and active control, ST-AC) are highly standardized and active in terms of their expected clinical effect, which was a precondition for a positive ethics approval.

Randomized: Patients are randomly assigned to the ST-EF or ST-AC condition according to a randomization list established by an independent statistician, and applied to incoming help-seeking patients by an independent admission management (managing nurse, not a member of the research team).

Single-blinded: Researchers are blind as regards group belonging of participants. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: schema therapy measure: Changes in emotion regulation capabilities measure: Improvement of BPD specific symptomatology measure: Change of personality traits measure: Changes of the intensity of early maladaptive schemas. measure: Changes of the intensity of schema modes. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Jena status: RECRUITING city: Jena zip: 07743 country: Germany name: Stefan Smesny, PhD role: CONTACT phone: +4936419390451 email: stefan.smesny@med.uni-jena.de lat: 50.92878 lon: 11.5899 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol: Study Protocol: Study design date: 2018-06-04 uploadDate: 2024-04-12T04:07 filename: Prot_000.pdf size: 653719 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol: Study Protocol: Study design date: 2018-06-04 uploadDate: 2024-04-12T04:14 filename: Prot_001.pdf size: 454285 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol: Information on reliability criteria of assessment tools date: 2018-06-04 uploadDate: 2024-04-12T04:22 filename: Prot_002.pdf size: 605787 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol: Core aspects of therapy conditions date: 2018-06-04 uploadDate: 2024-04-12T04:23 filename: Prot_003.pdf size: 440449 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2018-06-04 uploadDate: 2024-04-12T04:10 filename: SAP_004.pdf size: 692600 hasResults: False

 nctId: NCT06367894 id: STONECARE briefTitle: Treatment Optimization and Nephrolithiasis Recurrence Prevention With Interdisciplinary Care overallStatus: RECRUITING date: 2023-12-12 date: 2024-12-31 date: 2024-12-31 date: 2024-04-16 date: 2024-04-16 name: Agnieszka Pozdzik class: OTHER briefSummary: Nearly 10% of the Belgian population suffer from kidney stone disease. Recent reviews reported that kidney stones represent an underestimated risk factor for further kidney function deterioration. Preventive measures are recommended in lithiases patients to prevent the formation of new stones. The individual effects of different medicated prosthetic interventions have been documented in clinical trials. However, there is little data on the effectiveness of combining these different preventive measures in routine clinical practice (real-world context).

Patients with kidney stone disease require a complete metabolic assessment. The three main factors contributing to the stone's formation are the patient's metabolism, diet and lifestyle. Metabolic work-up is recommended by the American Urology Association to identify and correct the factors responsible for urinary stone formation such as hypercalciuria, hyperoxaluria, hyperuricuria, hypocitraturia or abnormalities of urinary pH. The metabolic work-up includes at minimum the 24h urine test, a blood test and spot urine test. Dietary habits and lifestyle are assessed by means of a questionnaire.

The CHU Brugmann Hospital has a specialized multidisciplinary clinic for renal lithiases and mineral metabolism. Preventive personalized and interdisciplinary care in CHU Brugmann consists of a full metabolic work-up allowing the identification of lithogenic risk factors by nephrologists, dietary assessment by specialized dieticians and specific treatment protocol associated with regular follow-up.

The aim of this study is to evaluate, in the context of a retrospective single-center cohort study, the effect of preventive personalized and interdisciplinary care on the evolution of all urinary lithogenic risk factors and the recurrence of kidney stones (rate of renal colics, emergency room admissions, and urological interventions). conditions: Kidney Stone studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 164 type: ESTIMATED measure: Number of acute renal colics measure: Number of emergency admissions measure: Number of surgeries measure: Number of hospitalizations measure: Identified genetics abnormalities measure: Wisconsin questionnaire measure: Kidney function outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Brugmann status: RECRUITING city: Brussels zip: 1020 country: Belgium name: Agnieszka POZDZIK role: CONTACT phone: 024772641 email: Agnieszka.POZDZIK@chu-brugmann.be name: Sirika Chhem role: PRINCIPAL_INVESTIGATOR lat: 50.85045 lon: 4.34878 hasResults: False

 nctId: NCT06367881 id: MD 185/ 2022 briefTitle: Assessment Of Dose-Dependent Immunomodulatory Effect Of Alveofact With or Without Steroisd In Neonatal RDS overallStatus: RECRUITING date: 2022-08-18 date: 2024-07 date: 2024-10 date: 2024-04-16 date: 2024-04-16 name: Ain Shams University class: OTHER briefSummary: An Exploratory Randomized double-arm controlled trial to evaluate the immunomodulatory effect of low versus high dose of Alveofact with or without Budesonide. conditions: Neonatal Respiratory Distress Syndrome conditions: Inflammatory Response conditions: Premature Lungs conditions: Neutrophil Extracellular Trap Formation conditions: Preterm Birth studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Alveofact name: Budesonide measure: Assessment of Neutrophil Extracellular Trap (NET) measure: comparison of Alveolar with whole blood NET formation measure: Clinical out come measure: Assessment of Reactive Oxygen Species (ROS) measure: oxygen needs measure: Hospital stay sex: ALL minimumAge: 1 Day maximumAge: 2 Days stdAges: CHILD facility: Egypt Neonatal Intensive Care Units (NICUs), Ain Shams University Cairo, Abbasia, Egypt, 11517 status: RECRUITING city: Cairo country: Egypt name: Ain Shams University role: CONTACT lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06367868 id: E-83045809-604.01.02-179951 briefTitle: Optic Nerve Sheath Diameter: A Non-Invasive Indicator of Intracranial Pressure in the Intensive Care Unit Monitoring overallStatus: COMPLETED date: 2021-09-09 date: 2022-06-01 date: 2022-12-01 date: 2024-04-16 date: 2024-04-16 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: Determination of high intracranial pressure (ICP) is necessary for the treatment of patients with raised ICP to improve long-term neurological outcomes. Ultrasonographic optic nerve sheath diameter (ONSD) measurement is a noninvasive, easily performed and cost effective technique for detecting high ICP. conditions: ICP (Intracranial Pressure) Increase conditions: Optic Nerve Sheath Diameter conditions: Intracranial Hypertension studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 44 type: ACTUAL name: After 5 ml CSF Drainage measure: Intracranial Pressure-1 (ICP-1) measure: Optic Nerve Sheath Diameter-1 (ONSD-1) measure: Intracranial Pressure-2 (ICP-2) measure: Optic Nerve Sheath Diameter-2 (ONSD-2) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul University-Cerrahpasa city: Istanbul state: Fatıh zip: 34098 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06367855 id: KSKC20222025 briefTitle: Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF : Double Blinded, Randomized Control Trial acronym: MIS-TLIF overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2025-05-31 date: 2024-04-16 date: 2024-04-16 name: Potsawat Surabotsopon class: OTHER briefSummary: Researchers are considering Dexamethasone as preemptive medication before minimally invasive spine fusion surgery to minimize postoperative back pain with minimal side effects, aiming to enhance the effectiveness of surgery and improve patient outcomes. conditions: Spinal Stenosis Lumbar conditions: Disc Degeneration conditions: Disc Disease conditions: Fusion of Spine conditions: Surgery studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Dexamethasone name: Normal saline measure: effectiveness of dexamethasone measure: Morphine consumption measure: Complication measure: Fusion rate measure: Length of hospital stay sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06367842 id: MED-02-2023 briefTitle: Orthopaedic Specimen Pathology and Early Diagnosis of ATTR Cardiopathy (ATTR-ORTHO) acronym: ATTR-ORTHO overallStatus: RECRUITING date: 2024-02-27 date: 2025-04 date: 2025-09 date: 2024-04-16 date: 2024-04-16 name: Institut Mutualiste Montsouris class: OTHER briefSummary: The goal of this observational study is to learn about the frequency of ATTR amyloid, cardiac involvement and associated features, in 150 patients aged 50 or more years, and operated for an idiopathic carpal tunnel syndrome, lumbar spine stenosis or total hip or knee arthroplasty for primary osteoarthritis. The main questions to be answered are:

1. What is the frequency of ATTR deposits in samples retrieved during surgery?
2. What is the frequency of cardiac involvement in ATTR positive patients?
3. What are the preoperative predictors of ATTR deposits? Participants will

   * have operative samples stained by Congo red in search of amyloid, which will be typed by immunochemistry in positive samples,
   * undergo a multimodal imaging search for cardiac involvement, if ATTR is identified,
   * undergo a preoperative complete clinical examination, including collection of medical history, ECG, biochemical tests, and imaging (ultrasound scans of rotator cuff and hip capsule in all participating patients, of the carpal tunnel in patients operated at this site, and MRI + standing profile radiography of the lumbar spine, in patients operated for lumbar stenosis)
   * ATTR positive patients will be proposed to be followed-up by a reference center, with the aim of an early diagnosis of cardiac involvement, allowing efficient mamagement.

Researchers will assess the frequency of ATTR deposits at each operated site, the frequency or ATTR cardiopathy in ATTR + patients, and will compare demographic, clinical, biochemical, and imaging features in patients with and without ATTR deposits, to guide the indications of pathological examination during these frequent orthopedic surgeries conditions: ATTR Amyloidosis conditions: Cardiopathy conditions: Carpal Tunnel Syndrome conditions: Lumbar Spine Stenosis conditions: Hip Prosthesis conditions: Knee Prosthesis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 150 type: ESTIMATED measure: frequency of ATTR amyloidosis measure: presence of ATTR cardiopathy measure: proportion of wild type and hereditary ATTR measure: Description of preoperative predictors of ATTR measure: Description of preoperative predictors of ATTR measure: preoperative predictors of ATTR sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mutualist Montsouris Institute status: RECRUITING city: Paris zip: 75014 country: France name: Thomas M Bardin, Pr role: CONTACT phone: +33 156616263 email: thomas.bardin@imm.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06367829 id: WO.24.025 briefTitle: Lubinus SPII Hip Stem Target Trial Emulation (LARGE) acronym: LARGE overallStatus: ENROLLING_BY_INVITATION date: 2024-01-08 date: 2024-07-14 date: 2025-01-08 date: 2024-04-16 date: 2024-04-16 name: JointResearch class: OTHER name: OLVG name: Uppsala University name: Göteborg University name: Leiden University Medical Center briefSummary: The research questions this study aims to answer are as follows:

Primary research question:

"Do primary total hip arthroplasties for patients with OA, hip fracture or osteonecrosis with the 150mm Lubinus SPII hip stem have better mortality and stem revision rates than primary total hip arthroplasties with the 130mm hip stem?"

Secondary aims include:

* How does line-to-line cementation, compare to undersized cementation in primary total hip arthroplasty for patients with OA, hip fracture, or osteonecrosis when comparing equal size Lubinus SPII hip stems implanted with different cementation techniques?
* Does the Lubinus SPII 150mm hip stem perform equal to the Lubinus SPII 130mm hip stem in primary total hip arthroplasties for patients with OA, hip fracture or osteonecrosis when comparing patient reported outcome measures?

To answer these questions, this study has been allowed use of registered data from the LROI (dutch arthroplasty registry) and the SAR (swedish arthroplasty registry). After exclusion of patients who did not meet inclusion criteria between 2007-2020, approximately 110000 patients remain eligible for analysis. conditions: Treatment Outcome studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 110000 type: ESTIMATED name: Lubinus SPII hip stem 130mm name: Lubinus SPII hip stem 150mm measure: Mortality rate measure: Revision rate measure: NRS pain score measure: Oxford hip score measure: EQ - 5D measure: HOOS - PS measure: Revision rate measure: Mortality rate sex: ALL minimumAge: 5 Years maximumAge: 105 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: OLVG city: Amsterdam state: Noord Holland zip: 1090 HM country: Netherlands lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06367816 id: 13509 briefTitle: Brain Recovery With Automated VEntilation acronym: BRAVE overallStatus: RECRUITING date: 2024-04-11 date: 2024-12-31 date: 2024-12-31 date: 2024-04-16 date: 2024-04-16 name: University of Genova class: OTHER briefSummary: Thus far, the closed-loop ventilation mode INTELLiVENT-ASV has been extensively tested in various groups of critically ill patients, and has been shown to be effective and safe in various groups of ventilated patients, including those at risk of acute respiratory distress syndrome (ARDS), patients with ARDS, and patients with chronic obstructive pulmonary disease (COPD). Some of these studies included acute brain injury (ABI) patients, but the effectiveness, efficacy and safety of INTELLiVENT-ASV has never been thoroughly tested in these patients. The current study will investigate the effectiveness in providing both brain- and lung protective ventilation, the safety and the efficacy of a closed-loop ventilation mode (INTELLiVENT-ASV) in acute brain injury patients, using breath-by-breath data. conditions: Brain Injuries, Acute conditions: Respiration, Artificial conditions: Automation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: INTELLiVENT name: Conventional ventilation measure: Proportion of breaths in predefined zones of ventilation measure: Proportion of time in predefined zones of ventilation measure: Intracerebral changes assessed by multimodal neuromonitoring available measure: Changes on Electrical Impedence Tomography when available measure: Effectiveness in primary ABI patients vs non primary ABI patients measure: Episodes and time of high maximum airway pressure measure: Episodes and time of high respiratory rate measure: Incidence of severe hypoxemia measure: Incidence of severe hypercapnia measure: Discontinuation of ventilatory mode (yes or no) measure: Percentage of breaths in the predefined 'critical' ventilation zone measure: Incidence of pneumothorax measure: Efficacy on glascow coma scale measure: Duration of ventilation in survivors measure: Ventilator free days measure: Intensive care unit length of stay measure: Hospital length of stay measure: 28-day mortality measure: 90-day mortality measure: Number of alarms measure: Number of manual adjustments sex: ALL minimumAge: 18 Years maximumAge: 105 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UO Clinica Anestesiologica e Terapia Intensiva, IRCCS Ospedale Policlinico San Martino status: RECRUITING city: Genova state: GE zip: 16132 country: Italy name: Denise Battaglini, MD, PhD role: CONTACT phone: +39-0105554970 email: battaglini.denise@gmail.com name: Lorenzo Ball, MD, PhD role: CONTACT phone: +39-0105554970 email: lorenzo.ball@unige.it lat: 44.40478 lon: 8.94438 hasResults: False

 nctId: NCT06367803 id: DVS010 briefTitle: Cost Analysis of Vascular Surgical Techniques overallStatus: COMPLETED date: 2023-06-01 date: 2023-12-01 date: 2024-03-01 date: 2024-04-16 date: 2024-04-16 name: University Hospital of Limerick class: OTHER briefSummary: Whilst mortality rates and surgical limitations are widely known and understood for each intervention performed, the cost implications, in UHL, are not known. Therefore, it is deemed a matter of interest to understand these costs and weigh them against the mortality rates for each intervention if available. conditions: Critical Limb Ischemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 200 type: ACTUAL measure: A comparative assessment of the cost implications of the surgical modalities used in the treatment of CLTI i.e., revascularisation and amputation. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Limerick city: Limerick state: Munster country: Ireland lat: 52.66472 lon: -8.62306 hasResults: False

 nctId: NCT06367790 id: Bask-Pliomet briefTitle: Plyometry and Tapping in the Functional Improvement of Non-professional Basketball Players overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-06-10 date: 2024-07-01 date: 2024-04-16 date: 2024-04-16 name: Universidad Católica San Antonio de Murcia class: OTHER briefSummary: Introduction. In basketball, the lower extremities have the highest prevalence of injury, regardless of gender and professional category.

Objective. To analyse the efficacy of a physiotherapy intervention using a protocol of plyometric exercises and dry needling in non-professional basketball athletes.

Methods. Randomised clinical study. 20 players will be randomised to an experimental group (plyometric exercises and dry needling of the gastrocnemius muscles) and a control group (plyometric exercises). The intervention will include 8 sessions over 4 weeks. The study variables will be: range of motion in dorsal flexion in loading (Leg Motion®) and unloading (goniometer) and vertical jump (MyJump2®).

Expected results. An intervention of plyometric exercises and dry needling produces significant differences in range of motion and vertical jump in basketball players, compared to the isolated administration of plyometric exercises. conditions: Basketball Players studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Experimental group name: Control group measure: Change from baseline range of motion in loaded dorsal flexion after treatment and at 4 weeks measure: Change from baseline range of motion in unloaded dorsal flexion after treatment and at 4 weeks measure: Change from baseline vertical jump after treatment and at 4 weeks sex: MALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Rubén Cuesta-Barriuso city: Oviedo state: Asturias zip: 33006 country: Spain name: Rubén Cuesta-Barriuso, PhD role: CONTACT phone: 607547274 email: cuestaruben@uniovi.es lat: 43.36029 lon: -5.84476 hasResults: False

 nctId: NCT06367777 id: 2024/14MAR/132 briefTitle: Cervical/Thoracic Neuromodulation and Nociceptive Processing acronym: MICROVOLT2 overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-10 date: 2024-10 date: 2024-04-16 date: 2024-04-16 name: Université Catholique de Louvain class: OTHER briefSummary: Several studies have demonstrated that direct currents delivered through the skin at the level of the low-thoracic spinal cord can influence spinal cord function. In human volunteers, anodal low-thoracic transcutaneous spinal direct current stimulation (tsDCS) alters spinal processing of nociceptive inputs. Whether cervical tsDCS is able to do the same is less well known. In this double-blinded, sham-controlled and cross-over trial, the investigators will compare the effects on the nociceptive processing of healthy volunteers of cervical and low-thoracic tsDCS. conditions: Nociceptive Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: cervical a-tsDCS name: thoracic a-tsDCS name: sham tsDCS measure: Change in contact-heat evoked potentials amplitude measure: Change in intensity of perception to contact-heat nociceptive stimuli measure: Change in skin temperature measure: Change in cutaneous blood flow sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False

 nctId: NCT06367764 id: BPS-2022C3-30535 briefTitle: A Comparative Effectiveness Study of PTSD Treatments Among Sexual and Gender Minority Populations acronym: LIFESCAPE overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-06 date: 2028-06 date: 2024-04-16 date: 2024-04-23 name: University of California, San Francisco class: OTHER name: Patient-Centered Outcomes Research Institute name: Stanford University briefSummary: The goal of this clinical trial is see if Cognitive Processing Therapy and STAIR Narrative Therapy work to treat posttraumatic stress disorder (PTSD) among lesbian, gay, bisexual, transgender, queer/questioning, intersex, asexual/aromantic, and all other sexual or gender minority (LGBTQIA+) adults. The main questions it aims to answer are:

* Do these treatments reduce PTSD symptoms in LGBTQIA+ patients?
* Do these treatments help improve quality of life and reduce depression in LGBTQIA+ patients?
* Do stress from stigma and discrimination and drug/alcohol use change the impact of the treatment on PTSD symptoms?
* Are LGBTQIA+ patients satisfied with these treatments? Do these treatments work differently among different groups within the LGBTQIA+ community?
* Do LGBTQIA+ patients complete these treatments?

Study participants will receive one of these two PTSD treatments. Participants will complete assessments before and after receiving treatment. conditions: PTSD studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 400 type: ESTIMATED name: Cognitive Processing Therapy name: STAIR Narrative Therapy measure: Change in Posttraumatic Stress Disorder (PTSD) Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5) measure: Change in Depression Measured by Patient Health Questionnaire (PHQ-9) measure: Change in Quality of Life Measured by WHOQOL-BREF: Social Relationships and Environment Scales measure: Patient Satisfaction Measured By Satisfaction with Therapy and Therapist Scale-Revised (STTS-R) measure: Assessing Treatment Dropout Measured by Completion of Less than 8 Sessions measure: Minority Stress Measured by Cultural Assessment of Risk for Suicide (CARS) Minority Stress Subscale - Moderator measure: Substance Use Measured Alcohol and Substance, Smoking, and Substance Involvement Screening Test (ASSIST) - Moderator sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UCSF Alliance Health Project city: San Francisco state: California zip: 94103 country: United States name: Annesa Flentje, PhD role: CONTACT lat: 37.77493 lon: -122.41942 hasResults: False

 nctId: NCT06367751 id: 2024-00358; th23Kasenda briefTitle: Implementation of Liquid Biopsies During Routine Clinical Care in Patients With Advanced Malignancies (LIQPLAT) acronym: LIQPLAT overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-10 date: 2026-10 date: 2024-04-16 date: 2024-04-19 name: University Hospital, Basel, Switzerland class: OTHER name: Research Center for Clinical Neuroimmunology and Neuroscience Basel briefSummary: The goal of this study is to assess the implementation and feasibility of ctDNA measurements from blood samples obtained during routine clinical care of cancer patients in the University Hospital Basel.

Researchers will compare clinical and patient reported outcomes from the LIQPLAT study with patients who did not receive ctDNA measurements (external comparator from registry AO_2023-00091).

Blood samples will be drawn from the patients as part of routine care and ctDNA measurements will be performed on these samples. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a trial using routinely collected health care data from an ongoing registry (AO_2023-00091) in cancer patients with advanced solid malignancies receiving first line systemic anti-cancer treatment for advanced disease. All patients will receive routine diagnostics, treatment and follow-up. All patients with a new cancer diagnosis will be assessed for eligibility based on the routinely collected information available in the registry. We will then randomly decide which eligible patients are invited to participate in the trial. If patients accept the invitation and intend to get a measurement of ctDNA, they have to provide written informed consent. The study comprises an external comparator arm with 75 (anticipated) cancer patients, and an active comparator arm with 150 (anticipated) cancer patients. primaryPurpose: OTHER masking: NONE count: 150 type: ESTIMATED name: ctDNA measurement measure: Number and proportion of patients in whom ctDNA was detectable before starting medical anticancer treatment measure: Patients in whom actionable alterations were identified in ctDNA analysis measure: Turn-around time of ctDNA analysis measure: ctDNA kinetics measure: Number of ctDNA testing results that were successfully made available to the molecular tumor board measure: Number of patients being positive for ctDNA and suspicious Clonal Hematopoiesis of Indeterminate Potential measure: Quality of life and physical function measure: Overall survival measure: Survival rate 6 months measure: Survival rate 12 months measure: Time to next treatment line measure: Unplanned hospital admissions and emergency room visits measure: Progression free survival measure: Number of ctDNA analyses with a valid result measure: Patients being referred and recruited to a different interventional clinical trial measure: Tissue biopsies per patient measure: Imaging per patient measure: Blood products per patient measure: Cumulative doses of cancer drug treatments administered sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06367738 id: 2024-11-14799 briefTitle: Investigating the Persisting Effects of a Single Dose of Psilocybin on Structural Plasticity in Healthy Older Adults overallStatus: NOT_YET_RECRUITING date: 2025-04-01 date: 2026-12-30 date: 2027-12-30 date: 2024-04-16 date: 2024-04-16 name: University of California, Berkeley class: OTHER briefSummary: We will use cognitive exams, perceptual tasks, brain imaging, peripheral psychophysiology, and surveys to investigate the persisting effects of psilocybin on cognition, predictive coding, and affect in healthy older adults. We will measure changes in these measures by comparing baseline to one-week and one-month post-treatment. Participants will be randomly assigned to receive a dose of psilocybin in a range from microdose to moderate-to-high dose. Dose response will be assessed. Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) will be used to assess changes in brain structure, while functional magnetic resonance imaging (fMRI) will be used to quantify changes in functional brain activity. We will assess whether changes in these brain measures underlie observed changes in cognition, predictive coding and affect. conditions: Aging studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Psilocybin measure: MRI measurements of brain structure measure: Amplitude and pattern of fMRI cortical responses measure: Peripheral psychophysiology measure: Perceptual measurements measure: Cognitive measurements sex: ALL minimumAge: 60 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06367725 id: 1-10-72-122-23 briefTitle: Pharmacokinetics of Dexamethasone in Childhood ALL and Reduction in Bone Mineral Density overallStatus: RECRUITING date: 2024-04-11 date: 2027-12-30 date: 2030-12-30 date: 2024-04-16 date: 2024-04-16 name: University of Aarhus class: OTHER briefSummary: The goal of this observational study is to learn about, the systemic exposure to dexamethason in childhood acute lymphatic leukemia (ALL). The main questions it aims to answer are:

* How does the intake of dexamethasone correlate with systemic exposure to dexamethason?
* Does systemic exposure to dexamethasone correlate with a reduction in bone mineral density?

Participants will:

* Continue to receive the best available therapy for ALL in Western Europe.
* Have blood samples taken from their central line to measure dexamethasone levels.
* When standard lumbar punctures are done as part of treatment, a sample of cerebrospinal fluid will also be taken to analyze dexamethasone.
* Visit the clinic four times for a DXA scans to measure bone density and vertebral fracture assessment: within three weeks of starting treatment, six months after starting treatment, one month after finishing treatment, and one year after finishing treatment. Biomarkers related to bone health will also be collected on these days. Additionally, participants will fill out questionnaires to track their daily physical activity levels. conditions: Acute Lymphoblastic Leukemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Area Under the Plasma Concentration Curve (AUC) of Dexamethasone measure: Mineral bone density by DXA-scan measure: Vertebral fracture assessment (VFA) by DXA-scan measure: Dexamethasone in cerebrospinal fluid measure: Physical activity questionnaire measure: Biomarkers of bone metabolism sex: ALL minimumAge: 1 Year maximumAge: 17 Years stdAges: CHILD facility: Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital Rigshospitalet status: NOT_YET_RECRUITING city: Copenhagen state: København Ø zip: 2100 country: Denmark name: Peter EL Pontoppidan, phd role: CONTACT email: peter.erik.lotko.pontoppidan@regionh.dk lat: 55.67594 lon: 12.56553 facility: Department of Paediatrics and Adolescent Medicine, Odense University Hospital status: NOT_YET_RECRUITING city: Odense state: Odense C zip: 5000 country: Denmark name: Peder S Wehner, phd role: CONTACT email: Peder.Skov.Wehner@rsyd.dk lat: 55.39594 lon: 10.38831 facility: Department of Paediatrics and Adolescent Medicine, Aalborg University Hospital status: NOT_YET_RECRUITING city: Aalborg zip: 9000 country: Denmark name: Marianne Olsen, phd role: CONTACT email: marianne.olsen@rn.dk lat: 57.048 lon: 9.9187 facility: Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital status: RECRUITING city: Aarhus N zip: 8200 country: Denmark name: Karen S Jensen, phd role: CONTACT email: kascje@rm.dk name: Birgitte K Albertsen, Professor role: CONTACT lat: 56.15674 lon: 10.21076 hasResults: False

 nctId: NCT06367712 id: Ahmed Kassab briefTitle: Letrozole Alone Protocol Versus Using Letrozole and HCG Protocol overallStatus: COMPLETED date: 2022-11-10 date: 2023-11-01 date: 2023-11-10 date: 2024-04-16 date: 2024-04-16 name: Egymedicalpedia class: INDUSTRY briefSummary: Letrozole is a chemical compound, CGS 20267 which is a third-generation, nonsteroidal aromatase inhibitor.

Letrozole blocks estrogen synthesis by directly affecting the hypothalamic-pituitary-ovarian axis, subsequently, increases gonadotropins which increase pregnancy rates. Possible positive outcomes of aromatase inhibitors over selective estrogen-receptor modulators include a more physiologic hormonal stimulation of the endometrium which increases receptivity, a lower multiple-pregnancy through single follicle growth, a lesser side-effect especially vasomotor and mood symptoms, and more prompt clearance from blood, hence, reducing the probabilities of periconceptional exposure conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 132 type: ACTUAL name: Letrozole tablets measure: Pregnancy test sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Ahmed Maher Teaching Hospital city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06367699 id: H-44821 briefTitle: Conversational Agents to Improve HPV Vaccine Acceptance in Primary Care (ECA-HPV) Clinical Trial overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-09 date: 2027-12 date: 2024-04-16 date: 2024-04-16 name: Tufts Medical Center class: OTHER name: Boston Medical Center name: Northeastern University briefSummary: The objective of this study is to assess the use of and satisfaction with the ECA-HPV intervention over a 16-month period, its ability to increase HPV vaccination, and the comparative effectiveness of clinic notification and adolescent ECA components on these factors. conditions: Human Papilloma Virus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 1750 type: ESTIMATED name: Usual Care name: ECA-HPV App with Clinic Notification and Adolescent Functions Disabled name: ECA-HPV App with Clinic Notification Function Enabled name: ECA-HPV App with Adolescent Function Enabled name: ECA-HPV App with Clinic Notification and Adolescent Functions Enabled measure: HPV vaccination series completion comparing the control group to the intervention groups measure: HPV vaccination series completion comparing the intervention groups measure: HPV Knowledge measure: HPV Attitudes measure: General Vaccine Attitudes measure: ECA-HPV App Satisfaction measure: Clinic Notification Feature Satisfaction sex: ALL minimumAge: 9 Years maximumAge: 12 Years stdAges: CHILD facility: Boston Medical Center city: Boston state: Massachusetts zip: 02118 country: United States name: Lori Henault, MPH role: CONTACT phone: 617-414-6935 email: lori.henault@bmc.org name: Rebecca Perkins, MD, MSc role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06367686 id: REK KULMU B 714179 briefTitle: Detecting Systemic Carbon Dioxide Levels With a Novel Biosensor acronym: DISCO overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2024-12 date: 2024-04-16 date: 2024-04-16 name: The Hospital of Vestfold class: OTHER name: Sensocure AS briefSummary: The study is an open, prospective, single center clinical observational pilot investigation. The aim is to compare the carbon dioxide values measured by the IscAlert sensor, which is inserted in proximity to the nasal mucosa. The study wants to investigate if the nasal mucosa application and measurements are feasible, what kind of possible complications such a measurement can cause, and if the measurements can be a surrogate marker for systemic carbon dioxide values. conditions: Hypercapnic Respiratory Failure conditions: Pulmonary Disease, Chronic Obstructive conditions: Neuromuscular Diseases conditions: Obesity Hypoventilation Syndrome (OHS) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 11 type: ESTIMATED name: IscAlert sensor measure: Partial pressure (level) of carbon dioxide at the nasal mucosa measure: Bleeding measure: Infection measure: Sinusitis measure: Ulceration measure: Pain at sensor insertion site measure: Muscular temperature level measure: Nasal temperature level measure: Temporal temperature level measure: IscAlert functionality measure: Number of pack-years measure: Length of sensor implantation time measure: Peripheral oxygen saturation measure: Arterial partial pressure (level) of carbon dioxide measure: Arterial partial pressure (level) of oxygen measure: Intramuscular partial pressure (level) of carbon dioxide measure: Transcutaneous partial pressure (level) of carbon dioxide measure: Patient-Reported Outcome Measures 1a - discomfort measure: Patient-Reported Outcome Measures 1b - discomfort measure: Patient-Reported Outcome Measures 2a - runny nose measure: Patient-Reported Outcome Measures 2b - runny nose measure: Patient-Reported Outcome Measures 3a - sneezing measure: Patient-Reported Outcome Measures 3b - sneezing measure: Patient-Reported Outcome Measures 3b - Ulceration measure: Patient-Reported Outcome Measures 3a - Ulceration measure: Patient-Reported Outcome Measures 4a - tenderness measure: Patient-Reported Outcome Measures 4b - tenderness measure: Patient-Reported Outcome Measures 5b - bleeding measure: Patient-Reported Outcome Measures 5a - bleeding measure: Patient-Reported Outcome Measures 6a - reduced sense of smell measure: Patient-Reported Outcome Measures 6b - reduced sense of smell measure: Patient-Reported Outcome Measures 7b - reduced sense of taste measure: Patient-Reported Outcome Measures 7a - reduced sense of taste measure: Patient-Reported Outcome Measures 8a - difficulty sleeping measure: Patient-Reported Outcome Measures 8b - easy to wake up while sleeping measure: Patient-Reported Outcome Measures 9 - problems with eating and drinking measure: Patient-Reported Outcome Measures 10 - difficult breathing measure: Patient-Reported Outcome Measures 11a - diagnosed infection in the nose or sinuses measure: Patient-Reported Outcome Measures 11b - diagnosed infection in the nose or sinuses sex: ALL minimumAge: 18 Years maximumAge: 110 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Vestfold Hopsital Trust city: Tønsberg zip: 3103 country: Norway name: Anne-Marie Gabrielsen, MD, PhD role: CONTACT phone: 92485580 phoneExt: +47 email: anne-marie.gabrielsen@siv.no name: Morten Waldvogel-Rønning, MD role: CONTACT phone: 95203195 phoneExt: +47 email: morten.waldvogel-ronning@siv.no name: Morten Waldvogel-Rønning, MD role: SUB_INVESTIGATOR name: Caroline Sahlstrøm, MD role: SUB_INVESTIGATOR lat: 59.26754 lon: 10.40762 hasResults: False

 nctId: NCT06367673 id: QH-ZYDC-01 briefTitle: Natural Killer(NK) Cell Therapy Targeting CLL1 or CD33 in Acute Myeloid Leukemia overallStatus: RECRUITING date: 2024-04-30 date: 2026-03-31 date: 2026-08-31 date: 2024-04-16 date: 2024-04-18 name: Zhejiang University class: OTHER name: Hangzhou Qihanjiyin Biotech Co.,Ltd. briefSummary: This is a phase 1, first-in-human (FIH), open-label, multicohort study to evaluate the safety, tolerability and preliminary efficacy of CLL1 or CD33 target Chimeric antigen receptor (CAR) -induced pluripotent stem cells derived NK cells in patients with relapsed/refractory AML conditions: AML, Adult studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: iPSC-NK cells measure: Incidence of Treatment-Emergent Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: the First Affiliated Hospital, School of Medicine, Zhejiang University status: RECRUITING city: Hangzhou state: Zhejiang zip: 321000 country: China name: Yongxian Hu role: CONTACT email: huyongxian2000@aliyun.com lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06367660 id: 98-2024 briefTitle: Comparison Between Hyperbaric Bupivacaine With Fentanyl vs. Hyperbaric Bupivacaine With Dexmedetomidine in Reducing Visceral Pain During Cesarean Delivery Under Spinal Anaesthesia overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-08 date: 2024-09 date: 2024-04-16 date: 2024-04-24 name: Tribhuvan University Teaching Hospital, Institute Of Medicine. class: OTHER briefSummary: In patients undergoing elective LSCS under subarachnoid block, group BF will receive 0.5% hyperbaric bupivacaine 10mg (2ml) with fentanyl 10 mcg (0.2ml) with total of 2.2 ml and group BD will receive 0.5% hyperbaric bupivacaine 10 mg with Dexmedetomidine 5mcg (0.2ml) total volume 2.2ml. Assessment of intraoperative visceral pain will be done by self-reporting of patients, who are previously educated, as poorly localized discomfort or dragging, pulling heaviness or unpleasant feeling or pain with or without nausea and will be categorized according to preformed scale conditions: Visceral Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Research method: Quantitative Type of study: Randomized, interventional, comparative study primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 168 type: ESTIMATED name: Intrathecal Bupivacaine-Fentanyl and Bupivacaine-Dexmedetomidine measure: Primary outcome measure: Secondary Outcome sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False

 nctId: NCT06367647 id: zhujiangjy-20240229 briefTitle: Investigation on the Detection Rate of Pathogenic Viruses in Feces of Parenteral Infected Individuals overallStatus: RECRUITING date: 2024-04-15 date: 2025-10-31 date: 2025-12-31 date: 2024-04-16 date: 2024-04-22 name: Zhujiang Hospital class: OTHER briefSummary: This project is a cross-sectional study. Investigators plan to search and collect 1600 publicly published fecal metagenomic and metatranscriptome data through the Pubmed database, by summarizing and analyzing them to construct an enterovirus database. 200 apparently healthy individuals are planned to be enrolled. At the time of enrollment, fecal specimens of participants will be collected, and their demographic characteristics, disease and medication history, gastrointestinal status, dietary habits, lifestyle habits, and mental health information will be recorded. Another 200 specimens will be collected from patients with parenteral virus infection. The demographic characteristics and pathogen test results of the parenteral virus infected patients will be reviewed and recorded. By virus metagenomic sequencing on fecal specimens, investigators will identify which viruses can be detected in the intestinal tract of apparently healthy people, and to explore whether parenteral infection viruses can be detected in feces. conditions: Virus Infections studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 2000 type: ESTIMATED measure: virus infection checklist measure: general information of apparently healthy individuals by questionnaire measure: Self-Rating Anxiety Scale SAS measure: Self-rating depression scale SDS measure: Pittsburgh sleep quality index PSQI measure: demographic characteristics case information of parenteral virus infected patients sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhujiang hospital of southern medical university status: RECRUITING city: Guangzhou state: Guangdong zip: 510280 country: China name: Yumei Liu, master role: CONTACT phone: +8618810795365 email: liuyumei1007@163.com lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06367634 id: TEO-TSUL-2301 briefTitle: TEOSYAL® PureSense ULTRA DEEP Versus Restylane® Lidocaine for the Correction of Moderate to Severe Nasolabial Folds in Chinese Adults overallStatus: RECRUITING date: 2024-01-19 date: 2025-01 date: 2026-02 date: 2024-04-16 date: 2024-04-16 name: Teoxane SA class: INDUSTRY briefSummary: This is a prospective, multi-center, randomized, controlled, subject- and evaluator-blinded clinical investigation to demonstrate non-inferiority of TEOSYAL® PureSense ULTRA DEEP compared to Restylane® Lidocaine for the correction of moderate to severe NLF in Chinese adults.

Eligible subjects will be enrolled and randomized either to the treatment group or control group in a 1:1 ratio on Day 0. Each subject assigned to the treatment group will receive TEOSYAL® PureSense ULTRA DEEP in both NLFs, whereas subjects assigned to the control group will receive Restylane® Lidocaine.

The treating investigator will administer the corresponding product in both NLFs of the subject on Day 0.

All subjects will return to the site at 4, 12, 24, 36, and 52 weeks after the last treatment for effectiveness and safety assessment. All subjects will receive a safety phone call 7 days after the initial treatment at baseline, and after the touch-up treatment, if applicable. conditions: Nasolabial Folds studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Blinded-Live evaluator whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 390 type: ESTIMATED name: injection in NLF measure: WSRS grading sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Second Provincial General Hospital status: RECRUITING city: Guangzhou country: China lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06367621 id: CLS-015C briefTitle: Retrospective Study of iStatis Syphilis Ab Test (POC) overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-15 date: 2024-04-15 date: 2024-04-15 date: 2024-04-16 date: 2024-04-16 name: bioLytical Laboratories class: INDUSTRY briefSummary: The purpose of this retrospective clinical trial is to establish the clinical performance of the iStatis Syphilis AbTest. The data will be used to demonstrate the product is safe and effective for its intended use. The data obtained will be used in the application for CE certification under In Vitro Diagnostic Medical Device Regulation (IVDR) and World Health Organization (WHO) prequalification. conditions: Syphilis conditions: Syphilis Infection studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 1500 type: ACTUAL name: iStatis Syphilis Antibody Test measure: Sensitivity and specificity of the iStatis Syphilis Ab Test sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Epicentre Health Research city: Hillcrest state: KwaZulu Natal zip: 3650 country: South Africa hasResults: False

 nctId: NCT06367608 id: HP-00104695 briefTitle: MRgFUS Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD) acronym: FUS Dystonia overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-06 date: 2028-06 date: 2024-04-16 date: 2024-04-25 name: University of Maryland, Baltimore class: OTHER name: Focused Ultrasound Foundation name: InSightec briefSummary: The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) for treating task specific focal hand dystonias (TSFD). TSFD is a type of dystonia that affects hand movements during specific tasks such as writing, playing instruments or typing, often causing involuntarily movements or cramping. conditions: Task-Specific Focal Dystonia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 10 type: ESTIMATED name: ExAblate Transcranial treatment measure: Incidence of Treatment related adverse events measure: Change in dystonia intensity measure: Change in patient's perception of quality of life measure: Change in patient's perception of the effect of the procedure sex: ALL minimumAge: 21 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Maryland Medical Center city: Baltimore state: Maryland zip: 21201 country: United States name: Kaitlyn Henry, MS role: CONTACT phone: 410-328-0939 email: khenry@som.umaryland.edu name: Rayne Noyes, BS role: CONTACT email: anoyes@som.umaryland.edu lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06367595 id: Intrathecal MgSO4 briefTitle: Effect of Intrathecal Magnesium Sulfate Versus Intravenous Magnesium Sulfate on Postoperative Pain After Abdominal Hysterectomy overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-10 date: 2026-11 date: 2024-04-16 date: 2024-04-16 name: Assiut University class: OTHER briefSummary: The present study aims to compare the effect of adding IV magnesium sulfate versus magnesium sulfate to intrathecal hyperbaric bupivacaine in total abdominal hysterectomy regarding the duration of postoperative analgesia, hemodynamic stability, and complications. conditions: Abdominal Hysterectomy studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 90 type: ESTIMATED name: Magnesium sulfate measure: effect on postoperative pain after abdominal hysterectomy using visual analog score measure: sedation by Ramsay sedation scale measure: time of the first opioid request measure: Mean arterial blood pressures (MAP) measure: Heart rate (HR) sex: FEMALE minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06367582 id: CV01-TK-SPINE briefTitle: SPINE BONE CEMENTS OUTCOMES overallStatus: RECRUITING date: 2019-09-04 date: 2029-09-04 date: 2039-09-30 date: 2024-04-16 date: 2024-04-16 name: Teknimed class: INDUSTRY briefSummary: A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Spine range of products: SPINEFIX, HIGH V+, OPACITY+ and F20 bone cements and mixing and injection systems, and all their private labels.

TEKNIMED bone cements are legacy products, some marketed for more than 10 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, prospective observational study. Patients will be followed as per local standard medical care of the sites. conditions: Vertebral Fracture conditions: Compression Fracture conditions: Osteoporotic Fractures studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 500 type: ESTIMATED name: Vertebroplasty (VP) name: Kyphoplasty (KP) name: Pedicular Screw Augmentation (PSA) measure: Alleviation of Pain measure: Restoration of quality of life measure: Patient satisfaction measure: Stabilization of vertebrae measure: Adverse events measure: Antalgic Consumption sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU HautePierre status: RECRUITING city: Strasbourg state: Bas-Rhin zip: 67200 country: France name: Vincent LAMAS, MD role: CONTACT email: vincent.lamas@chru-strasbourg.fr name: Vincent LAMAS, MD role: PRINCIPAL_INVESTIGATOR lat: 48.58392 lon: 7.74553 facility: Pôle Rachis Hôpital Privé d'Eure et Loir status: RECRUITING city: Mainvilliers state: Eure Et Loir zip: 28300 country: France name: Jean MEYBLUM, MD role: CONTACT email: jeanmeyblum@hotmail.com name: Jean MEYBLUM, MD role: PRINCIPAL_INVESTIGATOR lat: 48.45003 lon: 1.45607 facility: Hôpital Toulouse Purpan status: RECRUITING city: Toulouse state: Haute Garonne zip: 31130 country: France name: Marie FARUCH, MD role: CONTACT email: faruch.m@chu-toulouse.fr name: Marie FARUCH, MD role: PRINCIPAL_INVESTIGATOR lat: 43.60426 lon: 1.44367 facility: Pôle Sud Santé status: RECRUITING city: Le Mans state: Sarthe zip: 72100 country: France name: Alexandru NITULESCU, MD role: CONTACT email: alexandru_orto@yahoo.com name: Alexandru NITULESCU, MD role: PRINCIPAL_INVESTIGATOR lat: 48.0 lon: 0.2 facility: Centre Hospitalier Métropole Savoie status: RECRUITING city: Chambéry state: Savoie zip: 73000 country: France name: Cristian VASILE, MD role: CONTACT email: cristian.vasile@ch-metropole-savoie.fr name: Cristian VASILE, MD role: PRINCIPAL_INVESTIGATOR lat: 45.56667 lon: 5.93333 facility: Hospitale Cruz Vermelha Portuguesa status: RECRUITING city: Lisbonne zip: 1549-008 country: Portugal name: Miguel CORDEIRO, MD role: CONTACT phone: 914655121 email: miguel.cordeiro@hcvp.com.pt name: Miguel CORDEIRO, MD role: PRINCIPAL_INVESTIGATOR lat: 38.71667 lon: -9.13333 facility: Clínica Teknon Instituto de neurociencias status: RECRUITING city: Barcelona zip: 08022 country: Spain name: Daniel CRUZ MIRANDA, MD role: CONTACT email: dr.jdcruz@gmail.com name: David BOSCH GARCIA, MD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Hospital Neurotraumatologico status: RECRUITING city: Granada zip: 18013 country: Spain name: Fernando RUIZ SANTIAGO, MD role: CONTACT email: ferusan12@gmail.com name: Fernando RUIZ SANTIAGO, MD role: PRINCIPAL_INVESTIGATOR lat: 37.18817 lon: -3.60667 facility: Hospital Clínico Universitario Virgen de la Arrixaca status: RECRUITING city: Murcia zip: 30120 country: Spain name: Gonzalo DE PACO TUDELA, MD role: CONTACT email: gonzalodepaco@gmail.com name: Gonzalo DE PACO TUDELA, MD role: PRINCIPAL_INVESTIGATOR lat: 37.98704 lon: -1.13004 facility: Fundacio Assistencial Mutua de Terrassa - Edifici Estació status: RECRUITING city: Terrassa zip: 08222 country: Spain name: David BOSCH GARCIA, MD role: CONTACT email: dbosch@mutuaterrassa.com name: David BOSCH GARCIA role: PRINCIPAL_INVESTIGATOR lat: 41.56667 lon: 2.01667 facility: Hospital de Zafra status: RECRUITING city: Zafra zip: 06300 country: Spain name: Félix PANTA ANTON, MD role: CONTACT email: pantafelix74@gmail.com name: Félix PANTA ANTON, MD role: PRINCIPAL_INVESTIGATOR lat: 38.41667 lon: -6.41667 facility: Institute of Traumatology and Orthopaedics status: RECRUITING city: Kiev zip: 1601 country: Ukraine name: Andrii SHEVCHUK, MD role: CONTACT email: fasti@i.ua name: Andrii SHEVCHUK, MD role: PRINCIPAL_INVESTIGATOR lat: 50.45466 lon: 30.5238 hasResults: False

 nctId: NCT06367569 id: 2012//375 briefTitle: Evaluation of MRI of the Pineal Gland in Retinoblastoma acronym: TRbFU overallStatus: COMPLETED date: 2012-10-01 date: 2023-09-01 date: 2023-09-01 date: 2024-04-16 date: 2024-04-16 name: Amsterdam UMC, location VUmc class: OTHER briefSummary: Rationale: Currently baseline brain MRI (magnetic resonance imaging) with extended follow-up of pineal cysts is systematically performed in all new retinoblastoma (Rb) patients, because children with hereditary retinoblastoma have an increased risk of primitive neuroectodermal tumors (PNET) that are histopathologically identical to the retinal tumors (1). The prevalence of developing a PNET in combination with unilateral or bilateral hereditary Rb is 5-15% (2). Treatment is difficult and the prognosis is poor as only few survivors are reported. Only patients with small asymptomatic PNETs (\<15 mm) are potentially curable.

Objective: The main objective of this prospective multicenter study is to evaluate the current strategy of baseline MRI screening of the brain in newly diagnosed retinoblastoma patients, with extended follow-up of selected patients with simple and complicated pineal cysts.

Study design: The investigators propose a prospective cohort study (part of a larger multicenter study) to investigate the diagnostic accuracy and survival of baseline MRI screening of the pineal gland in new patients with retinoblastoma, with extended follow-up of selected patients with pineal cysts for early detection of pineoblastoma.

Study population: Within the European Retinoblastoma Imaging Collaboration (ERIC) about 150 new retinoblastoma patients are diagnosed every year. About 10 percent of all new retinoblastoma patients will be diagnosed at the VUmc. According to our sample size calculations the investigators will need 334 Rb patients.

Main study parameters/endpoints: The primary endpoint of the study is pineoblastoma or supra- / parasellar PNET on MRI (index test). Because a gold standard will not be available, tumor cells in cerebrospinal fluid, histopathological confirmation, clinical disease progression during follow-up, and/or follow-up MRI diagnostics will be used as a composite reference standard in case of a positive index test and clinical diagnosis of pineoblastoma or supra- / parasellar PNET within one year of the last MRI will be used as a composite reference standard in case of a negative index test. conditions: Retinoblastoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 607 type: ACTUAL name: Screening for trilateral retinoblastoma with MRI measure: Diagnostic accuracy of the screening measure: Survival analysis of trilateral retinoblastoma patients sex: ALL minimumAge: 0 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: VU University Medical Center city: Amsterdam state: Noord-Holland zip: 1081 HV country: Netherlands lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06367556 id: 4542 briefTitle: Emotion and Symptom-Focused Engagement (EASE) for Caregivers acronym: EASE overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-10-01 date: 2028-10-01 date: 2024-04-16 date: 2024-04-16 name: University Health Network, Toronto class: OTHER name: The Hospital for Sick Children name: Canadian Institutes of Health Research (CIHR) briefSummary: The goal of this two-site phase III randomized controlled trial is to evaluate the effectiveness of a novel psychotherapeutic intervention called Emotion and Symptom-focused Engagement (EASE) in parents caring for a child or adolescent with cancer. The main question it aims to answer is:

- Does EASE reduce traumatic stress symptom severity (primary outcome)?

To do so, researchers will compare parents receiving EASE to usual care. Participants in both groups will complete questionnaires package at enrolment, and 4, 8, and 12 weeks, and 6 months after enrolment. They will also be invited to participate in optional qualitative interviews to better understand their experience. conditions: Trauma and Stressor Related Disorders conditions: Pediatric Cancer conditions: Caregiver Burden studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Quantitative outcome assessors and data analysts will be blinded to participant treatment group. Blinding is not possible for trial participants, intervention providers, or pediatric oncology teams, as assignment cannot be hidden from these individuals. whoMasked: OUTCOMES_ASSESSOR count: 306 type: ESTIMATED name: EASE measure: Posttraumatic Stress Disorder Checklist for DSM-5 [PCL-5] measure: SF-36v2 Health Survey measure: Patient Health Questionnaire [PHQ-9] measure: Caregiving Health Engagement Scale [CHE-s] measure: Family Adaptability and Cohesion Evaluation Scales III [FACES-III] measure: Clinical Evaluation Questionnaire [CEQ] measure: Family Satisfaction with End-of-Life Care Tool, 10-item version [FAMCARE-10] measure: Traditional Masculinity-Femininity Scale [TMF] measure: Caregiver Reaction Assessment Scale [CRA] measure: ENRICHD Social Support Instrument [ESSI] measure: Experiences in Close Relationships Scale [ECR-16] measure: Hope of Improvement subscale of the Therapy Expectation and Evaluation Scale [PATHEVH] sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06367543 id: AZ 117/22 briefTitle: Guideline-recommended Basic Parameter Adherence in Neurocritical Care Patients acronym: NORMONICU overallStatus: ACTIVE_NOT_RECRUITING date: 2022-11-30 date: 2024-02-29 date: 2024-12-31 date: 2024-04-16 date: 2024-04-16 name: University of Giessen class: OTHER name: University of Leipzig name: University of Wuerzburg name: Technical University of Munich name: Heidelberg University name: University of Cologne name: University of Mannheim name: University Hospital, Essen briefSummary: The aim of the planned study project is to assess the current situation regarding the treatment of patients with severe stroke at the neuro-critical care unit. Specifically, determination of whether the target parameters recommended in the guidelines for temperature, systolic blood pressure, mean arterial blood pressure, blood glucose, arterial oxygen partial pressure and arterial carbon dioxide partial pressure had to be maintained. From the planned data analysis, the need for the introduction of cerebrovascular bundles can be derived and planned. conditions: Stroke studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 474 type: ACTUAL name: Time in therapeutic range of vital parameters measure: Time in Therapy range measure: Acute measures measure: Invasive measures performed in the course of the Stay measure: Duration of ventilation measure: Deceased on Intensive Care. measure: NIHSS (National Institutes of Health Stroke Scale). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitätsklinikum Gießen city: Gießen state: Hessen zip: 35392 country: Germany lat: 50.58727 lon: 8.67554 hasResults: False

 nctId: NCT06367530 id: GS-TRIO-2024 briefTitle: Trilateral Retinoblastoma: Incidence and Outcomes acronym: GS-TRIO overallStatus: RECRUITING date: 2024-01-01 date: 2027-12-31 date: 2029-12-31 date: 2024-04-16 date: 2024-04-16 name: Amsterdam UMC, location VUmc class: OTHER briefSummary: Patients with heritable retinoblastoma are at risk to develop an intracranial brain tumor, which is often fatal. The investigators intend to look at the incidence and survival of trilateral retinoblastoma (which is a brain tumor that can either be located in the pineal gland or elsewhere in the brain) in retinoblastoma patients globally. All retinoblastoma patients from participating centers will be included. The investigators hypothesize that the apparent incidence of trilateral retinoblastoma (especially the usually later diagnosed pineal trilateral retinoblastoma) in low-income countries will be lower because of low chances of surviving the ocular tumors at about 50% and also because of possible under-diagnosis. Therefore, as retinoblastoma care improves in low-income countries the incidence of (pineal) trilateral retinoblastoma might go up. Knowledge about incidence and survival can help improve health practices in parts of the world where this might be needed. Therefore this global study firstly aims 1) to evaluate survival after trilateral retinoblastoma and factors influencing survival and 2) to evaluate incidence of trilateral retinoblastoma by country income level. The study will run from 2024 through 2027. conditions: Trilateral Retinoblastoma conditions: Retinoblastoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 4351 type: ESTIMATED name: Incidence and survival of trilateral retinoblastoma and the differences globally measure: Number of participants (retinoblastoma patients) that will be diagnosed with trilateral retinoblastoma (incidence) measure: Overall and event-free survival after being diagnosed with trilateral retinoblastoma sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Amsterdam UMC status: RECRUITING city: Amsterdam state: Noord-Holland zip: 1082HV country: Netherlands name: Pim de Graaf, MD PhD role: CONTACT phone: 800-555-5555 email: p.degraaf@amsterdamumc.nl lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06367517 id: KB/114/2022 briefTitle: Tocilizumab in Corticosteroid-Resistant Graves' Orbitopathy (Thyroid Eye Disease) overallStatus: RECRUITING date: 2021-05-20 date: 2025-05-20 date: 2026-05-20 date: 2024-04-16 date: 2024-04-16 name: Medical University of Warsaw class: OTHER briefSummary: The aim of this study is to evaluate the efficacy and safety of Tocilizumab as second/third line treatment in patients with Active Moderate-to-Severe Corticosteroid-Resistant Thyroid Eye Disease. conditions: Orbitopathy, Graves conditions: Thyroid Eye Disease conditions: Ophthalmopathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Tocilizumab measure: Disease improvement measure: Improvement of quality of life measure: Disease inactivation measure: Proportion of patients achieving response in specific GO signs and symptoms measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 measure: Decrease in concentration of thyrotropin receptor antibodies measure: Decrease in levels of proinflammatory cytokines measure: Number of the rehabilitative surgeries performed after immunosuppressive therapy measure: The rate of disease relapse measure: Decrease in proptosis by at least 2 mm assessed using magnetic resonance imaging (MRI) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Internal Medicine and Endocrinology, Medical University of Warsaw status: RECRUITING city: Warsaw zip: 02-097 country: Poland name: Tomasz Bednarczuk, MD, PHD role: CONTACT email: tomasz.bednarczuk@wum.edu.pl name: Joanna Rymuza, MD, PHD role: CONTACT email: joanna.rymuza@wum.edu.pl name: Tomasz Bednarczuk, MD, PHD role: PRINCIPAL_INVESTIGATOR name: Joanna Rymuza, MD, PHD role: SUB_INVESTIGATOR name: Aleksander Kuś, MD, PHD role: SUB_INVESTIGATOR lat: 52.22977 lon: 21.01178 hasResults: False

 nctId: NCT06367504 id: DB/230904/DBMF/CDI briefTitle: A Study to Assess the Effect of Doctor's Biome Medical Food in Individuals With Clostridium Difficile Infection overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-15 date: 2024-12-30 date: 2024-04-16 date: 2024-04-16 name: Vedic Lifesciences Pvt. Ltd. class: INDUSTRY briefSummary: A randomized, double-blind, placebo-controlled, pilot clinical study to assess the effect of Doctor's Biome Medical Food (DBMF) in individuals with Clostridium difficile infection (CDI) conditions: Clostridium Difficile Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, parallel group, double-blind, placebo-controlled trial primaryPurpose: OTHER masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: DBMF name: Placebo measure: To evaluate the effect of Investigational product on the duration of Clostridium difficile diarrhea in comparison to placebo. measure: To assess the impact of the Investigational product on Number of CDI diarrhea episodes presence of Clostridium difficile in stool samples as assessed by C. difficile toxins A & B - CARD. measure: To assess the impact of the Investigational product on Change in the frequency of watery stools from Bristol Stool Form Scale (BSFS) score type 7 as compared to placebo. measure: To assess the impact of the Investigational product on Number of non-CDI diarrhea episodes as compared to placebo measure: To assess the impact of the Investigational product on Number of SOC medication consumed (antibiotics therapy) throughout the intervention period as compared to placebo. measure: To assess the impact of the Investigational product on Average number of days of consumption of SOC (antibiotics therapy) as compared to placebo. sex: ALL minimumAge: 30 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AIMS Hospital city: Dombivali state: Maharashtra zip: 421203 country: India name: Dr Sandeep Kardian, MBBS MD role: CONTACT phone: 870364574 email: sandeepkadian@rediffgmail.com lat: 19.21667 lon: 73.08333 facility: Stress Test Clinic city: Mumbai state: Maharashtra zip: 400059 country: India name: Dr Ramesh Dargad, MBBS MS role: CONTACT phone: 9820152828 email: rohitdargad@outlook.com lat: 19.07283 lon: 72.88261 facility: Nobel Hospital city: Pune state: Maharashtra zip: 411013 country: India name: Dr Pramod Katare, MBBS MD role: CONTACT phone: 8830793201 email: drkatareps@gmail.com lat: 18.51957 lon: 73.85535 facility: Gleneagles Hospital city: Hyderabad state: Telangana zip: 500004 country: India name: Dr G S Sameer Kumar, MBBS MD role: CONTACT phone: 8860031692 email: sameerzidane@gmail.com lat: 17.38405 lon: 78.45636 hasResults: False

 nctId: NCT06367491 id: IRST100.12 briefTitle: National Database of Bone Metastases acronym: BDMO overallStatus: RECRUITING date: 2013-10-08 date: 2030-01-01 date: 2030-01-01 date: 2024-04-16 date: 2024-04-16 name: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori class: OTHER briefSummary: BDMO is an Italian multicentre, observational, prospective study that collects data from all patients with bone metastases referred to each participating centre, using an on-line software 'tailor-made' for data collection. conditions: Bone Metastases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 800 type: ESTIMATED name: Registration in a database measure: The establishment of a National Bone Metastasis Database at the IRCCS IRST measure: Evaluation of clinical factors related to the primary tumor and metastases measure: Evaluation of clinical factors related to the primary tumor and metastases measure: Evaluation of clinical factors related to the primary tumor and metastases measure: Impact of treatment on skeletal events (SRE) measure: Analysis of overall efficiency of the mono- and multidisciplinary pathway on skeletal events (SRE) measure: Evaluation of biological factors related to the primary tumour and metastases sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: A.U.S.L. Imola status: RECRUITING city: Imola state: Bologna country: Italy name: Antonio Maestri, MD role: CONTACT lat: 44.35916 lon: 11.7132 facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) status: RECRUITING city: Meldola state: FC zip: 47014 country: Italy name: Nicoletta Ranallo, MD role: CONTACT phone: 0543739100 email: nicoletta.ranallo@irst.emr.it name: Nicoletta Ranallo, MD role: SUB_INVESTIGATOR lat: 44.12775 lon: 12.0626 facility: Osp. "Sacro Cuore di Gesù" status: NOT_YET_RECRUITING city: Gallipoli state: Lecce country: Italy name: Rosachiara Forcignanò, MD role: CONTACT lat: 40.05594 lon: 17.99088 facility: Osp. S. Vincenzo - ASP Messina status: RECRUITING city: Taormina state: Messina country: Italy name: Francesco Ferrarù, MD role: CONTACT lat: 37.85358 lon: 15.28851 facility: Osp. Ramazzini di Carpi - AUSL Modena status: RECRUITING city: Carpi state: Modena country: Italy name: Fabrizio Artioli, MD role: CONTACT lat: 44.78237 lon: 10.8777 facility: P.O. "S. Maria delle Grazie" status: RECRUITING city: Pozzuoli state: Napoli country: Italy name: Gaetano Facchini, MD role: CONTACT lat: 40.84394 lon: 14.0952 facility: Osp. degli Infermi status: RECRUITING city: Faenza state: Ravenna country: Italy name: Enrico Campadelli, MD role: CONTACT lat: 44.29007 lon: 11.87948 facility: Ospedale Umberto I status: RECRUITING city: Lugo state: Ravenna country: Italy name: Enrico Campadelli, MD role: CONTACT lat: 44.42137 lon: 11.91094 facility: Istituto Neurotraumatologico Italiano (INI) status: RECRUITING city: Grottaferrata state: Roma country: Italy name: Gaetano Lanzetta, MD role: CONTACT lat: 41.78664 lon: 12.67144 facility: A.O.U. Ospedali Riuniti status: RECRUITING city: Ancona country: Italy name: Rosanna Berardi, MD role: CONTACT lat: 43.5942 lon: 13.50337 facility: Centro di Riferimento Oncologico - IRCCS CRO status: RECRUITING city: Aviano country: Italy name: Alessandro Del Conto, MD role: CONTACT lat: 46.07056 lon: 12.59472 facility: A.O.U.C. Policlinico di Bari Osp."Giovanni XXIII" status: RECRUITING city: Bari country: Italy name: Stefania Succi, MD role: CONTACT lat: 41.11148 lon: 16.8554 facility: A.O. "S. Pio" status: RECRUITING city: Benevento country: Italy name: Vincenzo Ricci, MD role: CONTACT lat: 41.1307 lon: 14.77816 facility: IRCCS Ist. Ortopedico Rizzoli status: RECRUITING city: Bologna country: Italy name: Toni Ibrahim, MD role: CONTACT lat: 44.49381 lon: 11.33875 facility: ASST Spedali Civili di Brescia status: RECRUITING city: Brescia country: Italy name: Rebecca Pedersini, MD role: CONTACT lat: 45.53558 lon: 10.21472 facility: A.O. S. Croce e Carle status: RECRUITING city: Cuneo country: Italy name: Marcella Occelli, MD role: CONTACT lat: 44.39071 lon: 7.54828 facility: A.O.U. "Arcispedale S. Anna" - AUSL Ferrara status: RECRUITING city: Ferrara country: Italy name: Antonio Frassoldati, MD role: CONTACT lat: 44.83804 lon: 11.62057 facility: Ospedale Civile di Legnano - ASST Ovest Milanese status: RECRUITING city: Legnano country: Italy name: Elena Farè, MD role: CONTACT lat: 45.59788 lon: 8.91506 facility: Fond. IRCCS Istituto Nazionale dei Tumori - INT status: RECRUITING city: Milano country: Italy name: Valentina Guadalupi, MD role: CONTACT lat: 45.46427 lon: 9.18951 facility: A.O.R.N. "A. Cardarelli" status: RECRUITING city: Napoli country: Italy name: Ferdinando Riccardi, MD role: CONTACT lat: 40.85216 lon: 14.26811 facility: Istituto Oncologico Veneto status: RECRUITING city: Padova country: Italy name: Marco Maruzzo, MD role: CONTACT lat: 45.40797 lon: 11.88586 facility: Fond. IRCCS Policlinico San Matteo status: RECRUITING city: Pavia country: Italy name: Elisa Ferraris, MD role: CONTACT lat: 45.19205 lon: 9.15917 facility: Osp. Guglielmo da Saliceto status: RECRUITING city: Piacenza country: Italy name: Luigi Cavanna, MD role: CONTACT lat: 45.05242 lon: 9.69342 facility: Osp. S. Maria delle Croci status: RECRUITING city: Ravenna country: Italy name: Enrico Campadelli, MD role: CONTACT lat: 44.41344 lon: 12.20121 facility: IRCCS Arcispedale S. Maria Nuova - A.O. Reggio Emilia status: RECRUITING city: Reggio Emilia country: Italy name: Maria Banzi, MD role: CONTACT lat: 44.69825 lon: 10.63125 facility: Ospedale degli Infermi status: RECRUITING city: Rimini country: Italy name: Manuela Fantini, MD role: CONTACT lat: 44.05755 lon: 12.56528 facility: IRCCS Fond. Policlinico "A. Gemelli" - U.O.C. Oncologia Medica status: RECRUITING city: Roma country: Italy name: Emilio Bria, MD role: CONTACT lat: 41.89193 lon: 12.51133 facility: IRCCS Fond. Policlinico "A. Gemelli" - U.O.S. Senologia Medica / U.O.C. Ginecologia oncologica status: RECRUITING city: Roma country: Italy name: Alessandra Fabi, MD role: CONTACT lat: 41.89193 lon: 12.51133 facility: Ospedale di Treviglio - Caravaggio ASST Bergamo Ovest status: RECRUITING city: Treviglio country: Italy name: Andrea Luciani, MD role: CONTACT lat: 45.52081 lon: 9.59102 facility: A.O.U.I. Verona status: RECRUITING city: Verona country: Italy name: Jessica Menis, MD role: CONTACT lat: 45.4299 lon: 10.98444 hasResults: False

 nctId: NCT06367478 id: SPEMG briefTitle: Evaluation of Nerve Conduction Study acronym: SPEMG overallStatus: ACTIVE_NOT_RECRUITING date: 2021-08-01 date: 2021-10-22 date: 2024-10-22 date: 2024-04-16 date: 2024-04-16 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: the investigators study different modality to obtain nerve evoked reponses. They use different parameters of acquisition and stimulation and they compare amplitude and latency of nerve conduction response conditions: Nerve Condition conditions: Health, Subjective studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 125 type: ACTUAL measure: best amplitude of nerve conduction study sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico of Milan city: Milan zip: 20122 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06367465 id: 202308056 briefTitle: Feasibility and Acceptability of HCV Treatment in Pregnancy overallStatus: RECRUITING date: 2024-02-01 date: 2026-02-28 date: 2026-02-28 date: 2024-04-16 date: 2024-04-16 name: Washington University School of Medicine class: OTHER briefSummary: Pregnant adults over the age of 18 who are seen in the Washington University obstetrics and gynecology, maternal fetal medicine or infectious diseases clinic or admitted to BJH with hepatitis C virus infection who have a history of past or current drug use

Participant Duration: Approximately 1 year.

Aims:

Aim 1 - Evaluate adherence and treatment completion rates when glecaprevir-pibrentasvir is started during pregnancy for women who use drugs.

Aim 2 - Evaluate patient experience with hepatitis C virus treatment during pregnancy. conditions: Hepatitis C conditions: Pregnancy Complications studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Glecaprevir-pibrentasvir measure: Medication adherence and treatment completion rates. measure: Patient satisfaction Questionnaire measure: Virologic outcome and clinical success at Day 28 post treatment measure: Sample size estimation for future study sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Barnes Jewish Hospital status: RECRUITING city: Saint Louis state: Missouri zip: 63110 country: United States name: Tracey Bach role: CONTACT phone: 314-273-6075 email: habrockt@wustl.edu name: Laura Marks, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 38.62727 lon: -90.19789 facility: Washington Univeristy status: RECRUITING city: Saint Louis state: Missouri zip: 63110 country: United States name: Laura Marks, MD,PhD role: CONTACT email: marks@wustl.edu name: Tracey Habrock-Bach, MBA role: CONTACT phone: 314-273-6075 email: habrockt@wustl.edu lat: 38.62727 lon: -90.19789 hasResults: False

 nctId: NCT06367452 id: CAEP 107.001.23 briefTitle: Exploratory Pilot Study to Evaluate the Pharmacokinetic Profile of Magaldrate overallStatus: COMPLETED date: 2023-10-31 date: 2024-01-15 date: 2024-03-30 date: 2024-04-16 date: 2024-04-16 name: Tecnoquimicas class: INDUSTRY briefSummary: The goal of this clinical pilot study is to evaluate the pharmacokinetic profile of magaldrate in a group of 10 healthy women, after the administration of a 10 mL drug suspension containing 500 mg of sodium alginate, 267 mg of sodium bicarbonate, 800 mg of magaldrate and 120 mg of simeticone. The main question it aims to answer is the amount of magnesium and/or aluminum, if any, absorbed into the plasma from this oral administration.

Participants will take the medication 30 minutes after a standard breakfast. Both groups of participants will take the standard meal but one group will take the medication and the other one won't.

Researchers will compare the levels of both ions in plasma in a group to see if there is any absorption, quantifying the basal plasma levels and comparing with the levels obtained after the meal and the medication, when it applies. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 10 type: ACTUAL name: Sodium alginate + sodium bicarbonate + magaldrate + simeticone measure: Cmax for Aluminum measure: AUC for Aluminum measure: Cmax for Magnesium measure: AUC for Magnesium measure: Amount of aluminum ions absorbed after drug administration vs amount provided by food sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: CAEP city: Campinas state: Sao Paulo zip: 13087-567 country: Brazil lat: -22.90556 lon: -47.06083 hasResults: False

 nctId: NCT06367439 id: FN-10984 briefTitle: Examining the Effects of Virtual Reality Exercise on Mental Health acronym: UVIC VR Fit overallStatus: RECRUITING date: 2024-03-19 date: 2025-06 date: 2025-06 date: 2024-04-16 date: 2024-04-26 name: University of Victoria class: OTHER name: Meta Platforms, Inc. briefSummary: The primary purpose of this investigation is to examine the effectiveness of virtual reality (VR) exercise (Supernatural exergaming via Meta Platforms Technologies, LLC) for improving mental health as indicated by (1) both short-term mood (one exercise bout) and long-term (10-weeks) mood (depression and anxiety symptoms), (2) well-being (i.e., vitality) over a 10-week period, and (3) perceived cognitive function over a 10-week period. The secondary purpose of this study is to examine the effectiveness of VR exercise for improving both physical activity behaviour and physical activity motivation (attitudes, capability, opportunity, behavioural regulation, habit, identity) over a 10-week period. The tertiary purpose is to examine whether key motivational variables (e.g., attitudes, capability, opportunity, behavioural regulation, habit, identity) regarding Supernatural use explain variability in Supernatural use over time. conditions: Mental Health conditions: Mood conditions: Well-Being, Psychological conditions: Physical Activity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study will utilize a 10-week, two-arm, single-blinded, waitlist control, randomized controlled trial (RCT). Healthy adults (19-64 years) from the Victoria community participating in less than 75 minutes of vigorous physical activity per week will be randomized to either the Supernatural (SN) condition or the wait-list control (WLC) condition for a 10-week period. primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Single - Primary Investigator whoMasked: INVESTIGATOR count: 150 type: ESTIMATED name: Supernatural Condition name: Supernatural Condition measure: Depression and anxiety mood symptoms measure: Well-being: subjective vitality measure: Perceived cognitive function measure: Short-term Mood measure: Core Affect Measure - Feeling Scale measure: Core Affect Measure - Felt Arousal Scale measure: Perceived exertion measure: Supernatural Target Accuracy measure: Attitude towards physical activity measure: Attitude towards Supernatural physical activity measure: Perceived opportunity for physical activity measure: Perceived opportunity for Supernatural physical activity measure: Perceived capability for physical activity measure: Perceived capability for Supernatural physical activity measure: Intentions for physical activity behaviour measure: Intention for regular Supernatural physical activity behaviour measure: Behavioural regulation of physical activity behaviour measure: Behavioural regulation of Supernatural physical activity measure: Physical activity habit measure: Supernatural physical activity habit measure: Physical activity identity measure: Supernatural physical activity identity measure: Physical activity behaviour measure: Supernatural physical activity behaviour measure: Weekly Supernatural Physical Activity Behaviour measure: Direct assessment of Supernatural physical activity behaviour measure: Direct assessment of physical activity behaviour measure: Feasibility and Acceptability of Supernatural and the Meta Quest 3 headset measure: Supernatural usability measure: Meta Quest 3 headset usability measure: Personality measure: Physical Activity Environment sex: ALL minimumAge: 19 Years maximumAge: 64 Years stdAges: ADULT facility: Behavioural Medicine Lab status: RECRUITING city: Victoria state: British Columbia zip: V8W3N4 country: Canada name: Colin Wierts, PhD role: CONTACT name: Ryan Rhodes, PhD role: PRINCIPAL_INVESTIGATOR lat: 48.43294 lon: -123.3693 hasResults: False

 nctId: NCT06367426 id: Pharmacobio briefTitle: A Phase I Study of DDN-A-0101 in Healthy Volunteers and Elder People overallStatus: RECRUITING date: 2024-04 date: 2025-05 date: 2025-05 date: 2024-04-16 date: 2024-04-16 name: Pharmacobio class: INDUSTRY briefSummary: The study is a Phase I, randomized double-blind, placebo-controlled, single and multiple dosing, dose-escalation study of the oral administration of DDN-A-0101 in healthy adults and elderly subjects conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: To maintain double-blindness, DDN-A-0101 tablets and placebo with the same formulation and properties that cannot be distinguished in appearance will be used, and sub-packaging will also be the same. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: DDN-A-0101 (SAD) name: DDN-A-0101 (MAD) name: Placebo (SAD) name: Placebo (MAD) measure: Assessment of safety and tolerability of DDN-A-0101 by monitoring vital signs measure: Assessment of safety and tolerability of DDN-A-0101 by monitoring vital signs measure: Assessment of safety and tolerability of DDN-A-0101 by monitoring vital signs measure: Assessment of safety and tolerability of DDN-A-0101 by monitoring ECG measure: Assessment of safety and tolerability of DDN-A-0101 by C-SSRS measurement measure: Assessment of safety and tolerability of DDN-A-0101 by laboratory safety tests measure: Assessment of safety and tolerability of DDN-A-0101 by laboratory safety tests measure: Assessment of safety and tolerability of DDN-A-0101 by laboratory safety tests measure: Assessment of pharmacokinetics of Quercitrin, an indicator of of DDN-A-0101 in plasma measure: Assessment of pharmacokinetics of Quercitrin in plasma measure: Assessment of pharmacokinetics of Quercitrin in plasma measure: Assessment of pharmacokinetics of Quercitrin in plasma measure: Assessment of pharmacokinetics of Quercitrin in plasma measure: Assessment of pharmacokinetics of Quercitrin in plasma measure: Assessment of pharmacokinetics of Quercitrin in plasma measure: Assessment of pharmacokinetics of Quercitrin in plasma measure: Assessment of pharmacokinetics of Quercitrin in urine measure: Assessment of pharmacokinetics of Quercitrin in urine measure: Assessment of pharmacokinetics of Quercitrin in urine measure: Assessment of pharmacodynamics of DDN-A-0101 for PART2 MAD test measure: Assessment of pharmacodynamics of DDN-A-0101 for PART2 MAD test sex: ALL minimumAge: 19 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University College of Medicine and Hospital status: RECRUITING city: Seoul zip: 03080 country: Korea, Republic of name: In-Jin Jang, Doctor role: CONTACT phone: 82-2-740-8290 email: ijjang@snu.ac.kr lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06367413 id: UTH-PRoNAC Study briefTitle: Effects of Protein and NAC Co-ingestion on Skeletal Muscle Recovery acronym: PRoNAC overallStatus: RECRUITING date: 2024-04-08 date: 2024-06-20 date: 2024-09-30 date: 2024-04-16 date: 2024-04-16 name: University of Thessaly class: OTHER briefSummary: Previous evidence suggests that though N-acetylcysteine (NAC) supplementation following eccentric exercise-induced muscle damage disrupts the skeletal muscle's repair and remodelling process at 8 days of recovery, it attenuates substantially the decline of skeletal muscle performance during the first 48 hours of recovery. The enhanced performance capacity during the first phase of recovery in response to NAC supplementation might be attributed to the altered redox status in skeletal muscle as a consequence of the NAC-mediated elevation of reduced glutathione (GSH) levels. The rise in GSH results in a redox-dependent attenuation of immune cell mobilisation and reduction of oxidative stress response, leading to a blunted rise of muscle damage and inflammatory markers during the first 2-3 days of recovery. However, following exercise-induced muscle damage, protein synthesis increases in skeletal muscle over the next 24-48 hours to support its repair process, and thus protein supplementation might accelerate the recovery process by enhancing the protein synthetic response. Therefore, the present study aims at investigating for first time the combined effect of NAC and whey protein supplementation on the short-term (during the first 72 hours) recovery process of skeletal muscle following damaging exercise (eccentric exercise) and compared it with the well-documented efficacy of NAC supplementation. The results of this study might be particularly useful for athletes, such as those in soccer and basketball, that participate in 3 games or intense training sessions during the same macrocycle with only 48-72 hours of recovery in-between. conditions: Aseptic Muscle Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized, double-blind, placebo-controlled, parallel group model. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Participants, outcomes assessor and the principal investigator will be blinded until the intervention and the outcomes' assessment is done. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Placebo name: NAC name: NAC + Whey Protein measure: Change in maximal voluntary isometric muscle contraction. measure: Change in countermovement jump height. measure: Change in delayed onset of muscle soreness (DOMS) measure: Change in reduced glutathione content. measure: Change in oxidized glutathione content. measure: Change in catalase activity. measure: Change in protein carbonyl concentration measure: Change in myoglobin concentration in blood. measure: Participants' lean body mass measure: Participants' daily physical activity-related energy expenditure. measure: Participants daily dietary intake. measure: Participants' resting metabolic rate. measure: Participants' cardiorespiratory fitness status. measure: Participants' fat free mass. measure: Participants' fat mass. measure: Participants' body fat percent. sex: MALE minimumAge: 18 Years maximumAge: 27 Years stdAges: ADULT facility: Department of Physical Education and Sport Science, University of Thessaly status: RECRUITING city: Tríkala state: Karies zip: 42100 country: Greece name: Dimitrios Draganidis, PhD role: CONTACT phone: +30 2431047078 email: ddraganidis@uth.gr name: Ioannis G Fatouros, PhD role: CONTACT phone: +302431047047 email: ifatouros@uth.gr lat: 39.55493 lon: 21.76837 hasResults: False

 nctId: NCT06367400 id: SwePSQ briefTitle: Validation of Pediatric Sleep Questionnaire on a Swedish Cohort overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2034-12-31 date: 2024-04-16 date: 2024-04-16 name: Uppsala University class: OTHER name: Karolinska Institutet name: Örebro University, Sweden name: Umeå University name: Göteborg University briefSummary: This study is aimed to validate the questionnaire called Pediatric Sleep Questionnaire on a Swedish cohort of children from 18 months to 15 years old with obstructive sleep disordered breathing. conditions: Obstructive Sleep Apnea conditions: Sleep Disorder conditions: Sleep Disorders in Children conditions: Obstructive Sleep Apnea of Child studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 520 type: ESTIMATED name: Pediatric Sleep Questionnaire measure: Level of baseline PSQ measure: Changes of baseline PSQ after treatment measure: PSQ vs OSA-18 measure: PSQ vs. PSG measure: PSQ levels of healthy controls vs children with OSDB measure: 5 and 10 years follow-up sex: ALL minimumAge: 18 Months maximumAge: 15 Years stdAges: CHILD facility: Akademiska hospital status: RECRUITING city: Uppsala country: Sweden name: Isabella Sjölander role: CONTACT phone: 018-6110000 email: isabella.sjolander@uu.se lat: 59.85882 lon: 17.63889 hasResults: False

 nctId: NCT06367387 id: STUDY23080191 id: RM1DA055311 type: NIH link: https://reporter.nih.gov/quickSearch/RM1DA055311 briefTitle: Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment acronym: TREETOP overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2026-12 date: 2024-04-16 date: 2024-04-16 name: Jessica Merlin class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: This study seeks to improve the treatment of chronic pain in people who are taking buprenorphine (also known as Suboxone, Subutex, Zubsolv).

The research study is testing two different interventions along with usual clinical care:

1. Pain Self-Management (PSM): an educational program in which individuals with chronic pain work with a trained pain coach and a pain peer to explore strategies to effectively manage the daily problems that arise from chronic pain.
2. Patient-Oriented Dosing (POD): an alternative dosing of buprenorphine which will be adjusted based on pain levels.

The interventions will take place over a period of 12 weeks (3 months). Additionally, participants will complete surveys every 3 months for a period of 1 year (total of 5 survey visits). Participants will receive $50 compensation for each survey visit completed (up to $250 over one year) and can receive up to an additional $100 bonus compensation.

There are risks associated with participating in the study, including breach of confidentiality, psychological distress caused by discussing difficult topics, and risks associated with the POD intervention. conditions: Opioid Use Disorder conditions: Chronic Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: Participants will be stratified by recruitment clinic and dose of buprenorphine at enrollment (≤16 mg vs \>16 mg) and randomized in 2x2 factorial design: 1) either to PSM or Usual Care, and then 2) either to POD or standard buprenorphine dosing. The randomization schema will be generated by the TREETOP Data Core using a stratified permuted block design and will be integrated into the web-based data collection and management system (REDCap). primaryPurpose: TREATMENT masking: NONE count: 460 type: ESTIMATED name: Patient-Oriented Dosing (POD) name: Pain Self-Management (PSM) name: Usual Care name: Standard Buprenorphine Dosing Condition measure: Change from Baseline in Pain Interference as Assessed by the PROMIS SF v1.0 - Pain Interference 4a at 3 months Post-baseline measure: Proportion of Participants Retained in buprenorphine Treatment at 3 months Post-baseline measure: Change from Baseline in Overall Pain as Assessed by the PEG at 3 months Post-baseline measure: Change from Baseline in Pain Catastrophizing as Assessed by the Pain Catastrophizing Questionnaire-6-item at 3 months Post-baseline measure: Proportion of Participants Taking any MOUD at 3-, 6-, 9- and 12-months Post-baseline measure: Change from Baseline in Self-efficacy as Assessed by the PROMIS Self-Efficacy for Managing Symptoms SF-4a at 3 months Post-baseline measure: Number of Days Non-prescribed Opioids were Used in the past 30 days as Assessed by the Modified ASI at 3-months Post-baseline measure: Total score on the IMPOWR Opioid Misuse Screening scale at 3 months Post-baseline sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Outpatient Addiction Treatment Services (OATS) city: Baltimore state: Maryland zip: 21201 country: United States name: Research Team role: CONTACT email: HFitzsimons@som.umaryland.edu name: Eric Weintraub, MD role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 facility: Alcohol and Drug Abuse Program (ADAP) - UM Addiction Treatment Center city: Baltimore state: Maryland zip: 21223 country: United States name: Research Team role: CONTACT email: HFitzsimons@som.umaryland.edu name: Eric Weintraub, MD role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 facility: Comprehensive Care Practice (CCP) - Johns Hopkins Bayview Medical Center city: Baltimore state: Maryland zip: 21224 country: United States name: Research Team role: CONTACT email: TREETOP@pitt.edu name: Sophia Purekal, MD role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 facility: Wells House city: Hagerstown state: Maryland zip: 21740 country: United States name: Research Team role: CONTACT email: HFitzsimons@som.umaryland.edu name: Eric Weintraub, MD role: PRINCIPAL_INVESTIGATOR lat: 39.64176 lon: -77.71999 facility: Central City Concern (CCC) city: Portland state: Oregon zip: 97209 country: United States name: Research Team role: CONTACT email: treetop@ohsu.edu name: Jonathan Robbins, MD role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 facility: Recovery Works Northwest (RWNW) city: Portland state: Oregon zip: 97233 country: United States name: Research Team role: CONTACT email: treetop@ohsu.edu name: Jonathan Robbins, MD role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 facility: OHSU Harm Reduction Bridges to Care (HRBR) city: Portland state: Oregon zip: 97239 country: United States name: Research Team role: CONTACT email: treetop@ohsu.edu name: Jonathan Robbins, MD role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 facility: OHSU Internal Medicine Clinic (IMC) city: Portland state: Oregon zip: 97239 country: United States name: Research Team role: CONTACT email: treetop@ohsu.edu name: Jonathan Robbins, MD role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 facility: UPMC Latterman Family Health Center city: McKeesport state: Pennsylvania zip: 15132 country: United States name: Research Team role: CONTACT phone: 412-852-8499 email: TREETOP@pitt.edu name: Jessica Merlin, MD, PhD, MBA role: PRINCIPAL_INVESTIGATOR lat: 40.34785 lon: -79.86422 facility: UPMC St. Margaret Family Health Center city: New Kensington state: Pennsylvania zip: 15068 country: United States name: Research Team role: CONTACT phone: 412-852-8499 email: TREETOP@pitt.edu name: Jessica Merlin, MD, PhD, MBA role: PRINCIPAL_INVESTIGATOR lat: 40.56979 lon: -79.76477 facility: UPMC Internal Medicine Recovery Engagement Program (IM-REP) city: Pittsburgh state: Pennsylvania zip: 15219 country: United States name: Research Team role: CONTACT phone: 412-852-8499 email: TREETOP@pitt.edu name: Jessica Merlin, MD, PhD, MBA role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 facility: WVU Crisis Support & Recovery Center city: Martinsburg state: West Virginia zip: 25401 country: United States name: Research Team role: CONTACT phone: 304-290-9159 email: lychoo@hsc.wvu.edu name: Dorothy Van Oppen, MD role: PRINCIPAL_INVESTIGATOR lat: 39.45621 lon: -77.96389 facility: WVU Chestnut Ridge Comprehensive Addiction Treatment Program (COAT) city: Morgantown state: West Virginia zip: 26505 country: United States name: Research Team role: CONTACT phone: 304-290-9159 email: lychoo@hsc.wvu.edu name: Dorothy Van Oppen, MD role: PRINCIPAL_INVESTIGATOR lat: 39.62953 lon: -79.9559 hasResults: False

 nctId: NCT06367374 id: BGB-11417-2002-IIT；BDH-CLL-004 briefTitle: MRD Guided Sonrotoclax and Zanubrutinib in Newly Diagnosed CLL/SLL overallStatus: NOT_YET_RECRUITING date: 2024-05-30 date: 2030-02-28 date: 2030-07-30 date: 2024-04-16 date: 2024-04-16 name: Institute of Hematology & Blood Diseases Hospital, China class: OTHER briefSummary: This is a single-arm, open-label study of sonrotoclax plus zanubrutinib with MRD-driven treatment duration in patients with previously untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).

The primary goal of this study is to evaluate the efficacy of MRD-guided zanubrutinib plus sonrotoclax for first-line CLL/SLL treatment. conditions: Chronic Lymphocytic Leukemia conditions: Small Lymphocytic Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 66 type: ESTIMATED name: Sonrotoclax name: Zanubrutinib measure: 4-Year Progressive Free Survival (PFS) Rate measure: Rate of peripheral blood (PB) and Bone marrow (BM) undetectable minimal residual disease (uMRD) measure: Complete Response Rate (CRR; Complete Response/Complete Response with Incomplete Blood Count Recovery [CR/CRi]) Rate measure: Overall Response Rate (ORR) measure: Duration of Response (DOR) measure: Progression Free Survival (PFS) measure: Overall Survival (OS) measure: Time to Next Therapy (TTNT) measure: Overall survival rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06367361 id: SIDISI 201221 id: U01AI155323 type: NIH link: https://reporter.nih.gov/quickSearch/U01AI155323 briefTitle: One and Two Doses of Oxfendazole Versus a Schedule of Two Doses of Triclabendazole in Chronic Fascioliasis overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2028-03 date: 2028-03 date: 2024-04-16 date: 2024-04-16 name: Universidad Peruana Cayetano Heredia class: OTHER name: National Institute of Allergy and Infectious Diseases (NIAID) briefSummary: Randomized clinical trial comparing the efficacy and safety of oxfendazole at 20 mg/kg per dose in one and two dose regimens with a two-dose regimen of triclabendazole at 10 mg/kg in an endemic region of the highlands of Peru. Children and adults with fascioliasis in rural communities will be screened for inclusion and exclusion criteria and a total of 336 subjects (112 per study arm) with chronic Fasciola infection will be enrolled and assigned randomly to the study arms in a 1:1:1 ratio. The primary efficacy (cure and egg reduction) endpoints will be assessed on day 7 and 30 post treatment. The secondary safety endpoint visits will be performed in days 0, 3, 7 and 30 post-treatment and Population PK modeling studies will be performed in the first 24 hours after the first dose of oxfendazole. conditions: Fascioliasis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Study arm 1: Oxfendazole 100 mg tablets at 20 mg/kg of body weight as a single oral dose administered with a lipid containing meal under direct observation.

Study arm 2: Oxfendazole 100 mg tablets at 20 mg/kg of body weight per dose in two oral doses separated 24 hours each administered with a lipid containing meal under direct observation.

Study arm 3: Triclabendazole 250 mg tablets at 10 mg/kg of body weight per dose in two oral doses separated 24 hours each administered with a lipid containing meal under direct observation. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The laboratory personnel processing the stool microscopy tests will be blinded to the treatment assignment. Thus, the intervention will be blinded to the assessors of the primary endpoint. whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 336 type: ESTIMATED name: Oxfendazole name: Triclabendazole measure: Parasitological cure rate of chronic fascioliasis measure: Egg reduction rate day 7 measure: Egg reduction rate day 30 measure: Safety information on day 0 measure: Safety information on day 3 measure: Safety information on day 7 measure: Safety information on day 30 measure: Laboratory safety information day 7 measure: Laboratory safety information day 30 measure: Population pharmacokinetics model constructs for oxfendazole measure: Population pharmacokinetics model constructs for oxfendazole sulfone measure: Population pharmacokinetics model constructs fenbendazole sex: ALL minimumAge: 16 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06367348 id: R01AA031445 type: NIH link: https://reporter.nih.gov/quickSearch/R01AA031445 id: R01AA031445 type: NIH link: https://reporter.nih.gov/quickSearch/R01AA031445 briefTitle: An Economic and Relationship-strengthening Intervention to Reduce Alcohol Use in Malawi overallStatus: NOT_YET_RECRUITING date: 2025-01 date: 2028-05 date: 2028-05 date: 2024-04-16 date: 2024-04-24 name: University of California, San Francisco class: OTHER name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) briefSummary: With a full-scale randomized control trial, the investigators will evaluate the efficacy and cost effectiveness of Mlambe, an economic and relationship-strengthening intervention that provides incentivized saving accounts, financial literacy training, and relationship skills education to break the cycle of poverty around drinking, strengthen couple support and communication, and reduce heavy drinking among HIV-affected married couples with a partner who drinks alcohol in Malawi. conditions: HIV/AIDS conditions: Alcohol Abuse studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Couples will be randomized 1:1 to intervention or control arm primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 500 type: ESTIMATED name: Mlambe measure: Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test measure: Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test measure: Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test measure: Viral Suppression measured using whole blood viral load tests measure: Antiretroviral medication adherence measured using a Visual Analog Scale measure: Antiretroviral medication adherence measured using a Visual Analog Scale measure: Antiretroviral medication adherence measured using a Visual Analog Scale measure: Medical appointment adherence assessment measure: Medical appointment adherence assessment measure: Medical appointment adherence assessment measure: Number of drinking days measured using the "Timeline follow-back" method measure: Number of drinking days measured using the "Timeline follow-back" method measure: Number of drinking days measured using the "Timeline follow-back" method measure: AUDIT-C score measured using the Alcohol Use Disorders Identification Test. measure: AUDIT-C score measured using the Alcohol Use Disorders Identification Test. measure: AUDIT-C score measured using the Alcohol Use Disorders Identification Test. measure: PEth level measured using a Phosphatidylethanol biomarker test measure: PEth level measured using a Phosphatidylethanol biomarker test measure: PEth level measured using a Phosphatidylethanol biomarker test measure: Exploratory: Constructive Couple Communication measured using the mutually constructive communication subscale of the Communication Patterns Questionnaire. measure: Exploratory: Constructive Couple Communication measured using the mutually constructive communication subscale of the Communication Patterns Questionnaire. measure: Exploratory: Constructive Couple Communication measured using the mutually constructive communication subscale of the Communication Patterns Questionnaire. measure: Measuring alcohol-specific partner support using a measure adapted from the HIV-specific Partner Support Scale. measure: Measuring alcohol-specific partner support using a measure adapted from the HIV-specific Partner Support Scale. measure: Measuring alcohol-specific partner support using a measure adapted from the HIV-specific Partner Support Scale. measure: Exploratory: Assess the effects of Mlambe on Intimate Partner Violence (IPV) measure: Exploratory: Assess the effects of Mlambe on Intimate Partner Violence (IPV) measure: Exploratory: Assess the effects of Mlambe on Intimate Partner Violence (IPV) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Invest in Knowledge Initiative (IKI) city: Zomba country: Malawi lat: -15.38596 lon: 35.3188 hasResults: False

 nctId: NCT06367335 id: ETIC briefTitle: Characteristics and Predictors of Liver Injury in Cyclin-dependent Kinase Inhibitors 4/6 (CDK4/6)-Treated Patients With Advanced Breast Cancer acronym: ETIC overallStatus: COMPLETED date: 2022-06-01 date: 2022-09-01 date: 2022-12-31 date: 2024-04-16 date: 2024-04-16 name: University of Milano Bicocca class: OTHER briefSummary: The main objective of the study is to evaluate the presence of predictors (single characteristics at the baseline and / or a combination of two or more parameters) useful for predicting the development of Drug-Induced liver Injury (DILI) during treatment with cyclin-dependent kinase inhibitors (CKI) with the possibility of obtaining a pre-treatment prognostic score that can assist the clinician in pre-therapy decision making. conditions: DILI studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 128 type: ACTUAL name: Ribociclib, palbociclib, abemaciclib measure: Incidence of DILI measure: withdrawal of therapy measure: delayed reprise of antineoplastic therapy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Milano-Bicocca, city: Monza zip: 20900 country: Italy lat: 45.58005 lon: 9.27246 hasResults: False

 nctId: NCT06367322 id: EMP-PARA-20170-01 briefTitle: Statins and Post-ERCP Acute Pancreatitis (Stark Project) acronym: Stark overallStatus: COMPLETED date: 2017-01-10 date: 2018-07-31 date: 2018-09-30 date: 2024-04-16 date: 2024-04-16 name: Hospital General Universitario de Alicante class: OTHER name: European Pancreatic Club (EPC), Pancreas 2000 Educational Program briefSummary: Post-endoscopic retrograde cholangiopancrepatography (ERCP) acute pancreatitis (PEAP) is a frequent complication of this endoscopic procedure. Chronic statin intake has been linked to lower incidence and severity of acute pancreatitis (AP). Periprocedural rectal administration of non-steroidal anti-inflammatory drugs is protective against PEP, but the role of chronic acetylsalicylic acid (ASA) treatment is unclear. The aim of the study is to investigate whether statins and chronic ASA intake are associated with lower risk of PEAP. conditions: Post-ERCP Acute Pancreatitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1016 type: ACTUAL name: Statin measure: To assess the incidence and relative risk of PEAP according to statin use. measure: To assess the effect of chronic use of other drugs on the incidence and relative risk of PEAP. measure: To assess the effect of other factors (demographic and endoscopic) on the incidence and relative risk of PEAP and severity of PEAP (severity according to the Revised Atlanta Classification). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alicante city: Alicante zip: 03010 country: Spain lat: 38.34517 lon: -0.48149 facility: Hospital General Universitario de Alicante city: Alicante zip: 03010 country: Spain lat: 38.34517 lon: -0.48149 hasResults: False

 nctId: NCT06367309 id: 2023 - 02357 briefTitle: ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair acronym: ALPINE overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-12-31 date: 2030-12-31 date: 2024-04-16 date: 2024-04-16 name: University Hospital, Basel, Switzerland class: OTHER name: St. Clara Hospital, Basel, Switzerland name: Innklinikum Altötting, Germany briefSummary: This study investigates on the effect of two different operative techniques to treat abdominal wall hernias.

The goal of this clinical trial is to learn if the eTEP (Extended totally extraperitoneal repair) technique leads to a better outcome than the IPOM (Intraperitoneal onlay mesh) technique.

The main questions it aims to answer are:

* pain after the operation
* rate of complications
* rate of recurrence and reoperations
* quality of life.

Participants will:

Either be operated using the eTEP or the IPOM technique. Be followed up either in person or via email / phone call at day 1, day 7, day 14, 6 weeks, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes. conditions: Ventral Hernia conditions: Abdominal Wall Defect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The trial participants and the assessors (trained investigators not involved in the operative procedures) of the primary outcome are blinded regarding the performed procedure during the first seven days after the procedure to reduce bias. The blinding is guaranteed by not sharing the detailed operation report with anyone involved in the aftercare of the patient or in the assessment of study outcomes. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 138 type: ESTIMATED name: Extended totally extraperitoneal repair name: Intraperitoneal onlay mesh measure: primary outcome: pain numeric rating scale (NRS) measure: pain outcome using the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form 3a measure: pain mid-term measure: recurrence and reoperation measure: LOS measure: Functional recovery measure: Adverse events measure: Quality of life (SF 12) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St. Clara Hospital city: Basel state: Basel-Stadt zip: 4058 country: Switzerland name: Fiorenzo Angehrn, MD role: CONTACT email: fiorenzo.angehrn@clarunis.ch lat: 47.55839 lon: 7.57327 hasResults: False

 nctId: NCT06367296 id: RETOPO2024 briefTitle: Resistance Exercise Training in the Older Population With Obesity acronym: RETOPO overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-01-28 date: 2025-06-01 date: 2024-04-16 date: 2024-04-16 name: Universidad de La Frontera class: OTHER briefSummary: Background:

Aging leads to an alteration in the immune response, characterized by a chronic inflammatory state, and a progressive decrease in muscle quantity and quality, a situation that increases in women and in the presence of obesity. With respect to muscle quality, intramuscular infiltration of adipose tissue has been considered a relevant parameter, involved in the relationship between aging-obesity-inflammation. As a therapeutic strategy, physical training with resistance exercises (or also known as strength training) has been shown to be effective in increasing skeletal muscle mass in this age group. However, its role on muscle quality in normal-weight versus obese older women has not been fully addressed.

Hypothesis:

A 12-week resistance exercise training program is effective in improving muscle quality, immune response and physical performance in normal weight and obese older women. In addition to the above, the investigators hypothesize that women with obesity will present greater baseline alterations, so the percentage of change will be higher compared to older women with normal weight after the training program.

Goals:

The primary aim of this study is to evaluate the effects of a 12-week resistance exercise training on muscle quality (infiltration of intramuscular adipose tissue), immune response and physical performance in older women between 60 and 79 years of age with obesity compared to older women with normal weight of the same age range.

Methodology:

The present clinical trial will consider 2 groups of older women between 60 and 79 years old: normal weight (BMI=18.5 to 24.9 kg/m 2 and % fat \<25.9) and obese (BMI =30 to 39.9 Kg/m 2 and fat % \>32). Participants will perform 12 weeks of training with resistance exercises 3 times a week. Before and after training, intramuscular infiltration of adipose tissue (echogenicity) will be measured by ultrasound, followed by aspects of muscle architecture (muscle thickness, penile angle and fascicle length) and functional parameters of muscle quality (maximum strength determined by 1 repetition maximum-1RM, maximum voluntary isometric strength of knee extensors through a lower limb force and power transducer). Finally, fasting blood samples will be obtained (immune response) and physical performance, body composition, physical activity level, and quality of life will be evaluated. conditions: Aging conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: Prolonged resistance exercise training measure: Change in intermuscular adipose tissue (measured via ultrasonography) after prolonged resistance-type exercise training measure: Change in muscle thickness (measured via ultrasonography) after prolonged resistance-type exercise training measure: Change in pennation angle (measured via ultrasonography) after prolonged resistance-type exercise training measure: Change in fascicle length (measured via ultrasonography) after prolonged resistance-type exercise training measure: Change in physical performance (measured via Short physical performance battery (SPPB)) after prolonged resistance-type exercise training measure: Change in arms and legs strength (measured via 1-Repetition Maximum (1RM) testing) after prolonged resistance-type exercise training measure: Change in hand grip strength (measured via JAMAR(R) handheld dynamometer) after prolonged resistance-type exercise training measure: Change in maximum voluntary isometric strength (measured via Force transducer) after prolonged resistance-type exercise training. measure: Change in muscle power of the lower limbs (measured via Five Times Sit to Stand test) after prolonged resistance-type exercise training. measure: Change in Immune response in blood (measured via flow cytometry) after prolonged resistance-type exercise training. measure: Change in NETosis in blood (measured via IncuCyte) after prolonged resistance-type exercise training. measure: Change in Whole body lean mass (measured via Bioimpedance) after prolonged resistance-type exercise training. measure: Change in Whole body fat mass (measured via Bioimpedance) after prolonged resistance-type exercise training. measure: Change in Physical activity level (measured via IPAQ short version) after prolonged resistance-type exercise training. measure: Change in Quality of Life level (measured via SF-36) after prolonged resistance-type exercise training. sex: FEMALE minimumAge: 60 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universidad de La Frontera city: Temuco state: IX Región De La Araucanía zip: 4780000 country: Chile name: Nicolás Vidal-Seguel, MSc role: CONTACT phone: 998595445 email: nicolasenrique.vidal@ufrontera.cl name: GABRIEL MARZUCA, MSc, PhD role: CONTACT phone: 996343630 email: gabriel.marzuca@ufrontera.cl lat: -38.73965 lon: -72.59842 hasResults: False

 nctId: NCT06367283 id: 2023-509181-38-00 briefTitle: Metformin Treatment of Patients With Hand Osteoarthritis acronym: METRO overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2026-04 date: 2024-04-16 date: 2024-04-16 name: Marius Henriksen class: OTHER briefSummary: To compare metformin (2 g daily), or maximum tolerated dose, for 16 weeks with placebo as a treatment of hand osteoarthritis symptoms. conditions: Hand Osteoarthritis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Metformin name: Placebo measure: Finger pain measure: Function measure: Thumb base pain measure: Hand pain measure: Physician tender joint count measure: Patient global assessment measure: Quality of life assessed by the European Quality of life - 5 dimensions (EQ-5D) scale measure: Hand strength measure: Number of treatment responders measure: Stiffness of both hands measure: Composite of pain, function and stiffness measure: Physical function measure: Physician global assessment measure: Swollen joint count measure: Fatigue measure: Sleep quality measure: Absence or presence of inflammation of target hand measure: Change in use of analgesics measure: Inflammatory biomarker measure: Metabolic outcomes measure: Metabolic outcomes measure: Vitamin K measure: Proteomics sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Parker Institute, Bispebjerg and Frederiksberg hospital city: Copenhagen state: Frederiksberg zip: 2000 country: Denmark name: Kasper Staberg Madsen, MD role: CONTACT phone: +4538164162 email: kasperstabergmadsen@regionh.dk lat: 55.67594 lon: 12.56553 hasResults: False

 nctId: NCT06367270 id: UW 23-361 briefTitle: The Application of Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Surface Malignancies acronym: PIPAC overallStatus: RECRUITING date: 2023-09-01 date: 2026-08-31 date: 2027-08-31 date: 2024-04-16 date: 2024-04-16 name: The University of Hong Kong class: OTHER briefSummary: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel minimally invasive drug delivery system for patients with peritoneal metastases (PM). It has been considered as a safe and feasible palliative treatment alternative proven by previous phase I studies. Currently available evidence on feasibility, efficacy and tolerability in Asian populations is limited. In this open-label, single-arm, monocentric clinical trial, investigators aim to evaluate the therapeutic efficacy and complications of PIPAC with oxaliplatin as an alternative on patients of unresectable colorectal cancer with PM and doxorubicin and cisplatin on patients of unresectable gastric and pancreatic cancers with PM. Alternative regimen can be considered multidisciplinary tumour board meeting. Patients will be recruited according to the inclusion criteria and treated for 3 cycles of PIPAC and concurrent systemic chemotherapy. The goal was to repeat PIPAC every 6-8 weeks for at least three procedures, and the delay of the systemic chemotherapy is 2 weeks before and after each PIPAC procedure. If PM was considered to become resectable during PIPAC, patients were discussed at the multidisciplinary tumour board for curative intent cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The primary outcome is the clinical benefit rate (CBR), measured by an independent radiologist according to Response Evaluation Criteria In Solid Tumors (RECIST) and Peritoneal Cancer Index (PCI) assessed by laparoscopy and histopathological tumour response evaluated by pathologists blinded to clinical outcomes. Key secondary outcomes include the major and minor treatment-related adverse events according to the Common Terminology Criteria for Adverse Events (CTACE) up to 4 weeks after the treatment, Cytological tumour response of peritoneal lavage or ascites, treatment-related characteristics, hospital stay, progression-free survival, overall survival and readmission rate. The proposed study duration is 3 years from the start date and the estimated sample size is 51 according to centre capacity. conditions: Peritoneal Metastases studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Pressured Intraperitoneal Aerosol Chemotherapy measure: Clinical benefit rate (CBR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Queen Mary Hospital status: RECRUITING city: Hong Kong country: Hong Kong name: Ian WONG, Dr. role: CONTACT phone: +852 2255 4774 email: iyhwong@hku.hk name: Ian WONG, Dr. role: PRINCIPAL_INVESTIGATOR lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06367257 id: Emento App briefTitle: App-based Recording and Optimization of the Nutritional Status in Patients With Head and Neck Tumors During and After Radio(Chemo)Therapy overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2026-06-30 date: 2024-04-16 date: 2024-04-16 name: University of Erlangen-Nürnberg Medical School class: OTHER briefSummary: Patients with head and neck cancer requiring definitive or adjuvant radio(chemo)therapy can take part in the study. The aim is to record the nutritional status and diet of the patients during the trial and regularly at a period of 8 weeks after irradiation and to reduce the rate of weight loss and malnutrition. conditions: Squamous Cell Carcinoma of Head and Neck studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 148 type: ESTIMATED name: App Usage name: Standard of Care measure: Change in rates of weight loss with additional app-based Patient Care measure: Frequency of deteriorations in health status subjectively reported by patients and recorded via the app. measure: Frequency of additional app-triggered contacts of the clinic with the patients measure: Frequency of critical health conditions (physician-verified) detected earlier by the app. measure: Change in quality of life measured per questionnaires measure: Change of incidence of malnutrition and sarcopenia before, during and after radio(chemo)therapy. measure: Change of course of malnutrition and sarcopenia before, during and after radio(chemo)therapy. measure: Rate of therapy interruptions/discontinuations measure: Overall survival measure: Disease-free/progression-free survival measure: Change of Loco-regional tumor control sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitätsklinikum Erlangen, Strahlenklinik city: Erlangen state: Bavaria zip: 91054 country: Germany name: Marlen Haderlein, PD role: CONTACT phone: +49913185 phoneExt: 33968 email: marlen.haderlein@uk-erlangen.de name: Studiensekretariat role: CONTACT phone: +49913185 phoneExt: 33968 email: studiensekretariat.ST@uk-erlangen.de name: Allison Lamrani role: PRINCIPAL_INVESTIGATOR name: Charlotte Schmitter, Dr. role: PRINCIPAL_INVESTIGATOR lat: 49.59099 lon: 11.00783 hasResults: False

 nctId: NCT06367244 id: TWP2023 briefTitle: Transplant Wellness Program acronym: TWP overallStatus: RECRUITING date: 2023-11-16 date: 2033-11 date: 2033-11 date: 2024-04-16 date: 2024-04-16 name: University of Calgary class: OTHER briefSummary: Wellness is defined as the active pursuit of activities, choices and lifestyles that lead to a state of overall health. Prehabilitation, or using rehabilitation in the period before surgery, can improve the pre, during, and post operative experience for the patient. Although exercise as prehabilitation has been well established in organ transplant, the investigators believe a multiphase approach will help to better serve patients and support patient wellness in the long-term. Supporting wellness behaviour change, such as exercise, stress reduction, and sleep, is associated with improved quality of life (QoL), mood, and improvements in well-being. Including behaviour change support in an exercise program can help support transplant patients in long-term positive lifestyle changes. The Transplant Wellness Program (TWP) is an exercise behaviour change program that includes additional wellness components such as nutrition, stress reduction, and sleep programs to support overall health and QoL of transplant patients. Specifically, the TWP will implement physical activity and behaviour change support for patients pre- and post-transplant surgery, addressing functional (frailty, indices of fitness, physical activity levels) and mental (anxiety, stress) outcomes to improve overall QoL. The TWP includes a 12-week exercise program that is delivered either pre-transplant or post-transplant, depending on length of time from study enrollment to transplant surgery. In addition to the exercise intervention, the TWP includes maintenance resources (access to group exercise classes, wellness webinars, group wellness coaching etc.), and wellness behaviour change support. The goal of the TWP is to improve outcomes of participants throughout their transplant journey, as well as reduce health services use. Collected outcomes will include program reach, effectiveness measures such as changes in physical fitness, adoption by healthcare practitioners, implementation of the program, and maintenance. In addition, will also collect health care use measures as the investigators believe the TWP will result in the reduction of several health care use outcomes, such as the number of hospital admissions (including intensive care unit admissions), length of hospital stays and emergency room utilization. conditions: Transplantation studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The TWP is a parallel study design with two arms. Participants are assigned to either the kidney or liver arm depending on the organ transplant they are listed or in evaluation for. Each arm will have a pre- or post- transplant group. Participants will be assigned to group depending on length of time between study enrollment and transplant surgery. Those with more than 12-weeks until surgery will complete the TWP pre-transplant and those with less than 12-weeks will complete the TWP post-transplant. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 420 type: ESTIMATED name: Transplant Wellness Program - Kidney and Liver measure: Self-reported exercise measure: Generic self-reported quality of life measure: Kidney disease quality of life. measure: Liver disease quality of life measure: Frailty measure: Hand grip strength measure: Lower extremity flexibility measure: Aerobic Endurance measure: Lower extremity muscular strength measure: Balance measure: Nutrition measure: Sleep measure: Mental Health measure: Self-efficacy measure: Program implementation and evaluation measure: Health economic evaluation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Calgary status: RECRUITING city: Calgary state: Alberta zip: T2N 1N4 country: Canada name: Maneka Perinpanayagam, PhD role: CONTACT phone: 403-944-3699 email: maneka.perinpanayagam@ucalgary.ca name: S. Nicole Culos-Reed, PhD role: PRINCIPAL_INVESTIGATOR name: Kelly Burak, MD role: PRINCIPAL_INVESTIGATOR name: Debra Isaac, MD role: PRINCIPAL_INVESTIGATOR lat: 51.05011 lon: -114.08529 hasResults: False

 nctId: NCT06367231 id: Pro00134554 briefTitle: SCGs as a Proxy for Determining the Cognitive Status of Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-07-01 date: 2024-04-16 date: 2024-04-16 name: University of Alberta class: OTHER briefSummary: Detecting memory problems early is crucial for treating conditions like Mild Cognitive Impairment (MCI), which often leads to dementia. Currently, doctors use tests in clinics to check for these issues. However, there's a growing need for better methods to monitor our cognitive skills over time. Computer games emerge as a cost-effective solution for assessing the brain functions of older adults.

In our study, we are investigating the potential of computer games to reflect the cognitive skills of older adults. We developed the VibrantMinds platform, featuring five games: Whack-a-Mole, Bejeweled, Mahjong Solitaire, Word Search, and Memory Game. We have evaluated these games for ease of use, enjoyment, and their impact on brain functions. Now, our goal is to determine whether these games can offer valuable insights into the cognitive skills of older adults.

We are collecting demographic data, game-playing data, and cognitive test results. Our analysis will determine the correlation between game data, cognitive test outcomes, and demographic information. Additionally, we will assess both the perceived and observed engagement of older adults as they play the games. conditions: Mild Cognitive Impairment conditions: Dementia conditions: Alzheimer Disease conditions: Healthy Aging conditions: Cognitive Decline studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 58 type: ESTIMATED name: VibrantMinds measure: Cognition - Global measure: Cognition - Global measure: Cognition - Executive Function measure: Game Performance measure: Game Engagement sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06367218 id: S058 briefTitle: Opioid-Free Combined Anesthesia With Spontaneous Breathing for VATS overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-07-01 date: 2026-08-01 date: 2024-04-16 date: 2024-04-16 name: Tongji Hospital class: OTHER briefSummary: Non-tracheal intubated combined anesthesia with preserved spontaneous breathing significantly enhances the quality and speed of recovery post-VATS for patients undergoing lung nodule surgery. The "opioid-sparing strategy," which substitutes ketamine for opioids during surgery, not only provides effective analgesia but also protects perioperative lung function and reasonably prevents the occurrence of opioid-related adverse reactions; it also reduces medical costs and shortens the average hospital stay. However, the degree of benefit to patients lacks high-level clinical evidence. This study aims to comprehensively assess the effect of opioid-free combined anesthesia with preserved spontaneous breathing for VATS lung nodule surgery on postoperative rapid recovery from multiple aspects including postoperative lung function and pulmonary complications, pain, gastrointestinal function, nausea/vomiting, cognitive function, and depression/anxiety, intending to expand the dataset and application prospects in this field, and increase feasibility experience. conditions: Video-assisted Thoracoscopic Lung Surgery；Anesthesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 480 type: ESTIMATED name: opioid based strategy name: opioid-free strategy name: Laryngeal mask airway; Preserved spontaneous breathing name: Double lumen tracheal tube; Mechanical ventilation measure: Lung function 30 days after surgery measure: Intraoperative respiratory parameters measure: Intraoperative respiratory parameters measure: Intraoperative respiratory parameters measure: Intraoperative respiratory parameters measure: Intraoperative respiratory parameters measure: Perioperative stage indicators measure: Perioperative stage indicators measure: Postoperative pain measure: Postoperative Lung function measure: Postoperative Lung function measure: Postoperative pulmonary complications measure: Postoperative gastrointestinal function measure: Postoperative depression/anxiety measure: Postoperative cognitive function measure: Time of first exercise after surgery measure: The 6-minute walking experiment measure: Length of stay measure: Quality of life measurement measure: Intraoperative circulation parameters measure: Intraoperative circulation parameters measure: Intraoperative circulation parameters measure: Intraoperative circulation parameters measure: Intraoperative circulation parameters measure: Intraoperative circulation parameters sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06367205 id: LY2023-135-A briefTitle: Norepinephrine Infusion Combined With Goal-directed Fluid Therapy in Patients Undergoing Kidney Transplantations overallStatus: RECRUITING date: 2024-03-01 date: 2026-04-30 date: 2026-06-30 date: 2024-04-16 date: 2024-04-16 name: RenJi Hospital class: OTHER briefSummary: Delayed graft function (DGF), delineated by the necessity for dialytic intervention within the initial week post-transplantation, afflicts approximately 20%-50% of recipients. The primary objective of this study is to investigate the potential efficacy of norepinephrine infusion in conjunction with goal-directed fluid therapy (GDFT) in mitigating the occurrence of DGF among individuals undergoing kidney transplantations. The findings of this investigation have the potential to advance the field of perioperative care in kidney transplantations by providing insights into optimized management strategies. conditions: Delayed Graft Function conditions: End Stage Renal Disease conditions: Kidney Transplantation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 380 type: ESTIMATED name: Goal-Directed Fluid Therapy (GDFT) name: Regular Fluid Therapy measure: The incidence of delayed graft function (DGF) measure: The area under the curve of serum creatinine levels from postoperative day 1 to 7 measure: Duration of DGF measure: Number of dialysis sessions during postoperative hospitalization measure: Total urine output on the second postoperative day measure: Duration of intensive care unit (ICU) stay measure: Length of hospitalization measure: Incidence of readmission within 30 days post-discharge measure: The incidence of acute rejection during hospitalization measure: The survival rates of transplanted kidneys at the one-year postoperative mark measure: The survival rates of transplanted patients at the one-year postoperative mark measure: The occurrence of adverse events (AEs) sex: ALL minimumAge: 18 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 name: Jianjun Yang, Dr. role: CONTACT lat: 34.75778 lon: 113.64861 facility: General Hospital of Northern Theatre Command status: NOT_YET_RECRUITING city: Shenyang state: Liaoning zip: 110016 country: China name: Yugang Diao, Dr. role: CONTACT lat: 41.79222 lon: 123.43278 facility: Renji Hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200127 country: China name: Muyan Shi, B.S. role: CONTACT phone: +862168383702 email: jsqdsmy@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06367192 id: SKITS2 id: K23HL166697 type: NIH link: https://reporter.nih.gov/quickSearch/K23HL166697 briefTitle: School Readiness Intervention for Preschool Children With Sickle Cell Disease overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-10 date: 2028-10 date: 2024-04-16 date: 2024-04-16 name: St. Jude Children's Research Hospital class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The study participant is being asked to take part in this clinical trial, a type of research study, because the participant is a young child with sickle cell disease or the caregiver of a child with sickle cell disease. This study is being done to test a school readiness program for children with sickle cell disease (ages 4-6 years old).

Primary Objective

Assess feasibility and acceptability of an adapted school readiness intervention among preschool children (ages 4-6) diagnosed with sickle cell disease.

Secondary Objectives

Objective 1:

Measure preliminary efficacy of the adapted school readiness intervention compared to routine care among preschool children ages (4-6) diagnosed with sickle cell disease.

Objective 2:

Examine implementation factors (i.e., barriers and facilitators) during post-intervention. conditions: Sickle Cell Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: The adapted Kids in Transition to School Intervention name: Standard school resources measure: Feasibility of Intervention Measure measure: Acceptability of Intervention Measure measure: Bracken School Readiness Assessment - 3rd Edition measure: Woodcock Johnson Tests of Achievement - Fourth Edition measure: NIH Toolbox Flanker Test measure: Head-Toes-Knees-Shoulders Revised measure: Behavior Rating Inventory of Executive Functioning Preschool or Child measure: The Parenting Scale sex: ALL minimumAge: 4 Years maximumAge: 6 Years stdAges: CHILD facility: St. Jude Children's Research Hospital city: Memphis state: Tennessee zip: 38105 country: United States name: ANDREW HEITZER, PhD role: CONTACT name: ANDREW HEITZER, PhD role: PRINCIPAL_INVESTIGATOR lat: 35.14953 lon: -90.04898 hasResults: False

 nctId: NCT06367179 id: 202401039RINC briefTitle: Virtual Reality and AI Wound-detecting System overallStatus: RECRUITING date: 2024-03-22 date: 2025-02-04 date: 2025-02-04 date: 2024-04-16 date: 2024-04-16 name: National Taiwan University Hospital class: OTHER briefSummary: This study is an experimental study. The main caregivers of pressure injury patients in the plastics surgery ward and general medicine ward of the hospital in Taipei City who are over 20 years old, have good communication skills in Chinese and Taiwanese or who can read Chinese are the research objects. During the study process, pre-tests will be given to the accepted subjects, which are the correctness evaluation scale of caregiver's pressure injury wound dressing change and caregiver self-efficacy scale, and then the accepted subjects will be divided into experimental group and control group. The experimental group will receive interventions of virtual reality and artificial intelligence wound detecting system, while the control group maintained the traditional pressure injury health education with oral introduction and health education leaflet. After the intervention measures are given, a post-test (same as the pre-test content) will be conducted within two days. Finally, analyze the effectiveness of the intervention of virtual reality pressure injury education video and artificial intelligence wound detecting system on caregivers of pressure injury improve wound care correctness and increase self-efficacy. conditions: Pressure Injury studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 92 type: ESTIMATED name: Virtual reality and AI use name: Health education leaflet measure: Accurate dressing change rate of pressure injury measure: Pressure injury dressing change of self-efficacy sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Taiwan University Hospital status: RECRUITING city: Taipei zip: 100225 country: Taiwan name: Cian Huei Wang role: CONTACT phone: (02)23123456 phoneExt: 263502 email: chw0710@ntuh.gov.tw lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06367166 id: RyazanSMU briefTitle: Effects of Bioflavanoids on Vascular Wall Remodeling in Patients With Varicose Veins overallStatus: ACTIVE_NOT_RECRUITING date: 2023-04-01 date: 2026-04-01 date: 2026-05-01 date: 2024-04-16 date: 2024-04-16 name: Ryazan State Medical University class: OTHER briefSummary: The study is aimed at assessing the dynamics of changes in biochemical markers of venous wall remodeling (type 1 plasminogen activation inhibitor (PAI-1), fibronectin (fibronectin, FN), vimentin (vimentin, VM), von Willebrand factor (vWF), PECAM-1 (CD31) ) in patients with C2s-C3s varicose veins compared with healthy volunteers while taking Venarus® (diosmin in combination with hesperidin). conditions: Varicose Veins of Lower Limb conditions: Varix conditions: Vascular Diseases conditions: Leg Edema studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients with varicose veins will be assigned to different treatments to assess the venous wall remodeling parameters throughout treatment primaryPurpose: BASIC_SCIENCE masking: NONE count: 100 type: ACTUAL name: "Venarus®" (diosmin and hesperidin) name: Endovenous laser ablation (EVLA) with miniphlebectomy name: Elastic compression name: Evaluation of biomarkers of venous wall remodeling (fibronectin, PAI-1, vimentin, vWF, CD31), venous symptoms and severity scores measure: changes in biomarkers of venous wall remodeling measure: Changes in biomarkers expression in venous wall sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RyazanSMU city: Ryazan country: Russian Federation lat: 54.6269 lon: 39.6916 hasResults: False

 nctId: NCT06367153 id: 1447-0007 id: 2023-510461-10-00 type: REGISTRY domain: CTIS id: U1111-1303-9187 type: REGISTRY domain: WHO International Clinical Trials Registry Platform (ICTRP) briefTitle: A Study in Healthy Men and Women to Test Whether BI 1569912 Influences the Amount of Repaglinide, Midazolam and Bupropion in the Blood overallStatus: NOT_YET_RECRUITING date: 2024-05-07 date: 2024-08-24 date: 2024-08-24 date: 2024-04-16 date: 2024-04-17 name: Boehringer Ingelheim class: INDUSTRY briefSummary: The main objective of this trial is to investigate the effect of multiple oral doses of BI 1569912 on the pharmacokinetics of a single oral dose of repaglinide, midazolam and bupropion (i.e. sensitive CYP2C8, CYP3A4 and CYP2B6 substrates). conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: CROSSOVER interventionModelDescription: Patients cross over from test treatment (T) to reference treatment (R) (two periods, fixed sequence). primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: BI 1569912 name: repaglinide name: midazolam name: bupropion measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) measure: Maximum measured concentration of the analyte in plasma (Cmax) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06367140 id: SYU 2021-06-001-002 briefTitle: Effects of Electromyography-Triggered Constraint-Induced Movement Cycling Therapy on Patients With Chronic Stroke overallStatus: COMPLETED date: 2020-01-01 date: 2022-12-31 date: 2023-12-31 date: 2024-04-16 date: 2024-04-17 name: Sahmyook University class: OTHER name: Seoul National University Hospital name: Kyungdong University briefSummary: The study investigates the potential of Electromyography (EMG)-triggered Constraint-Induced Movement Cycling Therapy (CIMCT) versus General Cycling Training (GCT) to enhance balance, strength, and daily activities in chronic stroke patients. Over a period of four weeks, this single-blind randomized controlled trial aims to explore how these interventions can assist in stroke rehabilitation. The research has been approved by the Ethics Committee of Kyungdong University and adheres to the ethical standards laid out in the Declaration of Helsinki. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The evaluators were blinded to the intervention details of the participants. whoMasked: OUTCOMES_ASSESSOR count: 58 type: ACTUAL name: EMG-triggered CIMCT device name: general cycling training measure: Muscle Strength measure: Static Balance measure: Timed Up and Go (TUG) measure: Berg Balance Scale measure: Functional Reach Test (FRT) measure: Modified Barthel Index (MBI) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Physicla Therapy, Sahmyook University city: Seoul zip: 01795 country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06367127 id: Pingfanghu briefTitle: Utility of the Clamping Bean Test (CBT) for Covert Hepatic Encephalopathy Screening overallStatus: ENROLLING_BY_INVITATION date: 2023-10-09 date: 2024-12-31 date: 2024-12-31 date: 2024-04-16 date: 2024-04-16 name: Shanghai Changzheng Hospital class: OTHER briefSummary: Hepatic encephalopathy is a brain dysfunction caused by liver insufficiency and/or porto-systemic shunt. It manifests as a wide spectrum of neurological or psychiatric abnormalities ranging from subclinical alterations to coma. According to the symptoms, it is classified as covert HE (CHE) and overt HE (OHE). CHE can progress to OHE and is associated with reduced driving ability, increased risk of accidents and hospitalization and weakened health-related quality of life, resulting in poor prognosis and socio-economic status. However, due to the absence of readily identifiable clinical symptoms and signs, CHE is often neglected in clinical practice.

Presently, the diagnosis of CHE depends on psychometric and neurophysiological tests, including the psychometric hepatic encephalopathy score (PHES), critical flicker frequency (CFF) test, continuous reaction time (CRT) test, inhibitory control test, the SCAN test, and electroencephalography. Among them, PHES is most widely used and recommended by several guidelines. However, it is difficult to screen CHE among all cirrhotic patients in the clinic using PHES because of the time required and a dependence on trained experts.

Moving beans from one container to another with tweezers involves dexterity, agility and coordination.The hypothesis was that the utility of the Clamping Bean Test (CBT) will enable early screening patients with CHE. conditions: Hepatic Encephalopathy conditions: Covert Hepatic Encephalopathy studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Number of Beans Clamping in 1 minute measure: Participants' feedback on CBT1 test sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Changzheng hospital city: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06367114 id: ssCART-19-II-1 briefTitle: Clinical Trial of ssCART-19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (Including Central Nervous System Infiltration) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2025-12 date: 2024-04-16 date: 2024-04-19 name: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd class: INDUSTRY name: The First Affiliated Hospital of Soochow University name: Peking University People's Hospital briefSummary: This study is a Phase II, single-arm, open-label, non-randomized, dose-escalation clinical trial to evaluate the efficacy and safety of ssCART-19 Cell Injection in the treatment of patients with CD19 positive Relapsed or Refractory acute lymphoblastic leukemia, including central nervous system infiltration. conditions: Relapsed or Refractory Acute Lymphoblastic Leukemia studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: ssCART-19 name: Fludarabine name: Cyclophosphamide measure: Determine the efficacy of ssCART-19 cells in patients with CD19-positive relapsed or refractory acute B lymphoblastic leukemia (r/r B-ALL). measure: Observe the anti-tumor response of ssCART-19 cells to refractory or relapsed acute lymphoblastic leukemia. measure: Best overall response (BOR)assessment during the 3 months after ssCART-19 infusion. measure: Duration of response (DOR) measure: Recurrence free survival (RFS) measure: Event Free Survival (EFS) measure: Overall survival (OS) measure: Incidence of adverse events following ssCART-19 infusion measure: Pharmacodynamic of ssCART-19 cells measure: Pharmacodynamic of ssCART-19 cells measure: Pharmacodynamic of ssCART-19 cells measure: Anti-drug antibody sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai Unicar-Therapy Bio-medicine Technology Co., Ltd. city: Shanghai state: Shanghai zip: 201210 country: China lat: 31.22222 lon: 121.45806 facility: The First Affiliated Hospital of Soochow University city: Suzhou country: China name: Depei Wu, Dr. role: CONTACT lat: 31.30408 lon: 120.59538 hasResults: False

 nctId: NCT06367101 id: 202002525B0 briefTitle: AR Stimulation Effects on Gait, Anxiety, and Brain Connectivity in Parkinson's Disease overallStatus: RECRUITING date: 2022-01-18 date: 2025-05-31 date: 2025-07-31 date: 2024-04-16 date: 2024-04-16 name: Chang Gung University class: OTHER briefSummary: A project aims at addressing gait impairments and non-motor symptoms such as anxiety and stress in Parkinson's disease (PD) patients through a novel approach involving heart rate variability (HRV) feedback and Augmented Reality (AR) training. The project is based on the premise that improving HRV, which reflects the adaptability of the autonomic nervous system, can enhance both motor functions like gait and non-motor symptoms. conditions: Parkinson Disease(PD) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: AR training with gait and HRV feedback measure: Walking Speed measure: Step Length measure: Step Time measure: Time-Domain Index of Heart Rate Variability (HRV)：Standard deviation of RR intervals (SDRR) measure: Time-Domain Index of HRV：pNN50 measure: Time-Domain Index of HRV：Root mean square of successive RR interval differences (RMSSD) measure: Frequency-Domain Index of HRV: Low Frequency (LF) measure: Frequency-Domain Index of HRV: High Frequency (HF) measure: Frequency-Domain Index of HRV: Ratio of LF to HF Power measure: Total Time to Complete the Time Up and Go test (TUG test) measure: Double Support Time measure: Single Support Time measure: Swing Time measure: Stance Time measure: Cadence measure: Total UPDRS-III Score measure: Total NFOG-Q Score measure: Overall PDQ-39 Score measure: Total HADS Score measure: Overall PSQI Score measure: Non-linear Index of HRV: SD1 measure: Non-linear Index of HRV: SD2 measure: Non-linear Index of HRV: Ratio of SD1-to-SD2 sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chang Gung University status: RECRUITING city: Taoyuan zip: 333 country: Taiwan name: Ya-Ju Chang, PhD role: CONTACT phone: 88632118800 phoneExt: 5515 email: yjchang@mail.cgu.edu.tw lat: 24.95233 lon: 121.20193 hasResults: False

 nctId: NCT06367088 id: Sophia briefTitle: Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer overallStatus: RECRUITING date: 2024-05-01 date: 2026-04-30 date: 2027-04-30 date: 2024-04-16 date: 2024-04-16 name: Wuhan Union Hospital, China class: OTHER briefSummary: The prognosis of recurrent and metastatic triple negative breast cancer (TNBC) is poor, and chemotherapy is still the main treatment for TNBC. Some studies have shown that combination therapy of antibodies targeting cytotoxic T-lymphocyte antigen-4 (CTLA-4) and programmed cell death-1 (PD-1) significantly improves clinical benefit over PD-1 antibody alone. However, broad application of this combination has been limited by toxicities. Cadonilimab is a humanized immunoglobulin G1 bispecific antibody targeting PD-1 and CTLA-4. It mutates to eliminate Fc receptor and complement-mediated cytotoxic effects. The purpose of this study is to evaluate the efficacy and safety of Cadonilimab combined with chemotherapy as a first or second-line treatment of recurrent and metastatic TNBC. This study is a multicenter, single arm, phase II, non randomized, open label, Simon two-stage design. It is planned to enroll 27 late stage TNBC patients. conditions: Triple-negative Breast Cancer conditions: Cadonilimab studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: Cadonilimab measure: Objective Response Rate measure: AE measure: Progression-free survival measure: Overall survival measure: Disease control rate sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei zip: 430022 country: China name: Jie Xiong role: CONTACT phone: +8615927611872 email: xxiongjie2000@163.com lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06367075 id: AK104-sarcoma-202401 briefTitle: A Trial of Cadonilimab With Adriamycin in Patients With Advanced Soft Tissue Sarcoma overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-03-31 date: 2029-03-31 date: 2024-04-16 date: 2024-04-16 name: Wuhan Union Hospital, China class: OTHER name: Sun Yat-sen University name: Xiangya Hospital of Central South University name: Yunnan Cancer Hospital name: The Affiliated Hospital Of Guizhou Medical University name: First Affiliated Hospital of Guangxi Medical University briefSummary: This is a single-arm, multicenter trial of cadonilimab (AK104) with adriamycin in patients with first-line advanced soft tissue sarcoma. the primary objective is to evaluate objective response rate of cadonilimab with adriamycin. conditions: Advanced Soft-tissue Sarcoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: cadonilimab (AK104) with adriamycin primaryPurpose: TREATMENT masking: NONE count: 53 type: ESTIMATED name: Cadonilimab name: Adriamycin 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: Adverse event (AE) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06367062 id: SH9H-2023-T296 briefTitle: General Anesthesia/Surgical Exposure on White Matter Development in Children overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-11-30 date: 2026-12-31 date: 2024-04-16 date: 2024-04-16 name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University class: OTHER briefSummary: International large-scale clinical studies have found that prolonged or repeated exposure to general anesthesia drugs in infancy and early childhood can lead to an increased risk of long-term neurodevelopmental abnormalities in children. The study of neurodevelopmental toxicity of general anesthesia drugs is of great social significance. We have established a rhesus monkey model to study the neurodevelopmental toxicity of general anesthetic drugs, the first time to make a preliminary exploration of the mechanism of myelin developmental toxicity of general anesthetic drugs. Several studies using magnetic resonance scanning found a positive correlation between the number of anesthesia exposures and the maturity of distant brain white matter development in juvenile non-human primates. Clinical evidence for myelin developmental toxicity induced by general anesthetic drugs needs to be collected by conducting multicenter and large-sample clinical studies. Earlier studies have either had low sample sizes, which do not allow for better control of confounding factors; or the study population has been limited to specific disease populations, and the results cannot be extrapolated to normal children. In view of this, based on the applicant's earlier study, this project proposes to recruit children who underwent general anesthesia surgery between 0-3 years of age and are now 12-15 years old; children who did not experience surgery between 0-3 years of age were matched by age-sex to serve as a control group. MRI will be used to assess their brain white matter development, to explore the correlation between anesthesia and anesthesia-related factors and brain white matter development and related neurobehavioral development, and to clarify the effects of anesthesia and surgery on children's brain white matter and related neuropsychological development. conditions: Neurodevelopmental Delay studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 210 type: ESTIMATED name: MRI measure: MRI-based assessment of brain development sex: ALL minimumAge: 12 Years maximumAge: 15 Years stdAges: CHILD hasResults: False

 nctId: NCT06367049 id: 2023-FXY-230-NPC briefTitle: Methylation-specific PCR Test for Early Screening and Early Diagnosis of Nasopharyngeal Carcinoma overallStatus: COMPLETED date: 2023-06-01 date: 2023-09-30 date: 2024-03-01 date: 2024-04-16 date: 2024-04-16 name: Sun Yat-sen University class: OTHER name: Guangdong Women and Children Hospital name: Affiliated Cancer Hospital & Institute of Guangzhou Medical University briefSummary: Nasopharyngeal carcinoma is one of the most common malignant tumors in China, with the progress of radiochemical comprehensive treatment, early stage The 5-year survival rate of nasopharyngeal cancer is more than 95%. However, due to the hidden site of nasopharyngeal carcinoma and the lack of obvious early clinical symptoms, more than 70% of the 87,000 newly diagnosed cases each year belong to the advanced stage of nasopharyngeal carcinoma, and the 5-year survival rate of advanced nasopharyngeal carcinoma is only about 70%. Therefore, early screening and diagnosis and early treatment are the key to improve the survival of patients with nasopharyngeal cancer. Selecting a sensitive and accurate biomarker for nasopharyngeal cancer and relying on a simple and feasible examination method for sampling detection will greatly improve the early diagnosis rate of nasopharyngeal cancer.

DNA methylation is a form of chemical modification of DNA that can be done without altering the DNA sequence changes in genetic expression. The main role of DNA methylation is to regulate gene expression. Tumor suppressor genes play the functions of regulating cell differentiation, maturation and programmed death. However, if methylation of promoter region occurs, the expression of tumor suppressor genes is inhibited and the function is lost, resulting in cells remaining in the stage of low differentiation and proliferation, inhibition of apoptosis, formation of blood vessels by cluster cells, loss of cell adhesion, and formation of tumors. It can be seen that DNA methylation occurs in the early stage of tumor, and this biological feature makes it a strong application prospect in early tumor screening.

There are many methods to detect DNA Methylation, among which methylation-specific PCR (MSP) can easily and quickly determine the methylation status of a specific gene, meeting the affordable, convenient, and easy to generalize characteristics required for screening tests. In combination with previous MSP experiments and previous reports, we found that the methylation levels of promoter fragments of H4C6, Septin9 and RASSF1A genes in nasopharyngeal carcinoma tissues were significantly higher than those in healthy human nasopharyngeal tissues. This suggests that methylation of these three genes may be used as biomarkers for early screening and diagnosis of nasopharyngeal carcinoma.

Therefore, this study intends to detect the methylation status of H4C6, Septin9 and RASSF1A genes based on MSP method with simple operation and low cost. Using clinicopathological diagnosis as the gold standard, the value of this gene methylation index in early screening and early diagnosis of nasopharyngeal cancer was verified, providing a new detection index and method for improving the early diagnosis rate of nasopharyngeal cancer. conditions: Nasopharyngeal Carcinoma conditions: Early Diagnosis of Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 470 type: ACTUAL name: Methylation-specific PCR measure: Sensitivity measure: Specificity sex: ALL minimumAge: 18 Years maximumAge: 70 Years 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: NCT06367036 id: 2021-52 briefTitle: Effect of Hypericum Perforatum Oil on Ecchymosis and Pain overallStatus: COMPLETED date: 2022-01-02 date: 2022-12-29 date: 2023-06-15 date: 2024-04-16 date: 2024-04-16 name: Uskudar University class: OTHER briefSummary: Low molecular weight heparin is a drug with anticoagulant and antithrombotic effects. This drug is frequently administered subcutaneously to patients by nurses. Complications such as pain, ecchymosis and hematoma may commonly occur at the injection site. This study investigated the effect of Hypericum Perforatum oil in preventing pain and ecchymosis after subcutaneous injection low molecular weight heparin. This quasi-experimental and single blinded study was conducted with 160 patients in a coronary intensive care unit. The researcher nurse applied 5-6 drops of Hypericum Perforatum oil to one arm of the patients 2 hours before the injection. The other arm of the patient was considered as the control arm. A total of 320 injections were administered. The evaluation of the injection sites was performed by two other researchers at 48th hours. The data were analyzed using Wilcoxon and McNemar test. conditions: Pain conditions: Ecchymosis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: There is no control group in this research design. The participants themselves are also the control group. Intervention was applied to one injection site of the participants 2 hours before the injection and not to the other. Post-injection pain and ecchymosis were evaluated for both sites. The two researchers who analyzed the results do not know the region where the intervention was applied. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Two researchers do not know which site was injected. whoMasked: INVESTIGATOR count: 160 type: ACTUAL name: Topical hypericum perforatum oil intervention measure: Pain point measure: Ecchymosis sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Hatice Demirdağ city: Üsküdar state: İstanbul zip: 34672 country: Turkey lat: 41.02252 lon: 29.02369 hasResults: False

 nctId: NCT06367023 id: 32-2024 briefTitle: Effectiveness of Brahma Kumaris Raja Yoga Meditation on Quality of Life of Youth in the Deaddiction Center of Biratnagar overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-30 date: 2025-03-30 date: 2024-04-16 date: 2024-04-16 name: Manipur International University class: OTHER name: Brahmakumaris briefSummary: Drug addiction is a public health problem, mainly youths are involved in the addiction and the major reason were due to peer pressure. Spiritual meditation is thought to foster a deeper sense of meaning, which creates new sources of positive reinforcement, increasing motivation for alternative behavior patterns, such as entering treatment or maintaining abstinence. Cluster Randomized Control Trial will be performed for 1-year period where mixed method study design will be performed. The major variables will be Anxiety and depression score, Happiness index, Quality of life, Rate of Relapse, Age, Gender, Occupation, Education, Income, Family Size, Family Income, Family support, Social status- High/Middle/Low, History of drug use self, Types of drugs, Duration of usage: Reason of drug use, how they have started, Amount of drugs, Frequency of use, Family history of drug use, Money spent on drugs per month. A modified validated Questionnaire will be used. CRCT will be done by CONSORT Guidelines. A total of 160 samples will be taken, (40 from each center, two were given Meditation intervention and 80 were given standard treatment as a control group) and 16 qualitative interviews will be taken (4 from each center). The intervention will be given for 3 months, for 6 days one hour per day Rajyoga meditation basic course will be provided, followed by a 1-hour daily spiritual lesson, Positive thinking and motivation classes will be provided to the intervention group, and in the control group standard treatment will be given. Follow-up will be done after 1 month of discharge from the rehabilitation centers. Ethical clearance will be taken from the Ethical Review Board (ERB) of the Nepal Health Research Council (NHRC). This study will be useful for developing policy and practice in rehabilitation centers to apply the technique of Rajyoga Meditation in relapse prevention. conditions: Prevalence conditions: Depression conditions: Happiness conditions: Quality of Life conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 160 type: ESTIMATED name: Rajyoga Meditation Practice measure: Anxiety score measure: Depression score measure: quality of life score measure: Rate of Relapse sex: MALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Rehabilitation center city: Biratnagar state: Koshi zip: 56613 country: Nepal name: Rajiv Ranjan Karn, MPH role: CONTACT phone: +9779842068053 email: rajiv2061@gmail.com name: Ajaya Bhattarai, PhD role: CONTACT phone: +9779842077434 email: bkajaya@gmail.com lat: 26.45505 lon: 87.27007 hasResults: False

 nctId: NCT06367010 id: MR-36-24-010942 briefTitle: Clinical Efficacy of 125I Brachytherapy Combined With Anlotinib in Radioiodine Refractory Thyroid Carcinoma Patients overallStatus: COMPLETED date: 2019-01-01 date: 2024-04-01 date: 2024-04-01 date: 2024-04-16 date: 2024-04-16 name: Jiangxi Provincial Cancer Hospital class: OTHER briefSummary: A retrospective analysis was conducted on patients with radioiodine-refractory thyroid carcinoma (RRTC) who underwent radioactive 125I seed implantation combined with anlotinib from January 2019 to October 2024 at Jiangxi Cancer Hospital. Data on tumor size changes before and after treatment, serological tests (including serum TG, TgAb, CTn, CEA, etc.), changes in patients' pain scores, and side effects were collected to evaluate the clinical efficacy and safety of this therapy. conditions: Thyroid Neoplasms studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 8 type: ACTUAL name: Iodine-125 brachytherapy combine with Anlotinib measure: The CT images were used to measure the change in the maximum diameter of the lesion in millimeters. measure: Serological assessment measure: Use the Numerical Rating Scale (NRS) to record patients' pain scores. measure: Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Jiangxi Cancer Hospital city: Nanchang state: Jiangxi zip: 330029 country: China lat: 28.68396 lon: 115.85306 hasResults: False

 nctId: NCT06366997 id: CQGOG0207 briefTitle: Diagnosis of Epithelial Ovarian Cancer Using Ovarian Cancer Score (OCS) Test overallStatus: COMPLETED date: 2019-10-09 date: 2023-04-18 date: 2023-05-05 date: 2024-04-16 date: 2024-04-16 name: Chongqing University Cancer Hospital class: OTHER name: Zhejiang Cancer Hospital name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University name: The First Affiliated Hospital of Zhengzhou University name: 3D Medicines Corporation briefSummary: The study is designed to confirm the performance of the 3D Medicines Corporation OCS test in diagnosis of epithelial ovarian cancer in patients with adnexal mass. To this end, blood samples from female patients with adnexal mass required surgical resection from four centers are obtained and analysis in the study. conditions: Epithelial Ovarian Cancer conditions: Adnexal Mass studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1352 type: ACTUAL measure: the Performance of Discrimination of Benign Disease and Malignant tumors by the OCS Value. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: No.181, Hanyulu Road, Shapingba District city: Chongqing state: Chongqing zip: 400030 country: China lat: 29.56278 lon: 106.55278 hasResults: False

 nctId: NCT06366984 id: Adeel4 briefTitle: Outcome of Plastibell Circumcision Versus Open Method Circumcision overallStatus: COMPLETED date: 2022-01-11 date: 2022-07-11 date: 2022-08-11 date: 2024-04-16 date: 2024-04-16 name: Children Hospital and Institute of Child Health, Lahore class: OTHER briefSummary: To compare the outcomes of plastibell circumcision method with open surgical technique in infants presenting at tertiary care hospital.

Methods This randomized controlled trial (NCT??) was conducted at Pediatric surgery department, the Children's hospital and the University of Child health, Lahore. Study was carried out over a period of six months from 11-01-2022 to 11-07-2022. Non probability, purposive sampling was used. 174 infants presenting for circumcision were admitted and assigned a method of circumcision randomly. They were randomly divided in to 2 groups by using opaque sealed envelope technique. Infants in group A were underwent plastibell circumcision while infants in group B were underwent open technique circumcision. 87 circumcisions were performed by each method. The informed consent was taken from parents for inclusion into the study. All infants were underwent circumcision under local anesthesia as per assigned method. Same preoperative, per-operative, and postoperative care was given to each regardless of the technique. These patients were followed for 3 hours to assess bleeding as per operational definition. Then followed on an outpatient basis every 6th day until complete healing is achieved (30 days).The data regarding age, weight, duration of procedure, wound infection and post circumcision bleeding was recorded in a predesigned performa. (As per operational definition). conditions: Bleeding conditions: Site Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controll trial primaryPurpose: OTHER masking: SINGLE maskingDescription: outcome assessor is unaware of group allocated whoMasked: OUTCOMES_ASSESSOR count: 174 type: ACTUAL name: plastibell name: open method measure: infection sex: MALE minimumAge: 1 Day maximumAge: 12 Months stdAges: CHILD facility: The Children Hospital city: Lahore state: Punjab zip: 42000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06366971 id: auhucgun01 briefTitle: The Effect of Pelvic Proprioceptive Neuromuscular Facilitation Techniques in Patients With Sacroiliac Joint Dysfunction overallStatus: COMPLETED date: 2023-12-01 date: 2024-03-31 date: 2024-03-31 date: 2024-04-16 date: 2024-04-16 name: Biruni University class: OTHER briefSummary: The sacroiliac joint dysfunction (SIJD) which has a widely heterogeneous etiology, may cause impairment of stability, mobility, posture and flexibility as well as pain due to adaptive or pathological biomechanical changes. In 2020, the number of patients with low back pain (LBP) worldwide was more than half a billion and is expected to exceed 800 million by 2050. Although SIJD has been shown to be related with LBP in more than 30% of patients with LBP, SIJD is still often overlooked as a cause of LBP. Once the diagnosis of SIJD is confirmed by physical examination, the first treatment option consists of the use of a nonsteroidal anti-inflammatory drug or physiotherapy approaches. The proprioceptive neuromuscular facilitation (PNF) is a neurophysiological model-based multifaceted exercise method which is widely used in rehabilitation practice. However, despite the major role of SIJD among the causes of LBP, there are limited studies investigating the efficacy of PNF in SIJD and its effectiveness remains unclear. Thus, the aim of this study was to investigate the effect of pelvic PNF techniques on pain, mobility, flexibility, lumbar range of motion, posture, and trunk muscle endurance in patients with SIJD. conditions: Sacroiliac Joint Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 34 type: ACTUAL name: The Patient Education name: The Pelvic Proprioceptive Neuromuscular Facilitation Techniques Training measure: The Level of Low Back Pain measure: Mobility measure: Flexibility measure: Lumbar Range of Motion measure: Posture measure: Trunk Muscle Endurance sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Istanbul Atlas University city: Istanbul state: Kagıthane zip: 34408 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06366958 id: Dorsal wrist ganglion briefTitle: Arthroscopic Versus Open Excision of Dorsal Wrist Ganglion overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2025-02-02 date: 2025-04-02 date: 2024-04-16 date: 2024-04-16 name: Assiut University class: OTHER briefSummary: compare recurrence rates after open and arthroscopic excision of dorsal wrist ganglion conditions: Hand Ganglion studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 46 type: ESTIMATED name: excision of dorsal wrist ganglion measure: comparison of recurrence rate after open versus arthroscopic excision of dorsal wrist ganglion measure: compare post operative pain ,range of motion ,hang grip strength and post operative scar after open versus arthroscopic excision of dorsal wrist ganglion sex: ALL minimumAge: 10 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06366945 id: SYSKY-2024-157-02 briefTitle: Tirelizumab in Combination With Carboplatin and Polymeric Micellar Paclitaxel for Neoadjuvant Therapy in cN+ HNSCC overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2026-12-30 date: 2029-05-30 date: 2024-04-16 date: 2024-04-16 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: To explore the efficiency and safety of Tislelizumab combinated with carboplatin and polymeric micellar paclitaxel as a new neoadjuvant treatment regimen for resectable HNSCC patients with clinical positive lymph node metastasis conditions: Head and Neck Squamous Cell Carcinoma conditions: Head and Neck Cancer conditions: HNSCC conditions: Head Cancer Neck studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 85 type: ESTIMATED name: Carboplatin name: Tislelizumab name: Polymeric Micellar Paclitaxel name: Surgical Resection of Primary +/- Neck Dissection name: Post-operative radiation therapy measure: Major pathological response (MPR) rate of metastatic lymph nodes measure: Major pathological response (MPR) rate of primary tumor measure: Event-free survival (EFS) measure: Overall survival（OS） measure: Incidence of treatment-related adverse events measure: EORTC QLQ-C30 measure: pathological downstaging rate measure: Distant metastasis-free survival(DMFS) rate measure: logical regional-free survival(LRFS) rate measure: Correlation between ctDNA dynamic detection and 1-year and 2-year EFS and OS rate after Neoadjuvant immunochemotherapy sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06366932 id: DermAtOmics-II briefTitle: Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models overallStatus: RECRUITING date: 2023-09-25 date: 2025-09 date: 2025-09 date: 2024-04-16 date: 2024-04-16 name: Instituto de Investigación Hospital Universitario La Paz class: OTHER briefSummary: This is a low-intervention phase IV trial. The main objective is to optimize the treatment of patients with moderate-severe atopic dermatitis that require systemic treatment after failure, intolerance or contraindication to cyclosporine. conditions: Atopic Dermatitis studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase IV, low-intervention clinical trial to develop prediction models that allow to determine the most appropriate therapeutic strategy in patients diagnosed with atopic dermatitis that need second-line systemic treatment. primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: Second-line systemic treatment name: Folllow-up of second-line systemic treatment already started measure: Percentage of patients with primary non-response to second-line treatment. measure: Percentage of patients achieving EASI-75 measure: Time to treatment failure after week 16 measure: Mean percentage of change in Eczema Area and Severity Index (EASI) score measure: Percentage of change in SCORAD (SCORing Atopic Dermatitis) measure: Improvement of at least 75% in SCORAD (SCORing Atopic Dermatitis) measure: Change of IGA (Investigator Global Assessment) measure: Time to IGA score of 0/1 (Investigator Global Assessment) measure: Change of BSA (Body surface area) measure: Change in NRS measure: Change in RECAP measure: Percentage of patients having a variation of 4 points in their improvement in DLQI measure: Change in POEM (Patient-Oriented Eczema Measure) measure: Rate of adverse events associated to second-line systemic treatment measure: Percentage of patients reaching EASI-90 (Percentage of patients reaching 90 percentage) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital La Paz status: RECRUITING city: Madrid zip: 28046 country: Spain name: Irene García, MD role: CONTACT phone: +34-912071466 email: irene.ucicec@gmail.com lat: 40.4165 lon: -3.70256 hasResults: False

 nctId: NCT06366919 id: DPT/Batch-Fall19/559 briefTitle: Comparison of Effectiveness of Alexander Technique Versus Feldenkrais Technique in Non - Specific Neck Pain Patients overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-01 date: 2024-05-15 date: 2024-06-15 date: 2024-04-16 date: 2024-04-16 name: Superior University class: OTHER briefSummary: Comparison of Effectiveness of Alexander Technique Versus Feldenkrais Technique in Non - Specific Neck Pain Patients conditions: Neck Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 44 type: ACTUAL name: Alexander Technique (AT) name: Feldenkrais Technique (FT) measure: Northwick Park Neck Pain Questionnaire measure: REEDCO Posture Assessment and Sleep Quality Scale sex: ALL minimumAge: 20 Years maximumAge: 25 Years stdAges: ADULT facility: Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University city: Lahore state: Punjab country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06366906 id: SYSKY-2023-426-01 briefTitle: 10-year Retrospective Study of Oral and Maxillofacial Squamous Cell Carcinoma overallStatus: COMPLETED date: 2023-05-10 date: 2024-02-10 date: 2024-02-10 date: 2024-04-16 date: 2024-04-16 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: Introduction: The incidence of occult cervical lymph node metastases (OCLNM) is reported to be 20%-30% in early-stage oral cancer and oropharyngeal cancer. There is a lack of an accurate diagnostic method to predict occult lymph node metastasis and to help surgeons make precise treatment decisions.

Aim: To construct and evaluate a preoperative diagnostic method to predict occult lymph node metastasis (OCLNM) in early-stage oral and oropharyngeal squamous cell carcinoma (OC and OP SCC) based on deep learning features (DLFs) and radiomics features.

Methods: A total of 319 patients diagnosed with early-stage OC or OP SCC were retrospectively enrolled and divided into training, test and external validation sets. Traditional radiomics features and DLFs were extracted from their MRI images. The least absolute shrinkage and selection operator (LASSO) analysis was employed to identify the most valuable features. Prediction models for OCLNM were developed using radiomics features and DLFs. The effectiveness of the models and their clinical applicability were evaluated using the area under the curve (AUC), decision curve analysis (DCA) and survival analysis. conditions: HNSCC conditions: AI conditions: Radiomic conditions: MRI studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 319 type: ACTUAL name: The Resnet50 deep learning (DL) model measure: AUC(the area under the curve) values of the model sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sun yat-sen memorial hospital city: Guangzhou state: Guangdong zip: 510000 country: China lat: 23.11667 lon: 113.25 facility: Sun yat-sun memorial hospital city: Guangzhou state: Guangdong zip: 510000 country: China lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06366893 id: PR(AG)297/2019 briefTitle: Enteral Supplementation With Docosahexaenoic Acid and Arachidonic Acid (DHA-AA) in Preterm Infants overallStatus: RECRUITING date: 2024-03-04 date: 2025-03-04 date: 2025-03-04 date: 2024-04-16 date: 2024-04-19 name: Hospital Universitari Vall d'Hebron Research Institute class: OTHER briefSummary: Docosahexaenoic acid (DHA) and arachidonic acid (AA) have a critical effect on the health and neuronal development of the fetus and newborn. Their deficiency has been associated with increased neonatal morbidity, especially in preterm newborns at birth. Direct DHA supplementation during the first few weeks of life could prevent this deficiency.

The aim is to increase DHA levels in the red blood cell membrane while maintaining the fetal proportion to AA in preterm infants through enteral administration of DHA/AA in a safe, tolerated, and effective manner. This approach aims to avoid the decline in DHA/AA levels and the consequences of their deficiency.

The study is a single-center, prospective, randomized, controlled, open-label study involving preterm infants admitted to the Neonatology Department of Vall d'Hebron University Hospital in Barcelona. conditions: Infant, Premature, Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 80 type: ESTIMATED name: DHA/AA emulsion supplement for preterm infant measure: Percentage comparison of erythrocyte membrane levels of DHA and AA measure: Tolerance of DHA emulsion administration measure: Compare the presence of pathologies in preterm infants between the supplemented group and the control group sex: ALL maximumAge: 7 Days stdAges: CHILD facility: Hospital Materno Infantil Vall d'Hebron status: RECRUITING city: Barcelona zip: 08035 country: Spain name: Félix Castillo Salinas, Dr. role: CONTACT phone: +34 934893899 email: felix.castillo@vallhebron.cat name: Félix Castillo Salinas, Dr. role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False

 nctId: NCT06366880 id: 2022.HPS.DI.434 briefTitle: Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn overallStatus: RECRUITING date: 2024-03-11 date: 2024-12-15 date: 2025-12-15 date: 2024-04-16 date: 2024-04-16 name: Hospital Pediátrico de Sinaloa class: OTHER_GOV briefSummary: Background: Despite the use of parenteral nutrition cycling (PNC) in neonatal intensive care units (NICU), there is limited evidence regarding the benefits in relation to the nutrición parenteral total (NPT) in term and late preterm infants.

The recommendations from the recently published Latin American Society of Gastroenterology, Hepatology and Pediatric Nutrition guidelines are substantially different in this area, and surveys have reported variations in clinical practice.

The aim of this randomised controlled trial (RCT) is to evaluate the benefits and risks of PNC AND parenteral nutrition total (NPT) in term and late preterm infants. conditions: Cholestasis in Newborn studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 66 type: ESTIMATED name: Parenteral nutrition cycling measure: Incidence of cholestasis on Day 28 of admission. measure: are total plasma bilirrubine profiles measure: the incidence of hypoglycaemia sex: ALL minimumAge: 1 Hour maximumAge: 28 Days stdAges: CHILD facility: Hospital Pediatrico de Sinaloa status: RECRUITING city: Culiacán state: Sinaloa zip: 80200 country: Mexico name: Ana Karen Camargo Angulo, Dr. role: CONTACT phone: 6681890586 phoneExt: +52 email: anakarencamargo96@gmail.com lat: 24.79032 lon: -107.38782 hasResults: False

 nctId: NCT06366867 id: Pro00097579 briefTitle: An Open Platform of Serious Games for Cognitive Intervention overallStatus: RECRUITING date: 2022-08-03 date: 2025-08-01 date: 2025-12-01 date: 2024-04-16 date: 2024-04-16 name: University of Alberta class: OTHER name: Alberta Health services name: CapitalCare briefSummary: Computer games are increasingly utilized as tools for studying cognitive skills, aging, individual differences, and development. They offer a unique advantage by presenting challenges that more closely mirror the complexities and demands of everyday tasks compared to traditional laboratory experiments, clinical tests, and standardized assessments. Our team took an innovative step in this direction by developing a suite of tablet-based games, titled VibrantMinds. These games, varying in type, are designed to measure diverse cognitive indicators, acting as proxies for assessments typically conducted using paper-and-pencil tests in clinical settings.

VibrantMinds games have been specifically crafted to be user-friendly and engaging for older adults, including those with dementia. Our studies have shown that these individuals not only find the games accessible but also exhibit measurable improvement in gameplay, suggesting potential benefits for cognitive skill training.

Building on this foundation, we are now poised to conduct an in-depth investigation into the actual effectiveness of serious computer games (SCGs) for cognitive enhancement and their application in real-world settings for older adults. This next phase of research will leverage the VibrantMinds platform to carry out studies aimed at validating software-defined indicators of cognitive function and measuring the impact of game-based interventions on cognitive abilities, health-related quality of life, and other significant real-life outcomes.

The anticipated results promise to expand our understanding of the potential for new technologies in cognitive assessment and intervention. Moreover, by employing machine learning analysis of the data collected through VibrantMinds, we aim to develop a taxonomy that correlates game complexity and player performance with conventional clinical instruments for assessing cognitive status and functioning. conditions: Mild Cognitive Impairment conditions: Dementia conditions: Alzheimer Disease conditions: Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The experimental group will receive VibrantMinds, which consists of sessions with serious computer games in addition to the standard care, whilst the control group will receive the standard of care used at the healthcare facilities. primaryPurpose: DEVICE_FEASIBILITY masking: DOUBLE maskingDescription: Random allocation, 1:1 ratio by a computer-based randomizer whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 122 type: ESTIMATED name: VibrantMinds measure: Cognition - Global measure: Depression measure: Agitation measure: Occupational Performance measure: Engagement measure: Affect sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: CapitalCare Group Inc Facilities status: RECRUITING city: Edmonton zip: T5J 3M9 country: Canada name: Adriana Rios Rincon, PhD, R.OT role: CONTACT phone: 7804921728 email: aros@ualberta.ca lat: 53.55014 lon: -113.46871 hasResults: False

 nctId: NCT06366854 id: IRAS: 332418 briefTitle: UK ANDROMEDA-Shock-2 RCT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04-30 date: 2028-04-30 date: 2024-04-16 date: 2024-04-16 name: Guy's and St Thomas' NHS Foundation Trust class: OTHER name: Pontificia Universidad Catolica de Chile name: University of Rotterdam, The Netherlands briefSummary: The purpose of the trial is to test if a strategy of resuscitation guided by capillary refill time and individualised clinical hemodynamic phenotyping can improve important clinical outcomes within 28 days in septic shock patients compared to usual care. conditions: Septic Shock studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Personalised fluid and haemodynamic resuscitation measure: hospital mortality measure: organ support measure: length of stay measure: mortality measure: vital organ support measure: length of stay sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06366841 id: 6439 briefTitle: Stigma and Psychological profilE in REctal-anal caNcer pAtients acronym: SERENA overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04-30 date: 2026-04-30 date: 2024-04-16 date: 2024-04-16 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: In 2022, Italy is estimated to have 48,100 cases of colon-rectum cancer. Locally advanced mid-lower rectal cancers require preoperative chemo-radiotherapy with fluoropyrimidine. The diagnosis and treatment of rectal cancer have a significant impact on patients' well-being, causing physical and psychological distress. Symptoms such as abdominal pain, fatigue, diarrhea, are commonly reported. While distress levels have been examined before, the relationship between other aspects of the patient experience, such as psychosocial factors, stigma, temperament and personality, alexithymia, have not been extensively explored. Colorectal cancer is associated with specific socially stigmatized challenges. Stigmatization is defined as societal identification of an individual as abnormal and worthy of separation, leading to discrimination and loss of social status. Rectal cancer patients may perceive high levels of stigma and blame due to factors such as defecation-related symptoms, colonoscopy or rectal examinations, physical limitations, loss of work ability and the use of colostomy or ileostomy. Anal cancer, although traditionally surrounded by social stigma, is gaining awareness worldwide due to increasing diagnoses. In other forms of cancer, stigma has been linked to personality traits. Given the characteristics related to the illness and the profile of rectal and anal cancer patients, it is important to assess the psychological traits and psychological resources, also in order to establish tailored psychological pathways during the disease trajectory that comprehend chemoradiations and possible subsequent surgery. Currently, there is no documented data on the relationship between stigma, and psychological profiles in rectal and anal cancer patients. Aim of this protocol is to evaluate the stigma, and psychopathological profile in rectal and anal cancer patients and to evaluate changes in those variables over time. conditions: Rectal Cancer conditions: Anal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 148 type: ESTIMATED name: Psychological tests administration measure: Evaluation of rectal and anal cancer stigma measure: Evaluation of psychological characteristics in rectal and anal cancer measure: Temperament Evaluation of Memphis, Pisa, Paris and San Diego-autoquestionnaire brief version measure: Toronto Alexithymia Scale measure: EORTC QLQ - CR29 and EORTC QLQ-ANL27 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario A. Gemelli IRCCS city: Roma zip: 00168 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06366828 id: 11446 briefTitle: Prediction Models for Complications After CRT in Esophageal Cancer acronym: MODELS overallStatus: RECRUITING date: 2023-02-01 date: 2025-06 date: 2030-06 date: 2024-04-16 date: 2024-04-16 name: University Medical Center Groningen class: OTHER name: Dutch Cancer Society name: Comprehensive Cancer Centre The Netherlands name: Dutch Institute for Clinical Auditing (DICA) name: ZorgTTP briefSummary: The aim of this project is to develop and validate NTCP-models for complications after nCRT (and surgical resection), that can be uses for model-based dose optimization for PhRT and PRT, and for model-based selection for PRT, in patients with esophageal cancer conditions: The Aim of This Project is to Develop and Validate NTCP-models for Complications After nCRT (and Surgical Resection) studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 2000 type: ESTIMATED name: retrospective measure: Multivariable NTCP models will be developed for the prediction of the following measure: Cardiac events grade II or higher (CTCAE v 5.0), including: measure: Mortality measure: Complication Sum Score, that will be determined in Delphi consensus measure: Patient-rated dysphagia measure: Patient-rated nausea measure: Patient-rated fatigue / daily functioning measure: Hospitalization after esophagectomy (days) measure: Intensive care unit stay after esophagectomy (days) sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Radboud UMC status: RECRUITING city: Nijmegen state: Gelderland zip: 6525GA country: Netherlands name: H. Rutten, MD role: CONTACT lat: 51.8425 lon: 5.85278 facility: Maastro clinic status: RECRUITING city: Maastricht state: Limburg zip: 6229ET country: Netherlands name: M. Berbee, MD, PHD role: CONTACT lat: 50.84833 lon: 5.68889 facility: Amsterdam UMC status: RECRUITING city: Amsterdam state: Noord-Holland zip: 1105AZ country: Netherlands name: P. van Rossum, MD, PHD role: CONTACT name: H.W.M. van Laarhoven, MD, PHD role: PRINCIPAL_INVESTIGATOR lat: 52.37403 lon: 4.88969 facility: Erasmus MC status: RECRUITING city: Rotterdam state: Zuid-Holland zip: 3015GE country: Netherlands name: J. Nuyttens, MD, PHD role: CONTACT name: B. Wijnhoven, MD, PHD role: PRINCIPAL_INVESTIGATOR lat: 51.9225 lon: 4.47917 facility: Holland PTC status: NOT_YET_RECRUITING city: Delft country: Netherlands name: Yvonne Klaver, MD, PHD role: CONTACT lat: 52.00667 lon: 4.35556 facility: UMCG status: RECRUITING city: Groningen zip: 9715GZ country: Netherlands name: Christina Muijs, MD, PHD role: CONTACT phone: 0503616161 email: c.t.muijs@umcg.nl name: C. T. Muijs, MD, PHD role: PRINCIPAL_INVESTIGATOR name: J. A. Langendijk, Prof., MD, PHD role: SUB_INVESTIGATOR name: B. van Etten, MD, PHD role: SUB_INVESTIGATOR name: J. J. de Haan, MD, PHD role: SUB_INVESTIGATOR lat: 53.21917 lon: 6.56667 facility: Zuyderland hospital status: RECRUITING city: Heerlen country: Netherlands name: Meindert Sosef, MD role: CONTACT lat: 50.88365 lon: 5.98154 facility: UMCU status: RECRUITING city: Utrecht zip: 3584CX country: Netherlands name: G Meijer, PHD role: CONTACT lat: 52.09083 lon: 5.12222 hasResults: False

 nctId: NCT06366815 id: 4619 briefTitle: phenotypeS in Non Ambulant Duchenne Muscular Dystrophy acronym: GUP21003 overallStatus: RECRUITING date: 2022-08-30 date: 2024-09-30 date: 2025-12-30 date: 2024-04-16 date: 2024-04-16 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The aims of the study are to prospectively collect information on several aspects of function in non-ambulant DMD patients by using a structured battery of tests including motor, respiratory and cardiac function conditions: Duchenne Muscular Dystrophy conditions: Natural History conditions: Motor Function; Retardation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Different Phenotypes of non ambulant patients with Duchenne Muscular Dystrophy measure: motor function measure: respiratory function measure: cardiac function measure: identify patterns of severity and of progression related to differnt genotypes sex: MALE minimumAge: 8 Years maximumAge: 35 Years stdAges: CHILD stdAges: ADULT facility: IRCCS catholic univeristy status: RECRUITING city: Roma country: Italy name: Marika Pane, prof role: CONTACT phone: 0038063015 phoneExt: 6742 email: marika.pane@policlinicogemelli.it name: Daniela Leone role: CONTACT phone: 00390630158821 email: daniela.leone@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06366802 id: Prognosis model-MM09 briefTitle: Cohort Construction and Prognostic Model Construction for Multiple Myeloma overallStatus: ACTIVE_NOT_RECRUITING date: 2022-05-03 date: 2027-05-02 date: 2027-05-02 date: 2024-04-16 date: 2024-04-16 name: The First Affiliated Hospital of Soochow University class: OTHER briefSummary: Multiple myeloma (MM) is a disease caused by malignant plasma cell proliferation disorder. Survival outcomes continue to vary widely even within uniformly treated clinical trial populations. How to construct a clinical prognosis model of MM through real-world data to guide the selection of treatment options, standardize patient management, and improve survival expectations, is a major problem that needs to be solved urgently. It is necessary to build an MM-specific cohort in China to comprehensively understand the characteristics of MM patients, explore treatment options, and improve prognostic factors for survival outcomes. conditions: Multiple Myeloma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED measure: Overall survival measure: Progression free survival(PFS) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Soochow University city: Suzhou state: Jiangsu zip: 215006 country: China lat: 31.30408 lon: 120.59538 hasResults: False

 nctId: NCT06366789 id: ZE46-0134-0002 id: CT-2024-CTN-00161-1 type: OTHER domain: Therapeutic Goods Administration briefTitle: Dose Escalation and Expansion Study to Evaluate the Safety, PK, PD and Efficacy of ZE46-0134 in Adults With FLT3 Mutated Relapsed or Refractory Acute Myeloid Leukemia overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-09 date: 2027-12 date: 2024-04-16 date: 2024-04-16 name: Eilean Therapeutics class: INDUSTRY briefSummary: This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of ZE46-0134 in patients with FLT3 mutated Relapsed or Refractory Acute Myeloid Leukemia conditions: AML With Gene Mutations studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: dose escalation and dose optimization study primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: ZE46-0134 measure: The incidence of DLTs measure: Incidence of AE/SAE measure: Incidence of clinically significant abnormal laboratory results measure: Incidence of abnormal clinically significant ECG results measure: Number of patients with AEs of Grade ≥ 3 measure: Number of treatment-related deaths measure: Plasma Cmax measure: Plasma Css measure: Plasma Cmin measure: Plasma AUC measure: Number of patients attaining any type of Complete Remission (CR, CRh, CRi) by Cycle 6 measure: Number of patients attaining CR by Cycle 6 measure: Number of patients attaining response (CR, CRh, CRi, MLFS) by Cycle 6 measure: Proportion of patients who became FLT3 ITD and TKD undetectable measure: Number of patients with Genomic or proteomic abnormalities sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Linear Clinical Research Ltd city: Perth state: Nedlands, WA zip: 6009 country: Australia name: Carolyn Grove, Prof role: CONTACT lat: -31.95224 lon: 115.8614 hasResults: False

 nctId: NCT06366776 id: 23-278 briefTitle: Emulated Study of Vitamin D Correction vs Non-Correction overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-06 date: 2024-12 date: 2024-04-16 date: 2024-04-16 name: The Cooper Health System class: OTHER name: Won Sook Chung Foundation briefSummary: * This is a single-site retrospective electronic chart review of Cooper Health System Inpatients and Outpatients from 2008 through 2023 aged eighteen years or older. This review is designed as an emulation of a randomized clinical trial with a nonrandomized database.
* The primary objectives are to compare healthcare costs and healthcare utilization between subjects who have corrected low vitamin D levels and those without corrected low vitamin D levels. conditions: Vitamin D Deficiency studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 9000 type: ESTIMATED measure: Ten healthcare costs parameters among the corrected Treatment Group and the uncorrected Control Group A. measure: Ten healthcare utilization parameters among the corrected Treatment Group and the uncorrected Control Group A. measure: Ten healthcare costs parameters among patients with sufficient vitamin D levels (Control Group B). measure: Ten healthcare utilization parameters among patients with sufficient vitamin D levels (Control Group B). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06366763 id: ChengduUTCMvs5 briefTitle: Comparative Clinical Efficacy Between Multi-layer Bandage Pressure Therapy and Gradient Pressure Elastic Stocking Treatment After Endovenous Radiofrequency Ablation overallStatus: RECRUITING date: 2023-08-01 date: 2024-08-01 date: 2024-08-01 date: 2024-04-16 date: 2024-04-16 name: Chengdu University of Traditional Chinese Medicine class: OTHER briefSummary: Objective: To assess the clinical efficacy of different compression methods within 48 hours after endovenous radiofrequency ablation (RFA) in terms of great saphenous vein closure rate, postoperative complications, quality of life, time to return to normal work, and patient satisfaction. conditions: Vascular Diseases, Peripheral conditions: Venous Insufficiency of Leg conditions: Varicose Veins of Lower Limb studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Among the 210 patients included in the study (82 males, 128 females; average age of 59 years), 7 patients were lost to follow-up, and the remaining patients completed the treatment and follow-up.To assess the clinical efficacy of different compression methods within 48 hours after endovenous radiofrequency ablation (RFA) in terms of great saphenous vein closure rate, postoperative complications, quality of life, time to return to normal work, and patient satisfaction. primaryPurpose: TREATMENT masking: NONE count: 210 type: ESTIMATED name: Questionnaires measure: Pain after radiofrequency ablation measure: Bleeding after radiofrequency ablation measure: Tension blisters after radiofrequency ablation measure: The rate of occlusion of treated vein post-procedure measure: Quality of life score using the Chronic Venous Insufficiency Questionnaire(CIVIQ-14) measure: Clinical Change using Venous Clinical Severity Score (VCSS) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital of Chengdu University of Traditional Chinese Medicine status: RECRUITING city: Chengdu state: Sichuan zip: 610000 country: China name: Chunshui He, Doctor role: CONTACT phone: 86-18981885601 email: chunshuihe@msn.com name: Qiqi Wangqiqi, Master role: CONTACT phone: 86-15184495605 email: 285510746@qq.com lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06366750 id: CDX0159-10 id: 2023-510279-80-00 type: OTHER domain: EU CT briefTitle: A Study of Barzolvolimab in Patients With Prurigo Nodularis overallStatus: RECRUITING date: 2024-04 date: 2026-01 date: 2026-06 date: 2024-04-16 date: 2024-04-16 name: Celldex Therapeutics class: INDUSTRY briefSummary: The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with prurigo nodularis. conditions: Prurigo Nodularis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: barzolvolimab name: Matching Placebo measure: Proportion of participants with improvement in Worst Itch Numeric Rating Scale (WI-NRS) by ≥ 4 from baseline to Week 12. measure: Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Week 4. measure: Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Week 24. measure: Proportion of participants with improvement in WI-NRS by ≥ 4 from baseline to Day 169 (week 24). measure: Proportion of participants with Investigator Global Assessment for stage of chronic nodular prurigo score (IGA-CNPG-S) of 0 or 1 at Weeks 4, 12 and 24. measure: Proportion of participants with improvement in both WI-NRS by ≥ 4 from baseline and IGA-CNPG-S score of 0 or 1 at Weeks 4, 12 and 24. measure: Proportion of participants with Investigator Global Assessment for activity of chronic prurigo (IGA-CPG-A) score of 0 or 1 at Weeks 4, 12 and 24. measure: Absolute change from baseline in WI-NRS at Weeks 4, 12 and 24. measure: Percentage change from baseline in WI-NRS at Weeks 4, 12 and 24. measure: Absolute change from baseline in Sleep Quality Numerical Rating Scale (SQ-NRS) at Weeks 4, 12 and 24. measure: Percentage change from baseline in SQ-NRS at Weeks 4, 12 and 24. measure: Absolute change from baseline in Worst Pain Numerical Rating Scale (WP-NRS) at Weeks 4, 12 and 24. measure: Percentage change from baseline in WP-NRS at Weeks 4, 12 and 24. measure: Absolute change from baseline in Patient-Reported Outcomes Measurement Information System Fatigue - Short Form 7b Daily (PROMIS Fatigue-SF Daily) at Weeks 4, 12 and 24. measure: Percentage change from baseline in PROMIS Fatigue-SF Daily at Weeks 4, 12 and 24. measure: Absolute change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 12 and 24. measure: Percentage change from baseline in Dermatology Life Quality Index (DLQI) at Weeks 4, 12 and 24. measure: Proportion of participants with WI-NRS score < 2 at Weeks 4, 12 and 24. measure: Proportion of participants with improvement in SQ-NRS by ≥ 4 from baseline to Week 4, 12 and 24. measure: Proportion of participants with improvement in WP-NRS by ≥ 4 from baseline to Weeks 4, 12 and 24. measure: Proportion of participants with improvement of ≥ 4 in DLQI from baseline to Weeks 4, 12 and 24. measure: Proportion of participants achieving DLQI score of 0 or 1 at Weeks 4, 12 and 24. measure: Absolute change from baseline in PGIS, PGIS-SD, PGIC and PGIC-SD. measure: Percentage change from baseline in PGIS, PGIS-SD, PGIC and PGIC-SD at Weeks 4, 12 and 24. measure: Number of participants with Treatment-Emergent Adverse Events (TEAEs) throughout the study. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Revival Research Institute, LLC status: RECRUITING city: Troy state: Michigan zip: 48084 country: United States name: Sikar Grewal role: CONTACT email: grewal@rev-research.com lat: 42.60559 lon: -83.14993 facility: Center for Clinical Studies status: RECRUITING city: Webster state: Texas zip: 77598 country: United States name: Perla Rivas role: CONTACT email: privas@ccstexas.com lat: 29.53773 lon: -95.11826 hasResults: False

 nctId: NCT06366737 id: CEBD-CU-2024-03-02 briefTitle: En-mass Retraction by Lingual Retractor Versus Clear Aligner Appliances overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-03 date: 2024-04-16 date: 2024-04-16 name: Cairo University class: OTHER briefSummary: en-mass retraction by lingual retractor versus clear alighner therapy conditions: Maxillary Prognathism studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Lingual Retractor Appliance name: clear aligner measure: patient satisfaction ( time , cost , quality) measure: inclination of upper anterior teeth sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Dentistry city: Cairo country: Egypt name: zainab abdulrhman role: CONTACT phone: 00201092445775 email: zeinab_mohammed@dentistry.cu.edu.eg lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06366724 id: 2024P000087 briefTitle: LIFT: Life Improvement Trial acronym: LIFT overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-03 date: 2026-06 date: 2024-04-16 date: 2024-04-16 name: Brigham and Women's Hospital class: OTHER name: Open Medicine Foundation briefSummary: The LIFT will be conducted at Brigham and Women's Hospital (BWH) of Harvard Medical School, focusing on the effect of Pyridostigmine (Mestinon) and Low-Dose Naltrexone (LDN) in subjects aged 18-65 meeting the Canadian consensus criteria (CCC) for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) as well as having specifically Orthostatic Intolerance.

This double-blind, placebo-controlled study will involve 160 participants randomized into one of four possible groups: Pyridostigmine/LDN (40), Pyridostigmine/Placebo (40), LDN/Placebo (40), Placebo/Placebo (40). The dose of Pyridostigmine will be carefully titrated from 30mg to 60mg three times a day, and the dose of LDN will be titrated from 1.5 mg to 4.5 mg once daily.

The trial includes a scale-back plan, allowing participants to reduce their dosage if they experience intolerance symptoms, with adjustments made during weekly visits. This plan provides a personalized approach to medication tolerance, ensuring participant's safety and comfort throughout the trial.

The time commitment for the participant is approximately three (3) months, and during this time, there will be three (3) in-person visits to BWH and four (4) virtual visits. Study procedures will include two (2) submaximum cardiopulmonary exercise tests, questionnaires (virtually completed), and blood and urine collection. We will be recruiting from the BWH Dyspnea Clinic as well as the Open Medicine Foundation (OMF) StudyME Registry and anticipate the entire trial will take two (2) years to complete.

The LIFT represents a significant endeavor to improve treatment options for ME/CFS patients and contribute to the broader understanding of this debilitating condition. conditions: ME/CFS studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: Randomized factorial group double-blinded placebo-controlled trial primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: The Mass General Brigham Investigational Drug Services (IDS) will be responsible for randomizing the four arms. The rest of the study staff and collaborators will be blinded as well as the participant. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 160 type: ESTIMATED name: Pyridostigmine name: Low-Dose Naltrexone name: Placebo measure: Functional Capacity measure: Physiologic Response - Oxygen Uptake Efficiency Slope (OUES) measure: Physiologic Response - Oxygen Utilization (VO2) measure: Physiologic Response - Heart Rate Recovery (HRR) measure: Post-Exertional Malaise measure: PROMIS-29-Pain measure: Daily Activity measure: Heart Rate Variability measure: Blood Oxygen measure: Resting Heart Rate measure: DANA Brain Vital-Simple Reaction Time (SRT) measure: DANA Brain Vital-Procedural Reaction Time (PRT) measure: DANA Brain Vital-Memory Search (MS) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06366711 id: 23/BW/MAT/NO/754 briefTitle: Remote Telemedicine Fetal Monitoring Feasibility Study overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-08 date: 2024-10 date: 2024-04-16 date: 2024-04-16 name: Birmingham Women's NHS Foundation Trust class: OTHER_GOV name: GE Healthcare name: Nestmedic S.A. briefSummary: During pregnancy, certain conditions may arise that mean regular monitoring of both mother and baby are needed to ensure timely interventions and avoid the need for further treatments. These situations include problems with high blood pressure, obstetric cholestasis (characterised by liver-related itchiness), preterm premature rupture of membranes (PPROM), and a history of stillbirth. Monitoring typically involves assessing the mother's blood pressure and urine, recording the baby's heart rate over a specific duration, and conducting regular ultrasound scans. Such monitoring can require frequent hospital visits, often multiple times a week, which can be very time consuming. More recently, new technology has emerged, enabling remote monitoring of mother and baby outside of the hospital setting, such as their own home. However, research on these technologies is still very limited.

Our study aims to address this research gap by inviting women with the above conditions to volunteer for home-based monitoring, alongside their routine hospital care. Participants will be divided into three groups: one group will use transducers, attached to the mothers tummy, to capture the baby's heartbeat; another group will use a handheld ultrasound device connected to their mobile phones, allowing them to observe the baby; and a third group will use both devices. All device information will be transmitted securely to the healthcare professional for analysis. The investigators aim to assess the feasibility of conducting remote monitoring of mother and baby, whilst understanding how acceptable the technology is received.

Importantly, the data collected will only be evaluated by the research team and will not be intended to influence patient's current planned antenatal care. Women will receive comprehensive training on the devices. The study will additionally gather feedback from participating women through questionnaires, both at the study's outset and its conclusion, regarding their experiences and emotions related to the research. conditions: Pregnancy, High Risk conditions: Telemonitoring conditions: Telemedicine conditions: Ultrasound conditions: Cardiotocography studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: 15 participants split in to three arms. The sample size has been determined as a pragmatic sample taking into consideration the needs of the feasibility study to meet the stated objectives as well as being achievable within the time and cost constraints of the study. 15 participants will ensure a thorough assessment of the stated objectives. primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 15 type: ESTIMATED name: Pregnabit Pro device and PregnaOne platform name: Pulsenmore device measure: The number of participants that produce interpretable fetal ultrasound scans for each episode of intermittent home monitoring. measure: The number of participants that produce interpretable antenatal maternal-fetal monitoring cardiotocogram (CTG) traces for each episode of intermittent home monitoring. measure: The number of participants completing the full schedule of home maternal-fetal monitoring episodes. measure: To explore how acceptability and participant views can best be assessed within a future clinical trial using wearable technology at home? measure: The number of women approached who agreed to participate within the study. measure: What are the views of participants and healthcare professionals regarding acceptability of home maternal-fetal monitoring. measure: What are the views of participants and healthcare professional regarding acceptability of home maternal-fetal monitoring. measure: What are the emotions of participants prior to and following usage of home maternal-fetal monitoring. measure: What are the emotions of participants prior to and following usage of home maternal-fetal monitoring. measure: The number of participants with unexpected clinical outcomes detected whilst using home monitoring devices, which warrants patients to attend maternity triage for assessment and/or modification of ones antenatal care. sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False

 nctId: NCT06366698 id: 23-55 briefTitle: Intravenous Iron Versus Oral Iron for the Treatment of Iron Deficiency Anemia acronym: IDA overallStatus: RECRUITING date: 2023-11-21 date: 2025-12-30 date: 2025-12-30 date: 2024-04-16 date: 2024-04-16 name: Arrowhead Regional Medical Center class: OTHER briefSummary: This study aims to assess whether administering intravenous iron early in pregnancy, compared to standard oral iron treatment, can enhance hemoglobin levels before delivery and reduce the need for blood transfusions in patients with iron deficiency anemia. Patients diagnosed with iron deficiency anemia were randomly assigned to receive either oral or intravenous iron. Before treatment initiation, patients completed a symptom questionnaire baseline hemoglobin, and ferritin levels were measured. Follow-up visits occurred four weeks later and at 24 to 28 weeks gestation, involving reassessment of symptoms, laboratory testing, and monitoring of treatment adherence. Final hemoglobin levels were determined before delivery, and data on the need for blood transfusion at delivery were recorded. conditions: Iron Deficiency Anemia of Pregnancy studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Patients are initially randomized to either PO or IV iron, after the initial 4-week treatment patients in the PO iron group can switch to IV iron if labs continue to show persist iron deficiency anemia. primaryPurpose: TREATMENT masking: NONE count: 900 type: ESTIMATED name: Venofer 200 MG Per 10 ML Injection name: Ferrous sulfate measure: Hemoglobin difference measure: Ferritin difference measure: Delivery Hemoglobin measure: Rates of blood transfusion measure: Symptoms measure: Preterm delivery measure: Depression measure: Birthweight sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Arrowhead Regional Medical Center status: RECRUITING city: Colton state: California zip: 92324 country: United States name: Guillermo Valenzuela, MD role: CONTACT phone: 909-580-4145 email: jvalenzuelar@me.com name: Tina M Bui, DO role: PRINCIPAL_INVESTIGATOR name: Kristina Roloff, DO role: SUB_INVESTIGATOR name: Guillermo Valenzuela, MD role: SUB_INVESTIGATOR name: Lily Zhu, DO role: SUB_INVESTIGATOR name: Phoebe Jen, DO role: SUB_INVESTIGATOR name: Mary Tsaturian, MD role: SUB_INVESTIGATOR lat: 34.0739 lon: -117.31365 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-11-21 uploadDate: 2024-04-10T14:44 filename: ICF_000.pdf size: 165063 hasResults: False

 nctId: NCT06366685 id: YJS20230170 briefTitle: Development and Initial Application of a Combined Exercise and Psychological Intervention Program for Patients After Esophagectomy acronym: Recovery overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-31 date: 2025-02-01 date: 2024-04-16 date: 2024-04-16 name: Mengmeng Yuan class: OTHER name: Anhui Medical University briefSummary: Esophageal cancer imposes a significant burden in China, accounting for over 60% of the global disease burden. While surgery remains a common and highly effective treatment for esophageal cancer, patients often experience multiple physical and psychological symptoms postoperatively, severely affecting their recovery outcomes and quality of life. Although existing exercise or psychological intervention programs have shown some effectiveness, issues such as relatively singular intervention content, imprecise intervention timing, and vague intervention details persist.

This project, based on previous research foundations (including the development of symptom measurement tools and the identification of key recovery periods), is guided by symptom management theory and knowledge translation models. Taking a perspective of the synergistic impact of physical and psychological symptoms, the study focuses on patients undergoing esophageal cancer surgery. Initially, evidence-based literature review, focus group interviews, and expert consultations were conducted to develop a combined exercise and psychological intervention program, integrating subjective (CSCA_EC) and objective (6MWT) measurement indicators, named "Recovery For EC." Subsequently, the program was preliminarily applied in clinical settings using a mixed-methods approach, combining quantitative quasi-experimental design (108 cases) and qualitative interviews to assess its acceptability. The final clinical trial version of the Recovery For EC program was developed to provide patients with a tool for self-monitoring recovery outcomes and offer clinical healthcare professionals guidance for implementing precise and personalized rehabilitation management. conditions: Esophageal Cancer conditions: Exercise Training conditions: Psychotherapy conditions: Rehabilitation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Exercise and Psychological Intervention measure: the Convalescence Symptom Assessment Scale for EsophageCtomy patients (CSAS_EC) measure: 6-Minute Walk Test measure: Hospital Anxiety and Depression Scale (HADS) measure: Postoperative Complications sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anhui Medical University city: Hefei state: Anhui zip: 234000 country: China name: Mengmeng Yuan, Graduate role: CONTACT phone: 18205575607 email: 2510950595@qq.com name: Shaoxue Li, Graduate role: CONTACT phone: 18712335223 email: 2581558674@qq.com name: Shuwen Li, Professor role: PRINCIPAL_INVESTIGATOR lat: 31.86389 lon: 117.28083 hasResults: False

 nctId: NCT06366672 id: 202312043 briefTitle: Evaluating the Human Immune Response to the JYNNEOS Vaccine overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2025-12 date: 2024-04-16 date: 2024-04-16 name: Washington University School of Medicine class: OTHER briefSummary: This study is designed to evaluate the magnitude and duration of the human adaptive immune response to the JYNNEOS Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine in the blood, lung mucosa, skin and bone marrow. conditions: Vaccinia conditions: Virus Diseases studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Participants will be vaccinated with MVA-BN according to the FDA-approved labeling and immune responses in the blood, lung mucosa, skin, and bone marrow will be monitored prior to and following vaccination using phlebotomy, research bronchoscopy, skin punch biopsy, and bone marrow aspiration procedures. primaryPurpose: BASIC_SCIENCE masking: NONE count: 20 type: ESTIMATED name: JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Nonreplicating) suspension for subcutaneous injection name: Phlebotomy name: Research bronchoscopy name: Skin punch biopsy name: Bone marrow aspiration measure: Change in magnitude of the MVA-BN antigen-specific T cell response in the blood measure: Change in magnitude of the MVA-BN antigen-specific antibody response in blood plasma measure: Change in magnitude of the MVA-BN antigen-specific T cell response in the lower airways measure: Change in magnitude of the MVA-BN antigen-specific antibody response in bronchoalveolar lavage fluid measure: Evaluate the magnitude and surface phenotype of T cells in the blood, airspace, and skin over time measure: Evaluate the magnitude and surface phenotype of B cells in the blood and bone marrow over time. sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Washington University in Saint Louis School of Medicine Emergency Care and Research Core city: Saint Louis state: Missouri zip: 63110 country: United States name: Jamie Mills role: CONTACT phone: 314-305-1054 email: jamiem@wustl.edu lat: 38.62727 lon: -90.19789 hasResults: False

 nctId: NCT06366659 id: M2024049 briefTitle: Unraveling the Pathogenesis of Pruritus in Intrahepatic Cholestasis of Pregnancy overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-08-20 date: 2025-08-20 date: 2024-04-16 date: 2024-04-16 name: Peking University class: OTHER name: Peking University Third Hospital briefSummary: This study hopes identify the main pruritogens of ICP pruritus and provide new insights for the diagnosis, prediction, and treatment of ICP. Details are as follows: It is planned to include ICP confirmed pregnant women and healthy pregnant women who have given birth in the Peking University Third Hospital and Sichuan University West China Second University Hospital. Then progesterone sulfate levels in plasma samples will be quantified by High Performance Liquid Chromatography-Mass Spectrometry (HPLC-MS) and itch intensity will be quantified by questionnaires. Main study endpoint: To reveal new indicators of ICP diagnosis with high accuracy: single, multiple or combined indicators of progesterone sulfates and other molecules like bile acids; Secondary study endpoint: To determine whether progesterone sulfates can be used as an early screening indicator for ICP for disease prediction, specifically whether elevated levels of progesterone sulfates predate pruritus in pregnant women with ICP. conditions: Intrahepatic Cholestasis of Pregnancy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 600 type: ESTIMATED measure: Progesterone metabolites (levels in plasma) measure: Itch intensity measure: Total bile acids (levels in plasma) sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Peking University Third Hospital city: Beijing state: Beijing zip: 100000 country: China name: Guangyi Lan role: CONTACT phone: 13176881226 email: Guangyi_lan@stu.pku.edu.cn name: Yulong Li role: PRINCIPAL_INVESTIGATOR name: Yuan Wei role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Sichuan University West China Second University Hospital city: Chengdu state: Sichuan zip: 610001 country: China name: Guangyi Lan role: CONTACT phone: 13176881226 email: Guangyi_lan@stu.pku.edu.cn name: Yaoyao Zhang role: PRINCIPAL_INVESTIGATOR name: Xue Xiao role: PRINCIPAL_INVESTIGATOR lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06366646 id: 035901 briefTitle: Competency-based Intervention for Head Nurses overallStatus: COMPLETED date: 2022-12-01 date: 2023-04-30 date: 2023-04-30 date: 2024-04-16 date: 2024-04-16 name: Matrouh University class: OTHER briefSummary: Head nurses have a crucial leadership role in managing their units and providing high-quality and safe nursing care. Head nurse leadership competency and effectiveness are very essential to manage nursing care practices and management activities in their hospitals. Development leadership competency intervention programs would improve the head nurse's competency and effectiveness. conditions: Intervention conditions: Knowledge, Attitudes, Practice studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A quasi-experimental design primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: A quasi-experimental design utilized one group for pre-, post, and follow-up intervention. whoMasked: PARTICIPANT count: 90 type: ACTUAL name: Competency-based intervention measure: Questionnaire to measure head nurses' knowledge of leadership competency measure: Questionnaire to measure head nurses' ability to use leadership competency measure: Questionnaire to measure leadership effectiveness 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: NCT06366633 id: 2024P000713 id: 1K23AT012364-01 type: NIH link: https://reporter.nih.gov/quickSearch/1K23AT012364-01 briefTitle: Web-based Mind-body Program for Comorbid Nontraumatic Upper-extremity Condition and Risky Substance Use overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-01-31 date: 2025-03-31 date: 2024-04-16 date: 2024-04-22 name: Jafar Bakhshaie class: OTHER name: National Center for Complementary and Integrative Health (NCCIH) briefSummary: The investigator aims to conduct an open pilot study (N=12; 10 completers) to test the feasibility, acceptability, and credibility of an asynchronous web-based mind-body intervention (Toolkit for Resilient Life beyond Pain and Substance Use; Web-TIRELESS) for adult patients with a comorbidity of non-traumatic painful upper-extremity condition(s) (NPUC) and risky substance use.

Deliverables: 1) Adapt and refine open pilot protocol, patient recruitment, and other study materials. 2) Assess the feasibility, acceptability, and credibility of Web- TIRELESS in preparation for a future feasibility RCT.

Participants will complete 4 on-demand video sessions at their own pace (approximate pace of 1 session per week) and complete baseline and post-test assessments. participants may also partake in an exit interview to provide feedback on Web-TIRELESS to further refine the program and study protocol for future iterations. conditions: Orthopedic Disorder conditions: Nontraumatic Injury conditions: Substance Use conditions: Upper Extremity Problem studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Web-TIRELESS measure: Credibility and Expectancy Questionnaire (CEQ) measure: Client Satisfaction Questionnaire to assess satisfaction with/acceptability of treatment measure: The User Experience Scale to assess participants' satisfaction with (acceptability of) web-based delivery measure: The percent of patients that agree to participate to assess feasibility of recruitment measure: Rate at which program was accepted, measured by attendance to assess acceptability of treatment measure: Adherence to homework measure: Rate of participant's completion of self-report measures to assess feasibility of assessments measure: Adverse Events measure: Graded Chronic Pain Scale (GCPS) measure: Disabilities of the Arm, Shoulder and Hand (DASH) measure: Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression-Short Form 8b v1.0 measure: PROMIS Emotional Distress - Anxiety-Short Form 8b v1.0 measure: Pain Catastrophizing Scale (PCS) measure: Pain Anxiety Symptoms Scale - Short Form (PASS-20) measure: Pain Vigilance and Awareness Questionnaire (PVAQ) measure: Brief Experiential Avoidance Questionnaire (BEAQ) measure: Current Opioid Misuse Measure (COMM) measure: The Timeline Follow Back (TLFB) measure: Numerical Rating Scale (NRS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02129 country: United States name: Jafar Bakhshaie, MD, PhD role: CONTACT phone: 617-643-7641 email: jbakhshaie@mgh.harvard.edu lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06366620 id: STUDY00003416 briefTitle: Examining the Feasibility, Acceptability, and Fidelity of Utilizing Parent Training Graduates as Peer Supports overallStatus: RECRUITING date: 2024-04-10 date: 2024-06-19 date: 2024-06-19 date: 2024-04-16 date: 2024-04-16 name: Seattle Children's Hospital class: OTHER briefSummary: Disruptive behavioral disorders are common in early childhood, affecting up to 15% of preschool-aged children. Behavioral parent training programs are a first-line evidence-based treatment for child disruptive behaviors. There is evidence showing that (a) these programs are effective in reducing disruptive behavior and improving long-term outcomes, and (b) there is an excellent return on investment for early intervention. Nevertheless, there is limited availability of behavioral parent training programs, particularly in rural settings, due to shortages of trained clinicians. Thus, there is a pressing need for expanding the mental healthcare workforce in rural/underserved areas. The study will involve an established parent-based behavioral intervention (First Approach Skills Training for Behavior; or FAST-B) with added pilot component incorporating parents who have previously been through parent behavioral management training programs as Peer Supports. conditions: Child Disruptive Behavior Disorders conditions: Parent Child Relationship conditions: Parent Management Training conditions: Peer Support conditions: Child Behavior Problems conditions: Challenging Behavior conditions: Positive Parenting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 30 type: ESTIMATED name: FAST-B PEERS name: FAST-B (First Approach Skills Training - Behavior) measure: Acceptability of FAST-B PEERS measure: Acceptability of FAST-B measure: FAST-B PEERS support calls attended measure: Weekly Assessment of Child Behavior - P measure: Coping with Child Negative Emotions Scale measure: Strengths and Difficulties Questionnaire sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Seattle Children's status: RECRUITING city: Seattle state: Washington zip: 98115 country: United States name: Doug Mason role: CONTACT phone: 206-987-7000 email: doug.mason@seattlechildrens.org name: Alissa D Hemke, MD role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06366607 id: 0306066 briefTitle: Managing High-alert Medication Administration and Errors overallStatus: COMPLETED date: 2023-03-01 date: 2023-05-31 date: 2023-05-31 date: 2024-04-16 date: 2024-04-16 name: Matrouh University class: OTHER briefSummary: High-alert medications are drugs that may lead to serious harm when they are wrongly administered to patients. Safe medication administration is the crucial role of nursing staff. conditions: Knowledge conditions: Practice Nurse's Scope conditions: Competence conditions: Nurse's Role conditions: Error Disclosure studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 300 type: ACTUAL name: high-alert medication administration measure: Questionnaire to measure nurses' knowledge about high-alert medication administration measure: Questionnaire to measure medication safety climate measure: Questionnaire to measure nurses' competency measure: observational check list to measure nurses' practice during administration of high-alert medications measure: Questionnaire to measure errors associated with administering high-alert medications 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: NCT06366594 id: 0305897 briefTitle: First-line Nurse Manager Authentic Leadership Training Program overallStatus: COMPLETED date: 2022-12-01 date: 2023-04-30 date: 2023-04-30 date: 2024-04-16 date: 2024-04-16 name: Matrouh University class: OTHER briefSummary: Authentic leadership behavior is considered a mandatory strategy for enhancing the nurse manager capabilities and practice as well as achieving positive nurses' attitudes. conditions: Intervention studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: A quasi-experimental research design primaryPurpose: OTHER masking: SINGLE maskingDescription: A quasi-experimental design utilized one group for pre-, post, and follow-up intervention. whoMasked: PARTICIPANT count: 37 type: ACTUAL name: Authentic leadership training program measure: Questionnaire to measure first-line nurse managers' knowledge about authentic leadership measure: questionnaire to measure authentic leadership behavior among first-line nurse managers measure: Questionnaire to measure nursing care self-efficacy measure: Questionnaire to measure nurses' trust in their workplace 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: NCT06366581 id: HD20240307 briefTitle: Transcriptomic Analysis of Incisional Hernia Based on High-throughput Sequencing Technology overallStatus: COMPLETED date: 2023-03-01 date: 2023-09-01 date: 2024-03-01 date: 2024-04-16 date: 2024-04-16 name: Fudan University class: OTHER briefSummary: This study included patients who underwent surgical treatment for incisional hernia and non-hernia conditions. Surgical specimens were collected for transcriptome sequencing to obtain the gene expression list. Then genes analyzed by Gene Ontology, protein interactions, and signaling pathway enrichment using the expression matrix. conditions: Incisional Hernia conditions: Extracellular Matrix Alteration studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 36 type: ACTUAL name: Transcriptomic analysis measure: the gene expression list sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hua Dong Hospital Affiliated to Fu Dan University city: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06366568 id: CRO-2022-10-PG-MER-MW-JG briefTitle: Efficacy of a Eugenol-based Product to Improve the Quality of Toothbrushing and Relieving Gum Discomfort Areas overallStatus: COMPLETED date: 2024-02-19 date: 2024-03-06 date: 2024-03-06 date: 2024-04-16 date: 2024-04-16 name: Colgate Palmolive class: INDUSTRY briefSummary: The objective of this study is to evaluate the efficacy of a eugenol-based product in improving the quality of toothbrushing and relieving areas of gingival discomfort. This is a randomized, controlled, parallel, examiner-blind clinical trial. conditions: Plaque, Dental studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 86 type: ACTUAL name: fluoride toothpaste containing 1450 ppm of MFP in a PCC base and eugenol gum product name: fluoride toothpaste containing 1450 ppm of MFP in a PCC base measure: Turesky Modification of the Quigley & Hein Plaque Index measure: questionnaire sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitätsklinikum Carl Gustav Carus Technische Universität Dresden Department of Periodontology Fetscherstras city: Dresden zip: 01307 country: Germany lat: 51.05089 lon: 13.73832 hasResults: False

 nctId: NCT06366555 id: 24-02-0268 briefTitle: The Role of Manual Twirling Acupuncture in Reducing Muscle Pain and Stiffness After Biceps Curling in Healthy Untrained Individuals overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-06-22 date: 2024-06-22 date: 2024-04-16 date: 2024-04-26 name: Indonesia University class: OTHER briefSummary: Regular physical activity can help to prevent and control non-communicable disease. WHO recommends at least in adults to do moderate-vigorous physical activity includes muscle strengthening. But regardless the importance and recommendations of physical activity, not all of the world's population does it .Biceps Curling is a popular physical exercise which easy to do , it can strengthen the muscles in the upper body. However based on the International Association for the Study of Pain (IASP) in individuals who just starting to do physical exercise may experience pain and can become a barrier to do physical activity, so an approach is needed to prevent this and acupuncture is one of them. Currently, a lot of acupuncture research has been carried out to reduce the condition pain and stiffness after weight training, but there are not many study using manual acupuncture twirling in this condition .

That's why the aim of this study Is to see the efficacy of giving manual acupuncture with twirling stimulation for pain and stiffness post weight training. The study method will be a Single Blinded Crossover Randomized Controlled Trial which will compare the efficacy of Manual Acupuncture twirling with Manual Acupuncture Sham for post-exercise pain and stiffness . The outcomes consist of Visual Analog Scale, Pain Pressure Threshold, Range of motion of elbow flexor at 24 hours, 48 hours, and 72 hours post weight training conditions: Muscle Soreness conditions: Stiffness of Elbow, Not Elsewhere Classified studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This research design used a randomized controlled single-blind crossover trial method (Crossover Single Blinded Randomized Control Trial). Reasons for choosing to use the Crossover method because apart from being able to implement it, it can also provide far more output results with a smaller number of subjects.

The research subjects will then receive two treatments spaced 1 week apart which is called a wash out period to eliminate the carry-over effect of the treatment given. Research subjects will undergo randomization . Subjects in group A will undergo manual twisting acupuncture followed by sham manual acupuncture. The subject in group B will receive a sham acupuncture manual followed by a round of manual acupuncture twirling primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The Participant will be randomized using a computerized table and the Outcome Assessor dont know which Subjects receive the manual acupuncture twirling or sham manual acupuncture on each period whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Manual Acupuncture Twirling, name: Manual Acupuncture Sham measure: Visual Analog Scale measure: Pain Pressure Threshold measure: Range of Motion sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Sport and Exercise Studies, Indonesian Medical Education and Research Institute (IMERI) Research Tower city: Jakarta state: DKI Jakarta zip: 10430 country: Indonesia name: IMERI, Research Center role: CONTACT phone: 29189160 lat: -6.21462 lon: 106.84513 hasResults: False

 nctId: NCT06366542 id: 2/2024 briefTitle: Virtual Reality in People With Persistent Postural-Perceptual Dizziness: RCT overallStatus: COMPLETED date: 2022-05-01 date: 2023-12-31 date: 2024-03-01 date: 2024-04-16 date: 2024-04-16 name: University of Jordan class: OTHER briefSummary: This study aimed to compare the effectiveness of virtual reality (VR) and vestibular rehabilitation therapy (VRT) in enhancing balance in individuals with Persistent Postural-Perceptual Dizziness (PPPD). The experimental group received VR combined with VRT and optokinetic stimulation, while the control group received VRT and optokinetic stimulation. The study involved 42 individuals diagnosed with PPPD and administered ten intervention sessions over six weeks. The study also examined the impact of VR on various aspects of PPPD, including dizziness, visual vertigo, mental well-being, sleep quality, fall risk, and overall quality of life. conditions: Vestibular Dizziness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 42 type: ACTUAL name: Vestibular rehabilitation therapy name: Virtual reality exercises name: Optokinetic Stimulation exercises measure: The Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ) measure: The Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ) measure: The Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ) measure: Dizziness Handicap Inventory (DHI) measure: Dizziness Handicap Inventory (DHI) measure: Falls Efficacy Scale International (FES-I) measure: Falls Efficacy Scale International (FES-I) measure: Dynamic Gait Index (DGI) measure: Dynamic Gait Index (DGI) measure: Pittsburgh Sleep Quality Index (PSQI) measure: Pittsburgh Sleep Quality Index (PSQI) measure: Hospital Anxiety and Depression Scale (HADS) measure: Hospital Anxiety and Depression Scale (HADS) measure: Medical Outcomes Study Short Form 12 (SF-12) measure: Medical Outcomes Study Short Form 12 (SF-12) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Royal Medical Services city: Amman country: Jordan lat: 31.95522 lon: 35.94503 hasResults: False

 nctId: NCT06366529 id: TJ-IRB202308123 briefTitle: Explore New Magnetic Resonance Technology in Assessment of Renal Dysfunction overallStatus: RECRUITING date: 2023-09-01 date: 2030-09 date: 2030-09 date: 2024-04-16 date: 2024-04-17 name: Zhen Li class: OTHER briefSummary: Currently, renal biopsy is the gold standard for evaluating renal pathology and renal fibrosis, but it is invasive and carries the risk of serious complications; and the sampled tissue is only a small part of the kidney, which is prone to sampling bias. The lack of reliable, comprehensive test results has hindered the research of new anti-fibrotic drugs and delayed the clinical application of effective new drugs. Therefore, the development of a non-invasive dynamic detection method for renal insufficiency and renal fibrosis in vivo is an urgent clinical problem to be solved.

With the continuous development and update of technology, imaging provides a new way to non-invasively evaluate renal fibrosis. Due to the high resolution of soft tissue and the ability to perform multi-parameter analysis, magnetic resonance has developed the diagnosis of renal insufficiency and renal fibrosis from macroscopic simple biomorphological changes to microscopically complex pathophysiological changes. Many imaging techniques measure renal dysfunction and renal fibrosis by assessing the impact of fibrosis on the functional status, physical properties, and molecular properties of the kidney.

In recent years, in the context of precision medicine, artificial intelligence technologies such as radiomics and machine learning are rapidly becoming very promising auxiliary tools in the imaging assessment of renal fibrosis. It can extract and learn features in images with high throughput, make greater use of information in medical images that cannot be recognized by the human eye, and achieve disease diagnosis, prognosis assessment, and efficacy prediction by building models. However, most of the current research is in the preliminary stage, and there are still few studies on the assessment of renal insufficiency and renal fibrosis. I believe that with the continuous improvement of algorithms and the optimization of models, the progress of radiomics and machine learning will be great. To a certain extent, it promotes the development of personalized medicine and precision medicine for patients with renal insufficiency and renal fibrosis. conditions: Renal Insufficiency, Chronic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED measure: ESKD sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji hospital, NO.1095 jiefang avenue status: RECRUITING city: Wuhan state: Hubei zip: 430074 country: China name: Zhen Li, Doctor role: CONTACT email: zhenli@hust.edu.cn lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06366516 id: FUOBGY2024-23 briefTitle: Role of Methylation Test Triage in HPV Positive Women acronym: MTTRIHPW overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-08 date: 2026-02 date: 2024-04-16 date: 2024-04-16 name: Obstetrics & Gynecology Hospital of Fudan University class: OTHER name: Peking Union Medical College Hospital name: Chengdu Women's and Children's Central Hospital name: Guangdong Women and Children Hospital name: Second Hospital of Jilin University name: First Affiliated Hospital of Xinjiang Medical University name: Third Affiliated Hospital of Zhengzhou University briefSummary: The pathological results were used as the gold standard in this study and the investigators analyze the diagnostic value of six gene methylation status (ASTN1 DLX1, ITGA4, RXFP3, SOX17, ZNF671) in triaging high-risk human papillomavirus infection. The sensitivity and specificity of methylation test and cytology in the diagnosis of high-grade cervical lesions are compared in order to providing new methods and basis in improving the accuracy of cervical cancer screening. conditions: Precancerous Cervical Lesion studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Women who aged 25 to 65 years are screened for cervical cancer and they are all positive of high-risk HPV. primaryPurpose: SCREENING masking: NONE count: 10000 type: ESTIMATED name: Methylation Test measure: The sensitivity and specificity of methylation test in detecting CIN2+. measure: KAPPA value of methylation test. sex: FEMALE minimumAge: 25 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Obstetrics and Gynecology Hospital of Fudan University city: Shanghai state: Shanghai zip: 200011 country: China name: Long Sui, Professor role: CONTACT phone: 0086-021-33189900 email: suilong@fudan.edu.cn name: Qing Cong, PHD role: CONTACT phone: 0086-021-33189900 email: qingcong@fudan.edu.cn lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06366503 id: RS-2023-05 briefTitle: Evaluating Procedure Pairing of a Post-Procedure Cream Versus a Comparator in Patients Treated With Fractional Ablative CO2 Laser for Facial Rejuvenation overallStatus: COMPLETED date: 2023-10-03 date: 2023-12-29 date: 2023-12-29 date: 2024-04-16 date: 2024-04-16 name: Revision Skincare class: INDUSTRY briefSummary: This randomized, single-center, double-blinded, split-face, controlled clinical trial was conducted to investigate the tolerability, safety, and efficacy of a post-procedure cream when used immediately after fractional ablative CO2 laser treatment and for 14 days post-procedure with three times daily application in healthy female subjects aged 35 to 65 with moderate to severe global facial overall photodamage (score of 4 to 9 out of the 10-point Modified Griffiths' scale). Furthermore, this clinical trial compared the active post-procedure cream to a comparator anhydrous formulation often paired with skin rejuvenation procedures. This is a cosmetic study with a FDA-regulated device.

A total of 22 healthy female subjects completed the study. conditions: Photoaging conditions: Wrinkle conditions: Skin Laxity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, Single-Center, Double-Blinded, Split-Face, Controlled primaryPurpose: OTHER masking: DOUBLE maskingDescription: Subjects were randomly assigned to use the active post-procedure cream on one side of the face and the comparator anhydrous formulation on the opposite side of the face.

The products were packaged in the same container and labelled post-procedure cream. This was a double blinded study, where the investigator, study subject, and other study personnel involved in the evaluation of the efficacy or safety were blinded to group during the study. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 23 type: ACTUAL name: Fractional Ablative CO2 Laser name: Facial Cleanser name: Facial Moisturizer name: Sunscreen name: Basic Ointment measure: Investigator Tolerability measure: Incidence of Adverse Events measure: Subject Tolerability measure: Self-Assessment Questionnaire sex: FEMALE minimumAge: 35 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Dermatology Group city: Blue Ash state: Ohio zip: 45242 country: United States lat: 39.232 lon: -84.37827 hasResults: False

 nctId: NCT06366490 id: CIP2023-001 briefTitle: Safety and Immunogenicity of Innocell Autologous Cellular Immunotherapy in Recurrent Epithelial Ovarian Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-01 date: 2025-03-01 date: 2024-04-16 date: 2024-04-16 name: PhotonPharma, Inc. class: INDUSTRY briefSummary: Safety and Immunogenicity of InnocellTM Autologous Cellular Immunotherapy Administered in Patients with Recurrent Epithelial Ovarian Cancer conditions: Ovarian Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The study is a 2-part design. For each participant, Part 1 will involve tissue procurement and confirmation of the ability to manufacture the Innocell vaccine, followed by Part 2 which is the treatment phase, involving Innocell administration to patients. primaryPurpose: TREATMENT masking: NONE maskingDescription: Open label Phase I trial with no masking count: 8 type: ESTIMATED name: Innocell Autologous Cellular Immunotherapy measure: Saferty and Immunogenicity of Innocell in Ovarian Cancer Patients measure: Safety of Innocell in Ovarian Cancer Patients measure: Immunogenicity of Innocell in Ovarian Cancer Patients measure: Immunogemicity in Ovarian Cancer Patients measure: Immunogenicity of Innocell Vaccine in Ovarian Cancer Patients sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06366477 id: B-ER-103-417 briefTitle: Effects of Vibration Stimulation Combined With Task-oriented Training on Hand Motor Function in Chronic Stroke overallStatus: COMPLETED date: 2017-01-01 date: 2019-06-15 date: 2019-11-15 date: 2024-04-16 date: 2024-04-16 name: National Cheng-Kung University Hospital class: OTHER briefSummary: There is a lack of effective therapies for hand and finger function recovery in people with chronic stroke. This study assessed the effects of combining vibration stimulation with task-oriented training on functional recovery, and treatment persistence. Participants with chronic stroke underwent 24 sessions of vibration stimulation combined with task-oriented training over 12 weeks, in addition to regular therapy. Functional recovery was assessed using the Fugl-Meyer assessment for motor function (FMA-wrist and hand), the Box and Blocks Test (BBT) for hand dexterity, and the Motor Activity Log (MAL) for daily functional activities. Minimal detectable change (MDC) and minimal important difference (MID) criteria were applied to interpret changes in assessment scores. conditions: Rehabilitation conditions: Stroke conditions: Hand Grasp studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 3 type: ACTUAL name: Vibration stimulation combined with task-oriented training measure: Fugl-Meyer assessment - wrist and hand measure: Box and Blocks Test measure: Motor Activity Log measure: Quantitative Electroencephalography Analysis: Delta Brain Symmetry Index sex: ALL minimumAge: 20 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06366464 id: HBS-101-CL-312 briefTitle: A Study of Pitolisant in Patients With Prader-Willi Syndrome overallStatus: RECRUITING date: 2024-04 date: 2026-07 date: 2027-07 date: 2024-04-16 date: 2024-04-16 name: Harmony Biosciences, LLC class: INDUSTRY briefSummary: This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome.

The primary objective of this study is to evaluate the efficacy of pitolisant in treating excessive daytime sleepiness (EDS) in patients ≥6 years of age with Prader-Willi syndrome.

Secondary objectives include assessing the impact of pitolisant on:

* Irritable and disruptive behaviors
* Hyperphagia
* Other behavioral problems including social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech conditions: Prader-Willi Syndrome studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 134 type: ESTIMATED name: Pitolisant tablet name: Placebo tablet measure: Change in severity of EDS as measured by Patient-Reported Outcomes Measurement Information System Bank v1.0 - Sleep-Related Impairment (PROMIS-SRI) T-score measure: Change in severity of irritable and disruptive behaviors as measured by the Aberrant Behavior Checklist-Community, Second Edition (ABC-C) Irritability domain measure: Change in overall severity of EDS as measured by the Caregiver Global Impression of Severity for Excessive Daytime Sleepiness (CaGI-S for EDS) measure: Change in overall severity of EDS as measured by the Clinical Global Impression of Severity for Excessive Daytime Sleepiness (CGI-S for EDS) measure: Change in overall severity of irritable and disruptive behaviors as measured by the Caregiver Global Impression of Severity (CaGI-S) for Irritable and/or Disruptive Behaviors measure: Change in severity of hyperphagia as measured by the Hyperphagia Questionnaire for Clinical Trials (HQ-CT), in conjunction with the Food Safe Zone Questionnaire (FSZQ) measure: Change in severity of EDS as measured by the Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD [parent/caregiver version]) total score measure: Change in severity of other behavioral problems as measured by the Aberrant Behavior Checklist-Community, Second Edition (ABC-C) Hyperactivity/Noncompliance, Inappropriate Speech, Social Withdrawal, and Stereotypic Behavior Domains measure: Percentage of patients reporting TEAEs sex: ALL minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Santa Monica Clinical Trials status: RECRUITING city: Los Angeles state: California zip: 90025 country: United States name: Daniel Norman, MD role: CONTACT name: Pooja Patel role: CONTACT phone: (310) 586-0843 email: ppatel@smclinicaltrials.com lat: 34.05223 lon: -118.24368 facility: Atlanta Diabetes Associates status: RECRUITING city: Atlanta state: Georgia zip: 30318 country: United States name: David G. Robertson, MD role: CONTACT name: Amanda Maxson role: CONTACT phone: (404) 844-7775 email: amaxson@atlantadiabetes.com lat: 33.749 lon: -84.38798 hasResults: False

 nctId: NCT06366451 id: MST01-AZN-05 id: PBI-MST-01 type: OTHER domain: Presage Biosciences briefTitle: PBI-MST-01 (NCT04541108) Substudy AZN-05: Intratumoral Microdosing of Rilvegostomig, Volrustomig, and Sabestomig in HNSCC overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-03 date: 2024-04-16 date: 2024-04-16 name: Presage Biosciences class: INDUSTRY name: AstraZeneca briefSummary: This is a multi-center, open-label, Phase 0 substudy designed to evaluate the localized pharmacodynamics (PD) of rilvegostomig, volrustomig, and sabestomig within the tumor microenvironment (TME) when administered intratumorally in microdose quantities via the CIVO device in patients presenting with Head and Neck Squamous Cell Carcinoma (HNSCC) with a surface accessible lesion, who are scheduled for tumor and/or regional node dissection as part of their standard treatment. PD effects due to injected investigational agents will be compared to those elicited by pembrolizumab alone, which will also be injected in microdose quantities via the CIVO device. conditions: Head and Neck Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is an exploratory clinical trial to evaluate intratumoral mechanistic effects of novel and approved agents on intact human tumors. This is a cohort substudy of a Master Protocol (PBI-MST-01, NCT04541108) framework, under which comparisons will not be made between substudy cohorts. primaryPurpose: BASIC_SCIENCE masking: NONE count: 15 type: ESTIMATED name: Rilvegostomig name: Volrustomig name: Sabestomig name: Pembrolizumab measure: Evaluation of signature scores using Gene Set Variability Analysis within regions injected with microdoses of rilvegostomig, volrustomig, sabestomig, or pembrolizumab measure: Incidence of reported Adverse Events and/or Adverse Device Effects [Safety and Tolerability] sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UC Davis city: Sacramento state: California zip: 95817 country: United States name: Clinical Research Supervisor role: CONTACT name: Arnaud Bewley, MD role: PRINCIPAL_INVESTIGATOR lat: 38.58157 lon: -121.4944 facility: LSU Health Sciences Center - Shreveport city: Shreveport state: Louisiana zip: 71115 country: United States name: Research Coordinator role: CONTACT lat: 32.52515 lon: -93.75018 facility: Montefiore Medical Center city: Bronx state: New York zip: 10467 country: United States name: Research Coordinator role: CONTACT lat: 40.84985 lon: -73.86641 facility: University of North Carolina city: Chapel Hill state: North Carolina zip: 27599 country: United States name: Research Coordinator role: CONTACT lat: 35.9132 lon: -79.05584 facility: Oregon Health & Science University (OHSU) city: Portland state: Oregon zip: 97239 country: United States name: Research Coordinator role: CONTACT lat: 45.52345 lon: -122.67621 facility: University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19107 country: United States name: Research Coordinator role: CONTACT lat: 39.95233 lon: -75.16379 facility: Sarah Cannon Medical Center city: Charleston state: South Carolina zip: 29406 country: United States name: Research Coordinator role: CONTACT lat: 32.77657 lon: -79.93092 hasResults: False

 nctId: NCT06366438 id: ABC vs Parentweb briefTitle: A Trial of Two Universal Programs for Parents of Teenagers overallStatus: COMPLETED date: 2021-12-11 date: 2024-01-15 date: 2024-03-24 date: 2024-04-15 date: 2024-04-22 name: Karolinska Institutet class: OTHER briefSummary: Parent training programs in groups and over internet can help parents improve their interaction and communication with their children. There is however a lack knowledge of how programs work for parents of teenagers, as most studies have concerned younger children. Furthermore, most studies have been conducted on programs for selective populations with elevated risk. The aim of this study was to investigate the effectiveness of two universal preventive parenting programs for teenagers: The group-based program 'ABC-teen' and the online-based 'ParentWeb'. Both programs aim to strengthen the parent-adolescent relationship and reduce negative communication. The programs are developed in Sweden with content based on other established parenting programs (e.g., Comet, Incredible Years, the Triple P). The aim of the present study was to evaluate the effects of the the two programs, with adolescent mental health as primary outcome. Several secondary outcome measures concerning parenting and parent-adolescent relationship were also collected. Parents were randomized to ABC-teen, ParentWeb or a 6 months Wait-List control. Parent- and adolescent ratings were collected at baseline, after 4 and after 12 months. All data collection has now been completed and the next step is to process and analyze the data. conditions: Mental Health Issue conditions: Mental Disorder conditions: Adolescent Behavior conditions: Adolescent Development conditions: Parent-Child Relations conditions: Parenting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants are randomized to one of the three arms upon allocation. primaryPurpose: PREVENTION masking: NONE count: 1247 type: ACTUAL name: ABC-teen name: ParentWeb measure: The Strength and Difficulties Questionnaire (SDQ) measure: Patient Health Questionnaire (PHQ-9) measure: Parental stress scale (PSS) measure: General Anxiety Disorder Scale (GAD-7) measure: Conflict scale measure: Adult Child Relationship Scale (ACRS) measure: Adolescents' openness scale measure: Brief Family Relationship Scale measure: Positive and Negative Parenting Behaviors measure: Me as a Parent measure: Conflict Resolution Efficacy measure: School Adjustment Scale measure: Stockholmsenkaten measure: Satisfaction Questionnaire measure: Attendance and engagement measures measure: Demographics measure: Organizational and therapist factors sex: ALL minimumAge: 13 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT facility: Bromma stadsdel city: Bromma zip: 16867 country: Sweden lat: 59.34 lon: 17.94 facility: Danderyd kommun city: Danderyd zip: 18231 country: Sweden lat: 59.3987 lon: 18.02942 facility: Ovanåkers kommun city: Edsbyn zip: 82831 country: Sweden lat: 61.37692 lon: 15.81747 facility: Farsta stadsdel city: Farsta zip: 12347 country: Sweden lat: 59.24423 lon: 18.09088 facility: Värmdö kommun city: Gustavsberg zip: 13430 country: Sweden lat: 59.32684 lon: 18.38975 facility: Göteborgs kommun city: Göteborg zip: 41140 country: Sweden lat: 57.70716 lon: 11.96679 facility: Götene kommun city: Götene zip: 53380 country: Sweden lat: 58.52824 lon: 13.49458 facility: Hallsbergs kommun city: Hallsberg zip: 69480 country: Sweden lat: 59.06463 lon: 15.10993 facility: Haninge kommun city: Handen zip: 13640 country: Sweden lat: 59.16809 lon: 18.13796 facility: Huddinge kommun city: Huddinge zip: 14161 country: Sweden lat: 59.23705 lon: 17.98192 facility: Hägersten-Älvsjö stadsdel city: Hägersten zip: 12626 country: Sweden lat: 59.30586 lon: 17.98719 facility: Tellusborgsskolan city: Hägersten zip: 12649 country: Sweden lat: 59.30586 lon: 17.98719 facility: Aspuddens skola city: Hägersten zip: 12655 country: Sweden lat: 59.30586 lon: 17.98719 facility: Hässelby Vällingby stadsdel city: Hässelby zip: 16555 country: Sweden facility: Höörs kommun city: Höör zip: 24331 country: Sweden lat: 55.93444 lon: 13.5385 facility: Järfälla kommun city: Jakobsberg zip: 17757 country: Sweden lat: 59.42268 lon: 17.83508 facility: Skarpnäck stadsdel city: Johanneshov zip: 12153 country: Sweden lat: 59.29999 lon: 18.07903 facility: Enskede Årsta Vantör stadsdel city: Johanneshov zip: 12162 country: Sweden lat: 59.29999 lon: 18.07903 facility: Karlsborgs kommun city: Karlsborg zip: 54630 country: Sweden lat: 58.53724 lon: 14.5047 facility: Upplands-Bro kommun city: Kungsängen zip: 19640 country: Sweden lat: 59.47857 lon: 17.74834 facility: Kungälvs kommun city: Kungälv zip: 44281 country: Sweden lat: 57.87096 lon: 11.98054 facility: Leksands kommun city: Leksand zip: 79331 country: Sweden lat: 60.7303 lon: 14.99994 facility: Lidingö kommun city: Lidingö zip: 18182 country: Sweden lat: 59.36667 lon: 18.13333 facility: Lidköpings kommun city: Lidköping zip: 53132 country: Sweden lat: 58.50517 lon: 13.15765 facility: Lilla Edets kommun city: Lilla Edet zip: 46330 country: Sweden lat: 58.13333 lon: 12.13333 facility: Lindesbergs kommun city: Lindesberg zip: 71135 country: Sweden lat: 59.59202 lon: 15.2304 facility: Linköpings kommun city: Linköping zip: 58232 country: Sweden lat: 58.41086 lon: 15.62157 facility: Lomma kommun city: Lomma zip: 23431 country: Sweden lat: 55.67244 lon: 13.06849 facility: Lunds kommun city: Lund zip: 22223 country: Sweden lat: 55.70584 lon: 13.19321 facility: Mariestads kommun city: Mariestad zip: 54230 country: Sweden lat: 58.70971 lon: 13.82367 facility: Sigtuna kommun city: Märsta zip: 19547 country: Sweden lat: 59.62157 lon: 17.85476 facility: Nacka kommun city: Nacka zip: 13157 country: Sweden lat: 59.31053 lon: 18.16372 facility: Norrköpings kommun city: Norrköping zip: 60224 country: Sweden lat: 58.59419 lon: 16.1826 facility: Norrtälje kommun city: Norrtälje zip: 76128 country: Sweden lat: 59.75799 lon: 18.70496 facility: Nynäshamns kommun city: Nynäshamn zip: 14931 country: Sweden lat: 58.90337 lon: 17.94793 facility: Skellefteå kommun city: Skellefteå zip: 93131 country: Sweden lat: 64.75067 lon: 20.95279 facility: Skärholmen stadsdel city: Skärholmen zip: 12748 country: Sweden lat: 59.27549 lon: 17.90196 facility: Skövde kommun city: Skövde zip: 54183 country: Sweden lat: 58.39118 lon: 13.84506 facility: Sollentuna kommun city: Sollentuna zip: 19147 country: Sweden lat: 59.42804 lon: 17.95093 facility: Stenungsunds kommun city: Stenungsund zip: 44431 country: Sweden lat: 58.07046 lon: 11.8181 facility: Kungsholmen stadsdel city: Stockholm zip: 11218 country: Sweden lat: 59.33258 lon: 18.0649 facility: Norra Real city: Stockholm zip: 11355 country: Sweden lat: 59.33258 lon: 18.0649 facility: Norrmalm stadsdel city: Stockholm zip: 11526 country: Sweden lat: 59.33258 lon: 18.0649 facility: Östermalm stadsdel city: Stockholm zip: 11526 country: Sweden lat: 59.33258 lon: 18.0649 facility: Södermalm stadsdel city: Stockholm zip: 12030 country: Sweden lat: 59.33258 lon: 18.0649 facility: MFJ Hammarby Sjöstad city: Stockholm zip: 12068 country: Sweden lat: 59.33258 lon: 18.0649 facility: Sundbybergs stad city: Sundbyberg zip: 17458 country: Sweden lat: 59.36128 lon: 17.97114 facility: Sundsvalls kommun city: Sundsvall zip: 85232 country: Sweden lat: 62.39129 lon: 17.3063 facility: Sävsjö kommun city: Sävsjö zip: 57631 country: Sweden lat: 57.40327 lon: 14.66244 facility: Tidaholms kommun city: Tidaholm zip: 52231 country: Sweden lat: 58.18035 lon: 13.95824 facility: Trelleborgs kommun city: Trelleborg zip: 23142 country: Sweden lat: 55.37514 lon: 13.15691 facility: Botkyrka kommun city: Tumba zip: 147 41 country: Sweden lat: 59.19858 lon: 17.83317 facility: Täby kommun city: Täby zip: 18339 country: Sweden lat: 59.4439 lon: 18.06872 facility: Töreboda kommun city: Töreboda zip: 54530 country: Sweden lat: 58.70739 lon: 14.12597 facility: Vallentuna kommun city: Vallentuna zip: 18686 country: Sweden lat: 59.53436 lon: 18.07758 facility: Gotlands kommun city: Visby zip: 12142 country: Sweden lat: 57.64089 lon: 18.29602 facility: Vällingbyskolan city: Vällingby zip: 16264 country: Sweden lat: 59.36441 lon: 17.87407 facility: Växjö kommun city: Växjö zip: 35230 country: Sweden lat: 56.87767 lon: 14.80906 hasResults: False

 nctId: NCT06366425 id: RECHMPL23_0272 briefTitle: Screening for Chronic Liver Diseases in General Population acronym: HEPGEN overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-05-01 date: 2025-03 date: 2024-04-15 date: 2024-04-17 name: University Hospital, Montpellier class: OTHER name: On-call medical home (MMG) Clermont-Hérault briefSummary: Improving the care of patients with liver diseases in primary care and will allow patients with chronic liver disease to benefit from a course appropriate care. conditions: Fibrosis, Liver studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 260 type: ESTIMATED name: Blood sample then fibroscan measure: Evaluation of the liver fibrosis screening acceptability (FIB-4) measure: Evaluation of the liver fibrosis screening acceptability (FIB-4 and Fibroscan) measure: Prevalence of advanced liver fibrosis by elastometry pulse (Fibroscan®) with a FIB-4 score>2.67 measure: Prevalence of excessive consumption of alcohol measure: Prevalence of a history or drug use measure: The correlation between advanced liver fibrosis and risk factors for liver disease (presence of metabolic syndromes, viral hepatitis, alcool use disorders) measure: prevalence of viral hepatitis measure: Description of socio-demographic characteristics of participants sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Montpellier city: Montpellier zip: 34295 country: France name: Magdalena MESZAROS, MD role: CONTACT phone: : 04 67 33 02 57 email: m-meszaros@chu-montpellier.fr name: Magdalena MESZAROS role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 hasResults: False

 nctId: NCT06366412 id: serum Tau-217 in elderly briefTitle: Dexmedetomidine on Postoperative Cognitive Dysfunction and Serum Tau-217 Protein. overallStatus: RECRUITING date: 2024-04 date: 2025-03 date: 2026-03 date: 2024-04-15 date: 2024-04-15 name: Minia University Hospital class: OTHER briefSummary: To assess the effect of Dexmedetomidine on serum Tau-217 protein and its relation to the incidence and severity of postoperative cognitive dysfunction in elderly patients undergoing major surgery under general anesthesia. conditions: Cognitive Impairment studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 94 type: ESTIMATED name: Dexmedetomidine Hydrochloride name: normal saline measure: the effect of dexmedetomidine on serum Tau-217 protein value. measure: to evaluate the postoperative cognitive dysfunction using Mini-Mental State Scale in both the placebo and dexmedetomidine group. measure: Heart Rate changes in the intraoperative period after induction of anesthesia and every 10 minutes till the end of surgery and postoperative period after 1 hour and every hour till 6 hours postoperative then every 6 hours measure: Mean Arterial Blood Pressure changes in the intraoperative period after induction of anesthesia and every 10 minutes till the end of surgery and postoperative period after 1 hour and every hour till 6 hours postoperative then every 6 hours sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Arwa Essam status: RECRUITING city: Minya zip: 61111 country: Egypt name: Arwa essam Essam, assistant lecturer role: CONTACT phone: +201017565658 email: arwty26@gmail.com lat: 28.10988 lon: 30.7503 hasResults: False

 nctId: NCT06366399 id: 00156659 briefTitle: The Acute T-Rex (Timing of Resistance Exercise) Study overallStatus: RECRUITING date: 2023-11-15 date: 2024-12-31 date: 2024-12-31 date: 2024-04-15 date: 2024-04-15 name: University of Utah class: OTHER briefSummary: The primary aim of this study is to evaluate if a single bout of AM vs PM resistance exercise has different effects on insulin sensitivity and sleep. A randomized cross-over trial be used to compare resistance exercise at two different times of the day. Each condition will take place in a laboratory setting. Each condition will consist of exercise, overnight sleep, and oral glucose tolerance tests the following day. The AM exercise will occur \~1.5 hours after habitual wake, and PM exercise will occur \~11 hours after habitual wake. After a 2-6 week washout, participants will complete the other condition. The hypothesis is that PM exercise will be more beneficial than AM exercise in improving insulin sensitivity. This study could identify if there is a better time of day to perform resistance exercise to decrease risk of developing Type 2 Diabetes Mellitus. conditions: Diabetes Mellitus, Type 2 conditions: Insulin Resistance conditions: Glucose Intolerance conditions: Sleep Disturbance conditions: Overweight or Obesity conditions: Insulin Sensitivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Resistance Exercise Timing measure: Insulin sensitivity measure: Sleep Duration measure: Sleep Staging measure: Sleep Quality measure: Sleep Efficiency measure: Muscular Strength measure: Perceived Hunger measure: Perceived Fullness measure: Perceived Prospective Food Consumption measure: Glucose Area Under Curve measure: Insulin Area Under Curve sex: ALL minimumAge: 50 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Utah HPER E Buildling status: RECRUITING city: Salt Lake City state: Utah zip: 84112 country: United States name: Jason V Thomas, MS role: CONTACT email: jason.v.thomas@utah.edu name: Tanya M Halliday, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.76078 lon: -111.89105 hasResults: False

 nctId: NCT06366386 id: 5K43TW011963-03 type: NIH link: https://reporter.nih.gov/quickSearch/5K43TW011963-03 briefTitle: Integrating Hypertension Management in DSD for HIV acronym: HTN-DSD overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-30 date: 2026-05-30 date: 2024-04-15 date: 2024-04-18 name: Infectious Diseases Research Collaboration, Uganda class: OTHER briefSummary: The goal of this implementation science study is to design evidence based and stakeholder informed implementation strategies to integrate the management of hypertension (HTN) into existing community anti-retro-viral treatment (ART) delivery models of HIV care in Uganda and evaluate their effectiveness and implementation outcomes. The main questions it aims to answer are:

1. What are the perspectives of patients (hypertensive PLHIV) on integrating hypertension care in community ART delivery models of HIV care?
2. What are the perspectives of health care providers', district leaders', and policymakers' perspectives on integrating hypertension care in community ART delivery models of HIV care?
3. What implementation strategies would support integration of the management of hypertension into existing community ART delivery models in Uganda?
4. What is the effectiveness of implementation strategies to integrate the management of hypertension care in community ART delivery models of HIV care in Uganda?
5. What are the implementation outcomes of strategies to integrate hypertension care in community ART delivery models of HIV care in Uganda?
6. What is the cumulative incidence, types and severity of HTN medication-related adverse events and their predictors among PLHIV with HTN? Investigators will use qualitative research methods to explore key stakeholders' perspectives and preferences on integrating hypertension care in community ART delivery models in Uganda; design implementation strategies that integrate the management of hypertension into existing community ART delivery models; determine the effectiveness of implementation strategies that integrate the management of hypertension in community ART delivery models; evaluate implementation outcomes of strategies that integrate hypertension care in community ART delivery models; determine the cumulative incidence, types and severity of medication-related adverse events and their predictors; and assess the patients and provider costs, health related quality of life, cost-effectiveness of leveraging existing HIV differentiated service delivery models to screen and treat HTN among persons with HIV in Uganda. conditions: Hypertension conditions: HIV studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1100 type: ESTIMATED name: Screening and treatment of hypertension among PLHIV in DSD models for HIV measure: Number of PLHIV with controlled blood pressure (both systolic and diastolic blood pressure) measure: % of PLHIV with controlled blood pressure (both systolic and diastolic blood pressure) measure: Mean blood pressure (both systolic and diastolic blood pressure) measure: Number and % of hypertensive PLHIV with suppressed Viral load measure: Number and % of patients retained in care measure: Number and % of PLHIV screened for HTN at least once in six months measure: Implementation costs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Infectious Diseases Research Collaborations (IDRCUganda) city: Kampala state: Central zip: +256 country: Uganda name: Martin Muddu, MMED role: CONTACT phone: +256774004308 email: muddu.martin@gmail.com lat: 0.31628 lon: 32.58219 hasResults: False

 nctId: NCT06366373 id: 531118232022 briefTitle: An Evaluation on a Mental Health Art Exhibition's Impact on Reducing Stigma overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-02 date: 2025-02 date: 2024-04-15 date: 2024-04-15 name: Hunan University class: OTHER name: Central South University briefSummary: Mental health art exhibitions, as an intervention strategy integrating artistic expression and social contact, have the potential to positively impact the elimination of stigma and discrimination associated with mental health problems. This study will utilize a real-world quasi-randomized controlled trial design and a 6-month follow-up questionnaire survey to evaluate the intervention's impact on stigma/discrimination and related outcomes, such as mental health literacy. The evaluation will encompass four categories of people: those with lived experience of mental disorders, family members and friends of those with lived experience, health professionals, and the general public. Additionally, the cost-effectiveness of the art exhibition intervention will be analyzed. conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The interventional study model for this clinical trial is a quasi-randomized controlled trial design. The intervention is the exhibition, organized by "Qixi Charity," will publicly display offline artworks reflecting the diverse dimensions of mental health and ill-health. In contrast, the control group in this study will receive either printed or online educational materials, serving as a more traditional educational intervention. The study will include a baseline survey before the interventions (T0), a follow-up survey in the first month after the interventions (T1), and a follow-up survey in the sixth month after the interventions (T2) in both the experimental group (those who attend the offline exhibition) and the control group (those who are unable to attend the exhibition but will be provided with printed/online education materials). primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 1200 type: ESTIMATED name: A mental health art exhibition name: printed or online education materials measure: Stigma/discrimination regarding mental disorders measure: mental health literacy measure: intervention costs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06366360 id: Piano-Neglect briefTitle: Immersive Virtual Reality Treatment for Unilateral Spatial Neglect overallStatus: RECRUITING date: 2024-03-11 date: 2026-09 date: 2027-09 date: 2024-04-15 date: 2024-04-16 name: Hopitaux de Saint-Maurice class: OTHER briefSummary: Unilateral Spatial Neglect (USN) is a relatively common neuropsychological syndrome following stroke. It is characterized by difficulties in detecting, orienting and identifying events located in the hemispace contralateral to a brain lesion, unrelated to a primary motor or sensory disorder. Numerous methods have been developed for the rehabilitation of this syndrome. However, limitations in terms of efficacy are highlighted. These limitations may be linked to the fact that these methods are restricted to certain sensory modalities, thus failing to take into account the heterogeneity of the syndrome. Moreover, some patients' adherence to rehabilitation programs can also be complicated by motivational difficulties. Immersive Virtual Reality could help overcome these limitations. Indeed, it enables the introduction of new sensory modalities, notably auditory, to support a better apprehension of space.

The main objective of this study is to determine the efficacy of an immersive virtual reality rehabilitation protocol based on musical practice in patients suffering from USN. This study also aims to explore the benefits of this rehabilitation protocol on patients' daily lives, as well as to explore the influence of patients' mood and motivation on the benefits of the immersive virtual reality rehabilitation protocol.

To achieve these goals, patients will benefit from immersive virtual reality rehabilitation based on music practice. This rehabilitation will be compared to conventional USN rehabilitation. To this end, patients will be divided into two groups: classical rehabilitation only or classical rehabilitation and immersive virtual reality in parallel. Each patient will be randomly assigned to one of the two groups for a period of 2 weeks. Pre- and post-rehabilitation assessments will be provided. conditions: Stroke conditions: Unilateral Spatial Neglect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Each patient was assigned to a group that received 2 rehabilitations for 4 weeks, 1) both Immersive virtual reality therapy and a conventional rehabilitation first, and then conventional rehabilitation alone, or 2) A conventional rehabilitation alone and then both Immersive virtual reality therapy, and conventional rehabilitation. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Immersive Virtual Reality Intervention name: Conventional rehabilitation measure: Bells Test measure: Mesulam cancellation Task measure: Bisection Test measure: Copying Test measure: Scene description Task measure: Ecological scale of daily life activities measure: Piano bisection Task measure: Identifying the keys at the ends of the piano measure: Virtual reality Bells Test measure: Auditory Stimuli Localization Task in virtual reality measure: Ecological virtual reality bisection task measure: Virtual reality Baking Tray test measure: Mood assessment measure: Situational motivation questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpitaux de Saint-Maurice status: RECRUITING city: Saint-Maurice zip: 94410 country: France name: Secretary role: CONTACT phone: 01 43 96 68 22 phoneExt: +33 email: secretariat.ssrneuro@ght94n.fr lat: 48.82182 lon: 2.42716 hasResults: False

 nctId: NCT06366347 id: 23-695 briefTitle: ALPINE: Maintenance Letrozole/Abemaciclib vs Pembrolizumab overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2027-09-01 date: 2029-03-01 date: 2024-04-15 date: 2024-04-23 name: Dana-Farber Cancer Institute class: OTHER name: Eli Lilly and Company briefSummary: A standard treatment for endometrial cancer is chemotherapy and pembrolizumab together followed by pembrolizumab maintenance for two years. This treatment regimen has shown benefit in terms of delaying cancer progression in prior clinical trials, but the benefit of the pembrolizumab maintenance treatment and whether all participants need it is unclear. This research is being done on the maintenance portion of treatment to compare the efficacy between the combination of letrozole + abemaciclib and pembrolizumab alone following chemotherapy and pembrolizumab.

The names of the study drugs involved in this study are:

* Abemaciclib (a type of cyclin-dependent kinase (CDK) inhibitor)
* Letrozole (a type of aromatase inhibitor)
* Pembrolizumab (a type of monoclonal antibody) conditions: Endometrial Cancer conditions: Recurrent Endometrial Cancer conditions: TP53 studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 76 type: ESTIMATED name: Abemaciclib name: Letrozole name: Pembrolizumab measure: Median Progression Free Survival (PFS) measure: Grade 3-5 Adverse Events (AE) Rate measure: Median Overall Survival (OS) measure: Objective Response Rate (ORR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beth Israel Deaconess Medical Center city: Boston state: Massachusetts zip: 02215 country: United States name: Meghan Shea, MD role: CONTACT phone: 617-667-3723 email: mshea4@bidmc.harvard.edu name: Meghan Shea, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02215 country: United States name: Panagiotis Konstantinopoulos, MD, PhD role: CONTACT phone: 617-632-2334 email: Panagiotis_Konstantinopoulos@dfci.harvard.edu name: Panagiotis Konstantinopoulos, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Dana-Farber Cancer Institute city: Boston state: Massachusetts zip: 02215 country: United States name: Panagiotis Konstantinopoulos, MD, PhD role: CONTACT phone: 617-632-2334 email: Panagiotis_Konstantinopoulos@dfci.harvard.edu name: Panagiotis Konstantinopoulos, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Dana-Farber Cancer Institute at Foxborough city: Foxboro state: Massachusetts zip: 02035 country: United States name: Natalie Sinclair, MD role: CONTACT phone: 508-543-1700 email: natalie_sinclair@dfci.harvard.edu name: Natalie Sinclair, MD role: PRINCIPAL_INVESTIGATOR lat: 42.06538 lon: -71.24783 facility: Dana-Farber Cancer Institute at Milford city: Milford state: Massachusetts zip: 01757 country: United States name: Alexandra Bailey, MD role: CONTACT phone: 508-488-3700 email: alexandras_bailey@dfci.harvard.edu name: Alexandra Bailey, MD role: PRINCIPAL_INVESTIGATOR lat: 42.13982 lon: -71.51617 facility: Dana-Farber Cancer Institute at South Shore Hospital city: Weymouth state: Massachusetts zip: 02190 country: United States name: Meredith Faggen, MD role: CONTACT phone: 781-624-4800 email: meredith_faggen@dfci.harvard.edu name: Meredith Faggen, MD role: PRINCIPAL_INVESTIGATOR lat: 42.22093 lon: -70.93977 hasResults: False

 nctId: NCT06366334 id: 23/02E briefTitle: Study of IV Ketamine for Emergency Department Treatment of Adolescent Suicidal Ideation acronym: KSI overallStatus: RECRUITING date: 2024-01-15 date: 2024-08-30 date: 2024-09-30 date: 2024-04-15 date: 2024-04-15 name: Children's Hospital of Eastern Ontario class: OTHER briefSummary: Approximately 20% of Canadian adolescents experience thoughts of suicide, or suicidal ideation (SI), and suicide is the second leading cause of death among Canadians aged 15-19 years. The emergency department at CHEO sees approximately four patients per day with SI. Even though this is a medical emergency, there are no fast-acting treatments available.

Ketamine is a medication that is commonly used to safely sedate children who require painful procedures in the emergency department. For nearly ten years, intravenous ketamine has also been shown to rapidly reduce SI in adults. However, ketamine as a treatment for SI has never been studied in adolescents. The primary study objective is to pilot a clinical trial that investigates intravenous ketamine to emergently treat SI in adolescents.

If intravenous ketamine can relieve symptoms of SI for youth, this would have tremendous effects on patients and would dramatically change how physicians treat adolescent mental health emergencies. If ketamine is effective for several weeks, as it is in adults, it will help temporize patients until they receive more long-term psychiatric care. At the system level, it has the potential to reduce emergency visits and lengthy admissions. The investigators feel that the results of this study will be generalizable to pediatric centres across Canada and beyond. conditions: Suicidal Ideation conditions: Suicidal Ideas studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Ketamine Hydrochloride name: Normal saline measure: Proportion of eligible participants who complete the study protocol measure: Baseline distribution of responses to the first 5 questions of Beck Scale for Suicidal Ideation (SSI5) measure: Baseline distribution of responses to the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10) measure: Baseline distribution of responses to the suicide item (#9) from the Beck Depression Index (BDI9). measure: Baseline pragmatic assessment of the first 5 questions of the Beck Scale for Suicidal Ideation (SSI5), the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10), and the suicide item (#9) from the Beck Depression Index (BDI9). measure: Assessment of blinding measure: Treatment efficacy measured by the Beck Scale for Suicidal Ideation (SSI5) measure: Treatment efficacy measured by the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10) measure: Treatment efficacy measured by the suicide item (#9) from the Beck Depression Index (BDI9) measure: Treatment durability measured by the Beck Scale for Suicidal Ideation (SSI5) measure: Treatment durability measured by the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10) measure: Treatment efficacy measured by the suicide item (#9) from the Beck Depression Index (BDI9) measure: Admission to Hospital measure: Length of Stay in Hospital measure: ED revisits measure: Safety Outcome 1: Clinically significant tachycardia measure: Safety Outcome 2: Clinically significant hypertension measure: Safety Outcome 3: Vomiting measure: Safety Outcome 4: Dissociation measure: Safety Outcome 5: Death sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD facility: Children's Hospital Of Eastern Ontario status: RECRUITING city: Ottawa state: Ontario zip: K1H 8L1 country: Canada name: Maala Bhatt, MD, MSc. role: CONTACT phone: 6137377600 phoneExt: 4178 email: mbhatt@cheo.on.ca name: Tyrus Crawford role: CONTACT phone: 6137377600 phoneExt: 4178 email: tcrawford@cheo.on.ca lat: 45.41117 lon: -75.69812 hasResults: False

 nctId: NCT06366321 id: 23-067 briefTitle: Using Digital Technology Versus Conventional Relining Procedure for Correction of Loose Maxillary Complete Denture overallStatus: COMPLETED date: 2024-01-01 date: 2024-01-23 date: 2024-02-01 date: 2024-04-15 date: 2024-04-16 name: British University In Egypt class: OTHER briefSummary: This study aimed to evaluate the use of computer added designning / computer added manufacturing (CAD/ CAM ) technology versus conventional relining procedure for treating ill-fitted loose maxillary complete denture and its effect on patient satisfaction, denture retention, and denture adaptation to oral tissues. conditions: Dental Diseases conditions: Dental Trauma conditions: Bone Remodeling Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 12 type: ACTUAL name: relining technique name: CAD/CAM milling technique measure: patient satisfaction using questionnaire measure: denture retention measure: denture adaptation to oral tissues sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: British University in Egypt city: El Shorouk state: Cairo zip: 4914085 country: Egypt lat: 30.13806 lon: 31.61556 hasResults: False

 nctId: NCT06366308 id: ProBiox briefTitle: Decade-Long Insights Into Transperineal Prostate Biopsy in a West China Population overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-05-01 date: 2024-06-01 date: 2024-04-15 date: 2024-04-16 name: West China Hospital class: OTHER briefSummary: Prostate cancer (PCa) remains one of the most prevalent malignancies affecting men globally. The disease spectrum of PCa ranges from indolent tumors, which may require minimal to no intervention, to aggressive, potentially lethal forms. The complexity of PCa underscores the critical need for precise diagnostics, as early and accurate detection is key to improving patient outcomes and tailoring appropriate treatment strategies. There have been remarkable advancements in biopsy technology. Significant strides in magnetic resonance imaging (MRI), especially with the establishment of the Prostate Imaging Reporting and Data System (PI-RADS), have substantially improved the accuracy of PCa detection. The combination of MRI with traditional biopsy methods, including MRI-targeted biopsy (MRI-TBx) and systematic biopsy (SBx), also marks a major advancement in the field.

Despite advances in PCa detection, the need for improving diagnostics and in-depth assessment of the latest PBx techniques through extensive, longitudinal studies remains critical. Besides, based on the world health organization (WHO) classification, PCa includes a range of pathological forms beyond the commonly known acinar adenocarcinoma. However, the prevalence and demographic distribution of non-adenocarcinoma types, as well as the characteristics of patients with these rarer forms, remain unclear. Leveraging PBx records spanning over 10 years and involving 10,038 cases, this study aims to shed light on temporal trends in PBx positivity, the evolving clinical profiles of PCa patients, and the differences in clinicopathological characteristics of PCa between Western and Asian populations. conditions: Prostate Cancer conditions: Pathology studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 10000 type: ESTIMATED name: Transperineal Prostate Biopsy measure: Positive rate of prostate biopsy sex: MALE minimumAge: 40 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06366295 id: WUM.Perio.05 briefTitle: Comparison of Subgingival Mechanotherapy With and Without the Use of a Perioscope: Clinical Trial overallStatus: RECRUITING date: 2023-06-01 date: 2024-04 date: 2024-11 date: 2024-04-15 date: 2024-04-17 name: Medical University of Warsaw class: OTHER briefSummary: The study aims to comparatively assess clinical parameters, biochemical and microbiological parameters after treatment of periodontitis using subgingival mechanotherapy traditional and subgingival mechanotherapy using a perioscope. conditions: Periodontitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 26 type: ESTIMATED name: subgingival mechanotherapy with perioscopy name: classical subgingival mechanotherapy measure: Probing pocket depth (PPD) measure: Clinical attachment level (CAL) measure: Bleeding on probing (BoP) measure: Plaque index (PI) measure: Width of keratinized tissue (KTW) measure: Gingival thickness (GT) measure: Subgingival plaque pathogens (Aa, Pg, Td) levels measure: Gingival crevicular fluid levels of cytokines sex: ALL minimumAge: 20 Years maximumAge: 60 Years stdAges: ADULT facility: Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw status: RECRUITING city: Warsaw state: Mazowieckie zip: 02-097 country: Poland name: Bartlomiej Gorski, DDS, PhD role: CONTACT phone: +48 22 502 20 99 email: bartlomiej.gorski@wum.edu.pl lat: 52.22977 lon: 21.01178 hasResults: False

 nctId: NCT06366282 id: IRB00110030 briefTitle: Pediatric and Caregiver Traumatic Stress Intervention (PACTS) acronym: PACTS overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-03 date: 2025-03 date: 2024-04-15 date: 2024-04-26 name: Wake Forest University Health Sciences class: OTHER name: Childress Institute for Pediatric Trauma briefSummary: The purpose of this study is to learn more about how to help the caregiver and child survivor of a traumatic injury handle post-traumatic stress disorder and/or depression. conditions: Traumatic Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 24 type: ESTIMATED name: Caregiver Counseling for Childhood Traumatic Injury name: Standard of Care for Childhood Traumatic Injury measure: Change in Kessler 6 Scores measure: Change in Patient Health Questionnaire - 9 (PHQ-9) Scores measure: Change in Child and Adolescent Trauma Screen (CATS) Scores sex: ALL minimumAge: 1 Year maximumAge: 6 Years stdAges: CHILD facility: Wake Forest University Health Sciences city: Winston-Salem state: North Carolina zip: 27157 country: United States name: Elizabeth White, MA, LCMHCS role: CONTACT phone: 336-716-2801 email: ebwhite@wakehealth.edu name: Elizabeth Shilling, PhD role: PRINCIPAL_INVESTIGATOR lat: 36.09986 lon: -80.24422 hasResults: False

 nctId: NCT06366269 id: STUDY20240374 briefTitle: Acupuncture First for IC/BPS overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-06 date: 2024-04-15 date: 2024-04-17 name: David Sheyn class: OTHER briefSummary: The goal of this clinical trial is to learn if acupuncture in addition to behavioral changes can better treat in women with bladder pain syndrome (also known as interstitial cystitis) that have not received other treatments. The main question it aims to answer is:

Does acupuncture improve pain symptoms on the Interstitial Cystitis Index? Researchers will compare six (6) weeks behavioral management alone to behavioral management and acupuncture.

Participants will

* complete surveys about their bladder pain symptoms
* make behavioral changes that have been shown to improve bladder pain symptoms
* attend six (6) weekly acupuncture sessions
* attend six (6) weekly physical therapy sessions after finishing acupuncture conditions: Bladder Pain Syndrome conditions: Interstitial Cystitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Group allocation will be masked to the care provider and investigators only while participants undergo the initial 6 weeks of treatment. Due to the nature of the intervention (acupuncture) participants are not able to be blinded. whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 34 type: ESTIMATED name: Acupuncture name: Behavioral management name: Physical therapy measure: O'Leary-Sant Interstitial Cystitis Index (OLSICI) measure: Patient Global Impression of Improvement (PGI-I) measure: Short Form (SF-36) measure: Genitourinary Pain Index (GUPI) measure: Number of additional treatments used during study period measure: Number of unscheduled interactions sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06366256 id: 1R01DC017301-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01DC017301-01 briefTitle: Simplified Ultrasound Feedback for Speech Remediation acronym: SUFSR overallStatus: RECRUITING date: 2023-10-24 date: 2024-12 date: 2025-08 date: 2024-04-15 date: 2024-04-15 name: University of Cincinnati class: OTHER briefSummary: Recent research in motor control shows that people learn new movements best when they receive feedback external to the body. Traditional ultrasound speech therapy works well for many children, but involves teaching children to focus on their internal tongue movements. The goal of the study is to test whether ultrasound biofeedback delivered without showing children a display of their tongue movements will be effective as a treatment for residual speech sound disorders in children. We focus on children who have trouble producing the sound "r" as in "rabbit". The first aim is to develop a fast reliable system to track movements of different parts of the tongue using ultrasound and to identify which combinations of movements will produce a good "r" and which do not. The second aim is to develop a motivational game in which children receive feedback on the success of their tongue movements by what happens to an animated character on a screen. This developed version of ultrasound feedback therapy will be compared to the traditional version of ultrasound feedback therapy to determine how the two approaches can best be utilized in the clinic. conditions: Speech Sound Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Traditional ultrasound biofeedback name: Simplified ultrasound biofeedback measure: Change in percent accurate words in probe list at beginning and midpoint of study measure: Change in percent accurate words in probe list at beginning and end of study sex: ALL minimumAge: 7 Years maximumAge: 17 Years stdAges: CHILD facility: University of Cincinnati status: RECRUITING city: Cincinnati state: Ohio zip: 45220 country: United States name: Suzanne E Boyce, PhD role: CONTACT phone: 513-558-8509 email: boycese@ucmail.uc.edu name: Sarah M Dugan, PhD role: CONTACT email: hamilsm@ucmail.uc.edu lat: 39.12713 lon: -84.51435 hasResults: False

 nctId: NCT06366243 id: CVL-231-HV-1012 briefTitle: A Trial to Evaluate the Effect of Esomeprazole on the Pharmacokinetics of Emraclidine in Healthy Adult Participants overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2024-06-24 date: 2024-06-24 date: 2024-04-15 date: 2024-04-15 name: Cerevel Therapeutics, LLC class: INDUSTRY briefSummary: The primary purpose of this study is to evaluate the potential of gastric pH-dependent drug-drug interaction effect of esomeprazole, a proton pump inhibitor (PPI), on the pharmacokinetics (PK) of emraclidine in healthy adult participants. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Emraclidine name: Esomeprazole measure: Maximum Observed Plasma Concentration (Cmax) of Emraclidine measure: Time to Maximum (Peak) Plasma Concentration (Tmax) of Emraclidine measure: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUC0-t) of Emraclidine measure: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Emraclidine measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) measure: Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values measure: Number of Participants With Clinically Significant Changes in Vital Sign Parameters measure: Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments measure: Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results measure: Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False

 nctId: NCT06366230 id: 24-41450 briefTitle: Adding Urea to the Final Dialysis Fluid overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2028-06-30 date: 2028-06-30 date: 2024-04-15 date: 2024-04-15 name: University of California, San Francisco class: OTHER briefSummary: At times patients with advanced renal failure present with severe hyperkalemia or acidosis and very high serum blood urea nitrogen (BUN) concentrations. These patients cannot be dialyzed aggressively as the lowering of serum BUN may results in disequilibrium syndrome but on the other hand they need aggressive dialysis in order to lower their serum potassium or fix their severe acidosis. If one is able to add urea to the dialysis fluid, one can prevent the rapid lowering of serum BUN and osmolality at the same time as doing aggressive dialysis to lower serum potassium and/or fix the metabolic acidosis. conditions: Dysequilibrium Syndrome conditions: ESRD conditions: Hyperkalemia conditions: Metabolic Acidosis studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Urea in the dialysate measure: Disequilibrium measure: Serum potassium concentration measure: Serum CO2 concentration measure: Serum BUN concentration sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zuckerberg San Francisco General Hospital city: San Francisco state: California zip: 94110 country: United States name: Ramin Sam, MD role: CONTACT phone: 628-206-6605 email: ramin.sam@ucsf.edu lat: 37.77493 lon: -122.41942 hasResults: False

 nctId: NCT06366217 id: 20-32530A briefTitle: Efficacy of the MydCombi on Pupillary Dilation in Pediatric and Adult Patients overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-15 date: 2024-04-19 name: University of California, San Francisco class: OTHER briefSummary: To raise the standard of care, improve the overall patient experience and streamline practice flow, Eyenovia has developed an innovative mydriatic to be delivered as a microdose by a specialized dispenser. While still achieving effective pupil dilation, MydCombi has the potential to increase patient throughput at practicing offices by decreasing time spent eye dropping patients, eliminating time wasted waiting between drop instillations and ensuring more accurate drug delivery. The proposed study hopes to demonstrate the non-inferiority of using MydCombi to achieve pupillary dilation in patients compared to standard of care eye drops. conditions: Dilation conditions: Pupil Reaction Absent studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 100 type: ESTIMATED name: MydCombi Device name: MydCombi Drug measure: Percent change in Spherical equivalent measure: Percent Change in maximum pupil diameter measure: Percent Change in pupil constriction percentage measure: Percent Change in Intraocular Pressure sex: ALL minimumAge: 2 Years stdAges: CHILD 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: NCT06366204 id: H23-03119 briefTitle: Lysine Requirements During Lactation overallStatus: RECRUITING date: 2024-01-01 date: 2025-03-31 date: 2025-12-31 date: 2024-04-15 date: 2024-04-15 name: University of British Columbia class: OTHER name: Canadian Institutes of Health Research (CIHR) briefSummary: The study aims to establish lysine requirements using the indicator amino acid oxidation (IAAO) method in women exclusively breastfeeding a single infant aged 3-4 months, and how maternal lysine needs change once infant transition to complimentary feeding at a later age of 9-10 months. Each 8-hour study day will have an assigned test lysine intake ranging from deficient to excess. The diets will be provided in a complete protein shake format, meeting all nutrient requirements except for the test lysine intake. Breath samples evaluate the indicator's oxidation to determine protein synthesis in response to lysine intake. Urine and one blood sample will be collected to assess metabolite concentrations. conditions: Lactation conditions: Breastfeeding, Exclusive conditions: Breastfeeding studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single day interventions; Repeated measures design. primaryPurpose: BASIC_SCIENCE masking: NONE count: 15 type: ESTIMATED name: Dietary Lysine Intakes measure: Carbon 13 Oxidation sex: FEMALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: BC Children's Hospital Research Institute status: RECRUITING city: Vancouver state: British Columbia zip: V5Z 4H4 country: Canada name: Taylor Bailey, BSc role: CONTACT phone: 705-698-7648 email: taylor.bailey@bcchr.ca name: Rajavel Elango, PhD role: PRINCIPAL_INVESTIGATOR lat: 49.24966 lon: -123.11934 hasResults: False

 nctId: NCT06366191 id: 2023/CHU/08 briefTitle: Psychotrauma Prevention Algorithm : Randomized, Controlled Pilot Study acronym: A2P overallStatus: NOT_YET_RECRUITING date: 2024-10 date: 2025-04 date: 2025-07 date: 2024-04-15 date: 2024-04-15 name: Centre Hospitalier Universitaire de la Réunion class: OTHER briefSummary: A randomized pilot study which proposes to patients having suffered a traumatic event to have either only the standard care or the standard care associated with adaptated psychotrauma watch and prevention system. conditions: Psychological Trauma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 40 type: ESTIMATED name: prevention algorithm name: Standard care measure: study acceptability rate measure: Adherence of patient to the watch measure: Adherence of patient to the health watch measure: Patient satisfaction (quantitatif) measure: Patient satisfaction (qualitatif) measure: Strong points of the health watch measure: Evolution of the patient journey in experimental arm measure: Occurrence of post-traumatic stress disorder measure: Complications associated with post-traumatic stress disorder measure: Complications associated with post-traumatic stress disorder measure: Complications associated with post-traumatic stress disorder measure: Complications associated with post-traumatic stress disorder sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06366178 id: 2024/864 briefTitle: EPBONF : Evaluation of the Safety and Effectiveness of a Medical Device Aimed at Guiding Orbito-naso-frontal Band Surgery, for the Treatment of Craniostenoses acronym: EPBONF overallStatus: NOT_YET_RECRUITING date: 2024-12-01 date: 2026-12-01 date: 2026-12-01 date: 2024-04-15 date: 2024-04-15 name: Centre Hospitalier Universitaire de Besancon class: OTHER briefSummary: Craniostenosis is a congenital disorder caused by early fusion of the cranial sutures between the skull bones, resulting in orbito-naso-frontal deformities. The damage is primarily aesthetic, but intracranial hypertension may also be observed.

The treatment of craniostenosis involves surgery, to restore harmonious growth between the skull bones and the brain, and proper development of the latter.

There are various surgical techniques for correction, based on remodeling of the upper forehead and the orbito-naso-frontal band (BONF). However, BONF reshaping is difficult to tailor to each individual child. In most cases, the surgeon performs the reshaping "freehand", without a template. The result is therefore subject to the surgeon's experience and judgment.

A surgical instrument (template) has been developed to guide the surgeon in the ideal reshaping of the BONF in patients with anterior craniostenosis (anterior plagiocephaly and trigonocephaly), according to each child's specific morphology.

The aim of EPBONF research is to evaluate the benefits of using this template on the symmetry and angle of the BONF. conditions: Craniosynostoses studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ESTIMATED name: BONFIX system measure: Evaluating the performance of the medical device, for orbito-naso-frontal bandeau surgery, in the treatment of craniostenosis: evaluation of efficacy on orbito-naso-frontal bandeau conformation, angle and symmetry criteria. measure: Evaluating the performance of the medical device, for orbito-naso-frontal bandeau surgery, in the treatment of craniostenosis: evaluation of efficacy on orbito-naso-frontal bandeau conformation, angle and symmetry criteria. measure: Evaluating the performance of the medical device, for orbito-naso-frontal bandeau surgery, in the treatment of craniostenosis: evaluation of efficacy on orbito-naso-frontal bandeau conformation, angle and symmetry criteria. sex: ALL minimumAge: 4 Months maximumAge: 24 Months stdAges: CHILD hasResults: False

 nctId: NCT06366165 id: ACU-Med3 briefTitle: Linking Special Care Dentistry Curriculum to Seemingly Irrelevant Comedy overallStatus: RECRUITING date: 2021-10-01 date: 2021-10-01 date: 2024-08-30 date: 2024-04-15 date: 2024-04-15 name: Cairo University class: OTHER briefSummary: As Special care dentistry curriculum is very complicated and has a lot of details. Upon teaching it, the investigator will include memes and videos of movies and cartoons and will test the degree of retention of the information after years of passing the subject's exam. conditions: Learning Problem studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Testing the procedure of using a different mode of teaching medical content primaryPurpose: SCREENING masking: NONE count: 700 type: ESTIMATED name: seemingly irrelevant funny videos and memes in teaching measure: degree of retention of information sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ahram Candian University status: RECRUITING city: Giza country: Egypt name: Ayat Gamal-AbdelNaser role: CONTACT phone: 01001874257 email: ayat.gamal@acu.edu.eg lat: 30.00808 lon: 31.21093 hasResults: False

 nctId: NCT06366152 id: 43N2US2105 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-15 date: 2024-04-15 name: [Redacted] hasResults: False

 nctId: NCT06366139 id: Trigeminal RFT vs max/mand PRF briefTitle: Trigeminal Ganglion RFT vs Maxillary/Mandibular PRF in the Treatment of Trigeminal Neuralgia overallStatus: COMPLETED date: 2023-01-11 date: 2024-02-04 date: 2024-03-07 date: 2024-04-15 date: 2024-04-15 name: Diskapi Teaching and Research Hospital class: OTHER briefSummary: Trigeminal ganglion (TG) radiofrequency thermocoagulation (RFT) and ultrasound (US)-guided maxillary or mandibular (max/mand) pulsed radiofrequency (PRF) are two interventional procedures for the treatment of trigeminal neuralgia (TN). The aim of this study was to compare the efficacy and safety of these two procedures. For this evaluation, the numeric rating scale (NRS) was used to assess pain relief and the Medication Quantification Scale III (MQS III) was used to assess the effectiveness of the interventions on medication consumption. The rates of adverse events related to the interventions were also compared. conditions: Trigeminal Neuralgia conditions: Headache Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 44 type: ACTUAL name: Radiofrequency thermocoagulation of the trigeminal ganglion name: Maxillary/Mandibular nerve pulsed radiofrequency measure: Numerical rating scale (NRS) measure: The Medication Quantification Scale III (MQS III) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Diskapi Training and Research Hospital city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06366126 id: Child Abuse briefTitle: Long Term Impact of Child Abuse in University Students overallStatus: COMPLETED date: 2023-02-01 date: 2023-08-31 date: 2023-08-31 date: 2024-04-15 date: 2024-04-15 name: Delta University for Science and Technology class: OTHER briefSummary: Based on research and studies, a broad conceptualization of child abuse and neglect has progressively been constructed, defining it as all actions carried out by caregivers that significantly interfere in the child's optimum development and do not adhere to social standards. This conceptualization contemplates aspects such as neglecting physical-biological, cognitive, emotional, and social needs, and the different types of child maltreatment are also classified.

This study aimed too evaluate the psychological and social long-term effects of different types of child abuse. conditions: Child Abuse studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 242 type: ACTUAL measure: tailored questionnaire sex: ALL minimumAge: 18 Years maximumAge: 23 Years stdAges: ADULT facility: Amira Hussin Mohammed city: Gamasa zip: 35712 country: Egypt lat: 31.44112 lon: 31.53675 hasResults: False

 nctId: NCT06366113 id: 2023-A00363-42 briefTitle: Time of Exercise Re-training With Chronic Obstructive Pulmonary Disease (COPD) acronym: CHRONOBIO overallStatus: RECRUITING date: 2024-01-02 date: 2024-01-02 date: 2024-07-01 date: 2024-04-15 date: 2024-04-17 name: Michaël RACODON class: OTHER briefSummary: Pulmonary rehabilitation (PR) is an effective intervention for reducing hospital readmissions, secondary events, and mortality in patients with respiratory pathologies.

The program should not be improved by introducing new subjects such as circadian rhythm. conditions: Respiratory Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 90 type: ESTIMATED name: Pulmonary rehabilitation measure: 6-minute walk test (6MWT) measure: Time limit test (Time-lim) measure: Sit to stand test (STT) measure: Single arm curl Test (SAC) measure: Single-leg stance test (SLT) measure: Hospital Anxiety and Depression Scale (HAD) measure: Pittsburgh Sleep Quality Index sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinique la Mitterie status: RECRUITING city: Lille zip: 59130 country: France name: Michaël RACODON, PhD role: CONTACT phone: +33320223457 email: mracodon@clinique-mitterie.com lat: 50.63297 lon: 3.05858 hasResults: False

 nctId: NCT06366100 id: 2023I060 briefTitle: Implementation of Two Transdiagnostic Interventions Based on Emotional Regulation (DBT and UP) for Alcohol Addiction overallStatus: RECRUITING date: 2024-02-01 date: 2025-06-30 date: 2025-12-31 date: 2024-04-15 date: 2024-04-15 name: Universidad de Zaragoza class: OTHER name: Ministerio de Sanidad, Servicios Sociales e Igualdad briefSummary: The aim of this study is to evaluate the dissemination and implementation process of two transdiagnostic psychological interventions (Dialectical Behavioral Therapy for Substance Use Disorders-DBT-SUD and Unified Protocol-UP) to treat alcohol addiction by mental health practitioners in the Spanish National Health System. The main questions this study aims to answer are:

Are there differences before and after receiving DBT-SUD and UP training in the attitudes toward evidence-based psychological treatments (EBPTs), level of burnout and organizational climate and readiness to implement the interventions in mental health practitioners working with alcohol addiction?

What is the degree of acceptability and intention to use the interventions in clinical practice with people with alcohol addiction of the practitioners after each training (DBT-SUD and UP)?

In what degree the implementation outcomes (adoption, reach, appropriateness, feasibility, fidelity, sustainability) will be achieved by the practitioners implementing DBT-SUD and UP in clinical practice?

What are the main barriers and facilitators that practitioners will encounter during the process of implementing DBT-SUD and UP in clinical practice?

What variables will predict a successful implementation considering previous characteristics of the professionals and the organizational outcomes?

The study comprises two phases. In the first phase, mental health professionals working on addiction services of the Spanish National Health System will be randomly assigned to receive training in one intervention and then the other (DBT-SUD and UP) and will be evaluated before and after each training. In the second phase, participants will be randomly assigned to implement one intervention first and then the other in their workplaces with people with alcohol addiction and will be also assessed before and after the implementation. Qualitative and quantitate outcome measures will be analyzed using a Mixed- Methods-Design. conditions: Implementation Science studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants are assigned to two groups in parallel for the duration of the study. The specific design is an reverse counterbalanced (ABBA) intrasubject experimental study where participants will be randomly assigned to first (and then the other) receive DBT-SUD or UP online training in the phase 1 of the study, and randomly assigned to first implement DBT-SUD or UP intervention in the phase two. A balanced randomization (1:1) will be conducted in order to eliminate possible biases and ensure equivalence between groups. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 160 type: ESTIMATED name: Dialectical Behavior Therapy for Substance Use Disorder (DBT-SUD) name: Unified Protocol (UP) measure: Acceptability and Intention to Use Survey measure: Measures of Acceptability, Appropriateness and Feasibility of the intervention (AIM, IAM & FIM) measure: Normalization MeAsure Development Questionnaire (NoMAD) measure: Copenhagen Burnout Inventory (CBI) measure: Brief Scale of Understanding Substance Abuse (SUSS) measure: Implementation Climate Scale (ICS) measure: Organizational Readiness for Implementing Change (ORIC) measure: Evidence-Based Practice Attitudes Scale (EBPAS) measure: Program sustainability assessment tool (PASAT) measure: Barriers to Implementation Inventory (BTI) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Zaragoza status: RECRUITING city: Teruel state: Aragón zip: C/ Ciudad Escolar S/N44003 country: Spain name: María Vicenta Navarro Haro, PhD role: CONTACT phoneExt: 861145 email: mvnavarro@unizar.es lat: 40.3456 lon: -1.10646 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-04-02 uploadDate: 2024-04-09T12:23 filename: ICF_000.pdf size: 419669 hasResults: False

 nctId: NCT06366087 id: BP-C-24-001 briefTitle: Sublingual Atropine Bioequivalence by Route of Administration (SABER) acronym: SABER overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-05-24 date: 2024-05-24 date: 2024-04-15 date: 2024-04-15 name: Biomedical Advanced Research and Development Authority class: FED name: Rho Federal Systems Division, Inc. name: Allucent briefSummary: A randomized, two-period, two-sequence, crossover study to assess the bioequivalence, bioavailability, and pharmacokinetics (PK) of a single dose of atropine administered sublingually (SL) or intramuscularly (IM) in healthy adult volunteers. conditions: Atropine Bioequivalence studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 46 type: ESTIMATED name: Atropine Sulfate Ophthalmic Solution USP, 1% name: Atropine Sulfate Injection, USP 8 mg/20 mL (0.4 mg/mL) measure: The bioequivalence of atropine sulfate administered SL versus administered IM as measured by area under the analyte concentration versus time curve to infinity (AUCinf). measure: The bioequivalence of atropine sulfate administered SL versus administered IM as measured by area under the analyte concentration versus time curve to time of last quantifiable data point (AUCt). measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by area under the analyte concentration versus time curve to time 45, 60, 90, 120, 150, and 240 minutes (AUC45, AUC60, AUC90, AUC120, AUC150, and AUC240, respectively) measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by maximum measured plasma concentration (Cmax) measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by time to Cmax (tmax) measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by apparent terminal elimination half-life (t1/2) measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by terminal elimination rate constant (λz) measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by volume of distribution (Vd/F) measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by total body clearance (CL/F) measure: The relative bioavailability of atropine sulfate administered SL versus IM as measured by absorption rate constant (Ka) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johnson County Clin-Trials (JCCT) city: Lenexa state: Kansas zip: 66219 country: United States name: Carlos A Fierro, MD role: CONTACT phone: 913-825-4400 email: cfierro@jcct.com name: Mazen Zari role: CONTACT phone: 913-825-4400 email: mzari@jcct.com name: Carlos A Fierro, MD role: PRINCIPAL_INVESTIGATOR lat: 38.95362 lon: -94.73357 hasResults: False

 nctId: NCT06366074 id: HUM00252120 briefTitle: Early-feasibility Study to Evaluate Usability and Safety of the Watch-Transcutaneous Electrical Acustimulation (TEA) Device overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-08 date: 2025-08 date: 2024-04-15 date: 2024-04-15 name: University of Michigan class: OTHER name: Transtimulation Research, Inc briefSummary: This project is being completed to test the usability and safety of the Watch-Transcutaneous Electrical Acustimulation (TEA) Device.

This is a pilot study that will lead to future projects for cancer patients that may experience chemotherapy-induced symptoms. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Prevalence of delayed Chemotherapy-induced nausea, emesis, and dyspeptic symptoms (CINEDS) is 75% in women vs 51% in men (60% to 40% ratio). Therefore, every effort will be made to recruit at least 60% female subjects into the clinical study. primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: Watch-TEA group name: Tethered TEA device measure: Usability of the device for both groups day 3 measure: Number of adverse events related to the device noted on the safety questionnaire measure: Number of Transcutaneous Electrical Acustimulation (TEA)-related adverse events for both groups 3 days measure: Number of TEA-related adverse events for both groups 60 minutes at maximal tolerable level measure: Number of non-treatment TEA adverse events for both groups 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: Colin Burnett role: CONTACT phone: 734-647-2806 email: bucolin@umich.edu name: Jiande Chen, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False

 nctId: NCT06366061 id: 2020-02868 briefTitle: A COMPARISON OF LEFT VENTRICULAR FUNCTION IN THE APICAL 4 CHAMBER AND SUBCOSTAL 4 CHAMBER TTE VIEWS IN THE PERIOPERATIVE SETTING overallStatus: RECRUITING date: 2022-05-14 date: 2024-07-01 date: 2024-12-01 date: 2024-04-15 date: 2024-04-15 name: Eckhard Mauermann class: OTHER briefSummary: This study aims to examine the correlation and agreement of regional and global measurements of ventricular function in the apical 4 chamber and subcostal 4 chamber view. Additionally, we will explore limitations of the technology and explore the effect of left lateral positioning. conditions: Cardiac Functional Disturbances During Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: S'Tissue Doppler Index (TDI) AP4C supine vs. S'STE SC4C supine measure: Global longitudinal strain (GLS), AP4C supine vs. GLS, SC4C supine, i.e. clinical questions: can we use the SC4C for global markers of ventricular function? measure: Comparison of high Frame Rate (FR) vs. low FR of the following measures: [ i) S'STE AP4C supine, ii) GLS AP4C supine, iii) SR AP4C supine] measure: Comparison of the measured values in the cardiological gold standard (Left lateral decubitus (LLD)) vs. supine, for the following values [ i) S'TDI AP4C, ii) S'STE AP4C, iii) GLS] sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Basel status: RECRUITING city: Basel state: Basel Stadt zip: 4000 country: Switzerland name: Michael Lampart, Prakt. med. role: CONTACT phone: +41764006180 email: michael.lampart@usb.ch lat: 47.55839 lon: 7.57327 hasResults: False

 nctId: NCT06366048 id: EHBHKY2022-K-025 briefTitle: A Study on Relationship Between Resected Normal Liver Parenchymal Volume（RNLV）and Post-Hepatectomy Liver Failure (PHLF) acronym: RNLV overallStatus: ACTIVE_NOT_RECRUITING date: 2022-12-01 date: 2024-05-31 date: 2024-12-31 date: 2024-04-15 date: 2024-04-18 name: National Natural Science Foundation of China class: OTHER_GOV briefSummary: The post-hepatotectomy liver failure (PHLF) is still the most worrisome complication of hepatic resection. Surgeons have always been making efforts to preoperatively predict PHLF using kinds of techniques, scoring systems, and variables. The investigators of this study tried to create an individual predictive model based on the variable, resected normal parenchymal volume (RNLV), then assessing the performance and value of the model in clinical practice. conditions: Liver Failure studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 1133 type: ACTUAL name: the different definitions of PHLF according to 50-50 criteria and ISGLS criteria measure: Probability of PHLF was predicted with our individual model based on RNLV. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: The Third Affiliated Hospital of Naval Medical University city: Shanhai state: Shanghai zip: 201800 country: China hasResults: False

 nctId: NCT06366035 id: NMRR ID-24-00924-HPO briefTitle: LoVE4MUM: Virtual Engagement for Preventing Postpartum Depression acronym: LoVE4MUM overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-06-03 date: 2024-10-01 date: 2024-04-15 date: 2024-04-16 name: National Institutes of Health, Ministry of Health Malaysia class: OTHER briefSummary: Postpartum depression is a serious concern affecting mothers and their infants, especially with limited traditional support. This pilot study evaluates the effectiveness of a novel mobile app called LoVE4MUM, developed based on Cognitive Behavioral Therapy and Psychoeducation principles, in preventing postpartum depression. The pilot trial involves 64 mothers randomly assigned to receive either standard care or standard care plus the LoVE4MUM. Primary outcome is improvement in depression, with secondary outcomes including mental health literacy and automatic negative thoughts. This research aims to provide initial evidence on the potential of mobile health tools to support maternal mental health, paving the way for future accessible and effective interventions. conditions: Postpartum Depression conditions: Maternal Behavior conditions: mHealth Intervention conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Single Blinded, Pilot Randomized Control Trial primaryPurpose: PREVENTION masking: SINGLE whoMasked: INVESTIGATOR count: 64 type: ESTIMATED name: LoVE4MUM mobile application measure: Postpartum Depression measure: Postpartum Mental Health Literacy measure: Automatic Negative Frequency sex: FEMALE minimumAge: 19 Years maximumAge: 50 Years stdAges: ADULT facility: Hospital Tengku Ampuan Rahimah city: Klang state: Selangor zip: 41586 country: Malaysia name: Noor Fadzleeyanna Mohd Yahaya, MOG role: CONTACT phone: 03-3375 7000 name: Noor Fadzleeyanna Mohd Yahaya, MOG role: PRINCIPAL_INVESTIGATOR name: Shalisah Sarip, PhD role: SUB_INVESTIGATOR name: Norfazilah Ahmad, PhD role: SUB_INVESTIGATOR lat: 3.03333 lon: 101.45 facility: Hospital Shah Alam city: Shah Alam state: Selangor zip: 40000 country: Malaysia name: Siti Sabrina Kamarudin role: CONTACT phone: 0355263000 phoneExt: 3305 email: saby721@gmail.com name: Siti Sabrina Kamarudin, MBBS role: PRINCIPAL_INVESTIGATOR name: NNurul Syuhaida Abdul Razak, MOG role: SUB_INVESTIGATOR name: Idayu Badilla Idris, PhD role: SUB_INVESTIGATOR lat: 3.08507 lon: 101.53281 hasResults: False

 nctId: NCT06366022 id: Warsaw.06 briefTitle: Evaluation of the Treatment of Multiple Gingival Recession Using Modified Coronally Advanced Tunnel With Subepithelial Connective Tissue Graft Depending on the Positioning of the Graft overallStatus: RECRUITING date: 2023-05-30 date: 2024-05-30 date: 2024-05-30 date: 2024-04-15 date: 2024-04-15 name: Medical University of Warsaw class: OTHER briefSummary: Microsurgical coronally advanced tunnel procedures using subepithelial connective tissue grafts (sCTG) are predictable for healing of multiple adjacent type 1 and 2 gingival recessions (RT1 and RT2). In order to reduce patient morbidity and enhance periodontal wound healing with sCTG can be used. The aim of this study is to compare the results of the modified tunneling technique with subepithelial connective tissue graft in gingival recessions placed with the inner side towards the flap cover graft and the outer side towards the flap cover graft. conditions: Gingival Recession studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: The tunnel technique for root coverage with CTG with inner side of the graft name: The tunnel technique for root coverage with CTG with outer side of the graft measure: Clinical attachment level (CAL) measure: Recession height (RH) measure: Recession width (RW) measure: Width of keratinized tissue (KTW) measure: Thickness of keratinized tissue (GT measure: Average recession coverage (ARC) measure: Complete recession coverage measure: Probing pocket depth (PPD) measure: Root coverage esthetic score (RES) measure: Post surgical pain and swelling measure: Patient's satisfaction with treatment sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw status: RECRUITING city: Warsaw state: MAzowsze zip: 00-246 country: Poland name: Bartłomiej Górski, PhD role: CONTACT phone: 48225022099 lat: 52.22977 lon: 21.01178 hasResults: False

 nctId: NCT06366009 id: Warsaw Study briefTitle: Assessment of Patients With Drug-resistant Temporal Lobe Epilepsy With EEG Extended With Intra-auricular Electrodes overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2024-07-31 date: 2024-07-31 date: 2024-04-15 date: 2024-04-15 name: Przemyslaw Kunert class: INDUSTRY name: NaoX Technologies name: Warsaw Medical University Clinical Center name: Departments and Clinics of Emergency Medicine of the Medical University of Gdańsk briefSummary: The study aims to evaluate the effectiveness of long-term video EEG monitoring using 10-20 electrodes extended with intra-auricular electrodes in locating the seizure onset zone and interictal epileptiform discharges (IEDs) in patients with temporal lobe epilepsy (TLE) and nontemporal lobe epilepsy (non-TLE). conditions: Epilepsy conditions: Focal Epilepsy conditions: Drug Resistant Epilepsy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: NaoX in-ear EEG system measure: determination of the starting point of focal temporal epileptic seizures measure: Identification of subgroups of epileptic patterns measure: Assessment of ease-of-use and comfort of use of the NAOX in-ear EEG system by patients and the EEG technician sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kliniki Neurochirurgii CSK UCK WUM city: Warsaw country: Poland name: Przemysław Kunert, Prof. role: CONTACT name: Maja Kopytek-Beuzen, Dr. role: CONTACT lat: 52.22977 lon: 21.01178 hasResults: False

 nctId: NCT06365996 id: Core set geriatric ICF briefTitle: Development and Validation of the Polish Geriatric Core Set. overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-12-15 date: 2025-12-15 date: 2024-04-15 date: 2024-04-15 name: University of Rzeszow class: OTHER briefSummary: Population ageing is a global problem. With ageing, involutionary changes and multimorbidity increase, leading to limitations in the performance of daily activities and disability. Proposed by the World Health Organisation (WHO), the geriatric core set is a set of categories of the International Classification of Functioning, Disability and Health (ICF) that allows for a comprehensive assessment of a person of geriatric age. In Poland, the geriatric core set has not yet been adapted and validated. Therefore, the aim of this study is the cultural adaptation and validation of the Polish version of the ICF-based categorical profile for the assessment of older people. conditions: Aging studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 800 type: ESTIMATED measure: ICF Geriatric core set measure: Sociodemographic data of the sample measure: Disability - WHODAS 2.0 v 36 item sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Rzeszow city: Rzeszów state: Podkarpacie zip: 35-959 country: Poland name: Agnieszka Sozańska, professor role: CONTACT phone: 530172857 email: asozanska@ur.edu.pl lat: 50.04132 lon: 21.99901 hasResults: False

 nctId: NCT06365983 id: UFRGS-Cassio briefTitle: Comparison of Free Gingival Graft and Linear Incision for Connective Tissue overallStatus: RECRUITING date: 2023-04-28 date: 2025-04-28 date: 2026-04-28 date: 2024-04-15 date: 2024-04-15 name: Federal University of Rio Grande do Sul class: OTHER briefSummary: A randomized controlled non-inferiority trial will be conducted with 24 individuals aged 18 or older, who are periodontally healthy and require root coverage in bilateral multiple RT1-type recessions involving at least two teeth on each side of the mouth. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons.

Patients included in the study will undergo the bilateral multiple root coverage technique with coronally repositioned flap (Zucchelli and De Sanctis) in both groups. The donor areas for connective tissue will be the hard palate region, with grafts harvested using the linear technique on one side and the free de-epithelialized gingival graft technique on the other side.

Each patient will undergo a preparatory phase for study inclusion, consisting of supragingival scaling, polishing, and oral hygiene instructions at least 3 weeks before study inclusion. Patients will be instructed on personalized and proper use of toothbrush, dental floss, and/or interdental brush.

All surgical procedures in both groups will be performed by the same operator (CCO). Randomization will determine the side to be operated on first. The other side will be operated on after 30 days or until the patient reports complete absence of symptoms in the area of the first surgery to avoid confusion in patient-centered outcomes regarding pain and satisfaction with the techniques.

Outcomes evaluated at 3, 6, 9, and 12 months include: gingival recession depth, probing depth, visible plaque, bleeding on probing, width of keratinized tissue, three-dimensional tissue assessment from intraoral scanning, and quality of life related. Linear and logistic generalized estimating equation models considering the longitudinal nature of the study will be used for data analysis.

INCLUSION CRITERIA Patients aged 18 or older requiring root coverage in bilateral multiple recessions involving at least two teeth on each side of the mouth will be included. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons. Recessions should be RT1 type according to the 2017 Workshop on the Classification of Periodontal Conditions and Diseases (Jepsen et al. 2018) and without non-carious cervical lesions.

EXCLUSION CRITERIA

Individuals will not be considered eligible if they:

* Present any form of immunological compromise;
* Have diseases or systemic conditions contraindicating surgical procedures or affecting periodontal healing pattern, such as diabetes and autoimmune diseases;
* Present active periodontitis, defined by presence of \>=10% subgingival bleeding and probing depth and clinical attachment loss proximal \>4mm (Tonetti et al. 2018);
* Are current or ex-smokers;
* Have allergies to ibuprofen and chlorhexidine digluconate.

Research Objective:

PRIMARY OBJECTIVE The overall objective of this study is to compare free gingival graft and subepithelial connective tissue graft in outcomes related to multiple recession coverage.

SECONDARY OBJECTIVE

Compare the two grafts in terms of clinical outcomes of root coverage; Compare the two grafts in terms of digital outcomes of root coverage obtained in scanning and tomography; Compare the two grafts in terms of patient-centered outcomes. conditions: Connective Tissue conditions: Gingiva conditions: Gingival Recession conditions: Humans studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A randomized controlled non-inferiority trial will be conducted with 24 individuals aged 18 or older, who are periodontally healthy and require root coverage in bilateral multiple RT1-type recessions involving at least two teeth on each side of the mouth. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: All sample randomization procedures will be carried out by a researcher not involved in treatments and clinical examinations. An external researcher not affiliated with the study will be responsible for maintaining participant allocation confidentiality. Sides will be identified by numbers stored in opaque, sealed envelopes with the randomization sequence. Outcome assessors will be blinded to the experimental group to which participants belong. whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Connective Tissue with Free Gingival Graft name: Connective Tissue with Linear Incision measure: Percentage of root coverage measure: Recession depth sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alex Nogueira Haas status: RECRUITING city: Porto Alegre state: RS zip: 95780000 country: Brazil name: Cássio Cardona Orth role: CONTACT phone: 11999791876 email: cassio.orth@gmail.com lat: -30.03306 lon: -51.23 hasResults: False

 nctId: NCT06365970 id: HCC 23-056 briefTitle: Niraparib and Dostarlimab for Patients With MMR-D/MSI-H Colorectal Cancers overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2026-05-31 date: 2027-05-31 date: 2024-04-15 date: 2024-04-15 name: Ibrahim Halil Sahin class: OTHER name: GlaxoSmithKline briefSummary: The second line of therapy for patients with MSI-H CRC who experience disease progression on anti-PD1 based therapies is not well defined and there is an unmet need for research for patients with anti-PD1 refractory MSI-H CRC. This study will examine the combination of niraparib and dostarlimab for a synergistic antitumor effect for patients with MSI-H CRC. conditions: MMR-D/MSI-H Colorectal Cancers studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Niraparib name: Dostarlimab measure: Objective response rate (ORR) measure: Adverse Events Related to Treatment measure: Progression-free Survival (PFS) measure: Duration of Response (DoR) measure: Overall Survival (OS) 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: Debra Diecks, MSN role: CONTACT phone: 412-623-8364 email: diecksda@upmc.edu name: Ibrahim Sahin, MD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 hasResults: False

 nctId: NCT06365957 id: BSERE24-APP001-FED briefTitle: Acute Effects of Exercise Combined With Ketone Ester Supplement overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03 date: 2025-04 date: 2024-04-15 date: 2024-04-22 name: University of Macau class: OTHER briefSummary: To examine the acute changes in cardiometabolic and neurocognitive outcomes in response to exercise combined with ketone ester supplement in overweight/obese adults. conditions: Overweight and Obesity conditions: Cognitive Change conditions: Ketoses, Metabolic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Ketone monoester supplementation name: High-intensity interval exercise name: Moderate-intensity continuous exercise name: Placebo measure: Maximal Oxygen Uptake measure: Systolic Blood Pressure measure: Diastolic Blood Pressure measure: Concentration of Blood Lipid measure: Concentration of Blood Glucose measure: Concentration of Blood Beta-Hydroxybutyrate measure: Concentration of Blood Lactic Acid measure: Concentration of Blood Insulin measure: Reaction Time of Stroop Task measure: Accuracy of Stroop Task measure: Reaction Time of N-back Task measure: Accuracy of N-back Task measure: Cerebral Hemoglobin Concentration measure: Arousal Level sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False

 nctId: NCT06365944 id: CHUBX 2023/73 briefTitle: Concussion in French Non-professional Handball League : Efficiency of a Concussion Protocol, the White Card Process acronym: PRECCOCE overallStatus: RECRUITING date: 2024-04-20 date: 2026-04-20 date: 2026-04-20 date: 2024-04-15 date: 2024-04-24 name: University Hospital, Bordeaux class: OTHER briefSummary: Sport related concussion is a major issue for many contact sports, such as Rugby, Football, Hockey and Handball. As a response, some federations like World Rugby set up a concussion protocol, that starts with the referee having the responsibility to issue a blue card when suspecting a concussed player and thus have him off the field for medical examination. The French handball federation (FFHB) as well as its concussion protocol called "Protocole carton blanc", in this study we aim to describe the efficiency of this protocol. conditions: Brain Concussion conditions: Cerebral Concussion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED measure: Proportion, as a percentage, of participant declaring no medical care while being estimated at risk of having a concussion (assessed by answers to the questionnaire) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bordeaux University Hospital status: RECRUITING city: Bordeaux country: France name: Quentin LHUAIRE role: CONTACT lat: 44.84044 lon: -0.5805 hasResults: False

 nctId: NCT06365931 id: 160224 briefTitle: Physiological and Functional Effects of Percutaneous Neuromodulation vs Transcutaneous Neuromodulation overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-16 date: 2024-02-16 date: 2024-04-30 date: 2024-04-15 date: 2024-04-15 name: University of Extremadura class: OTHER briefSummary: INTRODUCTION: Clubfoot, drop foot or clubfoot, is a disorder that prevents reaching 100º of dorsiflexion actively. Its etiology is varied, and may be due to congenital problems, direct alteration of the bone structure, spasticity or shortening of the posterior musculature (triceps suralis), a neurological factor or a combination of several. Thus, we can differentiate between congenital clubfoot and acquired clubfoot. Stroke is one of the main causes of acquired clubfoot, which is due to paralysis of the dorsiflexor musculature and/or spasticity of the plantar flexor musculature. Electrical stimulation is able to increase muscle activation by depolarization of the motor plate and modulation of nerve conduction. This can be done transcutaneously, through surface electrodes or percutaneously through needles, so neuromodulation is presented as a tool applicable to the pathology of the equine foot, if we take into account the increased activation of the dorsiflexors of the foot.

OBJECTIVE: The main objective is to evaluate which of the techniques, percutaneous or transcutaneous, is more effective for the approach of clubfoot in post-stroke patients.

METHODOLOGY: a clinical trial with randomized probabilistic assignment in four groups is proposed: G1 (percutaneous neuromodulation): patients will receive a needle circuit approaching the deep peroneal nerve in an ultrasound-guided manner. They will receive a 20-30Hz symmetrical biphasic current; G2 (transcutaneous neuromodulation): patients will have a superficial electrode circuit placed over the belly of the tibialis anterior muscle. They will receive a symmetrical biphasic current of 20-30Hz; G3 (placebo-percutaneous group): in which the patients will receive the neuromodulation circuit with needles at 0 intensity; G2 (placebo-transcutaneous group): the patients will receive the electrodes at 0 intensity over the belly of the tibialis anterior muscle.

The variables to be analyzed are: anthropometric variables (age, weight, height, BMI), muscle oxygenation (SatO2, O2Hb, HHb and THb), muscle strength of the foot dorsiflexors measured with dynamometer, muscle activation by surface electromyography, active and passive joint balance with goniometry or inclinometer, assessment of gait and balance, assessment of load distribution by static and dynamic pressure platform, spasticity and questionnaire on quality of life and functionality. The acute effects after one intervention session (pre-post intervention of one session) and the effects after a 10-session program will be analyzed. conditions: Stroke/Brain Attack studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ACTUAL name: Percutaneous neuromodulation name: Transcutaneous neuromodulation name: Placebo-percutaneous name: Placebo-transcutaneous name: Percutaneous neuromodulation or Transcutaneous neuromodulation (optional) measure: Muscle activity measure: Displacement of the center of pressures (CoP) measure: Articular amplitude measure: Balance measure: Balance measure: Gait measure: Tissue oxygen in muscle measure: Muscular strength measure: Functionality measure: quality of life index measure: Spasticity sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mª Dolores Apolo Arenas city: Badajoz country: Spain lat: 38.87789 lon: -6.97061 hasResults: False

 nctId: NCT06365918 id: 2023-0836 id: NCI-2024-03236 type: OTHER domain: NCI-CTRP Clinical Registry briefTitle: Study of VG2025 Delivered Intraperitoneally in Patients With Advanced Solid Tumors With Carcinomatosis overallStatus: NOT_YET_RECRUITING date: 2024-09-30 date: 2028-03-22 date: 2030-03-22 date: 2024-04-15 date: 2024-04-15 name: M.D. Anderson Cancer Center class: OTHER briefSummary: To find the recommended dose of the investigational drug VG2025 that can be given intraperitoneally (given directly into the abdominal cavity) to participants with advanced solid tumors. conditions: Advanced Solid Tumor conditions: Carcinomatosis studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 21 type: ESTIMATED name: VG2025 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: Siqing Fu, MD,PHD role: CONTACT phone: 713-792-4318 email: siqingfu@mdanderson.org name: Siqing Fu, MD,PHD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06365905 id: 23-011680 id: NCI-2024-02550 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-011680 type: OTHER domain: Mayo Clinic in Rochester briefTitle: Non-Invasive Identification of Endometrial Cancer/Endometrial Atypical Hyperplasia With an AI-Based Classifier Applied to Transvaginal Ultrasound in Patients With Post-Menopausal Bleeding overallStatus: RECRUITING date: 2024-06-01 date: 2027-06-30 date: 2027-06-30 date: 2024-04-15 date: 2024-04-16 name: Mayo Clinic class: OTHER briefSummary: This study evaluates if AI can be used with transvaginal ultrasound images for early detection of endometrial cancer or premalignant lesions. conditions: Endometrial Carcinoma studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Non-Interventional Study measure: Accuracy of artificial intelligence (AI) algorithm applied to transvaginal ultrasound (TVUS) sex: FEMALE minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Arizona status: NOT_YET_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: Kristina A. Butler, M.D., M.S. role: PRINCIPAL_INVESTIGATOR lat: 33.50921 lon: -111.89903 facility: Mayo Clinic in Florida status: NOT_YET_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: Christopher C. DeStephano, M.D., M.P.H. 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: Gretchen E. Glaser, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False

 nctId: NCT06365892 id: 22-36548 briefTitle: Open-label Placebo (COLP) for Pain in Adolescent Idiopathic Scoliosis (AIS) Surgery+Surgical Treatment of Idiopathic Scoliosis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-01-01 date: 2026-01-01 date: 2024-04-15 date: 2024-04-15 name: University of California, San Francisco class: OTHER briefSummary: This study aims to investigate the effects of conditioning with open-label placebos on standard postoperative treatment for patients undergoing surgery for idiopathic scoliosis in a randomized controlled, 6-week trial with 64 AIS patients randomly assigned to one of two arms: Open-label Placebo (COLP) + treatment as usual TAU / TAU control. The study involves collecting data from your child's medical record. At each regular clinic visit, the patient clinical data will be collected by the research coordinator. Surveys will be collected including:• PROMIS for the age group 10 to 18 years. conditions: Adolescent Idiopathic Scoliosis (AIS) studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Both arms - Open-label Placebo (COLP) and Treatment As Usual (TAU) primaryPurpose: TREATMENT masking: NONE maskingDescription: Blinding of patients and providers will not be feasible due to the nature of the study. count: 64 type: ESTIMATED name: open-label placebo name: Treatment as usual measure: The total amount of opioids consumed in oral morphine equivalents (OMEs) following surgery measure: Weekly level of mobility and change from baseline in mobility on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Pediatric Mobility Short Form 7a at week 6. measure: Weekly level of anxiety and change from baseline in anxiety levels on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Anxiety Short Form 8a at week 6. measure: Weekly level of depressive symptoms and change from baseline in depressive symptoms on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Depressive Symptoms Short Form 8a at week 6. measure: The duration of time in days following surgery until patients establish Independence with Physical Therapy measure: The length of time in days following surgery until discharge from the hospital measure: The length of time in days following surgery until participant returns to school measure: Whether participants experience urinary retention following surgery. measure: Whether participants experience constipation measured by the number of days between surgery and first bowel movement measure: Whether participants experience an oxygen requirement and the duration of the requirement following surgery. sex: ALL minimumAge: 10 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: University of California, San Francisco city: San Francisco state: California zip: 94158 country: United States lat: 37.77493 lon: -122.41942 hasResults: False

 nctId: NCT06365879 id: CMAB007-003 briefTitle: To Compare Efficacy and Safety of CMAB007 and Xolair® in Patients With Chronic Spontaneous Urticaria overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-11-01 date: 2026-05-01 date: 2024-04-15 date: 2024-04-15 name: Taizhou Mabtech Pharmaceutical Co.,Ltd class: INDUSTRY briefSummary: This study is a multicenter, randomized, double-blind, positive parallel controlled phase III clinical trial to compare efficacy, immunogenicity, pharmacokinetics, pharmacodynamics and safety of omalizumab α(CMAB007) and Xolair® in patients with refractory chronic spontaneous urticaria conditions: Chronic Spontaneous Urticaria studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 392 type: ESTIMATED name: CMAB007 name: Xolair measure: Change From Baseline of the Itch Severity Score (ISS7) Score At Week 12 measure: Change From Baseline of Urticaria Activity Score (UAS7) At Week 12 measure: Change From Baseline of Number of Hives Score (NHS7) At Week 12 measure: Time to ISS7 MID Response by Week 12 measure: Percentage of Patients With UAS7≤6 at Week 12 measure: Percentage of Patients With ISS7 Minimally Important Difference (MID) at Week 12 measure: Change From Baseline of Urticaria Control Test (UCT) at Week 12 measure: Percentage of Patients With UCT≥12 at Week 12 measure: Percentage of Complete Controls (UCT=16) at Week 12 measure: Change From Baseline of Dermatology Life Quality Index (DLQI) Score at Week 12 measure: Percentage of Complete Responders (UAS7=0) at Week 12 measure: Percentage of Angioedema-free Days From Week 4 to Week 12 measure: Incidence of adverse events measure: Immunogenicity measure: AUC0-t measure: AUC0-inf measure: Half time measure: Cmax measure: Tmax measure: Clearance Rate measure: Apparent Volume of Distribution measure: Level of Total IgE and Free IgE sex: ALL minimumAge: 15 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06365866 id: 2022-06-008B briefTitle: Evaluate the Efficacy of Adding Intraluminal Brachytherapy After CCRT for Local-regional Thoracic Esophageal Cancer. overallStatus: RECRUITING date: 2024-02-19 date: 2024-12 date: 2024-12 date: 2024-04-15 date: 2024-04-15 name: Taipei Veterans General Hospital, Taiwan class: OTHER_GOV briefSummary: The purpose of this study is to observe the safety and effectiveness of the add-on of intraluminal brachytherapy with BRAXX esophageal brachytherapy applicator after definitive CCRT in patients with thoracic esophageal cancer. conditions: Esophageal Neoplasms conditions: Head and Neck Neoplasms conditions: Gastrointestinal Neoplasms conditions: Digestive System Diseases conditions: Digestive System Neoplasms conditions: Esophageal Diseases conditions: Neoplasms by Site conditions: Gastrointestinal Diseases conditions: Neoplasms studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Add-on treatment to standard treatment (fixed doses allowing dose reduction or dose delay according to the tolerability of individual patients); No control group. primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: "BRAXX" Esophageal Brachytherapy Applicator. name: Add-on of intraluminal brachytherapy measure: To estimate the local control rate at primary tumor site. measure: To estimate overall response rate. measure: To estimate distant metastasis rate. measure: To estimate progression-free survival rate. measure: To estimate overall survival status. measure: To estimate toxicity analysis. measure: To estimate adverse event. sex: ALL minimumAge: 20 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taipei Veterans General Hospital status: RECRUITING city: Taipei zip: 11217 country: Taiwan name: Pin-I Huang, Ph.D. role: CONTACT phone: +886 955-275-822 email: pihuang@vghtpe.gov.tw name: Pin-I Huang, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06365853 id: IMGN853-0424 id: 2023-505617-24-00 type: CTIS briefTitle: A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2026-05-26 date: 2027-05-26 date: 2024-04-15 date: 2024-04-15 name: ImmunoGen, Inc. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the incidence rate and severity of pre-specified mirvetuximab soravtansine (MIRV)-related ocular treatment-emergent adverse events (TEAEs) and assess prophylaxis strategies in all participants (symptomatic and asymptomatic) undergoing prospective ophthalmic evaluation with recurrent ovarian cancer (participants with either platinum-sensitive ovarian cancer \[PSOC\] or platinum-resistant ovarian cancer \[PROC\]) with high folate receptor alpha (FRα) expression. conditions: Recurrent Ovarian Cancer conditions: Folate Receptor-Alpha Positive studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Mirvetuximab Soravtansine name: Lubricating Eye Drops name: Prednisolone acetate ophthalmic suspension 1% eye drops name: Brimonidine tartrate ophthalmic solution eye drops measure: Number of Participants With MIRV-related Corneal AEs (≥ Grade 2) in Asymptomatic Participants measure: Number of Participants With All Ocular TEAEs in Participants Using Corticosteroid Versus Vasoconstricting Eye Drop Primary Prophylaxis measure: Number of Participants With MIRV-related Corneal AEs and All Ocular TEAEs in Asymptomatic Versus Symptomatic Participants measure: Number of Participants With MIRV-related Corneal AEs and All Ocular TEAEs in Participants Using Corticosteroid Versus Vasoconstricting Eye Drop Primary Prophylaxis measure: National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Composite Score measure: Area Under the Curve (AUC) of MIRV measure: Maximum Serum Concentration (Cmax) of MIRV measure: Trough Concentration (Ctrough) of MIRV sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado Health - University of Colorado Cancer Center (UCCC) - Anschutz Medical Campus (Anschutz Cancer Pavilion) (ACP) city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 facility: Yale School of Medicine - Yale Gynecologic Oncology city: New Haven state: Connecticut zip: 06510 country: United States lat: 41.30815 lon: -72.92816 facility: Holy Cross Hospital city: Silver Spring state: Maryland zip: 20910 country: United States lat: 38.99067 lon: -77.02609 facility: Baystate Regional Cancer Program - D'Amour Center for Cancer Care Location - Gynecologic Oncology city: Springfield state: Massachusetts zip: 01107 country: United States lat: 42.10148 lon: -72.58981 facility: New York Oncology Hematology city: Albany state: New York zip: 12208 country: United States lat: 42.65258 lon: -73.75623 facility: Women's Cancer Care Associates, LLC city: Albany state: New York zip: 12208 country: United States lat: 42.65258 lon: -73.75623 facility: New York-Presbyterian/Columbia University Medical Center - Herbert Irving Comprehensive Cancer Center (HICCC) - Herbert Irving Pavilion city: New York state: New York zip: 10032 country: United States lat: 40.71427 lon: -74.00597 facility: Duke Cancer Institute (DCI) - Duke Cancer Center city: Durham state: North Carolina zip: 27710 country: United States lat: 35.99403 lon: -78.89862 facility: University of Texas Southwestern Medical Center - Harold C. Simmons Comprehensive Cancer Center - University Hospital Gynecologic Oncology Clinic city: Dallas state: Texas zip: 75235 country: United States lat: 32.78306 lon: -96.80667 facility: Monash University - Monash Medical Centre (MMC) - Clayton city: Clayton state: Victoria country: Australia lat: -37.91667 lon: 145.11667 facility: Universitair Ziekenhuis Antwerpen (UZA) - Borstkliniek city: Edegem state: Antwerp country: Belgium lat: 51.15662 lon: 4.44504 facility: AZ Sint-Lucas - Campus Sint-Lucas - Borstkliniek city: Gent state: East Flanders country: Belgium lat: 51.05 lon: 3.71667 facility: Universitair Ziekenhuis Gent (UZ Gent) city: Gent state: East Flanders country: Belgium lat: 51.05 lon: 3.71667 facility: McGill University Health Centre (MUHC) - The Montreal General Hospital (MGH) - Cedars Cancer Centre city: Montreal state: Quebec country: Canada lat: 45.50884 lon: -73.58781 facility: Universite de Montreal - Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Notre-Dame city: Montreal state: Quebec country: Canada lat: 45.50884 lon: -73.58781 facility: Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Cochin city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Groupe Hospitalier Diaconesses Croix Saint-Simon - Hopital de la Croix Saint-Simon city: Paris country: France lat: 48.85341 lon: 2.3488 facility: Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud city: Pierre Benite country: France lat: 45.7009 lon: 4.82511 facility: Bon Secours Hospital - Dublin city: Dublin country: Ireland lat: 53.33306 lon: -6.24889 facility: Mater Misericordiae University Hospital (MMUH) (START Dublin) city: Dublin country: Ireland lat: 53.33306 lon: -6.24889 facility: Istituto Europeo di Oncologia (IEO) (European Institute of Oncology) city: Milan country: Italy lat: 45.46427 lon: 9.18951 facility: Institut Catala d'Oncologia (ICO) - Hospital Universitari Germans Trias i Pujol (HUGTP) Location city: Badalona state: Barcelona country: Spain lat: 41.45004 lon: 2.24741 facility: Parc Taulí city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 facility: Vall d'Hebron Institut d'Oncologia city: Barcelona country: Spain lat: 41.38879 lon: 2.15899 facility: Complejo Hospitalario de Jaen (University Hospital Ciudad De Jaen) city: Jaen country: Spain lat: 37.76922 lon: -3.79028 hasResults: False

 nctId: NCT06365840 id: IMC-001-202 briefTitle: A Study of Phase2, IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor acronym: TMB-H overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2027-12 date: 2024-04-15 date: 2024-04-15 name: ImmuneOncia Therapeutics Inc. class: INDUSTRY briefSummary: The goal of this clinical trial is to determine the efficacy of IMC-001 in metastatic or locally advanced TMB-H solid tumor patients. conditions: TMB-H conditions: Histologically or Cytologically Proven Metastatic or Locally Advanced Solid Tumors studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: IMC-001 measure: ORR sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06365827 id: AZ293/20 briefTitle: Perioperatively Assessed Biomarker I-FABP Level for Prediction of Acute Mesenteric Ischemia and Its Correlation With Acute Kidney Injury, Followed by Extracorporeal Circulation (aMIKI) acronym: aMIKI overallStatus: ACTIVE_NOT_RECRUITING date: 2022-03-01 date: 2023-12-31 date: 2024-07-31 date: 2024-04-15 date: 2024-04-22 name: University of Giessen class: OTHER briefSummary: Acute mesenteric ischemia (AMI) is a severe condition that might occur after cardiovascular surgery. Several risk factors for AMI, such as multimorbidity, the use of vasopressors, and an increase in inflammatory markers have been identified in the past. However, these risk factors also seem to influence the blood and urine levels of I-FABP. This prospective pilot study intends to evaluate the value of perioperatively assessed I-FABP levels and to correlate these values with clinical or angiographic findings in mesenteric ischemia to improve a standardised diagnosis. conditions: Cardiac Surgery With Cardiopulmonary Bypass conditions: Acute Mesenteric Ischemia conditions: Acute Kidney Injury conditions: Non-Occlusive Mesenteric Ischaemia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 500 type: ACTUAL name: observational study measure: Concentration of I-FABP values with/and without acute mesenteric ischemia measure: Time interval to mesenteric ischemia measure: Overall mortality rate measure: Correlation of I-FABP with biomarkers of acute kidney injury measure: Association of mesenteric ischemia with hypercoagulable states measure: Incidence of stroke measure: Association of I-FABP level and multi-organ failure or cardiovascular mortality sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Giessen, Cardiovascular surgery city: Giessen state: Hessen zip: 35392 country: Germany lat: 50.58727 lon: 8.67554 hasResults: False

 nctId: NCT06365814 id: ERASforNACT briefTitle: ERAS for Gastric Cancer Patients After NACT overallStatus: COMPLETED date: 2023-10-01 date: 2024-04-01 date: 2024-04-01 date: 2024-04-15 date: 2024-04-15 name: The Affiliated Hospital of Qingdao University class: OTHER briefSummary: Background: Gastric cancer patients receiving neoadjuvant chemotherapy (NACT) are more vulnerable to perioperative stress. Enhanced recovery after surgery (ERAS) is widely used in surgical patients aiming at reducing stress responses. However, whether this approach is safe and feasible for gastric cancer patients received minimally invasive radical gastrectomy after NACT remained determined. So, the objective of this study is to investigate the effects of ERAS for this special group of gastric cancer patients.

Materials and Methods: The data of gastric cancer patients who underwent minimally invasive radical gastrectomy after NACT were collected in this retrospective cohort study. Patients were divided into an ERAS group and a conventional group based on whether they received perioperative ERAS management. Propensity score matching was conducted to eliminate bias. Pre- and postoperative inflammatory and nutritional marker levels, postoperative complications, recovery indices and 3-year OS and RFS were observed. conditions: Gastric Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 252 type: ACTUAL name: enhanced recovery after surgery name: conventional perioperative management measure: postoperative infectious complications measure: postoperative recovery parameter measure: blood test result measure: 3-year overall survival measure: 3-years recurrence-free survival sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital city: Qingdao state: Shandong zip: 266000 country: China lat: 36.06488 lon: 120.38042 hasResults: False

 nctId: NCT06365801 id: 2022YFC3500401-IBS briefTitle: Investigation of Acupoint in Irritable Bowel Syndrome Based on Biological Characteristics overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2025-12 date: 2024-04-15 date: 2024-04-15 name: The Third Affiliated hospital of Zhejiang Chinese Medical University class: OTHER briefSummary: Irritable bowel syndrome (IBS) is a common functional disorder of the digestive system characterized by recurrent abdominal pain associated with bowel movements or changes in bowel habits. Although there are reviews and guidelines for treating IBS, the complexity and diversity of IBS manifestations make treatment difficult. By detecting and exploring the biological characteristics presented by the relevant meridian point reaction, this project clarified the specificity and regularity of the connection between the acupoint and the Zangfu reflected by this phenomenon, and conducted correlation analysis based on the intestinal flora, tryptophan metabolite levels and related scales of patients with IBS. conditions: Irritable Bowel Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Pain sensitivity measure: Thermal radiation characteristics measure: Microcirculation characteristics measure: Electrical characteristics measure: Biological ultra-weak luminescence measure: Intestinal flora measure: Tryptophan metabolites measure: Bristol Fecal Traits Grading Scale measure: Severity of IBS (IBS-SSS) measure: IBS Quality of Life (IBS-QOL ) measure: TCM Constitution Survey measure: Gastrointestinal Symptoms Rating Scale (GSRS) measure: Self-Rating Anxiety Scale (SAS) measure: Self-Rating Depression Scale (SDS) measure: Pittsburgh Sleep Quality Index (PSQI) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06365788 id: S66466 id: 2022-502272-23-00 type: OTHER domain: EU CT Number briefTitle: Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer acronym: ABBICAR overallStatus: RECRUITING date: 2024-04-08 date: 2027-12 date: 2027-12 date: 2024-04-15 date: 2024-04-15 name: Universitaire Ziekenhuizen KU Leuven class: OTHER name: Kom Op Tegen Kanker name: Eli Lilly and Company name: Teva Pharma briefSummary: This study has as goal to evaluate the use of abemaciclib and bicalutamide in androgen receptor positive metastatic triple negative breast cancer. conditions: Triple Negative Breast Neoplasms studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 53 type: ESTIMATED name: Abemaciclib name: Bicalutamide measure: Number of participants with disease control at 16 weeks measure: Number of participants with (serious) adverse events, death and clinical abnormalities per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 measure: HRQoL change from baseline as measured by EORTC QLQ-C30 measure: Number of participants with disease control at 16 weeks in subgroup with androgen receptor (AR) positivity on immunohistochemistry (IHC) in ≥10% of cells. measure: Number of participants with disease control at 16 weeks in subgroups A, B, C and D separate measure: Number of participants with disease control at 24 weeks measure: Number of participants with partial or complete response at 16 weeks measure: Duration of response measure: Months of progression free survival measure: Months of overall survival sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Antwerp University Hospital status: NOT_YET_RECRUITING city: Antwerp country: Belgium name: Sevilay Altintas, MD, PhD role: CONTACT phone: +3238213250 email: sevilay.altintas@uza.be name: Sevilay Altintas, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 51.21989 lon: 4.40346 facility: Gasthuiszusters Antwerpen status: NOT_YET_RECRUITING city: Antwerp country: Belgium name: Kevin Punie, MD role: CONTACT phone: +3234433737 email: kevin.punie@gza.be name: Kevin Punie, MD role: PRINCIPAL_INVESTIGATOR lat: 51.21989 lon: 4.40346 facility: University Hospital Brussels status: NOT_YET_RECRUITING city: Brussel country: Belgium name: Christel Fontaine, MD role: CONTACT phone: +3224776040 email: christel.fontaine@uzbrussel.be name: Christel Fontaine, MD role: PRINCIPAL_INVESTIGATOR lat: 50.85045 lon: 4.34878 facility: Ghent University Hospital status: NOT_YET_RECRUITING city: Ghent country: Belgium name: Hannelore Denys, MD, PhD role: CONTACT phone: +3293322692 email: hannelore.denys@uzgent.be name: Hannelore Denys, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 51.05 lon: 3.71667 facility: Jessa Ziekenhuis status: NOT_YET_RECRUITING city: Hasselt country: Belgium name: Annelies Requilé, MD role: CONTACT phone: +3211337979 email: annelies.requile@jessazh.be name: Annelies Requilé, MD role: PRINCIPAL_INVESTIGATOR lat: 50.93106 lon: 5.33781 facility: University Hospitals Leuven status: RECRUITING city: Leuven country: Belgium name: Patrick Neven, MD, PhD role: CONTACT phone: +3216344750 email: patrick.neven@uzleuven.be name: Kristien Borremans, MD role: CONTACT phone: +3216347795 email: kristien.borremans@kuleuven.be name: Patrick Neven, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 50.87959 lon: 4.70093 hasResults: False

 nctId: NCT06365775 id: TJ-IRB20221229 briefTitle: Multi-omics Characteristics and Prognosis of Idiopathic Sudden Sensorineural Hearing Loss overallStatus: NOT_YET_RECRUITING date: 2024-04-23 date: 2026-11-23 date: 2026-11-23 date: 2024-04-15 date: 2024-04-15 name: Dan Bing class: OTHER briefSummary: The goal of this observational study is to describe the multi-omics characteristics and to learn about the prognostic factors in patients with idiopathic sudden sensorineural hearing loss (SSNHL). The main problems it aims to deal with are:

* if there is a difference in data of exome and targeted sequencing among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls
* if there is a difference in the parameter of MRI among patients with SSNHL affecting bilateral and unilateral sides, and healthy controls
* to find out which factor from multi-omics data relates to outcomes of SSNHL
* to develop the best prognostics model based on the multi-omics data.

Participants will be received audiological tests, blood specimen collection and radiological examination. Researchers will explore the relationship between the multi-omics data and the prognosis and develop the predictive model. conditions: Sudden Sensorineural Hearing Loss conditions: Hearing Loss, Sensorineural conditions: Hearing Loss, Sudden studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED measure: Pure tone audiometry (PTA) measure: Speech reception thresholds measure: Speech discrimination scores measure: Variant detection efficiency measure: Exome coverage measure: Genome-wide variant distribution measure: Head MRI measure: Inner Ear MRI sex: ALL minimumAge: 4 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06365762 id: CK-0103 briefTitle: The Safety and Efficacy Study of Ethylenediaminetetraacetic Acid (EDTA) Ophthalmic Solution in Patients With Loss of Contrast Sensitivity Due to Age-Related, Low-Grade Nuclear Cataract overallStatus: COMPLETED date: 2006-01-01 date: 2006-12-31 date: 2007-04-30 date: 2024-04-15 date: 2024-04-16 name: Livionex Inc. class: INDUSTRY briefSummary: The study objectives were:

* To evaluate the efficacy of EDTA 1.3% and 2.6% ophthalmic solution (C-KAD) in improving visual function as assessed by contrast sensitivity;
* To evaluate the safety and tolerability of two doses of EDTA ophthalmic solution (C-KAD); and
* To determine the optimal clinical dose of EDTA ophthalmic solution (C-KAD) which to proceed into pivotal study(s). conditions: Age Related Cataracts studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 111 type: ACTUAL name: EDTA Ophthalmic Solution 2.6% name: EDTA Ophthalmic Solution 1.3% name: Saline Solution (Placebo) measure: Contrast Sensitivity (Mesopic) Responder Analysis measure: Cumulative Improvement in Contrast Sensitivity (Mesopic) measure: Mean Change in Contrast Sensitivity (Mesopic) measure: Mean Change in Best-Corrected Visual Acuity (BCVA) measure: Pentacam Imaging sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St Mary's Eye Specialists, Inc. city: San Francisco state: California zip: 94117 country: United States lat: 37.77493 lon: -122.41942 facility: Hunkeler Eye Institute city: Overland Park state: Kansas zip: 66210 country: United States lat: 38.98223 lon: -94.67079 facility: The Johns Hopkins Hospital & Health System, Wilmer Eye Institute city: Lutherville state: Maryland zip: 21093 country: United States lat: 39.42122 lon: -76.62608 facility: Harvard Medical School, Massachusetts Eye and Ear Infirmary city: Boston state: Massachusetts zip: 02114 country: United States lat: 42.35843 lon: -71.05977 facility: Charlotte Eye, Ear, Nose, and Throat Associates city: Charlotte state: North Carolina zip: 28210 country: United States lat: 35.22709 lon: -80.84313 facility: University of Utah, John Moran Eye Center city: Salt Lake City state: Utah zip: 84132 country: United States lat: 40.76078 lon: -111.89105 hasResults: False

 nctId: NCT06365749 id: TJ-IRB20221228 briefTitle: Genetic Feature of Congenital Hearing Loss in Chinese Population overallStatus: NOT_YET_RECRUITING date: 2024-04-23 date: 2026-11-23 date: 2026-11-23 date: 2024-04-15 date: 2024-04-15 name: Dan Bing class: OTHER briefSummary: Congenital hearing loss, as well as hearing loss present at birth, is one of the most common chronic conditions in children, with a prevalence of permanent bilateral hearing loss of 2.83 per 1000 children of primary school age, which is mainly caused by genetic factors. The goal of this observational study is to learn about novel causative genes in infants with hearing loss in the Chinese population. The main problem it aims to deal with are:

* to present the genetic characteristics of the infant with hearing loss in the Chinese population
* to build up a prognostic model base on diverse data.

Participants will be asked to receive audiological tests and collection of the peripheral blood sample. conditions: Congenital Hearing Loss conditions: Congenital Deafness studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Whole exome sequencing data measure: TEOAE-based otoacoustic emissions test outcome measure measure: Auditory brainstem response testing measure: Acoustic impedance measure: Audiogram sex: ALL maximumAge: 6 Months stdAges: CHILD hasResults: False

 nctId: NCT06365736 id: 240310 briefTitle: The Effect of a Contemplative Nature-based Intervention on Spiritual Well-being overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2024-09-04 date: 2024-09-04 date: 2024-04-15 date: 2024-04-15 name: University of Twente class: OTHER briefSummary: The goal of this randomized control trial is to test if contemplating in nature could benefit spiritual well-being in general adults. The main question it aims to answer is:

Does a 2-week contemplative nature intervention improve spiritual well-being?

Researchers will compare intervention conditions to active control (walking in nature) and passive control (waitlist) conditions to see if contemplating in nature works to improve spirituality.

Participants in the intervention condition will walk for 10 minutes and then choose a nice spot to sit for 10 minutes. During these minutes they will be asked to be silently present and observe trees, plants, flowers, or other aspects of nature and contemplate their connectedness to nature and their own awareness. Then walk back 10 minutes.

Participants in the active control condition will walk for 30 minutes without further instruction. conditions: Spiritual Well-being conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Contemplating in nature name: Walking in nature measure: Spiritual well-being assessed by Spiritual Attitude and Involvement List Short Form (SAIL-SF) measure: Spiritual well-being assessed by Spiritual Attitude and Involvement List Short Form (SAIL-SF) measure: Spiritual well-being assessed by Spiritual Attitude and Involvement List Short Form (SAIL-SF) measure: Spiritual well-being assessed by Daily Spiritual Experience Scale (DSES) measure: Spiritual well-being assessed by Daily Spiritual Experience Scale (DSES) measure: Spiritual well-being assessed by Daily Spiritual Experience Scale (DSES) measure: Client satisfaction of intervention condition assessed by Client Satisfaction Questionnaire (CSQ-8) measure: Client satisfaction of active control condition assessed by Client Satisfaction Questionnaire (CSQ-8) measure: Client satisfaction of passive control condition assessed by Client Satisfaction Questionnaire (CSQ-8) measure: Nature connectedness assessed by Connectedness to Nature Scale (CNS) measure: Nature connectedness assessed by Connectedness to Nature Scale (CNS) measure: Nature connectedness assessed by Connectedness to Nature Scale (CNS) measure: Nature connectedness assessed by the single item Inclusion of Nature with Self scale (INS) measure: Nature connectedness assessed by the single item Inclusion of Nature with Self scale (INS) measure: Nature connectedness assessed by the single item Inclusion of Nature with Self scale (INS) measure: Well-being assessed by Mental Health Continuum-Short Form (MHC-SF) measure: Well-being assessed by Mental Health Continuum-Short Form (MHC-SF) measure: Well-being assessed by Mental Health Continuum-Short Form (MHC-SF) measure: Psychological well-being assessed by Brief INSPIRE-O measure: Psychological well-being assessed by Brief INSPIRE-O measure: Psychological well-being assessed by Brief INSPIRE-O measure: Stress assessed by Perceived Stress Scale (PSS) measure: Stress assessed by Perceived Stress Scale (PSS) measure: Stress assessed by Perceived Stress Scale (PSS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Twente city: Enschede state: Overijssel zip: 7522NB country: Netherlands name: TALITHA RUARUS-BLANKERT role: CONTACT phone: +31534891289 email: pgt@utwente.nl name: Ernst Bohlmeijer, Prof. Dr. role: PRINCIPAL_INVESTIGATOR lat: 52.21833 lon: 6.89583 hasResults: False

 nctId: NCT06365723 id: SPH-2023-32410 briefTitle: Effects of Walking in Greenspace and the Built Environment in Adults With Prediabetes: A Randomized Crossover Trial overallStatus: NOT_YET_RECRUITING date: 2025-01-15 date: 2030-06-15 date: 2032-06-15 date: 2024-04-15 date: 2024-04-15 name: University of Minnesota class: OTHER briefSummary: Approximately 92 million U.S. adults (\~38% of population) have prediabetes (PreD). Because people with PreD are at high risk CMD, they are a target population for diabetes prevention programs. The focus is people with PreD because of their high risk for developing CMD and large numbers, providing an opportunity to investigate behavioral and environmental approaches as preventive measures in a well-defined population. Urbanization affords challenges and opportunities to public health that include exposure to obesogenic environments, air pollution, and psychosocial stressors. In healthy adults suggest exposure to nature has health benefits relative to exposure to built environments. Hypothesized mechanisms for health benefits of Greenspace exposure include increased physical activity (PA), attention restoration, stress reduction, and reduced exposure to pollution. Many of the health benefits are associated with reduced psychological and physiological stress leading to better autonomic functioning as assessed by heart rate variability (HRV) and other biomarkers. Multiple studies suggest that PA and exposure to natural environments may act together to improve health. Yet, aside from our preliminary studies, we are not aware of any studies that examined how physical activity may interact with exposure to urban Greenspace ('Green') compared with built urban environments ('Gray'), to reduce stress and improve health. The purpose of this proposed study is to conduct a randomized crossover trial comparing differences in the psychosocial and physiological effects of walking in urban Green and Gray spaces in adults with PreD. conditions: PreDiabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The study is a randomized crossover trial with a 4-week washout period. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 216 type: ESTIMATED name: Green Walk name: Gray Walk measure: Measure of Anxiety measure: Perceived stress assessment measure: Mood assessment measure: Heart Rate variability measure: Salivary cortisol levels measure: Ambient Particulate Matter measure: Black Carbon levels measure: CMD risk measure: State and Trait anxiety sex: ALL minimumAge: 25 Years maximumAge: 64 Years stdAges: ADULT hasResults: False

 nctId: NCT06365710 id: HUS/206/2022 briefTitle: Physiotherapy vs Telerehabilitation After Volar Plating of Distal Radius Fracture overallStatus: RECRUITING date: 2022-11-24 date: 2025-01-31 date: 2026-01-31 date: 2024-04-15 date: 2024-04-15 name: Töölö Hospital class: OTHER briefSummary: Trial purpose is to research the outcome comparing traditional physiotherapy vs telerehabilitation after volar plating of distal radius fracture.

Patients with distal radius fracture that meet the operative criteria set by the Finnish Current Care guidelines are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo operative treatment and traditional physiotherapy vs telerehabilitation.

Baseline data is collected preoperatively and patients are followed at 1, 3 and 12 months after enrollment. The primary end-point is 3 months and the primary outcome is the Patient-Rated Wrist Evaluation (PRWE). conditions: Orthopedic Procedures, Physical Therapy Modalities, Postoperative Care, Rehabilitation, Wrist Fractures studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 84 type: ESTIMATED name: Telerehabilitation name: Traditional physiotherapy measure: Patient-Rated Wrist Evaluation (PRWE) measure: Grip strength measure: Quick Disabilities of the arm, shoulder, and hand measure: Pain (Visual Analogue Scale) measure: Wrist range of motion (ROM) measure: Adverse events measure: Global improvement measure: Patient-rated Quality of Life (EQ-5D) measure: Cost-utility analysis sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Division of Musculosceletal and Plastic Surgery, Hand Surgery Unit, Helsinki University Hospital status: RECRUITING city: Helsinki state: Uusimaa zip: 00029 country: Finland name: Samuli Aspinen, M.D., Ph.D. role: CONTACT phone: +358406360546 email: samuli.aspinen@hus.fi lat: 60.16952 lon: 24.93545 hasResults: False

 nctId: NCT06365697 id: ZHTQ202301 briefTitle: Evaluation of the Ton-bridge Carotid Stent for Carotid Artery Stenosis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-11 date: 2025-10 date: 2024-04-15 date: 2024-04-15 name: Zhuhai Tonbridge Medical Tech. Co., Ltd. class: INDUSTRY briefSummary: The purpose of this trial is to evaluate effectiveness and safety of the Ton-bridge carotid stent for the treatment of carotid artery stenosis. conditions: Carotid Artery Stenosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 188 type: ESTIMATED name: Ton-bridge carotid stent name: WALLSTENT carotid stent measure: Incidence of non-MAE(major adverse events) within 30 days post-procedure measure: Technical success measure: Procedural success measure: Target lesion revascularization (TLR) measure: Ipsilateral stroke between 31 days and 1 year post-procedure measure: In-stent restenosis measure: mRS score measure: Device deficiency measure: Incidence of MAE measure: Incidence of Adverse events (AE) measure: Incidence of Serious adverse events (SAE) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The People's Hospital of Liaoning Province city: Shenyang state: Liaoning country: China name: Peizhuo Zang role: PRINCIPAL_INVESTIGATOR lat: 41.79222 lon: 123.43278 facility: Linyi People's Hospital city: Linyi state: Shandong country: China name: Hongxing Han role: PRINCIPAL_INVESTIGATOR lat: 35.06306 lon: 118.34278 facility: Qingdao Central Hospital city: Qingdao state: Shandong country: China name: Haicheng Yuan role: PRINCIPAL_INVESTIGATOR lat: 36.06488 lon: 120.38042 facility: The Affiliated Hospital of Qingdao University city: Qingdao state: Shandong country: China name: Yong Zhang role: PRINCIPAL_INVESTIGATOR lat: 36.06488 lon: 120.38042 facility: Central Hospital Affiliated to Shangdong First Medical University city: Jinan state: Shangdong country: China name: Liqun Jiao role: PRINCIPAL_INVESTIGATOR lat: 36.66833 lon: 116.99722 facility: Lishui Central Hospital city: Lishui state: Zhejiang country: China name: Xueli Cai role: PRINCIPAL_INVESTIGATOR lat: 28.46042 lon: 119.91029 facility: Xuanwu Hospital, Capital Medical University city: Beijing country: China name: Bin Yang role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06365684 id: 133548 id: 2023-507823-52 type: EUDRACT_NUMBER briefTitle: Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients With CKD Stage 3b and 4 acronym: LIBRAL overallStatus: NOT_YET_RECRUITING date: 2024-04-29 date: 2025-05-01 date: 2025-05-01 date: 2024-04-15 date: 2024-04-24 name: Leiden University Medical Center class: OTHER name: AstraZeneca briefSummary: Rationale: Several studies have shown that higher urinary potassium excretion (as proxy for potassium intake) is associated with better kidney outcomes, lower blood pressure and improved survival. These associations are also observed in patients with (advanced) CKD. However, application in daily practice in patients with CKD, is impaired by the risk of hyperkalemia, due to metabolic acidosis and impaired renal potassium excretion in these patients. As a consequence, patients with CKD are advised to restrict their intake of fruit and vegetables, as these healthy food components are important sources of dietary potassium. This is particularly undesirable for patients with CKD in view of the very high risk of cardiovascular disease.

Concomitant use of sodium zirconium cyclosilicate (SZC) could allow a more liberal intake of fruit and vegetables for patients with CKD, as SZC effectively treats hyperkalemia and counteracts metabolic acidosis \[1\]. With this strategy, the beneficial effects of potassium in fruits and vegetables on (vascular) health could also become accessible to patients with CKD.

Objective: To demonstrate that a potassium-rich diet, including the use of SZC as potential rescue treatment (in case of hyperkalemia), does not result in an unacceptable rise in plasma potassium (i.e. max rise of 0.5 mmol/L and no hyperkalemia). Study Design: Investigator initiated, single center, cross-over randomized clinical trial with non-inferiority design (14 weeks, 2 groups: regular diets vs. diet with potassium rich fruits and vegetables with sodium zirconium cyclosilicate if necessary) Study population: Outpatients ( age ≥ 18 years ) with chronic kidney disease stage IIIb/IV and use of inhibitor of the renin-angiotensin system (RASi).

Intervention: Addition of fruit- and vegetables that contain 40 mmol of potassium on top of regular diet. Addition of SZC after 1 week in case hyperkaliemia develops (serum potassium \&gt; 5,5 mmol/L). Weekly measurement of plasma potassium and dose adjustment of SZC if needed conditions: Hyperkalemia conditions: Diet Modification conditions: Chronic Kidney Disease conditions: Sodium Zirconium Cyclosilicate studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Single center, cross-over randomized clinical trial with non-inferiority design primaryPurpose: TREATMENT masking: NONE count: 16 type: ESTIMATED name: Sodium zirconium cyclosilicate measure: The difference of serum potassium at baseline and after six weeks of treatment with potassium enriched diet (non-inferiority design) compared to the control group. With an intention to treat analysis. measure: Ambulatory blood pressure (average systolic and diastolic blood pressure over 24 hours) measure: 24 hours albuminuria measure: urinary potassium (mmol/l) measure: Plasma bicarbonate measure: Quality of life, using SF36 questionnaire measure: Effect on stool (assessed with Bristol Stool Chart) measure: Difference in serum potassium one week after start of study (SCZ free period) measure: Per protocol analysis of difference in serum potassium after six week (end of study) measure: Incidence of severe hyperkalemia (serum potassium above 6.5 mmol/l or above 6.0 with ECG features of hyperkalemia) measure: Incidence of hyperkalemia (serum potassium above 5.5 mmol/l) measure: Necessity for treatment of hyperkalemia measure: urinary sodium (mmol/l) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06365671 id: ASCT-CART briefTitle: CAR-T Following ASCT for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) With High-Risk Prognostic Factors overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-04 date: 2027-04 date: 2024-04-15 date: 2024-04-15 name: Ruijin Hospital class: OTHER briefSummary: Clinical trial for the safety and efficacy of CD19 CAR-T following autologous hematopoietic stem cell transplantation (ASCT) for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) with High-Risk Prognostic Factors conditions: B-NHL, Extranodal, TP53 Alterations, Bulky Mass studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 16 type: ESTIMATED name: autologous stem-cell transplantation, Relmacabtagene autoleucel (relma-cel) measure: Best Complete Response (CR) Rate in 3 months measure: Objective remission rate (ORR) in 3months measure: Duration of Response (DOR) measure: Progression-Free Survival (PFS) measure: Overall Survival (OS) measure: Adverse Events rate as assessed by CTCAE version 5.0 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06365658 id: 2024/PTPiP/1 briefTitle: Cognitive Functioning in Adults With Somatic Diseases and General Population From a Biopsychosocial Perspective overallStatus: RECRUITING date: 2023-07-03 date: 2025-03 date: 2025-12 date: 2024-04-15 date: 2024-04-22 name: Bartosz M. Radtke class: OTHER_GOV briefSummary: The goal of this observational study is to investigate cognitive functioning profiles in adults with neurologically recognized aphasic syndromes and general population.

The study group consist of minimal 600 adults (over 18 y.o.) who will be examined by qualified diagnosticians. Participants will be evaluated with tasks related to the studied variables: memory, learning and language. Furthermore informations regarding past and present health condition will be collected from participants.

The main questions it aims to answer are:

1. What is the profile of memory and learning among polish adults?
2. Do gender and age moderates patterns of memory and learning functioning among polish adults?
3. What is a specific pattern of language functioning in adults with neurologically recognized aphasic syndromes?
4. Do gender moderates specific patterns of language functioning in adults with neurologically recognized aphasic syndromes?

Researchers will compare the following groups of adults:

1. general population/control group
2. with neurologically recognized aphasic syndromes
3. seniors (over 60 y.o.) conditions: Aphasia conditions: Development, Human conditions: Neuropathology studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 600 type: ESTIMATED name: Psychological assessment measure: Memory and learning measure: Language measure: Socio-demographic data measure: General mental state measure: Health related data measure: Education data sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Laboratory of Psychological and Educational Tests status: RECRUITING city: Gdansk state: Pomerania zip: 80-239 country: Poland name: Rafał Nowicki, M.A. role: CONTACT phone: +48509805591 email: nowicki@pracowniatestow.pl name: Urszula Sajewicz-Radtke, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Bartosz M Radtke, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Ariadna Łada-Maśko, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Beata Daniluk, Ph.D. role: SUB_INVESTIGATOR name: Piotr Markiewicz, Ph.D. role: SUB_INVESTIGATOR name: Paweł Jurek, Ph.D. role: SUB_INVESTIGATOR name: Michał Olech, Ph.D. role: SUB_INVESTIGATOR name: Artur Sawicki, M.A. role: SUB_INVESTIGATOR name: Rafał Nowicki, M.A. role: SUB_INVESTIGATOR lat: 54.35205 lon: 18.64637 hasResults: False

 nctId: NCT06365645 id: 2138752 briefTitle: Feasibility & Acceptability of App-based Cognitive Behavioral Therapy for Postpartum Depression Prevention overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-12 date: 2024-04-15 date: 2024-04-15 name: Women and Infants Hospital of Rhode Island class: OTHER briefSummary: Postpartum depression (PPD) affects up 10-15% of mothers overall, but the rate of PPD can be as high as 25% among mothers with personal or obstetric risk factors. The Mothers \& Babies Program (MB) is a cognitive behavioral therapy (CBT)-based program that has been shown to prevent PPD among high-risk mothers without a prior history of depression. MB has been so consistently effective that the United States Preventive Services Task Force recommends this program be given to high-risk pregnant patients. Originally designed to be given in-person and via groups, MB has been adapted to be given in person one-on-one in clinic or at home and via text message. However, MB has yet to be adapted to a smartphone application (app). Via evidence-based qualitative research and end-user centered design, MB has been adapted to a novel app, M.Bapp. This study aims to examine the feasibility and acceptability of M.Bapp as a study intervention for perinatal patients as well as provide preliminary estimates of effect for the intervention. conditions: Postpartum Depression conditions: Postpartum Anxiety conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: Participants who consent will be unaware of the existence of another version of M.Bapp. Obstetric care providers will be aware of participant's enrollment in this trial but not of the study group and will be encouraged to provide standardized care. The research team and outcomes assessors will be blindd to the randomization group. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: M.Bapp name: App-based parenting education measure: Feasibility measure: Acceptability measure: Edinburgh Postnatal Depression Scale measure: General Anxiety Disorder-7 measure: Perceived Stress-Scale 4 measure: Dyadic Adjustment Scale measure: UCLA Loneliness Scale measure: Frequency of Mothers and Babies Skills Use measure: De novo psychiatric diagnosis measure: Screening positive on study survey sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Women & Infants Hospital of Rhode Island city: Providence state: Rhode Island zip: 02905 country: United States lat: 41.82399 lon: -71.41283 hasResults: False

 nctId: NCT06365632 id: OLTOSPAN-02 briefTitle: Clinical Study of the Effectiveness, Tolerability and Safety of the Drug "Anti-spike, Gel, 100 g in Bottles in Package No. 1" Produced by the Republican Unitary Enterprise "Unitekhprom BSU", With a Single Intraperitoneal Use After Surgery in Adult Patients With Acute Phlegmonous Appendicitis acronym: OLTOSPAN-02 overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2024-12 date: 2024-12 date: 2024-04-15 date: 2024-04-15 name: Research Institute for Physical Chemical Problems of the Belarusian State University class: OTHER name: Unitary Enterprise UNITEHPROM BSU name: City Clinical Hospital of Emergency Medical Care of Minsk briefSummary: The purpose of the clinical trials is the evaluation of the effectiveness and safety of a single intraperitoneal use of the drug "Antispike, gel, 100 g in a bottle" produced by Unitary Enterprise Unitehprom BSU, Belarus in patients after surgical control of acute phlegmonous appendicitis to prevent abdominal adhesions. conditions: Abdominal Adhesions studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: Antispike gel, 100 g in a flask, produced by UNITEHPROM BSU, Republic of Belarus name: antegrade appendectomy measure: Number of patients with acute phlegmonous appendicitis cured measure: absence of signs of adhesions measure: increase in the sliding distance of the cecum sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CITY CLINICAL EMERGENCY HOSPITAL of Minsk city: Minsk zip: 220024 country: Belarus name: Olga Svetlitskaya role: CONTACT phone: +375297752697 email: info@bsmp.by name: Yulia Shabalina role: CONTACT phone: +375 (17) 287 00 15 email: info@bsmp.by lat: 53.9 lon: 27.56667 facility: CITY CLINICAL EMERGENCY HOSPITAL of Minsk city: Minsk zip: 220024 country: Belarus name: Olga Svetlitskaya role: CONTACT phone: +375297752697 email: info@bsmp.by name: Yulia Shabalina role: CONTACT phone: +375 (17) 287 00 15 email: info@bsmp.by name: Stanislav Tretiak, Doctor of Medicine role: PRINCIPAL_INVESTIGATOR name: Alexander Zhura, Doctor of Medicine role: SUB_INVESTIGATOR lat: 53.9 lon: 27.56667 hasResults: False

 nctId: NCT06365619 id: HCI168525 briefTitle: Neoadjuvant Ipilimumab/Nivolumab for Patients With Recurrent, High Risk, Resectable Melanoma acronym: NeoRelapse overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2026-08 date: 2029-08 date: 2024-04-15 date: 2024-04-15 name: University of Utah class: OTHER briefSummary: The goal of this clinical trial is to study the impact of Neoadjuvant ipilimumab and nivolumab for melanoma patients that had recurrence during or after adjuvant anti-PD-1 therapy.

Participants will receive 2 cycles of treatment prior to their standard of care surgery. After surgery participants will receive standard of care adjuvant therapy and be followed for response. conditions: Melanoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Ipilimumab name: Nivolumab measure: Rate of pathologic response rate (pCR, mCR/nCR, or pPR) at the time of surgery. measure: Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment. measure: Rate of adverse events that occur within 30 days post-surgery. measure: Rate of Event Free Survival (EFS). measure: Rate of Overall Survival (OS). measure: Objective response rate (ORR) defined as the proportion of subjects achieving a confirmed PR and CR as defined by RECIST 1.1 prior to surgical resection. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Huntsman Cancer Institute city: Salt Lake City state: Utah zip: 84112 country: United States lat: 40.76078 lon: -111.89105 hasResults: False

 nctId: NCT06365606 id: CLS-015A briefTitle: Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis Syphilis Ab Test at the Point- Of-Care Sites overallStatus: RECRUITING date: 2024-03-14 date: 2024-04-10 date: 2024-05-29 date: 2024-04-15 date: 2024-04-15 name: bioLytical Laboratories class: INDUSTRY briefSummary: This study is a prospective cross-sectional study in which surgically non-invasive sample- taking is done only for the purpose of the study. Capillary (fingerstick) whole blood and plasma (i.e., obtained through venous EDTA whole blood collection and processing) are collected by a healthcare professional. The collected samples are tested in a routine testing environment, i.e., healthcare providers at conditions: Syphilis Infection conditions: Syphilis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: DOUBLE maskingDescription: Participants and the healthcare providers are not aware of the syphilis status. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 4500 type: ESTIMATED name: iStatis Syphilis Ab Test measure: Sensitivity and specificity of the iStatis Syphilis Ab Test sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Epicentre Health Research status: RECRUITING city: Hillcrest state: KwaZulu Natal zip: 3650 country: South Africa name: Cherie Cawood role: CONTACT phone: +27 828202955 email: cheriec@epicentre.org.za hasResults: False

 nctId: NCT06365593 id: D8450R00005 briefTitle: hATTR Polyneuropathy in Russia acronym: PRIMER overallStatus: RECRUITING date: 2023-12-29 date: 2024-05-31 date: 2024-05-31 date: 2024-04-15 date: 2024-04-15 name: AstraZeneca class: INDUSTRY briefSummary: A multicenter observational retrosPective Registry of patIents with transthyretin aMyloid polynEuropathy (hATTR-PN) and chRonic idiopathic axonal polyneuropathy (CIAP) in the population of the Russian Federation (PRIMER) There are no comprehensive epidemiological data on patients with hereditary ATTR-PN (hATTR-PN) and CIAP in the Russian Federation. Therefore, there is a need to conduct a large-scale observational study in the Russian population to obtain information on clinical, electrophysiological and demographic characteristics of patients with hATTR-PN and CIAP. Obtaining the study data will help to identify the patients with axonal polyneuropathy, who deserve TTR gene sequencing, and therefore to allow early treatment and potentially modify disease progression in patients. conditions: Hereditary Transthyretin Amyloidosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED measure: In order to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Mean age at the hATTR-PN or CIAP diagnosis information will be collected measure: In order to describe the baseline demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Proportion of women and men will be collected measure: In order to describe the baseline demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Proportion of patients with each race and ethnicity will be collected measure: to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIA, information on Proportion of patients from each federal district of the Russian Federation will be collected measure: in order to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, tha following Anthropometric characteristics will be collected: measure: In order to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with underweight will be collected measure: in order to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Proportion of patients with negative lifestyle factors will be collected: measure: in order to describe the baseline demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Proportion of patients with positive family history in close relatives will be collected measure: to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP, information on Mean (or median) time from the first symptoms of neuropathy to the diagnosis of PN will be collected measure: to describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP, Proportion of patients with different firstly suspected etiology of PN will be calculated measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP, information on Mean (or median) time from first PN manifestation/diagnosis to the hATTR-PN or CIAP diagnosis will be collected measure: To describe the baseline electrophysiological and clinical characteristics of patients, Proportion of patients with chronic sensory or sensorimotor polyneuropathy and progressive chronic polyneuropathy among patients with CIAP will be calculated measure: To describe the baseline clinical characteristics of patients with hATTR-PN and CIAP, Proportion of patients with each result of TTR gene testing will be calculated measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with each clinical manifestation will be calculated: measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with each PND score will be calculated measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with each score by each parameter of neurological examination will be calculated measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean point by MRS will be calculated measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean point by INCAT scale (total score, arm disability, leg disability) will be collected measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean left ventricular ejection fraction (LVEF) will be collected measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information Mean wall thickness of the left ventricular (LV) will be collected measure: To describe the baseline electrophysiological characteristics of patients with hATTR-PN and CIAP, information Mean variables based on the results of electrophysiological investigation, including the following (on both extremities) will be collected measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with diagnosis of HFpEF will be calculated measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean NT-proBNP level will be collected measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information Mean estimated glomerular filtration rate (eGFR) will be collected measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean urine albumin-to-creatinine ratio (UACR) in a spot urine sample will be collected measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with a positive paraprotein blood test result will be calculated measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, information on Mean blood pressure (BP) (systolic and diastolic) and Mean heart rate (HR) measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients with each concomitant disease will be calculated measure: To describe the baseline electrophysiological, clinical and demographic characteristics of patients with hATTR-PN and CIAP in the Russian Federation, Proportion of patients underwent surgery for CTS to the moment of diagnosis will be calculated measure: To arrange a score to select patients with axonal neuropathy who deserve screening for TTR mutation. measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP in the Russian Federation during retrospective follow-up period Mean changes in BMI at visits 2, 3 will be compared to baseline measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with newly diagnosed clinical manifestations will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period, Proportion of patients with different newly diagnosed clinical manifestations will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with each PND score at visits 2, 3 will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP, Proportion of patients with worsening of PND score at visits 2, 3 compared to baseline will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with hospitalisations (one or more) will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of different reasons for hospitalisations will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with death for all causes will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients during follow-up period Proportion of patients with different causes of death will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients during retrospective follow-up period Proportion of patients with each score by each parameter of neurological examination at visits 2, 3 will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in MRS at visits 2, 3 compared to baseline will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in INCAT scale at visits 2, 3 compared to baseline will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with diagnosis of HFpEF at visits 2, 3 will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in LVEF at visits 2, 3 compared to baseline will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in wall thickness of the LV at visits 2, 3 compared to baseline will be calculated measure: To assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes at visits 2, 3 compared to baseline will be calculated measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in NT-proBNP at visits 2, 3 compared to baseline will be calculated measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in eGFR at visits 2, 3 compared to baseline will be calculated measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in UACR at visits 2, 3 compared to baseline will be calculated measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with a positive paraprotein blood test result at visits 2, 3 will be calculated measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in BP at visits 2, 3 compared to baseline will be calculated measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Mean changes in HR at visits 2, 3 compared to baseline will be calculated measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with new concomitant diseases will be calculated measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with different new concomitant diseases will be calculated measure: to assess the changes in the clinical and electrophysiological characteristics of patients with hATTR-PN and CIAP during retrospective follow-up period Proportion of patients with presence of CTS surgery will be calculated sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: RECRUITING city: Kazan country: Russian Federation lat: 55.78874 lon: 49.12214 facility: Research Site status: RECRUITING city: Moscow country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Research Site status: RECRUITING city: Saint-Petersburg zip: 194354 country: Russian Federation lat: 59.93863 lon: 30.31413 hasResults: False

 nctId: NCT06365580 id: Kylo-0603-I-C01 briefTitle: Dose Escalation Study of Kylo-0603 in Healthy Subjects overallStatus: RECRUITING date: 2023-05-23 date: 2024-06-30 date: 2024-06-30 date: 2024-04-15 date: 2024-04-16 name: Kylonova (Xiamen) Biopharma co., LTD. class: INDUSTRY briefSummary: This clinical trial is the first-in-human study of Kylo-0603. The purpose of this randomized, double-blind, placebo-controlled phase 1 study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and effect of food of Kylo-0603 in healthy Chinese adult subjects. conditions: Nonalcoholic Steatohepatitis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 124 type: ESTIMATED name: Kylo-0603 capsule name: Placebo measure: incidence of adverse events measure: Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax) measure: PK parameter of time of maximum observed concentration (Tmax) measure: PK parameter of area under the concentration time curve (AUC) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: The first affiliated hospital, Zhejiang University School of Medicine status: RECRUITING city: Hangzhou state: Zhejiang zip: 310000 country: China lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06365567 id: CE209/2023 briefTitle: Dietary Fructose: a Metabolic Switch in Pediatric Obesity-related Disease. acronym: EO2022 overallStatus: RECRUITING date: 2024-03-04 date: 2025-03-05 date: 2026-03-02 date: 2024-04-15 date: 2024-04-15 name: Azienda Ospedaliero Universitaria Maggiore della Carita class: OTHER name: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari briefSummary: The increase in childhood obesity is a multifactorial phenomenon influenced by dietary patterns, commercial factors, and social determinants; it has long-term consequences for both individual health and society as a whole. Despite recommendations for maintaining good health throughout life and promoting the Mediterranean Diet, due to the increased availability of ultra-processed and more appealing foods, children and adolescents are shifting towards a "Western" diet. One in four children consumes sugary and carbonated drinks every day, which contributes to a high intake of fructose in the diet, while fruits and vegetables are consumed less, and legumes are included in the diet of only 38% of children less than once a week.

Fructose is a monosaccharide naturally found in fruits, vegetables, and honey; due to its high sweetness and taste-enhancing properties, fructose is widely used in the food industry. High-fructose corn syrup, in particular, is one of the most widely used ingredients in the production of soft drinks, jams, breakfast cereals, and bakery products. Non-alcoholic fatty liver disease (NAFLD), now also called metabolic dysfunction-associated fatty liver disease (MAFLD), is considered the hepatic manifestation of metabolic syndrome and currently represents the most common chronic liver disease in pediatric age in Western countries. Recent studies suggest that fructose consumption is implicated in the development of NAFLD both directly by providing metabolites that can be used for triglyceride and free fatty acid synthesis, and indirectly through increased uric acid production. High-fructose foods also appear to be a risk factor for bone loss. Numerous studies conducted over the past 25 years, during which fructose consumption has exponentially increased, have shown that this sweetener tends to increase the incidence of fractures and osteoarthritis and decrease bone mineral density (BMD) and new bone tissue deposition.

The objective of this study is to understand the effect of fructose on the molecular events that contribute to the evolution of the pediatric age, and its effective relationship with the onset of liver and osteoarticular complications in this population. Understanding the mechanisms of fructose regulation and its effects on the body could be an important target to address the clinical and social problems arising from its spread in children. conditions: Pediatric Obesity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED measure: assessment of fructose intake with questionnaires measure: correlation of fructose consumption with hepatic complications, detected trough echo-abdomen and blood analysis measure: Correlation of fructose consumption with bone metabolism, detected through QUS measure: Characterization of the concentration of intestinal microorganisms measure: Evaluate sociodemographic and cultural determinants with questionnaires ( questions with multiple answers) sex: ALL minimumAge: 3 Years maximumAge: 16 Years stdAges: CHILD facility: SCDU Pediatria, AOU Ospedale Maggiore della Carità status: RECRUITING city: Novara zip: 28100 country: Italy name: Flavia Prodam, MD PHD role: CONTACT lat: 45.44694 lon: 8.62118 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-21 uploadDate: 2024-04-11T05:17 filename: Prot_SAP_000.pdf size: 972421 hasResults: False

 nctId: NCT06365554 id: 2 briefTitle: On-Premise and Remote Robotic Neurointervention overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-01-01 date: 2025-06-01 date: 2024-04-15 date: 2024-04-15 name: Remedy Robotics, Inc. class: INDUSTRY name: Unity Health Toronto briefSummary: This study is a prospective, single arm, single-center study to evaluate the safety and feasibility of the Remedy Robot for on premise and remote robotic Neurointervention. conditions: Cerebrovascular Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 10 type: ESTIMATED name: Remedy Robot measure: Procedural safety measure: Procedural Technical Success sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06365541 id: GYLLPJ-2024006 briefTitle: The Efficacy and Safety of Dapagliflozin in Improving Heart Failure in Dialysis Patients overallStatus: RECRUITING date: 2024-03-01 date: 2024-08-31 date: 2024-08-31 date: 2024-04-15 date: 2024-04-15 name: The People's Hospital of Gaozhou class: OTHER briefSummary: Dialysis patients have a higher incidence of cardiovascular events and require more effective measures to delay the progression of heart failure. Many studies have shown that dapagliflozin has cardioprotective effect, but most studies focus on non-dialysis patients with eGFR more than 20ml/min/1.73m2. However, the data on patients with eGFR less than 20ml/min/1.73m2 or dialysis patients, especially peritoneal dialysis patients, is less. Exploring the efficacy and safety of Dapagliflozin in improving heart failure in dialysis patients is of great clinical significance. conditions: The Efficacy and Safety of Dapagliflozin in Improving Heart Failure in Dialysis Patients studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Exploring the efficacy and safety of dapagliflozin in improving heart failure in dialysis patients by the analysis and comparison of patients' own data before and after dapagliflozin treatment primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Dapagliflozin measure: N-terminal B-type natriuretic peptide precursor (NT-proBNP) measure: Left ventricular ejection fraction (LVEF) sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The People's Hospital of Gaozhou status: RECRUITING city: Maoming state: Guangdong zip: 525200 country: China name: Mingsheng Zhu role: CONTACT phone: 15016656405 email: ms160@163.com lat: 21.65 lon: 110.9 hasResults: False

 nctId: NCT06365528 id: 2023-0232 briefTitle: Tunneled Peripherally Inserted Central Catheter (PICC) in Adult Patients and Associated Outcomes overallStatus: NOT_YET_RECRUITING date: 2024-05-02 date: 2025-12-31 date: 2026-07-31 date: 2024-04-15 date: 2024-04-15 name: Hospital de Clinicas de Porto Alegre class: OTHER name: Hospital Moinhos de Vento name: Irmandade Santa Casa de Misericórdia de Porto Alegre briefSummary: The aim of this multicenter randomized clinical trial is to compare the tunneling technique of PICC insertion with the non-tunneled insertion technique in the incidence of the combined or isolated outcome of catheter-related bloodstream primary infection, thrombosis, obstruction, and accidental dislodgement in the adult population within a period of up to 30 days. conditions: CLABSI - Central Line Associated Bloodstream Infection conditions: Deep Vein Thrombosis conditions: Dislodged Catheter conditions: Occlusion conditions: Catheter Rupture conditions: Catheter (Other); Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE maskingDescription: Prospective Randomized Open, Blinded End-point (PROBE Study) whoMasked: OUTCOMES_ASSESSOR count: 840 type: ESTIMATED name: Subcutaneous tunnelling name: Non-tunnelling measure: End of therapy or catheter removal free from complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital de Clínicas de Porto Alegre city: Porto Alegre country: Brazil name: Eneida R Rabelo da Silva, ScD role: CONTACT lat: -30.03306 lon: -51.23 hasResults: False

 nctId: NCT06365515 id: TUE010_IRTG_P5 briefTitle: Dopamine, Reward Learning and Sex Hormones overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2025-12 date: 2024-04-15 date: 2024-04-15 name: University Hospital Tuebingen class: OTHER name: German Research Foundation name: Uppsala University briefSummary: Hormonal transition periods during the menstrual cycle may predispose women to mental disorders. Hormonal fluctuations provide specific neuroendocrine conditions that modulate brain structure and function and these actions affect cognitive and emotional behaviors and affect energy and mood homeostasis. It is thought that these changes are driven by altered dopamine transmission. Here, we aim to examine (1) how sex hormones and dopamine are linked and also (2) how hormonal changes affect motivation, mood, and energy homeostasis.

To this end, dopamine intervention will be tested on effort-based decision-making and motivational circuits in three hormonal stages (i.e., women in early-follicular phase (EF), women in mid-luteal phase (ML), and men). Additionally, we are testing the effects of hormonal status on metabolic indices and its effects on mood fluctuations in a period of a month.

The investigator hypothesizes that women in EF cycle phase (1) have naturally less dopamine and show less effort, and (2) they show greater improvement in effort-based decision-making after Levodopa administration. We have exploratory outcomes about (3) sex differences in reward-learning with and without Levodopa administration and explore if these differences correlate with elevated female sex hormone levels. Moreover, it is hypothesized that (4) hormonal fluctuations affect energy homeostasis, thus women in their EF cycle phase have higher energy expenditure and (5) they report more negative mood than in their mid-luteal (ML) cycle phase. conditions: Hormonal Changes conditions: Menstrual Cycle studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The investigators will assess the effects of Levodopa administration on reward-learning using a double-blind randomized cross-over design. In a within-subject design, participants will get both conditions (Levodopa/placebo) at different time points (a few days apart). After drug/placebo administration we will assess cerebral blood flow and functional connectivity at rest (via functional MR imaging) during effort-based decision making task. primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: Neither participants nor investigators will know at which time point the participant will receive Levodopa and placebo tablets. The tablets will be prepared by independent members of the university hospital. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Levodopa administration name: Placebo administration measure: Motivation to work for rewards: force of pressing grip force device (GFD) to gain food and monetary rewards circuitry during effort-based decision-making measure: Reward-related brain responses in the reward network during effort-based decision-making measure: Reward anticipation on a neural level measure: Execution of effort on a neural level measure: Resting-state functional connectivity measure: Changes in reinforcement learning measure: Menstrual cycle induced changes in mood and food cravings measure: Changes in resting energy expenditure measure: Changes in metabolic hormone levels during the menstrual cycle sex: ALL minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: Department of Psychiatry & Psychotherapy, University of Tübingen city: Tübingen state: BW zip: 72076 country: Germany name: Andrea Heberle role: CONTACT email: Andrea.Heberle@med.uni-tuebingen.de lat: 48.52266 lon: 9.05222 hasResults: False

 nctId: NCT06365502 id: KY2023-156 briefTitle: Preventive Drug-coated Balloon Angioplasty in Vulnerable Atherosclerotic Plaque (RESTORE Trial) overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-12 date: 2030-12 date: 2024-04-15 date: 2024-04-15 name: Harbin Medical University class: OTHER name: Shanghai Shenqi Medical Technology Co., Ltd briefSummary: The objective of this multicenter, prospective, open-label, controlled, randomized trial is to demonstrate the superiority of drug-coated balloon (DCB) treatment on non-flow limited vulnerable plaque as compared to guideline-directed medical therapy (GDMT) in improving clinical cardiovascular outcomes in patients with acute coronary syndrome. conditions: Acute Coronary Syndrome (ACS) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 1860 type: ESTIMATED name: Drug-coated balloon name: Guideline-directed medical treatment measure: Target lesion failure (TLF) measure: Target lesion failure (TLF) measure: Target lesion failure (TLF) measure: Target lesion failure (TLF) measure: Major cardiac adverse event (MACE) measure: Major cardiac adverse event (MACE) measure: Major cardiac adverse event (MACE) measure: Major cardiac adverse event (MACE) measure: All-cause death measure: All-cause death measure: All-cause death measure: All-cause death measure: Cardiac death and target lesion MI measure: Cardiac death and target lesion MI measure: Cardiac death and target lesion MI measure: Cardiac death and target lesion MI measure: Cardiac death measure: Cardiac death measure: Cardiac death measure: Cardiac death measure: Target lesion myocardial infarction measure: Target lesion myocardial infarction measure: Target lesion myocardial infarction measure: Target lesion myocardial infarction measure: Periprocedural myocardial infarction measure: Periprocedural myocardial infarction measure: Periprocedural myocardial infarction measure: Periprocedural myocardial infarction measure: Periprocedural and non-periprocedural myocardial infarction measure: Periprocedural and non-periprocedural myocardial infarction measure: Periprocedural and non-periprocedural myocardial infarction measure: Periprocedural and non-periprocedural myocardial infarction measure: Target vessel failure (TVF) measure: Target vessel failure (TVF) measure: Target vessel failure (TVF) measure: Target vessel failure (TVF) measure: Minimal lumen area after DCB treatment measure: Plaque burden after DCB treatment measure: FCT after DCB treatment measure: Lipid arc after DCB treatment measure: FCT <75 μm after DCB treatment measure: PB >65% after DCB treatment measure: PB >70% after DCB treatment measure: MLA <3.5 mm^2 after DCB treatment measure: Maximal lipid arc >180° after DCB treatment measure: Cardiac biomarkers: GDF-15, interleukin-6, interleukin-1β and ceramide etc. sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affiliated Beijing Luhe Hospital of Capital Medical University city: Beijin state: Beijing zip: 101149 country: China name: Guangyao zhai role: CONTACT name: Guangyao zhai role: PRINCIPAL_INVESTIGATOR facility: Affiliated Hospital of Zunyi Medical University city: Zunyi state: Guizhou zip: 563000 country: China lat: 27.68667 lon: 106.90722 facility: Daqing Oilfield General Hospital city: Daqing state: Heilongjiang zip: 150000 country: China lat: 46.58333 lon: 125.0 facility: The Second Affiliated Hospital of Harbin Medical University city: Harbin state: Heilongjiang zip: 150000 country: China name: Haibo Jia, PhD role: CONTACT name: Bo Yu, PhD role: PRINCIPAL_INVESTIGATOR name: Haibo Jia, PhD role: SUB_INVESTIGATOR lat: 45.75 lon: 126.65 facility: The First Affiliated Hospital of Jiamusi University city: Jiamusi state: Heilongjiang zip: 150000 country: China name: Guangyuan Yang role: CONTACT name: Guangyuan Yang role: PRINCIPAL_INVESTIGATOR lat: 46.79927 lon: 130.31633 facility: Mudanjiang Cardiovascular Hospital city: Mudanjiang state: Heilongjiang zip: 150000 country: China name: Kai Liu role: CONTACT name: Kai Liu role: PRINCIPAL_INVESTIGATOR lat: 44.58333 lon: 129.6 facility: Fuwai Central China Cardiovascular Hospital city: Zhengzhou state: Henan zip: 450000 country: China lat: 34.75778 lon: 113.64861 facility: The First Affiliated Hospital of Zhengzhou University city: Zhengzhou state: Henan zip: 450000 country: China name: Chunguang Qiu role: CONTACT name: Chunguang Qiu role: PRINCIPAL_INVESTIGATOR lat: 34.75778 lon: 113.64861 facility: Tongji Hospital Tongji Medical College of HUST city: Wuhan state: Hubei zip: 430022 country: China lat: 30.58333 lon: 114.26667 facility: The Third Second Hospital of Jilin University city: Changchun state: Jilin zip: 132000 country: China name: Bin Liu role: CONTACT name: Bin Liu role: PRINCIPAL_INVESTIGATOR lat: 43.88 lon: 125.32278 facility: Dalian Municipal Central Hospital city: Dalian state: Liaoning zip: 116000 country: China name: Xiaoqun Zheng role: CONTACT name: Xiaoqun Zheng role: PRINCIPAL_INVESTIGATOR lat: 38.91222 lon: 121.60222 facility: The First Affiliated Hospital of Dalian Medical University city: Dalian state: Liaoning zip: 116000 country: China name: Bo Zhang role: CONTACT name: Bo Zhang role: PRINCIPAL_INVESTIGATOR lat: 38.91222 lon: 121.60222 facility: The People's Hospital of Liaoning Province city: Shengyang state: Liaoning zip: 132000 country: China facility: The Affiliated Hospital of Neimenggu Medical University city: Hohhot state: Neimenggu zip: 011500 country: China name: Fengying Chen role: CONTACT name: Fengying Chen role: PRINCIPAL_INVESTIGATOR lat: 40.81056 lon: 111.65222 facility: Shandong Provincial Hospital city: Jinan state: Shandong zip: 250000 country: China name: Haitao Yuan role: CONTACT name: Haitao Yuan role: PRINCIPAL_INVESTIGATOR lat: 36.66833 lon: 116.99722 facility: Affiliated Hospital of Jining Medical University city: Jining state: Shandong zip: 250000 country: China name: Lijun Gan role: CONTACT name: Lijun Gan role: PRINCIPAL_INVESTIGATOR lat: 35.405 lon: 116.58139 facility: The Affiliated Hospital of Qingdao University city: Qingdao state: Shandong zip: 250000 country: China name: Peng Li role: CONTACT name: Peng Li role: PRINCIPAL_INVESTIGATOR lat: 36.06488 lon: 120.38042 facility: Yantai Yuhuangding Hospital city: Yantai state: Shandong zip: 250000 country: China name: Lin Zhong role: CONTACT name: Lin Zhong role: PRINCIPAL_INVESTIGATOR lat: 37.47649 lon: 121.44081 hasResults: False

 nctId: NCT06365489 id: 113293 briefTitle: Comparison of Brachial Wrist Index Before and After Implantation of Arteriovenous Fistulas, Based on Brachial Artery overallStatus: ACTIVE_NOT_RECRUITING date: 2022-12-11 date: 2023-02-20 date: 2024-09 date: 2024-04-15 date: 2024-04-15 name: Golestan University of Medical sciences class: OTHER briefSummary: Arterio-Venous Fistula (AVF) is the most recommended vascular access for hemodialysis. Steal syndrome is a potential complication of AVF implantation and occurs secondary to diversion of the arterial flow of a limb to the venous system resulting in limb ischemia. Measuring wrist pressure compared to arm pressure before and after fistula implantation can be a suitable tool in predicting the possibility of Steal syndrome. In this study, the ratio of wrist to arm pressure and its relationship with Steal syndrome symptoms before and after fistula implantation are investigated. conditions: Vascular Access Complication studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 78 type: ACTUAL measure: Early post operative WBI changes following AVF implantation measure: Two-week post operative WBI changes following AVF implantation measure: Three-month post operative WBI changes following AVF implantation measure: Correlation between WBI changes following AVF implantation with age measure: Correlation between WBI changes following AVF implantation with sex measure: Correlation between WBI changes following AVF implantation with co-morbidities measure: Correlation between WBI changes following AVF implantation with steal syndrome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pezhman Kharazm, MD city: Gorgan state: Golestan zip: 4917956808 country: Iran, Islamic Republic of lat: 36.8427 lon: 54.44391 hasResults: False

 nctId: NCT06365476 id: 202309126RIND briefTitle: FlexWave Trial: Efficacy of Extracorporeal Shock Wave Therapy in Post-Stroke Upper Limb Spasticity overallStatus: RECRUITING date: 2024-04-15 date: 2026-04-15 date: 2027-04-15 date: 2024-04-15 date: 2024-04-22 name: National Taiwan University Hospital class: OTHER briefSummary: Extracorporeal shock wave therapy (ESWT) has emerged as an effective therapeutic intervention for addressing post-stroke limb spasticity. This research aims to explore the therapeutic implications of focused ESWT for wrist and finger flexor muscles in patients suffering from post-stroke upper limb spasticity. conditions: Stroke conditions: Spasticity, Muscle studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: focused extracorporeal shock wave therapy (ESWT) measure: passive range of motion for the wrist and finger joints measure: hand grip strength measure: Visual Analogue Scale (VAS) measure: modified Ashworth scale (MAS) measure: modified Tardieu scale (MTS) measure: Fugl-Meyer Assessment for the Upper Extremity (FMA-UE) measure: Action Research Arm Test (ARAT) measure: Barthel index measure: Functional Independence Measure (FIM) measure: ultrasound assessment measure: Box and Block Test measure: Wolf Motor Function Test sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital status: RECRUITING city: Taipei zip: 100 country: Taiwan name: Shu-mei Yang, MD role: CONTACT phone: 886-2- 23123456 email: b99401109@gmail.com name: Shu-mei Yang, MD role: PRINCIPAL_INVESTIGATOR lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06365463 id: URIS202401 briefTitle: Telerehabilitation to Improve Balance and Mobility in Patients After Stroke acronym: TeleHome overallStatus: RECRUITING date: 2024-04-09 date: 2024-05-31 date: 2024-05-31 date: 2024-04-15 date: 2024-04-23 name: University Rehabilitation Institute, Republic of Slovenia class: OTHER briefSummary: Telerehabilitation is an effective rehabilitation method that allows patients to receive physiotherapy remotely in their homes. The purpose of this study was to investigate the effects of home-based remote group training for balance and mobility on activities and body functions. conditions: Hemorrhagic Stroke conditions: Ischemic Stroke studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 16 type: ESTIMATED name: Telerehabilitation measure: Change in balance measure: Change in limits of stability measure: Change in weight-bearing symmetry measure: Change in mobility measure: Change in walking speed measure: Satisfaction with the remote training sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Rehabilitation Institute, Republic of Slovenia status: RECRUITING city: Ljubljana zip: 1000 country: Slovenia name: Urška Puh, PT, PhD role: CONTACT phone: +386 1 4758152 email: urska.puh@ir-rs.si lat: 46.05108 lon: 14.50513 hasResults: False

 nctId: NCT06365450 id: IRB00315481 briefTitle: Breast and Cervical Cancer Education Program acronym: OCEAP overallStatus: COMPLETED date: 2022-09-22 date: 2024-02-28 date: 2024-04-05 date: 2024-04-15 date: 2024-04-15 name: Johns Hopkins University class: OTHER name: Older Women Embracing Life name: The John G. Bartlett Specialty Practice briefSummary: The primary goal of this study is to improve cancer literacy in Black women living with HIV and ultimately improve breast and cervical cancer screening uptake. This study involves an educational intervention delivered virtually and in person, depending on the participants' preference. conditions: Cervical Cancer conditions: Breast Cancer conditions: Health Behavior studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Each participant is required to attend (in person or virtually via Zoom) two educational sessions one on breast cancer and the other on cervical cancer. primaryPurpose: OTHER masking: NONE count: 60 type: ACTUAL name: Educational Intervention measure: Health Literacy in Cancer Screening as assessed by the Assessment of Health Literacy in Cancer Screening (AHL-C) tool. measure: Number of participants recruited from each community partner measure: Number of participants who preferred virtual or in person sessions measure: Number of participants who were lost of follow up measure: Number of participants who needed help redeeming their gift codes sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins University School of Nursing city: Baltimore state: Maryland zip: 21205 country: United States lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06365437 id: TCD601B101 briefTitle: A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation overallStatus: RECRUITING date: 2021-06-06 date: 2025-08 date: 2025-08 date: 2024-04-15 date: 2024-04-15 name: ITB-Med LLC class: INDUSTRY briefSummary: The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients. conditions: Kidney Transplantation studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: BASIC_SCIENCE masking: NONE count: 40 type: ESTIMATED name: TCD601 name: Tacrolimus (TAC) name: Corticosteroids (CS) name: Mycophenolate Mofetil (MMF) name: ATG measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. measure: Measure Peak Plasma Concentration (Cmax) over time. measure: Measure the Area under the plasma concentration versus time curve (AUC). measure: Assess changes in peripheral immunophenotype, including T-, B-, and NK-cells, via Fluorescence-activated Cell Sorter (FACS) over time. measure: Measure anti-TCD601 antibodies in serum via Enzyme-linked Immunosorbent (ELISA) assay over time. measure: Measure peripheral CD2-receptor occupancy following TCD601 administration Receptor Occupancy will be reported as the % of target saturation. sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Innsbruck Medical University status: RECRUITING city: Innsbruck zip: A-6020 country: Austria name: Research Coordinator role: CONTACT lat: 47.26266 lon: 11.39454 facility: University of Vienna status: RECRUITING city: Vienna zip: 1090 country: Austria name: Research Coordinator role: CONTACT lat: 48.20849 lon: 16.37208 facility: Hospital Clinic de Barcelona status: RECRUITING city: Barcelona zip: 08036 country: Spain name: Research Coordinator role: CONTACT lat: 41.38879 lon: 2.15899 facility: Hospital Universitari de Bellvitge status: RECRUITING city: Barcelona zip: 08907 country: Spain name: Research Coordinator role: CONTACT lat: 41.38879 lon: 2.15899 facility: Karolinska University Hospital status: RECRUITING city: Stockholm state: Huddinge zip: 14157 country: Sweden name: Research Coordinator role: CONTACT lat: 59.33258 lon: 18.0649 facility: Sahlgrenska University Hospital status: RECRUITING city: Göteborg zip: 41345 country: Sweden name: Research Coordinator role: CONTACT lat: 57.70716 lon: 11.96679 facility: Skåne University Hospital status: RECRUITING city: Malmö zip: 20502 country: Sweden name: Research Coordinator role: CONTACT lat: 55.60587 lon: 13.00073 hasResults: False

 nctId: NCT06365424 id: KY20151230-5-1 briefTitle: Fenofibrate in Patients With Primary Biliary Cholangitis (PBC) overallStatus: RECRUITING date: 2017-04-08 date: 2027-04 date: 2027-04 date: 2024-04-15 date: 2024-04-15 name: Xijing Hospital of Digestive Diseases class: OTHER briefSummary: An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC) conditions: Primary Biliary Cholangitis studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 117 type: ESTIMATED name: Fenofibrate name: UDCA measure: Treatment emergent adverse events (TEAEs) measure: Percentage of patients with biochemical response sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xijing Hospital status: RECRUITING city: Xi'an state: Shaanxi country: China name: Ying Han role: CONTACT lat: 34.25833 lon: 108.92861 hasResults: False

 nctId: NCT06365411 id: GEM-KiT briefTitle: GEnomic Medicine in Kidney Transplantation Study acronym: GEM-KiT overallStatus: NOT_YET_RECRUITING date: 2024-06-03 date: 2030-01-01 date: 2035-01-01 date: 2024-04-15 date: 2024-04-24 name: Western Sydney Local Health District class: OTHER briefSummary: Investigator led, prospective, observational cohort study to detect genomic features which can predict outcomes following kidney transplantation.

1. Determine non-HLA genomic mismatches between donor-recipient pairs which impact kidney allograft survival following transplantation
2. Derive polygenic risk scores on pre-transplant blood and/or kidney biopsy samples which predict kidney allograft dysfunction
3. Derive polygenic risk scores on post-transplant blood and/or kidney biopsy samples which predict kidney allograft dysfunction conditions: Transplant Complication conditions: Kidney Transplant Rejection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Biomarker discovery and validation - with focus on genomic biomarkers measure: Death censored graft loss (DCGL) measure: Biopsy proven rejection (BPAR) measure: All cause graft loss measure: Death measure: Treatment resistant rejection measure: Hospital admission or emergency attendance measure: Delayed Graft Function (DGF) measure: Kidney function measure: Albuminuria measure: Surrogate end-point markers measure: Borderline rejeciton measure: chronic rejection; chronic transplant glomerulopathy; and interstitial fibrosis and tubular atrophy (IFTA) scores measure: Recurrent disease measure: BK virus complications measure: Major cardiovascular complications measure: Major infectious complications measure: Malignancy post transplantation measure: Kidney biopsy transcriptomic signature measure: Kidney cell type composition measure: Proteinomic signature sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06365398 id: SELECT id: XWHL-2018010 type: OTHER_GRANT domain: Xuanwu Hospital, Capital Medical University briefTitle: Safety and Efficacy of Low-dose hEparinization in Cerebral Angiography sTudy acronym: SELECT overallStatus: COMPLETED date: 2018-01-01 date: 2021-06-01 date: 2022-01-01 date: 2024-04-15 date: 2024-04-15 name: Xuanwu Hospital, Beijing class: OTHER briefSummary: Purpose: Systemic heparinization is a widely used technique on digital subtraction angiography (DSA). Heparin, however, is associated with a variety of complications, including hemorrhage, thrombocytopenia, and hematomas. This study aimed to investigate the safety and efficacy of micro-dose systemic heparinization or no heparinization on cerebral angiography for cerebrovascular diseases.

Methods: A prospective, single-blind, randomized controlled study on patients who experienced transient ischemic attacks (TIAs) or acute ischemic strokes and underwent DSA is performed. Participants are randomized into three groups: regular-dose systemic heparinization, micro-dose systemic heparinization, and no heparinization. Information on patient demographics, laboratory tests, perioperative complications, and back pain scores is collected. Safety endpoints are defined as cerebral ischemic events and local complications of puncture site. Efficacy endpoints were defined as the recovery of the patients. conditions: Cerebral Angiography conditions: Heparinization studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: All patients enrolled are randomly divided into three groups according to the random number principle, which includes conventional systemic heparinization group, micro-dose systemic heparinization, and heparin-free angiography. It is carried out with a 1:1:1 ratio and variable block sizes. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 180 type: ACTUAL name: Heparin name: Heparin Sodium Injection name: No heparinization measure: postoperative cerebral infarction measure: Numerical Rating Scale (NRS) for back pain measure: the incidence of paralysis of surgical limb measure: the incidence of pain of surgical limb measure: the incidence of postoperative urethral catheterization sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xuanwu Hospital, Capital Medical University city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Xuanwu Hospital, Capital Medical University. city: Beijing zip: 100053 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06365385 id: FOODSEQ-MARS briefTitle: Postprandial Metabolic and Appetite Responses to Different Food Intake Sequences in Athletes overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2024-10 date: 2024-04-15 date: 2024-04-15 name: Universidade do Porto class: OTHER name: Federação Portuguesa de Futebol name: Fundação para a Ciência e a Tecnologia briefSummary: Emerging evidence suggests that following a 'carbohydrate-last meal pattern', wherein foods rich in protein, fat, fiber, and/or polyphenols are consumed before sources of simple carbohydrate (CHO) in a meal, results in reduced postprandial glycaemic responses than the reverse food order or a co-ingestion pattern. This effect has been observed across the spectrum of glucose tolerance, from patients with diabetes to individuals with normal glucose tolerance (Kuwata et al., 2016; Nishino et al., 2018; Lu et al., 2019; Sun et al., 2020). Furthermore, reduced glucose excursions have been linked to decreased subsequent hunger and energy intake (Lu et al., 2019; Wyatt et al., 2021).

However, to date, no studies on food intake sequence have targeted athletes, despite their increased CHO demands (Thomas et al., 2016) which could expose them to repeated episodes of hyperglycaemia and high glycaemic variability, known to increase the risk of adverse cardiovascular outcomes and all-cause mortality (Loader et al., 2015; Cavero-Redondo et al., 2017; Faerch et al., 2018). Additionally, athletes often face pressure to meet body composition standards and may benefit from strategies that enhance satiety and craving control. Finally, there is reason to believe that better glycaemic control could lead to improved performance, given that enhancements in endurance activities have been observed with a low-glycemic-index diet compared to a high-glycemic-index diet (Heung-Sang Wong et al., 2017).

Therefore, this randomised crossover trial is part of a wider project which seeks to explore the impact of food intake sequence on metabolic health and performance in athletes. Specifically, this trial aims to investigate the acute, postprandial metabolic and appetite responses to consuming an identical meal in two intake sequences (CHO-last versus CHO-first) in athletes, while in the resting state. conditions: Healthy conditions: Nutrition, Healthy conditions: Postprandial Hyperglycemia conditions: Hunger conditions: Craving studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This study is a randomised controlled trial with a counterbalanced crossover design. Block randomisation will be performed by an external researcher, and allocation concealment will be ensured through the use of sequentially numbered, opaque, sealed envelopes. primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: This is a non-blind trial, since both participants and the investigator delivering the test-meal will be able to see the ingredients and the order in which they are consumed. However, outcome assessors will be blinded to the intervention sequence. whoMasked: OUTCOMES_ASSESSOR count: 15 type: ESTIMATED name: Carbohydrate-last meal pattern name: Carbohydrate-first meal pattern measure: Postprandial blood glucose concentrations measure: Postprandial subjective appetite ratings measure: Prospective ad libitum energy intake measure: Prospective ad libitum nutritional intake measure: Postprandial serum insulin concentrations measure: Postprandial plasma total GLP-1 concentrations measure: Postprandial plasma total GIP concentrations measure: Postprandial serum total ghrelin concentrations measure: Postprandial plasma total PYY concentrations measure: Postprandial serum triglyceride concentrations measure: Postprandial serum NEFA concentrations sex: MALE minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT hasResults: False

 nctId: NCT06365372 id: MrgD and PAH briefTitle: Circulating MrgD in Pulmonary Hypertension overallStatus: RECRUITING date: 2024-04-10 date: 2024-05-10 date: 2024-06-01 date: 2024-04-15 date: 2024-04-15 name: Qilu Hospital of Shandong University class: OTHER briefSummary: The aim of the study is to observe the change of the circulating MrgD level in patients with pulmonary hypertension compared with subjects without pulmonary hypertension. conditions: Pulmonary Hypertension studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 90 type: ESTIMATED name: Western blot measure: Circulating MrgD level sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Qilu Hospital of Shandong University status: RECRUITING city: Jinan state: Shandong zip: 250012 country: China name: Panpan Hao, MD, PHD role: CONTACT email: panda.how@126.com name: Hongyu Zhong, MD role: SUB_INVESTIGATOR lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06365359 id: 23_RIPH2-12 briefTitle: Systemic Lupus Erythematosus and Chlordecone Impregnation in Martinique acronym: LUNEK overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-10-15 date: 2025-11-15 date: 2024-04-15 date: 2024-04-15 name: University Hospital Center of Martinique class: OTHER name: Institut Pasteur de Guadeloupe name: Centre de Ressources Biologiques de la Martinique (CeRBiM) briefSummary: Chlordecone, an organochlorine pesticide, was widely used on banana farms in the French West Indies. Studies by Inserm and health authorities have confirmed the contamination of the food chain and the majority of the population of the French West Indies by chlordecone.

Epidemiological studies conducted in the French West Indies have shown that exposure to chlordecone at the levels observed is associated with an increased risk of developing several diseases, including premature birth and prostate cancer. Many of the adverse effects associated with chlordecone could be explained by its estrogenic hormonal properties, and systemic lupus erythematosus (SLE) is an autoimmune disease whose sensitivity to estrogen is well known and is reflected by 1) its clear predominance in women, 2) its predominance in women of childbearing age, 3) its risk of exacerbation in the event of pregnancy.

Chlordecone has the potential to modify the activity of SLE through mechanisms other than its pro-estrogenic effects. In rats, chlordecone was observed to induce alterations such as a reduction in lymphocyte count, thymic atrophy, and a decrease in splenic germinal centers and NK cells.

In a mouse model of systemic lupus erythematosus (SLE), exposure to chlordecone results in increased production of immune complexes and anti-DNA antibodies, which are markers of disease activity and monitoring.

Chlordecone also has a cellular effect that reduces the apoptosis of potentially auto-reactive lymphocytes and stimulates the production of GM-CSF, IL-2, TNF-alpha, and IFN-gamma. The latter is central to the pathophysiology of SLE. While experimental studies suggest a potential impact of chlordecone on SLE, no human studies have been conducted to date, and the chlordecone impregnation of lupus patients in Martinique remains unknown.

The most serious and feared complication of SLE is kidney damage. Kidney damage from the disease and the necessary immunosuppressive treatments can lead to significant morbidity and mortality, including death and end-stage chronic renal failure. Therefore, it is important to manage the disease carefully. Suspected lupus nephritis is confirmed by a renal biopsy, which allows for formal diagnosis and categorization into several classes. Suspected cases are identified by a proteinuria to creatininuria ratio greater than 0.5 g/g (or 24-hour proteinuria greater than 0.5g).

The objective of this project is to determine whether there is a positive association between lupus nephritis occurrence in patients followed by the internal medicine department of the Martinique University Hospital and organochlorine pesticide chlordecone impregnation. conditions: Systemic Lupus Erythematosus conditions: Renal Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Blood sample for analysis of plasma of organochlorine pesticides concentration name: Blood sample for cell collection measure: To estimate the risk of presenting a renal complication of lupus disease based on the level of impregnation with chlordecone in the lupus patients seen at the Martinique University Hospital. measure: To compare the activity of lupus according to the level of impregnation with chlordecone. measure: To compare the after-effects of lupus according to the level of impregnation with chlordecone. measure: To describe the distribution of the plasma concentration of chlordecone in lupus patients followed by the internal medicine department of the Martinique University Hospital. measure: To describe the distribution of the plasma concentration of p,p'-DDE in lupus patients followed by the internal medicine department of the Martinique University Hospital. measure: To describe the distribution of the plasma concentration of βHCH in lupus patients followed by the internal medicine department of the Martinique University Hospital. measure: To describe the distribution of the plasma concentration of γHCH in lupus patients followed by the internal medicine department of the Martinique University Hospital. measure: To describe the distribution of the plasma concentration of PCB 153 in lupus patients followed by the internal medicine department of the Martinique University Hospital. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Center of Martinique city: Fort-de-France zip: 97261 country: France hasResults: False

 nctId: NCT06365346 id: 2024.075-T briefTitle: Music Breathing Therapy for Children With Attention-deficit Hyperactivity Disorder and Their Caregivers overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-05-31 date: 2025-08-31 date: 2024-04-15 date: 2024-04-15 name: Chinese University of Hong Kong class: OTHER briefSummary: This pilot randomized controlled trial aims to evaluate the feasibility (in terms of rates of recruitment, retention, and attendance), acceptability, and potential effects of the dyadic video-assisted gamified music breathing therapy on dyads' resilience, children's emotional and behavioral symptoms, parents' parenting stress, and psychological distress. conditions: Resilience studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: Dyadic video-assisted gamified group-based music breathing therapy name: Online educational modules measure: Resilience levels of children measure: Resilience levels of parents measure: Children's emotional and behavioral symptoms measure: Parenting stress measure: Parents' psychological distress (i.e., depression, anxiety and stress) measure: Feasibility outcomes - recruitment rate measure: Feasibility outcomes - retention rate measure: Feasibility outcomes - attendance measure: Acceptability of the intervention - level of satisfaction measure: Acceptability of the intervention sex: ALL minimumAge: 7 Years maximumAge: 12 Years stdAges: CHILD facility: The Chinese University of Hong Kong city: Hong Kong country: Hong Kong name: Ankie Tan Cheung, PhD role: CONTACT phone: 852 39430515 email: ankiecheung@cuhk.edu.hk lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06365333 id: 1451_04/BVNTW-VNCSKTE briefTitle: Pneumatic Reduction For Intussusception In Children: A Retrospective Cohort Study overallStatus: COMPLETED date: 2016-01 date: 2017-12 date: 2024-04 date: 2024-04-15 date: 2024-04-15 name: National Children's Hospital, Vietnam class: OTHER name: Vinmec Research Institute of Stem Cell and Gene Technology briefSummary: In pediatric patients, intussusception predominantly occurs in the ileocecal region, with over 90% of cases lacking identifiable causative factors, initiating through peristalsis-driven invagination of bowel segments leading to compromised blood flow and subsequent bowel edema. Persistent obstruction may progress to bowel ischemia and infarction. Vietnam exhibits a higher incidence of intussusception compared to other countries, albeit with similar clinical presentations and anatomical locations, hinting at shared pathophysiology. Despite evidence supporting the safety and efficacy of non-surgical reduction techniques, many medical centers in low- to middle-income countries (LMICs) have not adopted these methods, resulting in unnecessary surgical interventions. The Vietnam National Hospital of Pediatrics (NCH) has employed air enema reduction since the early 2000s but lacks a comprehensive study on fluoroscopic-guided air-enema reduction (FGAR) techniques or success rates. Thus, this study aims to evaluate the long-term outcomes of pneumatic reduction for intussusception at NCH, a high-volume institution in a lower-middle-income country. conditions: Intussusception studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3562 type: ACTUAL name: Fluoroscopic-guided air-enema reduction (FGAR) measure: Complicated intussusception measure: ICU admission measure: Death measure: Failed FGAR measure: Recurrence sex: ALL minimumAge: 2 Months maximumAge: 30 Months 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: NCT06365320 id: PROTEOMET briefTitle: Association Between Training Load and Lactate and Other Metabolites Analyzed by Metabolomic and Proteomic Techniques acronym: PROTEOMET overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-07 date: 2024-07 date: 2024-04-15 date: 2024-04-15 name: Fundació Eurecat class: OTHER name: University Rovira i Virgili briefSummary: Physical exercise induces numerous changes in the body in a complex signalling network caused by or in response to increased metabolic activity of contracting skeletal muscles.

The application of omics analytical techniques such as proteomics and metabolomics in the field of sport allows us to understand how the human body responds to exercise and how sports results can be improved by optimising nutrition and training. Both omics techniques offer a quantitative measurement of the metabolic profiles associated with exercise and are able to identify metabolic signatures of athletes from different sports disciplines.

Basketball is a high-intensity exercise modality interspersed with low-intensity. The performance requirements of basketball include aerobic and anaerobic metabolism, with anaerobic metabolism being considered the main energy system. Therefore, basketball players need great athletic ability to produce a successful performance during competition.

For optimal sports performance it is important to adjust the training load, i.e. the degree of effort that the player can withstand in a single training session. Coaches require effective and objective load monitoring tools that allow them to make decisions about training plans based on the needs of each player.

Microsampling systems emerge as an alternative to venipuncture by facilitating self-sampling, which can be carried out outside healthcare centres, in a comfortable and precise way from a small finger prick that the user can perform. These systems are less expensive and can be effective in measuring the levels of glucose metabolism products, such as lactate, through the application of metabolomics and proteomics. On the other hand, the use of non-invasive methods of measuring lactate levels is becoming increasingly popular in sports medicine. The use of saliva as an alternative fluid to the blood shows promise for identifying the concentrations of metabolites that occur during and after sports training. conditions: Lactate conditions: Sports Performance conditions: Metabolomics conditions: Proteomics studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single-group pretest-posttest design (quasi- experimental) primaryPurpose: OTHER masking: NONE maskingDescription: Given the nature of the study (pretest-posttest design), masking will not be possible. count: 70 type: ESTIMATED name: Single basketball training measure: Correlation between blood lactate levels and the subjective sensation of perceived effort measure: Change in saliva lactate levels measure: Change in blood lactate levels measure: Change in levels of lipid metabolic markers determined in capillary blood samples measure: Change in levels of other lipid metabolic markers determined in capillary blood samples measure: Change in levels of polar metabolites determined in capillary blood samples measure: Change in levels of lipid metabolic markers determined in saliva samples measure: Change in levels of other lipid metabolic markers determined in saliva samples measure: Change in levels of polar metabolites determined in saliva samples measure: Change in levels of proteomic markers determined in capillary blood samples measure: Change in levels of proteomic markers determined in saliva samples measure: Pittsburgh Sleep Quality Index measure: Heart rate variations measure: Sociodemographic data: age and birth date measure: Sociodemographic data: sex measure: Lifestyle data: weekly training load measure: Lifestyle data: playing position measure: Clinical data: use of supplementation measure: Clinical data: use of medication measure: Clinical data: previous muscle injuries measure: Physiological data measure: Anthropometric data: weight measure: Anthropometric data: height measure: Anthropometric data: body mass index measure: Anthropometric data: fat mass percentage measure: Anthropometric data: muscle mass percentage sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Fundació Eurecat, Center for Omic Sciences city: Reus state: Tarragona zip: 43204 country: Spain name: Nuria Canela, PhD role: CONTACT phone: +34977300431 email: nuria.canela@eurecat.org name: Anna Crescenti, PhD role: CONTACT phone: +34977770958 phoneExt: 4832 email: anna.crescenti@eurecat.org lat: 41.15612 lon: 1.10687 hasResults: False

 nctId: NCT06365307 id: Histograft-SF-2023 briefTitle: Comparative Study of Gene-Activated Bone Substitute "Histograft" for Lumbar and Cervical Spinal Fusion overallStatus: RECRUITING date: 2023-11-13 date: 2024-04 date: 2025-04 date: 2024-04-15 date: 2024-04-15 name: Histograft Co., Ltd. class: INDUSTRY name: Petrovsky National Research Center of Surgery briefSummary: The goal of this clinical trial is to evaluate the safety and efficacy of the combination product "Histograft", a bone substitute based on octacalcium phosphate (OCP) and plasmid DNA encoding VEGFA gene, in spinal fusion prosedure in comparison with bone autografts and synthetic material based on β-TCP conditions: Cervical Disc Disorder With Radiculopathy conditions: Spinal Stenosis conditions: Lumbar and Other Intervertebral Disc Disorders With Radiculopathy conditions: Biomechanical Lesion, Unspecified studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: During the preliminary screening and indication for surgical treatment, patients are divided into 2 groups depending on the location of the pathological process: 1 - cervical spine, 2 - lumbar spine. During independent sequential randomization in a 1:1 ratio, patients in each of these groups are divided into clinical (A) and control (B) groups.

Distribution of treatment methods by groups:

1A - use of "Histograft" for spinal fusion of the cervical spine, 50 patients

1. B - use of synthetic osteoplastic material based on β-TCP for spinal fusion of the cervical spine, 50 patients
2. A - use of "Histograft" for spinal fusion of the lumbar spine, 100 patients

2B - use of bone autograft for spinal fusion of the lumbar spine, 100 patients primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Osteoplastic material based on octacalcium phosphate and biologically active nucleic acids for bone tissue regeneration Nucleostim-VEGF ("Histograft") name: Synthetic osteoplastic material based on β-TCP or bone autograft measure: Spinal fusion measure: Adverse events and Severe Adverse Events measure: SF- 36 score (The Short Form-36) measure: Unexpected Adverse Drug Reaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Scientific Clinical Center No. 2 of Federal State Budgetary Research Institution "Russian research center of surgery named after academician B.V.Petrovsky" status: RECRUITING city: Moscow state: Moscow Oblast zip: 117588 country: Russian Federation name: Renat Nurmukhametov role: CONTACT email: ethic@med.ru name: Mark Aleksanyan role: CONTACT name: Renat Nurmukhametov, MD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 hasResults: False

 nctId: NCT06365294 id: REVET Study briefTitle: Rescue Extracranial Vertebral Stenting in Tandem Occlusions acronym: REVET overallStatus: RECRUITING date: 2020-12-31 date: 2024-04-30 date: 2024-05-31 date: 2024-04-15 date: 2024-04-16 name: Dr. Cuong Tran Chi class: OTHER briefSummary: The acute vertebrobasilar occlusion associated with the poor prognosis, particularly tandem occlusion. However, few data on the efficacy of the endovascular therapy was indicated in this occlusion. The investigators reported whether the additional rescue extracranial stenting improved clinical outcome by modified Rankin Scale (mRS) score within 3 months after the procedure conditions: Acute Stroke conditions: Ischemic Stroke, Acute conditions: Vertebro Basilar Ischemia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 9 type: ESTIMATED name: Rescue extracranial stenting measure: The good 3-month outcome rate sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Can Tho SIS Hospital status: RECRUITING city: Cần Thơ zip: 900000 country: Vietnam name: Cuong Tran Chi, Doctor role: CONTACT phone: +84886559911 email: drcuongtran@dotquy.vn lat: 10.03711 lon: 105.78825 hasResults: False

 nctId: NCT06365281 id: CARIES PREVALENCE briefTitle: Caries Prevalence, Experience and Risk Related Factors Among Early Middle-aged Patients Attending Cairo University overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-08 date: 2024-04-15 date: 2024-04-15 name: Cairo University class: OTHER briefSummary: Dental caries, a widespread oral health issue, results from a complex interplay of factors including behavior, hygiene, diet, and socio-demographic aspects. While preventive measures are available, it remains prevalent globally, affecting numerous teeth per individual. Improved oral hygiene practices and increased awareness have led to a reduction in caries prevalence. However, rising sugar consumption exceeds dietary guidelines, contributing to the problem. Despite limited epidemiological studies in Egypt, addressing individual-level factors is crucial. Surveillance of oral health in the early middle age group is standard, allowing decision-makers to assess the impact of caries and oral health care provision. Stratifying data by age, geography, and gender aids in understanding prevalence and planning effective prevention strategies. Overall, promoting awareness of dietary habits and preventive practices is vital for improving oral health outcome So, The purpose of this study is to assess the prevalence of dental caries among early middle age patients attending dental hospital in Faculty of Dentistry, Cairo university and to analyze the related risk factors utilizing WHO Oral Health Questionnaire for Adults. conditions: Dental Caries conditions: Caries,Dental studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 350 type: ESTIMATED measure: Prevalence of dental caries measure: Caries experience measure: Caries risk related factors sex: ALL minimumAge: 35 Years maximumAge: 44 Years stdAges: ADULT hasResults: False

 nctId: NCT06365268 id: APHP231139 briefTitle: Perinatal Thoraco-abdomino-pelvic Tumors Study acronym: CONTRAST overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-09 date: 2024-09 date: 2024-04-15 date: 2024-04-15 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Congenital tumors are a rare diagnosis in the fetus and newborn. They differ from those of children and adults in terms of the nature, location and evolution of the tumor.

Indeed, some histologically benign tumors may have lethal potential in utero (e.g. sacrococcygeal teratomas) or even undergo malignant transformation if left untreated. In contrast, other tumors that are malignant by histological criteria may have a very good prognosis, regressing spontaneously within the first year of life (e.g. neuroblastoma).

Despite advances in imaging, benign and malignant solid tumors remain a major diagnostic and prognostic challenge in the antenatal context.

The management of congenital tumors requires multidisciplinary expertise, taking into account the perinatal context, which poses specific problems, particularly in terms of therapeutic aspects, but also the frequent existence of associated malformations and/or genetic predisposition syndromes.

This study focuses on solid tumors of the thoraco-abdomino-pelvic region, the main objective being to investigate the correlation between antenatal clinical and radiological analysis and confirmed postnatal diagnosis of congenital solid truncal tumors, as well as the developmental spectrum in which they fit. conditions: Perinatal Solid Tumors of the Thoraco-abdomino-pelvic Region studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: Collection of data from the patient's medical file measure: Correlation between antenatal clinico-radiological analysis and postnatal diagnosis of solid congenital truncal tumors measure: Description of the developmental spectrum of solid congenital truncal tumors measure: Characteristics and location of the tumor on pre- and post-natal imaging measure: Ile-de-France epidemiology of perinatal tumors measure: Evolution of solid congenital truncal tumors measure: Associated genetic abnormalities and malformations measure: Intercurrent obstetric events and obstetric outcomes based on the diagnoses made measure: Development of a management algorithm based on prenatal findings sex: ALL maximumAge: 3 Months stdAges: CHILD facility: Hôpital Necker-Enfants Malades city: Paris zip: 75015 country: France name: Sabine SARNACKI, MD, PhD role: CONTACT phone: 1 44 49 41 94 phoneExt: +33 email: sabine.sarnacki@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06365255 id: 2022-A01453-40 briefTitle: National Epidemiological Study of the Possible Impact of Stress on Glycaemic Control in Patients With Type 1 Diabetes acronym: EPISTRESS2 overallStatus: COMPLETED date: 2023-01-17 date: 2024-02-28 date: 2024-02-28 date: 2024-04-15 date: 2024-04-17 name: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète class: OTHER briefSummary: The EPISTRESS2 study is a one-off cross-sectional epidemiological survey, carried out via an online form in patients with type 1 diabetes followed up by participating investigating centres.

In type 1 diabetes (T1DM), studies on stress and its impact on glycaemia have led to ambiguous results, mainly because there are no solid epidemiological or experimental data in the literature. The aim of this study was to assess the impact of perceived stress on blood glucose levels in a population of subjects with T1DM at 10 national centres. conditions: Diabetes Type 1 studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 1344 type: ACTUAL name: questionnaires measure: The primary endpoint is the characterisation of 4 profiles of patients with type 1 diabetes on insulin pumps. measure: Identify sub-populations of patients who feel stressed measure: Establish and categorise the different stress factors measure: Establishing a relationship between personality type and the impact of stress measure: Evaluation of the quality of life score obtained according to the 4 profiles and/or personalities sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Angers University Hospital city: Angers zip: 49100 country: France lat: 47.46667 lon: -0.55 facility: Avignon Hospital city: Avignon zip: 84000 country: France lat: 43.94834 lon: 4.80892 facility: St André Hospital city: Bordeaux zip: 33076 country: France lat: 44.84044 lon: -0.5805 facility: Brest University Hospital city: Brest zip: 29200 country: France lat: 48.3903 lon: -4.48628 facility: Dijon University Hospital city: Dijon zip: 21079 country: France lat: 47.31667 lon: 5.01667 facility: CERITD city: Evry zip: 91058 country: France lat: 48.63333 lon: 2.45 facility: Grenoble University Hospital city: Grenoble zip: 38043 country: France lat: 45.16667 lon: 5.71667 facility: Lille University Hospital city: Lille zip: 59037 country: France lat: 50.63297 lon: 3.05858 facility: APHM- La Conception Hospital city: Marseille zip: 13000 country: France lat: 43.29551 lon: 5.38958 facility: Private practice in endocrinology and metabolic diseases city: Mérignac zip: 33700 country: France lat: 44.83248 lon: -0.63381 facility: Srasbourg University Hospital city: Strasbourg zip: 67091 country: France lat: 48.58392 lon: 7.74553 hasResults: False

 nctId: NCT06365242 id: DOACS1_2024 briefTitle: Direct Oral Anticoagulants and Management of Blleding Following Dental Extractions. A Prospective Cohort Study. acronym: DOACS_1 overallStatus: COMPLETED date: 2020-07-23 date: 2021-07-27 date: 2022-12-23 date: 2024-04-15 date: 2024-04-15 name: University of Pisa class: OTHER briefSummary: Evaluation of DOACs treatment on post-extraction bleeding conditions: Post Operative Hemorrhage studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 49 type: ACTUAL measure: Peri-operative hemorrhage measure: Post-operative bleeding sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: U.O. Odontostomatologia e Chirurgia del Cavo Orale city: Pisa zip: 56126 country: Italy lat: 43.70853 lon: 10.4036 hasResults: False

 nctId: NCT06365229 id: 2022-P2-336-02 briefTitle: Percutaneous Unilateral Biportal Endoscopy Versus Uniportal Endoscopy for Lumbar Spinal Stenosis: Study Protocol overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-15 date: 2024-04-15 name: Beijing Friendship Hospital class: OTHER briefSummary: A prospective study aimed to compare the efficacy and safety of Unilateral biportal endoscopic (UBE) technique and uniportal endoscopic (UE) technique for treating patients with lumbar spinal stenosis (LSS). conditions: Lumbar Spinal Stenosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED measure: Oswestry Disability Index (ODI) measure: Magnetic resonance imaging (MRI) measure: Computed tomography (CT) scans measure: Creatine kinase (CK) measure: Erythrocyte sedimentation rate (ESR) measure: Surgical complication measure: VAS (visual analogue scale) for leg pain measure: VAS (visual analogue scale) for lower back pain measure: Japanese Orthopaedic Association (JOA) score measure: Modified MacNab criteria measure: Operation time measure: Blood loss measure: Postoperative hospital stays measure: Age measure: Gender measure: Body mass index (BMI) measure: Medical comorbidity measure: Smoking status measure: Alcohol status measure: Symptoms duration measure: Physical examination finding measure: Previous spinal surgery measure: Affected level measure: Stenosis grade measure: Physical-component summary score of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Friendship Hospital city: Beijing state: Beijing zip: 100050 country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06365216 id: AXO-CLI-210c-03 id: 2023-508895-13-00 type: CTIS briefTitle: ALS Phase II Study of NX210c acronym: SEALS overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-02-01 date: 2026-02-01 date: 2024-04-15 date: 2024-04-15 name: Axoltis Pharma class: INDUSTRY name: ACT4ALS network briefSummary: This study will investigate the efficacy, safety, tolerability and pharmacokinetics (PK) of multiple intravenous infusions of NX210c, at two dose levels, in patients with Amyotrophic lateral sclerosis (ALS). conditions: Amyotrophic Lateral Sclerosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double-blind, randomized, placebo-controlled, multicentric, phase II study in adult patients with ALS to assess efficacy, safety, tolerability and pharmacokinetics of multiple intravenous infusions of NX210c.

Two doses of NX210c (5 mg/kg and 10 mg/Kg) will be investigated, along with a placebo group which will serve as a reference. Patients will be randomized to one of 3 arms in an allocation ratio of 3:3:2.

Patients will participate up to approximately 20 weeks: up to 30 days for screening, 26 days of treatment and 3 months of follow-up. Lumbar punctures will assess cerebrospinal fluid (CSF) NfL and other key CSF biomarkers related to ALS and drug mechanism of action. Blood sampling will be drawn for safety, PK and biomarkers testing. Urine will equally be collected for biomarkers. A comprehensive assessment of the disease, including the ALS Functional Rating Scale (ALSFRS-R) will be performed. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 80 type: ESTIMATED name: NX210c name: Placebo measure: The effect of NX210c on blood neurofilament light chain (NfL) or on a blood and cerebrospinal fluid (CSF) biomarker of BBB integrity. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Lyon HCL city: Bron zip: 69500 country: France name: Emilien Bernard, MD role: CONTACT phone: 0033 (0)4 72 35 72 18 email: emilien.bernard@chu-lyon.fr lat: 45.73333 lon: 4.91667 hasResults: False

 nctId: NCT06365203 id: Through knee amputation briefTitle: Comparative Study of Through Knee Amputation Versus Above Knee Amputation Regarding Infection Rate and Function overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2026-04 date: 2024-04-15 date: 2024-04-15 name: Assiut University class: OTHER briefSummary: The aim of this study is to search and compare outcomes of through knee amputation (TKA) and above knee amputation (AKA) in terms of Technique ,wound healing ,infection rate , function and ambulation conditions: Amputation of Knee studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Through knee amputation name: Above knee Amputation measure: Wound healing rate measure: Incidence of infection measure: Function of the limb Rehabilitation Quality of life measure: Mortality rate sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06365190 id: AHMU-PD-rTMS briefTitle: Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease overallStatus: ACTIVE_NOT_RECRUITING date: 2020-04-06 date: 2024-07-31 date: 2024-07-31 date: 2024-04-15 date: 2024-04-16 name: Anhui Medical University class: OTHER briefSummary: Previous studies have shown that repetitive transcranial magnetic stimulation(rTMS) can improve clinical symptoms of Parkinson's disease(PD). Continuous theta-burst stimulation(cTBS) is a novel rTMS protocol that produces physiological effects b acting on neurons in the brain, which can decrease the excitability of motor system. This study aims to explore the long-term effects of cTBS on improvement of movement symptoms in patients with PD. conditions: Transcranial Magnetic Stimulation conditions: Parkinson's Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 47 type: ACTUAL name: transcranial magnetic stimulation name: Pharmacotherapy（antiparkinsonian drugs） measure: Unified Parkinson's Disease Rating Scale III scores measure: Hoehn-Yahr(H-Y) stage measure: Levodopa equivalent dose sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cognitive Neuropsychology Lab Anhui Medical University city: Hefei state: Anhui zip: 230022 country: China lat: 31.86389 lon: 117.28083 hasResults: False

 nctId: NCT06365177 id: 29BRC22.0243 briefTitle: Evaluation of the Concordance of Five Times Sit To Stand Results Between a Physical Consultation and a Teleconsultation acronym: TELETEST overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-05-01 date: 2024-04-15 date: 2024-04-19 name: University Hospital, Brest class: OTHER briefSummary: This study concerns elderly person aged more than 65 years with autonomous mobility.

It is a multicentric randomized trial in two arms :

Arm one : remote consultation then physical consultation Arm two : physical consultation then remote consultation

Consultations consist to take a Five Times Sit To Stand test, in physical consultation with physiotherapist in the same room and in remote consultation with a physiotherapist in the next room to the patient. conditions: Rehabilitation conditions: Elderly Person conditions: Teleconsultation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Cross-sectional interventional multicenter study primaryPurpose: OTHER masking: NONE count: 108 type: ESTIMATED name: Physical consultation name: Teleconsultation measure: Five Time Sit To Stand test completion time in teleconsultation measure: Five Time Sit To Stand test completion time in face-to-face consultation measure: Satisfaction questionnaire measure: Five Time Sit To Stand test completion time in teleconsultation measure: Five Time Sit To Stand test completion time in face-to-face consultation measure: Presence or absence of falls measure: Number of falls sex: ALL minimumAge: 65 Years maximumAge: 110 Years stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06365164 id: 38RC23.0354 briefTitle: Study of the Emergence of Sensory Self-awareness in Premature Newborns Using the Rooting Reflex acronym: PREMATACT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-11 date: 2025-11 date: 2024-04-15 date: 2024-04-15 name: University Hospital, Grenoble class: OTHER name: Faculty of Psychology and Educational Sciences,University of Geneva briefSummary: The main objective is to demonstrate the presence of the rooting reflex in premature and the emergence of sensory self-awareness in premature by showing a difference in the response of the rooting reflex to external tactile stimulation and to facilitated tactile self-stimulation during quiet wakefulness.

The main hypothesis is to confirm the tactile skills of the very premature newborn in exploring the rooting reflex and then to evaluate the emergence of sensory self-awareness.

The investigators assume a difference in response in favour of a greater response of the newborn to external tactile stimulation compared to facilitated self-stimulation in favour of the distinction between self and non-self showing the emergence of a sensory awareness of self in the preterm newborn. conditions: Premature conditions: Development, Child conditions: Rooting Reflex studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 19 type: ESTIMATED name: Tactile stimulation measure: The emergence of sensory self-awareness in premature newborns by showing a difference in the response of the rooting reflex to external tactile stimulation and to facilitated tactile self-stimulation during calm awakening. measure: The secondary objective is to show a longitudinal progression in the emergence of the rooting reflex by repeated inclusions (seven days minimum) at different terms for the same newborn. sex: ALL minimumAge: 28 Weeks maximumAge: 37 Weeks stdAges: CHILD facility: University Hospital Grenoble city: Grenoble state: Isere zip: 38 000 country: France lat: 45.16667 lon: 5.71667 hasResults: False

 nctId: NCT06365151 id: TMDs fibromyalgia briefTitle: An Algorithm for Approaching Temporomandibular Disorders With Osteopathic Manual Therapy in Patients With Fibromyalgia overallStatus: RECRUITING date: 2024-04-05 date: 2025-04-05 date: 2026-04-05 date: 2024-04-15 date: 2024-04-15 name: Universitat de Lleida class: OTHER briefSummary: Nowadays, fibromyalgia is the rheumatic disorder with the highest levels of deterioration in quality of life. Among the comorbidities it presents, one of the most frequent is temporomandibular disorders. A randomized clinical study will be conducted to evaluate the effectiveness of an osteopathic manual therapy approach algorithm in a group of patients with fibromyalgia and temporomandibular disorders. conditions: Fibromyalgia conditions: Temporomandibular Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 114 type: ESTIMATED name: Osteopathic manual therapy name: Sham osteopathic manual therapy measure: catastrophizing measure: functional limitation measure: functional status, disability and pain measure: pain and tinnitus measure: myofascial trigger points measure: Range of motion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Osteopatia i Fisioteràpia Cornellà status: RECRUITING city: Cornella de Llobregat state: Barcelona zip: 08940 country: Spain name: Llanos de la Iglesia, MsC role: CONTACT phone: +34679536992 email: llanos.delaiglesia@gmail.com lat: 41.35 lon: 2.08333 hasResults: False

 nctId: NCT06365138 id: Aortic Rupture briefTitle: Analysis of Individual Activity at the Time of Aortic Rupture in Patients With Abdominal Aortic Aneurysms overallStatus: RECRUITING date: 2024-01-01 date: 2029-12-01 date: 2030-12-01 date: 2024-04-15 date: 2024-04-15 name: University Hospital Augsburg class: OTHER name: Epidemiology, Medical Faculty, University Augsburg briefSummary: It is currently unclear what activities aneurysms are involved in at the time of rupture. The aim of the study is to determine the activity performed at the time of aneurysm rupture. conditions: Aortic Aneurysm studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 500 type: ESTIMATED name: Bahaviour at the time of an aortic aneurysm rupture measure: Occupation at the time of the aortic aneurysm rupture sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Augsburg status: RECRUITING city: Augsburg zip: 86156 country: Germany name: Tobias Warm, MD role: CONTACT phone: +49821400161068 email: tobias.warm@uk-augsburg.de lat: 48.37154 lon: 10.89851 hasResults: False

 nctId: NCT06365125 id: 7313E briefTitle: College Student Daily Life and Alcohol Use Study overallStatus: RECRUITING date: 2024-03-22 date: 2025-05-01 date: 2025-05-01 date: 2024-04-15 date: 2024-04-15 name: Boston University Charles River Campus class: OTHER briefSummary: Heavy alcohol use among college students is associated with a range of negative consequences. However, college students rarely seek resources or treatment to change their alcohol use. Brief alcohol interventions (BAIs) have been developed as an alternative method to address heavy alcohol use among college students and show promise in reducing hazardous alcohol use in college students. Despite the established efficacy of BAIs, effects are often small and short-lived, and additional research is needed to investigate how BAIs can become more efficacious and endure for longer periods of time, particularly for computer-delivered interventions to improve accessibility and scalability of these interventions to a wider range of college students. Boosters or adjunctive components to BAIs have been suggested as a method to enhance the magnitude and duration of intervention effects. However, there remains a need to identify and test booster approaches that are both appealing and engaging to college students and effective in reducing heavy/hazardous alcohol use above and beyond the magnitude and duration seen by BAIs alone. The purpose of the study is to develop and test a novel, text-messaging booster as an adjunct to a current, evidence-based brief intervention, eCHECKUP TO GO, aimed at reducing college student heavy/hazardous alcohol use. Participants will complete baseline measures and will then be randomized to 1 of 3 conditions, stratified by sex at birth: 1) assessment only, 2) BAI only, and 3) Enhanced Intervention (BAI + four weeks of text messaging boosters). It is hypothesized that those randomized to the enhanced intervention condition will show a greater reduction in heavy/hazardous alcohol use at 3-month follow-up compared to the BAI and assessment only groups. conditions: Drinking, College conditions: Drinking Heavy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 129 type: ESTIMATED name: eCHECKUP TO GO name: Text messaging boosters measure: Heavy drinking episodes measure: Alcohol-related negative consequences sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Boston University Charles River Campus status: RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States name: Bonnie Rowland, MA role: CONTACT phone: 617-906-6645 email: browland@bu.edu name: Tibor Palfai, PhD role: CONTACT email: palfai@bu.edu name: Bonnie Rowland, MA role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06365112 id: R21154 briefTitle: Endoscopic Acetabulum Surgery overallStatus: RECRUITING date: 2024-04 date: 2026-01 date: 2028-01 date: 2024-04-15 date: 2024-04-24 name: Tampere University Hospital class: OTHER briefSummary: Try to develop an endoscopic surgical technique to treat acetabulum fractures conditions: Acetabulum Fracture studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 13 type: ESTIMATED name: Endoscopy assisted measure: Number of patients with major complications measure: Number of patients with minor complications measure: Operation time measure: Patient satisfaction using EQ5D sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tampere University hospital status: RECRUITING city: Tampere zip: 33521 country: Finland name: Piia Suomalainen role: CONTACT lat: 61.49911 lon: 23.78712 hasResults: False

 nctId: NCT06365099 id: STUDY00000896_Exp2 briefTitle: Identifying Personalized Brain States Predicting Residual Corticospinal Tract Output After Stroke overallStatus: RECRUITING date: 2024-02-02 date: 2026-03-31 date: 2026-03-31 date: 2024-04-15 date: 2024-04-15 name: University of Texas at Austin class: OTHER name: Emory University briefSummary: Transcranial magnetic stimulation (TMS) interventions could feasibly strengthen residual corticospinal tract (CST) connections and promote poststroke hand motor recovery. To maximize the effects of such interventions, they must be delivered during brain activity patterns during which TMS best activates the residual CST and enhances its neural transmission. This approach is termed brain state-dependent TMS. The investigators have recently developed a machine learning framework that identifies personalized brain activity patterns reflecting strong CST activation in neurotypical adults. In this study, the investigators will apply this framework to the poststroke brain for the first time. They will also evaluate relationships between this framework's ability to detect strong and weak CST activation states and measures of CST pathway integrity.

Participants will visit the laboratory for two days of testing that are separated by at least one night of sleep. On Day 1, participants will provide their informed consent. The MacArthur Competence Assessment Tool and the Frenchay Aphasia Screening Test will be used to evaluate consent capacity and confirm the presence of expressive aphasia as needed. Afterwards, participants will complete eligibility screening and clinical assessment of upper extremity motor impairment, motor function, and disability using the Upper Extremity Fugl-Meyer Assessment, the Wolf Motor Function Test, and the Modified Rankin Scale. Participants will then be screened for the presence of residual CST connections from the lesioned hemisphere to the affected first dorsal interosseous muscle. Recording electrodes will be attached to this muscle in order to record TMS-evoked twitches in these muscles. During this procedure, single-pulse TMS will be applied to each point of a 1 cm resolution grid covering primary and secondary motor areas of the lesioned hemisphere at maximum stimulator output. If TMS reliably elicits a muscle twitch in the affected first dorsal interosseous, that participant will be considered to have residual CST connections and will be eligible for the full study. If no muscle twitch is observed, the participant will not be eligible for the full study. Afterwards, recording electrodes will be removed and the participant will leave the laboratory.

On Day 2, participants will return to the laboratory. The investigators will confirm continued eligibility and place recording electrodes on the scalp using a swim-type cap. The investigators will also place recording electrodes on the affected first dorsal interosseous as well as the affected abductor pollicis brevis and extensor digitorum communis muscles. After identifying the scalp location at which TMS best elicits muscle twitches in the affected first dorsal interosseous muscle, the investigators will determine the lowest possible TMS intensity that such evokes muscle twitches at least half of the time. Then, the investigators will deliver 6 blocks of 100 single TMS pulses while participants rest quietly with their eyes open. Stimulation will be delivered at an intensity that is 20% greater than the lowest possible TMS intensity that evokes muscle twitches at least half the time. Afterwards, all electrodes will be removed, participation will be complete, and participants will leave the laboratory.

The investigators will recruit a total of 20 chronic stroke survivors for this study. conditions: Stroke studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: Single-pulse TMS measure: Personalized classifier performance measure: Corticospinal tract-lesion overlap sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Texas at Austin status: RECRUITING city: Austin state: Texas zip: 78712 country: United States name: Sara Hussain role: CONTACT phone: 512-232-2686 email: sara.hussain@austin.utexas.edu lat: 30.26715 lon: -97.74306 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-01-10 uploadDate: 2024-04-05T17:22 filename: ICF_000.pdf size: 462079 hasResults: False

 nctId: NCT06365086 id: STUDY00000608 briefTitle: Targeting Personalized Brain States Reflecting Strong and Weak Corticospinal Tract Output in Real-time overallStatus: ACTIVE_NOT_RECRUITING date: 2023-01-27 date: 2025-01-01 date: 2025-01-01 date: 2024-04-15 date: 2024-04-15 name: University of Texas at Austin class: OTHER name: Emory University briefSummary: Transcranial magnetic stimulation (TMS) interventions could feasibly strengthen residual corticospinal tract (CST) connections and enhance recovery of paretic hand function after stroke. To maximize the therapeutic effects of such interventions, they must be delivered during poststroke brain activity patterns during which TMS best activates the residual corticospinal tract and enhances neural transmission within it (i.e., brain state-dependent TMS). In this study, the investigators will test the feasibility of real-time, personalized brain state-dependent TMS in neurotypical adults.

Participants will visit the laboratory for one day of testing. Upon arrival, participants will provide their informed consent; afterwards, they will complete eligibility screening. The investigators will then place recording electrodes on the scalp using a swim-type cap and on the left first dorsal interosseous, abductor pollicis brevis, and extensor digitorum communis muscles. After determining the location at which TMS best elicits muscle twitches in the left first dorsal interosseous, the investigators will determine the lowest possible intensity at which TMS elicits muscle twitches at least half of the time in this muscle. Then, the investigators will deliver 6 blocks of 100 single TMS pulses while the participant rests quietly with their eyes open; stimulation will be delivered at an intensity that is 20% greater than the lowest possible intensity at which TMS elicits muscle twitches at least half of the time. Afterwards, the investigators will use the muscle and brain activity recordings acquired during these 6 blocks to build a personalized mathematical model that identifies which patterns of brain activity correspond to the largest TMS-evoked muscle twitches. The investigators will then use this model to detect the occurrence of these brain activity patterns in real-time; when these patterns are detected, single TMS pulses will be delivered. Afterwards, all recording electrodes will be removed, participation will be complete, and participants will leave the laboratory.

The investigators will recruit a total of 16 neurotypical adults for this study. conditions: Neurotypical Adults studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: CROSSOVER interventionModelDescription: Participants will receive single-pulse TMS during personalized brain activity patterns reflecting either strong or weak corticospinal tract activation primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 16 type: ESTIMATED name: Personalized brain state-dependent single-pulse TMS measure: Motor-evoked potential (MEP) amplitudes elicited from the left first dorsal interosseous muscle during personalized strong and weak CST states measure: State-targeting accuracy 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 lat: 30.26715 lon: -97.74306 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2023-10-04 uploadDate: 2024-04-05T16:56 filename: ICF_000.pdf size: 305303 hasResults: False

 nctId: NCT06365073 id: TJIRB20231276 briefTitle: A Case-control Study on the Clinical Characteristics of 28-day and 90-day Death From Severe Anthrax overallStatus: RECRUITING date: 2024-03-13 date: 2024-08-31 date: 2024-12-31 date: 2024-04-15 date: 2024-04-15 name: Qin Ning class: OTHER briefSummary: This study is a clinical, multi-center, retrospective, case-control study. Patients clinically diagnosed with severe anthrax who meet the inclusion and exclusion criteria will be included in this study for analysis. Respiratory, circulation, nerve and other vital signs of patients with severe anthrax during hospitalization were recorded, and clinical data such as blood routine, blood biochemistry, coagulation function, myocardial injury, therapeutic drug use, and survival time of patients were recorded, as well as the survival situation of patients 28 days and 90 days after discharge. conditions: Anthrax studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 80 type: ESTIMATED measure: mortality rates of severe anthrax measure: incidence of complications measure: Peripheral blood biomarkers associated with 28-day and 90-day mortality measure: the improvement in 28-day and 90-day mortality with treatment for severe anthrax sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei country: China name: Qin Ning, PHD,MD role: CONTACT phone: +8602783662391 email: qning@vip.sina.com name: Qin Ning, PHD,MD role: PRINCIPAL_INVESTIGATOR name: Tao Chen, PHD,MD role: SUB_INVESTIGATOR lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06365060 id: 00003143 id: R01CA279808 type: NIH link: https://reporter.nih.gov/quickSearch/R01CA279808 briefTitle: Screening for AL Amyloidosis in Smoldering Multiple Myeloma overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2029-02-27 date: 2029-02-27 date: 2024-04-15 date: 2024-04-15 name: Tufts Medical Center class: OTHER name: National Cancer Institute (NCI) briefSummary: In this multicenter study, we will recruit 400 patients 40 years of age or older at 15 centers with a diagnosis of smoldering multiple myeloma (SMM), a group of patients for whom standard of care is observation not treatment. The main goal of this study is to screen for the diagnosis of light-chain amyloidosis (AL) before the onset of symptomatic disease and to develop a training set for a likelihood algorithm. conditions: Smoldering Multiple Myeloma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 400 type: ESTIMATED measure: Creating a network to enroll patients on a collaborative study requiring marrow and blood specimens, to collect data for a training set of likelihood statistics and to plan a future validation study. measure: Validating an NGS assay that identifies IGLV genes in clonal plasma cells sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama Hospital city: Birmingham state: Alabama zip: 35233 country: United States name: Susan Bal, MD role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 facility: Cedars-Sinai Medical Center city: Los Angeles state: California zip: 90048 country: United States name: Robert Vescio, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: University of California, Irvine city: Orange state: California zip: 92868 country: United States name: Lisa Lee, MD role: PRINCIPAL_INVESTIGATOR lat: 33.78779 lon: -117.85311 facility: University of California, San Francisco city: San Francisco state: California zip: 94143 country: United States name: Tom Martin, MD role: PRINCIPAL_INVESTIGATOR lat: 37.77493 lon: -122.41942 facility: Cleveland Clinic Florida, Weston Hospital city: Weston state: Florida zip: 33331 country: United States name: Chakra Chaulagain, MD role: PRINCIPAL_INVESTIGATOR lat: 26.10037 lon: -80.39977 facility: Tufts Medical Center city: Boston state: Massachusetts zip: 02111 country: United States name: Denis Toskic, BS role: CONTACT phone: 617-636-5907 email: denis.toskic@tuftsmedicine.org name: Raymond Comenzo, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Dana-Farber Cancer Institute city: Boston state: Massachusetts zip: 02215 country: United States name: Giada Bianchi, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Columbia University Medical Center city: New York state: New York zip: 10032 country: United States name: Suzanne Lentzsch, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Memorial Sloan Kettering Cancer Center city: New York state: New York zip: 10065 country: United States name: Heather Landau, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: Atrium Health Levine Cancer Institute city: Charlotte state: North Carolina zip: 28204 country: United States name: Cindy Varga, MD role: PRINCIPAL_INVESTIGATOR lat: 35.22709 lon: -80.84313 facility: UNC Lineberger Comprehensive Cancer Center city: Durham state: North Carolina zip: 27705 country: United States name: Sascha Tuchman, MD role: PRINCIPAL_INVESTIGATOR lat: 35.99403 lon: -78.89862 facility: UT Southwestern, Harold C. Simmons Comprehensive Cancer Center city: Dallas state: Texas zip: 75390 country: United States name: Gurbakhash Kaur, MD role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 facility: University of Utah, Huntsman Cancer Hospital city: Salt Lake City state: Utah zip: 84112 country: United States name: Amandeep Godara, MD role: PRINCIPAL_INVESTIGATOR lat: 40.76078 lon: -111.89105 facility: VCU Medical Center city: Richmond state: Virginia zip: 23219 country: United States name: Hashim Mann, MD role: PRINCIPAL_INVESTIGATOR lat: 37.55376 lon: -77.46026 hasResults: False

 nctId: NCT06365047 id: STUDY00004926 briefTitle: Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-06-01 date: 2027-06-01 date: 2024-04-15 date: 2024-04-23 name: Tufts University class: OTHER name: Colgate Palmolive briefSummary: This is a clinical investigation to measure the changes in the oral environment resulting from a 3 month exposure to an arginine containing toothpaste. This study is a double blind, randomized controlled, parallel design. Seventy (70) male and female subjects who meet the inclusion/exclusion criteria will be enrolled in the study. Following oral health evaluations, subjects will be assigned to the treatment schedule and receive their assigned study product. conditions: Xerostomia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: double blinded whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 70 type: ESTIMATED name: 8% Arginine toothpaste name: 1000 ppm F toothpaste measure: Salivary pH Impact measure: Measuring the change in the oral microbiome sex: ALL minimumAge: 18 Years maximumAge: 80 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: NCT06365034 id: YKLL-KY-2024（024） briefTitle: Study on the Efficacy and Safety of Conversion Therapy in Patients With Initially Unresectable Hepatocellular Carcinoma overallStatus: RECRUITING date: 2024-03-01 date: 2024-10-01 date: 2025-01-31 date: 2024-04-15 date: 2024-04-15 name: Qianfoshan Hospital class: OTHER briefSummary: To evaluate the efficacy and safety of conversion therapy in patients with initially unresectable hepatocellular carcinoma (uHCC). conditions: Carcinoma, Hepatocellular studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 92 type: ESTIMATED measure: Pathologic response rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: the Qianfoshan Hospital status: RECRUITING city: Jinan state: Shandong zip: 250000 country: China name: Jing Liang, Dr role: CONTACT phone: +8618663761275 email: liangjing0531@163.com lat: 36.66833 lon: 116.99722 hasResults: False

 nctId: NCT06365021 id: 88887.687583/2022-00 briefTitle: ACT for Syndromic and Subsyndromic Depression in Bipolar Disorder overallStatus: RECRUITING date: 2024-05 date: 2025-08 date: 2026-08 date: 2024-04-15 date: 2024-04-15 name: Beny Lafer class: OTHER briefSummary: The goal of this clinical trial is to test the efficacy of Acceptance and Commitment Therapy (ACT) as a psychotherapeutic treatment for patients with Bipolar Disorder (BD). The following questions will be investigated:

* The efficacy of ACT in reducing depressive symptoms in patients with BD.
* The efficacy of ACT in improving the quality of life in patients with BD.
* The efficacy of ACT in improving functionality in patients with BD.
* The efficacy of ACT in improving sleep quality in patients with BD.
* The efficacy of ACT in improving psychological flexibility in patients with BD

Participants in the clinical group will undergo 12, 2 hours, weekly sessions of Acceptance and Commitment Therapy, in addition to their regular pharmacological treatment.

Participants in the control group will undergo 3, 2 hours, weekly sessions of Bipolar Disorder Psychoeducation Therapy, in addition to their regular pharmacological treatment.

Scales and assessments will be used to measure study outcomes on 3 different time-points: pre-intervention (month 0), post-intervention (month 3) and follow-up (month 6). Mood scales will be assessed every 2 weeks for the duration of treatment and every 4 weeks during the additional 12 week follow-up period. Psychological Flexibility scale will be assessed every week for the duration of treatment; as well as brief mood diary, which will be assessed daily for the duration of treatment.

Results will be compared among both groups to assess the effectiveness of Acceptance and Commitment Therapy as an intervention for syndromic and sub-syndromic depression in bipolar disorder. conditions: Bipolar Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: Acceptance and Commitment Therapy name: Bipolar Disorder Psychoeducation Therapy measure: Montgomery-Asberg Depression Scale measure: Young Mania Rating Scale measure: Functional Assessment Staging Tool measure: World Health Organization Quality of Life Brief Scale measure: Pittsburgh Sleep Quality Index measure: Psychological Flexibility Questionnaire measure: Generalized Anxiety Disorder 7-item Scale measure: Medication Recommendation Tracking Form measure: Regulatory Satisfaction Alertness Timing Efficiency Duration measure: Adhesion and Satisfaction Questionnaire measure: Life Events Scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tatiana Cohab Khafif status: RECRUITING city: São Paulo state: SP zip: 01231010 country: Brazil name: Tatiana Khafif, Master's degree role: CONTACT phone: +5511983389643 email: taticohab@gmail.com lat: -23.5475 lon: -46.63611 hasResults: False

 nctId: NCT06365008 id: SYSKY-2024-210-01 briefTitle: Sintilimab Plus FOLFIRI as Salvage Therapy for Patients With Advanced Gastric Cancer overallStatus: RECRUITING date: 2024-04-08 date: 2027-04-08 date: 2027-09-30 date: 2024-04-15 date: 2024-04-15 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: The combination of immune checkpoint inhibitors and platinum containing dual drugs are more used as a first-line therapeutic approach for patients diagnosed with advanced gastric cancer for its superior efficacy. However, there are no standard recommendations for subsequent treatment after progression on first-line therapy. Here, the investigators conduct this open-label, monocenter, single arm phase II study to evaluate whether sintilimab in combination with irinotecan, leucovorin folinate and fluorouracil can be the salvage therapy for patients diagnosed with unresectable or metastatic gastric cancer progression on first-line therapy. Patients participated in this study will receive sintilimab 3mg/kg for patients with body weight\<60kg or 200mg for patients with body weight ≥ 60kg, plus irinotecan 180mg/m2 intravenous infusion, leucovorin folinate 400mg/m2 intravenous infusion and fluorouracil 400mg/m2 intravenous injection followed by 2400mg/m2 intravenous infusion for 48 hours, repeated every two weeks. The primary endpoint is progression-free survival (PFS). The investigators estimated that 40 patients were necessary. Secondary endpoints include overall survival, objective response rate, disease control rate and safety for unresectable or metastatic gastric cancer. conditions: Unresectable/Metastatic Gastric Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients will receive sintilimab 3mg/kg for patients with body weight\<60kg or 200mg for patients with body weight ≥ 60kg, plus irinotecan 180mg/m2 intravenous infusion, leucovorin folinate 400mg/m2 intravenous infusion and fluorouracil 400mg/m2 intravenous injection followed by 2400mg/m2 intravenous infusion for 48 hours, repeated every two weeks. primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Sintilimab+irinotecan+leucovorin folinate+fluorouracil measure: Progression-free survival measure: Overall survival measure: Objective response rate measure: Disease control rate measure: Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen Memorial Hospital,Sun Yat-sen University status: RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Qiong Yang, Doctor role: CONTACT phone: 13632341201 email: yangqiong05@126.com name: Yajing Liu, Doctor role: CONTACT phone: 13631327315 email: liuyajing1030@126.com lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06364995 id: JKEUPM-2023-1364 briefTitle: Effects of Specialised Physical Education in Volleyball on Middle School Students' Physical Fitness and Performance overallStatus: RECRUITING date: 2024-01-10 date: 2024-06-28 date: 2024-07-05 date: 2024-04-15 date: 2024-04-16 name: Universiti Putra Malaysia class: OTHER briefSummary: Physical education stands as a collaborative, bilateral activity essential for the development and improvement of young people's physical qualities and plays a pivotal role in youth sports promotion. Volleyball offers a blend of aerobic and anaerobic exercises, developing muscle strength, bone density, cardiovascular health, and fine-tuning the nervous system. It is effective in improving physical attributes such as strength, speed, agility, endurance, and coordination, which are crucial for holistic student development and success in the standardized PE entrance examinations for senior high school.

Recent trends have highlighted a decline in physical fitness among youth, as evidenced by rising obesity rates and increasing failure rates in fitness assessments. To counteract this, the Ministry of Education of the People's Republic of China 2021 has initiated a shift towards "specialised physical education," integrating health knowledge with basic and specialised motor skills training. This innovative educational model hopes to improve student physical fitness across educational tiers.

Therefore, this study chose volleyball specialised physical education as an intervention to study the effect of physical fitness and The PE entrance examination for senior high school performance of middle school students. conditions: Physical Fitness conditions: Performance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: In this experiment, the experimental group used the intervention of specialised physical education teaching of volleyball. However, the control group only conducted traditional physical education teaching content primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Volleyball name: Traditional Physical Education measure: Effects of physical fitness of middle school students measure: Effects on middle school students' PE entrance examination for senior high school test performance sex: ALL minimumAge: 13 Years maximumAge: 15 Years stdAges: CHILD facility: Yimou MAO status: RECRUITING city: Chengdu state: Sichuan zip: 610044 country: China name: Yimou MAO, PHD role: CONTACT email: 912327111@qq.com lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06364982 id: PER-ECL-2023-05 briefTitle: Distance Between Dental Implants as a Risk Indicator for Peri-implant Disease. overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2024-12-31 date: 2024-12-31 date: 2024-04-15 date: 2024-04-15 name: Universitat Internacional de Catalunya class: OTHER briefSummary: The aim of this study is to analyse contiguous dental implants and its peri-implant status depending on different inter-implant distances. conditions: Peri-implant Mucositis conditions: Peri-Implantitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 180 type: ESTIMATED name: Two contiguous dental implants placed with less ≤ 3mm from each other. name: Two contiguous dental implants placed with > 3mm from each other. measure: Prevalence of peri-implant diseases. measure: FMPI measure: FMBI measure: mPI measure: mBI measure: SoP measure: PPD measure: MR measure: KM measure: Implant location measure: Implant position measure: Implant type measure: Implant brand measure: Implant roughness measure: Implant diameter measure: Implant length measure: Apico-coronal position of the implant measure: Inter-implant distances (IID) measure: Implant placement protocol measure: Bone grafting procedures (BGP) at implant placement measure: Implant-supported restorations measure: Cleansability of the prosthesis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clínica Universitaria de Odontologia city: Sant Cugat Del Vallès state: Barcelona zip: 08195 country: Spain lat: 41.47063 lon: 2.08611 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-04-10 uploadDate: 2024-04-10T16:21 filename: Prot_SAP_000.pdf size: 82991 hasResults: False

 nctId: NCT06364969 id: 2021-06-02 briefTitle: Investigation of the Pruritogens of Liver-related Diseases overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-08-01 date: 2025-08-01 date: 2024-04-15 date: 2024-04-16 name: Peking University class: OTHER briefSummary: This study hopes investigate the itch-inducing ability of different potential pruritogen candidates of cholestasis pruritus, especially the intrahepatic cholestasis of pregnancy (ICP). In this study, a combination of skin application and needle-free subcutaneous injection was used to investigate whether human endogenous molecules can cause itching. And a questionnaire is used to quantify the intensity of different candidates-induced itch. conditions: Cholestasis conditions: Intrahepatic Cholestasis of Pregnancy studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED measure: Itch intensity measure: Flare areas sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Peking University city: Beijing state: Beijing zip: 100000 country: China name: Guangyi Lan role: CONTACT phone: 13176881226 email: Guangyi_lan@stu.pku.edu.cn name: Yulong Li role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06364956 id: SYSKY-2024-124-02 briefTitle: Phase Ib/II Trail of Neoadjuvant of Tislelizumab Combined With Palbociclib in Patients With Platinum-refractory Bladder Urothelial Carcinoma overallStatus: RECRUITING date: 2024-05 date: 2025-06 date: 2026-06 date: 2024-04-15 date: 2024-04-15 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: In order to explore the safety and antitumor efficacy of different doses of CDK4/6 inhibitor Palbociclib in combination with the Tislelizumab in platinum-refractory cT2-4aN0M0 bladder urothelial carcinoma, a phase Ib/II study was conducted.

This study will adopt a 3+3 design and include two predefined dose groups of palbociclib: 100mg QD, 125mg QD. Initially, Tislelizumab, 200 mg administered by intravenous infusion on Day 1 of each 21-day will be administered in combination. The trial will use the first cycle (28 days) as the observation period for tolerability, observing and evaluating the occurrence of DLTs after medication and determining the maximum tolerated dose/maximum administered dose (MTD/MAD) and recommended phase 2 dose (RP2D) of the combination therapy (30 patients) .

This study provide further evidence for improving the efficacy of neoadjuvant treatment forplatinum-refractory cT2-4aN0M0 bladder urothelial carcinoma and to offer new options for precision treatment of bladder cancer. conditions: Bladder Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Tislelizumab combined with two predefined dose groups of palbociclib name: RP2D dose Of Tislelizumab combined with palbociclib was selected for phase II clinical trial. measure: Phase I: the safety dose of the combination of Tislelizumab and palbociclib measure: Phase II: Pathological complete response rate(pCR) measure: Pathological Downstaging(pDS) measure: Event-free survival (EFS) measure: overall survival (OS) measure: Safety and AE measure: Biomarker Endpoint Analyses sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanfang Hospital, Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong country: China name: Fan Wu, Ph.D role: CONTACT lat: 23.11667 lon: 113.25 facility: Sun Yat-sen Memorial Hospital status: RECRUITING city: Guangzhou state: Guangdong country: China name: Wenlong Zhong, Ph.D role: CONTACT lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital of Sun Yat-sen University status: RECRUITING city: Guangzhou state: Guangdong country: China name: Junxin Chen, Ph.D role: CONTACT lat: 23.11667 lon: 113.25 facility: The Third Affiliated Hospital of Sun Yat-sen University status: RECRUITING city: Guangzhou state: Guangdong country: China name: Yun Luo, Ph.D role: CONTACT lat: 23.11667 lon: 113.25 facility: Zhujiang Hospital of Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong country: China name: Ebai Xu, Ph.D 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 country: China name: Zheng Liu, Ph.D role: CONTACT lat: 30.58333 lon: 114.26667 facility: Hunan Cancer Hospital status: RECRUITING city: Changsha state: Hunan country: China name: Yu Xie, Ph.D role: CONTACT lat: 28.19874 lon: 112.97087 facility: Xiangya Hospital, Central South University status: RECRUITING city: Changsha state: Hunan country: China name: Xiongbing Zu, Ph.D role: CONTACT lat: 28.19874 lon: 112.97087 hasResults: False

 nctId: NCT06364943 id: 202400020B0 briefTitle: Tear Ferning Test for Dry Eye Diagnosis overallStatus: RECRUITING date: 2024-04-05 date: 2025-01-05 date: 2025-04-04 date: 2024-04-15 date: 2024-04-15 name: Chung Shan Medical University class: OTHER briefSummary: Application of tear ferning test for clinical dry eye diagnosis conditions: Dry Eye Syndromes studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 20 type: ESTIMATED name: with/without dry eye syndrome measure: Schirmer's test measure: Tear film breakup time measure: Ocular surface health evaluate measure: Ocular surface disease index measure: Intraocular pressure sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jen-Ai Hospital status: RECRUITING city: Taichung, zip: 412 country: Taiwan name: SHU-YAN PENG, Master role: CONTACT phone: 886-933-854862 lat: 24.1469 lon: 120.6839 hasResults: False

 nctId: NCT06364930 id: SGLT2i_HBV Study briefTitle: SGLT2i to Prevent of Liver Complications in Patients With CHB and Diabetes Mellitus overallStatus: RECRUITING date: 2024-03-26 date: 2030-10-31 date: 2031-03-30 date: 2024-04-15 date: 2024-04-15 name: Chinese University of Hong Kong class: OTHER briefSummary: This is a five-year, double blinded, randomised trial of dapagliflozin versus placebo in patients with chronic hepatitis B and DM or IFG complicated with compensated advanced chronic liver disease (cACLD). 412 subjects will be recruited. Subject will be randomly assigned to receive dapagliflozin 10mg daily or dapagliflozin placebo one tablet daily for up to 5 years. After randomization, subject will be followed up at month 3, month 6 and then 6-monthly until 60 months (follow up ± 4 weeks from scheduled clinic visit is allowed). At each visit, drug compliance, physical examination, observed or reported adverse events will be assessed. 10ml of blood will be taken at each visit and transient elastography to assess fibrosis regression will be performed at 60th month or at withdrawal visit. You are discouraged to use (pegylated)-interferon, any other NA including lamivudine, adefovir, and telbivudine, another SGLT2i Empagliflozin (Jardiance), Dapagliflozin + Metformin XR (Xigduo). conditions: Chronic Hepatitis B studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 412 type: ESTIMATED name: Dapagliflozin 10mg Tab name: Placebo 10mg Tab measure: The primary endpoint is liver complications measure: Cardiovascular complications measure: change in liver stiffness measurement measure: change anthropometric parameters measure: change anthropometric parameters sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prince of Wales Hospital status: RECRUITING city: Hong Kong country: Hong Kong name: Angel ML Chim, MSc role: CONTACT phone: 26324205 email: angelchim@cuhk.edu.hk name: Grace LH Wong, MD role: CONTACT phone: +85235053538 email: wonglaihung@cuhk.edu.hk lat: 22.27832 lon: 114.17469 hasResults: False

 nctId: NCT06364917 id: IRB-300012781 (UAB2432) briefTitle: DISCERN: Dual Versus Single ICB in PDL-1 Negative NSCLC overallStatus: NOT_YET_RECRUITING date: 2024-10-31 date: 2027-01-30 date: 2027-06 date: 2024-04-15 date: 2024-04-26 name: University of Alabama at Birmingham class: OTHER briefSummary: The purpose of this study, known as DISCERN, is to compare two different treatments for a type of lung cancer called non-small cell lung cancer (NSCLC) that does not show a marker known as PD-L1. This study will help us understand if using two types of immune therapy together with chemotherapy is better than using one type of immune therapy with chemotherapy. We're doing this by looking at changes in the subject's cancer's DNA in the blood after starting treatment. conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Pembrolizumab name: Carboplatin name: Paclitaxel name: Pemetrexed name: Nivolumab name: Ipilimumab measure: Rate of Molecular Response in Patients with PD-L1 Negative Advanced NSCLC Treated with Dual vs. Single ICB Plus CT Regimens measure: Efficacy Evaluation measure: Correlation Analysis measure: Progression-Free Survival (PFS) measure: Median Overall Survival (OS) measure: Tolerability Assessment sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama at Birmingham city: Birmingham state: Alabama zip: 35294 country: United States name: Margaret Thomas, MPH role: CONTACT email: margaretannthomas@uabmc.edu name: Aakash Desai, MD role: PRINCIPAL_INVESTIGATOR name: Maya Khalil, MD role: SUB_INVESTIGATOR name: Yanish Boumber, MD role: SUB_INVESTIGATOR lat: 33.52066 lon: -86.80249 hasResults: False

 nctId: NCT06364904 id: SYSKY-2024-123-02 briefTitle: An Phase III Study, Multicenter，Randomized Controlled Trail to Determine the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib for Patients With Untreated Unresectable and Metastatic Urothelial Carcinoma. overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-04-15 date: 2029-04-15 date: 2024-04-15 date: 2024-04-15 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: The aim of this study is to see whether the Trilaciclib is safe and effective in slowing down the growth of bladder cancer in patients while taking chemoimmunotherapy. conditions: Bladder Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 210 type: ESTIMATED name: Tislelizumab, Cisplatin, Gemcitabine and Trilaciclib name: Tislelizumab, Cisplatin, Gemcitabine measure: Progression-Free Survival(PFS) measure: Incidence of Grade 3/4 Neutropenia measure: ORR measure: overall survival (OS) measure: Safety and AE measure: Disease Control Rate(DCR) measure: During Of Response(DOR) measure: Biomarker Endpoint Analyses sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanfang Hospital, Southern Medical University city: Guangzhou state: Guangdong country: China name: Fan Wu, Ph.D role: CONTACT lat: 23.11667 lon: 113.25 facility: Sun Yat-sen Memorial Hospital city: Guangzhou state: Guangdong country: China name: Wenlong Zhong, Ph.D role: CONTACT lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital of Sun Yat-sen University city: Guangzhou state: Guangdong country: China name: Junxin Chen, Ph.D role: CONTACT lat: 23.11667 lon: 113.25 facility: The Third Affiliated Hospital of Sun Yat-sen University city: Guangzhou state: Guangdong country: China name: Yun Luo, Ph.D role: CONTACT lat: 23.11667 lon: 113.25 facility: Zhujiang Hospital of Southern Medical University city: Guangzhou state: Guangdong country: China name: Ebai Xu, Ph.D role: CONTACT lat: 23.11667 lon: 113.25 facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei country: China name: Zheng Liu, Ph.D role: CONTACT lat: 30.58333 lon: 114.26667 facility: Hunan Cancer Hospital city: Changsha state: Hunan country: China name: Yu Xie, Ph.D role: CONTACT lat: 28.19874 lon: 112.97087 facility: Xiangya Hospital, Central South University city: Changsha state: Hunan country: China name: Xiongbing Zu, Ph.D role: CONTACT lat: 28.19874 lon: 112.97087 hasResults: False

 nctId: NCT06364891 id: VMMC NEXUS briefTitle: Assessing the Impact of a Digital VMMC Platform acronym: VMMC NEXUS overallStatus: RECRUITING date: 2023-10-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-15 date: 2024-04-15 name: University of Alabama at Birmingham class: OTHER name: Centre for Infectious Disease Research in Zambia briefSummary: VMMC has been identified as a crucial intervention by UNAIDS to achieve the 2030 global target of a 90% reduction in new HIV infections compared with 2010 levels. CIDRZ, a key partner to the Ministry of Health, has worked with DesireLine to develop a mobile application that supports mobilisers to segment potential clients and provide them with targeted messaging based on their segmentation type. The hypothesis of our proposed study is that targeted interventions addressing the barriers for each of the seven segments, assisted by the Digital Mobilization Tool, will better meet the needs of potential clients and therefore improve uptake of VMMC services, specifically among the three most-resistant segments.

The objective of this study is to evaluate the effect of a segment-targeted mobilization intervention supported by the VMMC NEXUS Digital Mobilization Tool on the uptake of VMMC services at 30 intervention sites, compared with 30 control sites.

The research questions are:

1. What is the effect of segment-targeted mobilization interventions designed to address the specific psycho-behavioral barriers each of the seven segments face, supported by the VMMC NEXUS Digital Mobilization Tool, on the overall numbers of men receiving VMMC in each site?
2. What is the effect of the same on the numbers of men by segment receiving VMMC in each site?
3. What is the effect of the same on the numbers of men by age receiving VMMC in each site?

Secondary goals will be the following, to the extent possible:

* Assess the incremental cost of the intervention, including by MC
* Assess and document process learnings from the intervention
* Develop a workplan to enable national and regional scale-up of the mobilization model and NEXUS Digital Mobilization Tool if demonstrated as effective conditions: Voluntary Medical Male Circumcision studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Cluster randomised control study primaryPurpose: OTHER masking: NONE count: 2000 type: ESTIMATED name: VMMC NEXUS Digital application measure: Total number of VMMC's conducted in intervention vs control measure: Total number of VMMC's by segment measure: Total number of VMMC's by age measure: Costing measure: Process evaluation measure: Develop a workplan and handbook to allow for the intervention to be scaled up elsewhere. sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ministry of Health facilities status: RECRUITING city: Lusaka zip: 10101 country: Zambia name: Carolyn Moore role: CONTACT phone: 0966841034 email: carolyn.bolton@cidrz.org lat: -15.40669 lon: 28.28713 hasResults: False

 nctId: NCT06364878 id: 813533 briefTitle: Non-invasive Diagnostics of Microbial Keratitis overallStatus: RECRUITING date: 2023-08-23 date: 2025-03-01 date: 2028-04-08 date: 2024-04-15 date: 2024-04-15 name: Sorlandet Hospital HF class: OTHER_GOV briefSummary: Infectious keratitis is a significant cause of partial vision loss and blindness and places a large burden on eye care professionals. One of the main challenges for the ophthalmologist when presented with a case of suspected microbial keratitis is the determination of the subtype of keratitis. It must be determined whether the origin of the infection is bacterial, viral, fungal, or parasitic, in order to prescribe a correct, effective treatment aimed at the causative pathogen. In daily practice this can be challenging, and general treatments with antibiotics are prescribed. Some cases then experiences deterioration, resulting in more patients visits and further rounds of invasive treatments and progressive vision deterioration.

This project is designed to break this cycle of nonspecific diagnosis, suboptimal treatment, and progressive worsening of vision with increased interventions. New, advanced diagnostics will be brought into the clinic to provide additional information which, if our hypothesis is correct, will result in more rapid and accurate diagnosis of the keratitis subtype. This will translate into earlier administration of a more targeted treatment, avoiding the repeated round of non-targeted treatment and progressive worsening of the patient's vision. This can directly reduce to number of clinic visits and specialist time required for treatment and follow-up of keratitis, knowledge of how the eye responds to various microbes by initiating a specific cascade of molecular inflammatory signals and changes in protein expression in the tear film.

Using in vivo confocal microscopy (IVCM) we will document the cellular status of the cornea and identify microbes infecting the cornea in real-time. Secondly, tear samples will be obtained from patients with keratitis to evaluate and quantify the molecular cytokine signatures associated with specific microbial species, confirmed by microbiological culture. We will for the first time develop cytokine profiles for the various types of infection, identifying diagnostic cytokines which in the longer term can lead to development of rapid point-of-care biomarker diagnostics.

The project aims are translated into the following hypotheses:

H1: In vivo confocal microscopy imaging features detect microbial keratitis consistent with clinical assessment and outcome at a greater frequency than microbiological culture results.

H2: Cytokine profiles (or a subset of molecules) in the eye are specific for viral, bacterial, fungal, or amoebic keratitis; and H3: A combination of in vivo confocal microscopy and molecular profiling of the tear film can yield a specific keratitis diagnosis closely matching the clinical progression and outcome of keratitis. conditions: Infectious Keratitis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 125 type: ESTIMATED name: In vivo confocal microscopy name: Tear film sampling measure: IVCM findings and cytokine profile in infectious keratitis is specific for the different microbial subtypes. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sorlandet hospital status: RECRUITING city: Arendal country: Norway name: Neil Lagali role: CONTACT lat: 58.46151 lon: 8.77253 hasResults: False

 nctId: NCT06364865 id: 2022-04 briefTitle: AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study acronym: AE05ML overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2025-01-31 date: 2025-03-30 date: 2024-04-15 date: 2024-04-16 name: Teleflex class: INDUSTRY briefSummary: This clinical registry study aims to evaluate the safety and effectiveness of the AE05ML device for ligating vessels and tissue structures during laparoscopic surgery using Hem-o-lok® Medium Large (ML) polymer clips. The primary objective is to assess the device's safety and performance, with secondary objectives focusing on device performance characteristics and operator feedback. conditions: Gall Bladder Disease conditions: Bile Duct Diseases conditions: Acute Cholecystitis conditions: Kidney conditions: Liver conditions: Appendix conditions: Spleen Disease conditions: Prostate studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 161 type: ESTIMATED name: laparoscopic procedure measure: Evaluating the safety of AE05ML measure: Evaluating the performance of AE05ML measure: Evaluating device performance characteristics measure: Evaluating operator reported feedback sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06364852 id: LY007C1101 briefTitle: An Evaluation of LY007 Cell Injection for r/r B-NHL acronym: r/r B-NHL overallStatus: RECRUITING date: 2021-12-25 date: 2024-08-31 date: 2026-05-31 date: 2024-04-15 date: 2024-04-15 name: Ruijin Hospital class: OTHER name: The First Affiliated Hospital with Nanjing Medical University name: Shanghai Longyao Biotechnology Inc., Ltd. briefSummary: An evaluation of LY007 cell injection for recurrent/refractory CD20 was positive Tolerability, safety, and efficacy of B-cell non-Hodgkin lymphoma in open, single-arm Phsea I Clinical research conditions: B-NHL studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: LY007 measure: Maximum tolerated dose or clinically recommended dose; measure: Dose limiting toxicity measure: Adverse Events , Serious Adverse Events , Adverse Events of Particular Concern, Including cytokine release syndrome , neurotoxicity,physical examination, vital signs, ECOG score, ECG, laboratory testing, etc. measure: PK aspect measure: PK aspect measure: PD aspect measure: therapeutic effect measure: Anti LY007 antibody measure: The titer of human anti mouse antibody measure: Exploratory study endpoint sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ruijin hospital status: RECRUITING city: Shanghai country: China name: Weili Zhao, MD role: CONTACT phone: 13512112076 phoneExt: 610707 email: zwl_trial@163.com name: Zixun Yan, MD role: CONTACT phone: +8613482056727 phoneExt: 610707 email: yanzixun125@163.com lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06364839 id: CT2024-ZJU-OBS7 briefTitle: Liver Transplantation for Hepatocellular Carcinoma Arising in Non-cirrhotic Liver: a Propensity Score-matched Retrospective Cohort Study of Two National Databases overallStatus: COMPLETED date: 2024-02-20 date: 2024-03-23 date: 2024-03-25 date: 2024-04-15 date: 2024-04-15 name: Xiao Xu class: OTHER briefSummary: Background: Majority of liver transplantation (LT) recipients for hepatocellular carcinoma (HCC) were concomitant with liver cirrhosis, while few researches focusing on recipients without cirrhosis. Here we aim to investigate the prognosis of non-cirrhosis HCC recipients, expecting to provide theoretical basis for further improvement of these patients.

Methods: This retrospective study analyze outcomes between adult HCC recipients arising in non-cirrhotic and cirrhotic liver from two national databases (CLTR and UNOS, January 2015 to December 2020). Based on important variables, 1:2 and 1:1 propensity score matching (PSM) were performed respectively. conditions: Hepatocellular Carcinoma, Non-cirrhotic Liver studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1 type: ACTUAL measure: Postoperative complications were evaluated by postoperative imaging and serological examination measure: The overall survival rate was evaluated by follow-up investigation and outpatient review measure: The tumor-free survival rate was evaluated by follow-up investigation and outpatient review sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Xiao Xu city: Hangzhou state: Zhejiang country: China lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06364826 id: NPC-202403 briefTitle: Sintilimab Combination Therapy Plus IMRT in Nasopharyngeal Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2026-04-22 date: 2026-04-22 date: 2024-04-15 date: 2024-04-15 name: Zhejiang Cancer Hospital class: OTHER briefSummary: This is a prospective, single-center, single-arm, phase II clinical study. The study was intended to include patients with locoregionally advanced nasopharyngeal cancer identified by histology or cytology, who signed informed consent and met the screening criteria to enter the study. Patients will receive induction therapy (sintilimab + bevacizumab + gemcitabine, Q3W, 3 cycles) followed by IMRT+ Sintilimab. Consolidation therapy with sintilimab continued after radiotherapy until disease progression, intolerable toxicity, death, or the subject's decision to withdraw from the study, with a total treatment period of no more than 12 cycles. conditions: Nasopharyngeal Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Sintilimab, bevacizumab, gemcitabine name: IMRT measure: 3-year Event-free survival rate measure: Objective Response Rate measure: Disease Control Rate measure: Progression-Free Survival measure: Overall survival measure: adverse events(AEs) measure: biomarkers sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06364813 id: H20-01461 briefTitle: Co-developing a Novel Intervention to Promote Wellbeing of Family Caregivers of Individuals With Spinal Cord Injury overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-11 date: 2024-04-15 date: 2024-04-23 name: University of British Columbia class: OTHER name: The Craig H. Neilsen Foundation briefSummary: Family caregivers of individuals with spinal cord injury (SCI) provide the majority of care and are at high risk of experiencing caregiver burden, which not only impacts caregivers' own wellbeing, but also their ability to respond to patients' needs. Health education using online approaches (eHealth) has the potential to improve quality of care, enhance communication between health care users and providers, reduce costs and increase access to existing knowledge and education for family caregivers. Here, the investigators propose a research study to assess the quality of the eHealth program. The findings of this study will lead to the refinement of the eHealth program. conditions: Spinal Cord Injuries conditions: Caregiver Burden studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: COMPANION eHealth Program measure: Family caregivers' subjective burden as assessed by the Zarit Burden Interview measure: Participants' objective burden as assessed by the Dutch Objective Burden Inventory measure: Participants' distress as assessed by the Depression, Anxiety and Stress Scale measure: Participants' relationship quality satisfaction as assessed by the Dyadic Adjustment Scale measure: Participants' health-related quality of life as assessed by the Veterans RAND 12-item Health Survey measure: Caregiver competence as assessed by the Caregiving Competence Scale measure: Participants' opinion regarding the usability of the implementation as assessed by the System Usability Scale measure: Participants' health care use as assessed by a bespoke questionnaire measure: Participants' experience using the implementation as assessed by a qualitative interview measure: A composite measure of recruitment rate, consent rate, retention rate, perceived benefit, and assessor masking will be evaluated as "successful" or "revise" according to expectations measure: A composite measure of treatment adherence, participant and evaluator burden during data collection, and expert burden will be evaluated as "successful" or "revise" according to expectations measure: A composite measure of internet stability, participant processing time, and treatment administration issues will be evaluated as "successful" or "revise" according to expectations measure: A measure of dose level of training time sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06364800 id: GDT-001-07-02 briefTitle: Allogeneic Gamma-delta T Cells Combined With Targeted Therapy and Immunotherapy in a Phase 1 Clinical Trial of Hepatocellular Carcinoma Resistant to PD-1 Monoclonal Antibody overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2026-04-26 date: 2026-09-26 date: 2024-04-15 date: 2024-04-15 name: Beijing 302 Hospital class: OTHER name: Chinese Academy of Medical Sciences name: Beijing GD Initiative Cell Therapy Technology Co., Ltd. briefSummary: The purpose of this study is to evaluate the safety and efficacy of allogeneic γδ T cells combined with targeted therapy and PD-1 monoclonal antibody in patients with hepatocellular carcinoma resistant to PD-1 monoclonal antibody.

Hepatocellular Carcinoma conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: γδ T cells name: PD-1 monoclonal antibody name: targeted drugs measure: Safety evaluation: Incidence of Adverse events (AEs) measure: Safety evaluation: Dose limited toxicity (DLTs) measure: Efficacy evaluation: Objective Response Rate(ORR) measure: Efficacy evaluation: Duration of Response(DOR) measure: Efficacy evaluation: Progress Free Survival(PFS) measure: Efficacy evaluation: Overall Survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06364787 id: GDT-001-07-01 briefTitle: Allogeneic Gamma-delta T Cells Combined With Targeted Therapy and Immunotherapy in a Phase 1 Clinical Trial for First-line Treatment of Hepatocellular Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2026-04-26 date: 2026-09-26 date: 2024-04-15 date: 2024-04-15 name: Beijing 302 Hospital class: OTHER name: Chinese Academy of Medical Sciences name: Beijing GD Initiative Cell Therapy Technology Co., Ltd. briefSummary: The purpose of this study is to evaluate the safety and efficacy of allogeneic γδ T cells combined with targeted therapy and PD-1 monoclonal antibody in first-line treatment of patients with hepatocellular carcinoma. conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: γδ T cells name: Targeted drugs name: PD-1 monoclonal antibody measure: Safety evaluation: Incidence of Adverse events (AEs) measure: Safety evaluation: Dose limited toxicity (DLTs) measure: Safety evaluation: Maximum-tolerated dose (MTD) measure: Efficacy evaluation: Objective Response Rate(ORR) measure: Efficacy evaluation: Duration of Response(DOR) measure: Efficacy evaluation: Progress Free Survival(PFS) measure: Efficacy evaluation: Overall Survival (OS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06364774 id: 22-020309 briefTitle: ALS20-101 Lentiviral Gene Therapy for Beta Thalassemia overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-12-31 date: 2027-12-31 date: 2024-04-15 date: 2024-04-15 name: Children's Hospital of Philadelphia class: OTHER briefSummary: The main goal of this study is to find out if the blood disorder called transfusion-dependent beta thalassemia can be safely treated by modifying blood stem cells. This is done by collecting blood stem cells from the subject, modifying those cells, adding a healthy beta globin gene, and then giving them back to the subject. It is hoped that these modified cells will decrease the need for blood transfusions. The gene modified blood stem cells are called CHOP-ALS20 ("study drug"). This experimental gene therapy has not been tried on human beings before and is not FDA approved. conditions: Beta-Thalassemia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single arm pilot, phase I/II study of 12 subjects. primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: ALS20 measure: Neutrophil Engraftment measure: Platelet Engraftment measure: Overall Survival at 2 years measure: Incidence of transplant related mortality measure: Incidence of Graft Versus Host Disease measure: Incidence of Vector-Derived Replication Competent Lentivirus measure: Insertional Oncogenesis measure: Clonal Predominance measure: maintain total hemoglobin level of 9.0 g/dL or higher sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Children's Hospital of Philadelphia city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Janet Kwiatkowski, MD role: CONTACT phone: 215-590-5286 email: kwiatkowski@chop.edu name: Jaladhikumar Patel role: CONTACT phone: 267-426-5602 email: patelj23@chop.edu name: Janet Kwiatkowski, MD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06364761 id: 24103_BIL_EDOF briefTitle: Assesment of Intermediate Vision After BIL Cataract Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-15 date: 2024-04-15 name: Universitair Ziekenhuis Brussel class: OTHER briefSummary: The goal of this observational study is to learn about the intermediate and near vision in patiënts who underwent cataract surgery with a specific technique, called "bag in the lens".

The main question it aims to answer is whether patiens who underwent this type of cataract surgery have better intermediate vision without spectacle correction than patients who underwent the classic lens in the bag cataract surgery.

Participants will:

* Have to read with and without spectacle correction at different distances (4 meters, 66 centimeters, 40 centimeters)
* Have to fill in 2 questionnaires about visual functioning and spectacle independance

Researchers will compare these values to the same values from the standard population who underwent the classic lens in the bag cataract surgery with a monofocal intraocular lens . conditions: Cataract studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 38 type: ESTIMATED name: Bag in the lens cataract surgery measure: Intermediate vision measure: Near vision sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06364748 id: 002-2024-Shalowitz briefTitle: Expanding Access to Care Through Telemedical Support for Vital Sign Monitoring in High-risk Patients With Cancer overallStatus: RECRUITING date: 2024-03-11 date: 2025-03 date: 2025-09 date: 2024-04-15 date: 2024-04-15 name: West Michigan Cancer Center class: OTHER name: Veta Health briefSummary: A randomized trial of remote blood pressure monitoring, compared to usual care, in patients receiving bevacizumab to determine whether remote blood pressure monitoring improves the collection of blood pressure data, identification and management of clinically significant hypertension, and patient satisfaction. conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 72 type: ESTIMATED name: Cellular enabled blood pressure cuff name: Standard of Care Cuff measure: To determine whether remote blood pressure monitoring improves adherence to recommendations for daily systolic and diastolic blood pressure monitoring compared to usual care measure: Improvement of early identification of bevacizumab-induced hypertension with usual care blood pressure monitoring measure: Improvement of early identification of bevacizumab-induced hypertension with remote blood pressure monitoring measure: Patient satisfaction with usual care blood pressure monitoring measure: Patient satisfaction with remote blood pressure monitoring sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West Michigan Cancer Center status: RECRUITING city: Kalamazoo state: Michigan zip: 49007 country: United States name: Wendi Mitchell role: CONTACT phone: 269-373-7443 email: wmitchell@wmcc.org name: Kathleen Allen role: CONTACT phone: 269-373-7452 email: kallen@wmcc.org lat: 42.29171 lon: -85.58723 hasResults: False

 nctId: NCT06364735 id: Entità e variabili briefTitle: Entities and Variables Related to Catch-up Growth overallStatus: RECRUITING date: 2024-05-01 date: 2024-11-01 date: 2024-12-01 date: 2024-04-15 date: 2024-04-29 name: ASST Fatebenefratelli Sacco class: OTHER briefSummary: A retrospective monocentric observational no-profit study with the aim of evaluating the entity and potential variables influencing the catch-up growth of childhood gluten-free diet patients with celiac disease during a 10-year follow-up. The only extrapolation of the data collected in anonymized form from the medical records of patients who match the necessary study criteria will be planned in order to achieve this aim. A 900-patient sample size will be planned. conditions: Celiac Disease in Children studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 900 type: ESTIMATED measure: Measure the catch-up growth degree. measure: Calculate the degree of catch-up growth measure: Exploratory objectives 1 measure: Exploratory objectives 2 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ASST Fatebenefratelli Sacco status: RECRUITING city: Milan zip: 2015 country: Italy name: Elena MD Groppali role: CONTACT email: elena.groppali@asst-fbf-sacco.it name: Elena MD Groppali role: CONTACT name: Elena MD Groppali role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False

 nctId: NCT06364722 id: ZYS2024-02 briefTitle: Effect of Acupuncture on the Microbiota-gut-brain Axis in Crohn's Disease overallStatus: COMPLETED date: 2015-05-01 date: 2023-12-31 date: 2024-03-28 date: 2024-04-15 date: 2024-04-15 name: Shanghai Institute of Acupuncture, Moxibustion and Meridian class: OTHER name: Fudan University briefSummary: Multidisciplinary techniques such as multimodal neuroimaging, microbiology, and bioinformatics were applied to study the differences in correlation characteristics between gut microbes, functional brain networks, and peripheral inflammation among patients with active Crohn's disease (CD), CD in remission, and healthy subjects. conditions: Crohn Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Subjects, efficacy assessors and statisticians were blinded. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 64 type: ACTUAL name: Acupuncture treatment name: Sham acupuncture measure: Effect of Acupuncture on Crohn's Disease Activity Index (CDAI) measure: Effects of Acupuncture on Anxiety and Depression measure: Effects of Acupuncture on Quality of Life measure: Effect of acupuncture on intestinal inflammation measure: Effects of acupuncture on gut microbiota measure: Effects of acupuncture on the functional activity of brain networks measure: Effects of acupuncture on intestinal inflammation measure: Effect of Acupuncture on Brain Imaging-Gut Microbiological Correlations measure: Safety evaluation (number of participants with abnormal reactions to acupuncture and moxibustion treatment) measure: Safety evaluation (number of participants with abnormal routine blood tests) measure: Safety evaluation (number of participants with abnormal Liver function tests) measure: Safety evaluation (number of participants with abnormal Renal function tests) sex: ALL minimumAge: 16 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06364709 id: 4526 id: R01DC015516 type: NIH link: https://reporter.nih.gov/quickSearch/R01DC015516 briefTitle: Criterion-learning Based Naming Treatment in Aphasia overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2028-08 date: 2028-08 date: 2024-04-15 date: 2024-04-15 name: Albert Einstein Healthcare Network class: OTHER name: Thomas Jefferson University name: National Institute on Deafness and Other Communication Disorders (NIDCD) briefSummary: Aphasia is a disorder of spoken and written language, most commonly following a stroke. It is estimated that between 2.5 and 4 million Americans are living with aphasia today. A common problem in aphasia involves difficulty retrieving known words in the course of language production and comprehension. The overarching goal of this project is to develop and test early efficacy, efficiency, and the tolerability of a lexical treatment for aphasia in multiple-session regimens that are comprised of retrieval practice, distributed practice, and training dedicated to the elicitation of correct retrievals. The aim of this work is to add to and refine the evidence base for the implementation and optimization of these elements in the treatment of production and comprehension deficits in aphasia, and make important steps towards an ultimate goal of self-administered lexical treatment grounded in retrieval practice principles (RPP) to supplement traditional speech-language therapy that is appropriate for People with Aphasia (PWA) from a broad level of severity of lexical processing deficit in naming and/or comprehension. This project cumulatively builds on prior work to develop a theory of learning for lexical processing impairment in aphasia that aims to ultimately explain why and for whom familiar lexical treatments work, and how to maximize the benefits they confer. conditions: Aphasia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: Criterion-learning practice measure: Trained naming items (Experiment 1) measure: Trained naming items (Experiment 2) measure: Trained naming items (Experiment 3) measure: Trained comprehension items (Experiment 4) measure: Trained naming items (Experiment 1) measure: Trained naming items (Experiment 2) measure: Untrained naming items (Experiment 2) measure: Trained naming items (Experiment 3) measure: Trained naming items (Experiment 4) measure: Trained comprehension items (Experiment 4) measure: Untrained comprehension items (Experiment 4) measure: Treatment compliance (Experiment 2) measure: Connected speech output performance sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06364696 id: 4396-CL-0101 briefTitle: A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors overallStatus: RECRUITING date: 2024-04-16 date: 2027-04-30 date: 2027-04-30 date: 2024-04-15 date: 2024-04-29 name: Astellas Pharma Inc class: INDUSTRY briefSummary: Genes contain genetic code which tell the body which proteins to make. Some types of cancer are caused by changes, or mutations, in a gene called KRAS. Researchers are looking for ways to stop the actions of abnormal proteins made from the mutated KRAS gene. The so-called G12D mutation in the KRAS gene is common in people with some solid tumors.

ASP4396 is being developed as a potential new treatment for solid tumors in people who have the G12D mutation in their KRAS gene. ASP4396 is not currently available as a treatment for the public. In this study, researchers will learn how ASP4396 is processed by and acts upon the body. This information will help find a suitable dose and to check for potential medical problems from ASP4396.

In this study, ASP4396 is being given to humans for the first time.

People in this study will be adults with locally advanced (unresectable), or metastatic solid tumors with the G12D mutation in their KRAS gene. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. They may have been previously treated with standard therapies or refused to receive those treatments.

The main aims of the study are to check the safety of ASP4396, how well people cope with medical problems during the study (how well it is tolerated), and to find a suitable dose of ASP4396.

This is an open-label study. This means that people in this study and clinic staff will know that they will receive ASP4396.

This study will be in 2 parts.

Part 1 is called Dose Escalation. Different small groups of people will receive lower to higher doses of ASP4396. For each dose, all medical problems will be recorded. The first group will receive the lowest dose of ASP4396. A medical expert panel will check the results and decide if the next group can receive a higher dose of ASP4396. The panel will do this until all groups have taken ASP4396 or until suitable doses have been selected for Part 2.

Part 2 is called Dose Expansion. Other different small groups of people will receive ASP4396 with the most suitable doses worked out from Part 1. This will help find a more accurate dose of ASP4396 to use in future studies.

In both parts of the study, ASP4396 will be given through a vein. This is called an infusion. Each treatment cycle is 21 days long. People will continue treatment until: they have medical problems from the treatment they can't cope with (can't tolerate); their cancer gets worse; they start other cancer treatment; or they ask to stop treatment.

People will visit the clinic on certain days during their treatment, with extra visits during the first 2 cycles of treatment. The study doctors will check for any medical problems from ASP4396. Also, people in the study will have a health check including blood tests. On some visits they will also have scans to check for any changes in their cancer. Tumor samples will be taken at certain visits during treatment with the option of a tumor sample being taken after treatment has finished.

People will visit the clinic about 7 days after they stop treatment. They will be asked about any medical problems and will have a health check including blood tests.

After this, people will visit the clinic for a health check several times. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their treatment or not.

After treatment has finished, people in the study will be followed up for up to 45 weeks. conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 175 type: ESTIMATED name: ASP4396 measure: Incidence of Dose Limiting Toxicities (DLTs) for ASP4369 measure: Number of Participants with Adverse Events (AEs) measure: Number of Participants with Serious Adverse Events (SAEs) measure: Number of Participants with laboratory value abnormalities and/or AEs measure: Number of Participants with electrocardiogram (ECG) abnormalities and/or AEs measure: Number of Participants with vital sign abnormalities and/or AEs measure: Number of Participants with physical exam abnormalities and/or AEs measure: Number of Participants with Eastern Cooperative Oncology Group (ECOG) performance status score measure: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 measure: Duration of Response (DOR) per RECIST v 1.1 measure: Disease Control Rate (DCR) per RECIST v 1.1 measure: Progression Free Survival (PFS) per RECIST v1.1 measure: Overall Survival (OS) measure: Pharmacokinetics (PK) of ASP4396 in plasma: area under the concentration-time curve from the time of dosing to 24 hours after dosing (AUC24h) measure: PK of ASP4396 metabolite in plasma: AUC24h measure: PK of ASP4396 in plasma: AUC168h measure: PK of ASP4396 metabolite in plasma: AUC168h measure: PK of ASP4396 in plasma: Maximum Concentration (Cmax) measure: PK of ASP4396 metabolite in plasma: Cmax measure: PK of ASP4396 in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough) measure: PK of ASP4396 metabolite in plasma: Ctrough measure: PK of ASP4396 in plasma: Time of maximum concentration (tmax) measure: PK of ASP4396 metabolite in plasma: tmax measure: Change from baseline of Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D amino acid substitution (G12D) tumor samples sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: START Midwest status: RECRUITING city: Grand Rapids state: Michigan zip: 49546 country: United States lat: 42.96336 lon: -85.66809 facility: NEXT Oncology Dallas status: RECRUITING city: Irving state: Texas zip: 75039 country: United States lat: 32.81402 lon: -96.94889 facility: START Mountain Region status: RECRUITING city: West Valley City state: Utah zip: 84119 country: United States lat: 40.69161 lon: -112.00105 facility: NEXT Oncology Virginia status: RECRUITING city: Fairfax state: Virginia zip: 22031 country: United States lat: 38.84622 lon: -77.30637 hasResults: False

 nctId: NCT06364683 id: AIBU-HSF-SDEMIR-04 briefTitle: Coronary Artery Disease and Exercise Adherence overallStatus: NOT_YET_RECRUITING date: 2024-05-13 date: 2024-11-13 date: 2025-05-13 date: 2024-04-15 date: 2024-04-15 name: Abant Izzet Baysal University class: OTHER briefSummary: This study aims to determine the factors affecting exercise adherence in patients with coronary artery disease (CAD). For this purpose, the following measurement tools will be used respectively: (1) "Patient Information Form" including sociodemographic characteristics of the patients and medical information related to the disease, (2) the Exercise Adherence Rating Scale (EARS), (3) Exercise Self-Efficacy Scale (ESE) and, (4) Turkish-Health Literacy Survey Europe-Q12 (HLS-EU-19-12Q-TR). Statistical analyses will be carried out by descriptive statistics (number, percentage, mean, standard deviation, etc.), correlation analysis and regression analysis. conditions: Adherence, Treatment conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 200 type: ESTIMATED name: Survey study measure: exercise adherence measure: predictors for exercise adherence sex: ALL minimumAge: 18 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06364670 id: ZSLL-KY-2023-011-01 briefTitle: Application of Machine Learning Based on fNIRS in Predicting Acupuncture's Efficacy in Treating Tinnitus overallStatus: RECRUITING date: 2024-05 date: 2026-08-31 date: 2026-12-31 date: 2024-04-15 date: 2024-04-15 name: The Third Affiliated hospital of Zhejiang Chinese Medical University class: OTHER briefSummary: This trial aims to use machine learning to analyze fNIRS imaging data of specific brain regions of tinnitus patients, thereby constructing a predictive model of the clinical efficacy of acupuncture for SNT. conditions: Tinnitus studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 500 type: ESTIMATED name: acupuncture measure: Change in resting-state functional connectivity (RSFC) measure: Change in hemoglobin signals measure: Change in Tinnitus Severity Grading measure: Change in Tinnitus Handicap Inventory score measure: Change in average pure-tone threshold sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: the Third Affiliated Hospital of Zhejiang Chinese Medical University status: RECRUITING city: Hangzhou state: Zhejiang zip: 310000 country: China name: Hantong Hu, M.D role: CONTACT phone: 18667103032 phoneExt: 86 email: 413351308@qq.com name: Xiaohan Huang, M.M role: CONTACT phone: 18334334738 phoneExt: 86 email: 1215360683@qq.com name: Hantong Hu, M.D role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06364657 id: IRB00439625 briefTitle: Differences in Corneal Structure and Function in Patients With Sjogrens vs. Non-Sjogrens Dry Eye acronym: IIR overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-07-31 date: 2027-07-31 date: 2024-04-15 date: 2024-04-15 name: Johns Hopkins University class: OTHER briefSummary: In this study the investigators plan to enroll three groups of patients: non-Sjogren's dry eye, Sjogren's dry eye and controls. The study has the following primary goals:

1. To determine whether dry eye is associated with reduced corneal sensation
2. To determine whether reduced corneal sensation is due to the severity of the dry eye, the type of dry eye (primarily aqueous deficient versus primarily evaporative) or entirely related to the presence of Sjogren's
3. To determine whether corneal sensation is associated with ocular or systemic pain symptoms Additionally, the study aims to compare the novel corneal esthesiometer measurements to confocal biomicroscopy findings in determining neurotrophic keratitis (NK) and assess correlations between corneal sensation. conditions: Sjogren's Syndrome conditions: Dry Eye conditions: Neurotrophic Keratitis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: Eye Exam measure: Corneal Epithelium health measure: Corneal Nerve health measure: Correlations Between Corneal Staining Score measure: Correlations Between Patient Symptoms sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins Hospital Wilmer Eye Institute city: Baltimore state: Maryland zip: 21287 country: United States name: Esen K Akpek, MD role: CONTACT phone: 410-955-5490 email: esakpek@jhmi.edu name: Lee W Guo, OD role: SUB_INVESTIGATOR name: Michelle M Hessen, OD role: SUB_INVESTIGATOR name: Esen K Akpek, MD role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 hasResults: False

 nctId: NCT06364644 id: IRB00336599 id: 1P50MD017348-01 type: NIH link: https://reporter.nih.gov/quickSearch/1P50MD017348-01 briefTitle: Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure acronym: UNLOAD-HF overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-09-30 date: 2027-06-30 date: 2024-04-15 date: 2024-04-15 name: Johns Hopkins University class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: This study aims to determine whether a 6-month multilevel intervention involving problem-solving training, exercise training and support from community health workers is more effective in improving outcomes for individuals with low socioeconomic status, type 2 diabetes, obesity, and early cardiac dysfunction than receiving education and access to a community exercise facility. conditions: Type2diabetes conditions: Heart Failure conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The design of the study is a randomized 2:1 parallel-arm clinical trial. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Participants and interventionists will be unblinded, while those assessing outcomes will be blinded to the randomization arm . whoMasked: OUTCOMES_ASSESSOR count: 402 type: ESTIMATED name: Community Champions name: Homegrown Heroes measure: Change in cardiorespiratory fitness measure: Change in cardiac biomarker, hs-cTnT measure: Change in hemoglobin A1c measure: Change in specific problem solving skills as assessed by Health Problem-Solving Scale (HPSS) subscales. measure: Changes in self care measures as assessed by Summary of Diabetes Self-Care Activities Scale (SDSCA) measure: Changes in disease knowledge as assessed by Diabetes and Cardiovascular Disease (CVD) Knowledge Test measure: Changes in physical activity as assessed by Modified Physical Activity Questionnaire (MPAQ) measure: Change in weight (kgs) measure: Change in BMI measure: Change in hip and waist circumference (centimeters) measure: Change in Metabolic Syndrome Severity Z score measure: Change in self-management as assessed by the Patient Activation Measure (PAM-13). measure: Change in quality of life and overall health and well-being as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10 measure: Change in blood pressure (systolic and diastolic (mmHg)) measure: Change in cardiac biomarker, gal-3 measure: Change in cardiac biomarkers, NT-proBNP sex: ALL minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06364631 id: 2023-503317-29-00 id: 2023/3764 type: OTHER domain: CSET number briefTitle: CARE1 Pragmatic Clinical Trial acronym: CARE1 overallStatus: RECRUITING date: 2024-04-12 date: 2032-05-05 date: 2032-05-05 date: 2024-04-15 date: 2024-04-19 name: Gustave Roussy, Cancer Campus, Grand Paris class: OTHER name: European Commission name: CRIS Cancer Foundation name: National Cancer Institute, France name: Rennes University Hospital name: University Hospital, Essen name: Fundació Privada Institut d'Investigació Oncològica de Vall d'Hebron name: The Netherlands Cancer Institute name: Servicio Madrileño de Salud, Madrid, Spain name: Hospital Universitario 12 de Octubre name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano name: Medical University of Vienna name: FAKULTNI NEMOCNICE OLOMOUC name: International Kidney Cancer Coalition name: Association pour la Recherche sur les Tumeurs du Rein name: Resilience name: PRIMAA name: Queen Mary University of London briefSummary: Systemic therapy for renal cell carcinoma (RCC) relies on 2 classes of agents: anti-angiogenic targeted therapy (Vascular endothelial growth factor Tyrosine Kinase Inhibitor- VEGFR TKI) and immune checkpoint inhibitor (ICI), targeting either PD1/PDL1 axis or CTLA4. Combination therapy is SOC for clear cell RCC in all guidelines with either ICI-ICI or ICI-VEGFR TKI. However, no head-to-head comparison have been performed between the 2 approaches and patients are treated based on physician decision without clinical /biomarker factors to guide treatment selection. PDL1 staining is, to date, the biomarker that has demonstrated its ability to enrich for overall survival benefit favoring ICI-ICI strategy in PDL1(+) and ICI-VEGFR TKI in PDL1(-) patients.

Study design has been developed to demonstrate that ICI-ICI is superior to ICI-VEGFR TKI in prolonging Overall Survival (OS) for PDL1(+) patients and to demonstrate that ICI-VEGFR TKI is superior to ICI-ICI in prolonging Progression Free Survival (PFS) and OS for PDL1(-) patients. conditions: Metastatic Kidney Cancer conditions: Metastatic Kidney Carcinoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: International, multicenter, open-label, randomized, controlled Phase 3 trial - 2 arms (A and B) primaryPurpose: TREATMENT masking: NONE count: 1250 type: ESTIMATED name: Nivolumab name: Ipilimumab name: Pembrolizumab name: Cabozantinib name: Axitinib name: Lenvatinib measure: Overall Survival (OS). measure: Progression-free survival according to RECIST 1.1 measure: Objective Response Rate (ORR) according to RECIST 1.1 measure: Quality of Life via questionnaire EQ-5D-5L measure: Quality of Life via questionnaire NNCCN/FACT Kidney Cancer Symptom Index (NFKSI) measure: Quality of Life via questionnaire Kidney Symptom Index (KSI) measure: Duration of Treatment measure: Time to treatment discontinuation (TTD) measure: Treatment-free survival (TFS) measure: Time to subsequent systemic anticancer therapy (TTSST) measure: Incidence of AE's measure: Health Economic evaluation: healthcare costs [France & Netherlands only] measure: Health Economic evaluation: cost-utility [France & Netherlands only] sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gustave Roussy status: RECRUITING city: Villejuif zip: 94805 country: France name: Laurence ALBIGES, MD, PhD role: CONTACT phone: +33 (0)1 42 11 66 90 email: laurence.albiges@gustaveroussy.fr lat: 48.7939 lon: 2.35992 hasResults: False

 nctId: NCT06364618 id: G-24-07 briefTitle: Use of Wearables to Detect Infections in Kidney Transplant Recipients acronym: RENALERT overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-12-31 date: 2027-12 date: 2024-04-15 date: 2024-04-15 name: Institute for Clinical and Experimental Medicine class: OTHER_GOV briefSummary: The goal of this observational study is to develop a machine learning algorithm for early detection of infections in kidney transplant recipients using data recorded by wearable digital health technologies.

The main questions it aims to answer are:

1. What are the biometric data pattern changes in impending infections?
2. What accuracy the machine learning algorithm can achieve?

Participants will be given/use their own wearable device that will record biometric data. Any infection event will be recorded and an algorithm will be trained to recognize changes in biometric data preceding symptomatic infection. conditions: Kidney Transplant Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Accuracy of the algorithm at detecting infections at presymptomatic stage measure: Rate of in-patient admissions measure: Incidence of decrease/increase of Quality of Life sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute for Clinical and Experimental Medicine city: Prague zip: 14021 country: Czechia name: Tereza Metelcova, PhD role: CONTACT phone: +420261262125 email: tereza.metelcova@ikem.cz name: Ivan Zahradka, MD role: PRINCIPAL_INVESTIGATOR name: Vojtech Petr, MD role: SUB_INVESTIGATOR name: Katarina Jakubov, MD role: SUB_INVESTIGATOR lat: 50.08804 lon: 14.42076 hasResults: False

 nctId: NCT06364605 id: IIT_UVIP_MySpace briefTitle: MySpace: the Role of Vision in Representing Space overallStatus: ENROLLING_BY_INVITATION date: 2021-05-03 date: 2021-06-26 date: 2025-12-31 date: 2024-04-15 date: 2024-04-15 name: Istituto Italiano di Tecnologia class: OTHER briefSummary: My Space aims to identify the ontogenesis of spatial representation through cross-sectional and longitudinal studies in infants, children, and adolescents with typical and atypical development (visual impairments). The results will serve for the design and development of a novel multisensory device for sensorimotor rehabilitation in blind children from the early stages of life. conditions: Blindness conditions: Visual Impairment studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 720 type: ESTIMATED name: Rehabilitation with the iReach novel multisensory medical device measure: Perceptual responses to multisensory stimuli measure: Stimuli velocity perception measure: Distance stimuli perception measure: Eye movements measure: Saccade Analysis measure: ERP evaluation and analysis measure: Power of the cortical activity sex: ALL minimumAge: 3 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Unit For Visually Impaired People city: Genova zip: 16152 country: Italy lat: 44.40478 lon: 8.94438 hasResults: False

 nctId: NCT06364592 id: 2024-011-KY briefTitle: Electroacupuncture for Dysmenorrhea Secondary to Adenomyosis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-02 date: 2026-05 date: 2024-04-15 date: 2024-04-15 name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences class: OTHER briefSummary: The aim of this study is to preliminarily evaluate the is to assess the effects and safety of electroacupuncture for moderate to severe dysmenorrhea secondary to adenomyosis. conditions: Dysmenorrhea conditions: Adenomyosis conditions: Electroacupuncture studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Electroacupuncture name: Sham Electroacupuncture measure: The change from baseline in the numerical rating scale (NRS) score on the worst pain measure: The change from baseline in the numerical rating scale (NRS) score on the average pain measure: The change from baseline in the numerical rating scale (NRS) score on the worst pain. measure: Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on average pain. measure: Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on the worst pain. measure: The change from baseline in the Pictorial Blood Loss Assessment Chart (PBAC) score. measure: The change from baseline in the the Cox Menstrual Symptom Scale (CMSS). measure: The change from baseline in the Short Form Endometriosis Health Profile Questionnaire (EHP-5). measure: The change from baseline in the total and sub scores of Hospital Anxiety and Depression Scale (HADS). measure: Proportion of participants with positive expectance assessment measure: Blinding assessment measure: Adherence assessment measure: The change from baseline in the dose of rescue medicine. sex: FEMALE minimumAge: 18 Years maximumAge: 50 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 name: Min Yang role: CONTACT phone: +8618810268077 email: yangmin2019@yeah.net lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06364579 id: 6533 briefTitle: Patient Reported Outcomes (PROs) in Anal Cancer Patient Treated by Intensity Modulated Radiotherapy (IMRT). acronym: PROACT overallStatus: RECRUITING date: 2024-03-28 date: 2027-01-31 date: 2031-01-31 date: 2024-04-15 date: 2024-04-15 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: Radiochemotherapy is the standard treatment for neoplasms of the anal canal with excellent rates of local control and preservation of the anal sphincter. However, patients may experience a deterioration of quality of life related to sequelae of the treatment particularly at intestinal, anal sphincter and sexual level. Few studies to date have documented patient-reported outcomes (PROs) in this area. The aim of this observational study is to verify the quality of life (QOL) of the patients by means of self-completed questionnaires. conditions: Anal Cancer Patients studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 120 type: ESTIMATED measure: QOL analysis measure: Overall survival (OS) measure: Colostomy Free Survival (CFS) measure: Loco-Regional Recurrence (LRR) measure: Disease-Free Survival (DFS) measure: Acute toxicity measure: Late toxicity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario A. Gemelli IRCCS status: RECRUITING city: Rome state: Lazio zip: 00168 country: Italy name: Stefania Manfrida, MD role: CONTACT phone: +3900630154434 email: stefania.manfrida@policlinicogemelli.it name: Stefania Mandrida role: CONTACT phone: +390630155701 name: Stefania Manfrida, MD role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False

 nctId: NCT06364566 id: time-exploring briefTitle: Exploring the Optimal Timing of Minimally Invasive Surgery for Esophageal Squamous Cell Carcinoma overallStatus: COMPLETED date: 2010-10-15 date: 2016-10-15 date: 2019-10-15 date: 2024-04-15 date: 2024-04-15 name: Shanghai Zhongshan Hospital class: OTHER briefSummary: The optimal interval between neoadjuvant chemradiotherapy and esophagectomy is still a question that needs to be explored for patients with esophageal squamous cell carcinoma. In this study, based on previous studies, the investigators divided patients into two groups with a cutoff value of 50 days. By comparing the overall survival and disease-free survival of the entire population and non PCR population, the investigators ultimately obtained the optimal surgical timing suitable for clinical use conditions: Time studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 303 type: ACTUAL name: Neoadjuvant chemradiotherapy name: Minimally invasive esophagectomy measure: The overall survival of the overall population measure: The Disease-Free survival of the overall population measure: The overall survival of the non-PCR population measure: The Disease-Free survival of the non-PCR population measure: The overall survival of the PCR population measure: The Disease-Free survival of the PCR population sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongshan Hospital Affiliated to Fudan University city: Shanghai state: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2021-10-15 uploadDate: 2024-04-10T05:47 filename: SAP_000.pdf size: 119312 hasResults: False

 nctId: NCT06364553 id: NL86416.078.24 briefTitle: Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study acronym: ENTRANCE overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-05-01 date: 2024-04-15 date: 2024-04-15 name: Erasmus Medical Center class: OTHER briefSummary: A single center prospective observational non-randomized clinical study to assess the safety and efficacy of placement of a new esophageal self-expandable metal stent (SEMS) for palliation of patients with malignant dysphagia. conditions: Oesophageal Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Esophageal self-expandable metal stent measure: Complication: incidence of perforation measure: Complication: incidence of hemorrhage measure: Complication: incidence of fistula formation measure: Complication: incidence of gastroesophageal reflux measure: Complication: incidence of stent migration measure: Efficacy: clinical outcome measure: Efficacy: incidence of patients receiving technical successful stent placement measure: Incidence of recurrent dysphagia measure: Pain related to esophageal stent (placement) measure: Overall survival measure: Patient characteristic: age measure: Patient characteristic: gender measure: Patient characteristic: tumor location measure: Patient characteristic: tumor histology measure: Stent characteristic: length of the stent measure: Stent characteristic: diameter of the stent measure: Patient characteristic: prior radiotherapy measure: Patient characteristic: prior chemotherapy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06364540 id: 2023-08-14 briefTitle: Nebulized Ketamine to Nebulized Fentanyl for Treating Acute Painful Conditions in the ED acronym: KETAFEN overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-06-30 date: 2026-12-31 date: 2024-04-15 date: 2024-04-15 name: Antonios Likourezos class: OTHER briefSummary: In situations where intravenous access is not readily available or is unobtainable and the intranasal route is not feasible, another non-invasive route of ketamine administration, such as inhalation via breath-actuated Nebulizer (BAN), is becoming a viable alternative. The BAN allows the controlled, patient-initiated delivery of analgesics in a measured and titratable fashion. (18) Ketamine has been studied as a nebulized drug in a lot of different settings and for a lot of different reasons, such as to treat acute pain after surgery (like a sore throat after being intubated), as a pre-medication for general anesthesia, to treat cancer pain, and as a therapy for asthmaticus.

Our research team has published two case series of 10 adult patients who were given nebulized ketamine (via BAN) for a variety of acute traumatic and non-traumatic painful conditions. The patients showed a 60% decrease in pain and a small number of side effects. Furthermore, our group published a randomized, double-blind trial of 120 adult patients evaluating the analgesic efficacy and safety of nebulized ketamine at three different dosing regimens for acute pain in the ED (0.75 mg/kg, 1 mg/kg, and 1.5 mg/kg), showing similar analgesic efficacy between the three different dosing regimens for short-term (up to 120 minutes) pain relief. Lastly, we recently completed a randomized, double-blind, double-dummy clinical trial comparing the analgesic efficacy and safety of nebulized ketamine and intravenous ketamine in managing acute pain in adult ED patients, with data currently being analyzed.

Nebulized fentanyl given in the ED to adults with acute traumatic and non-traumatic pain syndromes at a dose range of 1.5-4 mcg/kg showed the same or even better pain-relieving effects than IV fentanyl and IV morphine alone.

Our objective is to compare the analgesic efficacy and rates of side effects of a 0.75 mg/kg dose of ketamine administered via breath-actuated nebulizer (BAN) to a dose of 3 mcg/kg of fentanyl administered via breath-actuated nebulizer (BAN) in adult patients presenting to the ED with acute painful conditions. conditions: Pain, Acute studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Ketamine name: Fentanyl measure: Reduction of pain scores on the numeric rating pain scale (NRS) measure: Need for Rescue Analgesia measure: Severity of Adverse Events measure: Evaluation of Severity of agitation and/or sedation sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-18 uploadDate: 2024-04-05T12:16 filename: Prot_SAP_000.pdf size: 208117 hasResults: False

 nctId: NCT06364527 id: ADH-BSA-02-23 briefTitle: Use of Aptar Digital Health's Respiratory Disease Management Platform for Asthma overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-11 date: 2024-04-15 date: 2024-04-15 name: CoheroHealth class: INDUSTRY name: Aptar Digital Health name: Lindus Health briefSummary: The United Kingdom has a high prevalence of asthma (over 12%) and some of the worst health outcomes in Europe. The management of respiratory disease and associated patient outcomes has long been an area of focus and improvement for the National Health Service. With the advancement of digital health technology, there is the potential to transform patient care and improve outcomes.

The Aptar Digital Health respiratory disease management platform, a digital therapeutic will be utilized to determine its value and how it supports: i) asthma patient engagement and facilitates communication between patients and providers to accelerate medication adherence; ii) asthma control through the use of the Asthma Control Questionnaire-5. In addition, spirometry and fractioned exhaled nitric oxide will be utilized during the study to validate and enhance current National Institute for Health and Care Excellence guidelines. conditions: Asthma Chronic studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 118 type: ESTIMATED name: Aptar Digital Health respiratory disease management platform measure: Asthma Control Questionnaire - 5 scores measure: Mini-Asthma Quality of Life Questionnaire measure: Rescue medication usage measure: Inhaled corticosteroid steroid daily adherence measure: Step-up from inhaled corticosteroids to biologics measure: Asthma related oral corticosteroids utilization and associated cost measure: Asthma related accident and emergency department visits and associated cost measure: Asthma related unscheduled outpatient clinic visits and associated cost measure: Asthma related inpatient hospitalization, associated length of stay, and associated cost measure: Computer System Usability Questionnaire measure: Semi-structured interviews using the 2019 Rudin et al study sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06364514 id: IRB-P00047313 briefTitle: PICNIC Study - PatIent Centered aNtIbiotic Courses in Children With Medical Complexity overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-07-01 date: 2025-10-01 date: 2024-04-15 date: 2024-04-15 name: Boston Children's Hospital class: OTHER briefSummary: To determine if clinicians can safely reduce antibiotic exposure in children with medical complexity (CMC) who are diagnosed with pneumonia by implementing an intervention that bases total antibiotic duration on an individual's clinical stability. conditions: Pneumonia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Clinical Stability Assessment measure: Proportion of eligible patients who consent to participate in the intervention measure: Rate of persistent and worsening respiratory symptoms measured by patient's clinical status; the rate of emergency department revisit or hospital readmission within 1 week of antibiotic discontinuation measure: Median days of antibiotics received for patients in the intervention group as well as from historical control group sex: ALL minimumAge: 2 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06364501 id: KH801 briefTitle: Phase 1 Trial of KH801 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2030-05-01 date: 2024-04-15 date: 2024-04-17 name: Beijing Kanghong Biopharmaceutical Co., Ltd. class: INDUSTRY briefSummary: KH801 is a injection used for advanced solid tumors which must be diluted with 5% Dextrose Or 0.9% sodium chloride Injection.

This study is expected to include a total of approximately 17-42 participants. conditions: Advanced Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 17 type: ESTIMATED name: KH801 measure: MTD measure: DLT measure: RP2D measure: AE measure: Cmax measure: Tmax measure: T1/2 measure: AUC0-t measure: CL measure: AUC0-inf measure: anti-drug antibody (ADA) measure: Objective Response Rate（ORR） measure: Disease Control Rate (DCR) measure: Duration of Response (DOR) measure: Median Progression-Free Survival (mPFS) measure: Overall Survival（OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Cancer Hospital city: Peking state: Beijing country: China name: Lin Shen role: CONTACT name: Lin Shen role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Sun Yat-sen Memorial Hospital,Sun Yat-sen University city: Guangzhou state: Guangdong country: China name: ErWei Song role: CONTACT phone: 18982182468 email: 022516@cnkh.com name: ErWei Song role: PRINCIPAL_INVESTIGATOR name: Junyan Wu role: PRINCIPAL_INVESTIGATOR name: Herui Yao role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: Central Hospital Affiliated To Shandong First Medical University city: Jinan state: Shandong country: China name: Meili Sun role: CONTACT name: Meili Sun role: PRINCIPAL_INVESTIGATOR lat: 36.66833 lon: 116.99722 facility: West China Second University Hospital,Sichuan University/West China Women's and Children's Hospital city: Chengdu state: Sichuan zip: 610000 country: China name: Rutie Yin role: CONTACT name: Rutie Yin role: PRINCIPAL_INVESTIGATOR lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06364488 id: 295721 briefTitle: TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-31 date: 2025-07-31 date: 2024-04-15 date: 2024-04-15 name: BlueSkeye AI class: INDUSTRY name: Institute of Mental Health Nottingham name: Nottinghamshire Healthcare NHS Trust name: Nottingham University Hospitals NHS Trust briefSummary: This trial will assess the safety, feasibility, acceptability, usability and agreement with validated scales of an automated mood monitoring App (TrueBlue), in adult, perinatal participants (recruited between 12 weeks of pregnancy and 12 weeks post-partum), recruited across multiple sites in Nottinghamshire, United Kingdom (UK). An initial within-study pilot phase will assess key aspects of the study including recruitment rate, usability issues and a detailed understanding of any device related adverse events; prior to full recruitment of a total 125 participants over a total 14-month period. conditions: Depression conditions: Depression, Postpartum conditions: Anxiety in Pregnancy conditions: Anxiety conditions: Anhedonia conditions: Perinatal Depression studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 125 participants, of whom 12 will enter the initial 5-month within-study pilot phase aimed at understanding any device-related adverse events and usability issues. primaryPurpose: OTHER masking: NONE count: 125 type: ESTIMATED name: TrueBlue App measure: The rate of device related adverse events measure: Rate of initial use (assessing feasibility and acceptability) measure: Rate of New Depression or Risk (Suicidality) events measure: Rate of referral to Perinatal Psychiatry services measure: Rate of acceptance of referrals to Perinatal Psychiatry measure: Diagnosis rate for depression, or other mental health problems, during the period of study. measure: Continued use (acceptability) measure: Loss to follow-up measure: Usability (quantitative measure) measure: Agreement between TrueBlue generated score and validated scales measure: Thematic results sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nottingham University Hospitals NHS Trust city: Nottingham state: Nottinghamshire zip: NG7 2UH country: United Kingdom name: Nia Jones role: CONTACT email: Nia.Jones@nottingham.ac.uk role: CONTACT email: TrueBlue@nottingham.ac.uk name: Nia Jones role: PRINCIPAL_INVESTIGATOR lat: 52.9536 lon: -1.15047 facility: Nottinghamshire Healthcare NHS Foundation Trust city: Nottingham zip: NG3 6AA country: United Kingdom name: Bonnie MILLAR role: CONTACT email: bonnie.millar@nottingham.ac.uk role: CONTACT email: TrueBlue@nottingham.ac.uk name: Neil Nixon, MBBS, DM role: PRINCIPAL_INVESTIGATOR name: Deepa Bagepalli Krishnan role: SUB_INVESTIGATOR name: Zaib un Nisa role: SUB_INVESTIGATOR name: Amy Au-Yong role: SUB_INVESTIGATOR name: Christina Kelly role: SUB_INVESTIGATOR lat: 52.9536 lon: -1.15047 hasResults: False

 nctId: NCT06364475 id: BezmialemVU-TF-AÖ-1 briefTitle: Could a Time-restricted Diet Compete With a Calorie-restricted 6-meal Diet? overallStatus: COMPLETED date: 2021-11-01 date: 2022-07-01 date: 2022-09-01 date: 2024-04-15 date: 2024-04-15 name: Bezmialem Vakif University class: OTHER briefSummary: The prevalence of obesity and obesity-related diseases are on the rise worldwide. The widely accepted approach in dietary treatment of obesity is the calorie-restricted three meals-three snacks a day diet; however, alternative approaches are needed. This study was conceived with a view to comparing time-restricted eating, a method which can be easily conveyed and applied in overcoming obesity, to a six meals a day diet. 174 participants aged between 18-65 with a BMI\>25 kg/m2 were included. Diet lists with similar calorie, macro counts suitable for their respective group were prepared. Anthropometric measurements, blood pressure, blood tests were analyzed before the study and at the end of the 8-week. conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: One group 16:8 time-restricted intermittent fasting and the other group energy-restricted six-meal eating. Both of groups with an eating plan suitable with their groups and 400 kcal lower than the total daily energy requirement and with similar macronutrient content (50% carbohydrates, 25% fat and 25% protein). primaryPurpose: PREVENTION masking: NONE count: 137 type: ACTUAL name: 16:8 Time-Restricted Intermittent Fasting Group name: Energy-Restricted Six-Meal Group measure: Weight measured in kilogram measure: Body composition measure: Body mass index measure: Waist-to-height ratio (WHtR) measure: Waist circumference in centimetres sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: İstanbul Sabri Artam Vakfi Family Medicine Center city: İ̇stanbul zip: 34473 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06364462 id: ZLRK202301 briefTitle: Precise Evaluation Criteria for Histological Regression of NASH Fibrosis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-03-09 date: 2027-04-01 date: 2024-04-15 date: 2024-04-15 name: Beijing Friendship Hospital class: OTHER briefSummary: It is an observational study of NASH patients with a calculated sample size of 220. Liver biopsy-proven NASH fibrosis with stage F2-F4 will be recruited in this study. A second biopsy will be performed after clinical trials or 1-3 years of lifestyle intervention. Patients will be followed up at baseline and every six months with h-CRP, liver function tests, fasting blood glucose, fasting insulin, ferritin, liver ultrasonography, and liver stiffness measurements. conditions: NASH conditions: Liver Fibrosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 220 type: ESTIMATED name: lifestyle intervention measure: Regression of NASH fibrosis measure: Dynamic changes of liver stiffness measurements (LSM) measure: Dynamic changes of CAP measure: Dynamic changes of MRE measure: Dynamic changes of MRI-PDFF measure: Dynamic changes of non-invasive liver fibrosis models measure: Dynamic changes of non-invasive liver fibrosis models measure: Dynamic changes of non-invasive liver fibrosis models measure: Dynamic changes of non-invasive liver fibrosis models measure: Dynamic changes of non-invasive liver fibrosis models measure: Dynamic changes of metabolic markers measure: Dynamic changes of metabolic markers measure: Dynamic changes of metabolic markers measure: Incidence of liver-related events measure: Incidence of extrahepatic related events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06364449 id: 202309052RIND briefTitle: Clinical Decision Tree Analysis of Hemodialysis Arteriovenous Access Choices and Creations - a Multiple-center Retrospective Cohort Study overallStatus: RECRUITING date: 2023-10-13 date: 2024-05-07 date: 2024-05-31 date: 2024-04-15 date: 2024-04-15 name: National Taiwan University Hospital class: OTHER briefSummary: Our study aim was to utilize a decision tree analysis (DTA) model to gain insight into the decision-making process within a multiple-center cohort. conditions: Decision Tree Analysis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 600 type: ESTIMATED name: No intervention measure: predicted AV access choices measure: to determine factors affecting clinical use of the targeted AV access over a variable timeframe sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Taiwan University Hospital status: RECRUITING city: Taipei country: Taiwan name: Chih-Yang Chan, MD Phd role: CONTACT lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06364436 id: AksarayU1 briefTitle: Distant Reiki Therapy on Postpartum Period Fatigue and Depression overallStatus: ACTIVE_NOT_RECRUITING date: 2022-06-03 date: 2024-03-18 date: 2024-04-10 date: 2024-04-15 date: 2024-04-15 name: Aksaray University class: OTHER briefSummary: This research was conducted to evaluate the effect of Reiki therapy applied to women in the postpartum period on the risk of fatigue and postpartum depression. conditions: PostPartum Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 85 type: ESTIMATED name: Reiki energy therapy measure: Visual Analog Scale for Fatigue (VAS-F) measure: Edinburgh Postnatal Depression Scale (EPDS) sex: FEMALE minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Aksaray University city: Aksaray state: Merkez country: Turkey lat: 38.37255 lon: 34.02537 hasResults: False

 nctId: NCT06364423 id: 10001599 id: 001599-C briefTitle: Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for Chronic Lymphocytic Leukemia (CLL) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2029-07-01 date: 2030-07-01 date: 2024-04-15 date: 2024-04-26 name: National Cancer Institute (NCI) class: NIH briefSummary: Background:

Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are blood cancers that affect certain white blood cells. Advanced forms of these diseases are difficult to treat. CD19 is a protein often found on the surfaces of these cancer cells. Researchers can modify a person's own immune cells (T cells) to target CD19. When these modified T cells are returned to the body-a treatment called anti-CD19 chimeric antigen receptor (CAR) T cell therapy-they may help kill cancer cells.

Objective:

To test anti-CD19 CAR T cell therapy in people with CLL or SLL.

Eligibility:

People aged 18 years and older with CLL or SLL that has not been controlled with standard drugs.

Design:

Participants will be screened. They will have imaging scans and tests of their heart function. If a sample of tissue from their tumor is not available, a new one may be taken; the sample will be tested for CD19.

Participants will receive a drug to reduce the leukemia cells in their blood. Then they will undergo apheresis: Blood will be taken from the body through a needle. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different needle. The collected T cells will be gene edited to make them attack cells with CD19.

Participants will take drugs to prepare them for treatment for 3 days. These drugs will start 5 days before the treatment. Then their own modified CAR T cells will be returned to their bloodstream. Participants will stay in the hospital for at least 9 days after the treatment.

Follow-up visits will continue for 5 years. conditions: B-Cell Chronic Lymphocytic Leukemia conditions: Leukemia, Lymphocytic, Chronic, B-Cell conditions: B-Lymphocytic Leukemia, Chronic studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 66 type: ESTIMATED name: Autologous HuCD19 ( Anti-CD19)CAR T cells name: Cyclophosphamide name: Fludarabine name: Rituximab measure: Phase I: Determine the safety of administering T-cells expressing a fully-human anti-CD19 CAR to participants with advanced CLL or SLL. measure: Phase II: Determine the overall response rate (ORR) of T cells expressing an anti-CD19 CAR with a fully-human single chain variable fragment (scFv) to participants with advanced CLL measure: Phase I: Assess overall response rate measure: Phase I+II: Assess complete response rate measure: Phase I+II: Assess duration of responses measure: Phase I+II: Determine the ORR for re treatment with rituximab, chemotherapy and CAR T cells in eligible patients measure: Phase II: Determine the frequency of grade 3-4 adverse events at the Optimal Dose 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: NCI Medical Oncology Referral Office role: CONTACT phone: 240-760-6050 email: ncimo_referrals@nih.gov name: Micaela Ganaden, M.D. role: CONTACT phone: (240) 858-3654 email: ncicar@mail.nih.gov lat: 38.98067 lon: -77.10026 hasResults: False

 nctId: NCT06364410 id: NCI-2024-02982 id: NCI-2024-02982 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 10554 type: OTHER domain: University of Texas MD Anderson Cancer Center LAO id: 10554 type: OTHER domain: CTEP id: UM1CA186688 type: NIH link: https://reporter.nih.gov/quickSearch/UM1CA186688 briefTitle: Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-08-30 date: 2026-03-31 date: 2026-03-31 date: 2024-04-15 date: 2024-04-25 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase I trial tests the safety, side effects, and best dose of azenosertib in combination with trastuzumab deruxtecan in treating patients with HER2-positive and cyclin E amplified gastric or gastroesophageal junction cancer and other HER2-positive solid tumors that have spread to nearby tissue or lymph nodes (locally advanced), that have spread from where it first started (primary site) to other places in the body (metastatic), or that cannot be removed by surgery (unresectable). Azenosertib is in a class of medications called kinase inhibitors. It inhibits a protein called Wee1. Inhibition of the Wee1 protein can make tumor cells more vulnerable to chemotherapy drugs, leading to tumor cell death. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers deruxtecan to kill them. Giving azenosertib in combination with trastuzumab deruxtecan may be safe, tolerable, and/or more effective in treating patients with locally advanced, metastatic, or unresectable HER2-positive gastric, gastroesophageal junction, or other solid tumors, compared to just trastuzumab deruxtecan alone. conditions: Clinical Stage III Gastric Cancer AJCC v8 conditions: Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 conditions: Clinical Stage IV Gastric Cancer AJCC v8 conditions: Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 conditions: Locally Advanced Gastric Carcinoma conditions: Locally Advanced Gastroesophageal Junction Adenocarcinoma conditions: Locally Advanced Malignant Solid Neoplasm conditions: Metastatic Gastric Carcinoma conditions: Metastatic Gastroesophageal Junction Adenocarcinoma conditions: Metastatic Malignant Solid Neoplasm conditions: Unresectable Gastric Carcinoma conditions: Unresectable Gastroesophageal Junction Adenocarcinoma conditions: Unresectable Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: Azenosertib name: Biopsy name: Biospecimen Collection name: Computed Tomography name: Echocardiography name: Magnetic Resonance Imaging name: Multigated Acquisition Scan name: Trastuzumab Deruxtecan measure: Maximum tolerated dose measure: Recommended phase 2 dose measure: Incidence of dose limiting toxicities (DLTs) measure: Incidence of adverse events (AEs) measure: Objective response rate (ORR) measure: Progression free survival (PFS) measure: Duration of response measure: Pharmacodynamic effects in the tumor measure: Predictors of response and acquired resistance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06364397 id: ESPRIT202403 briefTitle: Efficacy of ERCP in the Diagnosis and Treatment of Idiopathic Recurrent Acute Pancreatitis acronym: ESPRIT overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-03 date: 2026-05 date: 2024-04-15 date: 2024-04-18 name: Changhai Hospital class: OTHER name: Peking Union Medical College Hospital name: First People's Hospital of Hangzhou briefSummary: The goal of this clinical trial is to learn if endoscopic retrograde cholangiopancreatography (ERCP) works to treat idiopathic recurrent pancreatitis (IRAP) in adults. It also clarify the efficacy of ERCP in the diagnosis of IRAP. The main questions it aims to answer are:

Does ERCP reduce the frequency of pancreatitis episodes in IRAP patients? Does ERCP contribute to identify the etiology of IRAP patients?

Participants will be randomly allocated to receive ERCP (pancreatic sphincterotomy and pancreatic stent placement) or conservative treatment and be followed for 1 year. conditions: Recurrent Acute Pancreatitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 158 type: ESTIMATED name: ERCP name: Health education and conservative management of clinical routines measure: Recurrence rate of AP measure: Ratio of reduced AP episodes measure: Proportion of patients with reduced AP episodes measure: Severity of AP measure: Evaluation of quality of life measure: Evaluation of psychological condition measure: Proportion of patients diagnosed by ERCP. sex: ALL minimumAge: 18 Years maximumAge: 70 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: NCT06364384 id: E2024074 briefTitle: Radical Synchronous Chemoradiotherapy With DDP/5-FU and PD-1 for Non-metastatic Rectal Squamous Cell Carcinoma overallStatus: RECRUITING date: 2024-04-20 date: 2024-04-20 date: 2027-02-28 date: 2024-04-15 date: 2024-04-15 name: Sixth Affiliated Hospital, Sun Yat-sen University class: OTHER briefSummary: The goal of this clinical trial is to learn if PD-1 monoclonal antibody combined with radical chemoradiotherapy works to treat rectal squamous cell carcinoma (rSCC). lt will also learn about the safety of the regime. The main questions it aims to answer are:

Does PD-1 monoclonal antibody combined with radical chemoradiotherapy improve survival prognosis? What is the complete response rate (CCR) of the regime？ Researchers will compare PD-1 monoclonal antibody combined with radical chemoradiotherapy to previous study to see if this regime works to treat rSCCs.

Participants will receive chemotherapy with DDP and 5-FU, immunotherapy with PD-1 monoclonal antibody and radiotherapy with a total dose of 50-54GY. conditions: Rectal Squamous Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: PD-1 and CRT measure: 1-year tumor-free survival(DFS) measure: 1-year overall survival (OS) measure: 1-year relapse-free survival (RFS) measure: 1-year metastasis free survival (DMFS) measure: Incidence of chemotherapy and immunotherapy-related adverse reactions measure: Complete response rate (CRR) measure: 1-year stoma-free survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sixth Affiliated Hospital, Sun Yat-sen University status: RECRUITING city: Guangzhou state: Guangdong country: China name: Jun Huang, MD role: CONTACT phone: +86-13926451242 email: huangj97@mail.sysu.edu.cn lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06364371 id: E2023210 briefTitle: Dynamic Multi-omics Integration Model to Predict Neoadjuvant Therapy Response in Locally Advanced Rectal Cancer overallStatus: RECRUITING date: 2024-05-01 date: 2025-06-01 date: 2026-06-01 date: 2024-04-15 date: 2024-04-15 name: Sixth Affiliated Hospital, Sun Yat-sen University class: OTHER briefSummary: The goal of this observational study is to establish a dynamic multi-omics integration model for predicting pathological complete response (pCR) after neoadjuvant treatment in locally advanced (T3-4NxM0) rectal cancer, providing support for subsequent patient selection for the watch-and-wait strategy. The main question it aims to answer is:

What is the predictive value of this model to assess individual achievement of pathological complete response (pCR) after neoadjuvant treatment? Eligible patients will be prospectively enrolled, and the clinical features of their pre-neoadjuvant treatment, during-treatment, and post-treatment preoperative will be collected and annotated. conditions: Predictive Cancer Model conditions: Pathologic Complete Response studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 106 type: ESTIMATED name: Medical examination measure: Area under curve(AUC) measure: Sensitivity measure: Specificity measure: Negative predictive value(NPV) measure: Positive predictive value(PPV) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Sixth Affiliated Hospital, Sun Yatsen University status: RECRUITING city: Guangzhou state: Guangdong country: China name: Jun Huang role: CONTACT phone: 13926451242 email: huangj97@mail.sysu.edu.cn lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06364358 id: IRB23-0385 id: 5R21DK121262 type: NIH link: https://reporter.nih.gov/quickSearch/5R21DK121262 briefTitle: Interactive Computer-adaptive Chronic Kidney Disease Education Program acronym: ICCKD overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-04 date: 2024-04-15 date: 2024-04-15 name: University of Chicago class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: The goal of this pilot clinical trial is to evaluate a culturally tailored computerized education program in hospitalized African-American patients with advanced chronic kidney disease (CKD). The main question it aims to answer are: does computerized adaptive education (CAE) increase patients' knowledge about CKD self-care and renal replacement therapy (RRT) options compared to usual care (UC) and will CAE will be increase patients' intent to participate in CKD self-care and RRT preparation compared to UC conditions: Chronic Kidney Diseases conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Computerized CKD Education name: Usual Hospital Care measure: Change in CKD Knowledge baseline to post patient education intervention measure: Change in Knowledge about end stage kidney disease (ESKD) treatments from baseline to 1 day post patient education intervention measure: Change in ESKD Treatment Preferences from baseline to 1 day post-intervention measure: Change in Patient Activation Measure from Baseline to 30 days Post-intervention measure: Increase in Health Intent baseline to post intervention (at 1 day and 30 day follow-up) measure: CKD Self-Management from baseline to 30 day post-intervention sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Chicago Medical Center city: Chicago state: Illinois zip: 60637 country: United States lat: 41.85003 lon: -87.65005 hasResults: False

 nctId: NCT06364345 id: INOVA_POCAD_1 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-15 date: 2024-04-15 name: [Redacted] hasResults: False

 nctId: NCT06364332 id: ChatsafeNL id: 2023.0348 type: OTHER domain: Medical Ethics Committee VUmc briefTitle: #Chatsafe Netherlands: a Social Media Intervention to Improve Dutch Young People's Safe Communication About Suicide Online acronym: CSNL overallStatus: NOT_YET_RECRUITING date: 2024-04-04 date: 2024-12 date: 2025-03 date: 2024-04-15 date: 2024-04-15 name: 113 Suicide Prevention class: OTHER name: Orygen name: Mind briefSummary: Suicide is the leading cause of death among young people (YP) aged 10 to 25 years in the Netherlands. In addition, YP report high rates of suicidal ideation (16%). While suicidal behavior is a complex phenomenon with many factors and causes, the role of social media is becoming more prominent, especially for YP. Social media has been shown to be a source where YP can find support, but it's also a place where suicidal behavior is glorified or normalized, which can be triggering or harmful to other social media consumers.

The #Chatsafe guidelines were developed by Orygen Australia to better equip young people to communicate safely about suicide on social media. These guidelines are supported by a social media campaign to make the content of the guidelines more accessible to them. The #Chatsafe intervention consists of both the guidelines and the social media campaign. A small-scale Australian feasibility study showed promising results in terms of the acceptance and safety of the campaign, and safety regarding communicating about suicide on social media platforms. Currently, in Australia it is tested to what extent these results hold up in a Randomized Controlled Trial (RCT) (Robinson et al., 2023).

With funding from the Dutch National Agenda for Suicide Prevention, a contextualized replication study is conducted. The aim of this study is to determine whether the #Chatsafe intervention has an effect on the way in which Dutch YP communicate online about suicide. conditions: Suicide Prevention conditions: Communication conditions: Social Media studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants are randomized to the intervention or the control group using block randomization with varying block sizes (block sizes vary from 2 to 16). The distribution key will be 1:1. The randomization schedule is computer generated by a researcher who will not be part of the analysing researchers. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The research team will be kept blind to randomization. A safety procedure is drawn up in which a senior researcher is appointed who will be unblinded if absolutely necessary. Principally, this will not be needed, since the study psychologists are independently alerted when a subject wants to get in touch. whoMasked: INVESTIGATOR count: 400 type: ESTIMATED name: Social Media campaign measure: Safe communication about suicide online measure: Confidence when communicating about suicide online measure: Willingness to intervene against suicide online measure: Self-efficacy online measure: Safety of the #ChatsafeNL materials measure: Acceptability of the #ChatsafeNL intervention measure: Safety of the #ChatsafeNL intervention sex: ALL minimumAge: 16 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: 113 Suicide Prevention city: Amsterdam state: Noord Holland zip: 1105 BP country: Netherlands name: Elke Elzinga, dr role: CONTACT phone: 020 3113883 email: e.elzinga@113.nl name: Saskia Mérelle, dr role: CONTACT phone: 020 3113883 email: s.merelle@113.nl lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06364319 id: 2024PHD002-001 briefTitle: Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory cGVHD overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-12-31 date: 2028-06-30 date: 2024-04-15 date: 2024-04-15 name: Peking University People's Hospital class: OTHER briefSummary: The study plan aims to include patients who have been diagnosed with steroid-refractory chronic GVHD in the liver following allogeneic hematopoietic stem cell transplantation. After obtaining informed consent, the patients will be randomly assigned to either the Anti-CD25 rhMAb treatment group or the traditional treatment group. The objective is to assess the effectiveness and safety of Anti-CD25 rhMAb in the treatment of severe chronic GVHD affecting the liver. conditions: cGVHD studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 118 type: ESTIMATED name: anti-CD25 rhMAb name: Prednisone name: Ruxolitinib name: Cyclosporine measure: overall response rate (ORR) measure: duration of response（DOR） measure: patient-reported outcomes (PRO) measure: disease-free survival (DFS) measure: failure-free survival (FFS) measure: non-relapse mortality (NRM) measure: overall survival （OS） measure: adverse drug reactions (ADR) sex: ALL minimumAge: 16 Years maximumAge: 65 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06364306 id: 12032024 briefTitle: oPen Versus RobotIc retrOmuscular Repair in Medium to Large Ventral Hernias acronym: PRIOR overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-12-31 date: 2031-12-31 date: 2024-04-15 date: 2024-04-17 name: University Hospital, Basel, Switzerland class: OTHER name: St. Clara Hospital, Basel, Switzerland name: Klinikum Kempten, Kempten, Germany briefSummary: This study investigates on the effect of two different operative techniques to treat large abdominal wall defects.

The goal of this clinical trial is to learn if the minimally-invasive, robotically-assisted ventral hernia repair (RVHR) leads to a better outcome than the open ventral hernia repair (OVHR).

The main questions it aims to answer are:

length of stay after the operation rate of complications rate of recurrence and reoperations quality of life.

Participants will:

Either be operated using the RVHR or OVHR will be followed up either in person or via email / phone call at day 7, day 30, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes. conditions: Ventral Hernia conditions: Incisional Hernia conditions: Abdominal Wall Defect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Patients are blinded to their treatment allocation until hospital discharge criteria according to the primary endpoint are fulfilled. After discharge, blinding is difficult to be ensured because there is no control, if dressing have been removed or modified. To ensure patient blinding during hospital stay, patients from both treatment arms will receive identical dressings as if an open and minimal-invasive access had been performed. In case the dressing must be changed during the hospital stay, this will be performed while the patient is blinded using a cover.

In case for any reason the patient has been unblinded to his treatment allocation (accidental or intentional dressing removal, bed-side wound opening, other) all outcome data are assessed regardless and unblinding is documented and reported in the final report. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 140 type: ESTIMATED name: Robotically-assisted ventral hernia repair (RVHR) name: Open ventral hernia repair (OVHR) measure: Primary outcome: length of stay measure: Comprehensive complication index (CCI) measure: Adverse events measure: pain after surgery measure: Functional recovery measure: Quality of life using SF-12 form sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06364293 id: KY2023-261-01 briefTitle: An Early Warning Model of Unfavorable Outcomes Following Endovascular Interventional Treatment of Intracranial Aneurysm overallStatus: ENROLLING_BY_INVITATION date: 2024-01-01 date: 2026-12-31 date: 2026-12-31 date: 2024-04-15 date: 2024-04-15 name: Beijing Tiantan Hospital class: OTHER name: National Natural Science Foundation of China briefSummary: Endovascular treatment has become one of the primary treatment methods for intracranial aneurysms. The unfavorable outcomes during follow-up included aneurysm recurrence and long-term incomplete-occlusion, which would bring a high risk of rebleeding and retreatment. Previous studies have tried to predict the outcomes of aneurysms following endovascular treatment based on aneurysm characteristics including morphology, embolization packing degree, etc, but the conclusion was inconsistent. Hemodynamics of aneurysms and parent artery played a greater role in predicting outcomes following endovascular treatments. Investigators also found that the outcomes were determined by many factors, in which the demography, clinical indicators, treatment methods, and material selection can not be ignored, and the mechanism of unfavorable imaging outcomes should be explored using large samples of clinical cases and numerous variable parameters. The pre-experiment of investigators confirmed that artificial intelligence technology can meet the calculation requirements for deep mining and analysis of large sample data. This study aims to use the deep learning model to identify relevant risk factors and weights, establish a stable and accurate prediction model, then incorporate the prospective study to verify the model. The results will be very helpful in accurately predicting the adverse outcomes such as recurrence and long-term non-occlusion after endovascular treatment and help to improve the therapeutic strategy and avoid risk factors. Besides, the occurrence of ischemic or hemorrhagic complications during follow-up may affect the final follow-up outcome, so the analysis was included as one of the outcome events to evaluate the prognosis after intervention. conditions: Intracranial Aneurysm studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 750 type: ESTIMATED name: Observational design does not include interventional behavior. measure: Unfavorable imaging outcome measure: Hemorrhagic or ischemic complication occurred during the follow-up sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tiantan hospital city: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06364280 id: 2023X0135 id: UG3HL165019 type: NIH link: https://reporter.nih.gov/quickSearch/UG3HL165019 id: U24HL165014 type: NIH link: https://reporter.nih.gov/quickSearch/U24HL165014 briefTitle: Pediatric Prehospital Airway Resuscitation Trial acronym: Pedi-PART overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2029-08-31 date: 2029-09-30 date: 2024-04-15 date: 2024-04-15 name: Ohio State University class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) name: University of Utah briefSummary: This study is a Phase 3, multi-center, Bayesian Adaptive Sequential Platform Trial testing the effectiveness of different prehospital airway management strategies in the care of critically ill children. Emergency Medical Services (EMS) agencies affiliated with the Pediatric Emergency Care Applied Research Network (PECARN) will participate in the trial. The study interventions are strategies of prehospital airway management: \[BVM-only\], \[BVM followed by SGA\] and \[BVM followed by ETI\]. The primary outcome is 30-day ICU-free survival. The trial will be organized and executed in two successive stages. In Stage I of the trial, EMS personnel will alternate between two strategies: \[BVM-only\] or \[BVM followed by SGA\]. The \[winner of Stage I\] will advance to Stage II based upon results of Bayesian interim analyses. In Stage II of the trial, EMS personnel will alternate between \[BVM followed by ETI\] vs. \[Winner of Stage I\]. conditions: Heart Arrest, Out-Of-Hospital conditions: Wounds and Injuries conditions: Respiratory Insufficiency in Children conditions: Child, Only conditions: Critical Illness studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The trial uses a Bayesian Adaptive Sequential Platform Trial (BASIC-PT) framework.

The study interventions are strategies of prehospital airway management: \[BVM-only\], \[BVM followed by SGA\] and \[BVM followed by ETI\].

The trial will be organized and executed in two successive stages. In Stage I of the trial, EMS personnel will alternate between two strategies: \[BVM-only\] or \[BVM followed by SGA\]. The \[winner of Stage I\] will advance to Stage II based upon results of Bayesian interim analyses. In Stage II of the trial, EMS personnel will alternate between \[BVM followed by ETI\] vs. \[Winner of Stage I\].

The interventions will be quasi-randomized using alternate day assignment. primaryPurpose: TREATMENT masking: NONE count: 3000 type: ESTIMATED name: BVM name: SGA name: ETI measure: 30-day ICU-free survival measure: Neurologic outcome upon hospital discharge sex: ALL minimumAge: 24 Hours maximumAge: 17 Years stdAges: CHILD hasResults: False

 nctId: NCT06364267 id: BabyTears briefTitle: Babytam vs Babyexe in Post-menopausal Women at High Risk for Breast Cancer. acronym: BabyTears overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-09-01 date: 2026-09-01 date: 2024-04-15 date: 2024-04-15 name: Andrea DeCensi class: OTHER name: Dana-Farber/Brigham and Women's Cancer Center name: Herbert Irving Comprehensive Cancer Center name: Istituto Europeo di Oncologia name: Breast Cancer Research Foundation briefSummary: The purpose of the study is to determine if 6 and 12 months of treatment with Tamoxifen at lower dose is superior to Exemestane at lower dose on quality of life. conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 160 type: ESTIMATED name: Tamoxifen 10 MG name: Exemestane 25 MG measure: Quality of life MEnQol measure: Other domains measure: PMAS questionnaire measure: Customer Satisfaction questionnaire measure: BPI measure: Sex hormones biomarkers measure: Insulin biomarker measure: Bone biomarker sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: E.O. Ospedali Galliera city: Genova zip: 16128 country: Italy lat: 44.40478 lon: 8.94438 hasResults: False

 nctId: NCT06364254 id: 2311054791 briefTitle: Effects of CBD on 2 Mile Run Time Trial Performance overallStatus: RECRUITING date: 2023-11-11 date: 2024-05-30 date: 2024-05-30 date: 2024-04-15 date: 2024-04-15 name: University of Northern Colorado class: OTHER briefSummary: Individuals who engage in endurance events tend to experience higher levels of stress within the body, mind, and gut, that often lead to impairment of performance. Based on previous studies, CBD has the potential relieve gut distress, and reduce pre-race anxiety thus resulting in an improvement in sport performance. Given the current research on the use of CBD in active individuals, the aim of this pilot study is to explore the effects of CBD compared to a placebo on anxiety, GI distress and a 2-mile running performance in a moderately active population identifying as female. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 30 type: ESTIMATED name: Cannabidiol Capsules measure: Difference in Time Trial Times measure: Difference in Anxiety Measured with the State Trait Anxiety Inventory measure: Difference in Blood Lactate Concentrations measure: Difference in Gastrointestinal Distress measure: Different in Heart Rate Variability sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: University Of Northern Colorado status: RECRUITING city: Greeley state: Colorado zip: 80639 country: United States name: Laura K Stewart, PhD role: CONTACT phone: 970-351-1891 email: laura.stewart@unco.edu lat: 40.42331 lon: -104.70913 hasResults: False

 nctId: NCT06364241 id: 331760 id: 226706/Z/22/Z type: OTHER_GRANT domain: Wellcome Trust briefTitle: Focus Groups on Cognitive Function in Psychosis acronym: PRECOGNITION overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-07 date: 2026-09 date: 2024-04-15 date: 2024-04-15 name: King's College London class: OTHER name: South London and Maudsley NHS Foundation Trust briefSummary: Cognitive deficits are commonly observed in people with mental disorders. In psychosis, these impairments are frequently present early in the course of the disorder and have a substantial impact on functional outcomes. This project will gain insight into the cognitive deficits that people with lived experience of psychosis and their carers perceive to be the most troublesome. To achieve this, the investigators will conduct two sets of focus groups. During the first set of focus groups, the investigators will aim to identify the cognitive deficits that individuals with psychosis and their carers consider to be the most impairing.

The findings of these focus groups will provide important information about what areas of cognition and functioning should be considered in future analyses of large fully anonymised datasets collected in the past from individuals with psychosis. The focus groups will not form part of those analyses, but will provide input from people with lived experience of psychosis on what problems with thinking skills are the most important for them and that should be considered by further research.

The second set of focus groups will enable the investigators to determine the participants' perception of potential risks and benefits associated with the dissemination of findings on cognitive function in psychosis, to ensure this is done in a manner that is sensitive to the wishes and needs of people with lived experience of psychosis.

Each participant will be asked to attend one focus group, which will last approximately one hour. Focus groups will take place at the South London and Maudsley (SLaM) Trust or at the Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London, although provision will be made for participants to also participate online. conditions: Psychosis studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 32 type: ESTIMATED name: Focus group measure: Individual perception of impairments due to cognitive deficits associated with psychosis sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06364228 id: 0133-24-FB briefTitle: Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-04 date: 2026-04 date: 2024-04-15 date: 2024-04-15 name: University of Nebraska class: OTHER briefSummary: The proposed study is a double-blind, randomized, placebo-controlled study of intranasal oxytocin (OXT) to determine its efficacy in improving quality of life and reducing stress in caregivers to persons with dementia. Planned enrollment is 32 subjects over 2 years. conditions: Stress studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 32 type: ESTIMATED name: Placebo name: Oxytocin Intranasal Spray 12 International Unit (12IU) name: Oxytocin Intranasal Spray 24 International Unit (24IU) name: Functional MRI measure: Participants' chronic stress levels in the past thirty days. measure: Participant Quality of Life survey measure: Blood Oxygen Level Dependent (BOLD) responses in neural areas during the Affective Stroop task (AS) and EmpaTom task. sex: FEMALE minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Nebraska Medical Center, Department of Psychiatry city: Omaha state: Nebraska zip: 61898-5581 country: United States name: Minjoo Kang, MEd role: CONTACT phone: 402-552-6239 email: mkang@unmc.edu name: Soonjo Hwang, MD role: PRINCIPAL_INVESTIGATOR name: Janelle N Beadle, PhD role: SUB_INVESTIGATOR lat: 41.25626 lon: -95.94043 hasResults: False

 nctId: NCT06364215 id: 2024P000883 briefTitle: Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation acronym: (SMILE-AF) overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2025-12 date: 2024-04-15 date: 2024-04-22 name: Brigham and Women's Hospital class: OTHER name: Boston Scientific Corporation briefSummary: Compare the efficacy and safety between pulmonary vein isolation (PVI) alone versus PVI with left atrial (LA) posterior wall isolation (PWI) using pulsed-field ablation (PFA) in the treatment of patients with paroxysmal atrial fibrillation (PAF). conditions: Atrial Fibrillation Paroxysmal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 450 type: ESTIMATED name: Pulmonary Vein Isolation alone name: Pulmonary Vein Isolation and Left atrial Posterior Wall Isolation measure: Procedural success, defined as freedom from of all documented atrial arrhythmias episodes after the 3-month blanking period. measure: The primary safety endpoint is a composite of acute procedure-related complications and any other major adverse events within the 12 months following the ablation procedure. measure: Freedom from atrial arrhythmias medication measure: Procedural time measure: Procedure-related Recurrencies measure: Atrial Fibrillation Effect on Quality-of-life Questionnaire (AFEQT). measure: Use of amiodarone measure: Complications. measure: fluoroscopy time. measure: Pulsed field ablation (PFA) applications during procedure. measure: first-pass pulmonary vein isolation (PVI). sex: ALL minimumAge: 21 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital city: Boston state: Massachusetts zip: 02115 country: United States name: Obadah Aloum, MD role: CONTACT phone: 617-525-7047 name: Fernando Moreno role: CONTACT phone: 6175257047 name: Jorge E Romero, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False

 nctId: NCT06364202 id: 1928368 briefTitle: Effects of Peanut Butter on Sleep Quality and Daily Energy Levels in Fire Fighters overallStatus: COMPLETED date: 2022-08-01 date: 2023-11-01 date: 2023-11-01 date: 2024-04-15 date: 2024-04-15 name: Augusta University class: OTHER briefSummary: The purpose of this study is to examine the possible benefits of peanut butter consumption prior to bedtime on sleep and energy levels among fire fighters. Fire fighters require high levels of energy to perform their occupational tasks but commonly lack sleep as well as the amount of dietary protein and fat suggested for tactical athletes. By addressing this gap, we expect that if peanut butter consumption is shown to improve sleep and/or energy, this lifestyle change (peanut butter consumption) may be appealing to fire fighters because of the ease and low cost of peanut butter. Aim 1: Determine if consuming peanut butter prior to bedtime alters measures of sleep quality and quantity in fire fighters. It is hypothesized that firefighters who consume the peanut butter will have positive impacts in measure of sleep quality and energy levels.

Aim 2: Examine the effects of peanut butter consumption on morning and evening energy levels conditions: Sleep conditions: Body Composition conditions: Blood Pressure conditions: Physical Activity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: Peanut Butter measure: Body composition measure: Body composition measure: Sleep measure: Blood pressure measure: Blood pressure measure: Physical activity sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Augusta University city: Augusta state: Georgia zip: 30909 country: United States lat: 33.47097 lon: -81.97484 hasResults: False

 nctId: NCT06364189 id: FY22-119 id: R61AG084479 type: NIH link: https://reporter.nih.gov/quickSearch/R61AG084479 briefTitle: Inspiring Seniors Toward Exercise Promotion acronym: iSTEP overallStatus: RECRUITING date: 2024-04-15 date: 2025-04-30 date: 2025-04-30 date: 2024-04-15 date: 2024-04-15 name: University of North Carolina, Greensboro class: OTHER name: National Institute on Aging (NIA) briefSummary: The goal of this clinical trial is to test the benefits of beat-accented music stimulation (BMS) for behavioral changes of physical activity (PA) in older adults. Specific Aims are to determine (1) whether BMS beneficially influences PA behaviors and psychological responses to PA in older adults for 6 months, and (2) whether exercising with BMS differently influences physical and cognitive functioning as well as quality of life in older adults.

To test the effects of BMS on PA, participants will be randomly assigned to an exercise intervention that either includes BMS or does not include BMS. Participants will attend a supervised group strength training (ST) (30 min/day) and aerobic exercise (AE) (30-50 min/day) session for 3 days/week for the first 2 months, 1 day/week for the next 2 months (while encouraging participants to independently perform both AE and ST on other days), and independently for the final 2 months (always with a goal of performing \>150min/week AE and 3 days/week of ST for 30 min/day. conditions: Cognitively Normal Older Adults studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Music name: Exercise measure: Physical activity (objective) measure: Ecological Momentary Assessment (EMA): Affective response to PA measure: Ecological Momentary Assessment (EMA): Perceived autonomy measure: Ecological Momentary Assessment (EMA): Perceived exertion measure: Ecological Momentary Assessment (EMA): Behavioral intention measure: Ecological Momentary Assessment (EMA): Physical Activity setting measure: Ecological Momentary Assessment (EMA): Anticipated, remembered, and incidental affect measure: Ecological Momentary Assessment (EMA): Social Support for Exercise measure: Physical activity (self-report) measure: Cognitive performance - General measure: Cognitive performance - Tower of London measure: Cognitive performance - NIH Toolbox Oral Reading Recognition Test measure: Cognitive performance - NIH Toolbox List Sort Working Memory Test measure: Cognitive performance - NIH Toolbox Picture Sequence Test measure: Cognitive performance - NIH Toolbox Dimensional Change Card Sort Test measure: Cognitive performance - NIH Toolbox Flanker Inhibitory Control and Attention Test measure: Cognitive performance - Mnemonic Similarity Task measure: Cognitive performance - Perceptual Discrimination Task measure: Health Related Quality of Life measure: Physical activity (subjective) measure: Music Reward Experience measure: Treatment Satisfaction measure: Body Mass Index measure: Waist/Hip/Leg Circumference measure: Sagittal Diameter measure: Blood Pressure measure: Handgrip Strength measure: Timed Up and Go (TUG) measure: 10-Meter Walk measure: 4-Stage Balance Test measure: 6-Minute Walk Test (6MWT) measure: 30-second Chair Stand sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: University of North Carolina at Greensboro status: RECRUITING city: Greensboro state: North Carolina zip: 27402-6170 country: United States name: Project Coordinator, MS role: CONTACT phone: 336-334-4765 email: istep@uncg.edu name: Jennifer L Etnier, PhD role: PRINCIPAL_INVESTIGATOR name: Shin Park, PhD role: PRINCIPAL_INVESTIGATOR lat: 36.07264 lon: -79.79198 hasResults: False

 nctId: NCT06364176 id: STUDY00149479 briefTitle: Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis. overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-05 date: 2027-10 date: 2024-04-15 date: 2024-04-22 name: University of Kansas Medical Center class: OTHER briefSummary: The goal of this clinical trial is to test use of losartan in those with cystic fibrosis (CF) on modulator therapy. The main question it aims to answer is if treatment with losartan improves response of the CF transmembrane conductance regulator (CFTR) channel to modulator therapy.

Participants will be asked take losartan or placebo for twelve weeks and will have changes in sweat chloride levels measured as a marker of CFTR function. conditions: Cystic Fibrosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 42 type: ESTIMATED name: Losartan name: Placebo measure: Sweat chloride measure: Lung function - absolute measure: Lung function - relative measure: Transforming growth factor (TGF)-beta1 - airway measure: TGF-beta1 - systemic measure: Inflammatory mediators - airway measure: Inflammatory mediators - systemic measure: CFQ-R measure: Adverse events sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Kansas Medical Center city: Kansas City state: Kansas zip: 66160 country: United States name: Charles Bengtson, MD, MSc role: CONTACT phone: 913-588-6000 name: Carolina Aguiar role: CONTACT phone: 9139459295 name: Matthias Salathe, M.D. role: SUB_INVESTIGATOR name: Andreas Schmid, M.D. role: SUB_INVESTIGATOR lat: 39.11417 lon: -94.62746 hasResults: False

 nctId: NCT06364163 id: 697716 briefTitle: Effect of Herring Oil Concentrate on LDL Cholesterol Concentration in Adults overallStatus: NOT_YET_RECRUITING date: 2024-08-12 date: 2026-12-31 date: 2027-12-31 date: 2024-04-15 date: 2024-04-15 name: University of Bergen class: OTHER name: The Norwegian Seafood Research Fund briefSummary: High cholesterol concentration is a major risk factor for cardiovascular disease (CVD), and consumption of fish has been associated with a lower CVD risk in several studies. The beneficial health effects of consuming fish have traditionally been ascribed to the long-chain PUFA (LC-PUFA) EPA (C20:5n-3) and DHA (C22:6n-3), although consumption of fish oils or concentrates with high EPA and DHA contents does not affect the cholesterol concentration in humans and lowers the cholesterol concentration in rats and mice only when given in very high doses. Fish oils contain a plethora of fatty acids besides EPA and DHA, and in recent years, increased focus has been on the long-chain MUFA (LC-MUFA) cetoleic acid (C22:1n-11). Cetoleic acid is found in high amounts in oils from certain fish species such as herring, which has relatively low contents of both EPA and DHA. The investigators have recently summarised and meta-analysed the available literature that investigates the effects of diets containing fish oils or fish oil concentrates that have a high content of cetoleic acid but low or no content of EPA and DHA on cholesterol concentration in rodents, showing that cetoleic acid-rich fish oils and concentrates prevent high cholesterol concentration. conditions: High Cholesterol studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Herring oil concentrate name: Control measure: Serum concentration of LDL-cholesterol measure: Serum concentration of HDL-cholesterol measure: Serum concentration of total cholesterol measure: Serum concentrations of apolipoproteins measure: Serum concentrations of amino acids metabolites measure: Serum concentration of one-carbon pathway metabolites measure: Fatty acid composition in leukocytes measure: Serum concentration of glucose measure: Serum concentration of insulin measure: Urine concentrations of cystatin C measure: Urine concentrations of T cell immunoglobulin mucin-1 (TIM-1) measure: Body composition sex: ALL minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Bergen city: Bergen country: Norway name: Oddrun A Gudbrandsen, PhD role: CONTACT phone: 55975553 phoneExt: 47 email: nkjgu@uib.no lat: 60.39299 lon: 5.32415 hasResults: False

 nctId: NCT06364150 id: MAGIC6 briefTitle: Therapeutic Use of Angiopoietin-Primed Autologous Peripheral Blood Stem Cell in Myocardial Infarction acronym: MAGICcell6 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2026-08-01 date: 2024-04-15 date: 2024-04-15 name: Seoul National Hospital class: OTHER_GOV briefSummary: This study will evaluate the efficacy and safety of "Therapeutic Use of Autologous-Primed Autologous Peripheral Blood Stem Cell Treatment for Myocardial Regeneration in Acute Myocardial Infarction". conditions: Acute Myocardial Infarction studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a single arm, open label interventional study primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Autologous Peripheral Blood Stem Cell injection measure: Left ventricular systolic function measure: Regional wall motion score index measure: B-natriuretic peptide level measure: 6-minute walk test measure: All-cause death measure: Target lesion Revascularization measure: Readmssion measure: Cardiovascular death measure: non-Target lesion Revascularization sex: ALL minimumAge: 19 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06364137 id: 73203 briefTitle: Engagement and Clinical Impact of the Teleo Virtual Therapy Platform in Clinical Settings - Pilot RCT overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2025-06-30 date: 2025-06-30 date: 2024-04-15 date: 2024-04-15 name: Stanford University class: OTHER name: National Institute of Mental Health (NIMH) name: MainSquare Co. (dba 'Teleo') briefSummary: The research study will examine engagement in telehealth for children undergoing psychotherapy. The study in Phase I entails a pilot randomized trial with a goal to enroll 42 families, examining patient engagement in Teleo, a virtual therapy platform specifically designed for psychotherapy with youth, as compared to standard video conferencing.

Engagement will be assessed using well-established measures - PRIME-O (modified) video coding, MTT-Y/MTTCG and attendance data (sessions 1-4). Clinicians in the study will deliver therapy to clients for 4 sessions, providing opportunity to measure temporal sustainment of any engagement differences. conditions: Anxiety Disorders conditions: Mood Disorders studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 42 type: ESTIMATED name: Teleo name: Standard videoconferencing measure: PRIME-O Video Coding Score measure: My Thoughts about Therapy - Caregiver (MTT-CG) engagement questionnaire scores measure: My Thoughts about Therapy - Youth (MTT-Y) engagement questionnaire scores measure: Attendance during Psychotherapy Sessions sex: ALL minimumAge: 5 Years maximumAge: 14 Years stdAges: CHILD facility: Stanford University city: Stanford state: California zip: 94305 country: United States lat: 37.42411 lon: -122.16608 hasResults: False

 nctId: NCT06364124 id: Beijing_LH_CCU2024 briefTitle: Effects of PCSK-9 Inhibitor Treatment Prior to Undergoing Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction overallStatus: RECRUITING date: 2023-06-01 date: 2024-06-01 date: 2025-06-01 date: 2024-04-15 date: 2024-04-18 name: Beijing Luhe Hospital class: OTHER briefSummary: Acute ST-segment elevation myocardial infarction (STEMI) is a common manifestation of cardiovascular emergencies. Percutaneous coronary intervention (PCI) and guideline-recommended pharmacotherapy have reduced mortality rates associated with STEMI, but the incidence of recurrent ischemic events, particularly early ischemic events, remains high. Current research suggests that low-density lipoprotein cholesterol (LDL-C) levels not meeting guideline-recommended levels and inflammation are closely related to early recurrent ischemic events. Evolocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, rapidly and effectively reduces LDL-C levels and suppresses inflammation. Long-term use in patients with acute coronary syndromes can reverse atherosclerosis and improve prognosis. However, data on its use in STEMI patients are limited, particularly regarding the cardioprotective effects of preoperative administration of 420mg evolocumab subcutaneous injection. This study aims to evaluate the effects of administering evolocumab 420mg before emergency PCI on lipid profiles, inflammatory markers, myocardial injury, and short-term prognosis in STEMI patients through a single-center, randomized, open-label study. It aims to provide theoretical evidence for further reducing the risk of recurrent cardiovascular events in STEMI and identifying more optimized treatment strategies. conditions: STEMI studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 84 type: ESTIMATED name: evolocumab name: Atorvastatin measure: Average percent change from baseline in LDL-C levels to discharge and day 30 measure: Average percent change from baseline in total cholesterol, high-density lipoprotein cholesterol, triglycerides, apolipoprotein A and apolipoprotein B to discharge and day 30 measure: Average percent change from baseline in MMP-9, CSF-1, IL-18R1 to discharge and day 30 measure: Number of cardiovascular events to day 30 sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing luhe hospital status: RECRUITING city: Beijing country: China name: rui yan role: CONTACT phone: 17746570262 email: yanrui4112@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06364111 id: Vibrabot Capsule briefTitle: Comparative Study on the Efficacy of Vibrabot Capsule and Polyethylene Glycol for Chronic Functional Constipation overallStatus: RECRUITING date: 2024-01-08 date: 2025-06-14 date: 2025-08-30 date: 2024-04-15 date: 2024-04-15 name: Beijing Tsinghua Chang Gung Hospital class: OTHER briefSummary: This is a single-center trial that enrolls 20 18 to 85-year-old patients with moderate to severe FC to study the efficacy of Vibrabot capsule (dosage: 5 capsules/week) and polyethylene glycol, as well as the mechanism of action of the Vibrabot capsule. conditions: Chronic Functional Constipation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Vibrabot capsule name: polyethylene glycol measure: The proportions of responders to the three therapies during the treatment period. measure: Evaluation of intestinal motility measure: Assessment of neurotransmitters in peripheral blood measure: Assessment of changes in intestinal flora measure: Evaluation of the treatment cycle of Vibrabot Capsules sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: XuanJiang status: RECRUITING city: Beijing state: Beijing zip: 102218 country: China name: Xuan Jiang, professor role: CONTACT phone: 13671006525 email: jxa01998@btch.edu.cn name: Jinzhe Liu, physician role: CONTACT phone: 18810831618 email: ljza02528@btch.edu.cn lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06364098 id: prevention of PPH briefTitle: Comparative Study Between the Roles of Intrauterine Misoprostol Versus the Sublingual Route for Prevention of Postpartum Blood Loss in Elective Cesarean Sections overallStatus: COMPLETED date: 2022-01-01 date: 2023-02-01 date: 2023-02-01 date: 2024-04-15 date: 2024-04-15 name: Cairo University class: OTHER briefSummary: Study design:

A prospective randomized control trial was carried out at labor and delivery unit at Kasr Al Aini Hospital, Cairo University.

Population of study:

192 pregnant women at the age range from 20 to 35 years, with BMI \< 30kg/m2 presenting with a full-term singleton healthy living fetus (gestational age \>39 weeks confirmed by the first day of the last menstrual period or first-trimester ultrasound scan) and candidate for elective cesarean delivery (Previous one or two cesarean section) were included in our study. Patients with uterine over distension as due to multiple pregnancies or polyhydramnios, multipara (parity ≥3), women with uterine fibroids, antepartum hemorrhage presentation such as placenta previa, placental abruption or vasa previa, moderate to severe anemia with hemoglobin level \<9mg/dl, patient on anticoagulant during pregnancy or having coagulopathy or thrombocytopenia or blood dyscrasias, hypertension, cardiovascular, DM, hepatic, or renal disorders and women with any contraindication for the use of misoprostol or oxytocin as allergy to prostaglandin and concomitant drugs that have drug interaction with prostaglandins as topical dinoprostone, antacids containing magnesium were excluded from our study. conditions: Postpartum Hemorrhage studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 192 type: ACTUAL name: Misoprostol measure: The amount of blood loss measure: Changes in hematocrit values in both groups after delivery measure: Changes in Hemoglobin level measured by gm/dl in both groups after delivery measure: Incidence of side effects of study medications sex: FEMALE minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: Faculty of medicine, Kasr Alainy city: Cairo state: Al Manyal zip: 11956 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06364085 id: DBS2024 briefTitle: Enhancing Epilepsy Management With Precision Deep Brain Stimulation acronym: EPI-BOOST overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-01 date: 2026-06 date: 2024-04-15 date: 2024-04-15 name: Nova Scotia Health Authority class: OTHER briefSummary: The goal of this study is to evaluate the effectiveness of objective neural response feedback on deep brain stimulation (DBS) programming for drug-resistant epilepsy in a prospective observational cohort study. conditions: Epilepsy, Drug Resistant studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Neuromodulation programming measure: Seizure reduction measure: Change in disease score on Patient Weighted Quality Of Life In Epilepsy measure: Change in depression score on Neurological Disorders Depression Inventory in Epilepsy measure: Change in anxiety score on Anxiety General Anxiety Disorder-7 sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Queen Elizabeth Health Science Centre city: Halifax state: Nova Scotia zip: B3H 3A7 country: Canada name: Lutz Weise role: CONTACT lat: 44.64533 lon: -63.57239 hasResults: False

 nctId: NCT06364072 id: PDC 01-0202 id: 2023-504023-63-00 type: CTIS briefTitle: Safety, Tolerability, Analgesic Effect, and Feasibility of Intranasal CT001 in Pediatric Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-09-15 date: 2024-09-20 date: 2024-04-15 date: 2024-04-15 name: Cessatech A/S class: INDUSTRY briefSummary: The proposed study aims to investigate the safety, tolerability, analgesic efficacy, and feasibility of intranasal sufentanil/ketamine (CT001) in pediatric participants attending an acute care (i.e. emergency) setting. The study is a part of the clinical development plan for the development of CT001 nasal spray for treatment of acute pain in children. conditions: Pain studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 150 type: ESTIMATED name: CT001 measure: To assess the safety and tolerability measure: To evaluate the analgesic effect measure: To assess medication errors sex: ALL minimumAge: 1 Year maximumAge: 17 Years stdAges: CHILD hasResults: False

 nctId: NCT06364059 id: aSDH-TT briefTitle: A Comparative Analysis of Prognostic Factors for Functional Outcomes in Patients With Acute Subdural Hematoma overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-09 date: 2024-11 date: 2024-04-15 date: 2024-04-15 name: Charles University, Czech Republic class: OTHER name: Military University Hospital, Prague briefSummary: Acute subdural hematoma (ASDH) is the most common intracranial traumatic lesion that requires surgical intervention. Although there is extensive published research on acute subdural, there remains uncertainty regarding mortality risk and functional outcomes for patients. This study aims to evaluate the effectiveness of contemporary scoring systems in different age groups of ASDH patients to predict functional outcomes. conditions: Acute Subdural Hematoma conditions: Acquired Brain Injury studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 200 type: ESTIMATED name: Decompressive craniectomy with evacuation of subdural hematoma measure: Level of consciousness at time of injury measure: Initial size of subdural hematoma measure: Initial midline shift measure: Chronic use of anti-clotting medication measure: Trauma severity analyzed using Injury Severity Score (ISS). measure: Severity of illness analyzed using Acute Physiology and Chronic Health Evaluation II score (APACHE II) measure: The Glasgow Outcome Scale (GOS) at the time of discharge from the Intensive Care (IC). measure: The Glasgow Outcome Scale Extended (GOSE) evaluation of global disability and recovery after 6 months. measure: The Glasgow Outcome Scale Extended (GOSE) evaluation of global disability and recovery after 12 months. measure: Number of revisions. measure: Time from injury to surgery. measure: Time of operation. measure: The need for reversal of the effects of anticoagulants. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Military University Hospital Prague city: Praha zip: 16209 country: Czechia name: Michal Soták, M.D., Ph.D. role: CONTACT phone: +420973202999 email: michal.sotak@uvn.cz name: Tomáš Tyll, M.D., Ph.D. role: CONTACT phone: +420973202999 email: tomas.tyll@uvn.cz name: Tomáš Tyll, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 50.08804 lon: 14.42076 hasResults: False

 nctId: NCT06364046 id: ZJLS-KLDMIR-22006 briefTitle: Efficacy and Safety of DEB-BACE Combined With Serplulimab in First-line Treatment of SCLC overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2025-12-31 date: 2024-04-15 date: 2024-04-15 name: The Central Hospital of Lishui City class: OTHER briefSummary: This project aims to conduct a prospective, single-center, randomized, open-label, two-arm study to compare the clinical efficacy and safety of bronchial arterial chemoembolization with drug-eluting beads (DEB-BACE) combined with serplulimab versus conventional intravenous chemotherapy combined with Serplulimab as first-line treatment for SCLC patients. The objective is to provide evidence-based support for clinical practice. conditions: Carcinoma conditions: Small Cell Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: Drug-eluting beads bronchial arterial chemoembolization name: Serplulimab name: Intravenous chemotherapy measure: Objective response rate measure: Progression Free Survival measure: Overall Survival measure: Time to tumor untreatable progression measure: Disease Control Rate measure: Duration of Overall Response measure: Tumor biomarkers measure: Tumor biomarkers measure: Tumor biomarkers measure: Tumor biomarkers measure: Eastern Cooperative Oncology Group Score measure: Recurrence rate of hemoptysis measure: Quality of life Questionare-Core score measure: The incidence of adverse events and serious adverse events measure: Pain assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lishui central hospital city: Lishui state: Zhejiang zip: 323000 country: China lat: 28.46042 lon: 119.91029 hasResults: False

 nctId: NCT06364033 id: CLL2624 briefTitle: Biological and Clinical Efficacy of Shingrix in Patients With CLL overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-11 date: 2028-10 date: 2024-04-15 date: 2024-04-15 name: Gruppo Italiano Malattie EMatologiche dell'Adulto class: OTHER briefSummary: This is a biological study. Patients who are eligible to receive Shingrix through the Italian National Health System will be invited to participate in the study. According to AIFA indication, the two doses of vaccine will be administered 4-8 weeks apart. Blood samples will be collected prior to the first vaccine dose (i.e. within the time frame of 3 months prior to the first dose) and 1, 6, 12, 24 and 36 months after the second vaccine dose to evaluate the serological response of Shingrix. conditions: Chronic Lymphocytic Leukemia conditions: Small Lymphocytic Lymphoma conditions: CLL-like MBL conditions: Varicella-zoster Virus Reactivation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 312 type: ESTIMATED name: serologic response evaluation measure: Serologic response evaluation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UOC Ematologia ASST dei Sette Laghi city: Varese country: Italy name: Marta Coscia role: CONTACT lat: 45.82058 lon: 8.82511 hasResults: False

 nctId: NCT06364020 id: APHP230067 briefTitle: Assessment of Risk Factors in Patients With Non-carious Cervical Lesions acronym: LACIS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-15 date: 2024-04-15 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: In the management of patients with noncarious cervical lesions (NCCL), we observe that they frequently present signs of anxiety, traumatic brushing, bruxism or eating disorders. These multifactorial and interrelated etiologies make diagnosis and management difficult. Furthermore, in the literature, there is a lack of studies that evaluate the relationship between these risk factors and NCCL. A better understanding of the etiology and risk factors would help to optimize patient management and direct patients to the most appropriate therapies. conditions: Anxiety conditions: Stress conditions: Non-carious Cervical Lesions studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED measure: To investigate the association between anxiety/stress and the presence of NCCL. measure: To investigate the association between bruxism and the presence of NCCL. measure: To investigate the association between eating disorders and the presence of NCCL. sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Hôpital Rothschild - Service Odontologie city: Paris zip: 75012 country: France name: Caroline Mocquot, MCU-PH role: CONTACT phone: +33622971627 email: caroline.mocquot@aphp.fr name: Maria Clotilde Carra, Professor role: CONTACT phone: +33630746555 email: mariaclotilde.carra@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06364007 id: SLiu0401 briefTitle: HAIC Combined With Durvalumab and Tremelimumab and Lenvatinib in uHCC overallStatus: RECRUITING date: 2024-03-03 date: 2025-12-31 date: 2026-03-31 date: 2024-04-12 date: 2024-04-12 name: Sulai Liu class: OTHER briefSummary: The treatment options for unresectable HCC have rapidly developed, and immunotherapy has shown significant survival benefits in hepatocellular carcinoma. The STRIDE regimen of Single Tremelimumab (high, priming 300-mg dose) Regular Interval Durvalumab (1500 mg every 4 weeks) improved OS vs sorafenib in pts with unresectable HCC. In Asian region, HAIC is applied for HCC patients who are not suitable for surgical resection or local ablation treatment. Retrospective studies suggested a potent antitumor effect and survival benefit of HAIC plus programmed death-1 inhibitor and Lenvatinib. This phase II study was aimed to evaluate the efficacy and safety of STRIDE plus lenvatinib, given concurrently with HAIC in pts with unresectable HCC. conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: HAIC+STRIDE+Len measure: ORR measure: PFS measure: OS measure: DCR measure: AE sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hunan Provincial People's Hospital(The First Affiliated Hospital of Hunan Normal University) status: RECRUITING city: Changsha state: Hunan country: China name: Chuang Peng, PhD role: CONTACT phone: 15200850489 email: pengchuangcn@163.com lat: 28.19874 lon: 112.97087 hasResults: False

 nctId: NCT06363994 id: ICP-CL-00128 briefTitle: A Global Phase 3 Study of Orelabrutinib+BR vs.BR in Pts With TN MCL overallStatus: NOT_YET_RECRUITING date: 2024-05-25 date: 2034-12-25 date: 2035-12-25 date: 2024-04-12 date: 2024-04-12 name: InnoCare Pharma Inc. class: INDUSTRY briefSummary: Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL) conditions: Mantle 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: 490 type: ESTIMATED name: Orelabrutinib name: Bendamustine Injection name: Rituximab name: Orelabrutinib Placebo measure: Dose-limiting toxicity (DLT) measure: Progression-free Survival (PFS) for Arm A vs. Arm C sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06363981 id: JagiellonianU72 briefTitle: Multisite rTMS for Mood, Cognitive Impairment and Other Symptoms of Depression overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-12 date: 2027-04 date: 2024-04-12 date: 2024-04-15 name: Jakub Antczak class: OTHER name: Andrzej Frycz Modrzewski Krakow University briefSummary: Depressed mood is the main symptom of depression, but other symptoms like cognitive impairment, anhedonia or sleep disorders may also contribute to patients suffering and are difficult to treat. rTMS is a relatively novel treatment option, whose therapeutic potential is still investigated and optimized. The aim of this study is to assess the effect of rTMS applied over two stimulation sites on cognitive impairment, anhedonia and sleep disorders in depression. conditions: Unipolar Depression conditions: Bipolar Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment Prospective, randomized, sham-controlled clinical trial in parallel design primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Placebo intervention will be delivered with a programmable coil for magnetic stimulation, which can be switched by a third person between modes of active (therapeutic) and sham stimulation. In the sham-mode coil elicits similar sounds as in the active stimulation, but induces only negligible magnetic field. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Active rTMS over the left DLPFC and over the left DMPFC name: Active rTMS over the left DLPFC name: Sham rTMS measure: Beck Depression Inventory 2 measure: Froward digit span measure: Language part of Addenbrooke's Cognitive Examination measure: Dimensional Anhedonia Rating Scale measure: Athens Insomnia Scale measure: Pittsburgh Sleep Quality Index measure: Epworth Sleepiness Scale sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Education of Research and Development Center, Babinski Clinical Hospital city: Cracovia zip: 30393 country: Poland name: Wojciech Korzeniowski, MD role: CONTACT phone: +48 12 652 42 00 email: wojciech.korzen@gmail.com name: Jakub Antczak, MD role: CONTACT phone: +48 12 25 50 email: jakub.antczak@uj.edu.pl lat: 50.06143 lon: 19.93658 hasResults: False

 nctId: NCT06363968 id: 1743326 briefTitle: Biomarkers in the Retina for Prognosticating Mental Health Treatments acronym: BRIGHT overallStatus: RECRUITING date: 2024-02-12 date: 2025-09-01 date: 2030-09-01 date: 2024-04-12 date: 2024-04-12 name: VA Puget Sound Health Care System class: FED briefSummary: Title: ERG as a potential biomarker of SSRI-responsive PTSD: A pilot study

Posttraumatic stress disorder (PTSD) affects many individuals who experience a traumatic event. Previous studies suggest that there is a connection between the brain and the retina, and that the electroretinogram (ERG) may be a valuable biomarker to tell us more about signals in the brain that are related to mental health disorders like PTSD. The goal of this observational study is to examine the ERG waveform in veterans with PTSD before and after a single dose of the selective serotonin reuptake inhibitor (SSRI), sertraline. Sertraline is one of two FDA-approved medications for the treatment of PTSD. The main questions this pilot study aims to answer are:

1. How does sertraline, an SSRI, influence the ERG waveform in veterans with PTSD?
2. Is there a significant correlation between baseline ERG signals and the change in ERG following SSRI treatment?

Participants will be asked to:

* Undergo ERG recordings before and after a single dose of sertraline.
* Provide relevant clinical information related to PTSD symptoms and treatment history.

Following the initial study visits, participants will enter an optional open label phase of the study in which qualifying participants who initiate antidepressant treatment through routine clinical care will be invited back for a follow-up ERG recording. conditions: PTSD conditions: Posttraumatic Stress Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 50 type: ESTIMATED name: RETeval measure: ERG b-wave amplitude response to SSRI measure: Total Clinician Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; CAPS-5) score measure: Total PTSD Checklist for DSM-5 (PCL-5) sex: ALL minimumAge: 21 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VA Puget Sound Health Care System status: RECRUITING city: Seattle state: Washington zip: 98108 country: United States name: Rebecca C Hendrickson, MD, PhD role: CONTACT phone: 206-277-5054 email: rebecca.hendrickson@va.gov name: Katharine J Liang, MD, PHD role: SUB_INVESTIGATOR name: Rebecca C Hendrickson, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False

 nctId: NCT06363955 id: INTM-PMCF-UNIMOUTH id: 750/13.02.2023 type: OTHER domain: National and Kapodistrian University of Athens briefTitle: Assessing the Efficacy of a Hydrogen Peroxide Mouthwash for Oral Wound Healing, Oral Hygiene and Xerostomia Relief overallStatus: COMPLETED date: 2023-04-25 date: 2024-04-01 date: 2024-04-01 date: 2024-04-12 date: 2024-04-26 name: National and Kapodistrian University of Athens class: OTHER name: Ioulia And Irene Tseti Pharmaceutical Laboratories S.A. briefSummary: The aim of this study is to evaluate the efficacy and safety of a hydrogen carbamide/peroxide mouthwash, named UNISEPT® MOUTHWASH, regarding oral wound healing, postoperative symptoms, xerostomia (dry mouth) and oral hygiene improvement. Study participants have reported dry mouth and are scheduled for a diagnostic biopsy of minor labial salivary glands to investigate Sjögren's Syndrome, following consultation with their rheumatologist. This is a standardized diagnostic procedure that leads to healing by primary intention (i.e. wound edges are closely re-approximated with sutures).

Researchers are comparing this mouthwash with a placebo (a look-and-taste-alike substance that contains no active ingredients) to see if it is helpful with healing of wounds in the mouth and associated symptoms, improving dry mouth and/or oral hygiene. Participants randomly get the hydrogen carbamide/peroxide mouthwash or the placebo one to use for 14 days after the biopsy. The investigators will not know which one they are providing as the bottles will be identical.

Oral wound healing, postoperative symptoms (such as pain, eating and speech difficulties), oral hygiene (dental plaque and gingival inflammation), improvement of dry mouth and quality of life are assessed during a 14-day period after the biopsy. Participants are required to visit the clinic three times, one for the initial consultation and the biopsy, one at 7 days and one at 14 days after the biopsy. They are asked to fill in some questionnaires, while certain procedures (such as measuring saliva) and assessments (like evaluating the dental plaque and gingival inflammation) take place. During the first week they, also, keep a diary of their symptoms, as instructed. conditions: Wound Heal conditions: Oral Dryness conditions: Postoperative Pain conditions: Sjogren's Syndrome conditions: Biopsy Wound conditions: Mouth; Wound conditions: Mouth Dryness conditions: Dental Plaque conditions: Gingival Inflammation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This trial is designed as a prospective, randomized, placebo-controlled, triple blinded, with two parallel groups and an equal allocation ratio in all groups. In this study, the intervention consists of delivery of a hydrogen carbamide/peroxide mouthwash or placebo mouthwash, made by the same manufacturer. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 54 type: ACTUAL name: Hydrogen Carbamide/Peroxide Mouthwash name: Placebo mouthwash measure: Assessment of wound healing based on the modified Landry Healing Index on day 14 measure: Assessment of wound healing based on a modified version of the Early Wound Healing Score (EHS) on day 14 measure: Assessment of wound healing based on the modified Landry Healing Index on day 7 measure: Assessment of wound healing based on a modified version of the Early Wound Healing Score (EHS) on day 7 measure: Postoperative symptoms (pain, eating and speech difficulty) during the first week (at home) measure: Postoperative symptoms (pain, eating and speech difficulty) on day 7 measure: Postoperative symptoms (pain, eating and speech difficulty) on day 14 measure: Wound healing based on the incision/wound length measure: Subjective oral dryness symptoms (8-item VAS questionnaire) measure: Observed (objective) signs of oral dryness measure: Change in Unstimulated Saliva Flow Rate measure: Oral Hygiene - Dental Plaque: Full-Mouth Plaque Index measure: Oral Hygiene - Gingival Inflammation: Full Mouth Gingival Index measure: Oral Health Related Quality of Life measure: Assessment of swelling in the biopsy area measure: Adverse Events measure: Participant's comments and satisfaction regarding the provided treatment/use of the products measure: Compliance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Oral Medicine & Pathology and Hospital Dentistry, School of Dentistry, National and kapodistrian University of Athens city: Athens state: Attiki zip: 11527 country: Greece lat: 37.97945 lon: 23.71622 hasResults: False

 nctId: NCT06363942 id: 2024-5973 briefTitle: A Personalized Video-based Exercise Program for Fall Prevention in Frail and Pre-frail Older Adult overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-04-15 date: 2026-04-15 date: 2024-04-12 date: 2024-04-12 name: McGill University Health Centre/Research Institute of the McGill University Health Centre class: OTHER briefSummary: This is a randomized interventional clinical trial, whereby 100 participants will be randomized to either follow the SAFE exercise program (experimental group) or not (control group). At the end of the intervention, the experimental group will be encouraged to continue doing the exercises, and the control group will have the opportunity to participate in the SAFE exercises. 12 weeks post-intervention, the investigators will follow up with participants by telephone to follow up whether they are still following the SAFE program or not. conditions: Fall Injury conditions: Frailty conditions: Old Age; Atrophy conditions: Age-Related Atrophy conditions: Age-Related Sarcopenia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: SAFE program (exercise intervention) measure: Objective 1 measure: Objective 2 measure: Objective 4 sex: ALL minimumAge: 70 Years stdAges: OLDER_ADULT facility: Royal Victoria Hospital - Glen site city: Montréal state: Quebec zip: H4A 3J1 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06363929 id: 341-23 briefTitle: Continuous Glucose Monitoring in Neonatal Hyperinsulinism overallStatus: RECRUITING date: 2023-06-01 date: 2025-06-01 date: 2025-12-31 date: 2024-04-12 date: 2024-04-12 name: MemorialCare Health System class: OTHER name: DexCom, Inc. briefSummary: The investigators are studying the accuracy of Dexcom G6 continuous glucose monitors placed on babies with hyperinsulinism in the Miller Children's Hospital Neonatal Intensive Care Unit. The participants will wear the device for 10 days on their lateral thigh. Whenever blood sugars are checked by glucometer, the investigators will also record the continuous glucose monitor sugar. Additionally, if the continuous glucose monitor alarms for a low sugar or an impending low sugar, the investigators will check the blood sugar by glucometer and, if verified to be low, treat the low blood sugar accordingly. conditions: Hyperinsulinism conditions: Hypoglycemia Neonatal studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 15 type: ESTIMATED name: Dexcom G6 continuous glucose monitor measure: Mean absolute relative difference (MARD) measure: Mean absolute difference (MAD) sex: ALL minimumAge: 24 Hours maximumAge: 3 Months stdAges: CHILD facility: Miller Children's Hospital status: RECRUITING city: Long Beach state: California zip: 90806 country: United States name: Erin Okawa role: CONTACT phone: 310-825-6244 email: eokawa@memorialcare.org lat: 33.76696 lon: -118.18923 hasResults: False

 nctId: NCT06363916 id: 2023-A00335-40 briefTitle: Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System acronym: SEECLOOP overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-11 date: 2025-12 date: 2024-04-12 date: 2024-04-12 name: Medtrum France class: INDUSTRY name: Axonal-Biostatem briefSummary: The purpose of this study is to evaluate the safety and effectiveness of the MEDTRUM Hybrid Closed Loop (HCL) System in children, adolescents, and adults with type 1 diabetes (7-75 years old) in a home setting and to test the function of meal announcement in an extend study.

The main question it aims to answer is :

• Is the Hybrid Closed Loop system superior at increasing the time spent in the target glucose range of 70-180 mg/dL when compared to the Open (manual) Loop system ?

Participants will be :

* Trained into the use of the Insulin pump MEDTRUM A8 TouchCare® Insulin Management system
* Randomized to the Open Loop or Closed Loop group
* Respond to self administered questionnaires : the Hypoglycaemia Fear Survey, the Diabetes Quality of Life Questionnaire, and the Diabetes treatment Satisfaction Questionnaire status

Researchers will compare the time spent in the target glucose range of 70-180 mg/mL during the last 12 weeks of the study between the patients randomised to the Open Loop group and those randomised to the Closed Loop group. conditions: Type 1 Diabetes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 160 type: ESTIMATED name: Insulin Management System in Manual mode of operation name: Insulin Management System in Automatic mode of operation measure: Superiority of the algorithm on Time In Range (TIR) between the 2 randomised groups measure: Evolution of TIR measure: Evolution of coefficient of glycemic variation measure: Superiority in Glycated Haemoglobin (HbA1c) improvement measure: Evolution of Time spent Above Range (TAR) measure: Evolution of Time spent Below Range (TBR) measure: Body Mass Index change measure: Glucose sensor measurement change measure: Percentage of patients with TIR > 70% measure: Percentage of patients with TIR > 70% and TBR < 4%, and with TIR > 70% and TBR < 1% measure: Evolution of glucose management indicator (GMI) measure: Evolution of dosage of insulin measure: Time of device usage and time in automatic mode of insulin delivery (hybrid closed loop) measure: Evolution of Self-administered Questionnaires scores measure: Evolution of Diabetes Treatment Satisfaction score measure: Safety Events measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on TIR measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on glucose sensor measurements measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on TAR measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on TBR measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on GMI measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on dosage of insulin measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on Self-administered Questionnaires scores sex: ALL minimumAge: 7 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Angers city: Angers country: France name: Regis COUTANT role: CONTACT name: Regis COUTANT role: PRINCIPAL_INVESTIGATOR lat: 47.46667 lon: -0.55 facility: CHU Besançon city: Besançon country: France name: Sophie BOROT role: CONTACT name: Sophie BOROT role: PRINCIPAL_INVESTIGATOR lat: 47.24878 lon: 6.01815 facility: CHU Bordeaux city: Bordeaux country: France lat: 44.84044 lon: -0.5805 facility: CHU Caen city: Caen country: France name: Michael JOUBERT role: CONTACT name: Michael JOUBERT role: PRINCIPAL_INVESTIGATOR lat: 49.18585 lon: -0.35912 facility: Centre Hospitalier Sud-Francilien city: Corbeil-Essonnes country: France name: Freddy PENFORNIS role: CONTACT name: Freddy PENFORNIS role: PRINCIPAL_INVESTIGATOR name: Thanh-Lan DANG DUY role: PRINCIPAL_INVESTIGATOR lat: 48.60603 lon: 2.48757 facility: Centre Hospitalier de Gonesse city: Gonesse country: France name: Jennifer ALLAIN role: CONTACT name: Jennifer ALLAIN role: PRINCIPAL_INVESTIGATOR lat: 48.98693 lon: 2.44892 facility: Centre Hospitalier Saint-Louis city: La Rochelle country: France name: Didier GOUET role: CONTACT name: Didier GOUET role: PRINCIPAL_INVESTIGATOR lat: 46.16667 lon: -1.15 facility: Hôpital Hôtel-Dieu city: Le Creusot country: France name: Sylvaine CLAVEL role: CONTACT name: Sylvaine CLAVEL role: PRINCIPAL_INVESTIGATOR lat: 46.80714 lon: 4.41632 facility: Hospices Civils de Lyon city: Lyon country: France lat: 45.74848 lon: 4.84669 facility: Hôpital Européen city: Marseille country: France name: Denis RACCAH role: CONTACT name: Denis RACCAH role: PRINCIPAL_INVESTIGATOR lat: 43.29551 lon: 5.38958 facility: Hôpital La Timone city: Marseille country: France name: Rachel REYNAUD role: CONTACT name: Rachel REYNAUD role: PRINCIPAL_INVESTIGATOR lat: 43.29551 lon: 5.38958 facility: CHU Montpellier city: Montpellier country: France name: Fabienne DALLA VALE role: CONTACT name: Fabienne DALLA VALE role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 facility: CHU Nantes city: Nantes country: France lat: 47.21725 lon: -1.55336 facility: Hôpital Lariboisière city: Paris country: France name: Jean-Pierre RIVELINE role: CONTACT name: Jean-Pierre RIVELINE role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Hôpital Necker city: Paris country: France name: Jacques BELTRAND role: CONTACT name: Jacques BELTRAND role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Hôpital Robert Debré city: Paris country: France name: Elise BISMUTH role: CONTACT name: Elise BISMUTH role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Hôpital Rangueil city: Toulouse country: France name: Vincent MELKI role: CONTACT name: Vincent MELKI role: PRINCIPAL_INVESTIGATOR lat: 43.60426 lon: 1.44367 hasResults: False

 nctId: NCT06363903 id: 2022-MMC-051 briefTitle: ASIA-Mesh: a Pilot Study for Diagnostics and Treatment on ASIA Syndrome Caused by Polypropylene Mesh Implantation overallStatus: RECRUITING date: 2022-05-09 date: 2024-05 date: 2025-05 date: 2024-04-12 date: 2024-04-12 name: Maxima Medical Center class: OTHER name: Amsterdam UMC name: Maastricht University Medical Center briefSummary: In the present pilot study, a possible relation between the implantation of PP mesh for inguinal hernia, vaginal prolapse and SUI repair and subsequent systemic auto-immune complaints is investigated by testing immunologic and allergic responses in fifty patients with suspected ASIA syndrome. Additional value of MAT is investigated and effectiveness of (partial) PP mesh removal for these complaints is assessed. If so, a profound insight in diagnostics and treatment for systematic complaints will be attained that may provide opportunities for future diagnostics. conditions: Autoimmunity conditions: Inguinal Hernia conditions: Stress Urinary Incontinence conditions: Pelvic Organ Prolapse conditions: Implant Complication conditions: Systemic Autoimmune Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: mesh allergy test name: blood tests name: Mesh removal measure: Positive diagnostic tests measure: Autoimmune complaints and objective findings in immunologic blood test measure: Autoimmune complaints and objective findings in mesh allergy test (MAT) measure: Mesh removal and subjective complaints measure: Mesh histopathology measure: Patient demographics sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maastricht University Medical Centre status: ACTIVE_NOT_RECRUITING city: Maastricht state: Limburg zip: 6229HX country: Netherlands lat: 50.84833 lon: 5.68889 facility: Maxima Medical Centre status: RECRUITING city: Veldhoven state: Noord-Brabant zip: 5504DB country: Netherlands name: Willem AR Zwaans, MD PhD role: CONTACT phone: +31408888550 email: willem.zwaans@mmc.nl name: Maurits JC Gielen, MD role: SUB_INVESTIGATOR lat: 51.41833 lon: 5.40278 facility: Amsterdam UMC status: NOT_YET_RECRUITING city: Amsterdam state: Noord-Holland zip: 1105AZ country: Netherlands name: Prof. Dr. J.P. Roovers role: CONTACT lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06363890 id: TD02 briefTitle: Etiology of Travelers' Diarrhea in Australian Tourists Traveling to Southeast Asia acronym: AusTD overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-10-01 date: 2025-12-01 date: 2024-04-12 date: 2024-04-12 name: Lumen Bioscience, Inc. class: INDUSTRY briefSummary: The study proposed here will determine the frequency and etiology of diarrhea in Australian adult tourists traveling to Southeast Asia, including Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Thailand, Timor-Leste, and Vietnam. The results from this study will inform the feasibility and design of subsequent clinical trials of travelers' diarrhea interventions in this population. conditions: Travelers Diarrhea studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 1200 type: ESTIMATED name: TAQMan Array Card measure: Characterize the frequency and etiology of travelers' diarrhea in this participant population of Australian adult tourists traveling to Southeast Asia. sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06363877 id: 5220078 briefTitle: Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-10 date: 2025-11 date: 2024-04-12 date: 2024-04-12 name: Loma Linda University class: OTHER briefSummary: This is a multicenter randomized controlled trial of 1100 patients to evaluate the superiority of combined intraoperative wound irrigation with intraoperative peritoneal lavage with dilute aqueous povidone-iodine compared to normal saline in male and female patients between the ages of 18 and 80 years old undergoing emergency laparotomies with Centers for Disease Control (CDC) class 2 and 3 wounds. conditions: Surgical Site Infection studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 1100 type: ESTIMATED name: Povidone-Iodine name: Normal Saline measure: Surgical Site Infection measure: Readmission measure: Return to the Operating Room measure: Ileus measure: Small Bowel Obstruction sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Loma Linda University Health city: Loma Linda state: California zip: 92354 country: United States name: Martin G Rosenthal, MD role: CONTACT email: mrosenthal@llu.edu name: Martin Rosenthal, MD role: PRINCIPAL_INVESTIGATOR name: Mohamed H El-Farra, MD role: SUB_INVESTIGATOR lat: 34.04835 lon: -117.26115 hasResults: False

 nctId: NCT06363864 id: LL-IRB-2401 briefTitle: Investigation of Metabolomics Differences Between Metabolic Syndrome and Healthy Individuals in Taiwan overallStatus: NOT_YET_RECRUITING date: 2024-04-14 date: 2029-10-31 date: 2029-10-31 date: 2024-04-12 date: 2024-04-12 name: Leeuwenhoek Laboratories Co. Ltd. class: INDUSTRY briefSummary: The prevalence of metabolic syndrome in Taiwan has been increasing yearly. In this project, the database of blood test results from healthy and metabolic syndromes individuals will be analyzed to identify the small molecules related to the severity of metabolic syndrome. These identified small molecules could be used as biomarkers to predict the development of metabolic syndromes in the future. conditions: Metabolic Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 1200 type: ESTIMATED measure: Concentration changes of small molecules in blood. sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06363851 id: Kylo-11-I-C01 briefTitle: Single-ascending Dose Study of Kylo-11 in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2025-05-31 date: 2025-11-30 date: 2024-04-12 date: 2024-04-12 name: Kylonova (Xiamen) Biopharma co., LTD. class: INDUSTRY briefSummary: This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers. Kylo-11 will be evaluated in approximately 60 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects. conditions: Cardiovascular Diseases studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Kylo-11 name: Placebo measure: Incidence of adverse events measure: Incidence of adverse events measure: Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax) measure: PK parameter of time of maximum observed concentration (Tmax) measure: PK parameter of area under the concentration time curve (AUC) measure: Change in serum Lp(a) over time measure: Percent change in serum Lp(a) over time sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Chengdu Xinhua Hospital city: Chengdu state: Sichuan zip: 610000 country: China name: Xiaolan Yong role: CONTACT lat: 30.66667 lon: 104.06667 hasResults: False

 nctId: NCT06363838 id: ordu eah briefTitle: Evaluation of Neuromuscular Morphometry of the Vaginal Wall overallStatus: COMPLETED date: 2019-12-01 date: 2020-06-25 date: 2020-06-30 date: 2024-04-12 date: 2024-04-12 name: Gaziosmanpasa Research and Education Hospital class: OTHER_GOV name: T.C. ORDU ÜNİVERSİTESİ briefSummary: In this prospective study, women aged between 40 and 75 years who had not undergone any vaginal surgery and had not undergone any abdominal prolapse surgery were included. Thirty-one women diagnosed with rectocele on examination were included in the study group. Thirty-one patients who underwent vaginal intervention and hysterectomy for reasons other than rectocele (colposcopy, conization, etc.) without anterior or posterior wall prolapse were included in the control group. conditions: Pelvic Organ Prolapse studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 62 type: ACTUAL measure: epithelial thickness measure: smooth muscle density sex: FEMALE minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hakan Timur city: Ordu country: Turkey lat: 40.97782 lon: 37.89047 hasResults: False

 nctId: NCT06363825 id: MRCTA,ECFAH Of FMU[2024]373 briefTitle: A Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma overallStatus: RECRUITING date: 2024-04-12 date: 2026-04-11 date: 2027-05-11 date: 2024-04-12 date: 2024-04-17 name: Fujian Medical University class: OTHER briefSummary: To evaluate the efficacy and safety of TAE+HAIC combined with camrelizumab and apatinib in the treatment of advanced liver cancer with high tumor load conditions: Advanced Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 57 type: ESTIMATED name: camrelizumab measure: Objective response rate (ORR) measure: Disease control rate (DCR) measure: Progression-free survival (PFS) measure: Tumor progression time (TTP) measure: Overall survival (OS) measure: AE sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xinhua Chen status: RECRUITING city: Fuzhou country: China name: Yiping Chen role: CONTACT phone: 13805066904 lat: 26.06139 lon: 119.30611 hasResults: False

 nctId: NCT06363812 id: The POST briefTitle: Probability of OncotypeDx to Reallocate as Low or High Risk of Recurrence Breast Cancer Patients With Uncertain Biology overallStatus: ACTIVE_NOT_RECRUITING date: 2018-03-08 date: 2021-05-15 date: 2024-12-31 date: 2024-04-12 date: 2024-04-15 name: Fondazione Sandro Pitigliani class: OTHER name: Genomic Health®, Inc. name: Istituto Toscano Tumori briefSummary: In some cases of hormone receptor positive, human epidermal growth factor receptor 2 (HER2) negative early breast cancer the benefit of adding adjuvant chemotherapy to hormonal treatment, estimated on the basis of the classical clinico-pathological parameters, is unclear. In these cases the application of a genomic test could be useful in guiding the therapeutic choice. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 258 type: ACTUAL measure: the proportion of tumor samples with a useful OncotypeDx measure: the proportion of patients in which the result of the test has induced a modification in the initial treatment plan measure: the proportion of tumor samples with an intermediate risk or not evaluable at OncotypeDx sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital of Prato city: Prato zip: 59100 country: Italy lat: 43.8805 lon: 11.09699 hasResults: False

 nctId: NCT06363799 id: OST1_010 briefTitle: Osteopathic Protocol for Insomnia in College Students overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2024-12 date: 2024-12 date: 2024-04-12 date: 2024-04-29 name: Escola Superior de Tecnologia da Saúde do Porto class: OTHER briefSummary: In this randomized controlled experimental trial, it is aimed to determine the effectiveness of an osteopathic protocol treatment for insomnia in college students. In this study, will be used the Compression of 4th ventricle (CV4) and the diaphragmatic breathing technique. conditions: Insomnia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: 4th ventricle compression technique and diaphragmatic breathing name: Sham Technique measure: Change from the baseline insomnia episodes and symptoms through Pittsburgh questionnaire score sex: ALL minimumAge: 18 Years maximumAge: 28 Years stdAges: ADULT hasResults: False

 nctId: NCT06363786 id: GOOSEBERRY briefTitle: Reducing Skin Surface pH During Skin Occlusion: Changes to Skin Microbiome and Skin Parameters overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-05-30 date: 2024-09-30 date: 2024-04-12 date: 2024-04-12 name: Essity Hygiene and Health AB class: INDUSTRY briefSummary: The main aim of this exploratory research study is to investigate how exposure to a material with low pH affects the skin microbiome and skin parameters. This investigation involves an experimental setup in which application of test patches with lowered pH levels or control patches without lowered pH are used. The test patches are applied on healthy adult volunteers. About 20 subjects are planned for the study. The skin microbiome preservation and diversity will be addressed employing Molecular Sequencing and qPCR. In addition, skin pH, composition and hydration will be measured with various methods, e.g., AquaFlux, Moisture Meter, TEWL and Confocal Raman spectroscopy. The study will span three consecutive days in total. Each participant will be provided with four patches on each forearm: two patches will be applied to each dorsal forearm and two on each volar forearm. The first day will be for study inclusion and application of pathces. In day two the patches will be changed and on day three measurements for pH, TEWL, skin hydration, Raman and tape stripping will be conducted and sampling for Molecular Sequencing and qPCR measurements will be done. There is no formal hypothesis in the study but our idea is that utilizing patches with a lower pH could maintain the diversity and richness of the natural skin microbiome while retaining and even enhancing key skin barrier parameters. A descriptive analysis will be conducted for all measurements with approproate statistical tests on 5% level for varaibles. In addition to descriptive data analysis statistics, Clinical Microbiomics and Bio-Me Microbiome Profiling will employ various statistical methods, such as paired Mann-Whitney U tests. The Benjamini-Hochberg (BH) method to control the false discovery rate (FDR) will be employed. conditions: Incontinence-associated Dermatitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Healthy volunteers get patches carrying a low pH or control formula applied to the forearms. The patches are carried over two days and the skin parameteres and skin mictrobiome is measured on day 3. primaryPurpose: BASIC_SCIENCE masking: NONE count: 20 type: ESTIMATED name: Test patches measure: Changes in skin microbiome as measured by molecular sequencing measure: Changes in skin microbiome diversity as measured by qPCR measure: Skin surface pH measure: Change in Trans Epidermal Water loss measure: Change in skin hydration measure: Change in Skin water profile measure: Presence of low pH formula on the skin sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Essity Study Site city: Gothenburg zip: SE40503 country: Sweden name: Fredrik Agholme, PhD role: CONTACT phone: +46730323634 email: fredrik.agholme@essity.com name: Ulrika Husmark, PhD role: PRINCIPAL_INVESTIGATOR lat: 57.70716 lon: 11.96679 hasResults: False

 nctId: NCT06363773 id: RESTO-IMMUNO id: 2023-A02451-44 type: OTHER domain: ANSM briefTitle: A Study to Assess the Ability of Stereotactic Radiotherapy to Restore the Efficacy of Immunotherapy in Patients With Metastatic Cancer. acronym: RESTO-IMMUNO overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-09 date: 2026-06 date: 2024-04-12 date: 2024-04-17 name: Elsan class: OTHER briefSummary: This study aims at enrolling patients with solid tumors at metastatic stage, considered long responders to immunotherapy (\> 6 months) and displaying disease progression.

In this study, the investigator wants to evaluate specific modalities of stereotactic radiotherapy, with 3 sessions, each of 8 Gy, lasting 20 minutes and spaced 72 hours apart (Day 1, Day 4, Day 7). The radiotherapy device itself is not the subject of this study and will be used in accordance with its CE mark and indications.

The objective of the study is to assess the ability of stereotactic radiotherapy to restore the lost efficacy of immunotherapy. In particular, the abscopal effect will be assessed, i.e. the action of irradiating a particular target lesion and observing an effect on other distant metastases. conditions: Metastatic Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pilot, exploratory, prospective, monocentric study primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Stereotactic Radiotherapy measure: Objective Response Rate according to iRECIST criteria at 3 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy. measure: Objective Response Rate according to RECIST 1.1 criteria at 3 months after stereotactic RT in patients with progression after initial response to immunotherapy. measure: Objective Response Rate according to iRECIST criteria up to 12 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy. measure: Objective Response Rate according to RECIST 1.1 criteria up to 12 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy. measure: Duration until new systemic treatment start. measure: Incidence of Adverse Events (safety) measure: Progression-Free Survival measure: Overall Survival measure: Objective Response Rate according to iRECIST criteria on the irradiated lesion only. measure: Objective Response Rate according to RECIST 1.1 criteria on the irradiated lesion only. measure: Objective Response Rate according to iRECIST criteria on all untreated lesion(s) (abscopal effect). measure: Objective Response Rate according to RECIST 1.1 criteria on all untreated lesion(s) (abscopal effect). measure: Objective Response Rate according to iRECIST criteria on each untreated lesion taken independently from others (abscopal effect). measure: Objective Response Rate according to RECIST 1.1 criteria on each untreated lesion taken independently from others (abscopal effect). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Clinical city: Soyaux state: Charente zip: 16800 country: France lat: 45.65 lon: 0.2 hasResults: False

 nctId: NCT06363760 id: EDIT-301-LTFU-001 briefTitle: A Long-Term Follow-Up Study of Participants With Sickle Cell Disease or Transfusion Dependent β-Thalassemia Who Received EDIT-301 overallStatus: NOT_YET_RECRUITING date: 2024-06-04 date: 2040-08 date: 2040-08 date: 2024-04-12 date: 2024-04-12 name: Editas Medicine, Inc. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the long-term safety and efficacy of EDIT-301 in participants with severe sickle cell disease (SCD) or transfusion-dependent β-thalassemia (TDT) who have received EDIT-301. conditions: Sickle Cell Disease conditions: Transfusion-dependent Beta-Thalassemia conditions: Hemoglobinopathies studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 54 type: ESTIMATED name: Safety and efficacy assessments measure: Adverse events of special interest (AESI) measure: Adverse events of interest (AEI) measure: All-cause mortality measure: Adverse events (AEs) related to EDIT-301 measure: Serious adverse events (SAEs) measure: Proportion of SCD participants with severe vaso-occlusive events (sVOEs) over time post-EDIT-301 infusion measure: Proportion of SCD participants with vaso-occlusive events (VOEs) over time post-EDIT-301 infusion measure: Frequency of SCD-related transfusions over time post-EDIT-301 infusion for SCD participants measure: Proportion of TDT participants with sustained transfusion independence (TI) over time measure: Proportion of TDT participants with sustained transfusion reduction (TR) over time measure: Frequency of TDT-related transfusions over time post-EDIT-301 infusion for TDT participants measure: SCD and TDT: Percent of peripheral red blood cells (RBCs) containing HbF (F-cells) over time measure: SCD and TDT: Total hemoglobin (Hb) concentration (g/dL) over time measure: SCD and TDT: Proportion of alleles with intended genetic modification present in peripheral blood nucleated cells and bone marrow derived CD34+ over time measure: Average HbF (pg) per RBC over time for SCD participants measure: Complete Blood Count (CBC) red cell indices assay over time for SCD participants measure: Average HbF (pg) per F-cell over time for SCD participants measure: HbF and HbS concentration (g/dL) over time for SCD participants measure: The level of HbF production determined by fractionation of different forms of Hb (including but not limited to HbA, HbA2, HbC, HbD, HbE, and HbS) over time for SCD participants. measure: Percentage of HbF over total non-transfused total Hb (non-transfused total Hb refers to the total g/dL of all Hb variants, excluding HbA) over time for TDT participants. measure: HbF concentration (g/dL) over time for TDT participants measure: Iron overload of TDT participants measure: Proportion of TDT participants receiving iron chelation therapy over time. sex: ALL minimumAge: 12 Years maximumAge: 50 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06363747 id: 123456 briefTitle: The Medically Reproducing Bariatric Surgery (MRB) II Study overallStatus: NOT_YET_RECRUITING date: 2024-06-03 date: 2025-06-03 date: 2025-06-03 date: 2024-04-12 date: 2024-04-15 name: Durham VA Medical Center class: FED name: Société des Produits Nestlé (SPN) briefSummary: Roux-en-Y (RYGB) gastric bypass reduces the size and capacity of the stomach and bypasses a portion of the small intestine which leads to decreased food intake and higher levels of a gut hormone called GLP-1 (glucagon-like-peptide-1). These changes lead to weight loss, improved blood sugars and often remission of type 2 diabetes but most patients do not qualify or want surgery. The investigators are searching for ways to make the beneficial effects of RYGB available to most type 2 diabetes patients rather than a select few that undergo RYGB.

The investigators believe that parts of RYGB can be medically reproduced through a combination of diet and medicine. Once weekly injectable GLP-1 medicine that leads to weight loss and improved blood sugar control in type 2 diabetes are now FDA approved. Optifast is a medically supervised diet that safely reduces calorie intake to 800 calories per day for three months by replacing normal meals with specially prepared bars and shakes which leads to weight loss and improved blood sugar control in type 2 diabetes. Normal meals are then gradually reintroduced over 6 weeks and the bars/shakes are stopped. The investigators hypothesize that Optifast (diet) + once weekly GLP-1 will lead to weight loss and improvement in blood sugar control in type 2 diabetes similar to what is seen after RYGB. conditions: Type 2 Diabetes conditions: Obesity studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Control--\[GLP-1 agonist +/- DM2 meds + medical management + nutritional/behavioral counseling\] Experimental---\[Optifast + GLP-1 agonist + medical management + nutritional/behavioral counseling\] primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Very Low Calorie Diet measure: Glycemic Control measure: Weight lost measure: Medication Intensity measure: Health Related Quality of Life measure: Symptom Item Checklist sex: ALL minimumAge: 25 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Greenville VA Health Care Center city: Greenville state: North Carolina zip: 27834 country: United States lat: 35.61266 lon: -77.36635 hasResults: False

 nctId: NCT06363734 id: DAL20240409 briefTitle: Osimertinib Plus Dalpiciclib in Patients With EGFR-mutant, CDK4/6 Pathway Aberrant, Advanced Non-small Cell Lung Cancer Following Acquired Resistance to Third-generation EGFR TKI: a Phase II Trial overallStatus: RECRUITING date: 2024-04-09 date: 2025-12-15 date: 2026-12-31 date: 2024-04-12 date: 2024-04-16 name: Tianjin Medical University Cancer Institute and Hospital class: OTHER briefSummary: This study is a prospective, single-arm, phase II trial. It is aimed to evaluate the efficacy and safety of the combination of osimertinib and dalpiciclib in patients with EGFR-mutant, CDK4/6 pathway aberrant, advanced NSCLC following acquired resistance to third-generation EGFR TKI. conditions: Non-small Cell Lung Cancer conditions: EGFR Activating Mutation conditions: Cell Cycle Deregulation conditions: EGFR-TKI Resistant Mutation studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: Osimertinib plus Dalpiciclib measure: Objective Response Rate (ORR) measure: disease control rate (DCR) measure: Duration of Response (DoR) measure: Progression Free Survival (PFS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Thoracic Medical Oncology, Tianjin Medical University Cancer Hospital status: RECRUITING city: Tianjin state: Tianjin zip: 300060 country: China name: Peng Chen, M.D. role: CONTACT phone: +86-22-23340123 phoneExt: 3201 email: chenpeng@tjmuch.com name: Peng Chen, M.D. role: PRINCIPAL_INVESTIGATOR lat: 39.14222 lon: 117.17667 hasResults: False

 nctId: NCT06363721 id: DFH00125 briefTitle: A Pilot Study of a Commercially-available Oil Rinse Product (PerioPull™) on Markers of Dental Health overallStatus: RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-12 date: 2024-04-12 name: Designs for Health class: INDUSTRY briefSummary: The primary purpose of this study is to evaluate the impact of a commercially-available oil rinse product (PerioPull™) on parameters of dental health among a sample of adults. PerioPull™ is commercially available and sold primarily from clinicians' offices.

A 12-week pilot study will be conducted to achieve the purpose of this study. The research team hypothesizes that PerioPull™ will improve a variety of validated markers of dental health that are commonly used in clinical practice. conditions: Oral Health studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The proposed study is a 12-week pilot study of PerioPull™. Eligible participants will be recruited from within the clinical practice of the periodontist. All study outcomes will be measurements and testing during three dental visits spaced 6 weeks apart. These are typical assessments in routine clinical practice. All study outcomes are described in detail in an ensuing section. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 18 type: ESTIMATED name: PerioPull™ measure: Plaque Index measure: Gingival Index measure: Pocket Depth measure: Intraoral Photos measure: MyPerioPath® sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Julian Center for Comprehensive Dentistry status: RECRUITING city: Ellicott City state: Maryland zip: 21042 country: United States name: Eugene Sambataro, DDS role: CONTACT phone: 410-834-0796 email: drsam@julianctr.com name: Eugene Sambataro, DDS role: PRINCIPAL_INVESTIGATOR name: Chris D'Adamo, PhD role: SUB_INVESTIGATOR name: Michael Jurgelewicz, DC role: SUB_INVESTIGATOR name: David Brady, ND, DC role: SUB_INVESTIGATOR lat: 39.26733 lon: -76.79831 hasResults: False

 nctId: NCT06363708 id: 2024050 briefTitle: Tislelizumab in Combination With Chemotherapy as a Neoadjuvant Treatment for Advanced Endometrial Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-12-01 date: 2026-06-30 date: 2024-04-12 date: 2024-04-12 name: Zhongnan Hospital class: OTHER briefSummary: The goal of this clinical trial is to evaluate the efficacy and safety of tislelizumab in combination with chemotherapy as a neoadjuvant treatment for advanced endometrial cancer. conditions: Endometrial Neoplasms studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Tislelizumab name: Paclitaxel name: Carboplatin measure: R0 resection rate (R0 %) measure: Pathological complete response rate (pCR%） measure: Objective Response Rate (ORR%) measure: Progression free survival (PFS) measure: Recurrence free survival (RFS) measure: Overall survival (OS) measure: Incidence and severity of adverse events as assessed by the NCI-CTCAE v5.0 sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Central Hospital of Wuhan city: Wuhan state: Hubei zip: 430014 country: China name: Xun Tian, MD,PhD role: CONTACT phone: 15327205656 email: tianxun@126.com lat: 30.58333 lon: 114.26667 facility: Zhongnan Hospital of Wuhan University city: Wuhan state: Hubei zip: 430062 country: China name: Zheng Hu, MD,PhD role: CONTACT phone: 13632120686 email: Huzheng1988@163.com lat: 30.58333 lon: 114.26667 facility: Hubei maternal and child health care hospital city: Wuhan state: Hubei zip: 430070 country: China name: QuanFu Ma, MD,PhD role: CONTACT phone: 13728133014 email: dm626925@126.com lat: 30.58333 lon: 114.26667 hasResults: False

 nctId: NCT06363695 id: 131-22 id: 1R01HD112043-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01HD112043-01 briefTitle: Building Community Health Volunteers' Capacity to Support Parents With Young Children With SafeCare Kenya overallStatus: RECRUITING date: 2024-03-14 date: 2028-01 date: 2028-05 date: 2024-04-12 date: 2024-04-12 name: Pacific University class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) name: Africa Mental Health Research and Training Foundation name: Georgia State University briefSummary: The goal of this clinical trial is to implement and examine the impact of SafeCare Kenya, an adapted parenting program, to improve parents' skills and knowledge related to the care of their children between the ages of 18 months and 5 years old. The main questions it aims to answer are:

* Will SafeCare Kenya improve child and parent outcomes?
* Is virtual delivery as effective as in-person delivery of SafeCare Kenya?
* Is SafeCare Kenya feasible to deliver by community health volunteers?

Mothers will:

* Complete study assessments at three timepoints: baseline, 6 months and 18 months
* Mothers in the SafeCare Kenya group will receive the program from their community health volunteer

Researchers will compare SafeCare Kenya to care as usual by community health volunteers to see if SafeCare Kenya families show improvements in parent interaction skills, safety and health knowledge, potential for child abuse, child behavior problems, child injuries, parenting stress, and child and parent quality of life. conditions: Child Maltreatment conditions: Parenting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 369 type: ESTIMATED name: SafeCare Kenya name: Care as Usual by Community Health Volunteers measure: Change from Baseline in score on Child Planned Activities Training (cPAT) at 6 months measure: Change from Baseline in score on Child Planned Activities Training (cPAT) at 18 months measure: Change from Baseline in scores on Parenting Young Children (PARYC) at 6 months measure: Change from Baseline in scores on Parenting Young Children (PARYC) at 18 months measure: Change from Baseline in score on How to Keep your Child Safe and Healthy Quiz at 6 months measure: Change from Baseline in score on How to Keep your Child Safe and Healthy Quiz at 18 months measure: Change from Baseline in score on Brief Child Abuse Potential Inventory (BCAPI) at 6 months measure: Change from Baseline in score on Brief Child Abuse Potential Inventory (BCAPI) at 18 months measure: Change from Baseline in score on Child Behavior Checklist (CBCL) at 6 months measure: Change from Baseline in score on Child Behavior Checklist (CBCL) at 18 months measure: Change from Baseline in scores on Parenting Stress Index at 6 months measure: Change from Baseline in scores on Parenting Stress Index at 18 months measure: Change from Baseline in score on Childhood injuries at 6 months measure: Change from Baseline in score on Childhood injuries at 18 months measure: Change from Baseline in score on Child Quality of Life at 6 months measure: Change from Baseline in score on Child Quality of Life at 18 months measure: Change from Baseline in score on Parent Quality of Life at 6 months measure: Change from Baseline in score on Parent Quality of Life at 18 months measure: Client satisfaction measure: Provider fidelity measure: Parent Interview measure: Provider Interview measure: Trainer Interview measure: Stakeholder Interview measure: Readiness Assessment for the Prevention of Child Maltreatment (RAP-CM) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Africa Mental Health Research and Training Foundation status: RECRUITING city: Nairobi country: Kenya name: Victoria Mutiso, PhD role: CONTACT phone: (254) 202 651 360 email: vmutiso@amhf.or.ke name: Christine Musyimi, PhD role: CONTACT phone: (254) 202 651 360 email: christine.musyimi@amhf.or.ke name: David Ndetei, MD role: PRINCIPAL_INVESTIGATOR lat: -1.28333 lon: 36.81667 hasResults: False

 nctId: NCT06363682 id: 2023PI225 briefTitle: Interventional Reference Levels (IRL) in Digestive Endoscopy acronym: EndoscopX overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-11 date: 2024-06-11 date: 2024-04-12 date: 2024-04-12 name: Central Hospital, Nancy, France class: OTHER briefSummary: Scopy uses X-rays and is not without risk (deterministic and stochastic effects) for the patient and the nursing staff present in the room at the time of an endoscopic procedure requiring its use: its use must be reasoned with a benefit/risk balance in favour of carrying out the interventional procedure. In France, there is currently no multicentre study exploring the radiation doses used for each type of endoscopic procedure.

Main objective: To define IRL (interventional reference levels) adapted to each type of endoscopic procedure.

Secondary objective(s) :

* Application of regulatory texts
* Assessment of patient radiation protection
* Radiation protection assessment for workers conditions: Each Endoscopic Intervention Using X-rays studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: ERCP name: endoscopic ultrasound name: gastroscopy name: Colonoscopy name: placement of a nasojejunal tube measure: To define IRL (interventional reference levels) adapted to each type of endoscopic procedure. measure: Application of regulatory texts measure: Assessment of patient radiation protection measure: Radiation protection assessment for workers sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital University of Nancy city: Nancy state: Meurthe-et-Moselle zip: 54000 country: France name: MUNIER W Munier Wendy role: CONTACT phone: +3383155457 email: w.munier@chru-nancy.fr name: CHEVAUX JB Doctor CHEVAUX Jean-Baptiste, PhD role: PRINCIPAL_INVESTIGATOR lat: 48.68439 lon: 6.18496 hasResults: False

 nctId: NCT06363669 id: 1_CAF_AWF briefTitle: Effects of Caffeine-based Supplement on Physical Performance overallStatus: COMPLETED date: 2018-01-15 date: 2024-03-30 date: 2024-03-30 date: 2024-04-12 date: 2024-04-12 name: University School of Physical Education, Krakow, Poland class: OTHER briefSummary: The aim of the study was to determine the acute effects of multi-ingredient pre-workout supple-ment (MIPS) containing: beta-alanine, taurine, caffeine, L-tyrosine, and cayenne pepper (capsaicin) on physical performance in untrained men conditions: Muscle Power studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: PARTICIPANT count: 12 type: ACTUAL name: multi-ingredient pre-workout dietary supplement (caffeine-based) measure: anaerobic power measure: aerobic power sex: MALE minimumAge: 19 Years maximumAge: 30 Years stdAges: ADULT facility: University School of Physical Education in Cracow city: Krakow zip: 31-571 country: Poland lat: 50.06143 lon: 19.93658 hasResults: False

 nctId: NCT06363656 id: 76455623.5.0000.0068 briefTitle: Assessment of Smartwatch SAMSUNG to Monitor Sleep Quality: an Observational Prospective Study - SleepEx2 Protocol acronym: SLEEP-EX2 overallStatus: RECRUITING date: 2024-02-15 date: 2024-05-28 date: 2024-07-30 date: 2024-04-12 date: 2024-04-26 name: University of Sao Paulo General Hospital class: OTHER name: Samsung Eletrônica da Amazônia Ltda name: Academic Research Organization of Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP briefSummary: The goal of this study is to learn if a smartwatch is effective to identify factors related to sleep quality and habits of adults (30 years old or more), enabling the improvement and/or creation of instruments to assess overall health status and sleep quality.

The main question it aims to answer is:

- Does the smartwatch application (software) indicate sleep habits and measure sleep quality in accordance to the standardized clinical instruments commonly used to assess sleep? conditions: Insomnia conditions: Sleep Initiation and Maintenance Disorders conditions: Health Status conditions: Wearable Electronic Devices conditions: Sleep studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 158 type: ESTIMATED name: Wears the smartwatch during the sleep time to capture sleep characteristics and answer questionaires measure: Concordance between the smartwatch application and clinical assessment sex: ALL minimumAge: 30 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Instituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo status: RECRUITING city: São Paulo zip: 05403-900 country: Brazil name: ARO-InCor Academic Research Organization Office role: CONTACT phone: +55 11 2661-5795 email: aro@incor.usp.br name: Daniel Queiroz, PhD role: CONTACT phone: +55 11 9-4138-5473 email: daniel.queiroz@incor.usp.br name: Geraldo Lorenzi Filho, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: -23.5475 lon: -46.63611 hasResults: False

 nctId: NCT06363643 id: Prehab01 briefTitle: Lower Limb Arthroplasty: Effects of a Tele Prehabilitation Program With Indirect Electrostimulation. overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-07-26 date: 2024-07-26 date: 2024-04-12 date: 2024-04-12 name: University of Pavia class: OTHER briefSummary: Preoperative fitness is known to predict postoperative outcomes following lower limb arthroplasty, but many patients, especially the most fragile, arrive at surgery with reduced mobility and functional capacity.

Prehabilitation (Prehab) encompasses a series of interventions that are intended to help patients improve their physical state and psychological well-being pre-intervention to reduce the days of hospitalization and the number of post-operative complications. Patients who participate in Prehab require less postoperative care and consequently have less impact on the cost of the healthcare system. However, adherence to a face-to-face program is usually poor and presents both organizational and psychophysical barriers. In the last years, telerehabilitation has proven to be a viable alternative to face-to-face treatment and has already been adopted for the Prehab. Electrostimulation (ESM) is regularly used successfully in clinical settings for the recovery of muscle tone in patients with orthopedic pathologies. In addition, it has already been used for Prehab, showing an increase in muscle strength and a decrease in postoperative hospital stay following knee arthroplasty. Also Exercise offers benefits in the treatment of orthopedic patients because improve: strength, cardiovascular fitness, functional capacities and quality of life. Therefore, in a group of patients who are candidates for elective lower limb arthroplasty surgery, it was decided to evaluate the effects of a Tele Prehab program, based on the ESM, and compare them with those of an Tele Prehab exercise program, equal in dose and duration. The proposal differs from those present in the literature for complete administration in telerehabilitation, including evaluations. conditions: Osteo Arthritis Knee and Hip conditions: Lower Limb Arthroplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 44 type: ESTIMATED name: ELECTROSTIMULATION (ES) name: EXERCISE (C) measure: Change from baseline in functional capacities on 30 Seconds Chair Stand Test (30CST) at week 4 measure: Change from baseline in functional capacities on Timed Up and Go test (TUG) at week 4. sex: ALL minimumAge: 55 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: "Città di Pavia Healthcare Institute" city: Pavia zip: 27100 country: Italy name: Luca Marin role: CONTACT phone: 0382 433658 phoneExt: +39 email: luca.marin@unipv.it name: Luca Marin role: PRINCIPAL_INVESTIGATOR name: Matteo Chiodarono role: SUB_INVESTIGATOR lat: 45.19205 lon: 9.15917 hasResults: False

 nctId: NCT06363630 id: CA073-1000 briefTitle: A Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Drug Levels of Golcadomide (BMS-986369) in Healthy Participants overallStatus: NOT_YET_RECRUITING date: 2024-04-16 date: 2024-08-19 date: 2024-08-19 date: 2024-04-12 date: 2024-04-12 name: Celgene class: INDUSTRY briefSummary: The purpose of this study is to evaluate the drug-drug interaction (DDI) potential of coadministration of itraconazole or rifampin on the single dose drug levels of golcadomide. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Itraconazole name: Rifampin name: Golcadomide measure: Maximum observed plasma concentration (Cmax) measure: Area under the plasma concentration-time curve from time zero to time of the 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 physical exam abnormalities measure: Number of participants with vital sign abnormalities measure: Number of participants with clinical laboratory safety test abnormalities measure: Number of participants with electrocardiogram abnormalities measure: Number of participants with concomitant medications measure: Number of participants with concomitant procedures measure: Time of maximum observed plasma concentration (Tmax) measure: Apparent terminal phase half-life (T-HALF) measure: Apparent total body clearance (CLT/F) measure: Apparent volume of distribution (Vz/F) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Local Institution - 0001 city: Lenexa state: Kansas zip: 66219 country: United States name: Site 0001 role: CONTACT lat: 38.95362 lon: -94.73357 hasResults: False

 nctId: NCT06363617 id: CSAPG-58 briefTitle: Implementation of the Fatty Liver Index in Primary Care acronym: FLI-AP overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-12 date: 2024-04-15 name: Consorci Sanitari de l'Alt Penedès i Garraf class: OTHER briefSummary: This trial aims to evaluate the impact on cardiovascular risk control in individuals in risk of being affected by hepatic steatosis through the implementation of a screening test (Fatty Liver Index) in Primary Care. Medical teams in a primary care center will be divided into 2 groups, with one group using the screening test in their clinical practice. The number of interventions on cardiovascular risk occurring in patients attended by each group of medical teams will be evaluated and compared. conditions: Hepatic Steatosis conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 434 type: ESTIMATED name: FLI measure: Lifestyle Intervention measure: Low-density lipoprotein cholesterol measure: Triglycerides measure: Gamma-glutamyl transpeptidase measure: Medical and nursing visits measure: Analytical checks in the first year measure: Lipid-lowering drugs measure: Healthcare spending measure: FLI administration sex: ALL minimumAge: 14 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Centro de Salud Vilanova i la Geltrú 3 Baix A Mar city: Vilanova I La Geltrú state: Barcelona country: Spain name: M Carmen Rosas, MD role: CONTACT phone: +34 938 10 30 03 email: mrosas@csapg.cat name: Noemí Casaponsa role: CONTACT phone: +34 938960026 phoneExt: 43197 email: recerca@csapg.cat name: M Carmen Rosas, MD role: PRINCIPAL_INVESTIGATOR lat: 41.22392 lon: 1.72511 hasResults: False

 nctId: NCT06363604 id: XHEC-C-2023-128-2 briefTitle: Evaluation of PWI Assisted by Marshall Ethanolization in Ablation of Persistent Atrial Fibrillation overallStatus: RECRUITING date: 2023-12-01 date: 2026-09 date: 2026-11 date: 2024-04-12 date: 2024-04-12 name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine class: OTHER briefSummary: This is a prospective, randomized controlled, single-blind, multi-center clinical trial study aiming to investigate whether the strategy of posterior wall isolation (PWI) assisted by vein of Marshall ethanol infusion (VOMEI) could improve the success rate of persistent atrial fibrillation ablation. conditions: Atrial Fibrillation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A total of 260 participants with persistent AF who undergo radiofrequency catheter ablation and received VOMEI + PVI will be randomized assigned to two groups at 1:1 ratio.

Group 0 (Control): VOMEI + PVI + linear ablation of mitral isthmus. Group 1 (Experimental): VOMEI + PVI + linear ablation of mitral isthmus + PWI primaryPurpose: TREATMENT masking: SINGLE maskingDescription: This study used a single-blind design for the subjects. A statistician created a random sequence of numbers using a randomization scheme. The sequence was then placed in opaque coded envelopes and sealed in numerical order. When a patient met the inclusion and exclusion criteria and was assigned a number, the researcher notified the manager to obtain the corresponding envelope and perform the intervention according to the grouping plan inside the envelope. Group 0 correspond to the control group not receiving PWI isolation, while group 1 correspond to the experimental group for PWI isolation. whoMasked: PARTICIPANT count: 260 type: ESTIMATED name: VOMEI + PVI + linear ablation of mitral isthmus name: Posterior wall isolation measure: Recurrence of atrial arrhythmias measure: Procedural complications sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xinhua Hospital, Shanghai Jiao Tong University status: RECRUITING city: Shanghai state: Shanghai zip: 200092 country: China name: Mu Chen role: CONTACT phone: +86 021 25077275 email: chenmu@xinhuamed.com.cn lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06363591 id: Wise vs wide briefTitle: Single- vs Two-staged Excisions of Thin Melanoma acronym: WvW overallStatus: NOT_YET_RECRUITING date: 2024-10-01 date: 2034-12-31 date: 2034-12-31 date: 2024-04-12 date: 2024-04-15 name: Vastra Gotaland Region class: OTHER_GOV name: Stockholm Region name: Region Skane name: Region Västerbotten name: Region Örebro County name: Blekinge County Council Hospital name: Region Östergötland name: Dalarna County Council, Sweden briefSummary: The overall aim of this national, multicenter, prospective, randomized, and controlled study is to enhance the management of patients with thin melanoma (≤1 mm Breslow thickness). The investigators hypothesize that wide local excisions (WLEs) following complete excision of thin melanoma do not affect the risk of recurrence, defined as the occurrence of local, regional, distant disease, or melanoma-specific death during a 5- to 10-year follow-up period. conditions: Melanoma (Skin) conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients with thin (≤1.0 mm) invasive melanomas excised with a histopathological margin ≥1.5 mm will be offered to participate following informed consent and randomization (1:1) to either:

1. Standard treatment with a WLE of the diagnostic excision scar with a lateral clinical surgical margin of 10 mm and a deep clinical surgical margin down to the muscular fascia as recommended by the Swedish national guidelines.

   or
2. Experimental treatment with no WLE. primaryPurpose: TREATMENT masking: NONE count: 2486 type: ESTIMATED name: Wise vs wide measure: Recurrence rate at 5 years. measure: Recurrence rate at 10 years. measure: Postoperative complications measure: Scar length, width and quality measure: Scar length, width and quality measure: Patients' quality of life measure: Patient satisfaction measure: Patients' quality of life measure: Patient satisfaction measure: Patients' quality of life measure: Patient satisfaction measure: Direct and indirect costs per patient sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06363578 id: 36264PR604/3/24 briefTitle: Different Doses of Dexmedetomidine in External Oblique Intercostal Plane Block in Splenectomy overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2024-10-01 date: 2024-10-01 date: 2024-04-12 date: 2024-04-12 name: Tanta University class: OTHER briefSummary: The aim of this study is to compare the analgesic effects of different doses of dexmedetomidine as an adjuvant in external oblique intercostal plane block (EOIPB) in splenectomy. conditions: Dexmedetomidine conditions: External Oblique Intercostal Plane Block conditions: Splenectomy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Dexmedetomidine 0.5 μg/kg name: Dexmedetomidine 1 μg/kg measure: Time to the 1st rescue analgesia measure: Intraoperative fentanyl consumption measure: Total morphine consumption measure: Degree of pain measure: Heart rate measure: Mean arterial pressure measure: The incidence of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tanta University city: Tanta state: El-Gharbia zip: 31527 country: Egypt name: Mohammed S Elsharkawy, MD role: CONTACT phone: 00201148207870 email: mselsharkawy@med.tanta.edu.eg name: Saad A Moharam, MD role: PRINCIPAL_INVESTIGATOR lat: 30.78847 lon: 31.00192 hasResults: False

 nctId: NCT06363565 id: MN-2022-11 briefTitle: Effects of Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults overallStatus: RECRUITING date: 2023-06-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-12 date: 2024-04-12 name: Sun Yat-sen University class: OTHER briefSummary: The purpose of this study is to determine whether supplementation of compound nutrients, including folic acid, vitamin B6, vitamin B12, and betaine, will decrease the level of plasma homocysteine in Chinese adults with homocysteine levels above 10 μmol/L. conditions: Homocysteine studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 220 type: ESTIMATED name: supplementation of compound nutrients name: placebo control measure: levels of homocysteine sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SunYat-sen University status: RECRUITING city: Guangzhou state: Guangdong zip: 510080 country: China name: Zhu Huilian role: CONTACT lat: 23.11667 lon: 113.25 hasResults: False

 nctId: NCT06363552 id: WETARI briefTitle: A Study of SC-0191 in Subjects With Metastatic Colorectal Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-04 date: 2025-12 date: 2024-04-12 date: 2024-04-12 name: Tianshu Liu class: OTHER briefSummary: The goal of this clinical trial is to evaluate the preliminary safety and efficacy of SC0191 as single agent or in combination with bevacizumab or 5-FU/LV in advanced colorectal cancer. conditions: Metastatic Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 36 type: ESTIMATED name: SC0191 name: SC0191 + Bevacizumab name: SC0191 + 5-FU/LV measure: Objective Response Rate measure: Incidence and Severity of Dose Limiting Toxicities (DLTs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongshan Hospital Affiliated to Fudan University city: Shanghai state: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06363539 id: Adeel5 briefTitle: Silver Nitrate Versus Topical Steroid For Umbilical Granuloma overallStatus: COMPLETED date: 2022-09-20 date: 2023-03-20 date: 2023-05-01 date: 2024-04-12 date: 2024-04-12 name: Children Hospital and Institute of Child Health, Lahore class: OTHER briefSummary: Umbilical granuloma is most frequent abnormality of umbilicus in infants that is defined as a moist, fleshy and pink granulation tissue at the center of umbilicus. The most commonly used treatment for umbilical granuloma is silver nitrate cauterization. Various other treatment options for umbilical granuloma include dressing with alcohol and antiseptic solutions, topical table salt, topical steroid application, suture ligation, surgical excision, electrocautery and cryotherapy. Topical steroid ointment is easily available in market, it is cheaper and safer than silver nitrate. OBJECTIVE: To compare the outcome of treatment with silver nitrate versus topical steroid for umbilical granuloma in terms of healing after 3 weeks of treatment. MATERIALS AND METHODS Study Design: Randomized Controlled Trial Setting: Department of Pediatric Surgery, Children Hospital, Lahore Duration: 6 months after approval of synopsis \[Sept 20, 2022 till March 20, 2023\] DATA COLLECTION PROCEDURE 2 After approval of study from hospital Ethical committee \& CPSP, all patients fulfilling the inclusion criteria were admitted through the pediatric surgery outpatient department of The Children's Hospital Lahore. 354 Patients were divided in two equal groups randomly, using lottery method Group A (control group) in which silver nitrate was applied to the lesion once a week and Group B (experimental group) in which topical steroid ointment was applied to the lesion twice a day. Patients were followed after 3 weeks to see healing of umbilical granuloma. Photographs were taken before start of treatment and on regular intervals at each follow up visit. All data was collected by myself. conditions: Umbilical Granuloma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized control trial primaryPurpose: TREATMENT masking: NONE count: 354 type: ACTUAL name: Clobetasol Propionate .05 Mg in 100 mL TOPICAL LOTION name: Silver Nitrate measure: healing sex: ALL minimumAge: 1 Month maximumAge: 1 Year stdAges: CHILD facility: Children Hospital city: Lahore state: Punjab zip: 42000 country: Pakistan lat: 31.558 lon: 74.35071 hasResults: False

 nctId: NCT06363526 id: UMalagaDRIP briefTitle: Effectiveness of 5-week Digital Respiratory Practice in a Group of Children With Duchenne Muscular Dystrophy and Becker Muscular Dystrophy. acronym: DMDrespy2024 overallStatus: NOT_YET_RECRUITING date: 2024-05-05 date: 2024-10-30 date: 2024-11-30 date: 2024-04-12 date: 2024-04-12 name: University of Malaga class: OTHER briefSummary: The purpose of this study is to analyze the effectiveness of a 5-weeks respiratory digital intervention program in patients with Duchenne muscular dystrophy and Becker muscular dystrophy. conditions: Duchenne Muscular Dystrophy conditions: Becker Muscular Dystrophy conditions: Muscular Dystrophy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 12 participants were randomized to follow a digital respiratory physiotherapy program for 5 weeks. The participants were evaluated at the beginning and at the end of the study, and the results will be measured before and after each intervention during the study. primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: Digital respiratory intervention program measure: Analyze the improvement of the forced vital capacity (FVC). measure: Perform an anthropometric study of the patient's characteristics, taking into account weight; and also a general physical examination. measure: Perform an anthropometric study of the patient's characteristics, taking into account age. measure: Perform an anthropometric study of the patient's characteristics, taking into account height. measure: Perform an anthropometric study of the patient's characteristics, taking into account sex. measure: Examine changes in forced expiratory pressure measure: Analyze changes in maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP). measure: Check if there are changes in the sniff nasal inspiratory pressure (SNIP) measure: Evaluate the fatigue in patients using an EPInfant test. measure: Evaluate the quality of life of patients using a scale called "Kindscreen-52". sex: ALL minimumAge: 5 Years maximumAge: 20 Years stdAges: CHILD stdAges: ADULT facility: Rocío Martín-Valero city: Málaga country: Spain lat: 36.72016 lon: -4.42034 hasResults: False

 nctId: NCT06363513 id: SUR2567-0150 briefTitle: The Efficacy of Aescin in Combination With MPFF in the Early Control of Bleeding From Acute Internal Hemorrhoids, A Randomized Controlled Trial overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-05 date: 2024-05 date: 2024-04-12 date: 2024-04-12 name: Chiang Mai University class: OTHER briefSummary: Hemorrhoidal disease, characterized by symptomatic enlargement and distal displacement of anal cushions, has been a subject of recognition and management for centuries. The etymology of "hemorrhoid" is traced back to the Greek words haima (blood) and rhoos (flow). Prevalent in over 20% of the population across various life stages, this anorectal condition impacts both genders. The multifaceted development of the disease incorporates theories encompassing abnormal dilation of hemorrhoidal plexuses, distension of arteriovenous anastomoses, prolapse of anal pads, and a myriad of genetic, anatomical, dietary, and lifestyle factors. Manifestations range from venous distension to bleeding and thrombosis, with classification based on location (internal/external/combined) and degree of prolapse (grade 1-4).

Upon comprehensive history-taking and examinations, including digital rectal and proctoscope assessments, a definitive diagnosis is established, leading to the treatment phase. Although outpatient procedures demonstrate efficacy, patients may persist with pain and discomfort. Medical intervention assumes significance for stages 1 and 2, incorporating approaches such as rubber-band ligation, injection sclerotherapy, and dietary modifications. Micronized Purified Flavonoid Fraction (MPFF), integral to hemorrhoid treatment, has been scrutinized for its ability to mitigate pathogenic processes culminating in acute bleeding. The stagnation of blood in vascular plexuses prompts an inflammatory response, activating white cells and increasing vessel wall permeability. MPFF's flavonoid compounds are posited to alleviate bleeding by augmenting venous tone, reducing stasis, inhibiting inflammatory mediators, and enhancing lymphatic drainage\[8\]. Multiple trials substantiate MPFF's efficacy in ceasing bleeding, alleviating symptoms, and preventing hemorrhoid relapse.

Aescin, a saponin mixture found in Aesculus hippocastanum (horse chestnut). The primary active component, β-aescin, contributes to the plant's medicinal attributes. Experimental investigations in animal models underscore its anti-edematous, anti-inflammatory, and venotonic properties, attributed to molecular mechanisms facilitating ion entry into channels and elevating venous tension. While the therapeutic benefits of aescin for hemorrhoids are acknowledged, the absence of randomized control trials impedes the conclusive validation of its efficacy. In the realm of diverse treatment options, this proposed randomized controlled trial aims to assess the comparative effectiveness of combining aescin with MPFF versus MPFF alone in managing hemorrhoid-related symptoms. The study aspires to furnish valuable insights for refining therapeutic strategies in the management of hemorrhoids and enhancing patient outcomes. conditions: Anorectal Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Aescin in Horse Chestnut name: Flavonoid measure: Cessation of bleeding sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maharaj Chiang Mai hospital city: Chiangmai state: Maung zip: 50200 country: Thailand name: WITCHA VIPUDHAMORN, FRCS role: CONTACT phone: 0863645085 email: witcha.vip@cmu.ac.th lat: 18.79038 lon: 98.98468 hasResults: False

 nctId: NCT06363500 id: ChantalIRCB briefTitle: Characterization of HIV-1 Reservoirs in HIV-1 Non-B Infected Adolescents on ART in Cameroon acronym: AVIR overallStatus: COMPLETED date: 2021-11-01 date: 2023-10-30 date: 2023-11-30 date: 2024-04-12 date: 2024-04-12 name: Chantal Biya International Reference Centre for Research on Prevention and Management of HIV/AIDS class: OTHER_GOV briefSummary: Background: Combination antiretroviral therapy (cART) can bring HIV-1 in blood plasma to level undetectable by standard tests and allow a near-normal life expectancy for HIV-infected individuals. Unfortunately, cART is not curative, as within a few weeks of treatment cessation, HIV viremia in most patients rebounds except for rare elite or post-treatment controllers of viremia. The primary source of this rebound is the highly stable reservoir of latent yet replication-competent HIV-1 proviruses integrated into the genomic DNA of resting memory CD4+ T cells. To achieve a cure for HIV, understanding the cell reservoir environment is of paramount importance. The size and nature of viral reservoir might vary per timing of therapy, therapeutic response, ART duration, and immune response. Mechanisms of reservoir maintenance generally depend on levels/type of immune recognition, dynamics of viral persistence are different between pediatric and adult populations, owing to, but not limited to, types/numbers of target cells, efficiency in clearing HIV-infected cells, plasma viremia and HIV drug resistance patterns. This difference could become more evident as these children grow toward adolescence (increasing population due to ART benefits), a stage during which suboptimal adherence is frequent, leading to viral rebound and archiving of resistant patterns.

Objectives: We plan to conduct a cross sectional study with the aim to characterize HIV reservoirs and their variability according to virological and immunological profiles of non-B HIV-1 vertically infected adolescents receiving antiretroviral therapy. Specifically, we shall (1) evaluate the size of HIV reservoir; (2) Determine HIV-1 genetic variability and drug resistance in cellular reservoirs; (3) Characterize immune activation/inflammation of HIV infected adolescents.

Methods: We plan to conduct an observational and comparative study involving 90 HIV-1 non-B infected adolescents aged 10-19 years vertically infected, have been on ART for at least 12 months selected from a cohort of the ongoing EDCTP-READY study; intravenous blood will be collected for CD4/CD8 count, plasmatic viral load, PBMCs isolation, immune activation/inflammatory markers, genotyping and Viral reservoir quantification. We will as well recruit a group of 30 HIV-negative adolescents as control for immunological profiling.

Overall impact: Our findings will help in advancing knowledge on HIV reservoir, in terms of size and genetic variability in adolescents living with HIV (ADLHIV). Such evidence will also help in understanding the effects of ART timing and duration on the size of reservoirs among ADLHIV, a unique population from whom findings generated will largely contribute in designing functional cure strategies in this vulnerable population. conditions: Characterization of HIV Reservoirs in Adolescents studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 140 type: ACTUAL name: non applicable measure: Archived HIV drug resistance mutations measure: HIV-1 reservoirs measurement sex: ALL minimumAge: 10 Years maximumAge: 19 Years stdAges: CHILD stdAges: ADULT facility: Chantal Biya International Reference Centre city: Yaounde state: Centre zip: 99999 country: Cameroon lat: 3.86667 lon: 11.51667 hasResults: False

 nctId: NCT06363487 id: R87970/RE001 briefTitle: Semaglutide and Cognition in Healthy Volunteers acronym: OxSENSE overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2024-04-08 date: 2024-06-08 date: 2024-04-12 date: 2024-04-12 name: University of Oxford class: OTHER name: NIHR Oxford Health Biomedical Research Centre briefSummary: Semaglutide is a glucagon-like peptide 1 receptor agonist (GLP-1RA). It is a safe medication approved for use in type-2 diabetes mellitus (T2DM) and obesity. Primarily, it works by counteracting insulin-resistance and inducing weight loss. It also acts on several other interconnected neurobiological, immunological (esp. inflammatory), endocrine-metabolic, and gut-brain axis processes that play a role in depressive symptoms. Its effects on cognition and energy are currently unknown. In this study we are using semaglutide as an experimental tool to further investigate these relationships. conditions: Cognitive Change 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: Semaglutide, 0.5 mg/mL name: Placebo, 0.9% NaCl 1.5mL measure: Reward (learning) measure: Reward (effort-based) measure: Reward (primary) measure: Emotional processing measure: Emotional impulsivity measure: Memory (short- and medium-term) processing measure: Memory (working) processing measure: Energy/activity sex: ALL minimumAge: 21 Years maximumAge: 55 Years stdAges: ADULT facility: Department of Psychiatry, University of Oxford city: Oxford state: Oxfordshire zip: OX3 7JX country: United Kingdom lat: 51.75222 lon: -1.25596 hasResults: False

 nctId: NCT06363474 id: UHS 5532 briefTitle: Cisternostomy Vs Decompressive Craniectomy for Severe Traumatic Brain Injury overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-05-01 date: 2024-04-12 date: 2024-04-12 name: University of Health Sciences Lahore class: OTHER briefSummary: The objective of this clinical study is to compare the outcomes of two neurosurgical interventions, Cisternostomy and Decompressive Craniectomy (DC), for the management of severe Traumatic Brain Injury (TBI), assessed using the Glasgow Outcome Scale (GOS). Severe TBI presents challenges in managing intracranial pressure (ICP) and cerebral perfusion, often requiring surgical intervention. DC involves the removal of a section of the skull to reduce ICP, while Cisternostomy, a technique rooted in microsurgery, aims to alleviate brain edema and lower ICP by creating additional space for cerebrospinal fluid (CSF) circulation.

This prospective study will be conducted at the Department of Neurosurgery, Punjab Institute of Neurosciences, Lahore. Patients meeting inclusion criteria will be randomized into Group A (DC) and Group B (Cisternostomy) following brain CT scans. Clinical evaluation will include regular follow-ups for 6 months post-surgery, recording data on GOS, duration of mechanical ventilation, ICU, and hospital stays. Analysis will be performed using SPSS 24, comparing outcomes between groups using Chi-square test and t-test. A significance level of p≤0.05 will be applied.

It is hypothesized that Cisternostomy, as an adjunct to traditional TBI management, will effectively reduce ICP, resulting in improved GOS and reduced complications postoperatively, including decreased duration of mechanical ventilation and ICU stay, with sustained improvement observed at 6 months conditions: Severe Traumatic Brain Injury studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The intervention model of this study is a parallel model. Patients meeting inclusion criteria are enrolled from the neurosurgery department of Punjab Institute of Neurosciences, Lahore. After obtaining consent, patients undergo detailed assessments and investigations. They're randomly assigned to Group A (decompressive craniectomy) or Group B (cisternostomy). Both procedures are performed by a single surgical team under anesthesia. Postoperatively, patients are monitored for mechanical ventilation duration, ICU and hospital stay lengths, and Glasgow Outcome Scale at discharge. This model enables outcome comparison between intervention groups while controlling confounding variables. primaryPurpose: TREATMENT masking: NONE count: 190 type: ESTIMATED name: Decompressive Craniectomy name: Cisternostomy measure: comparison of patient outcomes between the two intervention groups (Decompressive Craniectomy and Cisternostomy) in terms of the Glasgow Outcome Scale (GOS). sex: ALL maximumAge: 60 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06363461 id: 239-13851-202 briefTitle: Study of TDM-180935 in Atopic Dermatitis Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-09-30 date: 2024-10-31 date: 2024-04-12 date: 2024-04-12 name: Technoderma Medicines Inc. class: INDUSTRY name: Therapeutics, Inc. briefSummary: Randomized, Vehicle-controlled, Parallel Group Study of TDM-180935 in Atopic Dermatitis Patients conditions: Atopic Dermatitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: TDM-180935 topical ointment 1.0% name: TDM-180935 topical ointment 2.0% name: TDM-180935 topical vehicle ointment 1 name: TDM-180935 topical vehicle ointment 2 measure: Change in m-EASI (modified Eczema Area and Severity Index) score measure: Proportion of patients with a ≥ 2 point improvement in vIGA-AD score (validated Investigator's Global Assessment for Atopic Dermatitis score) measure: Change in m-EASI (modified Eczema Area and Severity Index) score measure: Proportion of patients with a 50% improvement in m-EASI (modified Eczema Area and Severity Index) score measure: Proportion of patients with a 75% improvement in m-EASI (modified Eczema Area and Severity Index) score measure: Proportion of patients with a 90% improvement in m-EASI (modified Eczema Area and Severity Index) score measure: Change in BSA (body surface area) affected measure: Proportion of patients with a 4-point improvement from Baseline in WI-NRS (Worst Itch-Numeric Rating Scale) score measure: Incidence (severity and causality) of any local and systemic AEs (adverse events) measure: Number of patients with presence (and severity) of the following LSRs (local skin reactions): skin pigmentation (hyperpigmentation and hypopigmentation), edema, erosion,scaling, and burning/stinging measure: Changes from Baseline in vital signs (temperature) measure: Changes from Baseline in vital signs (systolic and diastolic blood pressure) measure: Changes from Baseline in vital signs (heart rate) measure: Changes from Baseline in vital signs (respiration rate) measure: Changes from baseline in clinical laboratory tests (including Blood Chemistries, Hematology, and Urinalysis) measure: Number of participants with abnormal ECG readings sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Site 3 city: Rolling Meadows state: Illinois zip: 60008 country: United States lat: 42.08419 lon: -88.01313 facility: Site 7 city: Covington state: Louisiana zip: 70433 country: United States lat: 30.47549 lon: -90.10042 facility: Site 5 city: New Brighton state: Minnesota zip: 55112 country: United States lat: 45.06552 lon: -93.20189 facility: Site 6 city: Anderson state: South Carolina zip: 29621 country: United States lat: 34.50344 lon: -82.65013 facility: Site 1 city: Austin state: Texas zip: 78759 country: United States lat: 30.26715 lon: -97.74306 facility: Site 4 city: College Station state: Texas zip: 77845 country: United States lat: 30.62798 lon: -96.33441 facility: Site 2 city: Norfolk state: Virginia zip: 23502 country: United States lat: 36.84681 lon: -76.28522 hasResults: False

 nctId: NCT06363448 id: Soh-Med-24-3-04PD briefTitle: Yamani Technique Versus Proline Mesh for Intraocular Lens Scleral Fixation in Aphakia overallStatus: RECRUITING date: 2024-01-01 date: 2024-06-30 date: 2024-07-30 date: 2024-04-12 date: 2024-04-12 name: Sohag University class: OTHER briefSummary: The study aims to describe a new method of sulcus fixation of intraocular lenses (IOLs) using a prolene mesh and to compare its outcomes with Yamani technique. conditions: Aphakia, Postcataract studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in Aphakia measure: Best corrected visual acuity (BCVA) in LogMAR sex: ALL minimumAge: 40 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_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 facility: Elshimaa A.Mateen status: RECRUITING city: Sohag country: Egypt name: Elshimaa A.Mateen, Doctor role: CONTACT phone: 0201282223427 email: elshimaa.moussa@yahoo.com lat: 26.55695 lon: 31.69478 hasResults: False

 nctId: NCT06363435 id: #2022-01302-02-PSMA briefTitle: AI-based Measurements of Tumour Burden in PSMA PET-CT overallStatus: RECRUITING date: 2024-03-29 date: 2031-03 date: 2033-03 date: 2024-04-12 date: 2024-04-12 name: Elin Tragardh class: OTHER name: Lund University briefSummary: The primary aim of the present study is to evaluate how automatically calculated (by an AI-based method) tumour burden, measured as tumour volume (TV) and as tumour uptake (TU: TV x SUVmean) in the prostate/prostate bed, pelvic lymph nodes, distant lymph nodes, bone and as the total tumour burden predicts overall survival (OS) in patients with prostate cancer (newly diagnosed and patients with biochemical recurrence). conditions: Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1500 type: ESTIMATED name: AI-based detection and quantification of suspected tumour/metastases in PSMA PET/CT scans measure: Tumour burden (cm3) in relation to overall survival measure: Tumour burden (cm3) in relation to biochemical recurrence measure: Number of tumours/metastases in relation to OS measure: Comparing two different segmentation methods in relation to OS measure: Comparing total tumour burden (cm3) measured manually and by the AI-based mehtod sex: MALE minimumAge: 20 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Skåne University Hospital status: RECRUITING city: Lund country: Sweden name: Elin Tragardh, Prof role: CONTACT phone: +4640338724 email: elin.tragardh@skane.se lat: 55.70584 lon: 13.19321 facility: Skåne university hospital status: RECRUITING city: Malmö country: Sweden name: Elin Tragardh, Prof role: CONTACT phone: +4640338724 email: elin.tragardh@skane.se lat: 55.60587 lon: 13.00073 hasResults: False

 nctId: NCT06363422 id: JY2024-012 briefTitle: The Value of Epicanthoplasty on the Modification of Upper-eyelid Appearance overallStatus: COMPLETED date: 2024-01-01 date: 2024-03-15 date: 2024-04-01 date: 2024-04-12 date: 2024-04-12 name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University class: OTHER briefSummary: In East Asian populations, the combination of an epicanthic fold and mono-eyelid is one of their anatomical characteristics. Misalignment of the orbicularis oculi muscle and fibrous connections leads to longitudinal tension, forming the epicanthic fold. The epicanthic fold may diminish the aesthetic effects of eyelid cosmetic surgery, shorten the horizontal length, and affect the postoperative shape of double eyelids. As upper eyelid cosmetic surgery is one of the most common cosmetic procedures in Asia, there is increasing attention on the modification of the epicanthic fold and its impact on the formation of double eyelids. conditions: Patient Satisfaction conditions: Epicanthus; Fold studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 14 type: ACTUAL name: Epicanthoplasty measure: inter-epicanthal distance (IED) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shanghai ninth people's hospital city: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False

 nctId: NCT06363409 id: 2023-1353 briefTitle: The Acute and Accumulative Effects of Snack Foods on Exercise Recovery overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-01 date: 2027-01-01 date: 2024-04-12 date: 2024-04-12 name: San Diego State University class: OTHER briefSummary: The purpose of the research is two-fold. One goal is to determine if post-exercise almond or cereal bar consumption can promote muscle gain as well as increasing muscular strength throughout an eight-week weight training program. The other goal is to assess the short-term effects of almonds or cereal bar on recovery that may explain the overall long-term adaptations. conditions: Muscle Strength studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 60 type: ESTIMATED name: Cereal Bar as a recovery food snack name: Almond measure: delayed onset of muscle soreness measure: markers of muscle damage measure: changes in strength measure: changes in body composition sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT hasResults: False

 nctId: NCT06363396 id: K 2023-7081 briefTitle: Fatigue and Cognitive Dysfunction After Allogeneic Stemcell Transplantation, Prospective PET Study overallStatus: RECRUITING date: 2024-02-22 date: 2026-02-22 date: 2027-02-22 date: 2024-04-12 date: 2024-04-12 name: Karolinska Institutet class: OTHER name: Karolinska University Hospital briefSummary: This study is the academic study and continuation and further development of a prior project under the leadership of Professor LeBlanc. Patients undergoing allogenic stem cell transplantation are followed up in the outpatient clinic. Here, patients are offered participation the fatigue study measuring both fatigue and cognitive impairment systematically by international standard. Previous study by Boberg et al suggested distinct mRNA and proteomic profiles segregating fatigued from non-fatigued patients as well as patients with or without cognitive impairment. A larger well-defined patient cohort is necessary to confirm these results. Investigators aim to identify specific sets of proteins in the CSF that can serve as potential biomarkers of cognitive dysfunction and/or fatigue. This will be performed with two methods:

* by using mass spectrometry-based proteomics approaches
* Olink technology

PET examinations will be performed on both fatigued and non-fatigued. We will utilize the second generation TSPO radioligand \[ 11C\]PBR28 as well as the SV2A radioligand \[ 11C\]UCB-J, both showing high signal-to-noise ratio and adequate test-retest properties. conditions: Fatigue conditions: Cognitive Dysfunction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Results of cognitive tests measure: Potential biomarkers for fatigue and cognitive dysfunction measure: PET results measure: Global analyses of the neural connections sex: ALL minimumAge: 20 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Karolinska status: RECRUITING city: Stockholm zip: 14186 country: Sweden name: Ksenia Boriskina, MD role: CONTACT phone: 0858580675 email: ksenia.boriskina@regionstockholm.se name: Kirsti Niemelä, study nurse role: CONTACT name: Katarina Le Blanc, professor role: PRINCIPAL_INVESTIGATOR lat: 59.33258 lon: 18.0649 hasResults: False

 nctId: NCT06363383 id: MB-001-101 briefTitle: A Phase 1 Study to Evaluate the Safety of an Oral Biologic in Healthy Participants overallStatus: RECRUITING date: 2024-05-09 date: 2025-05 date: 2025-05 date: 2024-04-12 date: 2024-04-18 name: Mage Biologics class: INDUSTRY name: Alimentiv Inc. briefSummary: The goal of this clinical trial is to learn if the oral biologic MB-001 is safe in healthy volunteers. The main questions it aims to answer are:

Is the drug safe when administered orally at increasing doses? Researchers will compare the drug with placebo to see if there are more side effects in those receiving the drug.

Participants will receive a single or five daily doses of the drug or placebo and will be asked to stay in the clinic for five days following the last dose. conditions: Ulcerative Colitis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: two-stage, single-center, double-blinded, randomized, placebo-controlled primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: double-blinded using matching placebo capsules containing matching pellets whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: MB-001 measure: Incidence and severity of adverse events (AEs) measure: Clinically significant changes from baseline in vital signs measure: Clinically significant changes from baseline in physical examination findings measure: Clinically significant changes from baseline in clinical laboratory assessments measure: Clinically significant changes from baseline in ECG parameters measure: Area under the concentration-time curve measure: Maximum plasma concentration measure: Time to reach observed maximum plasma concentration after administration measure: Trough concentration sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CMAX status: RECRUITING city: Adelaide state: South Australia zip: 5000 country: Australia name: Jessica Lehman role: CONTACT phone: +61 8 7088 7900 email: cmax@cmax.com.au lat: -34.92866 lon: 138.59863 hasResults: False

 nctId: NCT06363370 id: KXZY-GB05-201 briefTitle: Human Interferon α1b Inhalation Solution Against Respiratory Syncytial Virus in Children With Lower Respiratory Tract Infections overallStatus: RECRUITING date: 2024-03-27 date: 2026-06-30 date: 2026-06-30 date: 2024-04-12 date: 2024-04-12 name: Kexing Biopharm Co., Ltd. class: INDUSTRY briefSummary: To evaluate the efficacy and safety of interferon α1b (GB05) in the treatment of children under 2 years of age with respiratory syncytial virus infection. conditions: Respiratory Syncytial Virus Infections studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 322 type: ESTIMATED name: Human interferon α1b Inhalation Solution name: Inhalation Solution Placebo measure: Wang bronchiolitis score chanced by percentage from baseline measure: Wang bronchiolitis score chanced by percentage from baseline measure: Wang bronchiolitis score of 0 in proportion measure: Wang bronchiolitis score total score < 5 points measure: Wang bronchiolitis score, the first time the total score reaches < 5 points measure: RSV viral load sex: ALL minimumAge: 2 Months maximumAge: 2 Years stdAges: CHILD facility: Children's Hospital, Capital Institute of Pediatrics status: RECRUITING city: Beijing state: Beijing zip: 100000 country: China name: Ling Cao, MD role: CONTACT phone: 13910610319 lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06363357 id: 24B-007-0000 briefTitle: The Effect of a Muscle-mimicking, Fabric-type Shoulder Orthosis on Functional Movements of the Upper Limb in Patients With Duchenne Muscular Dystrophy overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-12-31 date: 2025-12-31 date: 2024-04-12 date: 2024-04-12 name: Seoul National University Hospital class: OTHER briefSummary: The goal of this clinical trial is to investigate the effect of a muscle-mimicking, fabric-type shoulder orthosis on functional movements of the upper limb in patients with Duchenne muscular dystrophy.

The main questions it aims to answer are:

* What is the impact of the muscle-mimicking, fabric-type shoulder orthosis on upper limb functional movements in patients with Duchenne muscular dystrophy?
* Are there observable differences in upper limb function when the shoulder orthosis is worn versus when it is not?

Participants will:

* Receive education on how to wear and use the shoulder orthosis.
* Undergo evaluations, including assessment of upper limb performance, shoulder muscle strength testing, active range of motion measurements, assessment of functional workspace, goal attainment scale evaluation, surface electromyography, physiological measurements such as blood pressure and heart rate, fatigue assessment, and assessment for any musculoskeletal or skin-related issues.

Researchers will compare Duchenne muscular dystrophy patients before and while wearing and operating the shoulder orthosis to see if there are any significant effects on variables such as upper limb function, range of motion, functional workspace, goal attainment scale, and surface electromyography. conditions: Muscular Dystrophy, Duchenne conditions: Orthotic Devices conditions: Upper Extremity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study compares variables before and after wearing the shoulder orthosis in patients with Duchenne muscular dystrophy. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ESTIMATED name: Shoulder orthosis measure: Performance of the upper limb module 2.0 (PUL 2.0) measure: Active Range of motion measure: Functional workspace measure: Goal Attainment Scale (GAS) measure: Surface electromyography (sEMG) sex: ALL minimumAge: 10 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Seoul National University Hospital city: Seoul state: Jongno-gu zip: 03080 country: Korea, Republic of name: Woo Hyung Lee, MD, Ph.D role: CONTACT phone: +82-2-2072-4178 email: whlee909@snu.ac.kr lat: 37.566 lon: 126.9784 hasResults: False

 nctId: NCT06363344 id: APHP231022 id: IDRCB: 2023-A00660-45 type: REGISTRY domain: IDRCB ANSM briefTitle: Follow-up in Pediatric Intensive Care Unit acronym: APRELAREA overallStatus: RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-09-01 date: 2024-04-12 date: 2024-04-15 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Background In developed countries, mortality rates in pediatric intensive care units (PICUs) are around 4% and thus, most children admitted to these units survive. However, some pediatric survivors experience long-term morbidity (cognitive, psychological, social and/or physical disorders) associated with their intensive care stay. Currently in France, there are no recommendations for the management of these patients and most of them do not have standardized follow-up.

Objectives Main objective: To assess the feasibility of implementing systematic and comprehensive management of pediatric patients who have been admitted to the PICU.

Intermediate objectives are to study:

* The needs of the children and their families which should be met by this management
* The acceptability of this organizational innovation for all the actors involved
* The cooperation between actors of the hospital and city health system + social professionals involved
* The costs of implementation and the budgetary impact of such a system

Methods Needs assessment: questionnaires and interviews with patients and their families (parents and possibly siblings if involved) to collect the medico-psycho-social impact of the PICU stay at the time of discharge and 3 months later.

Study of acceptability: quantitative survey of health professionals involved in the care of these children and expected care modalities. This includes pediatric intensivists, professionals from the children's usual care services (if applicable), attending physician.

Study of cooperation: analysis of needs and of the network usually solicited for the children benefiting from this care: who is identified, who remains to be identified, obstacles. Quantitative analysis of consultation reports and survey of professionals.

Budgetary impact analysis: study of the cost of setting up consultations for the health care system, and study of its financial and health consequences for the main needs identified, on the basis of data from the literature and expert opinions

Perspectives Compare the benefit of this systematic, multi professional and comprehensive management of pediatric patients after PICU discharge versus standard of care conditions: Intensive Care Psychosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 120 type: ESTIMATED name: Questionnaires : PHQ-9 (Kroenke, 2001), the PSC (Sheldrick, 2012), the ASQ-SE (Squires, 2015), the PedsQL (Varni, 1999) measure: Emotional and behavioral problem of the children measured by the PSC questionnaire (Sheldrick, 2012) measure: Mental disorders measured by the PHQ-9 (Kroenke, 2001) questionnaire measure: Social-emotional development measured by the ASQ-SE (Squires, 2015) questionnaire measure: Pediatric Quality of Life measured by the the PedsQL (Varni, 1999) questionnaire sex: ALL minimumAge: 1 Day maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Robert Debre Hospital status: RECRUITING city: Paris zip: 75019 country: France name: Michaël LEVY, MD, PhD role: CONTACT phone: +33.1.40.03.40.98 email: michael.levy@aphp.fr name: Enora LE ROUX, PhD role: CONTACT phone: +33.1.40.03.23.66 email: enora.leroux@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False

 nctId: NCT06363331 id: 2020I054 briefTitle: Efficacy of the Social Cognition Rehabilitation Program E-motional Training in the Treatment of Patients With Substance-related Disorders overallStatus: COMPLETED date: 2022-03-01 date: 2022-12-01 date: 2023-12-30 date: 2024-04-12 date: 2024-04-12 name: Fundacin Biomedica Galicia Sur class: OTHER briefSummary: Drug use, substance use disorders (SUD) and other addictive behaviors are problems of enormous socio-health impact that still require a great research effort to improve the diagnostic and therapeutic procedures used in healthcare practice.

Since addictive behaviors have been consistently associated with the presence of alterations in cognitive and executive functions, it is necessary to be able to detect, evaluate and have specific therapies for these dysfunctions and investigate, among other issues, the role they play in the onset and course evolutionary. After implementing neuropsychological evaluation techniques for diagnostic improvement, addresses the search for procedures that allow working on cognitive and executive deficits, as a specific therapeutic target.

To characterize the presence of alterations in the domains that make up social cognition (SC) in patients with SUD and test in our healthcare units the ET® program already tested both experimentally and at beta level. It is an online self-training program for CS rehabilitation that includes modules for emotion recognition (RE), Theory of Mind (ToM) and attributional style (AS).

To replicate the RCT carried out in schizophrenia in patients with SUD with difficulties in RE or ToM, in addition to searching for a biomarker or a pattern of them that predict the patient profile that will benefit from the training, using advanced LC-ESI proteomics techniques. MS/MS in saliva since previous studies in a population with schizophrenia, subjected to different neurorehabilitation therapies. It is also intended to subsequently improve the instrument (ET®) through the implementation of big data analysis and machine learning and the introduction of automated user management. At this level, the objective is to determine, after the first games, the type of game and the intensity required to improve the user's performance until it reaches normality.

From the perspective of the State Plan for Scientific and Technical Research and Innovation, this project combines CLINICAL AND TRANSLATIONAL RESEARCH, based on the evidence of scientific and technological knowledge, and the use of ENABLING TECHNOLOGIES of e-health in the area of Health Services. Health for people with SUD. conditions: Social Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 231 type: ACTUAL name: Emotional Training measure: Assess the presence of dysfunctions in the subdomains of social cognition measure: Accuracy and efficacy of ET® in patients with SDB sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Galicia Sur Health Research Institute (IISGS) - Hospital Álvaro Cunqueiro city: Vigo state: Pontevedra zip: 36213 country: Spain lat: 42.23282 lon: -8.72264 facility: Galicia Sur Health Research Institute city: Vigo state: Pontevedra zip: 36213 country: Spain lat: 42.23282 lon: -8.72264 hasResults: False

 nctId: NCT06363318 id: 0003 briefTitle: Comparison of Open and Laparoscopic Appendectomy in Pediatric Population acronym: Appendicitis overallStatus: COMPLETED date: 2019-07-01 date: 2019-11-30 date: 2019-11-30 date: 2024-04-12 date: 2024-04-15 name: King Edward Medical University class: OTHER briefSummary: Introduction: In the era of minimally invasive surgery, changing trends are towards laparoscopic surgery, first introduced in 1983. Now the preferred operation for children with appendicitis, laparoscopic appendectomy is associated with a reduced risk of wound infection, less postoperative pain and shorter hospital stay as compared to open appendectomy.

Objectives: To compare the outcome of open and laparoscopic appendectomy in children presenting with appendicitis in terms of operative time, postoperative pain, wound infection and hospital stay. conditions: Appendicitis Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: children were randomly divided in two groups. In group A, laparoscopic appendectomy was done. In group B, open appendectomy was done primaryPurpose: TREATMENT masking: NONE count: 100 type: ACTUAL name: Laparoscopic appendicectomy measure: Operative time measure: wound infection measure: Hospital stay measure: Postoperative pain sex: ALL minimumAge: 7 Years 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: NCT06363305 id: 2402-1139 briefTitle: Impact of Sex in the Effect of Dietary Capsaicin on Cardiovascular Health overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-01 date: 2025-12-31 date: 2024-04-12 date: 2024-04-18 name: Skidmore College class: OTHER name: American Heart Association briefSummary: The investigators long-term goal is to better understand novel interventions to promote cardiovascular health in humans. The goal of the proposed research is to investigate whether there is sex-specificity in the effects of dietary capsaicin on mechanisms regulating nitric oxide (NO) bioavailability, its effect on key markers of cardiovascular (CV) health, including BP, macro- and microvascular function, and arterial stiffness. This knowledge will provide critical insight into the effects of dietary capsaicin on CV health and will guide future trials. conditions: Pre Hypertension conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel: Participants are randomly assigned to one of two groups in parallel for the duration of the study primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: The capsules will be placed into solid white color bottles, and labeled discreetly by a third party not directly involved with the research. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Dietary capsules measure: Blood Pressure and Vascular Stiffness measure: Heart Rate (HR) and HR variability (HRV) measure: Flow Mediated Dilation measure: Passive Leg Movement Hyperemia measure: Near Infrared Spectroscopy (NIRS) Vascular Occlusion Test measure: Urinary Capsaicinoids measure: Blood Lipids sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Skidmore College city: Saratoga Springs state: New York zip: 12866 country: United States name: Stephen Ives, Ph.D. role: CONTACT phone: 518-580-8366 email: sives@skidmore.edu lat: 43.08313 lon: -73.78457 hasResults: False

 nctId: NCT06363292 id: SOPH231-1221/I briefTitle: Study to Evaluate the Safety and Tolerability of PRO-231 Ophthalmic Solution Versus VIGAMOXI® on the Ocular Surface of Healthy Subjects. overallStatus: RECRUITING date: 2024-01-30 date: 2024-05-30 date: 2024-05-30 date: 2024-04-12 date: 2024-04-15 name: Laboratorios Sophia S.A de C.V. class: INDUSTRY briefSummary: This is a phase I clinical study evaluating the safety and tolerability of PRO-231 ophthalmic solution through the incidence of unexpected adverse events, incidence of conjunctival hyperemia and chemosis, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, compared to VIGAMOXI®. conditions: Ophthalmological Agent Toxicity conditions: Bacterial Conjunctivitis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase I, controlled, comparative, parallel-group, single-blind, single-center, controlled clinical trial. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Single-blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: PRO-231 name: VIGAMOXI® measure: Incidence of unexpected adverse events related to the interventions measure: Incidence of conjunctival hyperemia and chemosis measure: Changes in Best Corrected Visual Acuity (BCVA) measure: Changes in the integrity of the ocular surface (fluorescein staining) measure: Changes in the Ocular Comfort Index (OCI) score between interventions. measure: Incidence of unexpected adverse events (excluding conjunctival hyperemia and chemosis) measure: To assess the tolerability of PRO-231 ophthalmic solution sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: IIMET Investigación e Innovación en Medicina Traslacional status: RECRUITING city: Guadalajara state: Jalisco zip: 44610 country: Mexico name: Alejandro González, MD role: CONTACT lat: 20.66682 lon: -103.39182 hasResults: False

 nctId: NCT06363279 id: 2024/24JAN/044 briefTitle: Validation of the French ATI Scale and Predisposition to Use Technological Tools in Rehabilitation. overallStatus: RECRUITING date: 2024-04-04 date: 2024-09 date: 2024-10 date: 2024-04-12 date: 2024-04-12 name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain class: OTHER briefSummary: Aim of the study: The first aim of this study is to validate the translation of the Affinity for Technology Interaction (ATI) questionnaire. This questionnaire was developed in English by Franke, Attig and Wessel in 2019. It consists of 9 items and was developed to assess a person's tendency to actively engage in technological interaction, or the ease with which a person uses technological tools. Currently, the questionnaire has been translated into French by our research team according to good practice recommendations (Guillemin, Bombardier and Beaton, 1993; Tsang et al., 2017), but this French version has not yet been validated. To validate the translation of a questionnaire, it is necessary to have it completed by a large number of subjects from the population of interest. In neurorehabilitation, measuring this affinity will make it possible to better identify patients who are more likely to adhere to tele-rehabilitation and thus direct them towards this type of treatment as a complement to conventional rehabilitation.

The second objective is to determine the extent to which the general population is prepared to use technological tools as part of their rehabilitation. The aim is to gain a better understanding of the profile of people who could potentially benefit from tele-rehabilitation. Accessibility to the technologies, their expectations and barriers will also be explored as part of this study. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 1000 type: ESTIMATED name: Conducting questionnaires measure: ATI - affinity technology interaction scale measure: Scale for assessing a person's readiness to use technological tools as part of their rehabilitation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinique Universitaires Saint-Luc status: RECRUITING city: Brussel state: Woluwé-Saint-Lambert zip: 1200 country: Belgium name: Thierry Lejeune, MD, PhD role: CONTACT phone: +3227641648 email: thierry.lejeune@saintluc.uclouvain.be name: Mathilde Van Durme role: CONTACT phone: +3227641675 email: mathilde.vandurme@saintluc.uclouvain.be lat: 50.85045 lon: 4.34878 hasResults: False

 nctId: NCT06363266 id: 190211_1 briefTitle: A SMART Design to Optimize the Delivery of TEMPO for Men With Prostate Cancer and Their Caregivers overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-08-31 date: 2028-08-31 date: 2024-04-12 date: 2024-04-12 name: St. Mary's Research Center, Canada class: OTHER name: Princess Margaret Hospital, Canada name: University of Calgary name: Sunnybrook Health Sciences Centre name: University of British Columbia name: McGill University name: Simon Fraser University name: Université de Sherbrooke name: Memorial University of Newfoundland name: Université de Montréal name: Centre intégré de santé et de services sociaux (CISSS) de Laval briefSummary: Men with prostate cancer and their family caregivers face many physical and emotional challenges from the cancer itself and its treatment(s), which often lead to high anxiety. The pandemic has highlighted the importance of protecting our physical and mental health, and the complex responsibilities that caregivers have in supporting their loved ones. To improve the health of men with prostate cancer and of their caregivers, the research team developed TEMPO: a self-directed Tailored, wEb-based, psychosocial and physical activity self-Management PrOgram. TEMPO was developed with men with prostate cancer and their caregivers over the past 8 years. It also combines the investigators' research conducted over the past decade on providing the best support to those affected by cancer. Because the cancer care workforce is already overstretched, the research team designed TEMPO to be used without guidance from a health care professional. TEMPO is one-of-a kind in its support of both patients and caregivers, and the integration of coping skills training on a wide range of cancer challenges along with a home-based exercise program. Patients and caregivers who have used TEMPO said they improved their communication, learned new skills to cope with both physical and emotional challenges of cancer, and increased their physical activity. The present project builds on this work to further evaluate the cost and impact of TEMPO on men's and caregivers' health. Men with prostate cancer and their caregivers will be assigned by chance to one of two groups a) TEMPO or b) monitor their anxiety for 12 weeks. After 12 weeks, patients' and caregivers' needing more support will be identified based on an assessment of their anxiety level. For those already using TEMPO and needing more support, non-health care professional guidance might be offered. All those in the monitoring group needing more support will now have access to TEMPO. All participants complete surveys to determine whether TEMPO led to improved health outcomes. conditions: Cancer of the Prostate conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Using a stepped care approach, TEMPO will be provided across two intervention stages with variations on timing (initial vs. delayed) and intensity (self-directed vs. guided). All dyads will continue to access usual care (a co-intervention measure is included). primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 376 type: ESTIMATED name: TEMPO name: Active Monitoring dyads' anxiety measure: HADS-Anxiety measure: TEMPO's key mechanisms of action sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St. Mary's Research Centre city: Montreal state: Quebec zip: H3T1M5 country: Canada name: Sylvie Lambert, PhD role: CONTACT phone: 514-398-3685 email: sylvie.lambert@mcgill.ca lat: 45.50884 lon: -73.58781 facility: St Mary's Hospital Research Centre city: Montréal country: Canada name: Manon de Raad role: CONTACT email: manon.deraad@ssss.gouv.qc.ca lat: 45.50884 lon: -73.58781 hasResults: False

 nctId: NCT06363253 id: CIRB Ref: 2023/2073 briefTitle: Pilot Study of the Human Metagenome in Metabolic Diseases overallStatus: RECRUITING date: 2023-08-14 date: 2026-12-31 date: 2027-12-31 date: 2024-04-12 date: 2024-04-12 name: Sengkang General Hospital class: OTHER name: Singapore General Hospital name: Lee Kong Chian School of Medicine, Nanyang Technological University name: Duke-NUS Graduate Medical School briefSummary: This is a cohort study to understand the role of the human metagenome, and associated metabolites, in health and in various diseased states, in particular obesity as well as sarcopenia.

Recruited participants will have their fecal, salivary, urine, serum, and in certain instances, mucosal samples taken, for metagenomic sequencing and metabolite testing.

We hope to uncover various differences and signatures in the metagenome and metabolome in various diseased states, with potential future therapeutic applications in personalised medicine. conditions: Obesity conditions: Sarcopenia conditions: Sarcopenic Obesity conditions: Chronic Inflammation conditions: Metabolic Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED name: No specific intervention measure: Metagenomic alterations measure: Metabolomic alterations sex: ALL minimumAge: 21 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sengkang General Hospital status: RECRUITING city: Singapore zip: 544886 country: Singapore name: Koy Min Chue role: CONTACT phone: 69305000 email: chue.koy.min@singhealth.com.sg lat: 1.28967 lon: 103.85007 hasResults: False

 nctId: NCT06363240 id: CBBLCIP001 briefTitle: Evaluation of Broadband Light Treatment for Solar Lentigines overallStatus: RECRUITING date: 2024-03-12 date: 2024-12-20 date: 2025-01-30 date: 2024-04-12 date: 2024-04-12 name: Sciton class: INDUSTRY briefSummary: Broadband light treatment for Solar Lentigines conditions: Solar Lentigo studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Broadband Light measure: Changes in skin post treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sanctuary Plastic Surgery status: RECRUITING city: Boca Raton state: Florida zip: 33431 country: United States name: Jonathan Cook, MD role: CONTACT lat: 26.3669 lon: -80.13033 hasResults: False

 nctId: NCT06363227 id: ANEST-0003 briefTitle: Postoperative Pain After Implementation of Standardized Pain Therapy Management in Orthopaedic Patients acronym: PAIN overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-02 date: 2025-04 date: 2024-04-12 date: 2024-04-16 name: Schulthess Klinik class: OTHER briefSummary: The aim of this study is to examine the impact of implementing a standardized pain therapy protocol and their components on postoperative pain trajectories and postoperative outcomes such as increased opioid consumption and to compare it for different orthopaedic operations, i.e. major shoulder, hip, knee und spine surgery. conditions: Postoperative Pain, Acute studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 12000 type: ESTIMATED name: Standardized pain management measure: Perioperative pain trajectories measure: Increased risk for postoperative pain measure: Total amount of opioids administered measure: Correlation of pain trajectories and patient reported outcome measures (e.g. postoperative nausea and vomiting) sex: ALL minimumAge: 16 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06363214 id: ANEST-0002 briefTitle: Impact of Patient Blood Management (PBM) at the Schulthess Clinic acronym: PBM overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-02 date: 2025-04 date: 2024-04-12 date: 2024-04-16 name: Schulthess Klinik class: OTHER briefSummary: Aim of this study is to analyze the transfusion requirements of allogenic blood products at the Schulthess Clinic for patients that had major orthopedic or major spine surgery between 2019 and 2024 order to identify patients at risk for transfusion. Moreover, impact of transfusion requirements and other measures of PBM on patient outcomes will be assessed. These data are required to further improve PBM at the Schulthess Clinic. conditions: Patient Blood Management studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 16000 type: ESTIMATED name: Patient blood management measure: Perioperative transfusion rates measure: Risk factors for perioperative transfusion Risk factors for perioperative transfusion Risk factorsfor perioperative transfusion measure: Perioperative rates of coagulation products administered measure: Clinical outcomes sex: ALL minimumAge: 16 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06363201 id: CAT2024/PED01 briefTitle: Effect and Safety of Ocoxin Oral Solution on the Quality of Life of Paediatric Patients With Advanced Stage Solid Tumours overallStatus: NOT_YET_RECRUITING date: 2024-04-28 date: 2024-12-15 date: 2025-12-15 date: 2024-04-12 date: 2024-04-12 name: Catalysis SL class: INDUSTRY briefSummary: Exploratory study to evaluate the effect and safety of the use of Ocoxin® oral solution on the quality of life of paediatric patients with advanced stage solid tumours. conditions: Advanced Cancer conditions: Advanced Solid Tumor conditions: Lymphoma, Hodgkin conditions: Central Nervous System Tumor conditions: Sarcoma conditions: Germ Cell Tumor conditions: Pediatric Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 40 type: ESTIMATED name: Ocoxin Oral solution measure: Quality of Life measure: Degree of toxicity related to oncospecific treatment measure: Nutritional Status measure: Presence of Adverse Events (AE) measure: Metabolic Status measure: Physical Status measure: Response to oncospecific treatment sex: ALL minimumAge: 7 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Hospital Escuela, Tegucigalpa (Honduras) city: Tegucigalpa state: Francisco Morazan zip: 504 country: Honduras name: Ingrid C. Arambú Elvir, Dr. role: CONTACT phone: 50498878486 email: ingridcarolinaa@yahoo.com name: Ingrid C. Arambú Elvir, Dr. role: PRINCIPAL_INVESTIGATOR name: Alejandra Elonor Zapata, Dr. role: SUB_INVESTIGATOR name: Clarissa L. Aguilar Molina, Dr. role: SUB_INVESTIGATOR name: Darío Vinicio Cáceres, Dr. role: SUB_INVESTIGATOR name: Gerardo Ismael Castro, Dr. role: SUB_INVESTIGATOR lat: 14.0818 lon: -87.20681 hasResults: False

 nctId: NCT06363188 id: effect of ESWT on fractures briefTitle: The Impact of ESWT on Healing of Fractured Mandible overallStatus: RECRUITING date: 2024-02-01 date: 2024-08-01 date: 2025-08-30 date: 2024-04-12 date: 2024-04-12 name: Cairo University class: OTHER briefSummary: studying if using extracorporeal radial shockwave therapy as an adjuvant therapy help in accelerating the bone healing and regeneration in mandibular fractures by comparing it with the standard protocol for fractures fixation by plates and screws. conditions: Fractured Mandible Due to Trauma studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 10 type: ESTIMATED name: Radial Extracorporeal shockwave measure: bone healing (denisty of bone) measure: pain sensation sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cairo Univeristy status: RECRUITING city: Cairo country: Egypt name: khloud nasr eldin, GP role: CONTACT phone: 01014919174 email: khloud.ahmed@dentistry.cu.edu.eg name: Emad Saied, prof. role: CONTACT phone: 01222117986 lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06363175 id: 8737 id: 343073 type: OTHER domain: Integrated Research Application system (IRAS) briefTitle: PREMs In Vascular SurgERy Enhancement Study acronym: PREMIERE overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-08-01 date: 2026-06-01 date: 2024-04-12 date: 2024-04-15 name: Cardiff and Vale University Health Board class: OTHER_GOV name: Welsh Value in Health Centre (WViHC) name: Centre for Healthcare Evaluation, Device Assessment, and Research (CEDAR) briefSummary: THE PROBLEM:

Patient Reported Experience Measures (PREMs) ask patients about their healthcare service experience. It gives them a voice to share their views. PREMs allow healthcare providers (HCPs) to see where care is good, and where they could improve. Vascular surgery is a surgical speciality looking after people's blood vessels (arteries and veins).

There is no PREM available for vascular patients. The research team want to create a PREM for this patient group.

WHY IT IS IMPORTANT:

A PREM allows HCPs to record and understand patients' experiences of their treatment. It gives patients a way to provide feedback on their healthcare experience. PREMs can help HCPs make changes to patients' care, identifying areas of good practice and areas for improvement. The Welsh Government is keen to support the use of PREMs.

AIMS:

To develop a PREM specific to vascular surgery patients.

RESEARCH PLAN:

The research team will summarise the literature about PREMs in surgery. The research team will then run focus groups and interviews with patients and staff to create a 'draft' PREM for vascular patients in Wales. The 'draft' PREM will be translated into Welsh.

In the second phase, a larger number of vascular patients (100-300 depending on how long the 'draft' PREM is) from hospitals across Wales will complete the questionnaire. Statistical tests will look at the results to see if the questionnaire works well to capture patients' experiences. Based on these results, small changes will be made to make the 'draft' PREM better. This will make sure the 'final PREM' is ready for widespread use in Wales and beyond.

PATIENT AND PUBLIC INVOLVEMENT:

The patients' experience team at CAVUHB has reviewed our patients' materials. Our research team includes PPI co-applicants (DC and AH). DC a double amputee who has had many vascular operations. DC has experience raising awareness about vascular disease through public forums like the Limbless Association Charity and BBC Radio Wales. AH has issues with her leg due to smoking and had a keyhole operation to help with that. She had some problems after the procedure This is her first time as a PPI representative. DC and AH supported our research design and will be steering group members. Also, our research focuses on giving patients a voice and will include patients across Wales. A diverse group of patients will be involved across all stages of the PREM development. conditions: Vascular Diseases conditions: Patient Empowerment conditions: Patient Satisfaction conditions: Patient Engagement conditions: Surgery studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 330 type: ESTIMATED measure: Degree of Validity of the PREM measure: Degree of Reliability of the PREM measure: Degree of Responsiveness of the PREM measure: Degree of Feasibility of implementing the PREM in clinical practice sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Southeast Wales Vascular Network-Cardiff and Vale University Health Board city: Cardiff state: Wales country: United Kingdom lat: 51.48 lon: -3.18 hasResults: False

 nctId: NCT06363162 id: LRR202404 briefTitle: Evaluate the Effectiveness and Safety of Raman IVD Analyzer in the Molecular Diagnosis of Gliomas During Surgery overallStatus: RECRUITING date: 2022-12-01 date: 2025-06-30 date: 2025-12-31 date: 2024-04-12 date: 2024-04-12 name: Beijing Tiantan Hospital class: OTHER name: West China Hospital name: The First Affiliated Hospital of Zhengzhou University name: Capital Medical University name: Jiangsu Raman Medical Equipment Co., Ltd. briefSummary: To distinguish various molecular subtypes of gliomas by spectra data obtained from Raman analyzer, including IDH mutant, 1p/19q-codeleted, ATRX deletion, TERT promoter mutation, MGMT promoter methylation, EGFR amplification, H3 K27-altered, TP53 mutant, PTEN deficiency, ki 67, AQP4, VEGF, and so on, comparing with the results of Immunohistochemistry or genetic test on the same brain tissue samples. conditions: Glioma studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The same sample was diagnosed using Raman spectroscopy and immunohistochemistry or genetic test, respectively. Calculate the AUC, the accuracy, the sensitivity and specificity of a Raman analyzer using immunohistochemistry or genetic test results as the gold standard. primaryPurpose: DIAGNOSTIC masking: NONE maskingDescription: Blind assessment: Researchers using Raman analyzer during surgery are not aware of the subjects' preoperative diagnostic results, while researchers conducting immunohistochemistry or genetic test after surgery are not aware of the subjects' preoperative diagnostic results and the diagnostic results of Raman analyzer. count: 200 type: ESTIMATED name: Immunohistochemistry or genetic test measure: Area Under the Curve measure: Accuracy measure: Sensitivity measure: Specificity measure: Kappa coefficient measure: Time consumption for the Raman analyzer in detection measure: Adverse Event Incidence Rate measure: Serious Adverse Event Incidence Rate measure: Operator adverse events sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tiantan Hospital status: RECRUITING city: Beijing state: Beijing zip: 100071 country: China name: Yinyan Wang, MD and PhD role: CONTACT phone: +86 13581698953 email: tiantanyinyan@126.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06363149 id: 2024-11-DM-136 briefTitle: Disseminated Intravascular Coagulation (DIC) Score and Organ Dysfunction in Septic Shock Patients overallStatus: RECRUITING date: 2024-04-12 date: 2025-09 date: 2025-09 date: 2024-04-12 date: 2024-04-16 name: Sanjay Gandhi Postgraduate Institute of Medical Sciences class: OTHER_GOV briefSummary: Septic shock is common complication in patients with critical illnesses, with higher incidence in low and medium income countries like ours. Disseminated intravascular coagulation (DIC) is also common in patients presenting to intensive care units. Further DIC is common coexisting condition seen in many patients presenting with sepsis and septic shock.

Both DIC and septic shock individually are associated with very high mortality and morbidity and coexistence of both increase risk manifold. Organ dysfunction is a complication of both septic shock and DIC individually and in presence of coexistence risk further multiply. DIC scoring of every patient at risk as in patients presenting with septic shock help us to predict about patients having more chances to convert to overt DIC.

Understanding effects of DIC on organ dysfunction in septic shock patients can help to prognosticate and guide towards early intervention. Also, there is paucity of literature on effect of DIC score changes on organ dysfunction in patients with septic shock. conditions: Septic Shock conditions: Disseminated Intravascular Coagulation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED measure: Effect of Disseminated Intravascular Coagulation score changes on organ dysfunction in septic shock patients at day 7 measure: Effect of Disseminated Intravascular Coagulation score changes on organ dysfunction in septic shock patients at day 14 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sanjay Gandhi Postgraduate Institute of Medical Sciences status: RECRUITING city: Lucknow state: Uttar Pradesh zip: 226014 country: India name: Mohan Gurjar, MD, PDCC role: CONTACT name: Dinesh Chandra, MD, DM role: CONTACT name: Mohan Gurjar, MD, PDCC role: PRINCIPAL_INVESTIGATOR name: Sanjay Chaudhary, MD role: SUB_INVESTIGATOR name: Dinesh Chandra, MD, DM role: PRINCIPAL_INVESTIGATOR lat: 26.83928 lon: 80.92313 hasResults: False

 nctId: NCT06363136 id: 14.06.2023-111176 briefTitle: Foot Posture, Strength, Performance, and Postural Control in Isolated Gastrocnemius Tightness overallStatus: RECRUITING date: 2024-02-01 date: 2024-05-30 date: 2024-06-30 date: 2024-04-12 date: 2024-04-12 name: Bezmialem Vakif University class: OTHER briefSummary: Studies on gastrocnemius tightness in healthy children are limited, but there is evidence that ankle dorsiflexion decreases with increasing age in children. It is not known whether gastrocnemius tightness is a normal finding in children, but recurrent leg pain is common in children. It is also known that flexible flatfoot is a normal observation in developing children and that the medial longitudinal arch develops during the first decade of life. Both foot morphology and ankle dorsiflexion change in developing children; however, it is not known whether there is a relationship between them or not.

In the literature, there is no study evaluating foot posture, muscle strength, functional performance, and postural control in children with isolated gastrocnemius muscle tightness. It was planned to evaluate postural control using computerized dynamic posturography (Biodex Balance System), lower extremity muscle strength using a hand-held dynamometer, foot posture using the Foot Posture Index (FPI-6), and functional performance using single-foot-double-foot jump tests in healthy children with isolated gastrocnemius muscle tightness. conditions: Gastrocnemius Tightness conditions: Postural Control conditions: Muscle Strength conditions: Functional Performance conditions: Foot Posture studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 28 type: ESTIMATED measure: Postural Control Assessment measure: Lower extremity muscle strength measurement measure: Foot posture assessment measure: Functional performance assessment sex: ALL minimumAge: 7 Years maximumAge: 16 Years stdAges: CHILD facility: Bezmialem Vakif University status: RECRUITING city: Istanbul country: Turkey name: Deniz Tuncer, PhD, PT role: CONTACT name: Fatma Eren, PT role: CONTACT name: Fatma Eren, PT role: SUB_INVESTIGATOR name: Deniz Tuncer, PhD, PT role: PRINCIPAL_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06363123 id: BFHHZML20240009 briefTitle: Plasma Metabolic Biomarkers for Multi-Cancer Diagnosis overallStatus: RECRUITING date: 2024-03-29 date: 2024-10 date: 2025-04 date: 2024-04-12 date: 2024-04-15 name: Beijing Friendship Hospital class: OTHER briefSummary: The aim of this observational study is to comprehensively analyze the metabolites in plasma samples from multi-cancer patients using advanced mass spectrometry detection technology, in conjunction with metabolomics approaches. The goal is to construct a plasma metabolite database for multi-cancer patients. Simultaneously, we will delve into the exploration and validation of a series of metabolic biomarkers for early multi-cancer diagnosis. The objective is to establish a safer, more convenient, and more sensitive early screening method, thereby providing a reliable scientific foundation and critical evidence for improving the early diagnostic process for individuals at high risk of multi-cancer. conditions: Lung Cancer conditions: Breast Cancer conditions: Colorectal Cancer conditions: Thyroid Cancer conditions: Gastric Cancer conditions: Cervical Cancer conditions: Liver Cancer conditions: Pancreatic Cancer conditions: Cholangiocarcinoma conditions: Prostate Cancer conditions: Esophageal Cancer conditions: Ovarian Cancer conditions: Renal Cell Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2700 type: ESTIMATED measure: Plasma metabolite content sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Hospital Chinese Academy of Medical Sciences status: RECRUITING city: Beijing state: Beijing zip: 100021 country: China name: Yibin Xie, Ph.D. role: CONTACT lat: 39.9075 lon: 116.39723 facility: Beijing Friendship Hospital, Capital Medical University status: RECRUITING city: Beijing state: Beijing zip: 100050 country: China name: Li Min, Ph. D. role: CONTACT phone: +86 13552652141 email: minli@ccmu.edu.cn name: Bilian Kang, Ph.D. role: CONTACT phone: +86 18001218793 email: kbl@mail.ccmu.edu.cn lat: 39.9075 lon: 116.39723 facility: Hebei Tumor Hospital status: RECRUITING city: Shijiazhuang state: Hebei zip: 050010 country: China name: Lianmei Zhao, Ph.D. role: CONTACT lat: 38.04139 lon: 114.47861 facility: Zhejiang Cancer Hospital status: RECRUITING city: Hangzhou state: Zhejiang zip: 310022 country: China name: Qian Song, Ph.D. role: CONTACT lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06363110 id: 22724 briefTitle: An Observational Study to Learn More About Vericiguat Treatment Patterns and Its Safety in People With Chronic Heart Failure With Reduced Ejection Fraction in Routine Medical Care in the United States acronym: HOVER overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-10 date: 2024-06-30 date: 2024-06-30 date: 2024-04-12 date: 2024-04-16 name: Bayer class: INDUSTRY briefSummary: This is an observational study in which data already collected from people with chronic heart failure with reduced ejection fraction (HFrEF) are studied.

In observational studies, only observations are made, without participants receiving any advice or any changes to healthcare.

Chronic HFrEF is a long-term condition in which the heart becomes weak and cannot pump enough blood to the rest of the body with each heartbeat. This leads to a reduced supply of oxygen, which the body requires to function properly.

The study treatment, vericiguat, works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC), which relaxes the blood vessels and allows more blood to flow. As a result, the heart can pump better.

It is already approved for doctors to prescribe to people with chronic HFrEF in the United States (US) who are stabilized after a recent "decompensation event". The treatment with vericiguat starts at a low dose, which should be increased gradually to the target dose based on how a patient tolerates the treatment.

The participants in this study are already receiving treatment with vericiguat as part of their regular care from their doctors.

The main purpose of the study is to learn more about the dosage pattern of vericiguat in people with chronic HFrEF in the US. To do this, researchers will collect the following information for 3 months after participants' first dose of vericiguat:

* starting dose of vericiguat
* daily changes in dosage pattern
* time taken to reach the target dose
* number and percentage of participants:
* with specific changes in dosage pattern
* reaching the target dose of vericiguat

They will also collect information on how often low blood pressure or fainting occurs, which are well known events in people with chronic HFrEF.

The data will come from the participants' information stored in a database called the HealthVerity HF dataset. Data collected will be from people with chronic HFrEF who started taking vericiguat between January 2021 and April 2023.

Researchers will only look at the health records of participants in the US.

Researchers will track participants' data and will collect information for a maximum of 6 months before and 3 months after their first dose of vericiguat.

In this study, only available data from routine care are collected. No visits or tests are required as part of this study. conditions: Chronic Heart Failure With Reduced Ejection Fraction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1400 type: ESTIMATED name: Vericiguat (Verquvo, BAY1021189) measure: Number of patients having vericiguat daily dose of 2.5 mg, 5 mg and 10 mg at index date measure: Number of patients having daily dose of 10 mg/day within the 90 days after vericiguat initiation measure: Days from index date to first occurrence of 10 mg/day dose measure: Number of patients who received a dose of 2.5 mg/day, 5 mg/day and 10 mg/day, or discontinued drug therapy each day over the 90-day follow-up period measure: Number of patients having any Vericiguat up-titration within the 90 days after vericiguat initiation measure: Number of patients having specific titration scenarios within the 90 days after vericiguat initiation measure: Number of patients having hypotension or syncope in the entire 90 days after vericiguat initiation and by 30 days intervals sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bayer city: Whippany state: New Jersey zip: 07981 country: United States lat: 40.82454 lon: -74.4171 hasResults: False

 nctId: NCT06363097 id: ΔΔ5032 briefTitle: Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease overallStatus: RECRUITING date: 2023-09-04 date: 2024-12 date: 2025-06 date: 2024-04-12 date: 2024-04-12 name: Aristotle University Of Thessaloniki class: OTHER briefSummary: In chronic kidney disease (CKD), hypertension is characterized by the phenomenon of sodium-sensitivity, i.e., the disproportionate increase in blood pressure (BP) due to an increase in dietary sodium consumption to maintain homeostasis through urinary sodium excretion. Impaired renal circulation, blunt suppression of renin-angiotensin-aldosterone system, sympathetic nervous system overactivity, paradoxically reduced levels of atrial natriuretic peptide and hyperinsulinemia represent the main pathophysiologic mechanisms. Accumulated evidence has suggested that uromodulin plays a central role in the development of sodium-sensitive hypertension. Uromodulin is a kidney-specific glycoprotein which is exclusively produced by the epithelial cells lining the thick ascending limb and early distal convoluted tubule. It is currently recognized as a multifaceted player in kidney physiology and disease, with discrete roles for intracellular, urinary, interstitial and serum uromodulin. Among these, urinary uromodulin modulates renal sodium handling through regulating tubular transporters that reabsorb sodium and are targeted by diuretics, i.e., the loop diuretic-sensitive Na+-K+-2Cl- cotransporter type 2 (NKCC2) and the thiazide-sensitive Na+/Cl- cotransporter (NCC). Given these roles, the contribution of uromodulin to sodium-sensitive hypertension has been proposed. In preclinical models, uromodulin deficiency causes decreased BP that is resistant to dietary salt, while uromodulin overexpression causes hypertension due to increased tubular sodium reabsorption that is responsive to furosemide. Genetic human studies have identified robust associations of specific UMOD gene variants with sodium sensitivity and incident hypertension risk, while comprehensive Mendelian randomization studies have affirmed these associations by highlighting the causal relationship between UMOD variants, urinary uromodulin levels and hypertension. Furthermore, clinical studies in both healthy individuals and hypertensive patients have indicated a link between sodium sensitivity and uromodulin, directly affecting mean BP levels and BP response to salt intake. With regards to CKD population, solid data on the link of uromodulin with sodium sensitivity are currently missing from the literature. There is only a pediatric study in the setting of CKD (stages 2-3), which failed to show an association between urinary uromodulin levels indexed to urinary creatinine (UMOD/uCr) and either 24-hour or office BP; however, this study has several limitations, and its results should be interpreted with caution. To best of our knowledge, there is no study up to date investigating the effect of dietary sodium intake on 24-hour ambulatory blood pressure depending on urinary uromodulin levels in adult CKD patients. conditions: Chronic Kidney Disease conditions: Hypertension studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 130 type: ESTIMATED measure: Effect of urinary uromodulin levels on the relationship between 24-hour urinary sodium excretion and 24-hour ambulatory systolic blood pressure. measure: Effect of urinary uromodulin levels on the relationship between 24-hour urinary sodium excretion and 24-hour ambulatory diastolic blood pressure. measure: Effect of urinary uromodulin levels on the relationship between nighttime/daytime ratio of urinary sodium excretion and 24-hour ambulatory systolic blood pressure. measure: Effect of urinary uromodulin levels on the relationship between nighttime/daytime ratio of urinary sodium excretion and 24-hour ambulatory diastolic blood pressure. measure: Effect of urinary uromodulin levels on the relationship between urinary sodium-to-potassium (Na+/K+) ratio and 24-hour ambulatory systolic blood pressure. measure: Effect of urinary uromodulin levels on the relationship between urinary sodium-to-potassium (Na+/K+) ratio and 24-hour ambulatory diastolic blood pressure. measure: The difference in 24-hour ambulatory brachial SBP/DBP between patients with high and low urinary uromodulin excretion. measure: The difference in 24-hour ambulatory brachial SBP/DBP standard deviation (SD) between patients with high and low urinary uromodulin excretion. measure: The difference in 24-hour ambulatory brachial SBP/DBP weighted SD (wSD) between patients with high and low urinary uromodulin excretion. measure: The difference in 24-hour ambulatory brachial SBP/DBP coefficient of variation (CV) between patients with high and low urinary uromodulin excretion. measure: The difference in 24-hour ambulatory brachial SBP/DBP average real variability (ARV) between patients with high and low urinary uromodulin excretion. measure: Effect of 24-hour urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP standard deviation (SD). measure: Effect of 24-hour urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP weighted SD (wSD). measure: Effect of 24-hour urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP coefficient of variation (CV). measure: Effect of 24-hour urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP average real variability (ARV). measure: Effect of nighttime/daytime ratio of urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP standard deviation (SD). measure: Effect of nighttime/daytime ratio of urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP weighted SD (wSD). measure: Effect of nighttime/daytime ratio of urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP coefficient of variation (CV). measure: Effect of nighttime/daytime ratio of urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP average real variability (ARV). measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on 24-hour ambulatory brachial SBP/DBP standard deviation (SD). measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on 24-hour ambulatory brachial SBP/DBP weighted SD (wSD). measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on 24-hour ambulatory brachial SBP/DBP coefficient of variation (CV). measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on 24-hour ambulatory brachial SBP/DBP average real variability (ARV). measure: Effect of 24-hour urinary sodium excretion on hydration status (US-B lines). measure: Effect of nighttime/daytime ratio of urinary sodium excretion on hydration status (US-B lines). measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on hydration status (US-B lines). measure: Effect of 24-hour urinary sodium excretion on MMSE score. measure: Effect of nighttime/daytime ratio of urinary sodium excretion on MMSE score. measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on MMSE score. measure: Effect of 24-hour urinary sodium excretion on PSQI score. measure: Effect of nighttime/daytime ratio of urinary sodium excretion on PSQI score. measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on PSQI score. measure: Effect of 24-hour urinary sodium excretion on ESS score. measure: Effect of nighttime/daytime ratio of urinary sodium excretion on ESS score. measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on ESS score. measure: Effect of 24-hour urinary sodium excretion on nocturnal urinations. measure: Effect of nighttime/daytime ratio of urinary sodium excretion on nocturnal urinations. measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on nocturnal urinations. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 1st Department of Nephrology status: RECRUITING city: Thessaloníki state: Central Macedonia zip: 54642 country: Greece name: Artemios G Karagiannidis, MD, MSc role: CONTACT phone: +30 6970362392 email: artemiskaragiannidis@gmail.com lat: 40.64361 lon: 22.93086 hasResults: False

 nctId: NCT06363084 id: IST-Nim-PC-6 briefTitle: A Retrospective Study for Nimotuzumab Plus Postoperative Adjuvant Chemotherapy for Resectable Pancreatic Cancer overallStatus: COMPLETED date: 2016-05-01 date: 2022-07-31 date: 2023-06-30 date: 2024-04-12 date: 2024-04-12 name: Ruijin Hospital class: OTHER briefSummary: This trial is a retrospective, observational study, patients who underwent surgical resection of the pancreas for non-metastatic pancreatic cancer between 2016 and 2022 were selected and divided into two groups according to with (study arm) or without (control arm) nimotuzumab. The primary efficacy endpoint was overall survival (OS). conditions: Resectable Pancreatic Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 64 type: ACTUAL name: Nimotuzumab measure: overall survival (OS） measure: disease-free survival (DFS) measure: locoregional recurrence-free survival (LRRFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06363071 id: 202000495A3 briefTitle: APA and PAS Training for Gait Initiation in Parkinson's Disease overallStatus: RECRUITING date: 2022-06-13 date: 2025-03-31 date: 2025-05-31 date: 2024-04-12 date: 2024-04-12 name: Chang Gung University class: OTHER briefSummary: Our research focused on understanding the interplay between brain excitability and balance function in patients with Parkinson's disease (PD), alongside evaluating effective physical therapy methods. It highlights the prevalence of non-motor disorders and cognitive impairments among PD patients, including balance and postural issues, cognitive function decline, and gait instability. Additionally, it notes that PD patients exhibit abnormal electrophysiological responses, indicating altered central excitability. conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Weight shift training and APA feedback name: Paired associative stimulation measure: Balance Performance measure: COP Path Length in Balance Tasks measure: COP Displacement in Balance Tasks measure: Motor Evoked Potentials (MEPs) measure: Intracortical Facilitation (ICF) measure: Intracortical Inhibition (ICI) measure: Walking Speed measure: Step Length measure: Step Time measure: COP Velocity in Balance Tasks measure: COP Area in Balance Tasks measure: Double Support Time measure: Single Support Time measure: Swing Time measure: Stance Time measure: Cadence sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chang Gung University status: RECRUITING city: Taoyuan zip: 333 country: Taiwan name: Ya-Ju Chang, PhD role: CONTACT phone: 88632118800 phoneExt: 5515 email: yjchang@mail.cgu.edu.tw lat: 24.95233 lon: 121.20193 hasResults: False

 nctId: NCT06363058 id: 201902166B0 briefTitle: Electrical Stimulation Cycling Training Effects on SCA overallStatus: RECRUITING date: 2022-04-08 date: 2025-07-31 date: 2025-07-31 date: 2024-04-12 date: 2024-04-17 name: Chang Gung University class: OTHER briefSummary: To focuses on the challenges faced by individuals with spinocerebellar ataxia (SCA), highlighting the major clinical sign of ataxia that affects their stability and ability to perform daily activities, thereby impacting their quality of life. It outlines the concept of neural plasticity, which is the brain's ability to adapt through changes in excitability, and notes that these changes are more enduring in the central nervous system (CNS) than in the peripheral nervous system (PNS). This adaptability, crucial for memory and motor learning, is compromised in SCA patients due to impaired brain areas and pathways. The summary further delves into motor learning, distinguishing between explicit and implicit learning, and points out that SCA patients exhibit deficiencies in procedural learning and cerebellar function. It also introduces the concept of priming as a preparatory mechanism that can enhance the effectiveness of physical therapy by modifying subsequent responses to stimuli. The document suggests that cycling, as an aerobic exercise, could prime the brain for improved blood flow and oxygenation, thereby supporting synaptic plasticity and the release of beneficial neurotrophic factors. Finally, the project aims to deepen the understanding of motor performance and learning mechanisms in SCA patients and apply these insights to clinical rehabilitation strategies. conditions: Spinocerebellar Ataxia (SCA) studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 145 type: ESTIMATED name: ES Cycling Training measure: Overall Response Time measure: Overall Error Rate measure: Motor Evoked Potentials (MEPs) measure: Intracortical Facilitation (ICF) measure: Intracortical Inhibition (ICI) measure: Total Scale for the Assessment and Rating of Ataxia (SARA) Score measure: Total Berg Balance Scale (BBS) Score measure: Total Time to Complete the Time Up and Go test (TUG test) measure: Walking Speed measure: Step Length measure: Step Time measure: Double Support Time measure: Single Support Time measure: Swing Time measure: Stance Time measure: Cadence sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chang Gung University status: RECRUITING city: Taoyuan zip: 333 country: Taiwan name: Ya-Ju Chang, PhD role: CONTACT phone: 88632118800 phoneExt: 5515 email: yjchang@mail.cgu.edu.tw lat: 24.95233 lon: 121.20193 hasResults: False

 nctId: NCT06363045 id: NIDEK-TONOREF-UK-0001 briefTitle: Comparative Study of the NIDEK TONOREF III With Predicate Devices overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-11 date: 2024-11 date: 2024-04-12 date: 2024-04-17 name: Nidek Co. LTD. class: INDUSTRY briefSummary: The primary objective of this clinical study is to prove that tonometry values for NIDEK TONOREF III are comparable to the predicate device and to prove that the pachymeter function of NIDEK TONOREF III is equivalent to the predicate device. The secondary objective is to demonstrate that the test device is as safe as the predicate devices. conditions: Intraocular Pressure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 220 type: ESTIMATED name: NIDEK TONOREF III name: Haag-Streit, PERKINS HAND-HELD APPLANATION TONOMETER name: NIDEK CEM-530 measure: Equivalent to legally-marketed devices measure: Equivalent to the pachymeter function measure: The numbers of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aston University city: Birmingham zip: B4 7ET, UK country: United Kingdom lat: 52.48142 lon: -1.89983 hasResults: False

 nctId: NCT06363032 id: 202110104RINB briefTitle: Elastography in Predicting Renal Outcome overallStatus: RECRUITING date: 2021-12-27 date: 2024-12-31 date: 2025-12-31 date: 2024-04-12 date: 2024-04-12 name: National Taiwan University Hospital class: OTHER briefSummary: There are two types of elastography: strain elastography assesses the degree of strain when applying a given amount of force to the skin. Shear-wave elastography assesses the velocity of shear wave propagation within the target lesion. A part of the tissue is deformed by a "push pulse", the velocity of the shear waves propagating within the tissue is detected, and the stiffness of the tissue is assessed based on the detected shear velocity. Shear-wave elastography has been intensively studied in thyroid, breast, liver, cervical lymph nodes, and musculoskeletal diseases with promising result.

Transthoracic shear-wave ultrasound is also used for the prediction of lung malignancy.

In progressive renal disease, renal function decline correlates with the extent of interstitial fibrosis, irrespective of the original pathology. Experience and research in using shear-wave elastography to study the stiffness of renal parenchyma and renal fibrosis are scanty. The investigators will conduct a prospective observational study. This study aims to provide the information of tissue elasticity in different etiologies of renal diseases and to validate the predictive value of shear-wave elastography in predicting renal function and renal fibrosis.

By assuming a power of 0.8, a two-side p value of 0.05, a ratio of 0.2 (sample sizes in negative/positive groups) to detect the difference between area under ROC curve and null hypothesis value (0.8 and 0.7), a target sample of 273 (with a 5% cushion, 260\~290) patients is required. conditions: Kidney Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: elastography measure: collect medical record of blood urea nitrogen and Creatinine sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Taiwan University Hospital status: RECRUITING city: Taipei country: Taiwan name: Fan-Chi Chang role: CONTACT phone: 886-0223123456 email: leiny.fc@gmail.com lat: 25.04776 lon: 121.53185 hasResults: False

 nctId: NCT06363019 id: 2023/00158 briefTitle: Supporting At-Risk Mothers Across Perinatal Period acronym: SMART overallStatus: RECRUITING date: 2024-02-26 date: 2025-02-26 date: 2026-07-06 date: 2024-04-12 date: 2024-04-12 name: National University of Singapore class: OTHER name: Ministry of Health, Singapore briefSummary: The SMART app is a mobile application based psychosocial parenting intervention containing educational materials (articles, videos, audios, podcasts) on parenting, an integrated peer support chat function with experienced mothers and an integrated forum for interaction with other mother participants.

The goal of this interventional study is to test the effectiveness of a mobile-app health based intervention, SMART, mothers in the perinatal period.

The main questions this study aims to answer are:

1. What is the effect of a mobile-based health intervention, SMART, on maternal outcomes?
2. What is the effect of a mobile-based health intervention, SMART, on infant outcomes?
3. What is the cost-effectiveness of using SMART as compared to standard routine care?

Researchers will compare results with a control group that will undergo standard routine care. conditions: Perinatal Depression conditions: Parents conditions: Anxiety conditions: Self Efficacy conditions: Stress conditions: Infant Development studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two-group parallel-armed randomized controlled trial with a pretest and repeated post-test experimental design primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 200 type: ESTIMATED name: Supporting at-risk Mothers Across perinatal period: a Randomized controlled Trial (SMART) mobile application measure: Postnatal depression measure: Infant physical development measure: Infant cognitive development measure: Infant emotional development measure: Anxiety measure: Perceived stress measure: Perceived social support measure: Maternal-infant bonding measure: Parental satisfaction measure: Parental efficacy measure: Objective stress measure: Emotional availability measure: Health services and utilization measure: Infant Physical Development measure: Infant Social Development measure: Infant Social Development measure: Infant Social Development measure: Infant Emotional Development sex: FEMALE minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alice Lee Centre for Nursing Studies, National University of Singapore status: RECRUITING city: Singapore zip: 117597 country: Singapore name: Shefaly Shorey, PhD role: CONTACT phone: 66011294 phoneExt: +(65) email: nurssh@nus.edu.sg lat: 1.28967 lon: 103.85007 facility: National University of Singapore status: RECRUITING city: Singapore zip: 117597 country: Singapore name: Shefaly Shorey role: CONTACT phone: +6566011294 email: nurssh@nus.edu.sg lat: 1.28967 lon: 103.85007 hasResults: False

 nctId: NCT06363006 id: K23C3280 briefTitle: Combination of Cardonizumab Injection and TKI Second Line Therapy for Advanced Hepatocellular Cancer overallStatus: RECRUITING date: 2024-03-11 date: 2026-01-01 date: 2027-01-01 date: 2024-04-12 date: 2024-04-12 name: Peking Union Medical College Hospital class: OTHER briefSummary: The goal of this clinical trial is to evaluate the efficacy and safety of cardonilizumab injection combined with TKI in second-line treatment of advanced hepatocellular carcinoma. The main questions it aims to answer are:

* Objective response rate (ORR) for evaluation
* Disease Control Rate (DCR); Duration of relief (DoR); Progression free survival (PFS); Total survival time (OS); Safety。 conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: TKI+Cardunilimab measure: ORR Full single-arm, open, multicenter prospective clinical study measure: Progression-free Survival (PFS) measure: Disease Control Rate (DCR) measure: Overall Survival (OS) measure: Duration of Response (DOR) measure: Stable Disease (SD) measure: Progression free survival rate measure: Any adverse events related with treatment with TKI plus Cardonizumab. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chinese Academy of Medical Sciences & Peking Union Medical College Hospital (CAMS&PUMCH) status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: Haitao Zhao, Professor role: CONTACT phone: +861069156042 email: zhaoht@pumch.cn lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06362993 id: STUDY00021561 briefTitle: Breast Cancer Screening in Ghana overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-11 date: 2025-03 date: 2024-04-12 date: 2024-04-15 name: Penn State University class: OTHER name: University of Ghana briefSummary: This study is designed to test the feasibility of two intervention on promoting early screening for breast cancer in rural Ghana. In one intervention, screening for breast cancer, diabetes and hypertension will be offered together. In another intervention, a series of sessions with men will be conducted with a goal to change gender attitudes and increase support to women. The investigators' long-term goal is to test these interventions in a large-scale randomized controlled trial. The specific aims of this feasibility study are to: 1) refine the study materials, including the curriculum for the sessions with men, by consulting with an expert advisory committee and a local committee, and 2) determine the feasibility of the two interventions in four clinic zones in Yilo-Krobo district in eastern Ghana (1 clinic in control, 1 clinic in the first intervention, and 2 in the second intervention). This trial registration is for the second specific aim. conditions: Breast Cancer Female studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 150 type: ESTIMATED name: Bundling name: MEGH measure: Clinical breast exam (CBE) utilization at the local clinic sex: FEMALE minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06362980 id: BPI-1178-IIT01 briefTitle: A Study With BPI-1178 and Osimertinib in Advanced Non-small Cell Lung Cancer Patients With EGFR Mutations acronym: EGFR overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2026-04-01 date: 2024-04-12 date: 2024-04-12 name: National Cancer Center, China class: OTHER briefSummary: BPI-1178 is a novel, orally administered inhibitor of both cyclin-dependent kinase 4 (CDK4) and CDK6 kinase activity. This open-label investigator-initiated trial (IIT) phase I study was designed to evaluate the safety and efficacy of oral BPI-1178 in combination with osimertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) Mutations. conditions: NSCLC studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: BPI-1178 name: Osimertinib measure: Number of patients with dose-limiting toxicity (DLT) 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: Intracranial ORR (iORR) measure: Intracranial DCR (iDCR) measure: Intracranial DoR (iDoR) measure: Intracranial Time to Progression (iTTP) measure: Intracranial PFS (iPFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06362967 id: Anti-HLA antibody briefTitle: The Efficacy and Safety of Desensitation Regimen for Patients With High Titers of Anti-HLA Antibodies Prior to Allo-HSCT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2026-06-30 date: 2024-04-12 date: 2024-04-12 name: Anhui Provincial Hospital class: OTHER_GOV briefSummary: Evaluation of the efficacy and safety of immunoadsorption or plasma exchange combined with rituximab and high-dose IVIG to reduce high titres of anti-HLA antibodies in patients prior to allogeneic haematopoietic stem cell transplantation conditions: High Titers of Anti-HLA Antibody (MFI ≥5000) studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG measure: Incidence of reduction of anti-HLA antibody MFI values to less than 5000 in subjects at the end of treatment measure: Incidence of primary graft failure measure: Incidence of TRM after allo-HSCT measure: Incidence of ineffective platelet transfusion after allo-HSCT measure: Cumulative incidence of neutrophil engraftment after allo-HSCT measure: Cumulative incidence of II-IV° acute GVHD measure: Cumulative incidence of relapse at 1 year post-transplant measure: Probability of overall survival post transplantation measure: Incidence of allergies and allergic reactions measure: Incidence of haemorrhagic events measure: Incidence of viral, bacterial and fungal infections measure: Incidence of hypocalcaemia sex: ALL minimumAge: 14 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT facility: The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) city: Hefei state: Anhui zip: 230036 country: China lat: 31.86389 lon: 117.28083 hasResults: False

 nctId: NCT06362954 id: AnkaraMedipolU-FTR-SS-01 briefTitle: The Relationship Between Muscle Oxygenation and Spasticity in Hemiparetic Stroke Patients overallStatus: RECRUITING date: 2023-12-31 date: 2024-04-01 date: 2024-06-01 date: 2024-04-12 date: 2024-04-12 name: Ankara Medipol University class: OTHER name: Gazi University briefSummary: Conditions such as hemiparesis, sensory and motor impairment, perceptual impairment, cognitive impairment, aphasia, and dysphagia may be observed after stroke. Motor impairment after stroke may occur due to damage to any part of the brain related to motor control. There is much clinical evidence that damage to different parts of the sensorimotor cortex in humans affects other aspects of motor function. Loss of strength, spasticity, limb apraxia, loss of voluntary movements, Babinski sign, and motor neglect are typical motor deficits following a cortical lesion (upper motor neuron lesion). Post-stroke spasticity can be seen in 19% to 92% of stroke survivors. Post-stroke hemiparesis is a significant cause of morbidity and disability, along with abnormal muscle tone. It has also been recognized that post-stroke hemiparesis may occur without spasticity. Spasticity seen after stroke causes loss of movement control, painful spasms, abnormal posture, increased muscle tone, and a general decrease in muscle function, and may affect limb blood flow. Studies in the literature show that spasticity can affect limb blood flow.

This study aims to investigate the relationship between muscle oxygenation and spasticity in post-stroke hemiparetic patients based on the idea that oxygenation may be insufficient as a result of restriction of blood flow on the affected side due to spasticity in stroke patients. conditions: Stroke conditions: Hemiparesis;Poststroke/CVA conditions: Spasticity as Sequela of Stroke studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 18 type: ESTIMATED name: Assessment measure: Plantar Flexors Muscle Oxygenation measure: Spasticity measure: Motor Function measure: 6-Minute Walk Test measure: Stair Climbing Test measure: Adipose tissue thickness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gazi University, Faculty of Health, Department of Physiotherapy and Rehabilitation status: RECRUITING city: Ankara state: Çankaya country: Turkey name: Gökhan Yazıcı, Assos. Prof. role: CONTACT phone: +90 506 316 0572 email: gokhanyazici38@hotmail.com name: Gökhan Yazıcı, Assos. Prof. role: PRINCIPAL_INVESTIGATOR name: Taylan Altıparmak, Asst. Prof. role: SUB_INVESTIGATOR name: Çağla Çağatay role: SUB_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False

 nctId: NCT06362941 id: NW-HGN-01 briefTitle: Evaluation of an Oral Hair Supplement to Improve Hair Strength and Support Growth in Women and Men overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-02-01 date: 2025-03-30 date: 2024-04-12 date: 2024-04-18 name: Nutraceutical Wellness Inc. class: INDUSTRY briefSummary: A single-center, open-label, prospective study to demonstrate the efficacy of an oral supplement to improve the strength and support the growth of thinning hair in men and women with self-perceived hair thinning. conditions: Hair Thinning studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single Group Assignment 6-month, single-center, prospective interventional study primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: Nutrafol Women's Hair Growth Supplemnt name: Nutrafol Women's Balance Hair Growth Supplement name: Nutrafol Women's Vegan Hair Growth Supplement name: Nutrafol Women's Postpartum Hair Growth Supplement name: Nutrafol Men's Hair Growth Supplement measure: Change in hair shaft diameter compared to baseline at Day 180. measure: Change in hair shaft diameter compared to baseline at Day 90. measure: Change in broken hairs recovered from the hair pull test compared to baseline at Day 180 measure: Change in broken hairs recovered from the hair pull test compared to baseline at Day 90 measure: Change in hair breakage during the hair pull test compared to baseline at Day 180 measure: Change in hair breakage during the hair pull test compared to baseline at Day 90 measure: Change in the number of hairs recovered from the hair pull test compared to baseline at Day 180 measure: Change in the number of hairs recovered from the hair pull test compared to baseline at Day 90 measure: Subject Self-Perceived Improvement in Hair Quality at Day 180 measure: Subject Self-Perceived Improvement in Hair Quality at Day 90 sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dermatology Consulting Services city: High Point state: North Carolina zip: 27262 country: United States name: Zoe Draelos role: CONTACT phone: 336-841-2040 email: zdraelos@northstate.net lat: 35.95569 lon: -80.00532 hasResults: False

 nctId: NCT06362928 id: CP-60005 briefTitle: Safety and Effectiveness of the Akura Thrombectomy System in the Treatment of Acute Pulmonary Embolism overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2025-06 date: 2025-08 date: 2024-04-12 date: 2024-04-12 name: Akura Medical class: INDUSTRY briefSummary: This study is a prospective, single-arm, non-randomized, interventional, multicenter feasibility study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE). conditions: Pulmonary Embolism Acute studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: ATC System measure: Effectiveness measure: Safety: Composite of Major Adverse Device-Related Events measure: Safety: Composite of Major Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06362915 id: FMASUR66/2024 briefTitle: Analgesic Effect of Illiohypogastic & Ilioinguinal Nerve Block in TAVR - TF (Prospective Randomized Study) overallStatus: RECRUITING date: 2024-01-02 date: 2024-07-15 date: 2024-08-30 date: 2024-04-12 date: 2024-04-12 name: Ain Shams University class: OTHER briefSummary: The purpose of the study is to compare the effect of illiohypogastric and ilioinguinal nerve block with the local infiltration with lidocaine in patients undergoing TAVI conditions: Anesthesia, Local studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: * Group (A): will receive blind local infiltration in femoral region on the operation side by an experienced anesthesiologist using 20 ml lidocaine 1% (9).
* Group (B): will receive ultrasound-guided ilioinguinal/iliohypogastric nerve block using 20 ml Bupivicane 0.25% by an experienced anesthesiologist. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 52 type: ESTIMATED name: Lidocaine name: Bupivacain measure: Extra Demand of sedation measure: Patient and surgeon satisfaction sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: maha sadek El Derh status: RECRUITING city: Cairo state: Heliopolis zip: 11721 country: Egypt lat: 30.06263 lon: 31.24967 facility: Ain Shams University status: RECRUITING city: Cairo country: Egypt name: maha S elDerh, Ass.prof role: PRINCIPAL_INVESTIGATOR lat: 30.06263 lon: 31.24967 hasResults: False

 nctId: NCT06362902 id: NOSES-VIII B briefTitle: Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction for Colon Cancer overallStatus: RECRUITING date: 2024-03-01 date: 2025-09-01 date: 2025-09-01 date: 2024-04-12 date: 2024-04-12 name: National Cancer Center, China class: OTHER briefSummary: The purpose of this study is to investigate the preliminary surgical outcomes of laparoscopic right hemicolectomy with transrectal specimen extraction. The hypothesis is that this type of natural orifice specimen extraction surgery (NOSES) could achieve good short-term and oncological outcomes for right colon cancer patients. conditions: Colon Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 37 type: ESTIMATED name: Laparoscopic right hemicolectomy with transrectal specimen extraction measure: The rate of postoperative complications measure: Operating time measure: Estimated blood loss measure: The time of first flatus measure: Postoperative hospitalization sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center status: RECRUITING city: Beijing state: Beijing zip: 100000 country: China name: Haitao Zhou, M.D. role: CONTACT phone: +8613381167333 email: zhouhaitao01745@163.com name: Yueyang Zhang, M.D. role: CONTACT phone: +8613552910035 email: yyzhang0129@163.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06362889 id: HealMD-CBD-1 briefTitle: Evaluating Microneedling With CBD and Hempseed Oil for Acne Vulgaris Safety and Efficacy overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-10 date: 2024-11 date: 2024-04-12 date: 2024-04-12 name: Rejuva Medical Aesthetics class: OTHER name: HealMD, LLC briefSummary: This is a prospective, single center, open label study to assess the safety and effectiveness of microneedling with CBD and hempseed oil for the treatment of moderate to severe acne in adults 22-years of age or older.The objective of this exploratory study is to evaluate the safety and efficacy of HealMD's CBD with hempseed oil to reduce the appearance of moderate to severe facial acne. conditions: Acne Vulgaris (Disorder) studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Microneedling with CBD measure: Primary efficacy endpoints measure: Secondary efficacy endpoints sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rejuva Medical Aesthetics city: Los Angeles state: California zip: 90025 country: United States name: LaRyel A Waldon, B.S. role: CONTACT phone: 424-644-2400 email: laryel@rejuvamedical.org name: Margaux Oldfield role: CONTACT phone: 4246442400 email: margaux@rejuvamedical.org lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06362876 id: BAlis briefTitle: The Effect of Breastfeeding Counseling Based on Motivational Interviewing overallStatus: ACTIVE_NOT_RECRUITING date: 2023-09-15 date: 2024-08-15 date: 2024-12-15 date: 2024-04-12 date: 2024-04-12 name: Mersin University class: OTHER briefSummary: This research was planned to determine the effect of breastfeeding counseling based on motivational interviewing method and standard breastfeeding counseling on breastfeeding self-efficacy and breastfeeding results in women who had a cesarean section. conditions: Breastfeeding Counseling Based on Motivational Interviewing studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 74 type: ESTIMATED name: Breastfeeding Counseling Based on Motivational Interviewing name: Standard Breastfeeding Consultancy measure: Level of breastfeeding self-efficacy measure: Level of breastfeeding self-efficacy measure: Level of breastfeeding self-efficacy measure: Level of breastfeeding self-efficacy measure: Level of breastfeeding self-efficacy measure: Breastfeeding Results Evaluation Form measure: Breastfeeding Results Evaluation Form measure: Breastfeeding Results Evaluation Form measure: Breastfeeding Results Evaluation Form sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Mersin University city: Mersin zip: 33180 country: Turkey lat: 36.79526 lon: 34.61792 hasResults: False

 nctId: NCT06362863 id: WDRY2024-K027 briefTitle: Evaluation of Enteral Nutrition Biscuits for Inducing Remission in Moderate-to-severe Crohn's Disease overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2025-12 date: 2024-04-12 date: 2024-04-12 name: Ping An class: OTHER briefSummary: By conducting a randomized controlled study of the role of enteral nutrition biscuits in the induction of remission in moderate-to-severe Crohn's disease, we will evaluate to investigate the role of enteral nutrition biscuits in the induction and remission phases of moderate-to-severe Crohn's disease; to assess patient adherence to enteral nutrition biscuits and the timing of their application; to assess the role of enteral nutrition biscuits in biologically refractory patients; and to assess the role of enteral nutrition biscuits in the remission of perianal, small bowel, and colonic lesions. conditions: Crohn's Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective randomized controlled study divided into intervention and control groups. primaryPurpose: TREATMENT masking: NONE count: 52 type: ESTIMATED name: enteral nutrition biscuits measure: Crohn's disease activity index, CDAI measure: Induced remission success rate measure: Gastrointestinal Symptom Rating Scale (GSRS) score measure: Gastrointestinal symptom remission measure: Detection of antibody levels to the biologics used in sera from patients with secondary loss of response to the biologics measure: Incidence and severity of perianal lesions in both groups measure: Rate of endoscopic remission of small bowel and colon lesions in both groups measure: Changes in inflammatory biomarkers (C-reactive protein, fecal calreticulin) in both groups measure: Adverse events and serious adverse events, safety and tolerability, with treatment-related adverse events and number of occurrences as assessed by CTCAE v5.0 sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06362850 id: 1253/2023 briefTitle: Tele-Support for Emergency Medical Technicians acronym: POHCA overallStatus: RECRUITING date: 2024-04-08 date: 2024-04-18 date: 2024-12-01 date: 2024-04-12 date: 2024-04-12 name: Medical University of Vienna class: OTHER name: Ludwig Boltzmann Institute Digital Health and Patient Safety briefSummary: In this manikin-based simulation study the impact of tele-support during a simulated pediatric out-of-hospital cardiac arrest scenario on emergency medical technicians' guideline adherence, on gaze behavior as well as on performance of resuscitation management and cognitive load will be analyzed. conditions: Cardiac Arrest studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In a manikin-based simulation study, the participants will be randomized to either performing the scenario with tele-support or without tele-support (80 participants 40 groups, 20 groups with tele-support, 20 groups without tele-support). primaryPurpose: OTHER masking: NONE count: 80 type: ESTIMATED name: Tele-support measure: guideline adherence measure: gaze behavior measure: teamwork performance measure: cognitive load measure: Performance of cardiopulmonary resuscitation measure: Technical feasibility measure: Usability sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna status: RECRUITING city: Vienna zip: 1090 country: Austria name: Christina Hafner, MD, PhD role: CONTACT phone: 004314040041020 email: christina.hafner@meduniwien.ac.at lat: 48.20849 lon: 16.37208 hasResults: False

 nctId: NCT06362837 id: P0117910-001 briefTitle: Evaluation of REACTS-IN, an Intervention to Improve Nutrition, Hygiene, and Sexual and Reproductive Health Services acronym: REACTS-IN overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2029-06-30 date: 2030-05-24 date: 2024-04-12 date: 2024-04-12 name: McGill University class: OTHER name: World Vision Canada name: Global Affairs Canada briefSummary: This is an independent evaluation of World VIsion's 7-year quasi-experimental intervention to improve nutrition, nutrition-related rights and gender equality for women, adolescent girls, and children under five years of age in rural Bangladesh, Kenya, and Tanzania. The evaluation will collect baseline, midline, and end-line data from intervention and comparison communities, schools, and health facilities. The evaluation objectives are to test if the intervention improved indicators for (i) child anthropometry, (ii) maternal and child dietary practices, (iii) women's empowerment, and (iv) equitable health service access for nutrition and sexual and reproductive needs. The evaluation analysis will take into account gender differences in the indicators. conditions: Stunting conditions: Gender Equality conditions: Acceptability of Health Care conditions: Diet; Deficiency conditions: Empowerment studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a quasi-experimental design for the evaluation of an intervention that is in the community (including schools) as well as in the local health service facilities. The data collection at baseline, midline, and end-line will occur simultaneously in the intervention and comparison selected communities. primaryPurpose: OTHER masking: NONE count: 13500 type: ESTIMATED name: Education intervention on nutrition, gender equity, WASH, sexual and reproductive health rights name: school-based iron-folic acid supplement program name: Health service training on equitable access to nutrition, health, and sexual and reproductive services name: bio-fortified crops measure: Gender equality measure: Child anthropometry measure: Antenatal care measure: Contraception use by women and partners measure: Child diet measure: Sexual and reproductive health services for adolescents measure: Gender equitable health services for nutrition, health, and sexual and reproductive health sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Brac University city: Dhaka country: Bangladesh name: Malay K Mridha, PhD role: CONTACT email: malay.mridha@bracu.ac.bd lat: 23.7104 lon: 90.40744 facility: Connar Consultants city: Nairobi country: Kenya name: Elizabeth Kamau, PhD role: CONTACT email: ekambu@gmail.com lat: -1.28333 lon: 36.81667 facility: Ifakara Health Institute city: Ifakara country: Tanzania name: Ester Elisaria, PhD role: CONTACT email: eelisaria@ihi.or.tz lat: -8.13333 lon: 36.68333 hasResults: False

 nctId: NCT06362824 id: 2094138 briefTitle: Promoting Physical Activity in Older Hispanic/Latino(a) Adults overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2028-09-30 date: 2029-09-30 date: 2024-04-12 date: 2024-04-15 name: Kaiser Permanente class: OTHER name: University of California, San Diego briefSummary: In this randomized controlled trial, study staff will randomize 130 Hispanic/Latino adults without dementia and over age 55 from Southern California to either the culturally adapted De Pie physical activity intervention or an active comparison program focusing on general brain health topics. The purpose of this study is to determine if 12 weeks of the culturally adapted and fully remote De Pie y a Movernos intervention improves self-efficacy, habit strength, social support, and enjoyment for physical activity (PA), thus promoting adherence to moderate-intensity physical activity (MIPA) guidelines (150 minutes/week). conditions: Sedentary Behavior conditions: Physical Inactivity conditions: Alzheimer Disease, Protection Against studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 130 type: ESTIMATED name: De Pie Intervention name: Active Comparison Group: Healthy Actions And Lifestyles To Avoid Dementia (HALT-AD) measure: Change in Moderate Intensity Physical Activity (MIPA) minutes/day measure: Meet MIPA guidelines of 150 minutes physical activity per week sex: ALL minimumAge: 55 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California San Diego city: San Diego state: California zip: 92093 country: United States name: Zvinka Z Zlatar, PhD role: CONTACT email: zzlatar@health.ucsd.edu name: Zvinka Z Zlatar, PhD role: PRINCIPAL_INVESTIGATOR lat: 32.71533 lon: -117.15726 hasResults: False

 nctId: NCT06362811 id: 483730 briefTitle: Assessment of Efficacy of Sacral Erector Spinae Plane Block for Postoperative Analgesia in Pediatric Rectal Biopsies overallStatus: COMPLETED date: 2023-01-01 date: 2023-12-31 date: 2023-12-31 date: 2024-04-12 date: 2024-04-16 name: Istanbul University class: OTHER briefSummary: The purpose of this study is to evaluate how sacral erector spinae block changed the postoperative analgesia requirements in pediatric patients undergoing rectal biopsies under general anesthesia. conditions: Analgesia conditions: Pain, Acute studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ACTUAL name: Sacral Erector Spinae Plane Block measure: Postoperative pain scores measure: Analgesia requirement measure: Complications sex: ALL minimumAge: 1 Day maximumAge: 5 Years stdAges: CHILD facility: Istanbul University Cerrahpasa city: Istanbul zip: 34098 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False

 nctId: NCT06362798 id: IRB22-0729 id: 1R01HD109293-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01HD109293-01 id: 6-23FY-0012 type: OTHER_GRANT domain: March of Dimes briefTitle: Effect of Support for Low-Income Mothers of Preterm Infants overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-05-01 date: 2028-12-01 date: 2024-04-12 date: 2024-04-15 name: Harvard School of Public Health (HSPH) class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) briefSummary: Preterm birth is a leading cause of childhood mortality and developmental disabilities. Socioeconomic disparities in the incidence of preterm birth and morbidities, mortality, and quality of care for preterm infants persist. An important predictor of the long-term consequences of preterm birth is maternal presence during the prolonged infant hospitalization (weeks to months) in the neonatal intensive care unit (NICU). Mothers who visit the NICU can pump breast milk, directly breastfeed and engage in skin-to-skin care, which facilitates breast milk production and promotes infant physiologic stability and neurodevelopment. Low-income mothers face significant barriers to frequent NICU visits, including financial burdens and the psychological impact of financial stress, which hinder their participation in caregiving activities. The investigators will conduct an randomized controlled trial (RCT) to test the effectiveness of financial transfers among 420 Medicaid - eligible mothers with infants 24 - 33 weeks' gestation in four level 3 NICUs: Boston Medical Center (BMC) in Boston, Massachusetts, UMass Memorial Medical Center (UMass) in Worcester, Massachusetts, Baystate Medical Center in Springfield, Massachusetts, and Grady Memorial Hospital in Atlanta, Georgia. Mothers in the intervention arm will receive usual care enhanced with weekly financial transfers and will be informed that these transfers are meant to help them spend more time with their infant in the NICU vs. a control arm (usual care). The primary hypothesis is that financial transfers can enable economically disadvantaged mothers to visit the NICU, reduce the negative psychological impacts of financial distress, and increase maternal caregiving behaviors associated with positive preterm infant health and development. conditions: Preterm Birth conditions: Low; Birthweight, Extremely (999 Grams or Less) studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two-arm single-blind 1:1 randomized controlled trial of financial transfers ($160 per week) versus usual care. Mothers in the intervention arm will access videos that explain the impact of the cash on their availability for benefits and social supports. They will also be able to ask questions to a benefits counselor about how the transfers affect their benefits during the trial. primaryPurpose: OTHER masking: DOUBLE maskingDescription: Enrolled mothers who are assigned to the intervention group will be informed to not discuss the financial transfers with anyone on the NICU care team (i.e., physicians, nurses, etc.) whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 420 type: ESTIMATED name: Financial Transfers measure: Provision of breast milk (proportion) measure: Provision of skin-to-skin care measure: Duration of mother's milk expression measure: Gestational weight-for-age measure: Gestational length-for-age z-score measure: Gestational head circumference measure: Necrotizing enterocolitis (NEC) measure: Late-onset bacterial or fungal sepsis (LOS) measure: NICU Visitation measure: Postpartum Bonding measure: Provision of breast milk (volume) measure: Breastfeeding episode measure: Maternal physical health measure: Maternal mental health (anxiety) measure: Maternal mental health (depression) measure: Reaction Time Modified Flanker Task measure: Accuracy Performance Modified Flanker Task measure: Reaction Time Psychomotor Vigilance Task measure: Accuracy Psychomotor Vigilance Task measure: Happiness measure: Life satisfaction measure: Sleep measure: Routine postpartum care measure: Financial distress measure: Financial hardship measure: Food insecurity measure: Housing instability measure: Housing insecurity measure: Transportation insecurity measure: Length of stay measure: Mother readmission between 4-8 weeks post-discharge measure: Baby readmission between 4-8 weeks post-discharge measure: Mother emergency department visit between 4-8 weeks post-discharge measure: Baby emergency department visit between 4-8 weeks post-discharge measure: Sleep position measure: Sleep location measure: Breastfeeding expression continuation measure: Skin-to-skin care knowledge measure: Breastfeeding knowledge measure: Perception of hospital experience sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Children's Healthcare of Atlanta and Emory University city: Atlanta state: Georgia zip: 30322 country: United States name: Michelle-Marie Peña, MD role: CONTACT email: michelle.marie.pena@emory.edu lat: 33.749 lon: -84.38798 facility: Boston Medical Center city: Boston state: Massachusetts zip: 02118 country: United States name: Gabriela Cordova Ramos, MD role: CONTACT email: gabriela.CordovaRamos@bmc.org lat: 42.35843 lon: -71.05977 facility: Baystate Medical Center city: Springfield state: Massachusetts zip: 01199 country: United States name: Laura Madore, MD role: CONTACT email: laura.Madore@baystatehealth.org lat: 42.10148 lon: -72.58981 facility: UMass Memorial Medical Center city: Worcester state: Massachusetts zip: 01605 country: United States name: Margaret Parker, MD role: CONTACT email: margaret.Parker@umassmemorial.org lat: 42.26259 lon: -71.80229 hasResults: False

 nctId: NCT06362785 id: Virtual Reality-Seniors briefTitle: Musculoskeletal Pain, Motor Control, Risk of Falls and Virtual Reality overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-06 date: 2026-06 date: 2024-04-12 date: 2024-04-12 name: Universidade da Coruña class: OTHER name: Centre for Information and Communications Technology Research (CITIC) briefSummary: The goal of this clinical trial is to learn about musculoskeletal pain, functionality, and risk of falls in community-dwelling adults aged 60 years and older. The main questions it aims to answer are:

* What are the characteristics of a community-dwelling population over 60 years and older in terms of musculoskeletal pain, functionality, and risk of falls?
* Does an intervention with virtual reality lower musculoskeletal pain, raise functionality and prevent falls in community-dwelling adults aged 60 years and older, compared to a control group that does not receive such intervention?

Participants will:

* Answer questionnaires.
* Perform physical laboratory tests through a camera-based motion capture system.
* Execute task-based exercises in a virtual environment through virtual reality.

Researchers will compare community-dwelling adults aged 60 years and older who execute task based exercises in a virtual environment through virtual reality and community-dwelling adults aged 60 years and older without any intervention to see if virtual reality improves musculoskeletal pain, functionality, and lowers fall risk. conditions: Musculoskeletal Pain conditions: Task Performance and Analysis conditions: Accidental Falls conditions: Virtual Reality studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 110 type: ESTIMATED name: Virtual Reality measure: Presence of musculoskeletal pain measure: Pain Intensity measure: Initial positioning measure: Final positioning measure: Angular velocity measure: Acceleration measure: Movement execution time measure: Range of joint movement measure: Neck disability measure: Lower back disability measure: Kinesiophobia measure: Falls history measure: General health status measure: Date of birth measure: Gender measure: Height measure: Weight measure: Body mass index (BMI) measure: Depressive symptoms measure: Cognitive capacity measure: Amount and type of medication consumed measure: Existence of comorbidity sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06362772 id: MR-36-24-010944 briefTitle: Clinical Efficacy of 125I Seed Implantation in the Treatment of Refractory Differentiated Thyroid Cancer overallStatus: COMPLETED date: 2015-01-01 date: 2022-02-01 date: 2023-04-01 date: 2024-04-12 date: 2024-04-12 name: Jiangxi Provincial Cancer Hospital class: OTHER briefSummary: A retrospective analysis was conducted on RAIR-DTC patients who underwent radioactive 125I seed implantation from January 2015 to February 2022 at Jiangxi Cancer Hospital. Prescription dose: 80\~120 Gy. All cases were followed up at 1, 3, and 5 months postoperatively to monitor changes in tumor size, serum thyroglobulin (Tg), and serum anti-thyroglobulin antibody levels in thyrotropin-inhibited states, pain scores, and postoperative adverse reactions. The data were processed and analyzed using IBM SPSS 26.0. Pairwise comparisons were conducted using the Wilcoxon signed-rank test, and a p-value of less than 0.05 indicated statistical significance. conditions: Thyroid Neoplasms studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 36 type: ACTUAL name: Iodine-125 brachytherapy measure: Tumor size measure: Serological assessment measure: Pain score measure: Adverse event sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06362759 id: TOUR006-C01 briefTitle: A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP acronym: TRANQUILITY overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2026-02 date: 2024-04-12 date: 2024-04-12 name: Tourmaline Bio, Inc. class: INDUSTRY briefSummary: This study will evaluate the safety, tolerability, pharmacokinetics, and CRP-lowering effect of quarterly and monthly subcutaneous administration of TOUR006 in participants with chronic kidney disease and elevated hs-CRP. conditions: Chronic Kidney Diseases conditions: Chronic Kidney Insufficiency conditions: Chronic Renal Diseases conditions: Chronic Renal Insufficiency conditions: Kidney Insufficiency, Chronic conditions: C-Reactive Protein conditions: High Sensitivity C-Reactive Protein conditions: Hs-CRP conditions: hsCRP studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: TOUR006 - 50 MG name: TOUR006 - 25 MG name: TOUR006 - 15 MG name: Placebo measure: Evaluate the effects of TOUR006 compared with placebo on hs-CRP measure: Evaluate the effects of TOUR006 compared with placebo on hs-CRP measure: Evaluate the pharmacokinetics by measuring serum concentrations of TOUR006 measure: Evaluate the safety and tolerability of TOUR006 in participants with elevated cardiovascular risk and CKD sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06362746 id: FORPE-2 briefTitle: Non-immunogenic Recombinant Staphylokinase vs Placebo in Patients With Intermediate High-risk Pulmonary Embolism overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2028-06-01 date: 2028-12-01 date: 2024-04-12 date: 2024-04-12 name: Supergene, LLC class: INDUSTRY briefSummary: Objective: to evaluate the efficacy and safety of the non-immunogenic recombinant staphylokinase with its single bolus administration in comparison with placebo in normotensive patients with intermediate high-risk pulmonary embolism (PE) conditions: Pulmonary Embolism studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: At clinical sites patients will be equally randomized into two groups to receive non-immunogenic recombinant staphylokinase or placebo.

Non-immunogenic recombinant staphylokinase or placebo will be administered intravenously at a dose of 15 mg as a single bolus for 10-15 seconds. All patients will be examined for 30 days. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Neither patient nor investigator knows treatment assignment. All eligible patients will be randomized in two equal groups for administration of non-immunogenic recombinant staphylokinase or placebo. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 486 type: ESTIMATED name: Non-immunogenic recombinant staphylokinase name: Placebo measure: Composite of death from any cause or hemodynamic collapse or recurrent PE measure: Right/left ventricular (RV/LV) end-diastolic diameter ratio measure: RV/LV end-diastolic diameter ratio measure: RV/LV end-diastolic diameter ratio measure: Right ventricular (RV) end-diastolic volume measure: Qanadli index measure: Systolic pulmonary artery pressure measure: In hospital death from all causes (assessed up to day 7) measure: Death from all causes measure: Safety endpoint - hemorrhagic stroke measure: Safety endpoint - BARC type 3 and 5 bleeding measure: Safety endpoint - number and severity of adverse events (AEs) and serious AEs in organs and systems sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: V.F. Dolgopolov Vyselki Central District Hospital city: Vyselki state: Krasnodar Region zip: 353100 country: Russian Federation name: Valerii V. Makukhin, PhD role: CONTACT phone: (86199) 123-53 phoneExt: +7 email: makuhinv@mail.ru name: Valerii V. Makukhin, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.58128 lon: 39.66409 facility: I.P. Pavlov Ryazan State Medical University city: Ryazan' state: Ryazan zip: 390026 country: Russian Federation name: Denis S. Yunevich, PhD role: CONTACT phone: (4912) 46-63-90 phoneExt: +7 email: yunevichden@ya.ru name: Denis S. Yunevich, PhD role: PRINCIPAL_INVESTIGATOR lat: 54.6269 lon: 39.6916 facility: Belgorod Regional Clinical Hospital of St. Joseph city: Belgorod zip: 308007 country: Russian Federation name: Sergei L Konstantinov, MD role: CONTACT email: konstantinov5@yandex.ru name: Sergei L Konstantinov, MD role: PRINCIPAL_INVESTIGATOR lat: 50.61074 lon: 36.58015 facility: Kuzbass Cardiology center city: Kemerovo zip: 650002 country: Russian Federation name: Vasilii V. Kashtalap, MD, PhD role: CONTACT phone: +7 (3842) 64-22-41 email: v_kash@mail.ru name: Vasilii V. Kashtalap, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.33333 lon: 86.08333 facility: City Clinical Hospital №1 city: Kirov zip: 610035 country: Russian Federation name: Oleg V. Solovyev, PhD role: CONTACT phone: (8332) 56-35-74 phoneExt: +7 email: ckn@medkirov.ru name: Oleg V. Solovyev, PhD role: PRINCIPAL_INVESTIGATOR lat: 58.59665 lon: 49.66007 facility: Regional Clinical Hospital №2 city: Krasnodar zip: 350012 country: Russian Federation name: Tamara A. Chirva, MD role: CONTACT phone: (861) 222-000-2 phoneExt: +7 email: makuhinv@mail.ru name: Tamara A. Chirva, MD role: PRINCIPAL_INVESTIGATOR lat: 45.04484 lon: 38.97603 facility: S.S. Yudin City Clinical Hospital city: Moscow zip: 115446 country: Russian Federation name: Bogdan B Orlov, MD, PhD role: CONTACT phone: 7 (499) 612-45-66 email: bborlov@mail.ru name: Bogdan B Orlov, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: V.V. Vinogradov City Clinical Hospital city: Moscow zip: 117292 country: Russian Federation name: Imad Merai, MD, PhD role: CONTACT phone: +7 (495) 103 46 66 email: imadmerai@yahoo.com name: Imad Merai, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: S.P. Botkin City Clinical Hospital city: Moscow country: Russian Federation name: Yuri V. Karabach, PhD role: CONTACT phone: (499) 490-03-03 phoneExt: +7 email: yu.karabach@ya.ru name: Yuri V. Karabach, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: N.N. Burdenko Penza Regional Clinical hospital city: Penza zip: 440026 country: Russian Federation name: Valentin E. Oleynikov, MD, PhD role: CONTACT phone: +7 (8412) 54-84-07 email: oleynikof@gmail.com name: Valentin E. Oleynikov, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 53.20066 lon: 45.00464 facility: G.A. Zakharyin Clinical hospital №6 city: Penza zip: 440071 country: Russian Federation name: Elena S. Panina, PhD role: CONTACT phone: (8412) 98-33-55 phoneExt: +7 email: panina.es@mail.ru name: Elena S. panina, PhD role: PRINCIPAL_INVESTIGATOR lat: 53.20066 lon: 45.00464 facility: City Clinical Hospital №4 city: Perm zip: 614107 country: Russian Federation name: Oleg M. Lapin, PhD role: CONTACT phone: 342-263-01-06 phoneExt: +7 email: heparin@yandex.ru name: Oleg M. Lapin, PhD role: PRINCIPAL_INVESTIGATOR lat: 58.01046 lon: 56.25017 facility: V.P. Polyakov Samara Regional Clinical Cardiology Dispensary city: Samara zip: 443070 country: Russian Federation name: Dmitrii V Duplyakov, MD, PhD role: CONTACT phone: 8 (846) 373-70-63 email: duplyakov@yahoo.com name: Dmitrii V Duplyakov, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 53.20007 lon: 50.15 hasResults: False

 nctId: NCT06362733 id: IRB-74165 briefTitle: Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-01 date: 2026-06-01 date: 2024-04-12 date: 2024-04-12 name: Stanford University class: OTHER briefSummary: The purpose of this open label trial is to examine the preliminary effectiveness of a 12-week behavioral intervention program (1 hour/week) to treat insistence on sameness (e.g., difficulty tolerating changes in routine) in youth with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of a combination of parent-training and child-focused intervention. conditions: Autism Spectrum Disorder conditions: Restricted Behavior conditions: Autism studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 44 type: ESTIMATED name: Modified Pivotal Response Treatment for Insistence on Sameness in Autistic Youth measure: Change from Baseline in Insistence on Sameness Subscale of the Dimensional Assessment of Restricted and Repetitive Behaviors (DARB). measure: Change from Baseline on Blinded Clinician Ratings of Clinical Global Impression Scale, Severity and Improvement Ratings. measure: Change from Baseline in Parent-Rated Emotion Dysregulation on the Strengths and Difficulties Questionnaire Dysregulation Profile (SDQ-DP) during treatment. measure: Change from Baseline in Parent-Rated Irritability as captured by the Aberrant Behavior Checklist (ABC), Irritability Subscale. measure: Change from Baseline in Ritualistic/Sameness Subscale of Repetitive Behavior Scale-Revised (RBS-R). measure: Change from Baseline in Parent-Rated Challenging Behaviors on the Open-Source Challenging Behaviors Scale (OS-CBS). measure: Change from Baseline in Parent-Rated Anxiety as captured by the Anxiety Scale for Children with Autism Spectrum Disorder (ASC-ASD). measure: Change from Baseline in Caregiver Self-Report on the Caregiver Strain Questionnaire Short Form (CGSQ-SF7). measure: Change from Baseline in Caregiver Self-Report on the Warwick-Edinburg Mental Wellbeing Scales (WEMWS). measure: Change from Baseline in the Caregiver Self-Report Depression, Anxiety, and Stress Scale (DASS21). measure: Caregiver Report Autism Symptoms Dimension Questionnaire (ASDQ). measure: Caregiver Report Executive Functioning Scale (EFS). measure: Daily Living Skills Scale (DLSS). sex: ALL minimumAge: 4 Years maximumAge: 17 Years stdAges: CHILD hasResults: False

 nctId: NCT06362720 id: 720/2566(IRB2) briefTitle: The Comparison the CMV Infection and Reactivation After Allogeneic Hematopoietic Stem Cell Transplantation Between Standard Regimen, Methotrexate Plus Cyclosporin A, and Post-transplant Cyclophosphamide-based Regimen acronym: CMV overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-31 date: 2024-12-31 date: 2024-04-12 date: 2024-04-12 name: Siriraj Hospital class: OTHER briefSummary: The goal of this observational study is to compare the CMV infection and reactivation after allogeneic hematopoietic stem cell transplantation Between Standard Regimen, Methotrexate plus Cyclosporin A, and Post-transplant Cyclophosphamide-based Regimen. The main questions it aims to answer are:

* How do CMV infection and reactivation differ between Allo-SCT patients who received a standard regimen versus those who received a Post-transplant Cyclophosphamide-based regimen?
* progression-free survival, Median overall survival, cumulative incidence of relapse, non-relapsed mortality (NRM) and GvHD at 2 years after Allo-SCT
* The impact of CMV infection and CMV reactivation on progression-free survival, overall survival, and NRM
* Averse events of GVHD prophylaxis medication Participants will be collected the data of treatment and treatment response during transplant until 2 years after transplant from hospital medical record. conditions: CMV Infection or Reactivation After Allogenic HSCT studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 158 type: ESTIMATED measure: Number of participants with CMV infection and reactivation measure: progression-free survival measure: Median overall survival measure: cumulative incidence of relapse measure: non-relapsed mortality measure: GvHD measure: Averse events sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06362707 id: 2023161001 briefTitle: Fasudil Trial for Treatment of Early Alzheimer's Disease (FEAD) acronym: FEAD overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-10-01 date: 2026-10-01 date: 2024-04-12 date: 2024-04-15 name: Helse Stavanger HF class: OTHER_GOV name: University of Exeter briefSummary: The goal of this placebo-controlled double-blind Phase 2 clinical trial is to test in people with early Alzheimer's Disease.

The main questions it aims to answer are:

* Does treatment with fasudil, a ROCK-inhibitor, lead to significant improvement in working memory (based on computer-based working memory composite scores) compared to placebo in individuals with early Alzheimer's disease (AD) over 12 months?
* What is the effect of fasudil treatment for 12 months on other cognitive functions, brain metabolism measured by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET), and other relevant clinical functions and biomarkers in individuals with early Alzheimer's disease (AD)?
* Treatment will be escalated to a maintenance dose of 120 mg total daily dose for up to 50 weeks, with regular clinic visits for efficacy and safety evaluations.
* Assessments will include cognitive tests, FDG-PET scans, and biomarker analyses, with follow-up by the Data and Safety Monitoring Board for ongoing safety review.

The study will compare participants receiving fasudil with those receiving placebo to see if fasudil treatment leads to improvements in cognitive functions, brain metabolism measured by FDG-PET. conditions: Cognitive Decline, Mild conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 200 type: ESTIMATED name: Fasudil name: Placebo measure: Cognition measure: Brain metabolism measure: Plasma levels of ptau217 measure: Plasma levels of nfl measure: Levels of cerebrospinal Aβ1-40 and Aβ1-42 measure: Levels of cerebrospinal tau and p-tau measure: Blood pressure (Safety assessments) measure: Pulse (Safety assessments) measure: Urine testing (Safety assessments) measure: Blood urea nitrogen (BUN) (Safety assessments) measure: Potassium (Safety assessments) measure: Sodium (Safety assessments) measure: Calcium (Safety assessments) measure: Glucose (Safety assessments) measure: Hemoglobin (Safety assessments) measure: Creatinine (Safety assessments) measure: Total and direct bilirubin (Safety assessments) measure: CRP (C-reactive protein) (Safety assessments) measure: Aspartate aminotransferase (AST) (Safety assessments) measure: Serum glutamic-oxaloacetic transaminase (SGOT) (Safety assessments) measure: Alanine aminotransferase (ALT) (Safety assessments) measure: Serum glutamic-pyruvic transaminase (SGPT) (Safety assessments) measure: Alkaline phosphatase (Safety assessments) measure: Electrocardiogram (ECG) (Safety assessments) measure: Columbia Suicide Severity Rating Scale (C-SSRS) (Safety assessments) sex: ALL minimumAge: 50 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06362694 id: 34 briefTitle: Study of the Rechallenge Concept in Patients With BRAF-positive Anaplastic Thyroid Cancer After Progression on Anti-BRAF Therapy overallStatus: RECRUITING date: 2024-03-25 date: 2026-03-25 date: 2026-06-25 date: 2024-04-12 date: 2024-04-12 name: Saint Petersburg State University, Russia class: OTHER briefSummary: This pilot phase 2 study evaluates the effectiveness and safety of the Rechallenge concept in patients with BRAF-positive anaplastic thyroid cancer after progression on anti-BRAF therapy. Patients with BRAF-positive anaplastic thyroid cancer who were previously treated with dabrafenib and trametinib (with a clinical or objective response at the start of treatment) and later with tumor progression during anti-BRAF therapy and subsequent lines of chemotherapy are scheduled to undergo targeted therapy (repeated administration of dabrafenib and trametinib in standard doses) and evaluate the outcomes according to the primary and secondary endpoints. conditions: Anaplastic Thyroid Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Dabrafenib + Trametinib measure: Objective response rate measure: Progression-Free Survival measure: Safety and Tolerability assessment (Incidence of Treatment-Emergent Adverse Events) measure: Overall survival measure: The assessment of conversion to resectability sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Saint Petersburg State University Hospital status: RECRUITING city: Saint Petersburg zip: 190020 country: Russian Federation name: Ernest Dzhelialov role: CONTACT phone: +7(911)134-50-44 email: ernest.dzhelialov@gmail.com lat: 59.93863 lon: 30.31413 hasResults: False

 nctId: NCT06362681 id: CF-2023-I-13 briefTitle: Effects of Different Remineralization Agents on Molar Incisor Hypomineralization Defects: a Randomized Clinical Study overallStatus: RECRUITING date: 2024-03-01 date: 2024-06-30 date: 2026-03-30 date: 2024-04-12 date: 2024-04-12 name: Universidad Nacional Autonoma de Mexico class: OTHER briefSummary: The aim of this study was to present a comparative evaluation of the long-term efficacy of fluoride varnish( Flúor protector), Clinpro™ White Varnish and pastes containing CPP-ACP in the remineralization of creamy-white and yellow brown defects in incisors and permanent first molars with Molar Incisor Hypomineralization (MIH) in schoolchildren 6-12 years-old in Mexico. conditions: Molar Incisor Hypomineralization studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: The children will be randomly divided into the experiment groups: control (oral hygiene motivation only), fluoride varnish, clinpro white Varnish and pastes containing CPP-ACP and followed up for 24 months. primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: using a block randomization technique in which a computer-generated sequence would be used to assign each participant to a particular group in the allocation ratio of 1:1. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Fluoride measure: Mineral Density sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Alvaro Garcia Pérez status: RECRUITING city: San Pedro Apatlaco state: Morelos country: Mexico lat: 18.79306 lon: -98.95972 hasResults: False

 nctId: NCT06362668 id: RCV-0006-EU briefTitle: EU Sites: Fluid Management of Acute Decompensated Heart Failure With Reprieve Decongestion Management System (FASTR-EU) acronym: FASTR-EU overallStatus: NOT_YET_RECRUITING date: 2024-04-09 date: 2024-10-01 date: 2024-12-31 date: 2024-04-12 date: 2024-04-12 name: Reprieve Cardiovascular, Inc class: INDUSTRY briefSummary: The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve DMS system to Optimal Diuretic Therapy (ODT) in the treatment of patients diagnosed with acute decompensated heart failure (ADHF). The main objective is to determine if the Reprieve DMS is non-inferior to state-of-the-art urine sodium guided aggressive diuretic titration in two European HF centers of excellence. conditions: Acute Decompensated Heart Failure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Reprieve Decongestion Management System name: Diuretic (furosemide, bumetanide, torsemide, hydrochlorothiazide, and/or acetazolamide) measure: Total sodium loss (in mmol of sodium) per 24 hours measure: Comparison of occurrence of composite endpoint comprised of clinically significant acute kidney injury, severe electrolyte abnormality, or symptomatic hypotension or hypertensive emergency. measure: Total net fluid volume loss (difference between urine output volume and fluid input volume) per 24 hours measure: Weight loss per 24 hours at end of randomized therapy measure: Time on IV loop diuretic measure: Number of participants with ≥ 0.3 mg/dL increase in serum creatinine sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Center Groningen city: Groningen country: Netherlands name: Kevin Damman, MD role: CONTACT lat: 53.21917 lon: 6.56667 facility: Wroclaw Medical University city: Wrocław country: Poland name: Jan Biegus, MD role: CONTACT lat: 51.1 lon: 17.03333 hasResults: False

 nctId: NCT06362655 id: ANID/FONDECYT 2013/1230801 briefTitle: ACTIBESE Project - Active Behaviour in School Education acronym: ACTIBESE overallStatus: ENROLLING_BY_INVITATION date: 2023-04-01 date: 2023-12-31 date: 2025-12-31 date: 2024-04-12 date: 2024-04-12 name: Pontificia Universidad Catolica de Valparaiso class: OTHER name: Universidad de La Frontera briefSummary: The ACtive BEhaviour in School Education (ACTIBESE) project aims to assess and intervene in Chilean schoolchildren's active behaviours by examining the influence of personal, interpersonal, and school factors. This study includes a cross-sectional and intervention study involving 152 schools in the Valparaíso and Araucanía Regions, representing urban and rural areas. Participants, divided into children (8-11 years old) and adolescents (12-17 years old), will undergo a comprehensive evaluation, including sociodemographic characteristics, physical activity (PA) levels, parental and peer support, teaching styles of the teachers, and school environment characteristics.

For the cross-sectional study, questionnaires, interviews, accelerometry, and pedometry will be used to collect data on various factors influencing PA in schoolchildren. In the intervention study, a 5-month continuous training program for teachers will be implemented, focusing on improving teaching styles and enhancing teaching competencies related to physical education and health classes. The program aims to positively affect schoolchildren's PA indirectly through improved teaching practices.

The research will use mixed models, ANCOVA (Analysis of Covariance) , and logistic regressions for data analysis, incorporating multilevel logistic regressions to account for school-level dependencies. The study's outcomes will contribute valuable insights into the complex interactions between school, interpersonal, and personal factors influencing schoolchildren's PA, aiding the development of targeted interventions. This comprehensive approach aligns with the project's goal of fostering a physically active lifestyle among Chilean schoolchildren. conditions: Physical Inactivity conditions: Child Behavior conditions: Family Support studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention Study primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: No apply count: 144 type: ESTIMATED name: Intervention measure: Physical activity levels sex: ALL minimumAge: 9 Years maximumAge: 17 Years stdAges: CHILD facility: IRyS Group, School of Physical Education, Pontificia Universidad Católica de Valparaíso, Valparaíso, Chile. city: Viña Del Mar state: Valparaiso zip: 2300000 country: Chile lat: -33.02457 lon: -71.55183 hasResults: False

 nctId: NCT06362642 id: PMV-586-105 briefTitle: A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of PC14586 in Healthy Participants overallStatus: RECRUITING date: 2024-03-28 date: 2024-08 date: 2024-12 date: 2024-04-12 date: 2024-04-12 name: PMV Pharmaceuticals, Inc class: INDUSTRY briefSummary: The purpose of this study is to assess the effect of PC14586 pharmacokinetics when co administered with itraconazole in healthy participants. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: The treatments will be: Day 1: single oral dose of PC14586, Day 20: oral dose of itraconazole BID, Day 21-22: single oral dose of itraconazole QD, Day 23: single oral dose of PC14586 and single oral dose of itraconazole, Day 24-27: single oral dose of itraconazole QD. primaryPurpose: OTHER masking: NONE count: 16 type: ESTIMATED name: PC14586 name: Itraconazole measure: Characterize the Maximum Plasma Concentration (Cmax) of PC14586 when co-administered with itraconazole in healthy participants. measure: Characterize the total drug exposure (AUC0-inf) of PC14586 when co-administered with itraconazole in healthy participants. measure: Characterize the time to peak drug concentration (Tmax) of PC14586 when co-administered with itraconazole in healthy participants. measure: Characterize the total drug exposure from time zero to 24 hours (AUC0-24) of PC14586 when co-administered with itraconazole in healthy participants. measure: Characterize the total drug exposure from time zero to the last timepoint (AUC0-t) of PC14586 when co-administered with itraconazole in healthy participants. measure: Characterize the half-life (t1/2) of PC14586 when co-administered with itraconazole in healthy participants. measure: Characterize the Maximum Plasma Concentration (Cmax) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants. measure: Characterize the total drug exposure (AUC0-inf) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants. measure: Characterize the time to peak drug concentration (Tmax) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants. measure: Characterize the total drug exposure from time zero to 24 hours (AUC0-24) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants. measure: Characterize the total drug exposure from time zero to the last timepoint (AUC0-t) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants. measure: Characterize the half-life (t1/2) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants. measure: Identification of the incidence of treatment emergent adverse events (TEAE) of PC14586 when administered alone and co-administered with itraconazole in healthy participants. measure: Identification of vital sign abnormalities after administration of PC14586 alone and when co-administered with itraconazole in healthy participants. measure: Identification of 12-lead electrocardiogram (ECG) abnormalities after administration of PC14586 alone and when co-administered with itraconazole in healthy participants. measure: Identification of laboratory abnormalities based on hematology and clinical chemistry after administration of PC14586 alone and when co-administered with itraconazole in healthy participants. sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Fortrea status: RECRUITING city: Madison state: Wisconsin zip: 53704 country: United States name: Christine Hale, MD role: CONTACT email: Christine.Hale@fortrea.com lat: 43.07305 lon: -89.40123 hasResults: False

 nctId: NCT06362629 id: WCH240407 briefTitle: AI App for Management of Atopic Dermatitis overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2028-12-31 date: 2029-08-31 date: 2024-04-12 date: 2024-04-12 name: West China Hospital class: OTHER briefSummary: Background: Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by recurrent rashes and itching, which seriously affects the quality of life of patients and brings heavy economic burden to society. The Treat to Target (T2T) strategy was proposed to guide optimal use of systemic therapies in patients with moderate to severe AD, and it is emphasized patients' adherence and combined evaluation from both health providers and patients. While effective treatments for AD are available, non-adherence of treatment is common in clinical practice due to the patients' unawareness of self-evaluation and lack of concern about the specific follow-up time points in clinics, which leads to the treatment failure and repeated relapse of AD.

Hypothesis: An Artificial Intelligence assistant decision-making system (AIADMS) with implementation of the T2T framework could help control the disease progression and improve the clinical outcomes for AD.

Overall objectives:

We aim to develop an AIADMS in the form of smartphone app to integrate T2T approach for both clinicians and patients, and design clinical trials to verify the effectiveness and safety of the app. Methods: This project consists of three parts, AI training model for diagnosis and severity grading of AD based on deep learning, development of Artificial Intelligence assistant decision-making system (AIADMS) in the form of app, and design of a randomized controlled trial to verify the effectiveness and safety of AIADMS App for improvement of the clinical outcomes in AD patients.

Expected results: With application of AIADMS based app, the goal of T2T for patients with AD could be realized better, the prognosis could be improved, and more satisfaction could be achieved for both patients and clinicians.

Impact: This is the first AIADMS based app for AD management running through thediagnosis, patients' self-participation, medical follow-up, and evaluation of achievement of goal of T2T. conditions: Atopic Dermatitis conditions: Artificial Intelligence studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 232 type: ESTIMATED name: Artificial Intelligence assistant decision-making system (AIADMS) App measure: The overall efficiency rate of treating objectives including PP-NRS, EASI, SCORAD, POEM, and DLQI at 12 weeks after treatment measure: The seperated efficiency rate of treating objectives including PP-NRS, EASI, SCORAD, POEM, and DLQI measure: The economic consumption measure: Satisfaction evaluation sex: ALL minimumAge: 1 Year maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06362616 id: N23PBD briefTitle: Preoperative Accelerated Partial Breast Irradiation in Patients With Locally Recurrent or Second Primary Breast Cancer acronym: PAPBI-3 overallStatus: RECRUITING date: 2024-04-12 date: 2026-10-11 date: 2027-04-11 date: 2024-04-12 date: 2024-04-18 name: The Netherlands Cancer Institute class: OTHER briefSummary: This study evaluates the acute toxicity and feasibility of repeat breast conserving therapy with preoperative accelerated partial breast re-irradiation (PAPBI) in female patients aged 51 years or older with ipsilateral recurrent or second primary low-risk breast cancer. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 31 type: ESTIMATED name: Preoperative accelerated partial breast irradiation name: Breast conserving surgery name: Sentinel node procedure name: Biopsy track removal measure: Acute post-treatment toxicity measure: Fibrosis/induration measure: Patient-reported Outcome Measures (PROMS): EORTC Quality of Life Questionnaire (QLQ)-C30 measure: Patient-reported Outcome Measures (PROMS): EORTC QLQ-BR23 measure: Patient-reported Outcome Measures (PROMS): Patient's Questionnaire Cosmesis measure: Cosmetic outcome according to the BCCT.core software program sex: FEMALE minimumAge: 51 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Netherlands Cancer Institute status: RECRUITING city: Amsterdam zip: 1066CX country: Netherlands name: Astrid Scholten, MD PhD role: CONTACT phone: +31205129111 email: a.scholten@nki.nl lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06362603 id: FB2022NIH briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-12 date: 2024-04-12 name: [Redacted] hasResults: False

 nctId: NCT06362590 id: LV-SPIND-001 briefTitle: Expanded Access Use of Ladiratuzumab Vedotin in Advanced Solid Tumors overallStatus: AVAILABLE date: 2024-04-12 date: 2024-04-12 name: Seagen Inc. class: INDUSTRY briefSummary: The purpose of this study is to provide the option of Ladiratuzumab Vedotin treatment to eligible patients in studies SGNLVA-005. studyType: EXPANDED_ACCESS name: ladiratuzumab vedotin stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06362577 id: TSC202202 briefTitle: Clinical Study of HIFU for Localized Prostate Cancer acronym: HIFU overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-11-30 date: 2026-12-31 date: 2024-04-12 date: 2024-04-12 name: RenJi Hospital class: OTHER briefSummary: In this study, the safety and effectiveness data of Sonablate system, a transrectal high-intensity focused ultrasound therapeutic instrument, in the treatment of localized prostate cancer were collected, and the treatment conditions of patients with other methods (such as radical prostatectomy) were compared and analyzed. Observe the differences in treatment effect, survival rate, postoperative PSA, recurrence and complications.

To analyze and compare the clinical outcome, postoperative complications and tumor control of HIFU and robot-assisted laparoscopic radical prostatectomy for localized prostate cancer, and to explore the effectiveness and safety of HIFU in the treatment of localized prostate cancer, so as to provide an alternative treatment for localized prostate cancer. conditions: Localized Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: EQ-5D-5L IPSS IIEF-5 EPIC-26 ECOG measure: Incidence of postoperative complications measure: The time to reach the lowest point of PSA measure: Assessment of quality of life and sexual function spontaneously reported at 2, 6, and 12 months after surgery measure: The negative rate of tumor exclusion was evaluated by imaging (mainly mp-MRI) at 2 and 12 months after surgery measure: The incidence of biochemical recurrence that requires remedial or systemic treatment 12 months after surgery measure: Postoperative overall survival rate sex: MALE minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06362564 id: CIPL-LBE-0101 briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA] overallStatus: WITHHELD date: 2024-04-12 date: 2024-04-12 name: [Redacted] hasResults: False

 nctId: NCT06362551 id: INC-GS-2024-002 briefTitle: Oocyte Donor Application Discrepancies overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-25 date: 2024-05 date: 2025-05 date: 2024-04-12 date: 2024-04-12 name: Inception Fertility, LLC class: INDUSTRY name: GeneScreen Counseling, LLC briefSummary: Retrospective observational study comparing information received on Inception Central Donor Recruitment's standardized online egg donor application compared to information reported during a genetic risk assessment consultation with a certified genetic counselor with contracted third party genetic counseling service, GeneScreen. All donor applicants completing a full application with Inception's Central Donor Recruitment and a GRA consultation with GeneScreen will be included. conditions: Infertility studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED measure: Rate of additional information measure: Rate of applicant decline sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Inception Fertility LLC city: Houston state: Texas zip: 77081 country: United States lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06362538 id: MCH-ProCardioPrev briefTitle: The Cardiovascular Prevention Program overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2027-04-15 date: 2027-04-15 date: 2024-04-12 date: 2024-04-16 name: Maria Cecilia Hospital class: OTHER briefSummary: Cardiovascular diseases represent one of the main public health problems being the leading cause of morbidity, disability and mortality. In recent decades, the global prevalence and cardiovascular disease mortality has increased, with 23.6 million annual deaths expected by 2030. In Europe, mortality per year is equal to 2.2 million women and 1.9 million men, representing 47% and 37% of all deaths respectively. In Italy, the situation in terms of deaths due to cardiovascular diseases it is in line with the world ranking and European, being responsible for 44% of all deaths. The only interventional or pharmacological approach is neither effective nor sustainable. The most deaths from cardiovascular diseases are due to atherothrombotic events, which are attributable to a series of risk factors, most of which are modifiable. Turns out itself as a targeted action on these factors with the aim of safeguarding the state of health cardiovascular, may represent the best applicable strategy. It is therefore necessary structure and activate prevention programs aimed at the general population and groups of subjects at higher risk. conditions: Cardiovascular Prevention studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL primaryPurpose: PREVENTION masking: NONE count: 150 type: ESTIMATED name: International Physical Activity Questionnaire name: Six minute walking test name: SF-36, Euro-Qol 5D-5L, Perceived stress scale-10, Pittsburgh Sleep Quality Index, Depression Anxiety Stress scale- 21. name: MEDAS name: Intima-media thickness (IMT) name: Blood sampling name: Stool Sample Culture Test measure: measure of body mass index measure: Adherence to the Mediterranean diet measure: blood test to check cholesterol levels measure: blood pressure measurement measure: blood glucose test sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT hasResults: False

 nctId: NCT06362525 id: 2022-389 briefTitle: Incidence of Episodes of (Dis)Connected Consciousness Among Emergency Patients Admitted in the Resuscitation Room overallStatus: RECRUITING date: 2023-10-09 date: 2025-09-30 date: 2027-09-30 date: 2024-04-12 date: 2024-04-12 name: University of Liege class: OTHER name: Centre Hospitalier Universitaire de Liege briefSummary: This observational study aims to describe the incidence of episodes of disconnected consciousness (including near-death experience (NDE)) and episodes of connected consciousness in patients admitted to the resuscitation room, who survived a critical condition and who meet at least one of these criteria during their stay in the resuscitation room: (1) deep sedation, (2) intubation, (3) cardiopulmonary resuscitation, or (4) (non-drug-induced) Glasgow Coma Scale score = 3. We also investigate the potential (neuro)physiological markers and biomarkers. In order to help determine the potential risk factors of such episodes, cognitive factors such as dissociative propensity are also investigated. Unexpected visual and auditory stimuli will be displayed. In addition, we assess the evolution of memory, as well as short- and long-term consequences on quality of life, anxiety, and attitudes towards care.

Memory of patients who did not meet the above-mentioned criteria are also investigated. A group of 15 healthy participants will be invited to test the stimuli display.

Finally, (neuro)physiological parameters of a subsample of dying patients are also investigated. conditions: Critical Illness conditions: Near-Death Experience conditions: Consciousness, Loss of conditions: Quality of Life conditions: Emergencies studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Detection of potential episodes of disconnected consciousness measure: Detection of potential episodes of connected consciousness measure: Risk factors measure: Quality of life assessment measure: Memory content and evolution assessment measure: Detection of post-traumatic stress disorder (PTSD) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU of Liège status: RECRUITING city: Liège zip: 4000 country: Belgium lat: 50.63373 lon: 5.56749 hasResults: False

 nctId: NCT06362512 id: Marco_PANG_2024 briefTitle: Cognitive-motor Exercise for Stroke Patients in Function, Cognition and Related Brain Changes. acronym: COGMOTION overallStatus: RECRUITING date: 2024-04 date: 2026-04 date: 2026-04 date: 2024-04-12 date: 2024-04-16 name: The Hong Kong Polytechnic University class: OTHER briefSummary: The purpose of this study is to evaluate a cognitive-motor exercise on dual-task interference during dual-task ankle movement and the corresponding alterations of brain activity. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: After stratification according to gender and walking speed, the participants will be randomly allocated to one of three groups: (1) dual-task training, (2) single-task training, and (3) control intervention, using a 1:1:1 allocation ratio. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: This will be a single-blinded randomized controlled trial . The assessor will be blinded during assessments. The participants and investigators (trainers) are not possible to be blinded as it is an exercise intervention. whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: Dual-task training name: Single-task training name: Upper limb strengthening exercise measure: Dual-task step frequency measure: Dual-task cognitive performance accuracy measure: Blood oxygenation level changes of the brain measure: Single-task walking speed measure: Dual-task walking performance measure: Mini Balance Evaluation Systems Test measure: Activities-specific Balance Confidence Scale measure: Trail Making Test measure: Digit Span Test measure: Montreal Cognitive Assessment measure: Fall incidence measure: Dual-task ankle movement degree measure: Dual-task cognitive performance time sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Hong Kong Polytechnic University status: RECRUITING city: Hong Kong zip: 000000 country: China name: Marco Yiu Chung Pang, PhD role: CONTACT lat: 22.39407 lon: 114.13737 hasResults: False

 nctId: NCT06362499 id: 01 briefTitle: Effects of Unsupervised Inspiratory Muscle Training on Ventilation Variability in Post-covid-19 Patients. overallStatus: RECRUITING date: 2024-04-01 date: 2024-07-31 date: 2024-07-31 date: 2024-04-12 date: 2024-04-17 name: Universidade Federal do Rio Grande do Norte class: OTHER briefSummary: Dysfunctional breathing and persistent hypocapnia can be associated with many of the symptoms experienced by patients such as dyspnea, fatigue, chest pain and palpitations. The identification of dysfunctional breathing and hypocapnia in these patients is important as it may represent a target for treatment.

In many of these patients, tachypnea at low levels of exertion suggests increased respiratory muscle activity, which can lead to the sensation of dyspnea. Sympathetic hyperactivity leads to excessive and irregular ventilation during exercise. In this way, inspiratory muscle training can improve symptoms (dysfunctional breathing), possibly by attenuating the metaboreflex (vagal modulation-attenuation of the sympathetic response) of the inspiratory muscle in post-covid-19 subjects, reducing ventilatory variability. conditions: COVID-19 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Experimental Group measure: Ventilation variability and ventilation efficiency measure: Respiratory muscle strength measure: Pulmonary function measure: Quality of life - Medical Outcomes Study 36-Item Short Health Form Survey (SF-36) measure: Peripheral muscle strength measure: Functional capacity measure: Adverse effects and adherence sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Federal University of Rio Grande do Norte status: RECRUITING city: Natal state: Rio Grande Do Norte zip: 59082-100 country: Brazil name: Gabriely Azevêdo role: CONTACT phone: 84999390004 email: gabrielyazevedo.ga@gmail.com name: Patrícia Nogueira role: CONTACT lat: -5.795 lon: -35.20944 facility: Patrícia Nogueira status: RECRUITING city: Natal state: Rio Grande Do Norte country: Brazil name: Patrícia Nogueira role: CONTACT name: Gabriely Azevêdo role: CONTACT phone: 5584999390004 email: gabrielyazevedo.ga@gmail.com lat: -5.795 lon: -35.20944 hasResults: False

 nctId: NCT06362486 id: SIGNATURE briefTitle: Stress in Pregnancy During the Covid19 Pandemic and Impact on the Newborn Neurodevelopment overallStatus: ACTIVE_NOT_RECRUITING date: 2021-08-01 date: 2023-08-01 date: 2024-08-01 date: 2024-04-12 date: 2024-04-12 name: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla class: OTHER briefSummary: The Covid19 pandemic, paradoxically, represents a valuable opportunity to carry out cohort studies that allow us to advance our knowledge about the relationship between inflammation, brain development and an increased risk of suffering from neuropsychiatric disorders or alterations. In addition, the current availability of sophisticated biological techniques and evaluation procedures represents an unique option for this purpose.

Here, we propose a cohort study of sars-cov-2 (type 2 coronavirus causing severe acute respiratory syndrome) infected pregnant women and newborns. We will try to answer the following questions: (i) what is the inflammatory / immune status of newborns (NBs) of mothers infected by Covid19 like?; (ii) is there a relationship between the clinical characteristics of the maternal infection (severity / moment / of infection) and the inflammatory status of the newborn?; (iii) could these features increase the vulnerability to developing central nervous system (CNS) alterations at an early age, and at some point during adult life ?; (iv) How is the Covid19 infected mother's placenta altered? Do the placental alterations Covid19 mediated contribute to develop CNS alterations?; (v) is the infection associated with phenotypes obtained through neurological and neurodevelopmental clinical evaluation (hypotonia, clumsiness, impaired communication and sociability) in children at 6 months and 12 months?

Our main objective is to explore how the presence of stressors and prenatal sars-cov-2 infection generates an abnormal inflammatory activity in the newborn, which is associated with neurodevelopmental disorders and which confers a greater risk of developing neuropsychiatric disorders. The biological information of the umbilical cord (fetus blood) and peripheral blood of the mother obtained after childbirth was provided by the cohort of women during the Covid19 pandemic monitored during their pregnancy, delivery, childbirth and postpartum. These samples and the clinical characterisation of the cohort of mothers and newborns, of which we will be able to do an exhaustive longitudinal follow-up, are tremendously valuable at this time. There is a need to establish new research strategies to understand the pathophysiology of neuropsychiatric diseases, and to discover new molecular and cellular mechanisms involved in the development of the CNS. conditions: Covid19 and Pregnancy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED name: Severity of infection, time of infection. name: Mental health assessment name: biological measure: explore how the presence of stressors and prenatal sars-cov-2 infection generates an abnormal inflammatory activity in the newborn sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Universitario Virgen del Rocío city: Sevilla zip: 41013 country: Spain lat: 37.38283 lon: -5.97317 hasResults: False

 nctId: NCT06362473 id: LIPIGEN-001 briefTitle: Lipid Transport Disorder Italian Genetic Record (LIPIGEN) acronym: LIPIGEN overallStatus: RECRUITING date: 2015-08-04 date: 2026-09-30 date: 2026-09-30 date: 2024-04-12 date: 2024-04-12 name: Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi) class: OTHER briefSummary: LIPIGEN is an observational study involving Italian physicians and researchers in the field of diseases related to blood lipid levels. This study aims to improve the diagnosis and treatment of people with familial dyslipidaemias, including very common conditions such as familial hypercholesterolaemia (FH) and less common ones such as familial chylomicronidaemic syndrome (FCS).

What does the study do?

It collects information on Italian patients with Familial Hypercholesterolaemia (FH), following them in their normal clinical examination without adding extra procedures.

It uses the data collected to further our understanding of diseases such as familial hypercholesterolaemia, examining how it is diagnosed clinically and by genetic testing, and evaluating the effectiveness of different treatments.

It seeks to identify the genetic mutations that cause familial hypercholesterolaemia and other dyslipidaemias, helping to choose the most effective treatments.

It evaluates the impact of long-term treatments and patient adherence to medication, as well as monitoring the incidence of cardiovascular events and other important outcomes.

Who can participate?

The study is aimed at people of all ages, from children to adults, with familial hypercholesterolaemia or other genetic dyslipidaemia.

More than 50 centres throughout Italy are involved, making the study accessible to many.

What does participation entail?

Participants will continue with their normal clinical practice.

Data such as family history, personal clinical findings and genetic information will be collected, without additional procedures.

For some, further evaluations, such as ultrasounds, may be required to better study their condition.

The LIPIGEN study not only helps to better understand diseases related to high cholesterol but also aims to improve patients\&#39; lives through more precise diagnosis and personalised treatments. conditions: Familial Hypercholesterolemia conditions: Genetic Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 10000 type: ESTIMATED name: Lipid-lowering treatments measure: Lipid profile of patients with genetic dyslipidemia measure: Genetic profile of patients with genetic dyslipidemia sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Multimedica status: RECRUITING city: Sesto san Giovanni state: Milano zip: 20099 country: Italy name: Fabio Pellegatta, MD role: CONTACT phone: 00390224209593 email: lipigen@sisa.it name: Fabio Pellegatta, MD role: PRINCIPAL_INVESTIGATOR lat: 45.53329 lon: 9.22585 hasResults: False

 nctId: NCT06362460 id: RAY1216-23-03 briefTitle: Mass Balance Study of [14C]RAY1216 in Healthy Adult Male Subjects in China overallStatus: COMPLETED date: 2023-09-18 date: 2023-11-01 date: 2023-11-15 date: 2024-04-12 date: 2024-04-16 name: Guangdong Raynovent Biotech Co., Ltd class: INDUSTRY briefSummary: This study is a single-center, open-label, and single-dose clinical study to evaluate the mass balance, biotransformation and pharmacokinetics of \[14C\]RAY1216 in healthy Chinese male participants, revealing the overall pharmacokinetic characteristics of RAY1216. conditions: Pharmacokinetics studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 6 type: ACTUAL name: [14C] RAY1216 measure: Total radioactivity in plasma PK measure: Total radioactivity in plasma PK measure: Total radioactivity in plasma PK measure: Total radioactivity in plasma PK measure: Mass balance recovery of total radioactivity in all (urine, faeces) amount excreted (Ae) expressed as a percentage of the administered dose (%Ae) measure: Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: The First Affiliated Hospital of Bengbu Medical College city: Bengbu country: China lat: 32.94083 lon: 117.36083 hasResults: False

 nctId: NCT06362447 id: RC31/22/0320 briefTitle: Efficacy of Injectable Gentamicin in Hereditary Ichthyosis acronym: GENTIC overallStatus: NOT_YET_RECRUITING date: 2024-04-23 date: 2026-04-01 date: 2027-04-01 date: 2024-04-12 date: 2024-04-12 name: University Hospital, Toulouse class: OTHER briefSummary: This study will evaluate the efficacy and safety of intravenous gentamicin in congenital ichthyosis due to a non-sens mutation. The primary objective is the severity of scales and erythema at the third month, compared to baseline. Secondary objectives will include: the importance of itching, trans epidermal water loss, cutaneous expression of the targeted protein, the security of the drug and patients' satisfaction. conditions: Ichthyosis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 26 type: ESTIMATED name: Gentamicin Injectable Solution measure: Gentamicin efficacity measure: Gentamicin efficacity measure: Gentamicin efficacity on quality of life sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Saint-Louis APHP city: Paris zip: 75010 country: France name: BOURRAT Emmanuelle, MD role: CONTACT phone: 01 42 49 90 90 phoneExt: 33 email: emmanuelle.bourrat@aphp.fr lat: 48.85341 lon: 2.3488 facility: CHU de Toulouse city: Toulouse zip: 31059 country: France name: SEVERINO-FREIRE Maella, MD role: CONTACT phone: 05 67 77 81 41 phoneExt: 33 email: severino-freire.m@chu-toulouse.fr name: TEXIER Hélène role: CONTACT phone: 05 67 77 81 80 phoneExt: 33 email: texier.h@chu-toulouse.fr name: MAZEREEUW-HAUTIER Juliette, MD, PhD role: SUB_INVESTIGATOR lat: 43.60426 lon: 1.44367 hasResults: False

 nctId: NCT06362434 id: UHN-HHREHAB-24-xxxx briefTitle: Visual Telerehabilitation in Children, Adolescents and Young Adults With Hemianopsia Consecutive to a Brain Tumour acronym: HHREHAB overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2027-06-01 date: 2027-06-01 date: 2024-04-12 date: 2024-04-12 name: University Health Network, Toronto class: OTHER name: Alberta Children's Hospital name: St. Justine's Hospital name: The Hospital for Sick Children name: British Columbia Children's Hospital briefSummary: Brain malignancies are the most common cause of death from cancer in the pediatric population and a major source of morbidity amongst survivors. Many children with a brain tumour often suffer from visual field defects (hemianopia) dramatically impacting their daily life with poorer social interaction, difficulties learning, playing sports and engaging with peers. Practically, they bump into people and objects and have problems in finding their way in unfamiliar places and in detecting incoming objects in their blind field. There is growing recognition of the diverse and deep impact of hemianopia on physical and mental health, quality of life, and social outcomes of the affected individuals and their family. However, despite the frequent impact of brain tumours on the visual function and functional vision, ophthalmologic evaluations are not standard of care for all brain tumour patients and there are no standardized protocols of vision loss management in the pediatric population with hemianopia. There is an unmet need of restoring perception in the blind field in individuals with hemianopia consecutive to pediatric brain tumor.

Our laboratory has developed a visual rehabilitation procedure based on the combination of adaptative audio and visual target tracking in a 3D environment in virtual reality. Participants perform audiovisual stimulation at home in a headset, with remote control from the laboratory. Preliminary on data on paediatric patients with hemianopia consecutive to a brain tumour indicate feasibility and potential effectiveness of a 6-week Re:Vision program on visual fields, visual perception and quality of life.

Our objective is to evaluate the effectiveness of Re:Vision, an 8-week visual telerehabilitation program, on visual perception in 50 individuals aged 10-40 years old with hemianopia consecutive to a pediatric brain tumor in a phase IIa/b multi-centric clinical study across Canada.

This intervention provides more equitable access to individuals, with the ability to receive rehabilitation therapy at home without supervision by a healthcare professional, meaning that Canadians living outside urban centres could take advantage of specialized therapies with remote supervision. This is the first study that could lead to a major change in the management of these patients. It could open the door for visual rehabilitation strategies to other population of visually impaired children, significantly impacting public health strategies. conditions: Hemianopsia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Audiovisual stimulation measure: Binocular Visual Field measure: Patient-related Outcome Measures - National Eye Institute - Visual Function Questionnaire - 25 measure: Patient-related Outcome Measures - World Health Organization - Quality of Life questionnaire - BREF measure: Reading Speed measure: Fixation Stability measure: Contrast Sensitivity measure: Brain Activity - Visually-evoked potentials measure: Retinal Integrity measure: Brain imaging - Tractography measure: Brain imaging - Retinotopy measure: Head tracking measure: Eye tracking sex: ALL minimumAge: 10 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Alberta Children's Hospital city: Calgary state: Alberta zip: T3B 6A8 country: Canada name: Lucie Lafay-Cousin, MD role: CONTACT phone: 403-955-7272 email: llafayco@ucalgary.ca name: Lucie Lafay-Cousin, MD role: PRINCIPAL_INVESTIGATOR lat: 51.05011 lon: -114.08529 facility: British Columbia Children's Hospital city: Vancouver state: British Columbia zip: V6H 3N1 country: Canada name: Sylvia Cheng, MD role: CONTACT phone: 604-875-2406 email: sylvia.cheng@cw.bc.ca name: Sylvia Cheng, MD role: PRINCIPAL_INVESTIGATOR lat: 49.24966 lon: -123.11934 facility: The Hospital for Sick Children city: Toronto state: Ontario zip: M5G 1E8 country: Canada name: Eric Bouffet, MD role: CONTACT phone: 416-813-7500 email: eric.bouffet@sickkids.ca name: Eric Bouffet, MD role: PRINCIPAL_INVESTIGATOR name: Uri Tabori, MD role: SUB_INVESTIGATOR name: Inci Yaman Bajin, MD role: SUB_INVESTIGATOR lat: 43.70011 lon: -79.4163 facility: Centre Hospitalier Universitaire Sainte-Justine city: Montreal state: Quebec zip: H3T 1C5 country: Canada name: Sebastien Perreault, MD role: CONTACT phone: 514-345-2372 email: s.perreault@umontreal.ca name: Sebastien Perreault, MD role: PRINCIPAL_INVESTIGATOR lat: 45.50884 lon: -73.58781 facility: CHU de Québec city: Québec state: Quebec zip: G1J 1Z4 country: Canada name: Valerie Larouche, MD role: CONTACT phone: 418-654-2282 email: valerie.larouche@fmed.ulaval.ca name: Valerie Larouche, MD role: PRINCIPAL_INVESTIGATOR lat: 46.81228 lon: -71.21454 hasResults: False

 nctId: NCT06362421 id: ONC-HN-2402 briefTitle: Saliva Testing for High-Risk Human Papillomavirus Infection Oral Cavity and Pharynx Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-06 date: 2026-07 date: 2024-04-12 date: 2024-04-12 name: Wake Forest University Health Sciences class: OTHER name: InnoTech Precision Medicine briefSummary: The purpose of this research study is to determine if saliva and oral swab samples can be used to detect human papillomavirus in patients with cancer. In this study, the methods required to detect human papillomavirus will be developed and tested in samples collected from patients with oropharyngeal squamous cell carcinoma and compared to samples collected from participants without cancer. conditions: Oropharyngeal Squamous Cell Carcinoma conditions: Human Papillomavirus Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Pre-Radiation Dental Evaluation/Sample Collection name: Pre-Study Visit name: Oral Medicine Consultation Visit/Sample Collection measure: Number of Participants with Sensitivity for Detection of HPV 16, 18 and gene ACTB measure: Number of Participants with Specificity Detection of HPV 16, 18 and gene ACTB measure: Overall Accuracy - All Participants sex: ALL minimumAge: 39 Years maximumAge: 59 Years stdAges: ADULT facility: Hayworth Cancer Center city: High Point state: North Carolina zip: 27262 country: United States name: Study Coordinator role: CONTACT phone: 336-713-1790 email: cbynum@wakehealth.edu lat: 35.95569 lon: -80.00532 facility: Atrium Health Wake Forest Baptist Comprehensive Cancer Center city: Winston-Salem state: North Carolina zip: 27157 country: United States name: Study Coordinator role: CONTACT phone: 336-713-1790 email: cbynum@wakehealth.edu name: Muhammad A Shazib, DMD role: PRINCIPAL_INVESTIGATOR lat: 36.09986 lon: -80.24422 hasResults: False

 nctId: NCT06362408 id: PLAGH-DEX-PSM/IPTW-001 briefTitle: Effect of Dexmedetomidine on Postoperative Mental Disorders and Long-term Survival in Elderly Patients overallStatus: COMPLETED date: 2022-06-01 date: 2023-05-25 date: 2023-06-01 date: 2024-04-12 date: 2024-04-12 name: Chinese PLA General Hospital class: OTHER name: Beijing Tiantan Hospital name: First Affiliated Hospital of Guangxi Medical University name: The Affiliated Hospital Of Guizhou Medical University name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School name: Wuhan Union Hospital, China name: Fudan University briefSummary: China's aging population is causing an increase in the number of senior persons undergoing surgery. More and more clinicians are paying attention to the postoperative survival and mental health of elderly surgical patients.

Dexmedetomidine (DEX) is an alpha-2 adrenergic agonist that works by inhibiting norepinephrine releasing renaline, which reduces inflammation and thus plays a protective role in the central nervous system. DEX has the potential to prevent and treat postoperative anxiety and depression in elderly patients undergoing non-cardiac surgery.

Further exploration of evidence for evidence-based medicine is needed. Based on the above research background, this hypothesis is proposed: in elderly patients undergoing noncardiac surgery, intraoperative DEX is associated with a reduction in short-term postoperative mental disorders and a reduction in long-term postoperative mortality. conditions: Cohort Studies studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 6000 type: ACTUAL name: Dexmedetomidine measure: Postoperative mortality rate measure: The incidence of postoperative delirium measure: The incidence of postoperative anxiety measure: The incidence of postoperative depression measure: Postoperative sleep disorders measure: Surgical related complications measure: Postoperative quality of life evaluation sex: ALL minimumAge: 65 Years maximumAge: 110 Years stdAges: OLDER_ADULT facility: Chinese PLA General Hospital city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06362395 id: 24-5022 briefTitle: Ultra-high Dose Radiation for Liver Metastasis Using MR-guided TReatment With Stereotactic Ablative Single-fraction acronym: ULTRAS overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2030-06 date: 2030-06 date: 2024-04-12 date: 2024-04-12 name: University Health Network, Toronto class: OTHER briefSummary: This international multi-centre phase 3 randomized control trial investigates whether giving a very high dose of radiation in a single treatment session (ultra-high dose: experimental) using advanced technology called MR-Linac is more effective than a high dose (control) for treating liver tumors that have spread from other parts of the body (liver metastases). This study also aims to identify predictors of treatment response and side effects by analyzing various factors such as imaging markers and genetic profiles.

Liver metastases are common in several cancers, but surgery is often not feasible for many patients. Stereotactic body radiotherapy (SBRT), which delivers focused radiation to tumors, is an alternative treatment option. Previous studies have shown promising results with SBRT, but the optimal radiation dose for liver metastases is still uncertain.

This study will look at patients with specific types of primary cancers known to respond well to SBRT. Treatment effectiveness will be assessed by monitoring tumor control, overall survival, and quality of life.

By comparing ultra-high dose SBRT with standard high dose, the study aims to determine if the former can provide better tumor control with fewer side effects. If successful, this approach could offer a significant advancement in the treatment of liver metastases, potentially improving outcomes and quality of life for patients. conditions: Liver Metastases studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 114 type: ESTIMATED name: Magnetic resonance (MR)-guided stereotactic ablative single-fraction (SBRT) measure: Local control (LC) of treated target lesion compared to high dose MR-guided stereotactic single-fraction radiation. measure: Overall survival (OS) measure: Progression free survival (PFS) measure: Intra-hepatic progression measure: Widespread progression. measure: Physician-assessed toxicities: National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) V.5. measure: Patients-reported toxicity: Patient Reported Outcomes - Common Terminology Criteria of Adverse Events (PRO CTCAE) V.1. measure: Quality of life (QOL): European Organization for Research and Treatment of Cancer Quality of Life Questionnaires, Core 15 for Palliative Care (EORTC QLQ-C15-PAL) measure: Quality of life (QOL): European Organization for Research and Treatment of Cancer Quality of Life Questionnaires, liver metastases (EORTC QOQ-LM21). measure: Changes in the levels of circulating biomarkers (cell-free tumor DNA) in response to SBRT. measure: Changes in the levels of circulating biomarkers (cytokines) in response to SBRT. measure: Changes in the levels of circulating biomarkers (metabolites) in response to SBRT. measure: Changes in the levels of circulating biomarkers (immune cell populations) in response to SBRT. measure: Identification of MR imaging biomarkers in response to SBRT. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06362382 id: 2024-zxm-01 briefTitle: Mobile Internet-based Remote Home Rehabilitation Improves Prognostic Function and Life Quality in Pulmonary Hypertension overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2026-04-22 date: 2026-05-01 date: 2024-04-12 date: 2024-04-12 name: China-Japan Friendship Hospital class: OTHER briefSummary: The goal of this clinical trial is to learn the effectiveness of remote home-based exercise rehabilitation using mobile Internet technology for patients with pulmonary hypertension，especically providing early and mid-term results of its effectiveness. The main questions it aims to answer are:

Dose tele-rehabilitation training improves prognostic function and quality of life in patients with pulmonary hypertension？ Researchers will compare tele-rehabilitation training group to a control group (receive health propaganda and education, and then follow their daily routine after discharge from the hospital) to see if tele-rehabilitation training works to improve prognosis.

Participants will:

During their stay in the hospital, the patients of tele-rehabilitation training group were accompanied by a rehabilitation trainer and a psychotherapist for a complete cycle of (7 days ± 3 days 1 week/times) standardized training. The scheme of rehabilitation is impedance training. A specialized professional team including cardiologists, rehabilitation trainers, psychotherapists and radiologists were involved. After discharge from the hospital, patients in the rehabilitation group underwent 3-5 weekly daily training sessions and intensive supervision and management by the online community at least once a week.

Visit the clinic at the 3rd month of the study. Extended follow-up up to 6 months may be considered if patients are cooperative and could complete the training program in the first 3 months. conditions: Pulmonary Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: tele-rehabilitation training name: health propaganda and education measure: changes in 6MWD after 3 months measure: changes in muscle mass after 3 months measure: peak VO2 measure: VO2peak% measure: VE/VCO2 slope measure: PET CO2 measure: Changes in muscle mass evaluated by CT measure: Changes in grip strength measure: the time for 5 sit-to-stand test measure: Quality of life measured by SF-36 after 3 months measure: Quality of life measured by SF-36 after 6 months measure: Quality of life measured by emPHasis-10 after 3 months measure: Quality of life measured by emPHasis-10 after 6 months measure: Changes in WHO Cardiac Function Classification measure: Change in NT-proBNP measure: Change in TAPSE by cardiac doppler ultrasound measure: Changes in hemodynamic indice after 6 months measure: Changes in sleep quality score after 3 months measure: Changes in sleep quality score after 6 months measure: Changes in psychosocial score after 3 months measure: Changes in psychosocial score after 6 months measure: All-cause mortality in 3 months measure: All-cause mortality in 6 months measure: The occurrence rate of primary events in pulmonary hypertension in 3 months measure: The occurrence rate of primary events in pulmonary hypertension in 6 months sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Fuwai Hospital city: Beijing state: Beijing zip: 100037 country: China name: Xiaoming Zhou, MD role: CONTACT phone: +86 88396992 email: zhouxmcmu@163.com name: Xiaoming Zhou, MD role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06362369 id: 7HP-111 briefTitle: A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2027-12-31 date: 2028-12-31 date: 2024-04-12 date: 2024-04-12 name: 7 Hills Pharma, LLC class: INDUSTRY briefSummary: This study is an open-label Phase Ib (Part A) dose escalation followed by a blinded, randomized, multi cohort Phase 2a (Part B) comparison of combination vs. reference regimens.

Currently study will only be enrolling the Phase 1b and the Phase 2a protocol requirements will be added to the study near completion of the Phase 1b conditions: Advanced Cancer conditions: Advanced Solid Tumor conditions: Melanoma conditions: Metastasis conditions: Pleural Mesothelioma conditions: Renal Cell Carcinoma conditions: MSI-High conditions: Mismatch Repair Deficiency conditions: Colorectal Cancer conditions: Hepatocellular Carcinoma conditions: Hepatocellular Cancer conditions: Renal Cell Cancer conditions: Kidney Cancer conditions: Skin Cancer conditions: Non Small Cell Lung Cancer conditions: NSCLC conditions: Anaplastic Lymphoma Kinase Genomic Tumor Aberrations conditions: ALK Genomic Tumor Aberrations studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE maskingDescription: Phase 1b - Open Label count: 126 type: ESTIMATED name: Alintegimod name: Ipilimumab name: Nivolumab measure: Number of participants treated with Alintegimod monotherapy with treatment related adverse events as assessed by CTCAEv5.0 measure: Number of participants treated with Alintegimod in combination with treatment related adverse events as assessed by CTCAEv5.0 measure: Define RPTDs for Alintegimod measure: Characterize Pharmacokinetics of Alintegimod monotherapy by measuring Maximum Plasma Concentration (Cmax) measure: Characterize Pharmacokinetics of Alintegimod monotherapy by measuring Area Under the Curve (AUC) measure: Characterize Pharmacokinetics of Alintegimod plus ipilimumab by measuring Maximum Plasma Concentration (Cmax) measure: Characterize Pharmacokinetics of Alintegimod plus ipilimumab by measuring Area Under the Curve (AUC) measure: Determine Progression Free Survival (PFS) response in patients treated with Alintegimod plus ipilimumab followed by nivolumab using RECIST v1.1 tumor assessment criteria. measure: Determine Overall Response Rate (ORR) in patients treated with Alintegimod plus ipilimumab followed by nivolumab using RECIST v1.1 response assessment criteria. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Florida Cancer Specialists city: Lake Mary state: Florida zip: 32746 country: United States name: Study Coordinator role: CONTACT phone: 407-804-6133 name: Alexander Philipovskiy, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 28.75888 lon: -81.31784 facility: Dartmouth Hitchcock city: Lebanon state: New Hampshire zip: 03756 country: United States name: Study Coordinator role: CONTACT phone: 603-650-6345 name: Konstantin H Dragnev, MD role: PRINCIPAL_INVESTIGATOR lat: 43.64229 lon: -72.25176 facility: MD Anderson Cancer Center city: Houston state: Texas zip: 77030 country: United States name: Study Coordinator role: CONTACT phone: 713-792-4259 name: Apostolia-Maria Tsimberidou, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 29.76328 lon: -95.36327 hasResults: False

 nctId: NCT06362356 id: 24-106 briefTitle: Microbial Metabolites and Outcomes of Pregnancy Study acronym: MMOPS overallStatus: RECRUITING date: 2024-03-05 date: 2026-12-31 date: 2026-12-31 date: 2024-04-12 date: 2024-04-18 name: The Cleveland Clinic class: OTHER briefSummary: Emerging data connect diet, the gut microbiota and its metabolites in cardiometabolic disease. Hypertensive disorders of pregnancy (HDP) are common and are a leading cause of maternal and neonatal morbidity. HDP likely share similar pathophysiology as cardiometabolic disease in non-pregnant people with a yet unrevealed role of diet and the gut microbiota, including systemic inflammation and endothelial dysfunction.

Despite high biological plausibility that nutrition, the gut microbiota and its metabolites may play a role in health and disease in pregnancy, there is a paucity of data regarding these associations, thus limiting advancement of the field. Similar to the proposed pathogenesis for diet, gut microbiota and the microbial metabolite trimethylamine-N-oxide (TMAO) in cardiovascular disease, we hypothesize that the interplay between maternal diet, the gut microbiota and its associated microbial metabolites play a mechanistic role in HDP. We propose to test this hypothesis in a racially-diverse US cohort to determine association with adverse pregnancy outcomes, specifically future development of HDP. We propose to prospectively collect plasma and urine TMAO throughout pregnancy from a cohort of 200 pregnant participants.

Through 1) characterizing plasma and urine TMAO levels across each trimester of pregnancy, and 2) assessment of this microbial metabolite as a predictor of development of HDP, we have the potential to identify a biomarker that would allow us to identify people at risk of HDP early in pregnancy and provide new opportunities for therapeutic interventions to improve maternal and neonatal outcomes. conditions: Hypertensive Disorder of Pregnancy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: TMAO level measure: TMAO level measure: TMAO level sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Cleveland Clinic status: RECRUITING city: Cleveland state: Ohio zip: 44195 country: United States name: Cara Dolin, M.D. role: CONTACT phone: 440-312-2229 email: dolinc@ccf.org lat: 41.4995 lon: -81.69541 hasResults: False

 nctId: NCT06362343 id: PUMCH-Rivaroxaban-Monitoring briefTitle: The Study of Monitoring and Dosing Guidance of Direct Oral Anticoagulants Based on Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics overallStatus: RECRUITING date: 2024-01-01 date: 2026-10-30 date: 2027-01-30 date: 2024-04-12 date: 2024-04-12 name: Peking Union Medical College Hospital class: OTHER name: Ruijin Hospital name: Xiangya Hospital of Central South University name: China-Japan Friendship Hospital briefSummary: 1. Integrate pharmacokinetic-pharmacodynamic (PK-PD) modeling and pharmacogenomics techniques to develop a population PK-PD model, aiming to explore monitoring and dose guidance schemes for Direct Oral Anticoagulants (DOACs).
2. Investigate the factors influencing PK-PD of DOACs in the pulmonary embolism population, clarifying the correlation between genotype characteristics and clinical outcomes.
3. Explore the correlation between drug concentrations, coagulation indices, and clinical outcomes of DOACs, defining the indications for DOACs testing and the overall monitoring process. conditions: Pulmonary Embolism studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Rivaroxaban measure: Bleeding events measure: Recurrent thromboembolic events sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: Juhong Shi, M.D role: CONTACT phone: +8613701178492 email: shijh@pumch.cn name: Min Peng, M.D role: CONTACT phone: +8613581888792 email: pengmin@pumch.cn lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06362330 id: 2022-SR-471 briefTitle: Multi-parametric MRI in Patients of Bladder Cancer overallStatus: RECRUITING date: 2021-07-01 date: 2024-05-30 date: 2024-06-30 date: 2024-04-12 date: 2024-04-12 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: Accurate preoperative detection of muscle-invasive bladder cancer remains a clinical challenge. The investigators aimed to develop and validate a knowledge-guided causal diagnostic network for the detection of muscle-invasive bladder cancer with multiparametric magnetic resonance imaging(MRI). conditions: Muscle-invasive Bladder Cancer conditions: Artificial Intelligence studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED name: magnetic resonance imaging measure: Muscle-invasive bladder cancer measure: Non-muscle-invasive bladder cancer sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Yu-Dong Zhang status: RECRUITING city: Nanjing zip: 210029 country: China name: Yu-Dong Zhang, MD;PHD role: CONTACT phone: 15805151704 email: njmu_zyd@163.com lat: 32.06167 lon: 118.77778 hasResults: False

 nctId: NCT06362317 id: K5247 briefTitle: Toripalimab With or Without Lenvatinib or Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer overallStatus: RECRUITING date: 2024-03-06 date: 2025-03-06 date: 2026-03-06 date: 2024-04-12 date: 2024-04-12 name: Peking Union Medical College Hospital class: OTHER briefSummary: Explore the impact of the first-line application of Toripalimab with or without Lenvatinib or chemotherapy, on the survival, disease progression, and drug safety of patients with advanced biliary tract cancers conditions: Biliary Tract Neoplasms Immunotherapy studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Toripalimab name: Lenvatinib name: Gemox Chemotherapy（Gemox or GC） measure: Objective response rate (ORR) measure: Disease control rate (DCR) measure: Progression-free survival (PFS) measure: Overall survival measure: Duration of response measure: Clinical benefit rate sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Chinese Academy of Medical Sciences & Peking Union Medical College Hospital (CAMS&PUMCH) status: RECRUITING city: Beijing state: Beijing zip: 100005 country: China name: Haitao Zhao, Professor role: CONTACT phone: +861069156042 email: zhaoht@pumch.cn lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06362304 id: 2024-DG-01 briefTitle: 99mTc-CNDG SPECT/CT in Brain Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-02 date: 2025-04 date: 2024-04-12 date: 2024-04-12 name: Peking Union Medical College Hospital class: OTHER briefSummary: The goal of this clinical trial is to evaluate the value of 99mTc-CNDG for diagnosis of brain tumors by comparing it with 18F-FDG-PET. The main questions it aims to answer are:

1. What is the diagnostic consistency between 99mTc-CNDG and 18F-FDG?
2. What is the correlation between the SUVmax value of 99mTc-CNDG and tumor type?

Participants will:

Receive18F-FDG-PET and 99mTc-CNDG examination within 2 weeks before surgery. Obtain pathological diagnosis by surgery or biopsy as the gold standard. conditions: Intracranial Tumor studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ESTIMATED name: 99mTc-CNDG SPECT/CT measure: SUVmax sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06362291 id: 2023IR27 briefTitle: Comparison of MRI AI-cTB Versus Routine cTB in Prostate Cancer Diagnosis: a Prospective Randomized Controlled Trial overallStatus: RECRUITING date: 2023-08-01 date: 2024-07-31 date: 2025-04-30 date: 2024-04-12 date: 2024-04-12 name: Peking University First Hospital class: OTHER briefSummary: The goal of this clinical trial is to compare the cancer detection rates of MRI artificial intelligence-guided cTB (AI-cTB) and routine cTB, and explore the added value of using AI for the guidance of cTB. The main questions it aims to answer are:

Does AI-cTB promote the accurate diagnosis and treatment of prostate cancer? What's the value of prostate MRI artificial intelligence assistant diagnosis system in developing the best scheme of prostate biopsy? What's the value of prostate MRI artificial intelligence assistant diagnosis system in predicting the pathological results of prostate targeted biopsy?

Researchers will compare the cancer detection rates of AI-cTB and routine cTB to explore the added value of using AI for the guidance of cTB.

Participants will:

Receive AI-cTB or routine cTB. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 340 type: ESTIMATED name: MRI-AI guided cognitive prostate targeted biopsy name: Routine cognitive prostate targeted biopsy measure: The clinically significant prostate cancer (csPCa) detection rate for targeted biopsy (TB) and TB combined with systematic biopsy (SB) measure: The PCa detection rate measure: The Gleason score (GS) of the biopsy sample measure: The GS of radical prostatectomy (RP) specimens sex: MALE minimumAge: 45 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University First Hospital status: RECRUITING city: Beijing state: Beijing zip: 100034 country: China name: Baowei Zhang role: CONTACT phone: +86 83572466 email: bdyyll@126.com lat: 39.9075 lon: 116.39723 hasResults: False

 nctId: NCT06362278 id: 026 briefTitle: A Multi-omics Study of "Healthy" Premature CAD Patients overallStatus: RECRUITING date: 2024-03-20 date: 2025-12 date: 2025-12 date: 2024-04-12 date: 2024-04-12 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: The goal of this multi-center observational clinical trial is to investigate the genetic risk factors of patients with premature CAD and none traditional CAD risk factors through a multi-omics approach.

The main questions it aims to answer are:

* Genetic risk factors \& metabolic fingerprints of patients with premature CAD and none traditional CAD risk factors remain unknown.
* How to optimize current primary prevention strategy for this rare CAD subgroup？ conditions: Coronary Artery Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 160 type: ESTIMATED name: multi-omics studies measure: common & rare variants associated with "healthy" pre-mature CAD phenotype measure: Unique metabolomic fingerprints associated with "healthy" pre-mature CAD phenotype sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu zip: 210000 country: China name: Chunjian Li, Phd、MD role: CONTACT phone: +86 13701465229 email: lijay@njmu.edu.cn lat: 32.06167 lon: 118.77778 facility: Qilu Hospital of Shangdong University status: ACTIVE_NOT_RECRUITING city: Jinan state: Shandong zip: 250012 country: China lat: 36.66833 lon: 116.99722 facility: The Second Affiliated Hospital of Zhejiang University Medical College status: ACTIVE_NOT_RECRUITING city: Hangzhou state: Zhejiang zip: 310009 country: China lat: 30.29365 lon: 120.16142 hasResults: False

 nctId: NCT06362265 id: 18437 id: I8H-MC-BDDB type: OTHER domain: Eli Lilly and Company briefTitle: A Study to Evaluate Pharmacokinetics of LY3209590 in Pediatric Participants With Type 2 Diabetes Mellitus overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-11 date: 2026-11 date: 2024-04-12 date: 2024-04-19 name: Eli Lilly and Company class: INDUSTRY briefSummary: The main purpose of this study is to evaluate how much of LY3209590 gets into the blood stream after a single dose and how long it takes the body to remove it in pediatric participants with Type 2 Diabetes Mellitus (T2DM). The study will last for approximately 100 days. conditions: Type 2 Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 22 type: ESTIMATED name: LY3209590 measure: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3209590 measure: PK: Maximum Observed Plasma Concentration (Cmax) of LY3209590 measure: Change from Baseline in Fasting Glucose sex: ALL minimumAge: 10 Years maximumAge: 17 Years stdAges: CHILD facility: Honor Health Research Institute city: Scottsdale state: Arizona zip: 85258 country: United States lat: 33.50921 lon: -111.89903 facility: Children's Hospital Los Angeles city: Los Angeles state: California zip: 90027 country: United States lat: 34.05223 lon: -118.24368 facility: Children's Healthcare of Atlanta - Center for Advanced Pediatrics city: Atlanta state: Georgia zip: 30329 country: United States lat: 33.749 lon: -84.38798 facility: University of Louisville, Norton Children's Research Institute city: Louisville state: Kentucky zip: 40202 country: United States lat: 38.25424 lon: -85.75941 facility: Johns Hopkins University School of Medicine city: Baltimore state: Maryland zip: 21287 country: United States lat: 39.29038 lon: -76.61219 facility: Joslin Diabetes Center city: Boston state: Massachusetts zip: 02215 country: United States lat: 42.35843 lon: -71.05977 facility: UBMD Pediatrics city: Buffalo state: New York zip: 14203 country: United States lat: 42.88645 lon: -78.87837 facility: NYU Langone city: New York state: New York zip: 10016 country: United States lat: 40.71427 lon: -74.00597 facility: Cincinnati Children's Hospital Medical Center city: Cincinnati state: Ohio zip: 45229 country: United States lat: 39.12713 lon: -84.51435 facility: Children's Hospital of Philadelphia city: Philadelphia state: Pennsylvania zip: 19104 country: United States lat: 39.95233 lon: -75.16379 hasResults: False

 nctId: NCT06362252 id: DS7300-189 id: 2023-509629-36 type: OTHER domain: EU CT briefTitle: A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03) overallStatus: NOT_YET_RECRUITING date: 2024-06-17 date: 2026-11-30 date: 2026-12-30 date: 2024-04-12 date: 2024-04-12 name: Daiichi Sankyo class: INDUSTRY name: Merck Sharp & Dohme LLC briefSummary: This study is designed to evaluate the safety and efficacy of ifinatamab deruxtecan (I-DXd) in combination with immune checkpoint inhibitor (ICI) atezolizumab with or without carboplatin in participants with extensive stage-small cell lung cancer (ES-SCLC) in the first-line (1L) setting. conditions: Extensive Stage-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 149 type: ESTIMATED name: Ifinatamab deruxtecan name: Atezolizumab name: Carboplatin name: Etoposide measure: Number of Participants Reporting Dose-limiting Toxicities Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A) measure: Overall Number of Participants With Treatment-emergent Adverse Events Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Progression-free Survival As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Number of Participants With Objective Response Rate Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Duration of Response As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Disease Control Rate As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Clinical Benefit Rate as Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Time to Response As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Best Percentage Change in the Sum of Diameters (SoD) of Measurable Tumors As Assessed by Blinded Independent Central Review and Investigator Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Overall Survival Following I-DXd in Combination With Atezolizumab With or Without Carboplatin (Part A and B) measure: Pharmacokinetic Parameter Maximum Serum Concentration of I-DXd measure: Pharmacokinetic Parameter Time to Maximum Serum Concentration of I-DXd measure: Pharmacokinetic Parameter Area Under the Concentration Curve of I-DXd measure: The Number of Participants Who Are Anti-Drug Antibody (ADA)-Positive At Any Time and Who Have A Treatment-emergent Anti-Drug Antibody sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06362239 id: STUDY00003853 briefTitle: Prospective Home-Based Palliative Care and Hospice Study overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-10 date: 2027-10 date: 2024-04-12 date: 2024-04-12 name: Steven Smith class: OTHER name: Akron Children's Hospital name: Medical University of South Carolina name: Nemours Children's Hospital name: Baylor College of Medicine briefSummary: The purpose of this study is to test the hypothesis that the addition of home-based hospice and palliative care (HBHPC) will provide a reduction in health care utilization, improve quality of life, and facilitate goal-concordant care that is superior to inpatient and clinic pediatric palliative care (PPC) alone. conditions: Pediatric Palliative Care studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Study Surveys measure: Hospital Utilization Differences measure: Demographic Differences measure: Location of death differences sex: ALL maximumAge: 19 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06362226 id: HM20029491 briefTitle: OPTIMIZING OCULAR OUTCOMES: A DUAL-ARMED STUDY FOR PERIORBITAL BURN MANAGEMENT overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-08 date: 2026-10 date: 2024-04-12 date: 2024-04-12 name: Virginia Commonwealth University class: OTHER briefSummary: The purpose of this study is to evaluate the effectiveness in using subcutaneous 5-FU/Kenalog \& antibiotic ointment with vitamin E as different therapeutic adjuncts in the prevention of pathologic remodeling after periorbital burns. conditions: Periorbital Burns studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Steroid/Antibiotic name: 5-FU/Kenalog measure: Comparison of wound healing time measure: Comparison of infection rate measure: Comparison of complication rates measure: Comparison of pain level measure: Comparison of quality of life measure: Comparison of cosmetic outcome through the Vancouver scar scale (VSS) measure: Comparison of cosmetic outcome through the Patient Observer Scar Assessment Scale (POSAS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06362213 id: NL76924.029.22 briefTitle: Gaining Insight Into Dual Sensory Loss acronym: DSL overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-04 date: 2025-04 date: 2024-04-12 date: 2024-04-12 name: Amsterdam UMC, location VUmc class: OTHER name: Royal Dutch Visio briefSummary: The goal of this observational study is to explore difficulties in information access, mobility, communication and fatigue in people with combined vision and hearing impairments. The main question it aims to answer is:

• What influence do varying severities of vision and hearing loss have on information access, mobility, communication and fatigue.

Participants will fill out questionnaires and the researchers will measure their vision and hearing functions. conditions: Dual Sensory Impairment of Vision and Hearing studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 300 type: ESTIMATED measure: information access measure: mobility measure: communication measure: fatigue sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Amsterdam UMC, location VUmc city: Amsterdam state: Noord Holland zip: 1081 HV country: Netherlands lat: 52.37403 lon: 4.88969 hasResults: False

 nctId: NCT06362200 id: LYG20230083 briefTitle: The Validation and Biological Index Studies on the Improved Social Function of ASD by 40 Hz tACS overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2028-12-31 date: 2028-12-31 date: 2024-04-12 date: 2024-04-12 name: Central South University class: OTHER briefSummary: In this proposed study, tACS will be used to intervene in the autism spectrum disorders of children and adolescents, and the efficacy of this intervention method will be evaluated, as well as the internal mechanism of adolescents' autism spectrum disorders will be discussed. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: 40 Hz tACS intervention measure: Autism assessment assessment index measure: EEG physiological detection index measure: Magnetic resonance detection index measure: Eye movement index measure: Emotion recognition index measure: Understanding of social interaction index measure: Understanding of thoughts and intentions index measure: Social Communication Changes index measure: Stereotyped behavior index measure: Sensory index measure: Abnormal behavior indicator measure: Sleep index measure: Plasma Metabolite Levels Assessment measure: Safety evaluation SAFTEE indicator sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False

 nctId: NCT06362187 id: STUDY00003238 briefTitle: VR Pilot for Pancreatitis overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2026-05 date: 2024-04-12 date: 2024-04-12 name: Cedars-Sinai Medical Center class: OTHER briefSummary: The purpose of the research is to test the feasibility and preliminary impact of a home-based, standardized, gut-directed, virtual reality cognitive behavioral therapy (VR CBT) on clinical and functional outcomes of patients with chronic pancreatitis (CP) and recurrent acute pancreatitis (RAP) pain. The primary research procedures are questionnaires and biometric Fitbit data. The study will enroll adult patients with CP or RAP. conditions: Chronic Pancreatitis conditions: Recurrent Pancreatitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, double-blind, controlled primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Gut Directed VR name: Sham Control VR measure: Feasibility of home-based VR measure: Impact of home-based VR sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marissa Podell city: Los Angeles state: California zip: 90048 country: United States lat: 34.05223 lon: -118.24368 hasResults: False

 nctId: NCT06362174 id: SHEBA-22-9902-SBH-CTIL briefTitle: Capsule & Omics for pRedicting Exacerbation of Crohn's Disease acronym: CORE-CD overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-07 date: 2025-12-31 date: 2025-12-31 date: 2024-04-12 date: 2024-04-12 name: Sheba Medical Center class: OTHER_GOV briefSummary: The research group have previously evaluated the benefit of serial consecutive capsule endoscopy as monitoring tool for Crohn's disease in remission, demonstrating its superior accuracy for disclosing inflammation and for prediction of flares in comparison to other diagnostic modalities such as magnetic resonance enterography and inflammatory biomarkers. Subsequently, deep learning algorithms had developed to provide excellent accuracy for identification and grading of ulcers and intestinal strictures on capsule endoscopy still images. The investigators will advance this knowledge using a parallel two-parts approach. conditions: Crohn's Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 62 type: ACTUAL measure: Crohn's Disease Activity Index score (CDAI) measure: Disease related complications measure: disease related hospitalization measure: Change of crohn's disease medications measure: opinion of the principle investigator (PI) or the treating physician measure: The rate of clinical flare accompanied by objective signs of mucosal inflammation. measure: The rate of inflammatory worsening with/without accompanying clinical symptoms sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sheba Medical Center city: Tel-Hashomer country: Israel lat: 32.04195 lon: 34.85623 hasResults: False

 nctId: NCT06362161 id: IRB-300011066 briefTitle: Establishment of an Interdisciplinary Functional Neurological Disorder (FND) Treatment Program and Development of a Clinical Care Pathway for FND overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-05-01 date: 2028-12-31 date: 2024-04-12 date: 2024-04-12 name: University of Alabama at Birmingham class: OTHER briefSummary: The purpose of this study is to help providers develop an interdisciplinary treatment pathway for functional neurological disorder (FND) at University of Alabama at Birmingham (UAB), and will involve psychiatry, speech therapy, physical therapy, and occupational therapy. The study will also help providers to evaluate the treatment pathway and publish results regarding the process and outcomes. conditions: Functional Neurological Disorder conditions: Convulsion, Non-Epileptic conditions: Functional Seizure studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 1100 type: ESTIMATED measure: Patient Demographic Information measure: Hospital Anxiety and Depression Scale (HADS) measure: ASM 121 functional assessment definitions measure: SF-36 (subjective health and wellbeing) measure: Work and Social Adjustment Scale (WSAS) measure: Patient Health Questionnaire 15 measure: Dizziness Handicap Inventory measure: Dizziness Symptom Profile measure: Adult Tic Questionnaire (ATQ) measure: Child Self-Report Tic Questionnaire measure: Parent Tic Questionnaire (PTQ) measure: Seizure Questionnaire measure: Level 2-Somatic Symptom report measure: Revised Children's Anxiety and Depression Scale (RCADS) measure: Functional Disability Inventory (FDI) measure: Impact on the Family Scale measure: Pediatric Quality of Life (Peds-QL) measure: Healthcare Utility Questionnaire measure: Assessment of control over symptoms sex: ALL minimumAge: 8 Years maximumAge: 89 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama at Birmingham city: Birmingham state: Alabama zip: 35294 country: United States name: Michelle Bumpers role: CONTACT lat: 33.52066 lon: -86.80249 hasResults: False

 nctId: NCT06362148 id: 1-10-72-134-23 briefTitle: Circulating Tumor DNA in Peripheral T-cell Lymphomas acronym: CIRCULATE overallStatus: RECRUITING date: 2024-03-01 date: 2026-12-31 date: 2030-12 date: 2024-04-12 date: 2024-04-22 name: University of Aarhus class: OTHER name: Aarhus University Hospital briefSummary: The aim of this study is to evaluate the feasibility of circulating tumor DNA (ctDNA) measurement in blood plasma for the applicability in prognostication, treatment evaluation and measurable residual disease (MRD) surveillance in a cohort of patients with newly diagnosed or relapsed/refractory peripheral T-cell lymphomas (PTCL). conditions: Peripheral T-cell Lymphoma conditions: NK/T-Cell Lymphoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Tumor- and plasma-informed, next-generation sequencing (NGS)-based patient-specific droplet digital (dd)PCR assay name: 18F-fludeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) measure: ctDNA occurrence measure: ctDNA quantification measure: Progression free survival measure: Overall survival measure: Radiographic assessment by PET/CT measure: Comparison of molecular and radiographic response measure: Spatial and temporal mutational homo- or heterogeneity measure: Fragment pattern analysis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Hematology, Aarhus University Hospital status: RECRUITING city: Aarhus state: Central Denmark Region zip: 8200 country: Denmark name: Patrick R Noerhave, MD role: CONTACT phone: +4551543715 email: panoer@rm.dk name: Francesco A d'Amore, MD, DMSc role: CONTACT phone: +4523708527 email: frandamo@rm.dk name: Patrick R Noerhave, MD role: PRINCIPAL_INVESTIGATOR name: Martin B Pedersen, MD, PhD role: SUB_INVESTIGATOR name: Francesco A d'Amore, MD, DMSc role: SUB_INVESTIGATOR lat: 56.15674 lon: 10.21076 hasResults: False

 nctId: NCT06362135 id: 0733 briefTitle: Virtual Home Visits for Stroke Patients and Their Caregivers acronym: INHABASAEV overallStatus: RECRUITING date: 2023-08-01 date: 2024-12-01 date: 2025-03-01 date: 2024-04-12 date: 2024-04-15 name: The Scientific and Technological Research Council of Turkey class: OTHER briefSummary: The primary aim of this study is to evaluate the effectiveness of virtual home care for stroke patients and their caregivers. The secondary purpose is to evaluate the usability of the application by developing a mobile application for use in virtual home visits.

The study will be carried out using the mixed research model, in which quantitative and qualitative methods are used together. The population of the research will consist of patients and caregivers with the diagnosis of hemorrhage, infarction, cerebrovascular accident and cerebral infarction, who applied to the Antalya Provincial Health Directorate Antalya Training and Research Hospital Home Health Unit, where the study is planned to be conducted. The sample of the study will consist of stroke patients and caregivers who meet the criteria for inclusion in the study. The first phase of the study was designed as a parallel group, single center and single blind randomized controlled trial to evaluate the effectiveness of virtual home visits in terms of time, cost and caregiver competence. The experimental group was the patient/patient relative group who made a virtual home visit, the control group will consist of 48 patients/patient relatives who have been visited face-to-face. In the second phase of the study, semi-structured interview method will be used to determine the views of patients/patient relatives about virtual home visits. In order to evaluate the usability of the developed application, a usability survey will be applied to the group that has visited the virtual home.

With the results of this study, telemedicine applications in home care services will help to increase accessibility to home care services and reduce health care costs.considered to contribute. At the same time, it is expected that the results of the study will contribute to the scientific literature in the field of design and application of telemedicine services, which are developing and spreading conditions: Stroke conditions: Caregiver conditions: Virtual conditions: Home Visit studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment Virtual visit with stroke patient and their caregiver primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: Telephone support or virtual meeting during the research process will be provided by an independent interviewer. whoMasked: OUTCOMES_ASSESSOR count: 96 type: ESTIMATED name: Virtual Home Visit name: Control Group measure: Effect of Virtual and Face to face to home visit measure: Level of competence of stroke caregiver measure: Frequency of unplanned hospital readmission measure: Effect of the virtual home visit sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Yasemin Demi̇r Avci̇ status: RECRUITING city: Antalya zip: 07058 country: Turkey name: Yasemin Demir Avcı, PhD role: CONTACT phone: +905514028492 email: ydemir@akdeniz.edu.tr lat: 36.90812 lon: 30.69556 hasResults: False

 nctId: NCT06362122 id: PREDICTO-POLYP briefTitle: Anatomo-clinico-biological Profiles in Severe Nasal Polyps overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2026-10-01 date: 2024-04-12 date: 2024-04-12 name: Poitiers University Hospital class: OTHER briefSummary: Nasal sinus polyposis is a chronic inflammatory pathology of the nasal cavity and sinus cavities that causes bilateral and multifocal polyp development and has a prevalence of 2 to 4% in the general population.

Therapeutic management consists of first-line medical treatment for anti-inflammatory purposes. Local corticosteroid therapy, using nasal sprays, is the background treatment. Surgical management is offered to patients in case of failure of medical treatment. Although effective, surgery does not protect patients from recurrence of symptoms related to regrowth of polyps. Recently, biologics have appeared, which despite its effectiveness, about 20% of patients have a partial or no response to these treatments. There is currently no possibility of determining the probability of response to treatments in patients.

It is therefore essential to determine an anatomo-clinico-biological correlation associating the anatomopathological profile, the clinical characteristics and the cytokine signature in order to best guide the patient's management, including the initiation of biotherapy. Indeed, patients, according to their clinical, biological characteristics and the cytokine signature of their polyps will react differently to different treatments, including surgery and biotherapy. This correlation will serve as a predictor of treatment response. conditions: NASAL POLYPS studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 200 type: ESTIMATED name: identification anatomo-clinico-biological profiles measure: Identify anatomical profiles present in nasal sinus polyposis resistant to medical treatment. measure: Evaluation of symptoms related to nasal sinus polyposis by visual analogue scale measure: Evaluation to quality of life by Sino-Nasal Outcome Test measure: Identify biological profiles for patients with nasal sinus polyposis measure: Evaluation to cytokine concentration in serum for patients with nasal sinus polyposis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06362109 id: Once tubefeeding briefTitle: The Impact of Intermittent Nutritional Tube Supplementation in Elderly Patients With Dysphagia overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-04-12 date: 2024-04-12 name: Zhao Song Ling class: OTHER_GOV briefSummary: This is a prospective, randomized controlled clinical trail involved Elderly Patients With Dysphagia.The goal of this clinical trial is to compare the clinical effect of Intermittent Oro-esophageal Tube Feeding in Elderly Patients With Dysphagia. The main questions it aims to answer:

Can Intermittent Nutritional Tube Supplementation help improve the nutritional status in Elderly Patients With Dysphagia.

Participants will be divided into two groups randomly. All patients are given routine rehabilitation and the intervention group is given Intermittent Oro-esophageal Tube Feeding once a day. conditions: Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Routine rehabilitation name: Intermittent Oro-esophageal Tube Feeding measure: Nutritional status-prealbumin measure: Nutritional status-albumin measure: Nutritional status-hemoglobin sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06362096 id: pyrotinib diarrhra briefTitle: A Multicenter, Prospective Study of Diarrhea Tolerance of Pyrotinib Combined With Trastumab and Taxane in the First-line Treatment of HER2-positive Advanced Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2026-05 date: 2024-04-12 date: 2024-04-12 name: Huihua Xiong class: OTHER briefSummary: To explore a reasonable and effective way to reduce the incidence of grade 3 or above diarrhea caused by pyrotinib conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 72 type: ESTIMATED name: Trastuzumab+pyrotinib+taxene measure: Incidence of ≥ grade 3 diarrhea sex: ALL minimumAge: 17 Years maximumAge: 75 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06362083 id: 34-317 ex 21/22 briefTitle: Urethral Stricture Database overallStatus: RECRUITING date: 2024-01-15 date: 2034-01-15 date: 2034-03-15 date: 2024-04-12 date: 2024-04-12 name: Medical University of Graz class: OTHER briefSummary: Establishment of a clinical urethral stricture database for a prospective longitudinal cohort study. conditions: Urethral Stricture studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Questionnaires and data collection measure: Success rate of urethral reconstructive surgeries measure: Complications of urethral reconstructive surgeries measure: Sexual function after urethral reconstructive surgeries measure: Health status after urethral reconstructive surgeries sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Röthl Martina Anna status: RECRUITING city: Graz state: Styria zip: 8036 country: Austria name: Marianne Leitsmann, Prof. Dr. role: CONTACT phone: +43 316 385 80550 email: martina.roethl@medunigraz.at name: Marianne Leitsmann, Prof. Dr. role: PRINCIPAL_INVESTIGATOR lat: 47.06667 lon: 15.45 hasResults: False

 nctId: NCT06362070 id: COMPAR-G briefTitle: Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy overallStatus: RECRUITING date: 2024-01-31 date: 2024-03-30 date: 2025-07-31 date: 2024-04-12 date: 2024-04-12 name: Azienda Ospedaliera Universitaria Integrata Verona class: OTHER briefSummary: The object of this exploratory clinical trial is to evaluate intra and post-operative complications in a population that underwent Robotic Gastrectomy, with multiple platforms:

* DaVinci;
* Hugo;
* Versius.

This study is divided into two phases: in the first phase, gastrectomy will be performed using both the new platforms (Hugo and Versius) and the standard platform (Da Vinci), to evaluate the feasibility of the surgical procedure. In the second phase, the three platforms will be compared to evaluate any differences in the learning curve for an upper-GI surgeon, expert in laparoscopic surgery but not with robotic one.

The questions it aims to answer are:

* Are differences (intra-operative, post-operative, oncological, functional, technical, and economic) among the three different platforms observable?
* Are there any differences between the three platforms related to the learning curve for surgeons?

Participants will be enrolled, after obtaining informed consent, in one of the following cohorts:

1. surgery with the daVinci platform;
2. surgery with the Hugo platform;
3. surgery with the Versius platform. conditions: Gastric Cancer conditions: Gastrointestinal Cancer conditions: Neoplasms conditions: Gastric Diffuse Adenocarcinoma conditions: Gastric Neoplasm conditions: Stomach Adenocarcinoma studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 75 type: ESTIMATED name: DaVinci® Surgical System name: Hugo™ RAS System name: Versius® Robotic Surgery System measure: Conversion rate to open or laparoscopic approach (Phase 1) measure: Number of participants with major intraoperative complications (Phase 1) measure: Evaluation of surgical times of the standardized procedures (Phase 2) measure: Analysis of video of surgical procedures (Phase 2) measure: Estimated Blood Loss measure: Overall duration of the surgery measure: Anesthesia, Lymphadenectomy, Gastrectomy (10 different surgical steps) measure: Number of participants with major postoperative complications measure: Compliance rate to ERAS protocol measure: Postoperative hospitalization measure: Postoperative pain measure: Re-admission rate to hospitalization measure: Damage due to positioning measure: Positive Surgical Margin measure: Lymph nodes resection measure: Quality of Life Evaluation measure: Time taken for platform-related technical steps measure: Possible malfunction of the platform measure: Non-Technical Skills Assessment (NTS) demonstrated by members of the surgical team during the intraoperative phase. measure: Procedure-related costs sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: General and Upper GI Unit status: RECRUITING city: Verona zip: 37126 country: Italy name: Simone SG Giacopuzzi, MD, Prof role: CONTACT phone: +39 0458127510 email: simone.giacopuzzi@univr.it name: Simone Giacopuzzi, MD, Prof role: PRINCIPAL_INVESTIGATOR name: Maria Bencivenga, MD, Prof role: SUB_INVESTIGATOR lat: 45.4299 lon: 10.98444 hasResults: False

 nctId: NCT06362057 id: ADMNF-0020324 briefTitle: Biomechanical Effects of Digitally Constructed Subperiosteal Implants overallStatus: RECRUITING date: 2024-04-04 date: 2024-06-20 date: 2024-07-27 date: 2024-04-12 date: 2024-04-12 name: Menoufia University class: OTHER briefSummary: Subperiosteal implants were first introduced in 1940 and then used worldwide for the treatment of edentulous maxilla or mandible with advanced bone atrophy. conditions: Bone Loss studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 9 type: ESTIMATED name: Subperiosteal implant framework measure: bone loss under the implants sex: ALL minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mohammed A. El-Sawy status: RECRUITING city: Mansoura zip: 12345 country: Egypt name: Mohammed A. El-Sawy, PhD role: CONTACT phone: 161314522 email: Dr_sawy@windowslive.com name: PhD role: CONTACT lat: 31.03637 lon: 31.38069 hasResults: False

 nctId: NCT06362044 id: P24-120 briefTitle: A Study to Assess Frequency of Undetectable Minimal Residual Disease (uMRD) in Adult Participants With Chronic Lymphocytic Leukemia (CLL) Receiving Oral Venetoclax Tablets ± Intravenously (IV) Infused Rituximab in Routine Clinical Practice in Japan overallStatus: RECRUITING date: 2023-06-07 date: 2024-12-31 date: 2024-12-31 date: 2024-04-12 date: 2024-04-12 name: AbbVie class: INDUSTRY briefSummary: Most cases of Chronic lymphocytic leukemia (CLL) remain an incurable disease with the goal of therapy being to improve quality of life and to prolong survival. This study will evaluate the participant's related outcomes and experience of CLL in adult participants who are treated in the Japan.

Study participants will receive oral treatments of Venetoclax±Rituximab for CLL as prescribed by their study doctor in accordance with approved local label. Adult participants prescribed various treatments Venetoclax±Rituximab will be enrolled. Around 89 participants will be enrolled in the study in sites in Japan.

Participants will receive oral venetoclax tablets ± intravenously (IV) infused rituximab treatments for CLL according to the approved local label. The overall study duration will be 27 months.

There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice. conditions: Chronic Lymphocytic Leukemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 89 type: ESTIMATED measure: Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center Hospital East /ID# 265970 status: RECRUITING city: Kashiwa state: Chiba zip: 277-8577 country: Japan lat: 35.86224 lon: 139.97732 hasResults: False

 nctId: NCT06362031 id: H18.Oncology.12-SR1812 briefTitle: A Study to Explore Treatment Patterns, Treatment Outcomes, Healthcare Resource Utilization in Adult Participants With Acute Myeloid Leukemia (AML) Receiving Venetoclax Through Chart Review overallStatus: WITHDRAWN date: 2023-06-01 date: 2024-04-30 date: 2024-04-30 date: 2024-04-12 date: 2024-04-12 name: AbbVie class: INDUSTRY briefSummary: Acute myeloid leukemia (AML), also referred to as acute myelogenous leukemia or acute non-lymphocytic leukemia, is a relatively rare, yet aggressive, type of cancer. This study will evaluate treatment patterns, treatment outcomes, healthcare resource utilization in adult participants with AML receiving venetoclax.

Data from up to 700 participants will be collected. No participants will be enrolled in this study.

Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the observation period is up to 10 months.

There is no additional burden for participants in this trial. All visits must be completed prior to data extraction and participants will be followed for up to 10 months. conditions: Acute Myeloid Leukemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 0 type: ACTUAL measure: Overall Survival (OS) measure: Event-free survival (EFS) measure: Percentage of Participants Achieving Best Overall Response measure: Duration of Response (DoR) measure: Percentage of Participants with Transfusion Independence (TI) measure: Number of Participants with Healthcare Resource Utilization (HRU) sex: ALL minimumAge: 18 Years maximumAge: 89 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06362018 id: MHC/CT/23-24/055 id: MHC/CT/23-24/055, Version No.: type: OTHER domain: Mprex Healthcare Pvt. Ltd. briefTitle: Bioavailability of Three Mitopure Formulations overallStatus: NOT_YET_RECRUITING date: 2024-04-09 date: 2024-05-31 date: 2024-06-30 date: 2024-04-12 date: 2024-04-12 name: Amazentis SA class: INDUSTRY name: Mprex Healthcare Pvt. Ltd. briefSummary: This study's design as an open-label, single-dose, randomized trial that aligns with the objective of characterizing the concentration-time profiles of three Urolithin A (Mitopure) formulations in a controlled setting. The inclusion criteria, stringent fasting requirements, standardized fluid intake and strict dietary restriction protocols ensure homogeneity among the study participants, enhancing the reliability of the outcomes.

Ultimately, this clinical trial aims to contribute valuable insights into the pharmacokinetic behavior of the different Urolithin A formulations, facilitating informed decisions for future developments and applications in the realm of health and wellness. conditions: Healthy Adults studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 36 type: ESTIMATED name: Mitopure (Urolithin A) measure: Plasma concentrations of Urolithin A over time and maximal plasma concentration (Cmax) measure: Exposure to Urolithin A over time measured as area under the curve (AUC) measure: Number of adverse events and serious adverse events throughout the study. sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Lokmanya Medical Research Centre and Hospital city: Pune zip: 411033 country: India name: Dr Ramshyam Agarwal, MD role: CONTACT lat: 18.51957 lon: 73.85535 hasResults: False

 nctId: NCT06362005 id: AUAREC2023011-1 briefTitle: The Efficacy of Selenium as an Alternative or Complementary Topical Treatment of Oral Lichen Planus acronym: RCT overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2024-10-01 date: 2025-03-01 date: 2024-04-12 date: 2024-04-23 name: Al-Azhar University class: OTHER name: Sphinx university briefSummary: evaluate clinically and biochemically the efficacy of topically applied selenium as complementary or alternative to triamcinolone acetonide 0.1% and tacrolimus 0.1% in patients with oral lichen planus. conditions: Lichen Planus, Oral studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: Triamcinolone Acetonide 0.1% Oint name: Tacrollimus Topical name: Selenium name: Selenium & Triamcinolone Acetonide 0.1% Oint name: Selenium& Tacrollimus topical measure: to assess a visual analog scale (VAS)of the oral lichen planus lesion measure: to assess The associated Oral Disease Severity Score 3- Glutathione biomarker level as an antioxidant enzyme in saliva by ELISA analysis measure: Biochemical evaluation of salivary Glutathione level using (ELISA) sex: ALL minimumAge: 20 Years maximumAge: 55 Years stdAges: ADULT facility: Alazhar university ,faculty of Dental Medicine city: Assiut zip: 0000 country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False

 nctId: NCT06361992 id: BC_SERBIA_2022 briefTitle: Efficacy and Safety of Blue Cap for the Treatment of Atopic Dermatitis in Children overallStatus: COMPLETED date: 2022-03-15 date: 2023-09-15 date: 2024-02-13 date: 2024-04-12 date: 2024-04-15 name: Catalysis SL class: INDUSTRY briefSummary: To verify the efficacy and tolerability of Activated Piroctone Olamine (Blue Cap Foam, label volume 100 ml) by CATALYSIS, S. L. Madrid, applied in the management of all types of dermatitis (atopic, seborrheic, eczema) in patients with significant manifestations of the disease in varying areas of the body of varying extent and to assess differences in individual tolerability and the final effect in a group of selected patients aged 3 to 18 years. conditions: Atopic Dermatitis conditions: Atopic Dermatitis and Related Conditions conditions: Atopic Dermatitis Eczema conditions: Atopic Dermatitis \(AD\) studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 58 type: ACTUAL name: Blue Cap Foam measure: Grade of Patient Tolerability to the investigation product measure: Clinical Improvement of Patients with Dermatitis measure: Clinical assessment of symptoms and sings associated with Dermatitis measure: Evaluation of the therapeutic effect of Blue Cap in paediatric patients with dermatitis. measure: Evaluation of the therapeutic effect of Blue Cap on healing of the skin at the patients sex: ALL minimumAge: 3 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: University of Niš Faculty of Medicine, Department of Dermatology and Venereology, University Clinical Center of Niš city: Niš state: Nišava zip: 18108 country: Serbia lat: 43.32472 lon: 21.90333 facility: City Institute for Skin and Venereal Diseases Belgrade city: Belgrade zip: 11000 country: Serbia lat: 44.80401 lon: 20.46513 facility: University of Belgrade Faculty of Medicine, University Clinical Center of Serbia city: Belgrade zip: 11000 country: Serbia lat: 44.80401 lon: 20.46513 hasResults: False

 nctId: NCT06361979 id: A1811 briefTitle: SHR-A1811 Combined With Bevacizumab in HER2-positive Breast Cancer With Brain Metastases overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2026-05 date: 2024-04-12 date: 2024-04-12 name: Huihua Xiong class: OTHER briefSummary: This study aimed to evaluate the use of SHR-A1811 and bevacizumab in HER2-positive Breast Cancer with brain metastases conditions: Breasr Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: SHR-A1811 name: Bevacizumab measure: CNS-ORR measure: PFS measure: ORR measure: AE sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

 nctId: NCT06361966 id: 2021/00638 briefTitle: Evaluating User Satisfaction and Feasibility of a Remote Model for 3d Scanned and Printed Transtibial Prosthetic Sockets overallStatus: COMPLETED date: 2022-01-11 date: 2023-01-09 date: 2023-01-09 date: 2024-04-12 date: 2024-04-12 name: Tan Tock Seng Hospital class: OTHER name: Prosfit Technologies JSC name: Centre for Allied Health and Pharmacy Excellence (CAPE) briefSummary: The goal of this clinical trial is to investigate the repeatability of application of a fully remote method of manufacturing 3D printing of prosthetic sockets for transtibial amputees, and determine user satisfaction of sockets produced through these methods. The study also aims to evaluate the time and cost effectiveness of this production model.

The main question\[s\] it aims to answer are:

1. To determine the repeatability and user satisfaction with transtibial sockets produced using a remote-digital method as compared to conventional manufacturing methods.
2. To determine if transtibial prosthetic users have greater prosthetic satisfaction scores across the 4 Prosthesis Evaluation Questionnaire (PEQ) subscales of Utility (UT), Appearance (AP), Sounds (SO) and Residual Limb Health (RL) with the 3D printed socket fabricated through the remote-digital method compared to the laminate socket made using the conventional method.
3. To determine if transtibial prosthetic users experience greater socket comfort with the 3D printed socket compared to the laminate socket.

Participants will receive a 3D printed socket (trial intervention) and a laminate socket (control intervention) and will use each socket for a period of 4 weeks.The order of socket use will be randomised. At the end of each 4 week period, participants will rate their comfort and satisfaction with the socket. At the end of the trial, participants will indicate their preferred socket, which will be fitted to their prosthesis.

Participants will attend 6 visits across a total duration of 11 weeks during the course of the study. conditions: Amputation conditions: Prosthesis User studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 16 type: ACTUAL name: 3d printed prosthetic socket measure: Prosthesis Evaluation Questionnaire measure: Socket Comfort Score sex: ALL minimumAge: 21 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tan Tock Seng Hospital city: Singapore zip: 308433 country: Singapore lat: 1.28967 lon: 103.85007 hasResults: False

 nctId: NCT06361953 id: IR.SBMU.MSP.REC. 1401. 161 briefTitle: Comparing the Efficacy of Two Neurofeedback Protocols for Generalized Anxiety Disorder overallStatus: COMPLETED date: 2022-06-01 date: 2023-07-01 date: 2023-07-01 date: 2024-04-12 date: 2024-04-12 name: Shahid Beheshti University of Medical Sciences class: OTHER briefSummary: Generalized anxiety disorder (GAD) is one of the most prevalent mental disorders in adults, marked by excessive and uncontrollable worry about various events or activities. It is accompanied by symptoms such as restlessness, irritability, fatigue, difficulty concentrating, problems with sleep, and somatic symptoms.

In addition, a critical and up-to-date comparison of different treatments for GAD is crucial due to their high costs and unsatisfactory outcomes. EEG neurofeedback training has not reached the same level of evidence as more extensively validated non-pharmacological treatments, such as cognitive behavioral therapy.This study aimed to compare the efficacy of two protocols: one targeting alpha-theta amplitude increase and the other concentrating on SMR. conditions: Generalized Anxiety Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ACTUAL name: EEG Neurofeedback measure: The Beck Anxiety Inventory measure: The Perceived Stress Questionnaire measure: Spielberger's state-trait anxiety test sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shahid Beheshti University of Medical Science city: Tehran zip: 4739-19395 country: Iran, Islamic Republic of lat: 35.69439 lon: 51.42151 hasResults: False

 nctId: NCT06361940 id: IIT-CHAUDHARY-ENDOCRINE2-OPP briefTitle: Molecular Analyses to Identify Pathways of Endocrine Resistance Following Short Term Neoadjuvant Endocrine Treatment in Patients With Hormone Receptor-Positive HER2-negative Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2028-12 date: 2029-12 date: 2024-04-12 date: 2024-04-15 name: Medical College of Wisconsin class: OTHER briefSummary: This is an exploratory phase II interventional study that initiates standard-of-care anti-estrogen treatment preoperatively for 4-12 weeks (+/- 2 weeks). conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Aromatase inhibitors or tamoxifen measure: Change from baseline in the number of subjects with increased HER-1 receptor tyrosine kinases protein expression in tumors. measure: Change from baseline in the number of subjects with increased HER-2 receptor tyrosine kinases protein expression in tumors. measure: Change from baseline in the number of subjects with increased HER-3 receptor tyrosine kinases protein expression in tumors. measure: Change from baseline in the number of subjects with increased HER-4 receptor tyrosine kinases protein expression in tumors. sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Froedtert Hospital and the Medical College of Wisconsin city: Milwaukee state: Wisconsin zip: 53226 country: United States name: Lubna N Chaudhary, MD role: CONTACT email: lchaudhary@mcw.edu lat: 43.0389 lon: -87.90647 hasResults: False

 nctId: NCT06361927 id: SSGJ-707-NSCLC-II-01 briefTitle: A Phase II Study of SSGJ-707 Monotherapy in First-line PD-L1 Positive Advanced NSCLC Patients overallStatus: RECRUITING date: 2024-05 date: 2025-06 date: 2025-07 date: 2024-04-12 date: 2024-04-12 name: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. class: INDUSTRY briefSummary: This study includes two cohorts, cohort A is for non-squamous NSCLC and cohort B is for squamous NSCLC. conditions: NSCLC studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: SSGJ-707 measure: ORR measure: Safety and tolerability sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Hunan Cancer Hospital status: RECRUITING city: Changsha state: Hunan country: China name: Lin Wu, MD,Ph.D role: CONTACT phone: 0731-89762302 email: wulin-calf@vip.163.com lat: 28.19874 lon: 112.97087 hasResults: False

 nctId: NCT06361914 id: 2314393 briefTitle: Digital CBT-I for Patients With Chronic Pain and Insomnia acronym: Back2Sleep overallStatus: RECRUITING date: 2024-04-12 date: 2026-03-01 date: 2026-09-01 date: 2024-04-12 date: 2024-04-18 name: Odense University Hospital class: OTHER name: Aarhus University Hospital name: University of Southern Denmark name: University of Aarhus name: Odense Patient Data Explorative Network name: T&W Engineering A/S briefSummary: Chronic pain constitutes an increasing health and social burden. More than 50% of patients with chronic pain report insomnia, and patients with comorbid insomnia often report stronger and widespread pain, compared to those who are sleeping well. Sleep disturbances are often considered a consequence to chronic pain. This means that insomnia is often overlooked or ineffectively managed with hypnotics or advice on sleep hygiene. Therefore, efficacious, easily accessible, and safe alternatives to the current pharmacological treatments for patients with chronic pain and insomnia are needed. Cognitive behavioral therapy for insomnia (CBT-I) is a cost-effective and safe treatment for insomnia and is recommended as first-line treatment. While highly efficacious, the challenge is to deliver CBT-I to those in need. The main barriers of face-to-face delivered CBT-I are availability of trained therapists, costs, as well as physical and geographical constraints.

The primary aim of this randomized controlled clinical superiority trial is to investigate whether digitally-delivered CBT-I has a greater effect on insomnia and pain than digitally-delivered sleep hygiene education in patients with chronic pain and comorbid insomnia.

Secondary objectives are to a) explore whether the pain-relieving effect is mediated by a change in physiological markers of sleep quality, b) whether health care cost and use of medications at 12 months are reduced after digital CBT-I, and c) to explore the effectiveness of digital CBT-I compared with sleep hygiene education on: